Science and Litigation: Products Liability in Theory and Practice

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Author: Terrence F. Kiely

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science and litigation: products liability in theory and practice

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science and litigation: products liability in theory and practice Terrence F. Kiely

CRC Press Boca Raton London New York Washington, D.C.

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Library of Congress Cataloging-in-Publication Data Kiely, Terrence F. Science and litigation : products liability in theory and practice / Terrence F. Kiely. p. cm. Includes bibliographical references and index. ISBN 0-8493-0025-8 (alk. paper) 1. Products liability—United States. 2. Actions and defenses—United States. 3. Forensic sciences—United States. 4. Science—Law and legislation—United States. 5. Products liability—United States—Legal research. I. Title. KF8925.P7 K543 2002 346.7303′8—dc21

2002017435

This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe.

Visit the CRC Press Web site at www.crcpress.com © 2002 by CRC Press LLC No claim to original U.S. Government works International Standard Book Number 0-8493-0025-8 Library of Congress Card Number 2002017435 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed on acid-free paper

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Dedication

This book is dedicated to my sister, Peggy Pisani. All my love. Thanks one more time for all the countless ways that you have enriched my life.

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For without Victory at the Trial, to what Purpose is the Science of the Law? The Judge can give no Sentence, no decision without it, and must give Judgement for that Side the Trial goes; therefore I may well say, tis the chief Part of the Practice of the Law. And if so, to whom shall I offer this Treatise, but to you the Practisers? — Giles Duncombe, Trails Per Pais, or the Law of England Concerning Juries by Nisi Prius (1725)

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Acknowledgments

The author wishes to thank again Dean Terri Foster of the DePaul University, College of Law, for her gracious and ongoing support during the research and writing of this book. Her support for this book and its companion volume Forensic Evidence: Science and the Criminal Law (CRC Press, 2000), has made this considerable undertaking possible. Many thanks to Becky McEldowney of CRC Press. She had the faith in the project and has gotten me through its metamorphosis with friendship, patience, and good humor. My greatest debt is to my students at DePaul University College of Law to whom I have had the privilege of teaching Torts and especially, Products Liability over these many years. Heartfelt thanks also to one of America’s premier litigators, Robert A. Clifford, for his high standards and example, and the many opportunities he provided to me to engage in the actual practice in this most exciting area of law. It goes without saying that my true reason for accomplishing anything, has, as always, been my wife, Sidni. The arrival into the world of our granddaughter, Ms Emma Jane Kiely, in April of 2001, has cheered and encouraged us beyond my ability to express. Thanks also for the constant good cheer, encouragement, and friendship of the Middle Fork gang in the Bighorn Mountains in Wyoming.

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The Author

Terrence F. Kiely is a Professor of Law and the Director of the DePaul University College of Law’s Center for Law and Science. Professor Kiely graduated from Loyola University (Chicago) (B.S. Humanities) in 1964, DePaul University College of Law (Juris Doctor) in 1967 and also received an LL.M (Foreign and Comparative Law) from New York University School of Law in 1970. Professor Kiely is an expert in the area of the interaction between science and the civil and criminal law. He is the author of four previous books: Preparing Products Liability Cases (John Wiley & Sons 1987) Using Litigation Databases (John Wiley & Sons 1989) Modern Tort Litigation (John Wiley & Sons 1990) Forensic Evidence: Science and the Criminal Law (CRC Press, 2001) Professor Kiely has been a full time member of the DePaul University College of Law faculty since 1972. He teaches in the areas of Torts, Products Liability, Criminal Law, Evidence and Forensic Evidence. During the academic years 1995-1996 he was the Robert A. Clifford Professor of Tort Law and Public Policy. His work with the Center for Law and Science involves the maintenance of a comprehensive law and science Web site and organizing and participating in forensic science and evidence seminars at the College of Law.

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Table of Contents

Introduction

xvii

Part I SCIENCE AND LEGAL THEORY.................................... 1

1

2

3

4

Science in American Litigation: India Rubber to Bioinformatics

3

Science and the Legal Process Science, Products Liability, and Commerce Historical Notes on Science and Technology Nineteeth-Century Science and Patent Litigation

3 10 11 18

Science, Products Liability, and the Courts

35

Science and Products Liability Science and the Civil Law Forensic Evidence and the Criminal Law Science and the United States Supreme Court Kumho Tire and Beyond

35 39 42 44 54

Science and Peer Review

77

Introduction Peer Review of Peer Review Peer Review and the Supreme Court Appendix: The Peer Reviewers Review Peer Review

77 81 85 105

Science and Legal Causation: A Primer on Proximate Cause Introduction: A Primer on Proximate Cause The Varieties of Cause: The Case of Dennis D. The Language of Cause xiii

131 131 133 141

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Science and Litigation: Products Liability in Theory and Practice Working Theories of Cause Differential Diagnosis Bellwether Cases and Inferential Statistics Extrapolation Theory The Parlodel Controversy

144 145 159 166 177

Part II SCIENCE AND LITIGATION PRACTICE .................. 205

5

Science and Pretrial Research Introduction Research Focal Points Research Topical Checklist Research In Depth Research Points of Reference Introduction to Detailed Research Focal Points for State-of-the-Art Research Information Sources

6

Science and Expert Witnesses Introduction Determining Expert Witness Needs Prioritizing Expert Witness Needs Choosing the Expert: General Considerations Choosing the Expert: Organizational Factors Choosing the Expert: Individual Factors Categories of Experts Initial Utilization of the Expert

7

Science and Business Documentation Introduction The Generation of Corporate Documents Design Documentation Testing Documentation Production Documentation Marketing Documentation Regulatory Documentation Organizational Documentation Operational Documentation

207 207 213 217 229 236 241 244 251

261 261 262 265 265 267 270 276 281

287 287 288 293 307 318 320 326 332 336

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Table of Contents

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Science and Pretrial Discovery Introduction Discovery Planning Interrogatories Requests for the Production of Documents Depositions Focal Points for Organization and Analysis Specialized Indexing and Cross-Referencing Defense Objections to Discovery The Motion to Compel Discovery

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339 339 340 348 356 362 368 382 391 398

Appendix: Researching the Science Case

429

Index

441

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Introduction

It is a capital mistake to theorize before you have all the evidence. It biases the judgment. — Sherlock Holmes to Dr. Watson, A Study in Scarlet (1887)

Science and Litigation: Products Liability in Theory and Practice is intended to serve two major purposes. First, it is an introduction to the appreciation and understanding of the significant historic, contemporary, and future relationship between the world of the physical and biological sciences, their commercial outcroppings, and the civil justice system. Second, it is designed to provide the reader with a detailed guide through the practical, litigationrelated processes within which science-related liability questions must be resolved in American civil law. The most important of such questions have been and will continue to be raised in products liability litigation. This book is not intended to be a close study of scientific method or the scientific paradigms currently holding sway in any particular discipline in engineering, biology, chemistry, or genetics. Nor is it meant to be a treatise on modern products liability theory. There are numerous excellent volumes available to the business community and practicing bar on virtually every aspect of products liability theory. The broadest purpose of this book is to provide an overview of the historical areas of interest in which the civil courts have been called upon to address science-based issues and their response to them up to the present day. Like any other area of legal analysis, what is likely to be found is dependent to a great degree on the historical context within which the questions are being asked. Science questions in contemporary products liability cases are resolved in a judicial law and science tradition that has been extensively drawn upon for over 200 years. Law and science discussions did not begin in 1993 with the decision of the U.S. Supreme Court in the famous Daubert case.1 An examination of selected 19th century patent, tort, and criminal cases, discussed below, will bring this point home. The slow and steady development of products liability theory was accompanied by litigants raising safety questions involving a dazzling variety of consumer goods, touching all aspects of chemical, mechanical and electrical xvii

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Science and Litigation: Products Liability in Theory and Practice

engineering, chemistry, and pharmacology, without major concern over the issue of the general acceptability or reliability of the science supporting any particular expert testimony. The obsession with so-called junk science is a product of the late 20th century and appears, at least linguistically, to have run its course. At the present time the speed of the developments in biotechnology leaves court and counsel with a science paradigm that really is no better than the old Frye2 idea, which was always the de facto idea in law and science history anyway. The Daubert reliability standard, eschewing a determinative focus on general acceptance in the relevant scientific community, may end up as a judicial bromide but may not be up to the task for the next 10 years of products liability litigation, let alone the next quarter century of the explosive growth of science and commerce. Products liability cases typically involve intensive pre-trial discovery processes, and the actual trial itself takes place in the broader context of the common law trial process. That historical litigation process has basic components within which products cases must function, and, as in all social conflict situations brought to litigation, are affected by them. A major point here is the function of a trial as, initially, an exercise in establishing a version of history. What happened in the past that warranted legal sanction? If that can be satisfactorily established, then the weight of liability theory is brought to bear to determine individual or corporate responsibility. Satisfactorily proving the historic event is the dispositive feature of the litigation process. In products cases such events are long and complex, involving questions of scientific, corporate, and regulatory history, corporate organization and product development systems, document discovery and analysis, as well as a host of other technical issues related to the utilization of expert testimony. Accordingly, Science and Litigation: Products Liability In Theory and Practice is devoted primarily to a study of the scientific context of modern products liability litigation. This involves two basic subjects: (1) the judicial response to claims of one or more sciences when used in the investigation, prosecution, and defense of a civil claim for damages in the highly volatile areas of products liability and environmental litigation; and (2) the extent of the reach and nature of the powerful modern discovery powers vouchsafed to litigators in this most complicated and contentious of fields. Because of these dual aspects of products liability practice, this book is divided into two major sections: Part I, Science and Legal Theory, and Part II, Science and Litigation Practice. The audience to which this book is directed is one that is intimately or potentially involved in such cases, whether it includes judges, expert witnesses, plaintiff or defendant trial counsel, law professors or students. It is also hoped that the subjects discussed here will be of value to corporate scientists and executives as well as graduate students

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Introduction

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in the areas of science and business. Products liability practice eventually involves players in all of these categories. Part I: Science and Legal Theory, which consists of Chapters 1–4, addresses the “science question” in terms of the legal theories that are determinative of the legal acceptability and applicability of scientific ideas, processes, and models in contemporary American products liability litigation. Chapter 1, Science in American Litigation: India Rubber to Bioinformatics, briefly examines the history and nature of the science question in the 19th and early to mid-20th century American legal history. It is an important subject and one that places today’s, and especially tomorrow’s, issues on a timeline that is now moving at warp speed toward the legal implications of science in the first decade of the 21st century. An examination of the first edition of Scientific American and more contemporary publications provides a most instructive frame of reference for the discussions to follow. For reference throughout this book, the chapter also attempts to identify contemporary fields of scientific/commercial endeavors, such as bioinformatics, in-silico biology or genome mapping, and the strains that such rapid commercial development projects will place on our ability to effectively address law and science issues in the ensuing decades of the 21st century. Lawyers will need a very different set of tools in the coming days. Chapter 2, Science, Products Liability, and the Courts, briefly examines the judicial development of strict liability for products since the early years of the 20th century. It also closely examines the development and current legal theoretical parameters of the “science” model developed in the Frye, Daubert, Joiner and Kumho Tire cases decided by the federal courts, especially in the past decade. The chapter also provides a detailed analysis of the most current decisions implementing those important guidelines, since Kumho Tire, the last decision in the series, decided by the court in 1999.3 Chapter 3, Science and Peer Review, provides a long overdue analysis of current thinking on the validity and objectiveness of the scientific peer-review processes considered so important by the U.S. Supreme Court in resolving conflicts over the general acceptability and/or reliability of scientific testimony in important contemporary science-centered tort litigation. The chapter examines the subject of in-house, proprietary studies, keenly sought in hotly contested discovery practice, as well as the wide variety of views on the appropriate standards to be used by juried peer-reviewed scientific journals. There is increasing criticism of peer-review standards regarding financial conflict of interest, ghost authors and many other concerns over this key component of the U.S. Supreme Court’s analysis of scientific reliability. Chapter 4, Science and Legal Causation: A Primer on Proximate Cause concludes Part I by addressing in detail the questions of the relationship

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between scientific causal theory and legal causation rules and their linguistic dress in contemporary litigation. This particular issue has been the driving concept in the development of modern legal thinking on the appropriateness of a seemingly endless number of scientific methodologies offered to bar or support expert testimony on the central cause issue. It will continue to be a if not the prime mover in impending law and science battles. Does long-term exposure to PCBs cause lung cancer? Can migrating silicone from a ruptured breast implant cause joint or auto-immune system problems? Can the drug Bendectin cause birth defects or can the drug Parlodel, when used for antilactation purposes, cause brain aneurysms? Can genetically altered food cause serious illness? Do genetically engineered pharmaceuticals cause death or injury? Scientific cause is inextricably intertwined with the legal theories of proximate cause, a major reason for the current hostility over the cause question in modern environmental, products and medical malpractice cases. This chapter attempts to clear a path through the thicket of this most contentious and persistent of law and science issues. Part II, Science and Litigation Practice, changes focus and addresses the practical issues involved in prosecuting or defending the science-based case, which issues include the heady tasks of science investigation, finding, choosing and effectively using expert witnesses, corporate document discovery and analysis, deposition practice and pretrial Daubert hearings used by both sides to challenge and shape the relevant science context for the litigation. Sciencebased cases are often deemed complex litigation, and as such are increasingly subject to a number of important pretrial strictures imposed by state and federal courts.4 Chapter 5, Science and Pretrial Research, examines the central scientific and commercial facts that must be researched, and their ongoing importance in the litigation of the science-based case. Detailed attention will be given to key investigative categories involved in these complex cases. Special attention will be given to the identification of publicly accessible scientific information resources, the identification of product defect types, whether design or communicative in nature and the consequences of such, and centrally important pointers on determining the appropriate investigative, discovery and trial time frames for information gleaned in the study of state of the art literature and corporate and regulatory histories. Conducting comparative product research will also be addressed. The appendix, A Research Guide for the Science-Based Case, provides a detailed breakdown of numerous on-line databases and Web sites that are available for use from the outset to the conclusion of complex products liability litigation. Chapter 6, Science and Expert Witnesses, addresses the issues of the search for and selection of expert witness and how they serve to educate the lawyers in the area of science involved and hone the scientific component of

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Introduction

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the case. Numerous issues revolving around the effective and cost-effective use of experts are discussed. The chapter also analyzes the significant issues involved in the preparation for examination and cross-examination of trial experts, including arguing of essential Frye or Daubert hearings that question the general acceptability or reliability of proffered expert testimony. Chapter 7, Science and Business Documentation, addresses a wide selection of business organization structures and resulting document generation that are part and parcel of a products liability litigator’s concerns in developing a science case, whether it be a products liability, toxic tort, or environmental litigation. Proof of knowledge of risk and a corresponding failure to act are at the center of these cases. The questions of how, when, and where science gets involved in each step of the commercial process from idea to inventory shelf is a serious one, and is usually determinative of the ultimate liability and damages issues. Extensive analysis of document-producing corporate processes are illustrated by a case involving a major manufacturing defendant. This illustrates the nature and importance of the commonly encountered documents sought in the discovery stage of such cases. Chapter 8, Science and Pretrial Discovery, focuses on the vitally important subjects of effectively using pretrial science and corporate research, the search for expert witness, and the central task of pretrial discovery — the most arduous and the most fruitful stage in science-based litigation. Discovery planning, drafting, protective orders, and discovery enforcement, all central components of modern science-based litigation, are discussed here, as well as the analysis and use of documents, noted in Chapter 7, that are unearthed in the discovery process. A company’s in-house state-of-the-art article gathering and responses to proposed or existing governmental regulation in the area of science involved are also covered. This chapter also addresses important pretrial motions typically filed in these cases, which often determine the ultimate outcome. The defendant corporation will object to most interrogatories and requests for documents. It will also seek encompassing protective orders in an attempt to prevent counsel from gaining assistance from more experienced counsel. Broad-based motions in limine will be filed that are aimed at the major components of plaintiff ’s case. Success or failure in a product liability case is directly related to the quality and aggressiveness of counsel’s efforts in opposing such motions. Finally, the appendix, Researching the Science Case, provides the reader with an overview of scientific information sources available to lawyers and other parties involved in the litigation of increasingly complex products liability and environmental cases in the 21st century. The appendix provides lists of books, associations and science sites in the rapidly expanding area of the Internet.

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Endnotes 1. Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 113 S.Ct. 2786 (1993). 2. Frye v. United States, 54 App.D.C. 46 293 F. 1013 (1923). 3. Ibid.; Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 113 S.Ct. 2786 (1993); General Electric v. Joiner, 118 S.Ct. 512, 522 U.S. 136 (1997); Kumho Tire Company, Ltd. v. Carmichael, 119 S.Ct. 1167 (1999). Also see, Margaret A. Berger, The Supreme Court’s Trilogy on the Admissibility of Expert Testimony, Reference Manual on Scientific Evidence, Second Edition, 2000, at 9.

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I

Science and Legal Theory

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1

We have circuits or visits of divers principal cities of the kingdom; where, as it cometh to pass, we do publish such new profitable inventions as we think good. And we do also declare natural divinations of diseases, plagues, swarms of hurtful creatures, scarcity, tempests, earthquakes, great inundations, comets, temperature of the year, and divers other things; and we give counsel thereupon what the people shall do for the prevention and remedy of them…. — Francis Bacon, The New Atlantis (1627)

Science and the Legal Process It is important to note that the term science in the discussions to follow has little or no connection to the utilization and understanding of that term as it is uniformly thought of by the international scientific community. John Horgan, former editor of Scientific American, in his excellent book, The End of Science: Facing the Limits of Knowledge in the Twilight of the Scientific Age,1 sought out the world’s leading philosophers of science — theoretical physicists, evolutionary biologists, mathematicians, astronomers, and chaos theorists — to get their perspective as to whether science was at a close and nothing significant was left to be discovered. This book is a superb survey of modern scientific thinking across a very wide field of fields. The present legal question regarding the adequacy of scientific methodology to support expert opinion is light years away from the type of scientific inquiry discussed by the scholars interviewed by Horgan. Horgan notes the criticism of Nobel prize winning chemist Professor Stanley Miller that scientific papers culled from other published papers that have no hard-won findings resulting from extensive laboratory work of their own, were “paper chemistry.” In hard fought science-based civil cases, such as the breast implant actions or PCBs and cancer litigation, we may borrow the idea and apply it to the use of previously published articles by way of extrapolation to prove or disprove cause. In such cases, to claim or deny causation as “paper science” is a charge that may only be made, in part, about forensic science-based testimony in criminal cases.2 3


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Attempts to formulate an overarching answer to the question of “What is science?” in the world of scientific endeavor and the American legal system are entirely distinct in terms of overall goals, methodology, and practical applications. When the question is restricted to the area of law, the use of science in civil tort cases and in criminal prosecutions is based on significantly different goals, methods, and practical effects. The issue of whether longterm exposure to PCBs can cause cancer in a products liability lawsuit is quite different from the forensic issue of whether hair or fiber expert testimony may be used to link a defendant to a crime scene in a homicide prosecution. It is also of central importance to understand the differences between civil and criminal cases with respect to the performance of actual laboratory work to answer key factual issues in the cases. Forensic scientists in white lab coats are routinely involved in criminal prosecutions. Their work is utilized to shed light on the physical dynamics that created the crime scene and, hopefully, to add significant information linking a defendant to a crime scene or the identification of the perpetrator. They are rarely involved in answering essential scientific causation issues at the center of modern products liability litigation. Failure to warn of risks associated with the intended use of the product or the providing of inadequate instructions, are the basis for a very large number of products liability cases. The true cause case, such as the breast implant controversy, is a rarity. It is this limited tort or civil law context, however, that has provided the source of the contemporary legal stimulus to fashion a “one-size-fits-all” definition of science and scientific methodology. A representative list of individuals or entities involved in resolving what is or is not adequate scientific method, as that question relates to tort litigation or criminal prosecutions, will rarely include scientists in universities or laboratories engaged in what is traditionally considered pure science. There are major distinctions between and among pure scientists, corporate research scientists, advertising executives, research physicians, and practicing physicians. By the time lawyers arrive on the scene, the injured party has come into contact on a short-term or long-term basis with a product that has a trade name, packaging, advertising, and a whole series of other marketing devices employed to encourage the consumer toward eventual purchase. In this context it is readily seen that the aspect of the science involved in the creation of the product is long past its involvement in respect to the injury suffered by the party. So, among science-based products liability or environmental cases, there is typically no science involved per se, but rather, questions of ethical business practice as regards to packaging, warnings, and instruction issues.3 In its simplest and most practical terms, the question of what is or is not science, typically revolves around the issue of whether an expert witness



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chosen by one side in civil or criminal litigation may testify at all, or render a particular opinion, assuming he or she is qualified to give any opinion. In cases involving a wide variety of commercially produced chemical compounds, pharmaceuticals, medical devices and engineered goods, court resources in both the state and federal system are being increasingly taxed in pretrial hearings seeking to determine the scientific validity of the methodologies or opinions of an amazingly disparate number of expert witnesses. The recent decision by the United States Supreme Court in Kumho Tire v. Carmichael,4 holding that the Daubert criterion is available to challenge all expert witness testimony, will significantly heighten this pressure in the upcoming century. The question of what is or is not science in the context of American common law and legislative measures is a most complex one. Initially, it is to be noted that the answer to this question depends initially on clearly identifying the reason why the question is being asked. Answers to questions regarding the meaning of science may focus on the adequacy of a particular scientific methodology, according to general acceptability or reliability standards, as in the broad areas of forensic evidence in criminal cases or products liability and toxic tort litigation. The answers may focus on the acceptability of utilizing one of several alternative treatment options in medical malpractice cases, or on the efficacy and clarity of a description, as opposed to adequacy of the scientific method, such as in patent cases. Standards for minimum safety are imposed with increasing rapidity by administrative agencies such as the Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC) and National Highway Transportation Safety Adminitration (NHTSA). Also, there are scientific standards utilized in creating privately developed industry standards for some of the world’s major commercial activities such as chemicals, pharmaceuticals, and automobiles. In significant late 20th century products liability litigation, proof of fact is increasingly focused on inferences flowing from the application of the findings of one or more of the natural sciences. As science progresses, methodologies change. The legal system has survived many such changes and will survive yet more as our national life rushes into the 21st century. The important aspect of this increasing dependence on scientific method as a basis for determining dispositive facts, as far as the litigants are concerned, is the fact generated, not the method used to do it. The existence or nonexistence of a matter of fact depends, in large part, on the fact-finding theory being used by the fact seekers. Historically, in the law, a central concern in science-based civil litigation is how the courts are to fashion a set of observational and linguistic guidelines to gauge the adequacy of a scientific opinion that is offered to establish a material fact in a trial. This old debate has come full circle in the search by


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modern courts for a one-size-fits-all definition of legally sound scientific methodology that will serve justice in the increasing and predictably complex products liability cases of the new century. It is essential to recognize that virtually all issues involving law and science, especially in the field of products liability, are, in reality, issues involving questions of a commercial application of one or more scientific principles or technological developments. This applies to commercial products seeking some form of government approval or those under scrutiny by any one of a variety of regulatory agencies. This is, of course, the central reality of the field of products liability, perhaps the most important and contentious category of modern science-centered litigation. This commercial product aspect of law and science includes all of the biological and pharmaceutical sciences, mechanical and electrical engineering, chemistry and, currently, bioinformatics and other issues related to the mapping of the human and plant genomes. Whether the legal issue involves a business entity’s efforts to protect or enforce a patent, develop, market, or defend a product’s integrity against injury claims, it is a commercial application that is the occasion for any such analyses. In the context of physics, astronomy, mathematics, or in any other high level investigative sense, pure science issues are simply not in play in contemporary science-centered products liability litigation. In his work, Reflections on the Decline of Science in England, and on Some of its Causes (1830), Charles Babbage, the great 19th century English mathematician and inventor of the precursor of the modern computer bemoaned the fact that commerce drove most science, not the other way around: …all abstract truth is entirely excluded from reward under this system. It is only the application of principles to common life which can be thus rewarded. A few instances may perhaps render this position more evident. The principle of the hydrostatic paradox was known as a speculative truth in the time of Stevinus [about the year 1600]; and its application to raising heavy weights has long been stated in elementary treatises on natural philosophy, as well as constantly exhibited in lectures. Yet, it may fairly be regarded as a mere abstract principle, until the late Mr. Bramah, by substituting a pump instead of the smaller column, converted it into a most valuable and powerful engine … long intervals frequently elapse between the discovery of new principles in science and their practical application: nor ought this at all to surprise us. Those intellectual qualifications, which give birth to new principles or to new methods, are of quite a different order from those which are necessary for their practical application.5

All of the late 20th century trilogy of the U.S. Supreme Court’s law and science case analyses, were had within a context of certain aspects of the science involved in three commercial products:6



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• Daubert: the pharmaceutical Bendectin • Joiner: PCBs in electrical transformers • Kumho Tire: an exploding vehicle tire In these cases, as in all products liability litigation, the courts have never been interested in questions of basic science theory or research. They always address some question, typically basic causation, in a case arising out of a death or injury associated with the plaintiff ’s interaction with some commercial utilization of science. Once that is recognized, it becomes clear that the science involved is actually some, usually stepped-down, application of a greater theory that has run the gauntlet of the corporate process that shapes the science to its market. That process results in the particular utilization involved, whether it be a pharmaceutical, a transformer, or a truck tire. This science must then be run through the legal process where its antecedents are examined toward validating one or more supporting scientific methodologies that would allow an expert for either side to render an opinion. • Does Bendectin cause fetal malformations? • Can long-term exposure to PCBs in old transformers cause certain types of cancer? • Can certain tire design modes lend themselves to a deadly explosion during repair or replacement work? Even in the legal arena of administrative hearings, such as before the Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC), Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA) or the National Highway Traffic Safety Administration (NHTSA), the proceedings are basically addressing questions involved in the desired initial or ongoing commercial application of scientific ideas. These complex hearings, such as products and environmental litigation, are far removed from front-line theorizing or pioneering efforts currently being conducted in science laboratories worldwide. This basic fact requires that any modern analysis of the interaction of law and science, especially products liability disputes, must actually be an analysis of the ongoing relationship between science and the international business community.7 Science in the context of contemporary products liability, toxic tort, medical malpractice and a host of issues revolving around federal regulation or the state of the art science utilized by industry, is inextricably intertwined with two strikingly nonscientific processes. The first is what we may refer to as the corporate process, which involves the standard and/or project-specific operating procedures through which any science is eventually incorporated into a commercial offering — be it a chemical, pharmaceutical, or engineered


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line of products.8 This is a complex subject that will be addressed in considerable detail in Part II of this book. The second process is the civil litigation process through which the disputed scientific questions at issue are reshaped into manageable and scientifically reliable information for judge or jury consumption.9 The administrative process is a related process most often encountered in pharmaceutical, environmental, energy, and workplace regulation. The science involved in the various agency processes is also a far cry from the science that would be published in major science journals, such as Nature, or be discussed in scientific conferences or working research laboratories.10 The corporate and legal processes intermesh in all complex litigation currently in play and will continue to do so in the biotechnology and geneticscentered world of this century’s international business life. The commercial aspect of science that drives complex products liability, toxic tort, and medical device litigation in the nation’s state and federal courts has been the driving force behind the development and publishing of two editions of the Reference Manual on Scientific Evidence by the Federal Judicial Center.11 The authors of the original manual stated in the preface that their principal purpose was to assist judges in litigation involving contested scientific issues by facilitating “the process of identifying and narrowing disputed issues concerning scientific evidence.”12 Both of these editions contain a series of primers or guides to a variety of complex science-based subjects that state or federal judges increasingly encounter.13 Barely six years apart, the first and second editions of the Reference Manual will be hard put to keep up with the nascent explosion of litigation centered in the new commercial outpouring of products grounded in bioinformatics, in-silico biology and genetics. 14 Both editions further the Federal Judicial Center’s goal of assisting federal judges in recognizing the characteristics and reasoning of “science” as it is relevant in litigation.15 What is often overlooked in the midst of the various law and sciencebased efforts to afford scientific due process16 in our civil courts, is the central part played by the corporate processes that results in any science reaching the public in some commercial product or service. The informational component of such processes are revealed through important pre-trial discovery and trial components of the legal process which, in turn, determine the level of corporate responsibility in a case questioning the legitimacy of a corporation’s use of science in its commercial offerings. This is where any full discussion of scientific due process must begin and end.17 The science that is involved in the increasingly complex products liability litigation of the 21st century may perhaps be best referenced as “science as business practices,” whether the focal point is inadequate consumer instructions or warnings, marketing misrepresentations of fact in marketing materials, or a claim of defective design. Liability claims can also rest on allegations



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of mass exposure to toxic chemical substances — often linked to allegations of company failure to communicate or careless or purposeful miscommunication — or a lack of scientific knowledge during the pre- or post-marketing life of the product. Complex issues involving both science and legal theory abound in such cases, including causation theory, pharmacological, chemical, or engineering standards, scientific peer-review practices, and a host of other complex questions. These more theoretical issues are always accompanied by a myriad of practice-oriented litigation-related questions involving pretrial discovery, scientific, corporate and regulatory research, corporate and governmental document discovery, deposition practice, and the central subjects of expert witness selection and pretrial and trial utilization. The time, expense and physical effort involved in the theoretical and practical components of modern products liability is considerable. The contemporary search for a one-size-fits-all test to determine what is or is not generally acceptable or reliable scientific methodology is an ongoing effort. Any paradigm set today will of course be supplanted as the new science of the 21st century proceeds apace. This has been and will continue to be the reality of all attempts to shape legal theory to the world it serves. Justice Oliver Wendell Holmes, Jr. stated this obvious fact nearly eighty years ago in the Rational Basis of Legal Institutions published in 1923: Any idea that has been in the world for 20 years and has not perished has become a platitude although it was a revelation 20 years ago. One might venture on the paradox that by the time a proposition becomes generally articulate it ceases to be true — because things change about as fast as they are realized.

The development of a philosophical and linguistic model for the validation of scientific discoveries and their attendant methodologies and technology has been a constant factor since the early period of modern scientific thinking in 16th and 17th-century England. The attempts by the nation’s courts to provide a stable linguistic model for the validation of the supporting science underlying expert opinion, however, has been of relative recent vintage.18 Robert Hooke, the early 17th-century pioneer in the use of the microscope and an associate of the great experimentalist Sir Robert Boyle, recognized the difficulty of finding adequate standards for the testing of the scientific validity of factual assertions, especially in cases of attempts by scientists themselves to fashion one uniform set of constructs for any such task: …for the limits to which our thoughts are confined, are small in respect of the vast extent of Nature itself; some parts of it are too large to be comprehended, and some too little to be perceived, and from thence it must follow


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Science and Litigation: Products Liability in Theory and Practice that not having a full sensation of the object, we must be very lame and imperfect in our conceptions about it, and in all the propositions which we build upon it; hence we often take the shadow of things for the substance, small appearances for good similitudes, similitudes for definitions; and even many of those, which we think to be the most solid definitions are rather expressions of our misguided apprehension then of the true nature of the things themselves…19

Hooke’s concern could easily be applied to the heightened scientific researches in the areas of bioinformatics, in-silico biology and proteome mapping, and related genome-based projects that seek new drugs, gene transplant techniques and chemical solutions for the host of the world’s personal and environmental ills. The number of biotech patent applications are growing at a historical rate, with a 22% increase noted in the past two years. 20 Dr. Jasemine C. Chambers, who heads the Patent and Trademark Office (PTO) division responsible for biotechnology, organic chemistry, and pharmaceuticals, recently told the Scientific American’s biosilico conference that such patents, particularly the controversial patent applications for gene chemical sequences, are outstripping all other traditional patent categories. 21

Science, Products Liability, and Commerce The basic inference-based proof structure used in modern trials, whether aimed toward a proffered scientific result or a more routine establishment of an important fact, has served the law as the primary historical method since the earliest days of all legal systems. The rhetorical and logical methods of argument made for centuries in Greek, Roman, and common-law based systems, still remains the primary method of convincing a jury to reach one version of history rather than another. The litigator’s goal is to convince the jury of both his version of history and what it says about the plaintiff or defendant’s actions or omissions. The central task of litigation, including science-based cases involving products liability and toxic torts, is the proof of past facts relative to the science at issue, as well as the very complex undertaking of tracing the known risks involved in any commercial utilization of it over the course of a corporate process of product development and marketing.22 While most of the recent legal literature aimed at law and science questions has focused on issues such as the propriety of an expert witness’ opinion and its foundation, that is only the final inquiry among a complex body of law and science issues facing the modern litigator.23 The ultimate goal of the legal process is not to find the unqualified truth. Any system that allows a jury to reach a verdict of guilty or not guilty in such



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important matters would appear to have something else in mind. 24 The goal of the American litigation system is to provide the best context, the fairest context, the optimal context, for a jury to find the truth. This goal of providing the best opportunity for a jury to find their version of the truth is especially important to understand before entering into an extended discussion of the nation’s products and environmental litigator’s current preoccupation with the science question. What is generally acceptable or reliable methodology in various fields that would justify any expert opinion, such as the cancer-causing potential of certain commercial products? Who determines the answers to these questions? What is the scientific standard to utilize in such an inquiry? At what point in the history of a product or a disputed event and its alleged victim are we to focus? Are civil and criminal cases sufficiently different in terms of their goals and processes to require different analyses? Every injury or death that is involved with some company’s commercial use of science is subject to extensive and years’ long pretrial scrutiny to test the adequacy of the corporate processes used prior to its marketing. Currently, virtually every expert seeking to render an opinion in cases centered on the injury or deathproducing aspects of a commercial product is subject to extensive pre-trial examination to test the adequacy of the scientific methodology supporting any such opinion.25

Historical Notes on Science and Technology A valuable perspective on these questions can be had by examining some of the history of the utilization of science in American litigation. Today’s questions were also yesterday’s, with the differences primarily resting in the perspective of the courts as to the hegemony and legitimacy of science and scientists in their world. As science and technology were developing very slowly in the 19th century, courts were necessarily more dependent upon and trusting of their scientific brothers and sisters. A knee-jerk, spirited challenge to their authority, their methodologies and their books was not the routine response it is today. For many years gratitude for assistance in complex matters was more the case. There was acceptance of what was generally accepted in the scientific community, a fact recognized in the citation-free opinion in the famous Frye26 case decided in 1923. Let’s look back and see just how far we have come once we did decide to challenge the litigant’s grateful offer of scientific testimony in law cases. How different is the assumption of Frye that the only place to look for guidance was to the scientific community and then only to those ideas generally acceptable by them. The patent cases provide clear indications of a


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general reluctance to challenge the extensive scientific testimony, affidavits, and testimonial proffers incorporating entire bibliographies in English, French, and German, numerous quotations, and in some instances, entire readings of scientific articles.27 In his Pulitzer Prize winning book, The Launching of Modern American Science,28 Professor Robert V. Bruce notes the very slow transfer and translation of leading books of science from the significantly advanced European universities, academies, and learned societies. Even the printers added to the problem by balking at the cutting of new plates to accommodate the new literature replete with chemical symbols: How was the European experience transmitted to America? The published proceedings of a few American societies listed their library acquistions, and these included European books and journals. Such lists of titles gave Americans some hints of what Europe was doing. But in 1846, the only periodic general account published in America appeared in the American Journal of Science, which regularly imported European publications for review, excerpting, and summary.29

Litigation involving questions of science or the nature of the validity of modes of scientific inquiry has been part and parcel of our legal life since the start of our national life, beginning in and primarily residing in cases brought up in the nation’s patent system. Professor Bruce also notes the important differences between the ideas of science and those of technology, and the centrality of the understanding of such differences to America’s industrial growth: Technology was so closely intertwined with industry and agriculture that its corresponding development was half-hidden. Government agencies (aside from the Patent Office) were less vital to it than they were to science, though federal subsidies for technological education loomed large. But the parallels to science were there: in the rise of professionalism through society’s higher education and specialization.30

In examining the American background to the current preoccupation of legal scholars and courts as respects the meaning and application of the term science in civil and criminal cases, one is struck by the absence of argument on that point over most of our national life. It is also important to note that the patent laws were among the earliest laws promulgated by the new American congress. Thomas Jefferson was not only a fervent amateur scientist, as were Benjamin Franklin and many of the Founding Fathers, but he was also a vocal and strong supporter of patent legislation. In fact, Jefferson served as the first official patent examiner.31



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Writing in 1889, in his famous history of America during the administrations of Thomas Jefferson, Henry Adams relates Noah Webster’s low opinion of American learning in about 1800. While Webster claimed for New England an acquaintance with theology, law, politics and “light” English literature, he complained bitterly about the virtual absence of scientific expertise: …but as to classical learning, history (civil and ecclesiastical), mathematics, astronomy, chemistry, botany, and natural history, excepting here and there a rare instance of a man who is eminent in some one of these branches, we may be said to have no learning at all, or a mere smattering … our learning is superficial in a shamefull degree, …our colleges are disgracefully destitute of books and philosophical apparatus … and I am ashamed to own that scarcely a branch of science can be fully investigated in America for want of books, especially original works. This defect of our libraries I have experienced myself in searching for materials for the History of Epidemic Diseases … As to libraries, we have no such things. There are not more than three or four tolerable libraries in America, and these are extremley imperfect. Great numbers of the most valuable authors have not found their way across the Atlantic.32

This complaint was made in the year 1800, and was the more significant because it showed that Webster, “a man especially at home in Philadelphia, New York, and Boston, thought his country’s deficiencies greater than could be excused or explained by its circumstances.”33 This same concern was raised by the great English mathematician Charles Babbage about the situation in England thirty years later: The pursuit of science does not, in England, constitute a distinct profession, as it does in many other countries. It is therefore, on that ground alone, deprived of many of the advantages which attach to professions. One of its greatest misfortunes arises from this circumstance; for the subjects on which it is conversant are so difficult, and require such unremitted devotion of time, that few who have not spent years in their study can judge of the relative knowledge of those who pursue them. It follows, therefore, that the public, and even that men of sound sense and discernment, can scarcely find means to distinguish between the possessors of knowledge, in the present day, merely elementary, and those whose acquirements are of the highest order.34

Babbage also complained of the lack of government or popular support for science and invention: Unless there exist peculiar institutions for the support of such inquirers, or unless the Government directly interfere, the contriver of a thaumatrope


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Science and Litigation: Products Liability in Theory and Practice may derive profit from his ingenuity, while he who unravels the laws of light and vision, on which multitudes of phenomena depend, shall descend unrewarded to the tomb.35

A similar observation was made by Henry Adams in his discussion of the slow development of commercially viable steam power in America at the beginning of the 19th century, due to both public and private apathy and conservatism. Adams stressed the importance of Americans in 1800 understanding the market value of scientific effort if it was to develop with the rapidity and substance that the growth of the country and its place in the world demanded: …as an independent people, with half a continent to civilize, they could not afford to waste time in following European examples, but must devise new processes of their own. A world which assumed that what had been must be, could not be scientific; yet in order to make the Americans a successful people, they must be roused to feel the necessity of scientific training. Until they were satisfied that knowledge was money, they would not insist upon high education; until they saw with their own eyes stones turned into gold, and vapor into cattle and corn, they would not learn the meaning of science.36

This was a point brought home personally to Robert Fulton, the primary inventor of the steamboat, who complained bitterly of the ridicule his efforts garnered: …As I had occasion to pass daily to and from the building-yard while my boat was in progress, I often loitered unknown near the idle groups of strangers gathering in little circles, and heard various inquiries as to the object of this new vehicle. The language was uniformly that of scorn, or sneer, or ridicule. The loud laugh often rose at my expense; the dry jest; the wise calculation of losses and expenditures; the dull but endless repetition of the Fulton Folly. Never did a single encouraging remark, a bright hope, or a warm wish cross my path.37

In the second half of the 19th century, science and the attendant advances in technology, eventually drove the economic development of America in rapid and explosive ways, not the least of which was the filing of thousands of patent applications and early litigation alleging infringement. 38 The first edition of the Scientific American, published in 1845, listed the patents issued in that year. They included a large number for improvements in the areas of bee hives, churns, corn sellers, cultivators, fruit-gatherers, harrows, hulling machines, mowers, ploughs, and a wide variety of advances in agricultural implements. Favorable grants were also made for fabrics made



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with India rubber, ship anchors, cooking stoves, pianofortes, truss pads, furnaces, turtle-shell bugles, type casters, door locks, and washing machines.39 One hundred and fifty-five years later, the July 2000 edition of the Scientific American presents a strikingly different profile. In a special edition devoted to the human genome business, there are extensive articles on the potential businesses associated with the human genome,40 and reports of advances in tracking nonhuman genomes such as the fruit fly, the worm, yeast, and the mouse.41 This special edition also provides an extensive article on the intense business competition revolving around the exploding area of bioinformatics,42 which is a very recent information source combining computer science and biology. Expectations of yielding great profits in the area of drug development, among others, are enthusiastically related. This detailed study also sheds light on the new field of in-silico biology, involving a melding of computer programming and cell biology, which will hopefully reveal the cell-signaling pathways linked to genetic regulatory pathways. Also included is a prospective analysis of the world of science and commerce beyond the completion of the mapping of the human genome.43 Tantalizing note is also taken of the emerging field of proteonomics, seeking to map the even more complex system of protein production.44 These scientific developments with their tremendous commercial potential are a far cry from the enthusiastic announcement of the advances in railroad car design trumpeted on the first page of the 1845 inaugural edition of Scientific American: There is, perhaps, no mechanical subject, in which improvement has advanced so rapidly, within the past ten years, as that of railroad passenger cars. Let any person contrast the awkward and uncouth cars of ‘35 with the superbly splendid long cars now running on several of the eastern roads, and he will find it difficult to convey to a third person, a correct idea of the vast extent of the improvement.45

The recognition of the importance of educating and informing the general public concerning the more commercially oriented scientific developments incorporated in the various mechanical arts was indeed the central task of the new publication. As stated in the lead editorial headed “To the American Public,” the editor stated: Having the pleasure of again appearing before you, though under a new title, and in new dress, we may be expected to advance some remarks on things in general, and particularly on the subject of our motives, intentions and prospects…we have been frequently solicited by enterprising mechanics, and others, to engage in the publication of a new scientific paper, for the advancement of more extensive intelligence in Arts and Trades in general, but


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Science and Litigation: Products Liability in Theory and Practice more particularly in the several new, curious and useful arts, which have recently been discovered and introduced.46

Various brief columns were devoted to brief overviews of functional scientific ideas such as the “First Principles of Mechanics,” describing the principle of inertia and one headed “New Inventions,” describing several inventions referencing advances in the daguerreotype process, the uses of centrifugal force to separate liquids, new cotton cleaning processes, and various advances in the utilization of India rubber. The new chemistry column promised a “series of brief essays” that would explain and illustrate “the principles and peculiarities of the science of chemistry as may be the most useful to mechanics, and the most interesting to the curious, and readers in general.”47 The same practical philosophy may be seen in even the most private areas of educational reform. It is interesting to note the testamentary wishes of one Stephen Girard, a French immigrant to America, late of Philadelphia, who, in establishing an educational fund for orphans in 1831, ordered that all recipients receive only a no-nonsense, practical, science and technology grounded course of study: They shall be instructed in the various branches of a sound education, comprehending reading, writing, grammar, arithmetic, geography, navigation, surveying, practical mathematics, astronomy, natural, chemical and experimental philosophy, the French and Spanish languages, (I do not forbid, but I do not recommend the Greek and Latin languages) — and such other learning and science as the capacities of the several scholars may merit or warrant. I would have them taught facts and things, rather than words or signs….48

For the greater part of the functioning of our state and federal judicial systems, the question of what was or was not proper scientific method was not viewed as a prerequisite to the discussion or resolution of a sciencerelated fact question. The focus for most of the 19th and 20th centuries has been on the qualifications of the proffered expert witness which, if deemed adequate, usually resulted in an acceptance of the propriety of the scientific materials and processes which served as a basis for the expert’s opinion. Until very recent times in our legal history, most courts routinely expressed appreciation, rather than suspicion, for the contribution of expert witnesses for assisting them in the difficult science-based fact-finding process. While the complexities of tort law and science issues lay far in the future, the single area of patent infringement litigation, however, was alive with discussions concerned with the state of the art of scientific theory and technological development in a wide variety of science-based endeavors. Patent



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case reports from the first 75 years of our national life are replete with discussions of the unique qualities of cotton and wool cards; cutting and heading nails; pumping machinery, banknote plates, carpet weaving machinery, stock quoting machines, glass knobs and a host of other products produced by the rapid expansion of the 19th century commercial world. The term “science” during that period was also used routinely as referring to some general expertise or extraordinary knowledge of some matter or subject. In the late 18th and entire 19th century courts often praised the “science” of legislation, international law, modern contracts, navigation, morality, writing, military affairs, heraldry, engineering, political economy and the like. Questions addressed to the appropriate standards for determining the admissibility of expert opinion based upon a relevant scientific methodology, however, were simply not asked. Recourse has always been to the scientific community involved for guidance. This was seen, however reluctantly, as an inevitable necessity in some form, from the earliest days of the common law. In Spencer Cowper’s Trial,49 held in England in 1699, the ongoing skirmish between courts and expert witnesses can be seen in the following exchange: Dr. Crell: Now, my lord, I will give you the opinion of several ancient authors. Baron Hatsell: Pray, doctor, tell us your own observations. Dr. Crell: My lord, it must be reading, as well as a man’s own experience, that will make anyone a physician, for without the reading of books of that art, the art itself cannot be attained to. Besides, my lord, I conceive that in such difficult cases as this we ought to have a great deference for the reports and opinions of learned men. Neither do I see why I should not quote the fathers of my profession in this case as well as you gentlemen of the long robe quote Coke upon Littleton in others.50

Baron Hatsell’s understandable reluctance to allow “testimony” of authors not subject to cross-examination notwithstanding, the common law’s dependence on the world of science and its experts remains. In early to mid-19th century American litigation, science, to the extent it was discussed at all, was discussed in patent infringement cases. An examination of a selection of ordinary, as well as famous, patent infringement cases demonstrates the casual and grateful acceptance of a very wide range of scientific expertise, often from English and European sources. For our purposes, it is of key importance to note the absence of a challenge to either the experts themselves, their basic methodology, or the books and articles contained in the copious bibliographies entered into some of the records. The widespread reliance on quotations and/or the reading of entire journal


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articles without a hearsay challenge would shock modern trial judges and litigators. All this was done without the current preoccupation with reliable supportive evidence as a precursor to the use of any opinion based upon such materials.

Nineteeth-Century Science and Patent Litigation Whittemore v. Cutter,51 decided in 1813 by the Federal Circuit Court in Massachusetts, was an action for the violation of a patent right in a machine for the making of cotton and wool cards. Justice Story charged the jury that it was necessary to advert to the third section of the act of 1793, which, among other things, required the party applying for a patent to deliver a written description of his invention, and of the manner of using, or process of compounding the same, in such full, clear, and exact terms, as to distinguish the same from all other things before known, and to enable any person skilled in the art or science, of which it is a branch, or with which it is most intimately connected, to make, compound, and use the same; and in the case of any machine, he shall fully explain the principle, and the several modes, in which he has contemplated the application of that principle, or character, by which it may be distinguished from other inventions.52

Justice Story noted that by the idea of the “principles of a machine” (as those words were used in the statute) was not meant the original elementary principles of motion, which philosophy and science had discovered, “but the modus operandi, the peculiar device or manner of producing any given effect.” The expansive powers of steam and the mechanical powers of wheels had been understood for many ages, he explained; yet a machine might well employ either the one or the other, and yet be so entirely new, in its mode of applying these elements, as to entitle the party to a patent for his whole combination. The intrinsic difficulty was to ascertain the exact boundaries between what was known and used before, and what is new, in the mode of operation. It was here that the courts required and sought the counsel of scientific men, books, and articles. The present machine, he continued, was invented to make cotton and woollen cards, which processes, Justice Story noted, were not only made before the present patent by similar machinery, but also by machinery which, at different times, exhibited very different stages of improvement. The necessary scientific history of such machines and their variations and adaptations was supplied by the scientific community to the court’s satisfaction:



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The gradual progress of the invention, from the first rude attempts to the present extraordinary perfection, from the slight combination of simple principles to the present wonderful combinations, in ingenuity and intricacy scarcely surpassed in the world, has been minutely traced by the witnesses on the stand.53

In Wyeth v. Stone,54 decided by the same circuit court in 1840, in an infringement claim involving an ice-cutting machine, issues on the other side of the question was likewise settled by scientific expertise gratefully received: Such a combination is not shown even to have been known or used before. It is not, therefore, a new use or application of an old machine. This opinion does not rest upon my own skill and comparison of the machine with the carpenter’s plough; but it is fortified and sustained by the testimony of witnesses of great skill, experience, and knowledge in this department of science, viz., by Mr. Treadwell, Mr. Darracott, and Mr. Borden, who all speak most positively and conclusively on the point.55

Bryan et al. v. Stevens,56 decided by a New York court in 1841, in an infringement claim involving friction matches, stressed the importance of experts and their books: And evidence has been produced from experts in the science of chemistry and from books to show either that the description ‘earthy material’ is too vague and indeterminate to designate any particular substance or class of substances known to the arts, or that if they are appropriately embraced within it, it necessarily excludes metals and their products.57

In Parker v. Stiles,58 an 1849 Ohio federal circuit court infringement case involving an improvement in the application of hydraulic power, the court again emphasized the central importance of the contributions of the scientific community in such complex matters: I will here, observe, that great respect is due to the views and opinions of scientific individuals, and practical mechanics, on the question of the identification of different mechanical structures. From their acquaintance with the elements of mechanical science, they are enabled satisfactorily to decide this question, while to others, it might seem involved in obscurity and doubt.59

The court’s desire for support from men of science, as opposed to solely that of mechanics, which, while very useful from a descriptive standpoint, was insufficiently scientific, was reaffirmed in Olcott v. Hawkins,60 an 1849 Wisconsin infringement decision involving a woodworking machine:


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Science and Litigation: Products Liability in Theory and Practice The court has been favored with the testimony of operatives and mechanics of intelligence; but not sufficiently with that of experts, or men of science, which is generally necessary to a proper understanding of the principle involved. The witnesses speak generally of the planing wheels and of certain principles connected therewith; but do not enter into, either an analysis of those wheels from actual measurement, or a mathematical demonstration of those principles, sufficiently scientific literature to satisfy a mind enquiring after truth.61

An Ohio court in Allen v. Hunter,62 expressed like sentiments in a case involving the alleged infringement of a dental compound formula: The words ‘known fluxes’ belong to chemistry, and none but those who understand the science of chemistry should have weight as experts on the subject. A dentist who extracts and fills teeth, or who sets teeth, may be expert in what he professes, and yet be ignorant of chemistry. This has been verified in the present case. As the invention is claimed to be a new and useful mode of setting teeth, it seems to be supposed that dentists are proper experts to define the meaning of chemical terms. But if they have not a scientific knowledge of chemistry, they are not experts in the application of chemical terms.63

The courts as well as the litigants relied heavily on published scientific treatises and journal articles, especially on the issue of the uniqueness of an idea, with the absence of any mention of or attribution of such an idea in world scientific literature before certain dates, often being decisive. Given the nascent state of scientific development in the United States hearsay objections were not forthcoming especially prior to the Civil War years of 1860–64. Further examples may be seen in a series of cases decided during that period. In Foote v. Silsby,64 an 1849 New York federal circuit court decision discussing an improvement in regulating the draft of stoves, the court was only concerned with notice to the opposite party of science articles, not the articles themselves: The defendant offered to read in evidence two articles, (from Ure’s Dictionary of Arts, Manufactures and Mines) one headed “Heat Regulator”on page 643, and the other headed “Thermostat,” on page 1237…The plaintiff objected to the reading of any part of the volume, on the ground that its title was not correctly indicated in the notice of defence. The court decided that the notice was insufficient, and excluded the volume…The defendant then offered to read in evidence several articles from pages 93, 130, 283, and 406 of The Journal of the Franklin Institutes, Vol. IX for 1832…[The court excluded it, on the ground that no sufficient legal notice of it had been given.65



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Nonetheless, an early sea-change may be detected, where a court expressed caution upon being buried with scientists’ affidavits and massive bibliographies of scientific treatises and carefully culled quotations from them or from numerous articles taken from the world’s scientific literature (usually English, French, or German). This caution may be seen clearly in the important Philadelphia federal circuit court case of French et al. v. Rogers et al.66 decided in 1851. This was a patent infringement case involving inventions for electromagnetic telegraphs originally granted to Samuel Morse. The court, when faced with two large volumes of exhibits and numerous depositions of a battery of scientific experts, diplomatically described his and like court’s dilemma in such an important science-centered case: There is no place in which the evidence of scientific men, upon topics within their own departments of knowledge, is more to be desired than in this court, when sitting for the trial of patent cases; and the opinions also of such men, when duly supported by reasoning founded on ascertained fact, must be valued highly. But it is a mistake to suppose that, even on a question of science, opinion can be dignified here or elsewhere with the mantle of authority… These remarks are not dictated by a spirit of unkind or uncourteous commentary on the depositions before us. We know that when opinion is active, it is not always easy to limit its range. There is, besides, very much of accurate scientific history, and of just and well-regarded deduction from it, in these two volumes of exhibits. But it must be confessed also, that there is to be found here and there not a little of imperfectly considered dogma, as well as something of doubtfully regulated memory — and it has seemed to us, in this case, as well as some others, that the toil and expense and excitement of litigation might have been moderated perhaps, if the appropriate tone and province of testimony had been more exactly understood by some of the witnesses.67

Two final cases, Goodyear v. Day,68 decided in 1852 and Mitchell v. Tilghman,69 decided in 1873, will be discussed in this section. These cases, famous in their day, merit extended attention due to their being representative of the basic continuation of the patent court’s grateful acceptance of the contribution of scientific experts, along with their generally accepted volumes of books, articles, affidavits, and deposition testimony. The patent courts were the only courts actually addressing science issues on an ongoing basis in the periods immediately preceding and following the Civil War. Following the examination of these cases, brief attention will be given to the relatively few 19th century nonpatent cases where the courts were not only faced with the same problems as their brothers in the patent area, but resorted to the same routine acceptance of assistance.


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A full-scale attack on the credibility of scientific experts did not come until the last two decades of the 20th century, long after the development and stabilization of the theoretical and practical components of the modern products liability litigation system which is the central subject of this book. 70 Goodyear v. Day,71 involved a challenge to the patent granted to Charles Goodyear in 1844 for the India rubber process. It was one of 32 patent infringement cases that Goodyear was forced to bring to protect his famous idea. In the Day case, however, Daniel Webster was counsel for Goodyear and was successful in obtaining a permanent injunction.72 While ultimately unsuccessful in stopping further attempts at challenging his process, the case was duly famous for the argument made by Webster.73 Justice Grier noted that the proofs and exhibits were very full, amounting to about 4000 pages. A jury trial, he continued, would last months, due to the need of a jury to read through the library of testimony and listen to the viva voce testimony of the numerous scientific witness likely to be called by both sides. It was thus agreed that the case would not be subjected to a jury due to the high volume and variety of complex scientific materials. The arguments of counsel lasted several days, Justice Grier observed, and involved many interesting inquiries, including an extensive history of the gum called India rubber, long known in Eastern countries, and first introduced into Europe by scientific French travelers in 1736. There were many pages of the history of the various natural substances and chemicals adapted to the product in the record, up to and including the currently disputed processes. The presentation of voluminous bibliographies, books, and journal articles was accepted by the court as a proper basis for the arguments of counsel focusing on the originality of Goodyear’s idea. Goodyear’s lawyer, the famous Daniel Webster, put the issue precisely: There is not a single question of fact in the case we have said, on which the court can feel the least doubt. We assert that Goodyear is the first man upon whose mind the idea ever flashed, or to whose intelligence the fact ever was disclosed, that by carrying heat to a certain height it would cease to render plastic the India rubber, and begin to harden and metallize it. If there is a man in the world who found out that fact before Goodyear, who is he? Where is he? On what continent does he live? Who has heard of him? What books treat of him? What man among all the men on earth has seen him, known him, or named him? Yet it is certain that this discovery has been made. It is certain that it exists. It is certain that it is now a matter of common knowledge all over the civilized world. It is certain that ten or twelve years ago it was not knowledge. It is certain that this curious result has grown into knowledge by somebody’s discovery and invention. And who is that somebody?74



23

The absence of reference to a similar process created by another before Goodyear in the books of science and mechanics told the tale according to Webster: If Goodyear did not make this discovery, who did make it? Who did make it? If the other side had endeavoured to prove that some one other than Mr. Goodyear had made this discovery, that would have been fair. But they do not meet Goodyear’s claim by setting up a distinct claim of any body else. They attempt to prove that Goodyear was not the inventor, by little shreds and patches of testimony. Here a little bit of sulphur, and there a little parcel of lead; here a little degree of heat, a little hotter than would warm a man’s hands, and in which a man could live for ten minutes or a quarter of an hour; and yet they never came to the point. There are birds which fly in the air, seldom lighting, but often hovering. Now this is a question not to be hovered over, not to be brooded over, and not to be dealt with as an infinitesimal quantity of small things. It is a case calling for a manly admission and a manly defence. I ask again, if there is any body else than Goodyear who made this invention, who is he?75

Not only did the negative evidence from scientific sources demonstrate the absence of any prior invention, but the testimony of other workers in the vineyard supported Goodyear’s claim to priority: There have been many respectable witnesses in this case, and the best and most intelligent of them say, after having been engaged in attempts in this manufacture for years and years, losing their time and fortunes, they never heard of or imagined any such thing, as the vulcanization of rubber until Goodyear’s invention was made.76

Justice Grier found for Goodyear, noting many earlier, but failed attempts to develop a similar process: The testimony shows that many persons had made experiments — that they had used sulphur, lead, and heat, before Goodyear’s patents, and probably, before his discovery. But to what purpose? Their experiments ended in discovering nothing, except, perhaps, that they had ruined themselves. The great difference between them and Goodyear is, that he persisted in his experiments, and finally succeeded in perfecting a valuable discovery, and they failed… when genius and patient perseverance have at length succeeded, in spite of sneers and scoffs, in perfecting some valuable invention or discovery, how seldom is it followed by reward! Envy robs him of the honour, while speculators, swindlers, and pirates, rob him of the profits. Every unsuccessful experimenter who did, or did not, come very near making the discovery, now claims it. Every one who can invent an improvement,


24

Science and Litigation: Products Liability in Theory and Practice or vary its form, claims a right to pirate the original discovery…The present case adds another chapter to this long and uniform history. But notwithstanding the indomitable energy and perseverance with which this attempt to invalidate the patent has been pursued, ‘the volumes of testimony with which it is oppressed, and the great ability with which it has been canvassed in the argument’, we are of opinion that the defendant has signaly failed in the attempt to show that himself or any other person discovered and perfected the process of manufacturing vulcanized India rubber before Goodyear. We shall give therefore our decree of perpetual injunction.77

The case of Mitchell v. Tilghman,78 decided over 20 years later, still exhibited, in a significant manner, the ongoing willingness of the courts to accept a wide variety of, often voluminous, scientific materials, if it appeared that they were generally acceptable to the scientific community.79 This case,80 decided by the U.S. Supreme Court in 1873, in a 130-page opinion, the court reversed two lower court decisions in Tilghman’s favor, one an award of $335,661, as the amount of the profits, with interest, which the defendant had made by infringement. Mr. Justice Clifford delivered the opinion of the court and found that, even without any discussion, it was obvious that the means and mode of operation practiced by the witness were widely different from the method or process described in the specification of the complainant’s patent.81 In the process of a lengthy trial, chemical and mechanical experts were examined as witnesses on both sides in about equal numbers and numerous quotations from scientific meetings, proceedings, chemical treatises and journals were read into the record. Each side offered extensive lists of such materials offered on the issue of precedent idea and practical use.82 There are a relatively small number of nonpatent cases that have had to resort to contemporary science for assistance, but such cases also illustrate a similar pattern of grateful acceptance, the idea of general acceptability and the lack of hearsay concerns over the extensive use of learned treatises, journal articles, and bibliographies. In The Isaac Newton,83 an 1847 breach of contract action regarding a boiler supplied to a ship, the court set out the unchallenged scientific material placed in the record: Experienced engineers, on the other hand, state, and this agrees with the theories of books of science, that if the cut-off is protracted so as to diminish sufficiently the aperture between the piston and the heads of the cylinder, the amount of steam generated by boilers of the capacity of these, would furnish forty pounds pressure to the square inch upon the piston, being the head of force claimed by the claimants.84



25

United States v. Taylor,85 decided in 1851, was a criminal negligence case involving the explosion of a steamboat boiler. The court relied heavily upon selections from materials found in scientific journals: Again, the defective materials of a boiler, such as flawy iron, is a frequent cause of explosions (Journal of Science, Vol. 35, p. 317; Prof. Renick, Id. Vol. 20, p. 339; Prof. Sullivan, Id. Vol. 19, p. 144, but not gas formations, as asserted by one of the experts (see Dr. Locke’s report on the Moselle explosion)…The engineer is liable to be deceived by the safety-valve on which no dependence can be placed (Journal of the Franklin Institutes, Vol. 7, p. 291; Journal of Science, vol. 19, p. 148) and also the gauge cocks (Ewbank in Franklin Institutes, Vol. 9, p. 366) by blowing ‘hoarse’ with foam (see Dr. Locke’s report on the Moselle explosion).86

In Adrian v. the Live Yankee,87 an 1855 California action against a vessel for damages to the cargo caused by moisture in the hold of the vessel, usually called “sweat,” the court indicated its necessary reliance on the development of generally accepted scientific knowledge: On the whole, I consider that under the evidence in this case it does not appear that the damage has occurred from causes originating in the agency of man…the effect of which the court cannot affirm the carrier could or ought to have guarded against…But while I feel called upon so to determine in this case and with the present imperfect knowledge of this subject, it is not to be inferred that the same decision will always hereafter be made. On the contrary, if it should hereafter appear that science has suggested, or experience has shown, a remedy or preventive of damage from this source, which shall be generally recognized and adopted, it will be negligence in the carrier to omit its use. But as at present it cannot be said with any certainty that such a remedy has been discovered, I cannot find the carrier guilty of negligence in having failed to resort to one that has been suggested and used to some extent, but the utility or efficacy of which is still a matter of discussion and dispute.88

A like result, on similar grounds of reliance on generally accepted science, is seen in the 1871 California case of Parrot v. Barney et al.,89 which involved damage to property caused by a tenant who shipped to the premises nitroglycerine, which then exploded. The defendant claimed he had no knowledge of such danger or any opportunity of reasonably learning of such. The court, agreeing, stated: …I think it might be safely assumed that not one in a thousand in the United States, or California, would have known anything about the substance or its properties…However, that may be, it is very evident, that it


26

Science and Litigation: Products Liability in Theory and Practice was known outside of the laboratory of the chemist to a very limited extent, and not sufficiently to be recognized as a part of the common knowledge of the country, even in intelligent circles…As an illustration of the state of knowledge, even among scientific men and chemists, of several professors of that science in our colleges and university, examined as experts on behalf of the respective parties, not one had heard of nitroglycerine, as an article of commerce, or of practical utility, or outside the domain of science, prior to the explosion in question in 1866…With so little general knowledge of the substance, at the time of the accident, outside the laboratory, even among chemists and scientific men, who usually take a special interest in such substances, and who are likely to notice the progress of their introduction into the practical affairs of life, it could scarcely be expected that the public generally engaged in the ordinary pursuits of agriculture, manufactures and commerce, would be informed on the subject….90

The foundational basis for the use of science in litigation, outside of the world of patents, was not seriously addressed, until the decision in the Federal Court of Appeals decision in Frye v. United States, in 1923.91 One could take the position that it was not seriously addressed there either. Given the fact that the court cited no authority for its position that what was generally accepted in the relevant scientific community was acceptable to them, they seemed in line with the general attitude of the cases discussed earlier in this chapter. It was not until 1993, in the Supreme Court’s major science decision in Daubert, and the Joiner and Kumho Tire decisions that followed,92 that the sea-change noted above turned to a tidal wave of change of attitude, resulting in our contemporary adversarial role with respect to the contributions of modern science in litigation practice. Chapter 2, Science and the Courts, closely examines the current judicial posture on the science issue after a brief historical examination of the development of the common law of products liability. This powerful set of ideas, primarily centered on wide-ranging issues of the commercial applications of science, was completed in the 70-year hiatus between Frye and the litigation storm created by Daubert and its progeny, without major concern about questions of scientific reliability to support expert opinion.

Endnotes 1. John Horgan, The End of Science: Facing the Limits of Knowledge in the Twilight of the Scientific Age (Addison Wesley, 1996). See also, John Maddox, What Remains to Be Discovered: Mapping the Secrets of the Universe the Origins of Life and the Future of the Human Race (Free Press, 1998). 2. Horgan, at 139.



27

3. If we examine a number of product liability cases from the past five years, one thing becomes apparent: the concern, central issue, and debate are pretty much restricted to the marketing aspects of the corporation who developed, tested, received government approval, and packaged the commercial product. The only time that science, in the sense of recent Supreme Court cases, is involved, is in pure physical cause cases. In the next century such cases will be increasingly less rare as the result of recent understanding of genetic damage. Thus, in most products liability cases, we are talking about the business repercussions of applied science, often completed many decades before the death or injury involved in the current case. 4. Kumho Tire Company, Ltd. v. Carmichael et al., 526 U.S.137, 119 S.Ct.1167 (1999). Dauber’s “gatekeeping” obligation, requiring an inquiry into both relevance and reliability of proffered expert opinion, applies not only to scientific testimony, but to all types and disciplines involving expert testimony (Fed.Rules Evid.Rule 702, 28 U.S.C.A.) 5. Charles Babbage, Reflections on the Decline of Science in England, and on Some of Its Causes (1830) (Irish University Press, Shannon, reprint, at 15). 6. See Chapter 3, Science and the Courts, for a detailed discussion of these and other important science-centered appellate decisions. 7. This has actually been the case since the earliest full-scale interactions between law and science in the mid-19th century. See discussion infra. 8. Part II of this book, Science and Litigation, will address the corporate process in considerable detail. See Chapters 5–9, infra. 9. Part I, Science and Legal Theory, will address selected complex legal issues that are typically involved in the products liability and environmental areas. See Chapters 1–4, infra. 10. The basic features of the science issues encountered in agency regulations are quite similar to those encountered in products liability litigation. See, e.g., D. Hiep Truong, “Daubert and Judicial Review: How Does an Administrative Agency Distinguish Valid Science from Junk Science?,” 33 Akron L. Rev. 365 (2000); Michael Gough, “How Much Cancer Can the EPA Regulate Away?” 10 Risk Analysis 1; Cass R. Sunstein, “Health-Health Tradeoffs,” 63 U.Chi.L.Rev. 1533 (1996); Peter H. Schuck and E. Donald Elliott, “To the Chevron Station: An Empirical Study of Federal Administrative Law,” 1990 Duke L.J. 984. See also, Thomas O. McGarity, Reinventing Rationality: the Role of Regulatory Analysis in the Federal Bureaucracy (Cambridge, 1991); Richard H. Pildes and Cass R. Sunstein, “Reinventing the Regulatory State,” 62 U.Chi.L.Rev. 1, 43–95 (1995). 11. Reference Manual on Scientific Evidence, 1st ed. (1996); 2nd ed. (2000), Federal Judicial Center. Also see, Johnson, Krafka, and Cecil, “Expert Testimony in Federal Civil Trials: A Preliminary Analysis,” (Federal Judicial Center, 2000), analyzing some of the findings of a study of federal judges in 1998 referencing the science-based litigation concerns addressed in the first edition of the Manual.


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Science and Litigation: Products Liability in Theory and Practice 12. Ibid. at 2nd ed., p. iv. 13. The first edition of the Manual contains chapters by respected experts on the following subjects: “Reference Guide on Toxicology” (Bernard 0. Goldstein and Mary Sue Henifin); “Reference Guide on Survey Research” (Shari Seidman Diamond); “Reference Guide on Forensic DNA Evidence” (Judith A. McKenna, Joe S. Cecil, and Pamela Coukos); “Reference Guide on Statistics” (David H. Kaye and David A. Freedman); “Reference Guide on Multiple Regression” (Daniel L. Rubinfeld), “Reference Guide on Estimation of Economic Losses in Damages Awards” (Robert E. Hall and Victoria A. Lazear). The second edition added material that addresses issues that have arisen since the first edition. An Introduction by Supreme Court Justice Breyer reviews the role of scientific evidence in litigation and the many challenges that trial courts face in considering such evidence. Professor Margaret Berger summarizes key post-Daubert decisions, such as the Joiner and Kumho Tire cases. David Goodstein provides a tutorial on the centrally important topic of the philosophy and practice of science. Additional reference guides are provided on the subjects of “Medical Testimony” (Mary Sue Henifin, Howard M. Kipen and Susan Poulter) and “Engineering Practice and Methods” (Henry Petroski). All previously published reference guides have been revised and updated. 14. See Chapter 1, Science in Litigation, India Rubber to Bioinformatics, infra. 15. Reference Manual on Scientific Evidence, 2nd ed. (2000), supra n. 5, at v. The reference manuals are but one part of a series of educational and research initiatives being undertaken by a variety of legal scholars and government supported entities. See, e.g., The C.A.S.E. project, sponsored by the American Association for the Advancement of Science (AAAS), which strives to supply federal courts with neutral expert scientific witness in complex science-based litigation, such as the breast implant controversy. See also, “Expert Testimony in Federal Civil Trials: A Preliminary Analysis,” by Molly Treadway Johnson, Carol Krafka, and Joe S. Cecil (Federal Judicial Center, 2000). See also, Chapter 6, Science and Expert Witnesses, infra. 16. The term “scientific due process” has come into our vocabulary of late in the context of demands for open public access to the details of government funded research, especially in light of the recent Shelby Amendment, allowing open access to large amounts of federally funded research. It is also being increasingly used as a catch phrase for a variety of information access issues in administrative as well as litigation contexts. See, e.g., Eugene Russo, “Debating Shelby: Tension Continues to Mount over Principles of Data Access,” Scientist 15(7):14 (April 2, 2001). 17. See Part II, Science and Litigation Practice. 18. See Chapter 2, Science and the Courts, for a detailed analysis of that late 20th century effort. 19. Robert Hooke, Micrographia, or Some Physiological Descriptions of Minute Bodies Made by Magnifying Glasses with Observations and Inquiries Thereon (1667), at Preface, 2.



29

20. See, Kate Fodor, “Biotechnology Boom Strains U.S. Patent Office,” Reuters, October 27, 2000. Also see, Q. Todd Dickinson, “Reconciling Research and the Patent System,” Issues In Science and Technology Online, Summer 2000: 1–7. 21. Id. These concerns over the past century have given impetus to the steady growth of the consumer-oriented products liability and environmental legal theories that are the driving force for the growth of increasingly complex litigation, pitting injured consumers against a very large number of national and international corporations. They may be expected to continue and develop in this new century of genetics. See Chapter 2, Science and the Courts. 22. See Part II, Science and Litigation Practice, Chapters 5–9, infra. 23. The utilization of a wide variety of forensic sciences in the criminal justice system is a related, but fairly distinct world of law and science questions. See Kiely: Forensic Evidence: Science and Criminal Law (CRC Press, 2000). Also see, Faigman: Legal Alchemy: the Use and Misuse of Science in the Law (W.H. Freeman, 2000) for a very general discussion of the range and broad outlines of a number of law and science categories. 24. The “not proven” option of the Scottish legal system provides an interesting third option, perhaps closer to the mark in many modern American civil and criminal trials. 25. See Chapter 2, Science and the Supreme Court, infra. 26. Frye v. United States, 54 App.D.C.46 293 F. 1013 (1923). 27. Bruce: The Launching of Modern American Science (Cornell, 1987) at 11. 28. Ibid. 29. Ibid. at 11. 30. Ibid. at 4. 31. For the year 1776, until an official patent system and staff were established, a part of Jefferson’s duties as Secretary of State in the Washington administration was the examination of patent applications and witnessing the applicant’s demonstrations, at times performed on his desk. The first patent issued by him was to Samuel Hopkins on July 31, 1790 for making pot and pearl ashes. See, Dumas Malone, Jefferson and the Rights of Man, Vol. I, (1951) at 282. But see a recent challenge to that distinction in David Maxey, “Inventing History, The Holder of the First U.S. Patent,” Journal of the Patent and Trademark Office Society (March 1998). Also see generally, Brooke Hindle, The Pursuit of Science in Revolutionary America 1735–1789 (Little, Brown & Co., New York, 1956); A. Hunter Dupree, Science in the Federal Government: A History of Policies and Activities to 1940 (Cambridge, 1957); Ralph S. Bates, Scientific Societies in the United States (Cambridge, 1945); Edward C. Walterscheid, “The Use and Abuse of History: the Supreme Court’s Interpretation of Thomas Jefferson’s Influence on the Patent Law,” 39 Idea: J.L. & Tech. 195(1999). See on the American background, I. Bernard Cohen, Benjamin


30

Science and Litigation: Products Liability in Theory and Practice Franklin’s Science (Harvard, 1990); I. Bernard Cohen, Science and the Founding Fathers (Norton, 1995). On 17th and 18th century English practice, see two excellent studies, Steven Shapin and Simon Schaffer, Leviathan and the Air Pump (Princeton, 1985) and Steven Shapin: A Social History of Truth (Chicago, 1994). Also see, John Carey, Eyewitness to Science (Harvard, 1995). 32. Quoted in Henry Adams, History of the United States of America During the Administration of Thomas Jefferson (Library of America, 1986), at 45. 33. Id. 34. Charles Babbage, Reflections on the Decline of Science in England, and on Some of its Causes (1830) (Irish University Press, Shannon, reprint, at 10). 35. Ibid. at 19. 36. Henry Adams, History of the United States of America During the Administration of Thomas Jefferson (Library of America, 1986), at 53. For useful studies of the history of science in a developing America, see, Bruce: The Launching of Modern American Science (Cornell, 1987); Daniels: American Science in the Age of Jackson (University of Alabama, 1968); Struick: Yankee Science in the Making (Dover Press, 1991, Reprint). 37. Quoted in Henry Adams: History of the United States of America During the Administration of Thomas Jefferson (Library of America, 1986), at 52. 38. It is of interest to note that of the only book listings contained in the first edition of the Scientific American, published nearly a half century later in 1845, under the heading “Valuable Recent Publications,” only two cite remotely technical volumes, McCulloch’s Gazeteer, covering aspects of geography and statistics, and Copland’s Dictionary of Medicine. The other 13 volumes addressed domestic economy, Platonic theology, Latin versification, Greek history, the philosophy of rhetoric, scriptural chronology, Prescotts’ histories of the conquest of Mexico and the reign of Ferdinand and Isabella, an essay on taste, a history of Europe, a philosophic treatise on the sublime, and Hallech’s Poems. See Scientific American 1(1), facsimile (August 25, 1845). 39. See Scientific American 1(1) facsimile (August 25, 1845) listing on its first page a “Catalogue of American Patents issued in 1844.” 40. Kathryn Brown, “The Human Genome Business Today,” Scientific American (July 2000) at 50–55. 41. Julia Karow, “The Other Genomes,” Scientific American (July 2000) at 53. 42. Ken Howard, “The Bioinformatics Gold Rush” Scientific American (July 2000) at 58-63. 43. Carol Ezzell, “Beyond the Human Genome,” Scientific American (July 2000) at 64–69. Also see, R.F. Service, “Structural Genomics Offers High Speed Look at Proteins,” Science 287 (March 17, 2000) at 1954–1956; A. Abbott, “A PostGenomic: Learning to Read Patterns of Protein Synthesis,” Nature, 402 (December, 1999), at 715–720. 44. Id.


Science in American Litigation: India Rubber to Bioinformatics 45. 46. 47. 48. 49. 50.

51. 52. 53. 54. 55. 56. 57.

58. 59.

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Scientific American 1(1), facsimile (August 25, 1845). Ibid. at p. 2. Id. Vidal et al. v. Girard’s Executors, 2 How127, 134, 43 U.S.127, 11 L.Ed.205 (1844). Spencer Cowper’s Trial, 13 How.St.Tr.1106, 1163 (1699). The Spencer Cowper case is cited as one of the earliest instances of the legal issues raised by attempts to utilize authoritative treatises to establish a fact or, alternatively, to effect impeachment of an expert under the strictures of the hearsay rule. The use of expert testimony in complex scientific and medical cases has a long and fascinating history. See, Stephan Landsman, “Of Witches, Madmen, and Products Liability: A Historical Survey of the Use of Expert Testimony” Behavioral Sciences and the Law 13, 131–157 (1995); Stephan Landsman, “One Hundred Years of Rectitude: Medical Witnesses at the Old Bailey, 1717–1817,” Law and History Review 3 (Fall 1998). 29 F.Cas.1123, 1 Gall.478 (Cir.Ct.Mass. 1813). Id. at 1124. Id. at 1124. 30 F. Cas. 723 (Cir.Ct.D.Mass. 1840). Id. at 725. 4 F. Cas. 510 (Cir.Ct.S.D.NY 1841). Id. at 512. Also see, Parker v. Hatfield, 18 Fed.Cas.1127, 1133 (D.Ct.Ohio 1845), an infringement claim involving hydraulic machinery. “The novelty of the invention has been called in question by the counsel, and a reference is made to the Dictionary of Arts and Sciences (page 2010) under the head of ‘Mills’; and to other treatises on mechanics, but we think without success. We think the invention of complainant is different in principle from any structures referred to.”; Van Hook v. Pendelton, 1 Fish. Pat. Rep. 120, 28 F.Cas.991 (Cir.Ct.S.D.NY 1846), an infringement claim as regards tongue and groove carpentry machinery. “Models of the respective machines were introduced, and the defendants read numerous affidavits made by engineers and mechanical experts, to show that the two machines were different in principle and mode of operation.” 18 Fed.Cas.1163 (Cir.Ct.D.Ohio 1849). Id. at 1176. Also see, Parker v. Sears et al., 18 F.Cas.1159, 1160 (Cir.Ct.E.D. Penn. 1850), a patent infringement case involving the patent on the Parker Water Wheel. “…The whole history and science of hydrodynamics has been discussed and numerous conflicting affidavits read…”; Many v. Sizer et al., 16 Fed.Cas.684, 1 Fish.Pat.Cas.17 (Cir.Ct.D.Mass. 1849) A patent infringement case involving a mode of constructing cast iron wheels for railroad cars. “There has been much evidence before you upon these points. You have the opinions of gentlemen of science and skill, of experts conversant with this



32

60. 61. 62. 63. 64. 65. 66. 67.

68. 69.

70. 71. 72.

73.

74. 75. 76. 77.

particular art, upon this question, and also many detailed facts from those acquainted with the operation of the wheels.” 18 F.Cas.639, 2 Am. L. J. (N.S.) 317 (D.Ct.Wis. 1849). Id. at 640. 1 F.Cas.476, 6 McLean 303 (Cir.Ct.D.Ohio 1855). Id. at 477. 9 F.Cas.373 (Cir.Ct.N.D.NY 1849). Id. 9 F.Cas.790, 797, 4 Am. L. J. (N.S.) (Cir.Ct.E.D.Penn. 1851). Id. at 797. See Stephan Landsman, “Of Witches, Madmen, and Products Liability: An Historical Survey of the Use of Expert Testimony,” Behavioral Sciences and the Law, 13, pp. 131–157 (1995), regarding the growth in American courts of the adversarial style of the examination of expert witnesses: Beginning in the 1840s America experienced its first malpractice crisis…The growth of malpractice litigation was fueled by the adoption of the contingency fee by American lawyers in the 1850s. Malpractice litigation drove a wedge between the medical elite and the bar that proved very difficult to close…Doctors were increasingly likely to feel themselves targeted in the courtroom not only as parties in malpractice cases but when they served as witnesses. Ibid. at 145. Also see, Stephan Landsman, “One Hundred Years of Rectitude: Medical Witnesses at the Old Bailey, 1717–1817,” Law and History Review, 16(3) (Fall 1998). 10 F.Cas. 678, 2 Wall.Jr.C.C. 283 (Cir.Ct. N.J. 1852). 86 U.S. 287, 22 L.Ed. 125, 19 Wall. 287 (Sp. Ct. 1873). This important patent was upheld in an earlier Ohio challenge. See, Tilghman v. Werk, 23 F.Cas.1260, 1 Bond 511, 2 Fish.Pat.Cas.229 (Cir.Ct.S.D.Ohio 1862). See, Chapter 2, Science, Products Liability and the Courts, infra. 10 F.Cas.678, 2 Wall.Jr.C.C. 283 (Cir.Ct.N.J. 1852). Webster was paid a fee of $15,000, the highest fee ever recorded up to that date. Opposing counsel was the famous American lawyer, Rufus Choate. See, “Charles Goodyear and the Strange Story of Rubber,” located at http://www.goodyear.com/us/corporate/strange.html. The full argument of Daniel Webster may be found in “Argument of Daniel Webster in the Goodyear Rubber Case,” Journal of the Patent Office Society 22(1), pp. 32–46 (1940). 10 F.Cas.678, at 682–683. Id. 10 F.Cas.678, at 682–683. Ibid. at 684. Also see, Burr v. Duryee, 17 L.Ed.650, 1 Wall. 531(1863), involving the alleged infringement of a patent for a machine for making hat-bodies. Justice Grier, the trial court in the Day v. Goodyear India rubber case, refers



78. 79.

80. 81. 82.

83. 84.

33

to the “large museum of exhibits in the shape of machines and models” which had “been presented to the court,” and which, he states, were “absolutely necessary to give the court a proper understanding of the merits of the controversy.” The whole process of making hats, from the disintegrating of the fur to the production of a hat-body, was carried on and exhibited in the courtroom. The decision contains an extensive history of the hatter industry in Russia, Europe, and America, a very detailed description of the hatter’s art of making hats from fibers of fur or wool felted together, and a close rendering of the design and functioning of the various machines historically and currently in use in the making of beaver hats. Burr v. Duree, at 533–549. Justice Grier in his trial opinion, also referred to the growing professionalism of the nation’s patent office and officers: The Patent Bureau in this country is composed of men of scientific attainments, who examine the merits of every claimant of a patent, and decide whether in their opinion it attempts to claim a monopoly of things before known or invented. They are not expected, as formerly, to grant a patent without inquiring, to every applicant who is ready to pay the fees. Such a course of conduct would be highly injurious to the public, by furnishing means to impose on the public by false pretences, and with threats of expensive and ruinous litigation. (Burr v. Duree, at 533–549). 86 U.S.287, 22 L.Ed.125, 19 Wall.287 (Sp.Ct. 1873). A decade earlier, Tilghman had successfully protected his patent as the first and original discoverer of a new and useful improvement in the process for the decomposition of fatty substances and oils for practical purposes. However, in the early 1870s the challenge was made again, with the verdict against Tilghman, based upon a significantly expanded record of quotations from scientific books and journal articles, expert witness affidavits and depositions, and numerous experiments used for demonstration at trial. Here practical demonstrations of the considerable differences between the plaintiff ’s and defendant’s processes were the deciding factors against Tilghman’s claim of infringement. 86 U.S.287, 22 L.Ed.125, 19 Wall.287 (Sp.Ct. 1873). Id. at 400. The second Tilghman case is an excellent example of the use of science in litigation, with little or no challenge to the scientific grounding or reliability of the very considerable science materials offered by the parties. Extensive quotes from the numerous treatises were attached as exhibits and readily accepted by the court. This case record may also serve as a reflection of the experts, treatises and scientific journals that were deemed to constitute the state of the art of chemistry at the beginning of the last quarter of the 19th century. 1 Abb. Adm. 11, 13 F.Cas.134 (D.Ct.S.D.NY 1847). Id. at 138.



34 85. 86. 87. 88. 89. 90. 91. 92.

28 F.Cas.25 (Cir.Ct.D.Ohio 1851). Id. at 28–29. 1 F. Cas. 187 (D.Ct.D.Cal. 1855). Id. at 190. 18 F.Cas.1236 (Cir.Ct.D.Cal. 1871). Id. at 1244–1245. 54 App.D.C.46 293 F1013 (1923). Daubert v. Merrell Dow Pharmaceuticals, 509 U.S.579, 113 S.Ct.2786 (1993); General Electric v. Joiner, 118 S.Ct.512, 522 U.S.136 (1997); Kumho Tire Company, Ltd. v. Carmichael et al., 119 S.Ct.1167 (1999). See Chapter 2, Science and the Courts, for a detailed analyses of these important cases and those following them to date.

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That there can be issues of fact which courts would be altogether incompetent to decide, is plain. If the question were, for example, as to the chemical reaction between a number of elements, it would be idle to give power to a court to pass upon whether there was ‘substantial’ evidence to support the decision of a board of qualified chemists. The court might undertake to review their finding so far as they had decided what reagents had actually been present in the experiment, for that presumably would demand no specialized skill. But it would be obliged to stop there, for it would not have the background which alone would enable it to decide questions of chemistry; and indeed it could undertake to pass upon them only at the cost of abandoning the accumulated store of experience upon the subject. — Judge Learned Hand, N.L.R.B. v. Standard Oil Co., 138 F.2d 885, 887 (2d Cir. 1943)

Science and Products Liability This chapter begins with a brief summary discussion of the basic theoretical components of the products liability litigation system, and is followed by a close examination of how the scientific components of such cases are practically analyzed prior to beginning the long, complex, and expensive products liability litigation itself. An analysis of recent efforts by the United States Supreme Court to establish a workable set of concepts and trial court guides in the effort to monitor the substance of scientific opinions in products liability and other science-centered litigation follows. For 70 years after the 1923 U.S. Court of Appeals decision in Frye v. United States,1 and in all the years preceding it, American courts fashioned our contemporary strict products liability theory in thousands of cases questioning the safety of some commercial application of science involving most areas of modern pharmacology, chemistry, and engineering. 2 The 1993 Daubert decision started the formal Supreme Court examination of the supportive science at the base of expert opinion. Its progeny, Joiner and Kumho Tire, currently hold sway on the essentials of supportive scientific method in a wide variety of cases. These important decisions are discussed at length below. 35


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In the mid-19th century, the specter of unlimited liability for manufacturers was raised as an impassable barrier to any idea of liability for injuries resulting from contact with defective goods without some type of contractual relationship between the parties. Indeed, stated the court in the famous case of Winterbottom v. Wright,3 decided in 1842: If the plaintiff may, as in this case, run through the length of three contracts, he may run through any number or series of them; and the most alarming consequences would follow the adoption of such a principle. For example, every one of the sufferers by such an accident as that which recently happened on the Versailles railway might have his action against the manufacturer of the defective axle.

At the beginning of the 20th century, and especially since the publication of Restatement 402A in 1965, the nation’s courts have virtually completed the slow process of supplying the marketplace referents for its various terms. Courts are fairly unanimous in their understanding of who is a “seller,” what constitutes a “product,” and what defenses are generally available to defendants. A new round of decisions will no doubt result from the publication of the Restatement of Torts, (Third) version of strict liability for products. While there continues to be disagreement as to the practical, business-world standard to be used to determine if a product is in a defective condition, there is at least a general consensus on the theoretical standards for determining that central issue. The Second Restatement’s Section 402A remains the theoretical centerpiece. The basic theoretical underpinning of strict liability for products has been settled for years. The uniformly accepted verbalization of the idea is still that stated in 402A of the Restatement (Second) of Torts. That section provides: Special Liability of Seller of Product for Physical Harm to User or Consumer (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) The rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.4



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In a products liability action premised on negligence, the plaintiff must prove that the manufacturer, seller, or distributor breached a duty of care owed to the plaintiff and thereby proximately caused the plaintiff to be injured.5 While the duties that are owed by defendants under a negligence theory in products liability suits may vary, all relate to the reasonableness of the defendants’ conduct. A manufacturer is required to exercise reasonable care in the planning, designing, and manufacturing of a product in order to ensure that it is reasonably safe to use.6 The duty of the seller or distributor is simply to exercise that care which a reasonably prudent person would under the same circumstances. Thus, in pursuing a theory of negligent design or manufacture, the conduct of the maker or seller is in question. On the other hand, in pursuing a theory of strict liability, the focus is theoretically on the product itself. 7 Pursuant to the theory of strict products liability, a seller or distributor can be liable for injury or loss resulting from a defective product that entered the stream of commerce, even in the absence of fault; under a negligence theory, fault on the part of the manufacturer, designer, or distributor is an element that must be established in order for an injured party to recover. 8 Strict products liability is invoked, and is intended to apply, in those instances in which traditional theories of negligence are inadequate or where it is practicably impossible to prove negligence. Moreover, strict liability is often a more realistic theory of recovery than that of contract warranty when a person suffers physical harm from a product that is dangerous if defective. The requirement of showing a defect is one element common to every products liability case, whether the case is brought under a theory of negligence, breach of an express or implied warranty, strict tort liability, or a combination of theories. The Restatement 402A definition of defect is still used by the majority of courts as the basis for jury instructions on the defect issue. This definition, known as the “consumer expectation test,” provides that a product may be deemed defective if it is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it.”9 The risk-utility test, on the other hand, attempts to focus the presentation of evidence — and the subsequent jury evaluation of it — on the safety of the product proper, rather than on the assumptions that may be made as to its safety by the ordinary consumer who purchases and/or uses it.10 Because of its multifaceted analytical focus, the risk-utility test encompasses much more than an undefined and murky reference to the expectations of the ordinary consumer.11 The many theoretical concerns regarding the application of the doctrine of strict liability to a wide range of industries have, after many years of developing case law, been resolved. None of those issues involved any perceived need to focus on the factual life’s blood of products liability, which is the commercial application of scientific ideas. Who was a seller? What was a product?



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Who was a proper party defendant? What were available defenses? and a series of intergovernmental issues, such as preemption and the impact of federal regulatory measures, have on the common law action. These questions have been central to the strict liability arena. The concept of sellers was quickly found to include actual retailers as well as manufacturers, wholesalers, distributors, assemblers, bulk suppliers, component parts manufacturers, trademark licensors, lessors, and sellers of used goods. In some instances the availability of the theory was also approved for successor corporations and in more restrictive settings, for an entire industry. The idea of a “product” or “good” was soon found to include virtually all manufactured products of whatever scientific origin, with a remaining debate on the delivery of a pure service, such as electricity. While actual allegations of defects in products liability cases obviously could cover hundreds of thousands of product-use settings, the courts quickly defined a limited number of generic defects within which any actual case could fit. These were designated as follows: • • • • • •

Manufacturing or unit defects Packaging defects Instruction defects Failure to warn defects Design defects Misrepresentation defects

Manufacturing defects alleged that the unit of the product purchased or used by the complaining party was defective in a real sense through mismanufacture. In effect, it was not, as a unit, properly made as were the others in the same product line. This category of defect is the only one where the alleged defect, if proven, can be characterized as a factual finding. As will be seen, the allegations of the other categories are essentially characterizations of aspects of the entire line of goods, which results in the “paper science” weighing of contending scientific testimony and involves the basic subject matter of the present volume. Packaging defects basically allege that while the actual product itself may be fine in all respects, the packing is so improperly designed that a reasonable consumer could suffer injury in a foreseeable attempt to access the product. This type of allegation is typically addressed to an entire line of product. Communications-related defects include instructions and warnings settings. Instruction defects involve claims that a reasonable consumer could follow the printed or taped instructions and suffer death or injury. This type of allegation is also typically addressed to an entire line of product. Failure



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to warn defects involve allegations that the manufacturer failed to warn at all about a foreseeable risk of death or injury or did so in an ineffective manner. These cases cover the range of manufactured goods, but are most obvious in cases involving pharmaceuticals, whether over-the-counter or prescription. Design defect cases allege that the product, whether machine, chemical, or drug, was misdesigned in some fashion that placed consumers in a foreseeable risk of death or injury. These cases can range from automobile rollover or rear-end collision fires, toxic emissions or spills, or a legion of alleged design problems across the international manufacturing arena. These and the failure to warn cases account for the bulk of the products liability litigation that has, and will continue to foment the law and science issue. This will especially be the case in the new world of genetically based products of the ensuing decade. Finally, misrepresentation defects address false statements of material fact set forth in advertising or other promotional literature designed to be relied upon by the consumer. The authors of the Restatement Third acknowledge the virtually uniform acceptance of these defect categories in statutes, case law, products liability treatises, and law review commentary. 12 In order to achieve a clear understanding of the place of science in our current products liability litigation system, we must now examine the broader, ultimately controlling litigation system itself, within which products cases, like all others, must function. A look at several key components of the trial process itself will shed considerable light on our central topic of the place of science in the litigation subset of products liability.

Science and the Civil Law The historian, Carl Becker’s observation on writing history applies with equal force to the investigation and prosecution of a civil case: I ought first of all to explain what I mean when I use the term history. I mean knowledge of history. No doubt throughout all past time there actually occurred a series of events which, whether we know what it was or not, constitutes history in some ultimate sense. Nevertheless, much the greater part of these events we can know nothing about, not even that they occurred; many of them we can know only imperfectly; and even the few events that we think we know for sure we can never be absolutely certain of, since we can never revive them, never observe or test them directly. The event itself once occurred, but as an actual event it has disappeared; so that in dealing with it the only objective reality we can observe or test is some material trace which the event has left…13


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On the criminal side, the highly publicized O. J. Simpson and Jon Benet Ramsey murder cases may serve as recent modern examples of this inherent difficulty in the history-finding function of the American justice system. Similar difficulties are experienced daily in American civil trials, as evidenced by the ongoing judicial debates on causation in the breast implant cases and a wide variety of chemical or pharmacological centered litigation. Both sides to the investigation of a case have their respective versions of “what happened that day.” The proof of facts in litigation is the proof of a relevant history within which individual or corporate responsibility is determined. The importance of getting our theories straight in determining past fact is essential in litigation. It is not simply some unimportant academic exercise that can be bandied about by law professors. As noted by Professors Steven Shapin and Simon Schaffer in their excellent study of the search for scientific fact, Leviathan and the Air Pump: A discarded theory remains a theory. There are good theories and bad theories, theories currently regarded as true by everyone and theories that no one any longer believes to be true. However, when we reject a matter of fact, we take away its entitlement to the description: it never was a matter of fact at all.14

Any trial, in any area of law, from the simplest to the most complex, is in essence an exercise in establishing a version of history. In a criminal case, such as murder, sexual assault, or robbery, the historical period of interest is typically a fairly restricted one, amounting to as little as several hours. However, in a protracted patent infringement, contract, antitrust or more particularly here, a complex products liability or toxic tort case, the relevant historical period can reach back decades, and involve the scrutiny of thousands of pieces of scientific scholarship and in-house corporate documents. If a case has proceeded to trial, then the existence or exact nature of one or more material facts are still in question and thus must be determined by the jury as case historians, the triers of fact. Once the jury has determined the basic facts, then the court can instruct them as to the law on any facts as found by them to have occurred. The history of Anglo-American common law trials is testimony to the great and ongoing difficulty in determining the factual basis of a case.15 The context in which the science-based questions addressed in this book arise are based in the proffer of expert testimony in civil or criminal cases, where one side, at a pretrial hearing or at trial, seeks to challenge the propriety of the other side’s experts testifying at all, or as is more frequently the case, to challenge the reliability or general acceptability of the methodology used by the expert in forming an opinion. For example, a lawyer in a civil products



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liability case wants his expert to testify that long-term exposure to PCBs caused cancer in his client. The company lawyers have their own experts, who will deny the carcinogenic potential of PCB. In a criminal prosecution for sexual assault and murder the state wishes to present complex DNA, hair, and fiber testimony to place the defendant at the crime scene.16 According to tried and true evidence law theory, any such witness may be challenged on four basic grounds. First, the case may simply not call for expertise at all and the jury may decide the disputed fact without the need for lengthy (and typically highly prejudicial) testimony. Second, a particular expert witness may be challenged on basic qualifications to give any opinion in the field at issue since he or she has insufficient background in education or experience to have anything of value to offer on the fact at issue. Third, either the methodology utilized by the expert to support the opinion is not, in fact, scientifically sound, thereby not capable of supporting the proffered opinion; or fourth, the methodology is sufficiently sound scientifically to support an opinion, but this witness’ opinion based on such method is not sufficiently derived from such scientific methodology.17 The latter two processbased objections are the key objections at the center of the current state and federal controversy over the utilization of scientific opinion in America’s courts. Civil cases with central science based issues are typically products liability or toxic tort litigation, where the essential science questions often revolve around whether the defendant’s product “caused” the death or injury allegedly suffered by the plaintiff. In such cases the defense routinely argues that there is no causative link between their product and the injury to the plaintiff. These defenses focus on the single issue of whether defendant caused the actual injury alleged, without the need to determine the contribution of defendant’s business practices as a major contributor to any injuries suffered. The evidentiary basis for such arguments is generally grounded in the findings of published peer reviewed studies, or proprietary in-house internally generated scientific studies obtained through discovery. These studies, often referenced as state of the art literature, rarely directly address the precise scientific issues that are at the center of the argument. It is from these types of data that an expert opinion is extrapolated. This process, in turn, has and will continue to foment science debates in current and future litigation. 18 In civil injury cases the scientific questions of cause are typically considered in the context of the legal doctrines of cause-in-fact or proximate cause, which concepts are far removed from questions of causal relation addressed in nonlegal, science-driven inquiries. In these drug, chemistry, and engineering based cases, the major issue is typically: Who has the most persuasive interpretation of what the literature directly, or by extrapolation, says, to the extent that it does, with respect to the physical connection between the


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plaintiff ’s injury and the components of defendant’s product that the plaintiff was in contact?19 Experts in a variety of products cases typically give extensive narrative testimony as regards to the scientific background or context of the instant litigation or a case-specific opinion, and it all looks and sounds very “scientific.” However, the fact remains that these exercises and the growing number of pretrial Frye or Daubert hearings seeking to exclude or limit a variety of expert opinions, primarily involve talking about the scientific work of others as to how, utilizing the principles of extrapolation theory, such studies may shed light on one or more of the causation centered-issues involved in the case.20 The area where “science” per se, as opposed to product-related commercial application, is actually the focus of the litigation are those rare cases actually centered in the existence or nonexistence of physical causation: Does silicone released in a breast implant patient’s body cause autoimmune damage? Does long-term exposure to certain chemical substances cause cancer? Did the ingestion by pregnant mothers of Bendectin cause birth defects? Did the ingestion of the antilactation drug Parlodel cause a mother’s brain aneurysm? Even here, opinions based upon preexisting scientific literature are used by hired experts to answer the questions. As noted, this typically is accomplished without any actual laboratory studies as case specific data. 21 A brief examination of the use of science-based forensic evidence in criminal cases will highlight the important differences in the use of science in the criminal and civil justice litigation systems.

Forensic Evidence and the Criminal Law Discussions of the use of science in the criminal law typically revolve around the subject of forensic evidence. Forensic evidence refers to facts or opinions proffered in criminal cases that have been generated or supported by the use of one, typically more than one, of the corpus of forensic sciences routinely used in criminal prosecutions. There is an extensive list of such disciplines, the legal ramifications of which will receive extended attention in this section. The central focus in the utilization of the findings of forensic science is the crime scene. The prosecutorial goal is to link a suspect to a crime scene. While a crime scene can consist of the basement of a counterfeiter or the broken door lock of a supermarket, typically the term refers to the scene of a violent crime such as a sexual assault or a homicide. The use of the crime scene paradigm is not only a familiar focus for the training of forensic scientists, it is also the central source and reference point for analysis of the many legal issues that are involved directly — or indirectly — in the field of forensic evidence.



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The term forensic evidence encompasses two distinct ideas and processes. The forensic part refers to the processes utilized in the forensic science at issue through which facts are generated. The manner in which DNA is extracted, tested, and subjected to population analyses serves as a major example. The methodologies of hair, fiber, and fingerprint examination are other illustrations. The area of forensic science encompasses a fairly discrete number of well-known disciplines. The more important among the body of forensic sciences are: • • • • • • • • • • • • • • • •

Hair analysis Fiber analysis Glass fragment and paint chip analyses Soil analysis Ballistics and toolmarks Fingerprints Footwear Tire impressions Blood spatter analysis DNA analysis Forensic anthropology Forensic archeology Forensic pathology Forensic odontology Questioned document analysis Forensic psychiatry and psychology22

In contrast, the “science” addressed in products liability and environmental cases does not lend itself to such finite boundaries. While there are repetitive areas of scientific focus in civil cases such as chemistry and pharmaceuticals or biological, mechanical, or electrical engineering, there is much less of an opportunity to discuss the general outlines of acceptable methodology in such cases. The forensic sciences, traditionally associated with the prosecution of crime, typically require in each case a broad methodological review of the basic principles of the forensic science under discussion. Nonetheless, the legal concerns, that is, the production of relevant case facts, are basically the same. Initially, it is important to recall the fundamentally different reasons for the introduction of scientifically generated information in the civil and criminal litigation systems. The use of the term litigation is important here since it is in the process of litigation that the issues discussed herein come to the fore. This is quite distinct from other contexts where the nature or acceptability of scientific methodologies or opinions are at the center of the inquiry, such as grant requests, patents, contractual disputes, or publication in a scientific peer-reviewed publication.


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The legal issues most involved in the science debates of the past decade are questions of the relationship between scientific and legal standards to determine causation. The evidence part of the concept of forensic evidence refers to a distinct set of procedures unique to the litigation process, separate and distinct from the processes of any forensic science or sciences that are the basis for the proffer of facts in a criminal case. In civil as well as criminal cases, the parties are seeking to prove or disprove a sufficiently strong connection between defendant’s act or omission and the death or injury in the suit. However, the science at issue usually consists of studies that may only be probative of any such connection by way of extrapolation, without the individualizing expert testimony typically provided by forensic scientists. 23 Forensic evidence in criminal cases deals with scenarios far different from civil law tort cases, in which no real science is done to serve the theoretical need to prove causation. In the criminal case the use of forensic science means that some form of laboratory work is performed to resolve factual matters in the case itself. In both civil and criminal cases the information provided from scientific sources must be relevant to one of the issues in the case. In civil cases this typically involves the question of whether some commercial application of some scientific formulation “caused” the plaintiff’s death or injury. The value of forensic evidence for police and prosecutors lies in its ability to interpret multiple physiological aspects of a crime scene and, hopefully, to link a particular suspect to it.24 The basic legal antagonism between forensic scientists and the courts can be encapsulated in a single question: How far do forensic scientists say they can go in making a definitive statement about a crime scene and/or the linking of a suspect to it because they have a microscope? and, How far do we let them go because we have a constitution? The importance of this question lies in the recognition of just how far and on what empirical basis any such statements can be made at all, and the impact that any such statements may have on a jury in causing any such match testimony, albeit given in a qualified manner, to be taken as true by a jury. The concern has always been that a criminalist’s testimony that a hair or fiber obtained from a suspect was consistent in all respects or not dissimilar will be internalized by jurors as statement of a definite match. It is important in this respect to realize that, with the possible exception of fingerprint and ballistics testimony, the opinions of most forensic experts typically are only permitted to be couched in such qualified terms.25

Science and the United States Supreme Court The key modern decisions addressing the science question have shifted focus as a result of the growth of biological, chemical, and engineering-based issues



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arising in modern products liability, toxic torts and, to a more limited degree, DNA-centered criminal prosecutions.26 Modern case law increasingly references a wide variety of science-based matters, which are being challenged in Daubert type pretrial hearings in even greater numbers. Modern civil procedure codes require that each party, within a certain number of weeks after the filing of a complaint, file the names of their expert witnesses plus a summary of any such opinion and the bases upon it was reached, to include a list of authoritative books or articles that went into the process. These provisions play a key role in the now routine pretrial challenge of expert witness testimony. State and federal courts in both civil and criminal cases are increasingly occupied with cases centered in the need for an encompassing and practiceoriented definition of science and scientific method as an essential precursor to the admissibility of opinions of experts based upon that science. Indeed, in the past decade, the whole subject of the propriety and extent of expert testimony in civil and criminal cases has been attacked from both sides in an ongoing battle as to what is a legally acceptable scientific foundation for the proffering of expert opinion. The following section will examine the key federal cases that set the current parameters for the introduction of sciencebased expert opinion in the nations courts. Frye v. United States The Frye test had its origin in Frye v. United States,27 a short and citationfree 1923 United States Court of Appeals decision concerning the admissibility of evidence derived from a systolic blood pressure deception test, a crude precursor to the polygraph machine. In Frye, the defendant was convicted of the crime of murder in the second degree. In the course of the trial defense counsel proffered an expert to testify to the results of a “deception test” made upon defendant. The test was characterized as a “systolic blood pressure deception test.” It was claimed that changes in blood pressure were caused by changes in the emotions of the witness, and systolic blood pressure rises were brought about by nervous impulses sent to the autonomic nervous system. Scientific experiments, the defendant asserted, confirmed that fear, rage, and pain routinely produced an elevation of systolic blood pressure, and that conscious deception or falsehood, concealment of facts, or guilt of crime, accompanied by fear of detection when the person is under examination “raised the systolic blood pressure in a curve, which corresponds exactly to the struggle going on in the subject’s mind, between fear and attempted control of that fear, as the examination touches the vital points in respect of which he was attempting to deceive the examiner.”28 The proffer was objected to by the government, and the court sustained the objection. Counsel for defendant then offered to have the proffered


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witness conduct a test in the presence of the jury, which was also denied. The defendant’s counsel agreed that no cases directly on point had been found. However, the broad ground upon which they based their case was that the opinions of experts or skilled witnesses were routinely admissible in cases in which the matter of inquiry is such that inexperienced persons were likely to be incapable of forming a correct judgment upon the matter, due to its subject being a matter of art or science with which they would be unfamiliar. When the question involved did not lie within the range of common experience or knowledge, but required special experience or knowledge, then the opinions of witnesses skilled in that particular science, art, or trade to which the question related were admissible in evidence.29 Here, rather than questioning the expertise of the defendant’s expert, the government challenged the basic foundation for the methodology of any such machine. Thus the court was required to construct a rule that would assist it and future courts in determining the sufficient level of confidence that should be reposed in a scientific methodology supporting any proffered opinion based upon it. Such analysis was to be had as a precursor to the admissibility of an opinion based upon it. The court, speaking through Judge Van Orsdel, noted that the issue of just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages was difficult to define: Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs. We think the systolic blood pressure deception test has not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made.30

Thus the court, realizing that legal doctrine had nothing to supplant the views of the scientists, took the position that if the methodology at issue was generally accepted by the relevant scientific community that would be acceptable to the law. The general acceptability rule was thus born and continued to be the rule for the next 70 years, until the decision by the United States Supreme Court in the famous case of Daubert v. Merrell Dow Pharmaceuticals,31 in 1993. It is of great interest to note that the period of 1923 to 1993 saw the gradual development of and eventual explosion of products liability law in the 1960s and 1970s.



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The major work of the nation’s courts in the products field was the creation and refinement of the mass of principles involved in forming the law of strict liability for products.32 It was not until 1993 when defendant Merrell Dow Pharmaceuticals challenged the methodology of plaintiff ’s expert in determining that the body of epidemiological studies established, according to his unique methodology, that the ingestion of the drug Bendectin was the cause of fetal malformations that the sea-change occurred. The plaintiffs in Daubert were children and their parents who claimed the children’s birth defects were caused by their mothers’ ingestion of Bendectin, a drug prescribed to combat nausea during pregnancy. Merrell Dow, the marketer of Bendectin, moved for summary judgment, supporting its motion with the affidavit of an expert who stated that no published study of patients had found Bendectin to cause malformations in fetuses. The plaintiffs responded with the testimony of eight experts who concluded that Bendectin can cause birth defects, basing their conclusions upon animal-cell and live-animal studies, pharmacological studies, and reanalyses of previously published epidemiological studies.33 After considerable discovery, Merrell Dow moved for summary judgment, contending that Bendectin does not cause birth defects in humans and that petitioners would be unable to come forward with any admissible evidence that it did. In support of its motion, Dow filed the affidavit of Dr. Steven H. Lamm, a physician and epidemiologist, who was an experienced and solidly supported expert on the risks from exposure to various chemical substances. Lamm said that he had reviewed all the 30 published studies on both Bendectin and human birth defects, involving over 130,000 patients and stated that none had found Bendectin to be a substance capable of causing malformed fetuses. Dr. Lamm concluded that maternal use of Bendectin during the first trimester of pregnancy had not been proven to be a risk factor for human birth defects.34 Plaintiffs did not contest this portrayal of the literature, but countered with the testimony of eight experts of their own, each of whom concluded that Bendectin can cause birth defects. Their conclusions were based upon in vitro (test tube) and in vivo (live) animal studies that found a link between Bendectin and malformations; pharmacological studies of the chemical structure of Bendectin that purported to show similarities between the structure of the drug and that of other substances known to cause birth defects; and the reanalysis of previously published epidemiological (human statistical) studies.35 The District Court granted respondent’s motion for summary judgment, where, citing Frye, the court stated that scientific evidence was admissible only if the principle upon which it is based was sufficiently established to have general acceptance in the field to which it belonged, concluding that petitioners’ evidence did not meet this standard. The court held that expert


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opinion which was not based on epidemiological evidence was not admissible to establish causation.36 The animal-cell and live-animal studies, and chemical-structure analyses on which petitioners had relied could not alone establish a reasonably disputable jury issue regarding causation. Petitioners’ epidemiological analyses, based as they were on recalculations of data in previously published studies that had found no causal link between the drug and birth defects, were ruled to be inadmissible because they had not been published or subjected to peer review.37 The United States Court of Appeals for the Ninth Circuit affirmed, 38 holding that expert opinion based on a scientific technique was unacceptable unless the technique was “generally accepted” as reliable in the relevant scientific community. The court held that expert opinion based on a methodology that significantly deviated from the procedures accepted by recognized authorities in the field could not be established to be generally accepted as a reliable technique.39 The court stressed that other Courts of Appeals that had addressed the alleged dangers of Bendectin had declined to accept reanalyses of epidemiological studies that had not been published nor subjected to peer review. 40 Those courts had indeed adjudged unpublished reanalyses exceptionally problematic in light of the great import of the original published studies supporting Merrell Dow’s, all of which studies had been subject to close review by the scientific community. The United States Supreme Court, speaking through Justice Blackmun, noted that in the 70 years since its formulation in the Frye case, the general acceptance test has been the dominant standard for determining the admissibility of novel scientific evidence at trial, and that while under increasing criticism, nonetheless continued to be followed by a majority of courts 41 including the Ninth Circuit. Justice Blackmun observed that the merits of the Frye test had been much debated, and that the scholarship on its proper scope had continued to grow at an ever increasing pace.42 Here the court agreed with Merrell Dow that the proper focus of such discussions should henceforth be the provisions of the federal rules of evidence, not the 70-yearold Frye decision. The court noted that they were required to interpret the legislatively enacted federal rules of evidence as they would any statute, and that Rule 401 and 402 provided the baseline theory.43 These two rules of relevancy were to be utilized in these cases in conjunction with Rule 702, setting forth the basic principle regarding the admissibility of expert testimony.44 The court observed that nothing in the language of Rule 702 or the rules as a whole ingrain general acceptance as an absolute prerequisite to admissibility and, indeed, would be at odds with the liberal thrust of the federal rules of evidence.



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Having concluded that the Frye test was replaced by the rules of evidence, however, did not mean that there were no checks on the admissibility of purportedly scientific evidence. Nor was a trial judge disabled from screening such evidence. Under the federal rules of evidence, the trial judge was required to warrant that any and all scientific testimony or evidence admitted was not only relevant, but reliable.45 The primary locus for this obligation was Rule 702. When presented an offer of expert scientific testimony, a trial judge must determine at the outset whether the expert is proposing to testify to scientific knowledge that would assist the trier of fact to understand or determine a fact in issue. If so, then a preliminary assessment is required of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology can properly be applied to the facts in issue.46 Several observations are in order with respect to the ruling in Daubert. Initially it will be convenient to set out a summary of the requirements for the admissibility of scientific expert witness opinion under Frye and Daubert. Under either decision, and regardless of what facts or factors get the nod in a particular case, there are only a limited number of questions that the courts could examine: • Are there any published peer-reviewed books or articles? • Is this methodology taught in universities or discussed in professional scientific meetings or colloquia? • Can this methodology be tested for accuracy? • Does it have a known error rate? • Is this methodology generally accepted in the relevant scientific community where similar concepts are studied and used? It is important to realize that there really are no other significant questions that can be asked and that the same questions are basically asked under either Frye or Daubert. In Daubert, in rejecting the Frye rule, the court essentially wrapped the above balancing criterion in a federal rules of evidence package, with a stated preference to treat general acceptability as only one, but not the essential, factor to receive attention. Hence, the relevant and reliable standard of Daubert, as opposed to the general acceptability rule of Frye, is functionally the same as far as its implementation is concerned. The Daubert relevancy standard simply means that the scientific information that a party seeks to introduce into evidence has the ability to make some fact that is of consequence to the action more probable or less probable than it would be without it.47


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The Daubert decision has yet to be formally accepted by all state courts, many of which retain their adherence to a Frye standard. However, the greatest number of those states have accepted Daubert’s more liberal, open analysis approach, making the real differences between the two models increasingly difficult to see. The Daubert case prompted another four years of decisions applying what was perceived as its requirements in an extensive variety of scientific methodologies.48 The important question of the extent to which the Daubert gatekeeper could make a pretrial judgment as regards the opinion of an expert arguably based on relevant and reliable methods was not addressed in Daubert. This important point was resolved in the affirmative in the 1997 decision of the U.S. Supreme Court in the case of General Electric v. Joiner,49 involving the question of whether long-term exposure to PCB’s could cause cancer. This case also provides an extended discussion of the Daubert criterion, especially with regard to the importance of the presence or absence of peerreviewed scientific articles on the questioned methodology. The above discussion and those to follow will involve a series of the key products liability decisions of the past decade. All of such cases involve common law actions for damages grounded in products liability theory. However, it is of great importance to realize that Daubert applies with full force to the numerous and extremely important science decisions made by federal regulatory agencies in their enforcement mission.50 General Electric v. Joiner Robert Joiner began work as an electrician in the Water & Light Department of Thomasville, Georgia (City) in 1973. Joiner’s job required him to work with and around the city’s electrical transformers, which used a mineralbased dielectric fluid as a coolant. Joiner often had to stick his hands and arms into the fluid to make repairs and the fluid would sometimes splash onto him, occasionally getting into his eyes and mouth. In 1983 the city discovered that the fluid in some of the transformers was contaminated with polychlorinated biphenyls (PCBs). PCBs are widely considered to be hazardous to human health. Congress, with limited exceptions, banned the production and sale of PCBs in 1978.51 Joiner’s theory of liability was that his exposure to PCBs and their derivatives “promoted” the cultivation of his lung cancer. In support of that theory he proffered the deposition testimony of a number of expert witnesses. Defendants argued that Joiner’s expert’s testimony regarding causation were nothing more than unscientific speculation, stressing the absence of any peerreviewed epidemiological studies, and was based exclusively on disconnected studies of laboratory animals. The trial court agreed with petitioners that the animal studies did not support Joiner’s position that exposure to PCBs had



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caused or significantly contributed to his cancer. The trial court also ruled that the four epidemiological studies on which Joiner’s experts had relied were not a sufficient basis for their opinions on causation.52 In an important concurring opinion, Justice Breyer addressed the perceived problem of the difficulty of the district court gatekeepers getting high level, objective expert support for its pretrial function in these cases. He noted that the trial judges would sometimes be required to make “subtle and sophisticated determinations about scientific methodology and its relation to the conclusions an expert witness sought to offer.”53 This would be particularly so in cases where the involved area of science was tentative or uncertain, or where epidemiological or laboratory testing was offered to prove individual causation. Amici had reminded the court of the dangers existent due to judge’s lack of scientific expertise and lack of opportunities for meaningful training.54 Justice Breyer was particularly impressed with the Amici brief filed by the New England Journal of Medicine and its editor-in-chief, Marcia Angell M.D.: [A] judge could better fulfill this gatekeeper function if he or she had help from scientists. Judges should be strongly encouraged to make greater use of their inherent authority … to appoint experts …. Reputable experts could be recommended to courts by established scientific organizations, such as the National Academy of Sciences or the American Association for the Advancement of Science.55

Justice Breyer concluded by stating his view that given this kind of offer of cooperative effort, from the scientific to the legal community, and given the various rules-authorized methods for facilitating the courts’ task, Daubert’s gatekeeping function would not prove overly arduous to achieve. 56 The Joiner decision thus expands the prerogative of the trial court gatekeeper to include rejecting an expert’s opinion, although admittedly based on acceptable or reliable methodology; the court is of the view that such opinion was not rational supported by such methodology.57 The most recent major Supreme Court decision in the Frye–Daubert line, decided on March 23, 1999, is Kumho Tire v. Carmichael,58 addressing the important question of whether the Daubert guidelines apply to all expert witness or exclude experts in applied technology or other forms of experience based expertise, thus depriving corporate defendants of a pretrial opportunity to challenge an expert witness. Kumho Tire v. Carmichael This case arose from the explosion of a minivan tire resulting in death and injuries. Plaintiff expert Carlson concluded that the tire at issue was defective


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in design, which defect led to the fatal explosion. Carlson’s conclusion was based upon a number of factors, including his personal examination of the tire carcass. Carlson concluded that the tire did not bear at least two of the four “overdeflection symptoms,” nor was there any less obvious cause of separation; and since neither overdeflection nor the punctures caused the blowout, he surmised that either a manufacturing or design defect caused the separation.59 Defendant Kumho Tire moved the District Court to bar Carlson’s testimony on the basis that his methodology for defect analysis was not reliable under a Daubert standard. Justice Breyer, speaking for the court, held that the primary preliminary issue here was whether the gatekeeping obligation imposed on federal trial courts applied only to scientific testimony or to expert testimony of all types, cutting edge or familiar. Justice Bryer and the court ruled that the Daubert factors analysis was available to test all manner and forms of expert testimony, not just opinions arising out of cutting-edge science. The court stated that it would prove difficult, if not impossible, for judges to administer evidentiary rules under which a gatekeeping obligation depended upon a distinction between “scientific” knowledge and “technical” or “other specialized” knowledge. There was no bright line that divides the one discipline from another. Engineering rested solidly on scientific knowledge, and so-called pure scientific theory itself often hinged for its emergence and evolution upon observation and properly engineered machinery. The court observed that conceptual efforts to distinguish the two were unlikely to produce clear legal lines capable of application in any particular case. 60 In addition, Justice Breyer continued, there was no perceived need to carve out any such demarcations between science and engineering: Neither is there a convincing need to make such distinctions. Experts of all kinds tie observations to conclusions through the use of what Judge Learned Hand called ‘general truths derived from … specialized experience.’ [citations omitted] And whether the specific expert testimony focuses upon specialized observations, the specialized translation of those observations into theory, a specialized theory itself, or the application of such a theory in a particular case, the expert’s testimony often will rest ‘upon an experience confessedly foreign in kind to [the jury’s] own.’ … The trial judge’s effort to assure that the specialized testimony is reliable and relevant can help the jury evaluate that foreign experience, whether the testimony reflects scientific, technical, or other specialized knowledge.61

The court answered in the affirmative when asked by the petitioners if trial courts may consider the several specific reliability factors that Daubert said could bear on a gate-keeping determination:



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The petitioners asked specifically whether a trial judge determining the admissibility of an engineering expert’s testimony may consider several more specific factors that Daubert said might ‘bear on’ a judge’s gate-keeping determination. Those factors include: — Whether a theory or technique can be (and has been) tested; — Whether it has been subjected to peer review and publication; — Whether, in respect to a particular technique, there is a high known or potential rate of error and whether there are standards controlling the technique’s operation; and — Whether the theory or technique enjoys general acceptance within a relevant scientific community.62

The court, after emphasizing the elastic nature of the Daubert Rule 702 criterion, observed that all those factors did not necessarily apply in a particular case and that one or more could serve as the deciding factor or factors in a particular instance. The court concluded that expert Carlson’s testimony here was not reliable under the Daubert criteria and would be barred. There was no indication in the record that other experts in the industry used Carlson’s two-factor test or that tire experts such as he generally made the very fragile distinctions about the symmetry of shoulder tread wear that were necessary, if based upon Carlson’s own theory, to support his conclusions. The court also emphasized that there was an absence of any peer-reviewed articles or papers that confirmed the reliability of Carlson’s method. Indeed, Justice Breyer continued, no one had argued that Carlson himself, were he still working for Michelin, would have concluded in a report to his employer that a similar tire was similarly defective on grounds identical to those upon which he rested his conclusion here. In sum, the court concluded, Rule 702 grants the district judge the discretionary authority, reviewable for its abuse, to determine reliability in light of the particular facts and circumstances of the particular case. As noted above, following the decision in General Electric v. Joiner, considerable interest was exhibited by Justice Breyer, the American Association for the Advancement of Science (AAAS), and the American Bar Association (ABA) in trying to develop experimental programs whereby independent scientists would serve as an advisory board for trial judges in scientifically complex mass tort cases such as the breast implant situation. The October 1999 ABA Journal reported the existence of new funding for the Court Appointed Scientific Experts (CASE Project), which is a five-year experiment of the AAAS, which will supply allegedly objective scientific expertise to federal trial courts in science-intensive litigation. The CASE Project is a direct outgrowth of Justice Breyer’s efforts flowing from the Joiner decision. In fact, the AAAS has agreed in principle to establish such a program. The first of such panels was established in one of the block of breast implant decisions set up pursuant to the Federal Manual of Complex Litigation.


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In the case of In re: Silicone Gel Breast Implant Products Liability Litigation,63 the Honorable Sam C. Pointer, Jr., Coordinating Judge for the Federal Breast Implant Multi-District Litigation, appointed a panel of four scientific experts in the fields of immunology, epidemiology, toxicology, and rheumatology to serve on a national science panel.64 The panel was instructed to review and critique the scientific literature pertaining to the possibility of a causal association between silicone breast implants and connective tissue diseases, related signs and symptoms, and immune system dysfunction. The panel met in October 1996, received instructions from the judge, and heard testimony from experts selected by the counsels for the plaintiffs and defendants. Additional hearings were held in July 1997, when experts identified by the parties provided testimony, and in November 1997, when the panel’s invited experts presented their research material.65 In spring 1997, over 2000 documents were submitted to the panelists from the legal counsels for both parties. Subsequently, the counsels pared these numbers down to the approximately 40 most important documents from each side for each panel member. The source of references, whether counsel for the plaintiffs or counsel for the defendants, was not identified to the panelists. The panel members also used their own literature-search strategies, and were neither limited to, nor obligated to use, those submitted by the respective legal counsels. The panel found no reliable evidence of a link between migrating silicone and autoimmune disorders. The case will proceed to its slow conclusion, with both plaintiff and defendant experts contributing to the extensive pretrial activities. There will be at least a year of depositions and considerable scrambling by plaintiffs lawyers before this question comes to rest. The negative findings by this court-appointed panel of experts cast a considerable shadow over the thousands of breast implant cases. As has been demonstrated, the judicial debate over setting usable reliability standards to assess the admissibility of science-generated fact has not been driven by criminal cases. Corporations with serious money at stake have set the terms of the inquiry over the past decade, with the decision in Kumho Tire being the latest Supreme Court word on the subject. It remains to be seen what form the issue will take in increasingly sophisticated geneticsdriven products cases in the 21st century.66

Kumho Tire and Beyond Since the Supreme Court’s decision in Kumho Tire,67 several important decisions have been rendered that examine the expert witness’ science obligations



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in much more detail. Specifically, the cases examine exactly what is the responsibility of any expert witness at trial in respect to the actual case on trial. Assuming that the expert witness is qualified and that the methodological basis for his proffered opinion is reliable or generally accepted in the relevant scientific community, all necessary but nonetheless unrelated to the case at hand, just what does the expert have to bring to the table? It has been emphasized in earlier chapters that, as opposed to forensic evidence offerings in criminal cases where actual case-specific “science” is routinely performed, that is typically not the case in civil damage trials. In the latter, experts rarely do other than provide a narrative of background profiles of the area of science, such as pharmacology, involved in the case, and/or offer an opinion on the right or wrong of the case issues by way of extrapolation from or on the simple number of articles and books by others in the field. Corporate defendants often also offer evidence of tests designed to replicate the injury-producing event, but certainly never attempt to go back in time and redo laboratory science for the historical period under scrutiny. All science in products cases is frozen in time. We are always attempting to judge the defendant company’s responsibility by proving that their corporate decisions were not reasonable, given the state of the art of whatever science is involved, at the historical time that final product decisions were finalized and the suspect product was released into the marketplace. It cannot be emphasized enough that the present discussion, regarding the adequacy of a scientific methodology to support expert opinion, is light-years away from the type of scientific inquiry posited by the scholars interviewed by John Horgan in his excellent book, The End of Science: Facing the Limits of Knowledge in the Twilight of the Scientific Age,68 discussed in Chapter 1. Horgan reported the sharp criticism of Nobel prize winning chemist, Professor Stanley Miller of scientific papers culled from other published papers, and extrapolated therefrom, where there has been no hard won finding resulting from extensive laboratory work. Professor Miller referred to such works as “paper chemistry.” The extensive use of the expert witness technique of basing their testimony solely on the basis of referencing the work of others, may be justly referred as “paper science.” It is a central part of the expert witnesses contribution to the products liability litigation system. The Daubert line of cases has set the theoretical requirements for acceptable testimony. Of course, like any general rule, it does not talk about any particular case. So the question remains as to just what is it that an expert must do as a minimum, while testifying, to actually support his or her opinions in the case at hand. Although forensic scientists are required to conduct a variety of sciencebased tests and report and interpret their own findings, this has not been the


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practice in products liability cases. For one thing, the scientific testimony in those cases typically references some generic design, instructions or warnings issues that was preexistent to the occurrence giving rise to the case. In addition, the purposes in doing any such case-science would be distinctly different from that supporting scientific inquiry in a criminal case. In a products liability lawsuit, the issue of whether the drug Parlodel can cause brain aneurysm is quite different from the forensic issue of whether blood, semen, hair, or fiber expert testimony may be used to link a defendant to a crime scene in a rape-homicide prosecution. It is quite likely that expert testimony by way of “paper science” is what will continue to be the basis of the expert witness contribution to the products liability process. Indeed, in some cases, such as the questioning of the adequacy of 1960s titanium alloy foundry techniques in the Iowa DC-10 crash filings and discovery, any other requirement may very well be both technological and economic impossibilities. However, in instances where the questioned science, engineering practice, or allegedly inadequate instructions or warnings are susceptible to actual work by the expert, should they not be required? A very important case, addressing this important issue of the actual courtroom responsibility of the expert witness, is Bourelle v. Crown Equipment,69 decided by the Seventh Circuit Court of Appeals in 2000. The excellent discussion of these issues warrants an extended discussion of the decision. In Bourelle, Rhonda Wendling and Darla Bourelle were injured in the course of their employment at Sears Logistical Systems (SLS) in Manteno, Illinois, alleging that the Crown Turret Stockpicker forklift that they were operating, and which was manufactured and placed in the stream of commerce by Crown Equipment Corporation, was improperly designed. The TSP is a forklift truck designed to move full pallets in and out of warehouse racks and also for order picking partial loads. The turret on the TSP allows the operator to work either side of a narrow warehouse aisle without turning the truck around. The unit in Bourelle was used in the warehouse aisle on an electronic wire guidance system, where the operator controlled the speed and direction, but not the steering, which was controlled by the wire. Plaintiffs also alleged that Crown was negligent in its maintenance of the TSP unit, as well as in the warnings it provided for the forklift operator. Judge Coffey, writing for the court, found that expert testimony regarding an alternative design for the forklift as well as testimony that the warning labels on the forklift unit were inadequate, unreliable, and thereby inadmissible. The separate injuries which occurred to the parties were described by the court: As the TSP was traveling along the wire system down a narrow warehouse aisle, a pallet became dislodged, hit the side of the aisle, entered the operator’s



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compartment, and violently struck Wendling in her abdomen. Bourelle was injured while operating the same TSP that was involved in Wendling’s accident; she was also transporting empty pallets down a narrow warehouse aisle when a pallet entered the operator’s compartment and struck her left knee, necessitating surgery.70

The plaintiffs’ proposed expert was Daniel Pacheco, a mechanical engineer who received his Bachelor of Science in mechanical engineering from the University of Massachusetts in 1964, and his Master of Science in management from the Graduate School of Management in Lake Forest, Illinois, in 1974. He testified to having experience investigating lift truck accidents. He had been a registered professional engineer in Illinois since 1970, and was employed for 17 years as an engineer for Fiat-Allis Construction Machinery Inc. of Deerfield, Illinois, and Pettibone Corporation of Chicago, Illinois, working on the product design and the development of heavy vehicles and forklift trucks. In 1982, Pacheco became a senior engineering consultant for Polytechnic, Inc. of Lincolnwood, Illinois. In 1989, he became president of Polytechnic, Inc., and now specialized in the safety analysis of construction and industrial equipment.71 In 1993, Pacheco co-authored a paper, “Risk Analysis of Forklift Drivers.” At oral argument, counsel for Wendling and Bourelle explained that a previously retained expert became ill, and that Pacheco was a last minute substitute. Wendling and Bourelle retained Pacheco in November 1998 to perform an engineering investigation and prepare a report concerning their respective accidents. Pacheco’s investigation consisted of reading the depositions of the plaintiffs and ten other people who had knowledge relevant to the two occurrences, reviewing Crown Equipment Corporation manufacturing and service documents for the TSP forklift, and also studying Crown sales brochures, a training manual and a number of engineering drawings for the TSP type units. Based upon that investigation and review, Pacheco rendered an opinion that the TSP was defective for two reasons: it was designed with inadequate guarding for the operator; and because it lacked an adequate warning regarding the risk of pallets becoming dislodged and entering the operator’s compartment. Pacheco testified that the wire mesh guarding, covering the area between the lower bar and the bottom of the operator’s compartment, could be (and should have been) extended up to the midbar, and that such guarding would have prevented Bourelle’s injury. He also testified that the “same type of structure as utilized in the overhead guard could be placed in front of the operator’s compartment on top of the midrail,” and that such guarding would have prevented Wendling’s injury. In short, Pacheco concluded that structurally, the defendant should have extended the already existing guarding features.72


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The district court rejected Pacheco’s testimony, not on the basis that he was not qualified to render such an opinion in such a case, but because the manner in which he did it here was totally devoid of any actual demonstrative support: [h]is opinion as to guarding has not been tested nor has any attempt been made to prove its feasibility. He did not prepare engineering drawings of his proposed design and undertook no study of strength of materials necessary to create the guards he proposes. His knowledge and experience with TSPs is limited to his examination of photographs and manufacturer’s literature. He has never seen one in operation in the narrow warehouse aisles for which the TSP was designed. The court can only conclude that Mr. Pacheco’s opinions about an unreasonably dangerous condition in the TSP fall into the category of subjective belief or unsupported speculation.The same can be said concerning his opinion about the absence of a warning about colliding with obstructions in the aisle and injury from intrusion. He has not designed a warning for the TSP operator that would seek to ameliorate the unsafe condition he believes exists. It’s just his opinion that common sense would say that a warning would be appropriate.73

After concluding that Pacheco’s opinions were not supported by sufficient scientific evidence, the district court granted summary judgment in favor of Crown on the product liability count. Judge Coffey, writing for the court, noted that the obligation imposed on trial judges by Daubert to see to it that any expert testimony be not only relevant but reliable, included a determination of whether Pacheco’s opinion was grounded in the methods and procedures of science,74 and whether his testimony had sufficient factual underpinnings.75 He also noted that the familiar nonexhaustive list of four factors that was deemed helpful in gauging the reliability of expert testimony need not be a focus of analysis when making an admissibility ruling under Fed.R.Evid.702.76 The court here quoted the language of the Supreme Court in Kumho Tire in expressing the basic purpose of the Daubert gatekeeping function: The objective of [Daubert’s gatekeeping] requirement is to ensure the reliability and relevancy of expert testimony. It is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.77 (Emphasis added)

Here the court noted, the plaintiffs’ expert, as is routinely done, surmised and claimed that an alternative design should have been implemented for the TSP unit, and that if it had, neither of the plaintiffs would have been



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injured. However, the court noted, when questioned by Crown’s counsel, Pacheco admitted that he had not done any scientific testing to support his alternative design theory. This most common mode of expert witness utilization points out not only the differences between the testimony of forensic experts on criminal cases, but the whole issue of the use of “paper science” in modern products liability, toxic tort, and environmental cases discussed above. The court focused on noted expert Pacheco’s deposition testimony: Q. Have you done any type of engineering testing to verify if your alternative design that you just described for us would eliminate the hazards that you claim exist? A. I haven’t done any testing, no. Q. Have you attempted to replicate the application of the TSP with this alternative design that you advocate? Have you done any studies to show that you could perform these applications with a barrier guard in front as you just described? A. I haven’t done any studies.78

The court noted that in his report, Pacheco recognized that in the stockpiling operation, the standing operator had a need to access racks outside the periphery of the truck and place loads onto the pallets in front of the operator’s compartment without interference by fixed barrier guards between the compartment and the forks. Pacheco also admitted in his deposition that he had not prepared any “detailed design or calculations,” performed “an economic feasibility study,” prepared “preliminary design drawings,” or performed “any risk utility type testing.” The trial judge had stated that without such work or testing, “[t]he court can only conclude that Mr. Pacheco’s opinions about an unreasonably dangerous condition in the TSP fall into the category of subjective belief or unsupported speculation.” The Court of Appeals noted that the trial judge did not impose testing as an absolute requirement.79 Pacheco, Judge Coffey continued, admitted that no lab or organization had tested his theories, that no other manufacturer incorporated his proposed design, and that he had not reviewed any industry studies regarding accident experience with the TSP forklift.80 Although the plaintiffs conceded that Pacheco had failed to perform any studies or testing of his proposed design and further acknowledged that their proposed expert never observed the TSP forklift in question (much less saw a loaded TSP operate in the narrow aisles of a warehouse), they nonetheless contended that the necessity for independent testing was diminished because Pacheco was relying on the testing already performed by Crown and received in the course of discovery.81


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However, the court felt strongly that the expert’s courtroom duties encompassed something more than a barebones review of discovered documents or a straight forward rendition of relevant paper science: [T]he appellants ignore the fact that Pacheco never: 1) saw or inspected the vehicle itself (only pictures and videotape); 2) never observed the vehicle loaded and operating within the narrow confines of the warehouse; 3) prepared any drawings in relation to his alternative design theory; 4) conducted any computer analysis; 5) submitted his alternative design theories to the American National Standards Institute (ANSI), despite the fact that he was aware of the organization; nor 6) had any recognized scientific approval of his alternative design theories. Furthermore, as the appellants admit, Pacheco did not satisfy the specific factors delineated in Daubert. And, although courts should be flexible in their application of Daubert, there is no requirement that judges apply only those criteria that the plaintiffs believe are important.82

Here, the court observed, the trial judge focused on the lack of testing performed by the plaintiffs’ expert and concluded that without such testing, Pacheco’s opinions were nothing more than speculation and were thus unreliable. Recognizing that a trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony was reliable, and that testing was important in alternative design cases such as this, the court was of the opinion that the judge did not abuse his discretion in excluding Pacheco’s testimony as unreliable. This conclusion was bolstered by the fact that Pacheco’s opinion was also unreliable under the other factors delineated in Daubert, in that no lab or organization had tested his theories and no other manufacturer had incorporated his proposed design. Additionally, Pacheco had not seen any industry studies regarding accident experience with the TSP forklift design.83 The court ruled that the same reliability requirements that apply to alternative design arguments apply to alternative warnings. The court observed that just as Pacheco had failed to test his proposed guarding requirements, he also failed to test (or even to draft) an alternative warning for the subject forklift. The court stressed Pacheco’s deposition testimony: A. I think there needs to be a specific warning to the operator about this particular hazard. Q. The hazard of pallets possibly entering the compartment? A. Yes. Q. And what kind of warning would you provide to so satisfy your belief one ought to be provided?



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A. You mean the language of a warning? Q. Yes, yes. A. I haven’t created the language for a warning, so I would have to do that. Q. So you haven’t done that task? A. That’s right… A. You’re not going to get the answer because I told you I have not drafted a warning. But that is the subject of the warning, is [sic] the hazard. Q. You can’t, as you’re sitting here today, give me the gist of the warning, the language that you would employ? A. Correct.84

The court emphasized the fact that, like his proposed design, Pacheco failed even to draft a proposed alternative warning for the TSP’s operation manual which, in their opinion, rendered his opinion regarding the alleged inadequacy of Crown’s existing warning concerning the risk of pallets entering the TSP operator’s compartment to be unreliable.85 The district judge’s decision to prevent Pacheco from testifying, far from being an abuse of discretion, was absolutely correct. Pacheco’s testimony was classic paper science: Many times we have emphasized that experts’ work is admissible only to the extent it is reasoned, uses the methods of the discipline, and is founded on data. Talking off the cuff — deploying neither data nor analysis — is not acceptable methodology [citations omitted]. The fact that Pacheco never even drafted a proposed warning renders his opinion akin to “talking off the cuff ” and not acceptable methodology. Accordingly, we conclude that the district judge did not abuse his discretion in excluding, as unreliable, Pacheco’s opinion regarding a warning for the TSP.86

While admitted that no particular court decision has the obligation, let alone the ability, to speak to an issue in any encyclopedic or comprehensive manner, it is the opinion of the present writer that this decision leaves many issues up in the air. It seems obvious that a plaintiff cannot simply assert that some alternative design was required to save the day. There must be testimony based upon a full study of the relevant existing literature in the field and as much as is possible, a full examination of the suspect unit–here, a forklift truck. However, it would be unjust, for example in an airplane crash setting, to require the plaintiff to actually forge the alloys and construct an airplane part to meet its burden. As far as using the failure of any other manufacturers to utilize a proposed alternative design, any such fact should never be deemed as decisive. The reality is that powerful trade associations exist in all industries to see to it


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that members are on the same page as far as basic alternative designs are concerned. It is becoming obvious that the question of the actual courtroom obligations of the expert is the next level down in the Daubert line of cases, and properly so. The alternative design burden is a complex one and will require a case-by-case analysis of the realities of proof beyond a solid paper science presentation. On the other hand the drafting of an alternative warning is something that should be expected of the expert, inasmuch as it does not involve excessively expensive or near impossible efforts by the proffering party. Most competent products liability lawyers not only would not object to any such requirement, but routinely provide such alternative drafts as a basic assumption of their responsibility. In another important recent Seventh Circuit decision, Frey v. Chicago Conservation Center,87 the plaintiffs alleged that Chicago Conservation Center (CCC) damaged pieces of their art collection by exposing certain of their artworks to ozone which caused a fading of their color properties. To support their claim, plaintiffs offered the testimony of Mr. Patrick B. King, an art appraiser and conservator familiar with the use of ozone on works of art. On July 8 and 9, 1998, following a fire at their home, the Freys arranged to have pieces of their art collection moved to the CCC. One of the conservation methods with which King testified he was familiar was the exposure of art to ozone, for destroying hydrocarbons and smoke odors on individual pieces of art. In his first report, King wrote that he “detected the smell of decaying ozone emanating” from the art work, and that he was “extremely familiar with the smell of ozone and [could] easily identify it.” King concluded that “the optical properties of Mr. Frey’s artwork have been altered” and that “the values of the objects of art have been diminished by 65%.” In his second report, King reiterated his belief that these “items have been exposed to ozone.” During his deposition, King was asked what he meant in his reports by “decaying ozone.” He replied that it was “the reaction between the ozone and the material,” and that it had an “odor all of its own as it reacts with the material.” He was then asked if it was different from an ozone odor, or if it was the same, replying that it was the same. Defendant argued that King should not be allowed to offer his testimony, because his methodology did not meet the reliability standards established by the Daubert line of cases. Specifically, they argued that the physical properties of ozone made it impossible for King to have smelled it six weeks after the alleged exposure. In addition, they questioned King’s ability to discern fading in the color of the works, especially based on the casual manner of his previous observation. The defendant also emphasized the lack of education King had in



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chemistry and related fields. The Freys responded that King was qualified to testify as an expert, his lack of education being overcome by his extensive experience with the treatment of art with ozone.88 In this case, the court noted, the subjective nature of King’s proffered testimony nullified the applicability of most of the Daubert factors. Peer review, error rate calculation, and testability were not germane to King’s individual ability to smell ozone, to notice color difference, or to extrapolate regarding the use of ozone. While stating that it was not fatal to his qualifications, it certainly weighed against plaintiffs in that it left the court with few resources to test the reliability of King’s methodology. However, the fourth Daubert criterion — whether the methodology was generally accepted in the relevant scientific community — was available: Would other conservators or appraisers find it acceptable for a conclusion, any conclusion, regarding ozone usage to have been drawn by King in this situation?…For this question the court has no answer. Plaintiff has presented no evidence to show that King’s processes would be considered by those in his industry to yield reliable results. There are allusions in King’s report to articles on the treatment of art with ozone, but none of these or any other articles or trade literature is before the court….Moreover, plaintiffs attach to their surreply an e-mail from a distraught person, frustrated by her inability to remove the odor of ozone from her house. In its form, this purely anecdotal evidence is hearsay, but it is indicative of the type of evidence absent from plaintiffs’ attempt to qualify their expert. Plaintiffs are correct when they contend that King’s experience with ozone and art could overcome his lack of formal education in the fields of general chemistry…But, if they seek to rely on his experience, then they must show that this type of conclusion is acceptable based on that experience.89

Furthermore, the court stated, there were a number of measures that could have been taken by Mr. King “to bolster the reliability of his methodology and lift it from its mire of subjectivity.” For instance, the court suggested, he could have undertaken objectively to confirm his conclusions by testing for ozone usage in some other way. Citing their ruling in Bourelle, the court noted that in this case, King similarly failed to perform any formal testing for the presence of ozone, something one of defendant’s witnesses claimed was quite feasible.90 The end result was that King’s methodology was totally unacceptable: King’s methodology (I smelled it, I saw it — therefore it is) is simply too subjective, unsupported, and speculative to be considered reliable for purposed of Federal Rule of Evidence 702. Without the support for King’s processes mentioned above, this court is left with a witness whose method for arriving at his proffered conclusion is called impossible by the defendant,


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Science and Litigation: Products Liability in Theory and Practice but so individual in its nature that plaintiffs seem unable or unwilling to validate its reliability. Simply put, we see a decided absence of any scientific validity to the conclusions reached by Mr. King, and thus they may not come into evidence under Fed.R.Evid. 702. Therefore, Mr. King may not opine in this case regarding alleged ozone use by the defendant, color fading due to ozone use, or the loss in value caused by such use. He may not draw conclusions based on his observations to the extent those conclusions extend beyond any topics with which he has first hand knowledge.91

The court did, however, allow two of King’s opinions as lay opinions. Based on his personal experience with the art works in question, King may testify as to perceiving the works as having faded, and based on his past exposure to the distinctive smell of ozone, King could testify that he smelled ozone while examining these works. Furthermore, the court ruled, he could explain how he had become acquainted with the smell of ozone. However, in keeping with their Daubert analysis, the court ruled that King could not testify about any conclusions he had drawn about whether or not the Frey art works had been exposed to ozone or whether ozone caused any fading to them, or that CCC had anything to do with either, because such testimony would have exceeded the boundaries of his personal knowledge.92 There are a growing number of very useful articles on the Daubert to Kumho Tire development by judges, 93 law professors94 and practicing litigators95 that bear reading, now that we seem to have a much clearer sense of what the Daubert case itself really meant for the future of products liability litigation.96 Chapter 3, Science and Peer Review, will examine a key and somewhat neglected Daubert factor: Has the methodology supporting an expert’s opinion been subject to peer review? This is a criterion that courts take most seriously in virtually every case of a challenge to scientific methodology, and is the least discussed or understood of the Daubert requirements.

Endnotes 1. 54 App.D.C.46 293 F.1013 (1923). 2. Mazzetti et al. v. Armour and Co. et al., 75 Wash.622, 135 P. 633 (Sp.Ct.Wash. 1913), implied warranty in tort for food and drug products; McPherson v. Buick Motor Company, 217 N.Y. 382, 111 N.E. 1050 (Ct. Appeals N.Y. 1916), duty in negligence runs from the manufacture to the foreseeable purchaser of the product; Baxter v. Ford Motor Co. et al., 12 P.2d 409 (Sp.Ct.Wash. 1932), express warranty in tort for misrepresentations of material facts in advertising



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or promotional materials; Henningson v. Bloomfield Motors, Inc., 32 N.J.358, 161 A.2d 69 (Sp.Ct.N.J. 1960), implied warranty in tort for all products; Greenman v. Yuba Power Products, 59 Cal.2d 57, 64, 377 P.2d 897, 27 Cal.Rptr. 697 (Sp.Ct.Cal. 1963, the fiction of express or implied warranties in tort was an unnecessary and clumsy theory and henceforth was deemed unnecessary to state a cause of action for strict liability in tort. The purpose of such liability is to insure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves. Sales warranties serve this purpose fitfully at best. 3. 10 M.&W. 109, 111, 152 Eng.Rep. 402, 403 (1842). 4. The Restatement Third formulation has yet to be accepted by most courts, and as with all new formulations of old ideas, is under steady criticism. The reformulation of the basic idea of defect on the way theses cases are properly analyzed, planned, or researched will not change in any significant way the manner in which experienced litigators will process such cases. s 1. LIABILITY OF COMMERCIAL SELLER OR DISTRIBUTOR FOR HARM CAUSED BY DEFECTIVE PRODUCTS: One engaged in the business of selling or otherwise distributing products who sells or distributes a defective product is subject to liability for harm to persons or property caused by the defect. s 2. CATEGORIES OF PRODUCT DEFECT: Restatement (Third) of Torts: Prod. Liab. s 2 (1997 Main Vol.): A product is defective when, at the time of sale or distribution, it contains a manufacturing defect, is defective in design, or is defective because of inadequate instructions or warnings. A product: (a) contains a manufacturing defect when the product departs from its intended design even though all possible care was exercised in the preparation and marketing of the product; (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe; (c) is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe. 5. See Caterpillar Tractor Co. v. Beck, 593 P.2d 871 (Alaska 1979); Sims v. General Motors Corp., 751 P.2d 357 (Wyo. 1988). See also Prosser, “The Assault Upon the Citadel (Strict Liability to the Consumer),” 69 Yale L.J. 1099 (1960); Restatement 402A comment c.


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Science and Litigation: Products Liability in Theory and Practice 6. Maxted v. Pacific Car & Foundry Co., 527 P.2d 832 (Wyo. 1974). 7. Gonzales v. Caterpillar Tractor Co., 571 S.W.2d 867 (Tex. 1978), on remand, 599 S.W.2d 633 (Tex.Civ.App. 1980). Experienced litigators understand that this principle does not excuse the plaintiff from establishing de facto disregard of knowledge of risk in all but true manufacturing defect settings. 8. Greenman v. Yuba Power Prods., 59 Cal. 2d 57, 377 P.2d 897, 27 Cal. Rptr. 697 (1963); Phillips v. Kimwood Mach. Co., 269 Or. 485, 525 P.2d 1033 (1974); East River S.S. Corp. v. Transamerica Delaval, Inc., 476 U.S.858, 106 S.Ct. 2295, 90 L.Ed.2d 865 (1986). 9. Restatement 402A comment i. See also Phillips v. Kimwood Mach. Co., 269 Or. 485, 525 P.2d 1033 (1974) and Barker v. Lull Eng’g Co., 20 Cal.3d 413, 573 P.2d 473, 143 Cal.Rptr. 225 (1978), leading cases discussing the comparative meaning and merits of the consumer expectation and risk-utility tests in litigation of strict products liability cases. 10. Lease v. International Harvester Co., 174 Ill.App.3d 897, 904, 529 N.E.2d 57, 60 (1988). 11. The generally accepted outlines of the risk-utility test were stated in the following, oft-quoted language provided by Prosser and Keeton’s text: Under this approach, a product is defective as designed if, but only if, the magnitude of the danger outweighs the utility of the product… . Under this test, a product can be said to be defective in the kind of way that makes it “unreasonably dangerous” if a reasonable person would conclude that the danger-in-fact, whether foreseeable or not, outweighs the utility of the product. There are three primary reasons for so concluding: (1) the harmful consequences in fact from intended and reasonably foreseeable uses resulting from the way the product was designed and marketed up to the time of plaintiff ’s injury outweighed the benefits in terms of wants, desires, and human needs served by the product; (2) although the harmful consequences in fact did not exceed the benefits, alternative products were available to serve the same needs or desires with less risk of harm; (3) although the harmful consequences did not outweigh the benefits, there was a feasible way to design the product with less harmful consequences. Most of the products liability litigation related to design hazards have been concerned with the feasibility of a safer alternative design. Prosser and Keeton 99(3), at 99-700. See also Keeton, “Manufacturer’s Liability: The Meaning of ‘Defect’ in the Manufacture and Design of Products,” 20 Syracuse L. Rev. 559 (1969); Wade, “On the Nature of Strict Liability for Products,” 44 Miss. L.J. 825 (1973). 12. The statements of authorities set out by the reporter constitute a very comprehensive listing of the major cases, treatises, and articles published over the last three decades. Restatement (Third) of Torts: Prod. Liab. Preface (1997 Main Vol.) 1998 American Law Institute Comment a. History:



13.

14. 15.

16. 17. 18. 19.

20.

21.

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Abundant authority recognizes the division of product defects into manufacturing defects, design defects, and defects based on inadequate instructions or warnings…[citations omitted] Support among the treatise writers for a functional definition of defect, differentiating among manufacturing, design, and failure to warn defects, is equally strong. Most casebook authors and treatise writers organize their discussions concerning defect around these functional categories [citations omitted]. Law review commentary similarly recognizes the distinction as necessary to a coherent discussion of the bases of liability [citations omitted]. Carl Becker, “Everyman His Own Historian,” American Historical Review, XXVII (January, 1932), quoted in Winks, The Historian as Detective (Harper Torchbooks, 1968) at 6. Also see, David Hackett Fischer, Historians’ Fallacies: Toward a Logic of Historical Fact (Harper Torchbooks, 1970). Steven Shaplin and Simon Schaffer, Leviathan and the Air Pump (Princeton, 1985), at 23. For very current and fascinating discussions of this historically vexing problem, see, Burnett, A Trial by Jury (Knopf, 2001) and Scheck, Neufeld and Dwyer: Actual Innocence (Doubleday, 2000). Also see, Wigmore: The Principles of Judicial Proof (Little, Brown, and Company, 1913); Robertson and Vignaux: Interpreting Evidence: Evaluating Science in the Courtroom (John Wiley, 1995). See, Kiely, Forensic Evidence: Science and the Criminal Law (CRC Press, 2001). See, Lilly: An Introduction to the Law of Evidence (West, 1996), at 554; Graham, Federal Rulers of Evidence in a Nutshell (West, 2001), at 310. See, Chapter 4, Science and Legal Causation. In most instances these civil products cases actually center on “science” in the context of science as reasonable business practice: Were the product warnings adequate? Was the warning sufficient? Were the instructions clear? Was the product misrepresented in marketing literature? It is important to recall that, aside from some comparative scientific testing typically done by a defendant corporation in attempts to replicate the dynamics of the death or injury producing event, there is no actual science engaged in to answer the causation related issues involved in the actual case being litigated. See, General Electric v. Joiner, 118 S.Ct.512, 522 U.S.136 (1997), where the parties argued the applicability of six published articles about the cancercausing potential for long-term exposure to PCB’s. See discussions to follow. It should also be noted at this point that the legal standard of proof of “facts” in criminal cases is “beyond a reasonable doubt,” whereas civil tort cases only require that a “fact” be proved by “a preponderance of evidence.” This is a critically important difference in the trial of civil and criminal cases. See, generally, Kiely: Forensic Evidence: Science and the Criminal Law (CRC Press, 2001).


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Science and Litigation: Products Liability in Theory and Practice 22. There are a growing number of excellent treatises on the various observational disciplines that constitute the forensic science corpus. This area will receive increased attention in the next decade as basic assumptions of these disciplines are challenged. See, generally, Saferstein, Criminalistics: An Introduction to Forensic Science (6th ed., Prentice Hall, 1998); Eckert: Introduction to Forensic Sciences (2d ed., CRC Press, 1997); Fisher: Techniques of Crime Scene Investigation (5th ed., CRC Press, 1993); Bodziak: Footware Impression Evidence (CRC Press, 1995); Geberth: Practical Homicide Investigation (3d ed., CRC Press, 1996); DiMaio and DiMaio: Forensic Pathology (CRC Press, 1993); Pickering and Bachman: The Use of Forensic Anthropology (CRC Press, 1997); Janes (ed.): Scientific and Legal Applications of Bloodstain Pattern Interpretation (CRC Press, 1999); Ogle and Fox: Atlas of Human Hair: Microscopic Characteristics (CRC Press, 1999). Also see, Cyril H. Wecht (ed.): Forensic Sciences. (Matthew Bender Co., 1997), a five-volume, 90-chapter loose-leaf collection of a wide variety of forensic science subjects, both traditional and contemporary. 23. See Duran v. Cullinan, 286 Ill.App.3d 1005, 677 N.E.2d 999 (1997). 24. See, generally, Geberth: Practical Homicide Investigation (3rd ed., CRC Press, 1996); Fisher: Techniques of Crime Scene Investigation (5th ed., CRC Press, 1993); Saferstein: Criminalistics: An Introduction to Forensic Science (6th ed., Prentice-Hall, 1998); Eckert: Introduction to Forensic Sciences (2nd ed., CRC Press, 1997). Also see the trial transcript testimony of Dr. Henry Lee in the O.J. Simpson murder trial, available on Westlaw. 25. This is a fact quite distinct from whether these forensic sciences have been sufficiently challenged on their basic assumptions to justify any opinion being given. See, Michael J. Saks, “Merlin and Solomon: Lessons from the Law’s Formative Encounters with Forensic Identification Science,” 49 Hastings L.J. 1069, 1081 (1998), for an analysis of the heretofore unquestioning acceptance by the courts of most forensic sciences, in particular, the much debated discipline of handwriting analysis. 26. Science-based disputes also abound in contract actions and regulatory proceedings, whether the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), the Consumer Product Safety Administration (CPSA) or a multitude of other science-based government organizations. 27. Frye v. United States, 54 App.D.C.46 293 F.1013 (1923). 28. Frye v. United States at 47, 1014. 29. Ibid. 30. Ibid. 31. 509 U.S.579, 113 S.Ct.2786 (1993). 32. See, generally, Owen: Products Liability and Safety (3rd ed., Foundation Press, 1996); Henderson and Twerski: Product Liability, Problems and Process



33. 34. 35. 36. 37. 38. 39. 40. 41.

42.

43.

44.

45.

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(Aspen Law and Business, 2000); David Owen, Products Liability Restated, 49 S.C. L.Rev. 273 (1998). Dauber, at 583. Daubert, at 582. Daubert v. Richardson Merrell Dow Pharmaceutical, at 2792. Daubert v. Richardson Merrell Dow Pharmaceutical [trial court], 727 F.Supp., at 575. Id. 951 F.2d 1128 (1991). Id., at 1130, quoting United States v. Solomon, 753 F.2d 1522, 1526 (CA9 1985). 951 F.2d at 1130–1131. Daubert, supra, n. 4, at 2793. For a comprehensive listing of the many cases on either side of this controversy, see P. Giannelli and E. Imwinkelried, Scientific Evidence (2d. ed., 1998, Supp. Vol. I §§’ 1-10-1-10(H). Justice Blackmun cited as examples, Green, “Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation,” 86 NW.U.L.Rev. 643 (1992) (hereinafter Green); Becker and Orenstein, “The Federal Rules of Evidence After Sixteen Years — the Effect of ‘Plain Meaning’ Jurisprudence, the Need for an Advisory Committee on the Rules of Evidence, and Suggestions for Selective Revision of the Rules,” 60 Geo.Wash.L.Rev. 857, 876–885 (1992); James Alphonzo Hanson, “Frye is Sixty-Five Years Old: Should He Retire?,” 16 West.St.U.L.Rev. 357 (1989); Black, “A Unified Theory of Scientific Evidence,” 56 Ford.L.Rev. 595 (1988); Imwinkelried, “The ‘Bases’ of Expert Testimony: The Syllogistic Structure of Scientific Testimony,” 67 N.C.L.Rev. 1 (1988); “Proposals for a Model Rule on the Admissibility of Scientific Evidence,” 26 Jurimetrics J. 235 (1986); Giannelli, “The Admissibility of Novel Scientific Evidence: Frye v. United States, a Half-Century Later,” 80 Colum.L.Rev. 1197 (1980); “The Supreme Court, 1986 Term,” 101 Harv.L.Rev. 7, 119, 125–127 (1987). Rule 402 provides: “All relevant evidence is admissible, except as otherwise provided by the Constitution of the United States, by Act of Congress, by these rules, or by other rules prescribed by the Supreme Court pursuant to statutory authority. Evidence which is not relevant is not admissible.” Rule 401 provides: “Relevant evidence is defined as that which has “any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.” Rule 702, provides: “If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise.” Daubert, supra, note 24, at 2795.


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Science and Litigation: Products Liability in Theory and Practice 46. 509 U.S. at 593. 47. Federal Rules of Evidence, Rule 401. 48. For an excellent discussion of Daubert and its considerable progeny, see, Michael H. Graham, “The Daubert Dilemma: At Last A Viable Solution,” 179 F.R.D.1 (1998). 49. General Electric v. Joiner, 118 S.Ct. 512 (1997). 50. For an excellent recent overview of the issues by federal regulatory agency encounters with Daubert issues, see, D. Hiep Truong, “Daubert and Judicial Review: How Does an Administrative Agency Distinguish Valid Science from Junk Science?” 33 Akron L. Rev. 365 (2000). As noted by the author: In regulating the nation’s health, regulatory agencies must often make risk assessments based on scientific paradigms that are incomplete at best and questionable at worst. Substantive review of agency decision making is the only assurance that agencies are basing their decisions on valid and legitimate scientific evidence. The rebuttal to this argument is that although regulatory agencies make educated predictions based on the best available scientific resources and evidence, these predictions are naturally going to be incomplete as agencies are given general grants of authority to fulfill their broad statutory mandates. …The agencies’ mandate to assess risk has greatly expanded the available sources of evidence from which administrators could base their decision making and with which they could characterize as dangerous, or presenting a level of risk that is unacceptable. These sources of evidence, however, may either be from scientific or nonscientific sources. Ibid. at 365–366. Also see, Cass R. Sunstein, “Health-Health Tradeoffs,” 63 U.Chi.L.Rev. 1533 (1996); Cass R. Sunstein, “On the Costs and Benefits of Aggressive Judicial Review of Agency Action,” 1989 Duke L.J. 522; Peter H. Schuck and E. Donald Elliott, “To the Chevron Station: An Empirical Study of Federal Administrative Law,” 1990 Duke L.J. 984; Richard J. Pierce, Jr., “Two Problems in Administrative Law: Political Polarity on the District of Columbia Circuit and Judicial Deterrence of Agency Rulemaking,” 1988 Duke L.J. 300; Peter L. Strauss, “Considering Political Alternatives to ‘Hard Look’ Review,” 1989 Duke L.J. 538. Also see, Andrew Trask, “Daubert and the EPA: An Evidentiary Approach to Reviewing Agency Determinations of Risk,” 1997 U.Chi.Legal.F. 569 [Cited in Truong, at n.13]. 51. See 90 Stat.2020, 15 U.S.C. ‘2605(e)(2)(A). 52. In concluding, the court held that abuse of discretion was the proper standard by which to review a district court’s decision to admit or exclude scientific evidence, and because it was within the District Court’s discretion to conclude that the studies upon which the experts relied were not sufficient, whether individually or in combination, to support their conclusions that Joiner’s exposure to PCBs contributed to his cancer, the District Court did not abuse its discretion in excluding their testimony. General Electric v. Joiner, at 519.



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53. Joiner, at 520. 54. See, e.g., “Brief for Trial Lawyers for Public Justice as Amicus Curiae,” 15; Brief for the New England Journal of Medicine et al. as Amici Curiae 2 (“Judges … are generally not trained scientists”). 55. Brief for the New England Journal of Medicine, 18–19; cf. Fed. Rule Evid. 706. The Joiner case drew an extraordinary number of amicus briefs from business interests seeking to support the decision to bar the testimony of plaintiff ’s experts. The one that made the most impression was that supplied by Marcia Angell, editor-in-chief of the New England Journal of Medicine. Also see, M. Angell, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case (W.W. Norton, 1996). 56. Justice Breyer has followed through on his enthusiasm for the idea of cooperation of scientists and courts in the legal task of analyzing the solidity of scientific methodology and opinions based on them. See, Breyer, “The Interdependence of Science and Law,” 1998 AAAS Meeting, February 16, 1998, advocating the now implemented program whereby the AAAS would facilitate the cooperation of members with federal trial courts in a selection of cases involving complex gatekeeper pretrial hearings. This experimental program is called Court Appointed Scientific Experts (CASE). 57. See Hall v. Baxter Healthcare Corp., 947 F. Supp.1387, 1392 (D. Or. 1996) (stating that “in an effort to effectively discharge my role as ‘gatekeeper’ under Daubert, I invoked my inherent authority as a federal district court judge to appoint independent advisors to the court”) Based upon a subsequent report by his experts, the district court dismissed a large block of breast implant cases. 58. 119 S.Ct.1167 (1999). Two excellent Texas cases, decided just prior to Kumho Tire addressed the issue of what types of expertise are covered by Daubert and whether all of the Daubert criteria needed to be addressed for a reliability finding. See, Gammil v. Jack Williams Chevrolet 972 S.W.2d 713 (Sp. Ct. Texas 1998) and Ford Motor Company v. Aguiniga, 9 S.W.3d 252 (Ct.App.Texas 1999). 59. Id. at 1172. 60. Id. at 1174. 61. Kumho Tire, at 1175. 62. Id. 63. MDL 926, Master File No. CV-92-10000-S, N.D. Ala. 64. Members of the panel included: Betty A. Diamond, M.D., an immunologist from Albert Einstein College of Medicine (Bronx, N.Y.); Barbara Sorenson Hulka, M.D., an epidemiologist from the University of North Carolina, Chapel Hill; Nancy I. Kerkvliet, Ph.D., a toxicologist with Oregon State University; and Peter Tugwell, M.D., a rheumatologist with the University of Ottawa.


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Science and Litigation: Products Liability in Theory and Practice The experts participating in Washington, D.C., included Harry Spiera, M.D., clinical professor of medicine at Mt. Sinai Medical School (New York, N.Y.); Janet Daling, Ph.D., professor of epidemiology with the University of Washington, Seattle; Dori Germolec, Ph.D., head of the environmental immunology laboratory with the National Institute of Environmental Health Science in Research Triangle Park, N.C.; Noel Rose, M.D., Ph.D., professor of pathology, molecular biology and immunology at Johns Hopkins Hospital (Baltimore, MD); Britta Ostermeyer Shoaib, M.D., with the Health Science Consultant Group, Lasker Biomedical Research Building, Columbia University Medical Center; and Charles Janeway, Ph.D., professor of immunology at Yale Medical School. 65. See, Breast Implant Panel: Executive Summary, at http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm (1998). Also see the MDL926 Breast Implant Litigation Home Page, at http://www.fjc.goc/BREIMLIT/md1926.htm. 66. It is important to note that the Daubert or Frye standards do apply with full force to the more common law and science questions routinely addressed in criminal prosecutions. The bulk of the currently utilized forensic science disciplines — as well as their relatively unchallenged legal acceptability — were perfected prior to heightened focus on these matters in the mid to late 1990s. 67. 119 S.Ct.1167 (1999). 68. J. Horgan, The End of Science: Facing the Limits of Knowledge in the Twilight of the Scientific Age (Addison Wesley, 1996). See also, John Maddox, What Remains to Be Discovered: Mapping the Secrets of the Universe the Origins of Life and the Future of the Human Race (Free Press, 1998). 69. 220 F.3d 532 (7thCir.Ct.App. 2000). 70. Id. at 533. 71. Bourelle at 534. 72. Bourelle at 535. 73. Id. 74. Daubert, 509 U.S. at 590, 113 S.Ct.2786. 75. Citing Walker v. Soo Line R.R. Co., 208 F.3d 581, 586 (7th Cir.2000). 76. The Daubert nonexclusive factors are: 1) whether the theory is scientific knowledge that will assist the trier of fact and can be tested; 2) whether the theory has been subjected to peer review or publication; 3) the known or potential rate of error and the existence of standards controlling the technique’s operation; and 4) the extent to which the methodology or technique employed by the expert is generally accepted in the scientific community. See Daubert, 509 U.S. at 593–94, 113 S.Ct. 2786. 77. Kumho Tire, 526 U.S. at 152, 119 S.Ct. 1167. 78. Bourelle v. Crown Equipment Corporation at 536.



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79. It is important to note that corporate defendants more often than not, when feasible, do conduct in-house testing protected as work product. See Chapter 8, Science and Pre-Trial Discovery. 80. See, Cummins v. Lyle Industries, 93 F.3d 362, 368 (7th Cir.1996): [o]ur cases have recognized the importance of testing in alternative design cases. It should be noted, however, that the existence of industry-wide trade associations such as the Automobile Manufacturers Association strive to ensure that no members exceed the industry agreed upon design standards. So it is no surprise that no other manufacturer incorporated his or anyone else’s proposed design. The same usually goes for industry-wide versions of instructions or warnings.” 81. This is typically the way in which products liability plaintiff counsel argue the alternative, i.e., by having their expert use the defendant’s tests to illustrate their points. 82. Bourelle, at 537. Also see, Clark v. Takata Corp., 192 F.3d 750 (7th Cir.1999), at 759, where the court stated: “[g]iven the state of the record, including the absence of any stated methodology, it is difficult for this Court to evaluate the scientific technique used by Dr. Lafferty in formulating his opinions. Thus, we sympathize with the trial judge’s inability “to determine [if the] methods are consistent with the generally accepted method for gathering and evaluating evidence in the field of biomechanics and mechanical engineering as applied to occupant dynamics and restraint system efficacy in motor vehicle accidents.” Dr. Lafferty’s second opinion, that a properly functioning lap belt would have prevented Clark from moving upward four inches and striking the roof of the vehicle, lacked reliance on any “stated methodology” or the scientific method. 83. Ibid. at 538. See, General Electric Co. v. Joiner, 522 U.S.136, 146, 118 S.Ct.512, 139 L.Ed.2d 508 (1997), “[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.” 84. Bourelle, at 538–539. 85. The court cited Jaurequi v. Carter Mfg. Co., Inc., 173 F.3d 1076, 1084 (8th Cir.1999). Excluding expert testimony that “warnings were deficient in placement, design, orientation, and content” as unreliable because “[n]either [expert] had created or even designed a warning device which would have been more appropriate, much less tested its effectiveness.” 86. Bourelle, at 539. Also see, Cummins v. Lyle Industries, 93 F.3d 362, 368 (7th Cir.1996) and Ancho v. Pentek Corp., 157 F.3d 512, 515 (7th Cir.1998) for similar positions on the courtroom obligations of expert witnesses in products liability cases. The Seventh Circuit appears to be taking the lead in addressing this difficult issue.



74 87. 88. 89. 90.

91. 92. 93.

94.

95.

119 F.Supp.2d 794 (7th Cir. Ct. App. 2000). Frey, at 796. Frey, at 798. King did testify that he used a “XRITE 528 Spectro Densitometer” to measure color saturation of some of the art works in question on April 13, and the remainder in June or July, 1999, presumably, to confirm the alleged fading. (King Dep., at 66–68). But he had no prior formal readings against which to compare his new saturation readings; and apparently, he did not even get a full set of readings. He testified that he stopped measuring at some point because he could “see the difference. You don’t have to measure it.” Id. Frey, at 798–799. Frey, at 799. See, Judge Harvey Brown, “Eight Gates for Expert Witnesses,” 36 Hous. L. Rev. 743 (1999); “Procedural Issues under Daubert,” 36 Hous. L. Rev. 1133 (1999) [the second of a two-part analysis of the admissibility of expert witness testimony after Daubert v. Merrell Dow Pharmaceuticals, Inc. and its progeny.] These are two excellent collections of cases and analysis by an experienced judge. The Kumho Tire decision unleashed a flood of law review articles, comments, case notes, and a rash of plaintiff and defendant newsletter publications. See, e.g., Michael H. Graham, “The Expert Witness Predicament: Determining ‘Reliable’ under the Gatekeeping Test of Daubert, Kumho, and Proposed Amended Rule 702 of the Federal Rules of Evidence,” 54 U. Miami L. Rev. 317 (2000); Practical Litigator (January 2000); Jerold S. Solovy and Joel J. Africk, “Use of Experts in Federal Courts in the Wake of Kumho Tire,” 11(1) Prac. Litigator 23 (2000); Paul Giannelli and Edward Imwinkelried, “Scientific Evidence: the Fallout from Supreme Court’s Decision in Kumho Tires,” 14-WTR Crim. Just. 12 (2000); Joseph P. H. Babington, “They Need to Hear from the Trenches (Or How a Young Trial Lawyer from Mobile, Ala. Came to Argue Kumho Tire v. Carmichael before the U.S. Supreme Court),” 48 La. B.J. 115 (2000); D. Michael Risinger, “Defining the ‘Task at Hand’: Nonscience Forensic Science after Kumho Tire Co. v. Carmichael,” 57 Wash. & Lee L. Rev. 767 (2000); Michael J. Saks, “Banishing Ipse Dixit: the Impact of Kumho Tire on Forensic Identification Science,” 57 Wash. & Lee L. Rev. 879 (2000); Robert J. Goodwin, “The Hidden Significance of Kumho Tire Co. v. Carmichael: a Compass for Problems of Definition and Procedure Created by Daubert v. Merrell Dow Pharmaceuticals, Inc.,” 2 Baylor L. Rev. 603 (2000). Also see several excellent practice-oriented articles written by and for the benefit of litigators in the heady world of products liability litigation. See, e.g., Michael C. Smith, “The Effect of Kumho Tire and Amended Federal Rule of Evidence 702 on Daubert Challenge Procedure,” (Winter 2001) ATLA-CLE 455 (2001); (Winter 2001) ATLA-CLE 295; Hon. John H. Whitfield, “An Overview of the Test for Determining the Admissibility of Scientific Evidence:



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Frye, Daubert, and Kumho (Winter 2001) ATLA-CLE 295 (2001); Ronald Simon, “Re-reading Daubert, Joiner, and Kumho: Pitfalls, Potholes, and/or Avoiding Being Off-track,” 2 Ann.2000 ATLA CLE 2723 (2000); Gerson H. Smoger, J.D., Ph.D., “From Rule 702 to Daubert to Joiner to Kumho Tire: a Review of the Supreme Court’s Analysis of the Admissibility of Expert Testimony,” No. 4 Andrews Diet Drugs Litig. Rep. 9 (2001); Ellen Relkin, “Warnings in Pharmaceutical Cases: Is the Learned Intermediary Obsolete in the New Millennium?,” 2 (Ann. 2000) ATLA CLE 2713 (2000). 96. Regarding the practice implications on the post-Kumho preparation of expert witness, see, e.g., David L. Harris, LaTisha S. Gotell, “Preparing Experts with Kumho in Mind,” 11 No. 6 PRACLIT 45 (Practical Litigator November 2000). Also note that the Federal Rules of Evidence committee’s addition to Federal Rule of Evidence 702 is an additional clause at the end of the rule, requiring that testimony, in addition to meeting the existing “assist the trier of fact” and “qualified witness” tests, meet three more criteria: (1) the testimony is based upon sufficient facts or data; (2) the testimony is the product of reliable principles and methods; and (3) the witness has applied the principles and methods reliably to the facts of the case.


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Atque inter silvas Academi quaerere verum. (And seek for truth in the groves of Academe.) — Horace, 65 A.D.–8 B.C.

Introduction This chapter is devoted to a broad-based examination of the scientific peerreview process, the centuries-old method whereby members of a scientific community hopefully receive the imprimatur of fellow scientists as to the validity and value of their written work. This process, extensively expanded in today’s genetically enhanced academic ambience, has been increasingly cited by the U.S. Supreme Court in the past decade as one of the primary factors to be considered by trial judges in their gatekeeping function of only allowing reliable science to serve as support for the opinion of an expert witness. Sir Francis Bacon, Lord Chancellor of England, and one of the fathers of modern scientific thinking, invented a work near the end of his life called the New Atlantis, wherein he created a mythical institution called Saloman’s House or the College of the Six Days Work on a mysterious island. On this unknown island the inhabitants were devoted to a serious and widespread search for the identification of scientific discoveries and the development of rigorous standards for testing their reliability and usefulness.1 Bacon decribed a complex system of experts, whose duties were focused on strict examination of practical results to serve as the basis for more generally applicable scientific principles. These are, my son, the riches of Salomon’s House: For the several employments and offices of our fellows, we have twelve that sail into foreign countries under the names of other nations (for our own we conceal), who bring us the books and abstracts, and patterns of experiments of all other parts. These we call merchants of light. We have three that collect the experiments which are in all books. These we call depredators. We have three that collect the experiments of all mechanical arts, and also of liberal sciences, and also of practices which are not brought into arts. These we call mystery-men. 77


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In addition to these basic researchers and information gatherers, Atlantis appointed others devoted to establishing a science policy to determine the appropriate uses of the research and development efforts: We have three that try new experiments, such as themselves think good. These we call pioneers or miners. We have three that draw the experiments of the former four into titles and tables, to give the better light for the drawing of observations and axioms out of them. These we call compilers. We have three that bend themselves, looking into the experiments of their fellows, and cast about how to draw out of them things of use and practice for man’s life and knowledge, as well for works as for plain demonstration of causes, means of natural divinations, and the easy and clear discovery of the virtues and parts of bodies. These we call dowry-men or benefactors. Then after divers meetings and consults of our whole number, to consider of the former labors and collections, we have three that take care out of them to direct new experiments, of a higher light, more penetrating into nature than the former. These we call lamps. We have three others that do execute the experiments so directed, and report them. These we call innoculators. Last, we have three that raise the former discoveries by experiments into greater observations, axioms, and aphorisms. These we call interpreters of nature.2

The research programs and goals of Bacon’s New Atlantis are clearly mirrored in the 21st century’s university laboratories and corporate research and development facilities. Today the goals sought for such efforts are decidedly more commercial than those expressed by Bacon and his successors in the 17th century, who succeeded in fostering a desire for an experimental philosophy grounded in rigorous experimentation and observation. Professors Steven Shapin and Simon Schaffer, in Leviathan and the Air Pump,3 their excellent study of that pivitol period, summarized the key inquires: What are the means by which experiments can be said to produce matters of fact, and what is the relationship between experimental facts and explanatory constructs? How is a successful experiment identified, and how is success distinguished from experimental failure?

Their goals in writing this study were essentially the same as those desired by the Supreme Court in Daubert and its progeny: Far from avoiding questions of ‘truth,’ ‘objectivity,’ and ‘proper method,’ we will be confronting such matters centrally. But we shall be treating them in a manner slightly different from that which characterizes some history and



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much philosophy of science. ‘Truth,’ ‘adequacy,’ and ‘objectivity,’ will be dealt with as accomplishments, as historical products, as actors’ judgments and categories. They will be topics for our inquiry, not resources unreflectively to be used in that inquiry.4

The existence of crucial scientific facts such as causation in complex science-centered products liability cases is often dispositive. If the crucial case fact goes, so goes the case. As noted by Shapin and Schaffer: A discarded theory remains a theory. There are ‘good’ theories and ‘bad’ theories — theories currently regarded as true by everyone and theories that no one any longer belives to be true. However, when we reject a matter of fact, we take away its entitlement to the description: it never was a matter of fact at all.5

The individuals referred to by Lord Bacon as the “riches” of his Salomon’s House came alive in the 20th and 21st-centurys grant-driven university laboratories and equally sophisticated proprietary corporate research facilities. The merchants of light, depredators, mystery-men, compilers, benefactors, lamps, innoculators and interpreters of nature, all have their modern counterparts in the 21st-century world of international conferences, scientific consortiums, peer-reviewed journals and university research facilities, all fueled by government and/or corporate funding sources. New questions about the ownership of one’s own genes6 as well as the appropriate response of traditional federal regulatory agency responses to current or proposed commercial outcroppings of recent scientific developments7 are being raised at an ever increasing rate. The need and desire for peer acceptance of a scientist’s work has driven modern science since its vigorous inception in the 17th century. Robert Hooke sought it in 1665 for his microscopic studies from the progenitors of today’s Royal Society: The Rules you have prescribed Yourselves in Your Philosophical Progress do seem the best that have ever been yet practiced. And particularly that of avoiding Dogmatizing, and the esposal of any Hypothesis not sufficiently grounded and confirmed by Experiments. This way seems the most excellent and may preserve both Philosophy and Natural History from its former Corruptions.…8

Hooke set out what he considered the optimum circumstances for a solid and effectual pre-approval peer-review examination: …nothing is to be admitted, and yet everything to pass a mature deliberation. No Intelligence from men of all Professions, and quarters of the World,


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Science and Litigation: Products Liability in Theory and Practice to be slighted, and yet all to be so severely examin’d that there remains no room for doubt or instability; much rigour in comparing, and above all, much slowness in debating and shyness in determining, is to be practised…10

The number, type and quality of the scientific societies and organizations from which scientists of varying stripes seek approval today, is legion. This is our initial topic — how has scientific peer review progressed and how is it considered by contemporary scholars in various fields of scientific endeavor? Several preliminary observations are in order. Initially, the increasing importance of peer-reviewed articles to support an expert’s methodology and opinion is clear evidence that the courts, as in the 19th century, still must and do essentially rely on generally accepted scientific thinking as conceded by the 1923 Frye decision. This is clearly so, regardless of a shift in language to reliable science, because there is simply nowhere else to go for assistance. Courts themselves cannot bring anything to the table as respects reliable science other than require trial court gatekeepers to put forth a bit more effort in trying to more find out more accurately how contemporary scientists judge the work of their brothers and sisters in the relevant field of expertise. Changing the linguistic focus of the inquiry from what scientists deem acceptable to what they deem reliable does not change where courts must go for assistance or how they judge any proffered methodology once there. As noted by the American torts scholar Dean Leon Green: Under whatever guise it has been undertaken, the search for a language technic which would solve the difficulties of government has been the falsest hope of legal scholarship…It is not that a scientific language device is not desirable. It is merely that too much emphasis has been put upon it, and too much expected of it. The attempt has been made and still is made to make language do the service of judging itself.10

Second, the weight and respect heretofore given the peer review process by scientists themselves has come under rapid and growing criticism as we enter the 21st century world of bioengineering and bioinformatics. However, it should be noted that scientific organizations and the academic publications they sponsor have always been a target for severe criticism. The English mathematician Charles Babbage complained about such attacks in his 1830 book Reflections on the Decline of Science In England and Some of Its Causes: Many attacks have lately been made on the conduct of various scientific bodies, and of their officers, and severe criticism has been lavished upon some of their productions. Newspapers, Magazines, Reviews, and Pamphlets, have all been put in requisition for the purpose. Odium has been cast upon some of these for being anonymous. If a fact is to be established



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by testimony, anonymous assertion is of no value; if it can be proved, by evidence to which the public have access, it is of no consequence (for the cause of truth) who produces it. A matter of opinion derives weight from the name which is attached to it; but a chain of reasoning is equally conclusive, whoever may be its author.11

There are not many cases post Daubert, Joiner and Kumho Tire, that actually talk about peer review and what it is or is not from the standpoint of the scientific peer review communities themselves. To begin, we will examine the manner in which the U.S. Supreme Court has addressed the subject of peer-reviewed scientific methodologies as mainstays of the Daubert reliability investigation.12 The discussion will then shift to an analysis of perceived problems with the process by scientist themselves over the past two decades. Such criticism has ballooned over the past 10 years, those in which the Supreme Court has consistently rubber-stamped peer review as a defining element in judicial acceptance of an expert witness’ supportive methodology. The chapter will conclude with a discussion of several important decisions rendered after Kumho Tire, that have begun to analyze the peer-review issue in more detail. An appendix to this chapter will set out a partial list of the numerous articles in scientific-oriented journals that have increasingly criticized their own peer-review processes. Reputable Internet sites such as that for the Scientist as well as newspapers of record such as the New York Times, are replete with articles describing the massive infusion of resources into the mining of the commercial potential of bioinformatics and genome-related databases and technologies. 13 The current law and science reliability or generally acceptable language paradigms and the discussions revolving about them, are getting very far away from the current issues involved in the world of bioinformatics and other gene-based scientific developments. We may be quickly losing touch with the new questions to ask about science and the contemporary and planned commercial uses of the world of biotechnology that are soon to follow.

Peer Review of Peer Review A reanalysis of current judicial thinking on the validity and objectiveness of the scientific peer-review processes considered so important by the U.S. Supreme Court in resolving conflicts over the general acceptability and or reliability of scientific testimony is long overdue.14 There is increasing criticism of peer-review standards regarding financial conflict of interest, ghost authors and a host of other concerns in this key component of the U.S. Supreme Court’s analysis of scientific reliability. This is only the latest occurrence of an historical cycle of criticism begun in early 19th century in


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England. Other than the cautions raised in excellent note “The ‘Brave New World’ of Daubert: True Peer Review, Editorial Peer Review, and Scientific Validity”15 by Effie Chan in 1995, courts and lawyers have continued the practices begun in the American 19th century of assuming that science’s publication house is in order.16 Peer review can be seen as two basic processes: (1) an actual examination of the data and methodologies used by scientists in the lab by other working scientists; or (2) determining whether the results or conclusions drawn from such work should be published in a relevant scholarly journal. 17 As far as any use by the courts as indicators of the reliability of any science is concerned, it is obvious that only the second meaning has any possible utility. Courts and lawyers in product liability or environmentally centered litigation are certainly not required to or capable of launching a re-evaluation of scientific efforts across a wide range of endeavors. All that courts and litigators can do is to trust in the integrity of those empowered to publish scientific findings, theories and conclusions in sufficiently authoritative journals. It is this data that serve as the basis for expert opinion, whether through extrapolation, differential diagnosis or other methods of reaching a finite conclusion in a particular case, based upon disparate and often partially unrelated scientific work. All of these discussions are part and parcel of the essentially “paper science” reality of modern products liability and environmental litigation and agency work discussed in Chapters 1 and 2.18 Prior to a close analysis of the peer review discussions of the U.S. Supreme Court in the Daubert line of cases and decisions rendered thereafter, it will be of considerable value to examine the current criticism of editorial peer review practices by science researchers themselves. There has been a steady, ever increasing litany of criticism about the way scholarly scientific articles, the grist for the mill of products liability cases, actually get chosen for publication. There appears to be no definitive criteria used to decide whether an article should be published in a peer-reviewed journal. Each journal has its own way of peer reviewing, some use only one reviewer while others use two or three. Some send a paper through review more than once. Some use statistical reviewers and some don’t. Some let the editor determine which papers should be initially rejected and then send the others to reviewers. Some send all papers to reviewers. Additionally, each journal has its own way of picking reviewers. Some use a large database full of volunteers. Others ask the author who is an expert in their field. Still others use people the editor and assistant editors know. The majority of journals, however, keep a database of their own for people that have reviewed for them before.



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Each journal also has a different policy as to how much weight to give a reviewer’s critique. Some editors use the critique only to give to the authors to make changes. Others use the critique to help make a decision whether to reject the paper, accept it with revisions, or outright accept it. Other editors take the reviewer’s opinion and that’s what they do with the paper with no decision making on their own. The reviewers are usually told if they should just critique the paper or also include their opinion as to whether the paper should be accepted or rejected. Peer review is supposed to decide if the methods used to get to the conclusion are scientifically sound, rational, reasonable, or logical. However, an author can have this requirement and still not get published for a variety of reasons, including writing style, the “originality” of the idea (a duplication of someone else’s work), or the “newness” of the idea (ideas that are too controversial, even if the results are valid, may not be published). On the other hand, an article may get published even if the results are not reasonable from the data. This occurs in fraudulent papers where the author leaves out data or in statistical calculations where an honest mistake is made, but no statistical reviewer is used, so the mistake is not caught. Who are the peer reviewers? Any person that works in the field can be a reviewer. The best reviewers, however, have the following characteristics: less than 40 years of age; have a lower ranking position; and attended a prestigious educational institution. These characteristics give them the ambition, the time, and the education to do a good review. There are many identified faults with peer review. One is the bias that occurs in the review process. A reviewer may be an opponent or a proponent of an idea or theory. If she is an opponent, she may be overly harsh and suggest rejection. On the other hand, an editor may want an opponent to point out any weaknesses. A proponent can show bias in one of two ways. She can like the idea so much that she does not give an objective critique or she may be working on this type of research herself. In the latter case, she may give a bad critique to delay publishing, so that she can use the information or, worse yet, publish it herself. Another weakness in peer review is the lack of the ability to always discover fraudulent and or financially influenced results. It is also slow and expensive. One other weakness is the way the system is set up. It allows for political maneuvering. This can occur when a friend gives a favorable review or an enemy gives an unfavorable review. It can also occur if a younger colleague gives an older colleague a favorable review, hoping the favor will be returned later. This can sometimes be fixed by a blinding process. There are two types: single blinding and double blinding. Single blinding is when the reviewer is


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anonymous to the author. Double blinding is when they are anonymous to each other. Although there are obvious advantages to blinding, there are also problems. Peer review is not only supposed to validate results, but it’s also supposed to encourage communication. This process hinders that. Additionally, if the author doesn’t know your identity, you’re more likely as a reviewer to “steal” an idea. The author won’t know who reviewed her paper, so she won’t know to look out for that person. Some suggestions to “better” peer review have been given. One is to forget it all together and allow the readers and other experts to decide. In a way, this is already done by letters published in the correspondence sections of journals. A second way is to require outside audits where an identical experiment is done to see if the same results are reached. This fixes the fraudulent problem, but not the slow and expensive problems. Several new issues have arisen with regard to peer review. The first is the Internet. Journals are starting to publish on the Web. It’s quicker, easier, and less expensive. Some publish their regular journal, while others publish an unreviewed version. Many of these journals then allow for others to write in to give their opinion on the articles. A big concern with this type of publishing is whether it will kill peer review altogether. The other issue is the dissemination of information before it has been peer reviewed in order to save lives. This has become a relatively common practice with important journals such as the New England Journal of Medicine. This occurred with a new treatment for children with AIDS. Some argue without this early dissemination lives will be lost. Others argue with dissemination the treatment has not been fully reviewed and we don’t know what injuries this could cause. The history of the peer review process is sketchy. It started some time in the 1600s or 1700s, but it was much more informal than it is today. The comments on the process noted above by Robert Hookes in 1665 indicate its longevity as a component of the science publishing phenomenon. Authors often asked friends to review their papers. Editors often did all of the reviewing themselves because science wasn’t split up into its specialties like it is today. It was done more in Europe than in the United States. It did not become widespread in the United States until the 1950s. Some startling facts about peer review are that reviewers often spend less than two hours reviewing an article. Additionally, if an article is rejected by one journal, the author can find another journal to get published in. Peer review doesn’t make an article any easier to read. Articles written in English will be published more often than articles in another language, even if the content is the same.



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Reading the increasingly strident literature written by players in the scientific community reveals how random and irrational peer review can be. It’s questionable at best for courts to require an expert to be published in a peer-reviewed journal when many innovative ideas aren’t allowed to be published there or, on the opposite side, if anyone can get published in one of these journals if they submit their articles to enough of them. The appendix to this chapter consists of an extensive, recent bibliography of peer-review articles addressing the controversies. It is not suggested here that courts require litigators to reinvent the wheel by limiting challenges to an opponents expert’s listing and or summarizing scientific literature to reanalysis of the data. However, given the inability to remove the import of scientific literature from the general acceptability or reliability equations, it seems only fair to allow Daubert challenges or cross-examination on the ethical issues involved in the editorial process facilitating the publication of one or more articles central to a contested issue such as causation. The current discussions in American courts revolve around whether the ideas underlying a theory or methodology have actually been published in a peer-reviewed journal or have suffered through some seemingly equivalent process to warrant admission of an opinion. Courts are very far away from entertaining the peer review concerns that are raging through the scientific world.

Peer Review and the Supreme Court Supreme Court Peer Review Discussions Chapter 2 provided a general discussion of the four key federal law and science cases, the last three being decided by the U.S. Supreme Court in the past decade: Frye v. United States (1923), Daubert v. Merrell Dow Pharmaceuticals (1993); General Electric v. Joiner (1997) and Kumho Tire Company, Ltd. v. Carmichael, (1999).19 There appears to be an assumption in each of these cases that the idea of peer review is a known quantity that somehow contains within it some undefined but set methodology for definitively sorting the academic and scientific wheat from the chaff in the disparate scientific disciplines brought before American courts.20 In the hundreds of pretrial Daubert hearings argued each year in state and federal courts, any assumption of the general scientific solidity of the conclusions drawn or opinions offered in supportive peer-reviewed articles, as a whole, is decidedly faulty. In an article published shortly after the United States Supreme Court’s Daubert decision, author Effie Chan,21 makes clear the distinction between what the author terms “true peer review,” scientists examining the data, and


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“editorial peer review,” which focuses on the standards used by journal editors in deciding whether to publish a submitted article: The inquiry must be premised on an understanding of true peer review as a multi-faceted process taking place at every level of the scientific endeavor. In addition, the inquiry requires an understanding of the close association between true peer review and ‘editorial peer review,’ the process by which scientific journals choose which scientific findings to publish and disseminate to the scientific community-at-large. The primary locus of the scientific validity inquiry is true peer review itself; its secondary locus is the process of editorial peer review.22

These distinctions have been clear for many years, but not until Daubert did they become legally significant. At best, the current post-Kumho decisions may be able to possibly question editorial decisions, but never have nor could second guess the science itself.23 There needs to be a new, critical focus on the validity of the peer review processes utilized in whatever scientific articles are offered by either side as support for the experts proffered opinion. Going behind any of such studies can be time consuming and costly, involving as it would a sub-battle of experts over the credibility of the publishing standards of a wide range of standard journals in all areas of science, let alone going behind the actual data supporting the particular author under review. This should not prevent an effort at such hearings by a party willing to make an ethical showing of one of the large number of concerns being expressed by the world of science itself, in increasingly strident terms. It would bring a needed new perspective to the general reliance on the work of the scientific community that American courts have had since the early 19th century.24 American courts are still reduced to piling up learned articles on a credibility scale based upon competing experts’ Daubert hearing testimony. What underlies such ongoing processes is an assumption of credibility in the respective editorial processes of the category of journals involved. These journals range from coverage of broad medical or biological subject matters such as Lancet, the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA), to very specialized journals addressing cardiology, oncology, neurology and the like. Each of the specialty journals, some having long pedigrees, have there own, often idiosyncratic editorial standards for publication. Whatever the subject matter or particular editorial processes, the courts are nonetheless limited to discussions and the weighing of articles published in such journals. It is paper science no matter how you cut it. There appears to be no reasonable alternative to the reality of the Daubert peer-review criteria. There never really has been. What worked in the past must work in the future, but in a much



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more judicially skeptical arena. There is no present alternative to a substantial judicial reliance on peer-reviewed articles as a major contributor to the reliability requirement. However, an acknowledgment of the considerable problems perceived by scientists themselves in the peer-review process may serve at least to temper the enthusiasm for and the importance given to journal articles as major definitive statements of the reliability of the scientific methodology or opinion at issue. In Daubert v. Merrell Dow Pharmaceuticals,24 the Supreme Court noted that many considerations would bear on the inquiry, including whether the theory or technique in question can be (and has been) tested, whether it has been subjected to peer review and publication, its known or potential error rate and the existence and maintenance of standards controlling its operation, and whether it has attracted widespread acceptance within a relevant scientific community.25 At the trial level, after extensive discovery, respondent moved for summary judgment, contending that Bendectin did not cause birth defects in humans and that petitioners would be unable to come forward with any admissible evidence that it did. In support of its motion, respondent submitted an affidavit of one Steven H. Lamm, physician and epidemiologist, who was a well-credentialed expert on the risks from exposure to various chemical substances. Dr. Lamm testified that he had reviewed all the literature on Bendectin and human birth defects — more than 30 published studies involving over 130,000 patients. No study had found Bendectin to be a human teratogen (i.e., a substance capable of causing malformations in fetuses). On the basis of this review, Dr. Lamm concluded that maternal use of Bendectin during the first trimester of pregnancy had not been shown to be a risk factor for human birth defects.26 It is important to note that the court took at face value the legitimacy of the “30 published studies,” without any discussion of the quality or prestige of any such publications, the data and processes underlying the methodologies and conclusions of the authors, or the editorial criteria and processes that determined their respective acceptance for publication. The petitioners did not contest Dr. Lamms’ characterization of the published record regarding Bendectin. Instead, they responded to respondent’s motion with the testimony of eight experts of their own, each of whom also possessed impressive credentials.27 These experts had concluded that Bendectin can cause birth defects, based upon in vitro (test tube) and in vivo (live) animal studies that found a link between Bendectin and malformations; pharmacological studies of the chemical structure of Bendectin that purported to show similarities between the structure of the drug and that of other substances known to cause birth defects; and the “reanalysis” of previously published epidemiological (human statistical) studies. 28 As with the


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journal studies put forth by respondents, there was no discussion of the quality or prestige of any such publications, the data and processes underlying the methodologies and conclusions of the authors, or the editorial criteria and processes that determined their respective acceptance for publication. Given the vast body of epidemiological data concerning Bendectin, the trial court concluded that expert opinion which was not based on epidemiological evidence was not admissible to establish causation.29 Thus, the animal-cell studies, live-animal studies, and chemical-structure analyses on which petitioners had relied could not raise by themselves a reasonably disputable jury issue regarding causation. Because the generally accepted way to look at tetragon claims was through epidemiological studies, that was what the court accepted with little or no independent analysis. Therefore, the court concluded, petitioners’ epidemiological analyses, based as they were on recalculations of data in previously published studies that had found no causal link between the drug and birth defects, were ruled to be inadmissible because they had not been published or subjected to peer review. The United States Court of Appeals for the Ninth Circuit affirmed, 30 noting that other Courts of Appeals considering the risks of Bendectin had also refused to admit reanalysis of epidemiological studies that had been neither published nor subjected to peer review.31 Those courts had found unpublished reanalysis particularly problematic in light of the massive weight of the original published studies supporting respondent’s position, all of which had undergone full scrutiny from the scientific community. The court failed to discuss what any such full scrutiny might consist of, let alone examine the journals and their editorial peer-review processes. Contending that reanalysis was generally accepted by the scientific community only when such a process was subjected to verification and scrutiny by others in the field, the Court of Appeals rejected petitioners’ reanalysis as “unpublished, not subjected to the normal peer-review process and generated solely for use in litigation.”32 The U.S. Supreme Court noted that a key factor in any reliability analysis was whether the theory or technique under scrutiny had been subjected to peer review and publication. Publication, the court noted (which is but one element of peer review), was not a sine qua non of admissibility, and did not necessarily correlate with reliability.33 The court also noted that in some instances, well-grounded but innovative theories will not have been published.34 Indeed the court observed, some propositions, were too particular, too new, or of too limited interest to be published. But submission to the scrutiny of the scientific community is a component of “good science,” in part because it increases the likelihood that substantive flaws in methodology will be detected.35 The fact of publication (or lack thereof) in a peer-reviewed journal was thus a relevant, though not dispositive, consideration in assessing



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the scientific validity of a particular technique or methodology on which an opinion is premised.36 Four years later, in General Electric v. Joiner,37 the court returned to the peer-review issue. In Joiner, a city’s electrician, who suffered from lung cancer, brought a products liability action against the manufacturer of polychlorinated biphenyls (PCBs) and manufacturers of electrical transformers and dielectric fluid. He contended that his cancer was caused by long-term exposure to PCBs during his work which involved work with and around the city’s electrical transformers, which used a mineral-oil based dielectric fluid as a coolant. Joiner often had to stick his hands and arms into the fluid to make repairs. The fluid would sometimes splash onto him, occasionally getting into his eyes and mouth. In 1983 the city discovered that the fluid in some of the transformers was contaminated with polychlorinated biphenyls (PCBs). PCBs are widely considered to be hazardous to human health. Congress, with limited exceptions, banned the production and sale of PCB’s in 1978.38 The peer-review issues revolved around the scientific literature used by Joiner’s experts to support a causation argument. This case at least examined four studies for their factual similarity to the present facts to determine if some valid extrapolation could be made to support Joiner’s causation theory. As in Daubert there was no concern or question raised as to the quality or prestige of any of the publications containing the articles, the data and processes underlying the methodologies and conclusions of the authors, or the editorial criteria and processes that determined their respective acceptance for publication. In support of the theory that his exposure to PCBs and their derivatives promoted his development of small-cell lung cancer, Joiner proffered the deposition testimony of several expert witnesses. Dr. Arnold Schecter testified that he believed it more likely than not that Mr. Joiner’s lung cancer was causally linked to cigarette smoking and PCB exposure. Dr. Daniel Teitelbaum testified that Joiner’s lung cancer was caused by or contributed to in a significant degree by the materials with which he worked. 39 Defendants argued that the testimony of Joiner’s experts was not supported by epidemiological studies and was based exclusively on isolated studies of laboratory animals. Joiner responded by claiming that his experts had identified relevant animal studies which support their opinions and directed the court’s attention to four epidemiological studies on which his experts had relied. Epidemiological studies examine the pattern of disease in human populations. The studies involved infant mice that had developed cancer after being exposed to PCBs. The infant mice in the studies had massive doses of PCBs injected directly into their peritoneums or stomachs.40 The PCBs were injected into the mice in a highly concentrated form. The fluid with which


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Joiner had come into contact generally had a much smaller PCB concentration of between 0 and 500 parts per million. The cancer that these mice developed was alveologenic adenomas; Joiner had developed small-cell carcinomas. No study directly demonstrated that adult mice developed cancer after being exposed to PCBs. One of the experts admitted that no study had directly demonstrated that PCBs lead to cancer in any other species. Joiner, rather than explaining how and why the experts could have extrapolated their opinions from these seemingly far-removed animal studies, chose to proceed as if the only issue was whether animal studies can ever be a proper foundation for an expert’s opinion.41 The court noted that whether animal studies can ever be a proper foundation for an expert’s opinion was not the issue: the issue here was whether these experts’ opinions were sufficiently supported by the animal studies on which they purported to rely. The court concluded that these particular studies were so dissimilar to the facts presented in the litigation that it was not an abuse of discretion for the District Court to have rejected the experts’ reliance on them. 42 The District Court also concluded that the four epidemiological studies on which respondent relied were also not a sufficient basis for the experts’ opinions. The first study involved workers at an Italian capacitor plant who had been exposed to PCBs.43 The authors observed that while lung cancer deaths among ex-employees at the plant were higher than might have been expected, they concluded that there were apparently no grounds for associating lung cancer deaths (although increased above expectations) and exposure in the plant. Given the fact that the authors were unwilling to say that PCB exposure had caused cancer among the workers they examined, the Supreme Court concluded that their study did not support the experts’ conclusion that Joiner’s exposure to PCBs caused his cancer. The second study traced Monsanto’s PCB production plant employees. 44 The authors of this study found that the incidence of lung cancer deaths among those workers was admittedly somewhat higher than would ordinarily be expected. The increase, however, was not statistically significant and the authors of the study did not suggest any link between the increase in lung cancer deaths and the exposure to PCBs.45 Once again, no concern was expressed over the possibility of faulty peer-review in the publication decision, let alone that of the author’s methodology or data utilization. The third and fourth studies were also deemed insufficient to support a causation argument. The third article involved workers at a Norwegian cable manufacturing company who had been exposed to mineral oil. 46 A statistically significant increase in lung cancer deaths had been observed in these workers, however, the study made no mention of PCBs and was expressly limited to the type of mineral oil involved in that study. No extrapolation was possible to the the causation issues involved in Joiner’s cancer allegation.



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The fourth and final study involved a PCB-exposed group in Japan that had seen a statistically significant increase in lung cancer deaths.47 The subjects of this study, however, the court observed, had been exposed to numerous potential carcinogens, including toxic rice oil that they had ingested.48 The court, speaking through Chief Justice Rehnquist rejected any position that would find a scientific connection just because an expert says there is one: But conclusions and methodology are not entirely distinct from one another. Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.49

This extrapolation based analysis of Joiner’s four studies, while obviously subject to debate, nonetheless appears to have reached an equitable decision without any perceived need to go behind the study data or examine the scholarly and ethical standards used to determine publication in the first place. Nor was there any felt need to place any particular journal in any ranking for importance, influence or discipline acceptance per se. The Joiner decision, while supplying courts and litigators with a much more detailed analysis — via extrapolation methodology — of how peerreviewed studies are to be utilized, still did not alter the assumption of the scientific solidity of peer-review scientific or editorial policies and processes. As noted, it is the latter that has and continues to receive increasing criticism from the scientific community itself. Finally, we will briefly examine the peer-review discussion of the last of the recent Supreme Court law and science cases, Kumho Tire Company, Ltd. v. Carmichael,50 decided in 1999. Here, in the process of determining that the Daubert criteria apply to all levels of expertise, including the tire explosion expertise at issue, the court, speaking through Justice Breyer, remarked: It might not be surprising in a particular case, for example, that a claim made by a scientific witness has never been the subject of peer review, for the particular application at issue may never previously have interested any scientist. Nor, on the other hand, does the presence of Daubert’s general acceptance factor help show that an expert’s testimony is reliable where the discipline itself lacks reliability, as, for example, do theories grounded in any so-called generally accepted principles of astrology or necromancy. The particular issue in the instant case concerned the use of plaintiff expert Carlson’s two-factor test and his related use of visual/tactile inspection to draw conclusions on the basis of what seemed small observational


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Science and Litigation: Products Liability in Theory and Practice differences. We have found no indication in the record that other experts in the industry use Carlson’s two-factor test or that tire experts such as Carlson normally make the very fine distinctions about, say, the symmetry of comparatively greater shoulder tread wear that were necessary, on Carlson’s own theory, to support his conclusions. Nor, despite the prevalence of tire testing, does anyone refer to any articles or papers that validate Carlson’s approach.51

Justice Breyer noted that the defendant cited three fairly recent articles detailing more traditional methods had been published in technical sources. 52 Non-Supreme Court Peer-Review Cases There are not many cases pre or post Daubert, Joiner, and Kumho, that actually talk about peer review and what it is or is not from the standpoint of the scientific peer-review communities. This discussion examines several of the more important decisions that do address the peer-review question in a number of important ways. None, given the absence of any challenge by counsel, examine the issues such as financial conflict of interest that are causing an increasing rift in the world of peer-reviewed science publishing. In the 1998 case of Black v. Rhone-Poulenc,53 plaintiffs were putative class representatives of persons seeking damages for events that occurred on February 15, 1996, as a result of a fire that broke out at the Rhone-Poulenc’s Institute, West Virginia plant. The fire occurred in the Toluene Drying System, a system that removes water from toluene, located in the Sevin Unit at the plant. It was extinguished within one hour. The apparent cause of the mishap was the failure of a pump. Following the fire, Rhone-Poulenc determined that 9,186 pounds of toluene was lost from the system. The toluene was over 99% pure and contained trace amounts of chemicals used in the Sevin manufacturing process including water, Sevin, methyl isocyanate (“MIC”), naphthol, ethyl benzene, dimethyl urea and chloroform. Plaintiffs retained Dr. Joseph Scotti, a clinical psychologist, in support of their emotional distress claims. Dr. Scotti filed a “Preliminary Report on Class Action Plaintiffs and General Population Survey” on September 23, 1996 and was deposed on September 25, 1996. Although discovery did not close until December 31, 1997, the Scotti report was never supplemented. The report is the result of a study Dr. Scotti performed for Plaintiffs concerning the emotional effects of the release on area residents. The study was designed by Dr. Scotti and an associate. Dr. Scotti commented as follows on the design of the study: [We were to] [d]ecid[e] what would be the most appropriate instruments to use for an evaluation of psychological behavioral effects, to determine the course of those symptoms over time, that is, what were people like before



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the event, right after and then currently, currently being July and early August. And what would be reliable valid measures, what measures are common to this area of research.54

As a result of the testing, Dr. Scotti and his associate concluded, in part, “that two factors were overwhelmingly related to the psychological and behavioral impact experienced by this sample of individuals … exposure to the toxic cloud … and being forced to shelter-in-place.” For each test used, Dr. Scotti and his associate provided two sources of comparative information: (a) established clinical norms for the test; and (b) the scores obtained with other trauma populations such as combat veterans and auto accident survivors.55 In addition to Dr. Scotti, Plaintiffs retained Dr. Thomas Schrager to testify on certain toxicology issues. Dr. Schrager’s proposed testimony, however, was much more circumscribed than that of Dr. Scotti. The court, after discussing the testability aspect of the Daubert criteria, offered a detailed analysis of the peer-review reliability factor set forth in Daubert as respects the methodology utilized by plaintiff ’s experts. The court began with a discussion of Dr. Scotti’s stated participation in two symposiums, one in Florida and one in New York, where he discussed his research in this case: Dr. Lees- Haley, however, obtained a copy of what Dr. Scotti delivered at the Florida conference. He testified Dr. Scotti did not present the methodology he used to his peers at the conference. He said the presentation was quite sketchy and was certainly not an accurate depiction of the Rhone-Poulenc study. The New York presentation appears to have a similar problem. The presentation was but 14 minutes and, again, Dr. Scotti did not reveal several significant issues relating to the study, such as (1) the content of the flyer; (2) the poor record keeping which occurred; and (3) his disclosure to participants of Neely & Hunter’s sponsorship of the study. In sum, there is little to support a finding that appropriate peer review occurred.56

While Dr. Scotti made reference to other similar studies found in peerreviewed literature, suggesting that his methods and results met the peer review requirement. The court observed, however, that he only rarely provided sufficient details to permit the court to perform the necessary comparative analysis between his work in the instant case and that of his colleagues elsewhere. In an important observation on the bibliography form of scientific support, the court noted: His reference to other works further assumed the publication of an article necessarily validates what is contained therein. As noted by Dr. Bernard,


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Science and Litigation: Products Liability in Theory and Practice [trial witness] however, ‘It depends upon how the peer review was performed and who the participants were. There are peer reviews ranging from those which are worthless to those which are of high quality.’ The superficial showing attempted by counsel and Dr. Scotti often did not provide the Court the necessary information to make a reasoned determination on this point, often lacking reference to the author’s reputation, much less that of the journal.57

The court noted the difficulty of simply assuming validity as the result of publication and found support in the article “The ‘Brave New World’ of Daubert: True Peer Review, Editorial Peer Review, and Scientific Validity,” 58 by Effie J. Chan: In addition to being wholly voluntary, editorial peer review also is completely unregulated. It is not a monolith but a variegated collection of different practices. Members of the scientific community are well aware that the types of editorial peer review at different scientific publications vary greatly. And although there is no official “pecking order” of publications based on quality of editorial peer review, there is a general correlation between a journal’s prestige and the quality of its editorial peer review.59

The importance of adequate, true peer review, the court continued, could not be overstated. Equally true was that mere publication of an article was not the end of the peer-review process; it was but the beginning. 60 Considering the hearing testimony, the court found that plaintiffs had failed to make the necessary showing on the peer review consideration. In Allison v. McGhan Medical Corporation,61 decided in 1999 by the Eleventh Circuit Court of Appeals, the recipient of silicone breast implants brought a products liability action against the manufacturers of the implants. The United States District Court for the Northern District of Georgia ruled inadmissible recipient’s proffered expert causation testimony and granted summary judgment to the manufacturers. Allison submitted proposed testimony by three experts to prove causation. Dr. Eric Gershwin was a board certified immunologist, Dr. Douglas Shanklin was a board certified pathologist and Dr. Sam Scatted was Allison’s treating board certified rheumatologist. Under Rule 104(a)62 the parties submitted hundreds of scientific studies and journal articles for the district court to examine. In addition, accompanying affidavits and depositions were submitted and were before the court during the three day Daubert hearing.63 Dr. Gershwin proposed to testify that silicone was capable of causing systemic harm in exposed women. More specifically, that (1) silicone was not inert; (2) silicone can induce inflammation; (3) silicone can induce granulomas; (4) silicone migrates; (5) silicone implants can induce autoantibody production; (6) silicone was an adjuvant; (7) silicone can emulsify; and



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(8) agents which induce chronic inflammation and granulomas are associated with systemic complaints and disease. Gershwin’s ultimate conclusion was that in his opinion, “to a reasonable degree of medical certainty, … silicone breast implants cause or exacerbate systemic conditions in some women.” Gershwin stated the bases of his opinion were his (1) his own research, (2) clinical experience, (3) peer-reviewed literature on silicone as an adjuvant, (4) the Marilyn Lightfoote study, (5) studies examining silicone oil treatment of detached retinas, (6) silicone related antibody studies, (7) studies showing biomarkers in women with implants, (8) case reports, and (9) epidemiological (human statistical) studies.64 The district court found that Gershwin’s opinion was unreliable under Daubert because of improper scientific methodology, stating that Gershwin’s theories had not been tested, were not subject to peer review and were not generally accepted by the scientific community. The district court found that the five animal studies Gershwin relied on in addition to the Lightfoote study were inadequate to support the theory that silicone is an adjuvant. The court noted in passing that the Lightfoote unpublished study was not subjected to peer review. While Allison established that Lightfoote’s oral presentation was subject to the review of her peers, that fact, the court ruled, was no more helpful than peer review in other forums. The court stressed that publication, which was but one element of peer review, was not a sine qua non of admissibility and did not necessarily correlate with reliability.65 Peer review was significant under Daubert because “scrutiny of the scientific community is a component of ‘good science,’ in part because it increases the likelihood that substantive flaws in methodology will be detected.”66 However, the court continued, if peer review alone was dispositive, then the Frye standard of general acceptability in the scientific community would have remained adequate. Consequently, the court ruled, a finding that Lightfoote’s animal study was peer-reviewed did not mean it constituted an adequate basis for Gershwin’s opinion that silicone breast implants cause systemic disease.67 The court addressed Allison’s complaints that Dr. Gershwin did indeed explain the linkage between the rat studies and her disease. Allison reasoned that the adjuvancy papers were not published in the animal toxicology literature and were certainly not intended to provide information on how to treat arthritic rats; they were published in peer-reviewed scientific journals intended to be read by clinicians and others treating real people — thus their relevance was established by the very books and journals in which they appeared. In rejecting this argument, the court stated: We are fully confident that the district court understood that these studies were not undertaken to treat silicone exposed rats. Publication in a peer


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Science and Litigation: Products Liability in Theory and Practice reviewed medical journal for humans, however, does not alone establish the necessary link required under Daubert. Cf. In re Paoli, 35 F.3d at 743 (explaining requirement for proper extrapolation from animal studies to show relevance). Furthermore, Allison does not explain why the results of these animal studies should trump more than twenty controlled epidemiological studies of breast implants in humans which have found no valid increased risk of autoimmune disease.68

The trial court had also examined four epidemiological studies Gershwin offered to support his opinion but, in each case, found reasons why these studies did not supply an adequate foundation for Gershwin’s causation opinion. This court accepted the ruling by the trial court.69 The trial court had also found that Gershwin’s proposed four studies were in direct contrast to over twenty other epidemiological studies which found no statistical correlation between silicone breast implants and systemic disease, strong evidence, the Court of Appeals found, that a consensus exists in the general scientific community that no such correlation exists. The Court of Appeals likewise rejected Allison’s complaint that the district court erred by looking at conclusions rather than methodology and principles as Daubert directed. While weighing the relative findings of the studies may seem to be a resurrection of the Frye standard (general acceptance in the scientific community), the present court observed that Daubert’s suggested criteria to examine whether the theory has attained general acceptance within the scientific community,70 does just that. Joiner made it clear that although principles and methodology were the focus, the court was not precluded from looking at conclusions.71 The court also dismissed Allison’s position that publication in a peerreviewed journal means that the article’s methodology was reliable: Allison states that because these studies were published in peer reviewed journals, then ipso facto their methodology has been determined sound. But as mentioned supra regarding the Lightfoote study, while peer review increases the likelihood that substantive flaws in methodology will be detected, scrutiny by one’s peers does not insure admissibility. Again, it is well established that ‘p]ublication … is not a sine qua non of admissibility.’72

While the trial court stated that Gershwin’s studies had not been subjected to peer review, that factor, the Court of Appeals observed, had bare mention in the court’s analysis of Gershwin’s testimony. This court found, in contrast to the district court, that many of Dr. Gershwin’s theories had been subjected to peer review, Dr. Gershwin being a prolific scientific author who had published numerous articles in peerreviewed journals, and was himself a peer reviewer. However, the court



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continued, the parties here disputed to what extent his premise that breast implants cause systemic disease has been subjected to the relevant scientific community for review. While the court did not question the scientific expertise of Dr. Gershwin, they found that the district court correctly excluded his testimony on the individual and collective bases noted. Even assuming that Dr. Gershwin’s work had been subjected to the most rigorous scrutiny by the scientific community, this factor would not nullify the court’s findings of unreliable foundation, inadequate extrapolation, the lack of human models and “fit.”73 Consequently, they held that the district court did not abuse its discretion in excluding Dr. Gershwin’s testimony. Accordingly, the district court did not abuse its discretion by considering that the proffered conclusions in studies with questionable methodologies were out of sync with the conclusions in the overwhelming majority of the epidemiological studies presented to the court. In Ford Motor Company v. Ammerman,74 a 1999 Indiana Court of Appeals case, passengers brought a products liability action against an automobile manufacturer, seeking recovery for severe injuries they sustained in a rollover accident involving a 1986 Bronco II 4×4. The Court of Appeals ruled that scientific evidence of emergency avoidance maneuver (EAM) tests conducted by passengers’ automotive engineering expert was admissible and that the exclusion of the manufacturer’s evidence that no make of automobile was immune from a potential rollover was not prejudicial. The Ammermans introduced expert testimony by Dr. Michael Kaplan, an engineer with a Ph.D. in solid mechanics. Dr. Kaplan testified that a vehicle’s SI (stability indices) determines whether it is stable and whether it would tend to roll over. According to Dr. Kaplan, the Bronco’s SI made it unstable. Dr. Kaplan also asserted that vehicles with higher stability indices would not roll over, and automobile manufacturers could make vehicles immune to rollover by increasing the indices. In support of his theory, Dr. Kaplan and his partner, Robert Hooker, presented their own emergency avoidance maneuver test. This test involved Hooker driving utility vehicles around pylons using simulated emergency maneuvers.75 Ford challenged the test as unscientific and inadmissible under Ind. Evidence Rule 702(b). The trial court admitted the test and all expert testimony based thereon. 76 Ford challenged the admissibility of Dr. Kaplan’s test results arguing that it lacked established protocols including instrumentation; was neither generally accepted nor reviewed by the relevant scientific community; and that Dr. Kaplan and Hooker designed and conducted the test exclusively for litigation purposes. According to Ford, Dr. Kaplan’s test was unreliable because it was performed without preset protocols or instrumentation. Ford argued that the lack of requirements rendered the test unreliable because it could not be duplicated nor verified and that one could not determine the test’s error rate due to a lack of standards controlling the test’s operation.


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The Ammermans countered that preset protocols and instrumentations were unnecessary and that any failure to establish protocols or instrumentations did not render EAM tests unreliable. They also argued that it was not uncommon to conduct EAM tests without instrumentation or specific protocols. The Court of Appeals noted that Ford did not appear to object to EAM tests in general. In fact, they did not question the methodology or theory behind EAM tests. Instead, the court emphasized, Ford challenged Dr. Kaplan’s opinion due to the procedures utilized during his EAM tests. Dr. Kaplan testified that there did indeed exist a protocol regarding the particular path traveled during the test. Dr. Kaplan further testified that he and Hooker performed the tests at the same speeds and that the only instrumentation utilized is an internal camera which records the amount the steering wheel is turned. According to Dr. Kaplan, instrumentation is irrelevant when determining a vehicle’s tendency to roll over; it is more appropriate when determining a vehicle’s handling properties.77 Ford also contended that the Ammermans’ failure to establish that Dr. Kaplan’s test was either reviewed by his peers or published brought its reliability into question. The court noted that whether a theory or technique has been subjected to peer review and publication was a pertinent consideration. However, publication was not a sine qua non of admissibility. Although publication may be considered a component of “good science” in that it increases the likelihood that substantive flaws in the given methodology will be detected, neither publication nor lack thereof is dispositive when considering the scientific validity of a particular technique or methodology on which an expert opinion is premised.78 The court noted that the Ammermans did not refute Ford’s claim that Dr. Kaplan’s test had not been published in a peer-reviewed journal. However, the court ruled, this fact alone should not render his expert testimony inadmissible. Rather, the reliability of a test should be brought into question through vigorous cross-examination and the presentation of contrary evidence. In this case, Ford had ample opportunity to attack Dr. Kaplan’s test with considerable preliminary questions. Following Ford’s preliminary examination, the trial court stated in pertinent part: The Daubert test also says that your theories must be subject to peer review, and I think that also goes to the repeatability aspect of the arguments that have been made here. I don’t think that peer review is required; but, obviously, these tests are documented well enough that they are subject to review of peers.79

The Court of Appeals agreed with the trial court, stating:



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Although not subjected to peer review in the formal sense, the adversary nature of the trial subjected Dr. Kaplan’s test to thorough scrutiny and increased the likelihood of detecting substantive flaws in his methodology. Ford had ample opportunity to contradict and disprove Dr. Kaplan’s testimony through cross-examination and presentation of its own evidence.80

This ruling, concluding that rigorous cross-examination by well prepared counsel may equate to some kind of substantive peer-review, leaves a lot to be desired and may very well open an opportunity for sidestepping the rule and spirit of Daubert. In Pillow v. General Motors,81 a 1998 Missouri federal district court case, the peer-review issue was addressed in the context of ruling on defendant’s motion-in-limine. This was a products liability action in which the plaintiff claimed that defendant defectively designed the brake system on her 1988 Chevrolet van, plaintiff having been injured when her van collided with the rear end of a pick-up truck. In its motion-in-limine, the defendant moved to exclude the testimony and opinions of plaintiff ’s expert witness, H. Boulter Kelsey, Jr., who would testify to three defective design problems: (1) that the forces placed on the front end of the brake master cylinder of plaintiff ’s van as a result of the frontal impact between the van and the rear end of a heavy duty pick-up truck were transmitted through the brake system of the van to the brake pedal and that the break pedal, independently from the crush to the front end of the van, was thrust rearward with significant force, so that a blow from the brake pedal moving backward caused injuries to plaintiff ’s ankle; (2) the design of the brake master cylinder and brake system in the van was defective and unreasonably dangerous because the design allowed significant and dangerous forces placed upon the brake master cylinder in a frontal collision to be transmitted independently to the brake pedal; and (3) the brake system in the van should have been redesigned so that the master cylinder was repositioned sideways, at an angle or in such a manner that significant and dangerous forces placed on the end of the brake master cylinder would not be transmitted to the brake pedal.82 First, the court considered whether Kelsey’s theories or techniques had been tested. Kelsey based his theory on his observation of plaintiff ’s van, personal observation of an exemplar van of the same model, his review of General Motors documents concerning the same automobile model and a videotape of the same model’s crash tests. Kelsey did not conduct an independent crash test of the model, but relied on the videotaped crash test, which depicted an accident that differs in several respects from the collision in which the plaintiff was involved. The court noted that while the videotape showed a van striking a fixed, immovable barrier, plaintiff ’s accident involved a collision with the rear of a


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pick-up truck that was in operation on a highway and was neither fixed nor immovable. In the videotape crash, the van hit the barrier at 31 miles per hour, but Kelsey was not certain how fast the plaintiff ’s van was traveling at the point of impact but calculated its speed at between 20 and 25 miles per hour. Also, the court noted, the angle of impact in the crash test differed from the angle at which plaintiff ’s van struck the pick-up truck. In addition, as plaintiff ’s van struck the pick-up truck there was some degree of underride as the nose of the van went under the rear of the pick-up truck. The crash test video did not depict any underride.83 Furthermore, the defendant contended, Kelsey’s use of the videotaped crash test demonstrated scientific unreliability because the stated purpose of the crash test was not to examine the speed or force of the brake pedal. In fact, defendant argued, no data was recorded regarding the speed or force of the brake pedal in the test.84 Automobile manufacturer defense lawyers commonly make the specious argument, that even in cases where the test, although specifically run for one purpose, nonetheless records relevant data, that such data is not admissible. This stock argument has had mixed success, depending upon the sophistication of both plaintiff counsel and local trial judges. Kelsey had neither personally tested his theory as to design defect nor his redesign theory. Essentially, the court found, his testimony and theories were extrapolated from crash tests of dubious similarity. His anticipated testimony consisted of entirely untested opinions. This kind of expert testimony, the court ruled, was not countenanced by Daubert or Rule 702, and hence was deemed unreliable. Second, the court considered whether Kelsey’s theories had been subjected to peer review. Kelsey’s theories had not been published. However, the court, citing Daubert, stated that publication was not a sine qua non of admissibility and did not necessarily correlate with reliability. Indeed in some instances well-grounded but innovative theories may not have been published, since they are too particular, new, or of too limited interest to be deemed publishable. It was obvious that “submission to the scrutiny of the scientific community was a component of ‘good science,’ in part because it increased the likelihood that substantive flaws in methodology would be detected. The fact of publication (or lack thereof) in a peer-reviewed journal thus will be a relevant, though not dispositive, consideration in assessing the scientific validity of a particular technique or methodology on which an opinion is premised.”85 In addition, the court noted, plaintiff had not established that Kelsey’s theories had been subjected to any other form of meaningful and favorable peer review. However, the court seemed to accept as in the Ammerman case discussed above, that cross-examination or here, mere pretrial examination by the defendant’s experts somehow constituted “peer-review.” Kelsey’s theories



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had in effect, been subjected to peer review by defendant’s experts, who had found significant problems with Kelsey’s theories.86 The third and fourth Daubert factors, the known or potential rate of error and the general acceptability in the scientific community of the proffered theories were also found wanting since Kelsey has not conducted any experiments or testing of any kind, thus there could not be a known rate of error for his results, nor any evidence concerning a potential rate of error. Furthermore, plaintiff had not offered any evidence regarding the general acceptance in the scientific community of Kelsey’s theories. Therefore, defendant’s motion-in-limine was granted.87 In Ruffin v. Shaw Industries,88 a 1998 Fourth Circuit Court of Appeals decision, the plaintiffs sued both the manufacturer, Shaw Industries, Inc., and Sherwin Williams Company the retailer of a carpet, claiming they suffered toxic injuries as result of chemicals in the carpet installed in their home. The Court of Appeals ruled that the report of a laboratory president who had analyzed a carpet sample was not reliable and was hence inadmissible. Following discovery, defendants moved for summary judgment and also filed a motion-in-limine to strike the testimony of two of plaintiffs’ experts, Dr. Rosalind C. Anderson, Ph.D. and Dr. Allan D. Lieberman, M.D. The court first addressed defendants’ objections to the affidavit and supporting testimony of Dr. Rosalind C. Anderson, who was president of Anderson Laboratories (Anderson Labs) and had been granted a master’s degree and a doctorate in physiology from Yale University School of Medicine. At the request of plaintiffs’ counsel Dr. Anderson analyzed a sample of the carpet removed from plaintiffs’ home and stated that her testing demonstrated that the carpet sample was “biologically active and produced sensory irritation, pulmonary irritation, and neurological changes in mice, which are indicative that human beings would suffer similar biological responses.” In her evaluation report, Dr. Anderson summarized the testing methodology she used in analyzing the section of carpet installed in plaintiffs’ home.89 Defendants, in their effort to evaluate the scientific reliability of the Anderson test, placed primary reliance on a study by the Environmental Protection Agency’s (EPA) Office of Research and Development (ORD). 90 The ORD study, the court noted, was a cooperative effort between Anderson Labs and the EPA to conduct simultaneous but separate tests on carpet samples previously identified by Anderson Labs as toxic. Based on these tests, the EPA and Anderson Labs prepared separate reports, which, the defendant’s stressed, reached radically different findings and conclusions. The EPA drew the following conclusions from its findings: The bottom line from our studies … is that despite our best efforts, which were considerable … we have not been able to independently replicate the severe toxicity described by Anderson Laboratories. In fact, we were not


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Science and Litigation: Products Liability in Theory and Practice able to produce any convincing signs of even mild toxicity attributable to carpet in our tests. Our present conclusion is that there must be an essential difference between the conditions of our experiments and those of Anderson Laboratories, which, despite our efforts, we have not been able to identify.91

The court found that the only evidence that Dr. Anderson’s findings had been replicated under the same conditions as used in evaluating plaintiffs’ carpet sample was the EPA and Dr. Alarie’s use of Dr. Anderson’s own apparatus on two occasions. No organization, public or private, had been able to independently obtain consistent findings using the techniques employed by Anderson Labs with their own equipment. Thus, the court concluded, plaintiffs had presented no evidence that the Anderson test methodology had been independently replicated, as that term was used in the scientific community. On the important issue of peer review, the court observed that in the present case, the EPA’s ORD carpet study contained four evaluations analyzing both the EPA and Anderson Labs toxicological studies. All four reviewers in the ORD carpet study concluded that the EPA’s methodology was scientifically valid and superior to that conducted by Anderson Labs. The court noted that although all four recommended further studies, they all, nonetheless, expressed more confidence in the EPA’s methodology and results than in those of Anderson Labs.92 In addition to the evaluations in the ORD study, defendants had submitted affidavits stating that another panel of peer reviewers assembled by the EPA were generally supportive of the scientific methods employed by the EPA and private laboratories but critical of the scientific methods employed by Anderson Labs. Plaintiffs, the court emphasized: … failed to submit any evidence of peer reviews supportive of Dr. Anderson’s methodology or any proof that her studies had been published. Therefore, the uncontradicted evidence before the court demonstrates that peers in the relevant scientific community have been critical of the methodology employed by Anderson Labs but generally supportive of the procedures employed by EPA and private laboratories cited by defendants, which failed to independently replicate Dr. Anderson’s findings.93

The court also stated that defendants submitted affidavits of other toxicologists which explicitly state that the Anderson test methodology had not been generally accepted by the toxicological community as reliable. In the 2000 decision of Theresa Canavan’s Case,94 by the Massachusetts Supreme Court, it was held that a treating physician’s opinion that the claimant suffered from multiple chemical sensitivities (MCS) was improperly admitted. The case was an appeal from a decision by the reviewing board of the Industrial Accident Board (board) affirming a decision of an administrative



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judge finding that Theresa Canavan was temporarily unable to work and that her medical treatment was reasonable and necessary. Dr. Laurentano, whose antibiotic treatment had proved only marginally effective for the employee’ complaints of fever, headache, and swelling of her nose and right cheek, referred her to Dr. N. Thomas LaCava. Dr. LaCava conducted an extensive medical examination, took her medical history, performed an examination and conducted a number of diagnostic tests. Dr. LaCava concluded that Ms. Canavan suffered from arthritis, paresthesias, organic brain syndrome, chemical induced headaches, immunodeficiency, and multiple chemical sensitivities (MCS) secondary to chemical poisoning, which Dr. LaCava believed was caused by exposure during her employment at the hospital. Dr. LaCava testified that MCS was a systemic reaction of the body with multiple symptoms to multiple kinds of chemicals, which might be chemically unrelated, and which were commonly present in the every day working and living environment where that environment has not been meticulously cleaned up and had the chemical sources removed.95 Dr. Donald D. Accetta96 testified by deposition for the hospital and directly contradicted the conclusions reached by Dr. LaCava. Dr. Accetta examined the employee on two occasions. He testified that the employee’s condition was not caused by chemicals present in her work environment and that MCS was “not accepted as a diagnostic disease by mainstream allergists/immunologists and occupational medicine physicians.” Also, he testified that the treatment recommended by Dr. LaCava is not accepted nor appropriate for the symptoms exhibited. He diagnosed the employee as suffering from chronic nonallergic rhinitis caused by nonspecific stimuli that exist in the every day environment. He also opined that Canavan’s symptoms had a psychogenic component.97 The court concluded initially that there was no logical reason why conclusions based on personal observations or clinical experience should not be subject to a Lanigan (Daubert type) analysis: Observation informed by experience is but one scientific technique that is no less susceptible to Lanigan analysis than other types of scientific methodology. The gatekeeping function pursuant to Lanigan is the same regardless of the nature of the methodology used: to determine whether ‘the process or theory underlying a scientific expert’s opinion lacks reliability [such] that [the] opinion should not reach the trier of fact.’ [Citation omitted]. Of course, even though personal observations are not excepted from Lanigan analysis, in many cases personal observation will be a reliable methodology to justify an expert’s conclusion. If the proponent can show that the method of personal observation is either generally accepted by the relevant scientific community or otherwise reliable to support a scientific conclusion relevant to the case, such expert testimony is admissible.98


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As regards to the Daubert/Lannigan peer review factor, the court noted that Dr. LaCava referred to “the literature” as confirming the existence of MCS and asserted that based on the examination and tests he conducted, the employee has symptoms “highly suggestive of … environmental sensitivity.” However, the court stated, Dr. LaCava did not identify any specific studies that showed the existence of MCS based on specific symptoms, nor identify tests that could be performed to prove that a patient suffered from MCS. On cross-examination, the court noted, he admitted that there was a dispute in the medical community regarding the very existence of MCS. Thus, the only evidence tending to show that the employee suffered from MCS was Dr. LaCava’s assertion: The purpose of the Lanigan test is to prevent an expert from offering testimony to a fact finder that is not based on reliable methodology. Commonwealth v. Lanigan, supra at 26, 641 N.E.2d 1342. We cannot conclude that the expert’s mere assertion that a methodology is reliable is sufficient to pass the Lanigan test absent any other evidence showing its reliability [Citation omitted]…We conclude that on this record it was an abuse of discretion for the judge to admit Dr. LaCava’s diagnosis testimony.99

The court’s conclusion that the diagnosis testimony was improperly admitted sufficiently disposed of the case. The judicial probing of the ethical issues involved in peer-reviewed studies that are offered to support the methodologies used by proffered expert witnesses has a long way to go. Given the centrality of peer-reviewed studies in the Daubert line of cases, it is incumbent on the courts to address the considerable ethical failings alleged to be part and parcel of academic science publishing in the new century. It would obviously be unfair and virtually impossible for lawyers to be required to set up their own laboratories in order to challenge the validity of one or more published works offered against them. The reference to published works — Professor Miller’s paper science — will continue, necessarily, to be the basis for the new cause arguments in the 21st century world of genetic-based pharmaceuticals and bioinformatics. Accepting ethical challenges to such publications, given the contemporary hue and cry raised by scientists themselves regarding financial manipulation of academic journals seems needed upon a sufficient showing. If American courts are required to rely on academic peer-reviewed journals for direction in the struggle to find reliable scientific reliability, they at a minimum, need to look deeper into the editorial processes that determine publication.



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Appendix: The Peer Reviewers Review Peer Review Selected Journals American Journal of Public Health • “Editor’s Report: Scientific Misconduct and the Responsibility of Journal Editors,” 80 Am. J. Pub. Health 399 (1990). The year 1989 was big for peer review. Before such attention was given to peer review, reviewers were not as conscious of prior publications and duplicate submissions. • “How Blind is Blind Review,” 81 Am. J. Pub. Health 843 (1991). After studying blind peer review it seems to be successful. Those reviewers that like blind review like it because it eliminates bias. Those that don’t like it think it does not blind enough. • “The Authorship and Fate of International Health Papers Submitted to the American Journal of Public Health in 1989,” 83 Am. J. Pub. Health 1618 (1993). In this study it was found that when a paper was accepted the editor had accepted both of the reviewers suggestions. When a manuscript was rejected there was not as much consensus — the editor only agreed with the reviewers in half the cases, in one-third of the cases the reviewers did not even agree, and in some cases the reviewers recommended acceptance. Many authors proceeded to have their articles published in another journal. • “Editorial: The Paper Route for Submissions to the Journal and Annotation: Seven Fatal Flaws in Submitted Manuscripts,” 84 Am. J. Pub. Health 717, 718 (1994). These articles describe the acceptance process for this journal. Notably an article may be rejected before it even gets to the reviewers. Interestingly, the authors may make a recommendation as to who would be a good reviewer because of their specialty in the field. British Medical Journal • “Promoting Research into Peer Review: An Invitation to Join In,” 309 Br. Med. J. 143 (1994). Studies show that articles published in peer review journals are low quality. They also show that blinding gives the best reviews. • “Guardians of Science: Fairness and Reliability of Peer Review,” 309 Br. Med. J. 488 (1994). This is a review of a book by a German analyzing the editing process of a German chemistry journal. Findings: (1) reviewers and editors don’t agree much; (2) the higher the academic rank of the author gives



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greater success in publishing; (3) foreign authors were less successful in getting published. “And Now, Evidence Based Editing,” 311 Br. Med. J. 826 (1995). Peer review can also be corruptible which was best illustrated in previous communistic countries. Although peer review is imperfect, it is better than nothing. Third Congress on Peer Review was held in Prague to get more European involvement. “Peer Review: Reform or Revolution?” 315 Br. Med. J. 759 (1997). Peer review is expensive, slow, biased, abused, anti-innovative, and cannot detect fraud. Other alternatives: (1) editor publishes what he/she wants and then lets the correspondence or letters column sort out the truth; (2) electronic publishing (discusses Australia’s present system). “Your Letter Failed to Win a Place,” 315 Br. Med. J. 1608 (1997). An article is actually peer reviewed twice. The second time is by the readers and their letters. The letters should also be peer reviewed because they often are also presenting scientific ideas. “What Makes a Good Reviewer of Manuscripts”? 316 Br. Med. J. 86 (1998). Many reasons for peer review. Most peer reviewers are not paid. Study shows editors are not looking for the following in a peer reviewer: (1) a recommendation on publishing; (2) scathing, negative reviews.

Journal of the American Medical Association (JAMA) • “Conflict of Interest and the Peer Review Process,” 258 JAMA 1375 (1987). JAMA required as of 1987, that reviewers not have a conflict of interest with an article they are reviewing. The article should be sent back if there is a conflict of interest, but no additional information is required. Furthermore, there is no penalty for a reviewer that keeps an article she has a conflict of interest with. It is more of a trust policy than anything else. • “Ensuring Integrity in Biomedical Publication,” 258 JAMA 3424 (1987). Articles that are suspicious are sent to many more reviewers. Along with reviewers the best way to encourage integrity is for editors to press authors to be honest in their research and the write ups of their findings. • “Reporting Provocative Results,” 258 JAMA 3428 (1987). One way for professionals to get their information out without submitting to the peer review process is to write letters to the editor. These are not peer reviewed. Although hot, new discoveries are important, they cannot always be published by journals because of the chance of



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a litigation outbreak, before all the facts are learned (even though many journals include a warning). “The Process of Peer Review of Scientific Manuscripts,” 260 JAMA 1761 (1988). A reviewer is chosen by different methods. Some use a database to choose by specialty. Some by field of expertise. Some purely by name. The database contains enough information about the reviewer to let the editor know what and who she is choosing. “The International Congress on Peer Review in Biomedical Publication,” 261 JAMA 749 (1989). The reason for the international congresses on peer review is to analyze the reasons for peer review, whether it causes unnecessary deaths due to a delay in distribution of information, the importance of peer review and the affect on the editor in choosing reviewers and choosing which reviewed articles to publish. “Editors and Auditors,” 261 JAMA 2543 (1989). An article was published in JAMA that was found later to not have all of the required data/facts. Peer review cannot catch these types of errors because it is only based on what is given to the reviewer and the reviewer’s knowledge. The only way to detect these types of errors is by outside audit. “New Requirements of Authors: Signed Statements of Authorship Responsibility and Financial Disclosure,” 262 JAMA 2003 (1989). In 1989, JAMA set forth harsher requirements for authorship responsibility and financial disclosure. Before, the requirements were very informal. Now, there are forms that must be signed by the author to meet certain responsibilities. “The Philosophical Basis of Peer Review and the Suppression of Innovation,” 263 JAMA 1438 (1990). Modern peer review blocks a lot of innovative work from being published. Peer reviewers may just make comments as to their own opinion on a subject, rather than an objective critique of the paper. To publish innovative ideas an editor needs to choose the reviewer carefully. “The Evolution of Editorial Peer Review,” 263 JAMA 1323 (1990). Peer review does not have a definite history, but this article tries to follow it through. In the 1800s only individuals used peer review for themselves. Journals didn’t use it routinely until the mid-1900s. Reasons for not using it include: articles were already too scarce and specialties were not as specific as they are today, so the editors generally had enough knowledge in the specialty to review a paper themselves. Then, articles became more numerous and specialties became very



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narrow, so that only a small percentage of the scientists knew enough about that field to review a paper. “The Communities of Scientists and Journal Peer Review,” 263 JAMA 1330 (1990). Peer review is a social process. It should not be seen as a truth-finding process, but as a discussion to publish the most accurate and informative articles. The history of peer review shows that initially peer review was only used when the editor did not know anything about a paper’s subject. Peer review only works when there is nothing at stake, therefore there is little outside pressure. “Who are the Peer Reviewers and How Much Do They Review?,” 263 JAMA 1338 (1990). There is some bias in choosing reviewers. Most reviewers are part of a network. The reviewers do give a lot of uncompensated time to reviewing. Reviewers are usually authors who are commonly cited by others. “Biomedical Information, Peer Review, and Conflict of Interest as They Influence Public Health,” 263 JAMA 1427 (1990). To detect undisclosed conflicts of interest or undisclosed problems with a study or its data, peer reviewers should be given any dissenting articles on the same study. By not giving the dissenting articles, editors are becoming the judges in control of what is printed and what is not. For the peer review process to function effectively the reviewer needs to have all information available regarding the scientific validity and merit of a paper. “Minimizing the Three Stages of Publication Bias,” 263 JAMA 1392 (1990). Bias by reviewers has to be acknowledged. Reviewers are not always just interested in the truth. There’s a double standard in the area of clinical trials. Peer review is only required for the articles not the experimental treatment given by doctors. “Correcting the Literature Following Fraudulent Publication, 263 JAMA 1416 (1990). Not right on target, but related article. Most journals don’t have a set of those that do have policies, their policies make it difficult to find the retraction in the National Library of Medicine index. “What Can and Should Be Done to Reduce Publication Bias?,” 263 JAMA 1390 (1990). Reviewers/referees are felt to be one of the major causes of bias in publishing. Great Britain defines peer review as a journal that sends out every single paper. Under this guideline very few journals are peer reviewed, including Great Britain’s journals.



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• “Effect of Acceptance or Rejection on the Author’s Evaluation of Peer Review of Medical Manuscripts,” 263 JAMA 1376 (1990). After a study was done it looks as though the strongest critics of peer review are authors who had rejected manuscripts, although, overall, many authors have a negative view of peer review. Authors seem to concentrate on the half of the review containing the negative aspects rather than the whole review. • “Peer Review in 18th-Century Scientific Journalism,” 263 JAMA 1321 (1990). Peer review came about in an informal manner in the 1700s. Many more scientists were involved in the process than there are today, from a percentage standpoint. • “Problems Identified by Secondary Review of Accepted Manuscripts,” 263 JAMA 1369 (1990). Studies show blinding may improve the quality of reviews. Arguments for blinding are that it removes bias. Others argue against blinding saying it removes useful information. One of the goals of peer review itself is to increase the standards of scientific communications. To increase scientific communications, peer review needs to be made better. Editors measure the quality of a peer review through many aspects including: the importance of any questions, methods, thoroughness, fairness, and knowledge demonstrated. In connection with this it seems a good reviewer has the following (1) knowledge; (2) skill and experience; (3) lack of bias; (4) time to review the article; and (5) signs her review. • “Variation in Journal Peer Review Systems,” 263 JAMA 1348 (1990). Journals have a wide range of outright rejection. The peer review systems also differ. Some journals send articles to only one reviewer. If the reviewer accepts, then the editor usually accepts. If the reviewer does not accept the paper, it is either sent back for revision or sent to another reviewer. Others use the traditional two reviewer process. The first system assumes there is a consensus in the field and among reviewers generally. The overall rejection rates also vary among journals. • “Quotational and Reference Accuracy in Surgical Journals,” 263 JAMA 1353 (1990). Not directly related, but worth noting. Study was done to reveal that many authors do not check their references and may not even read them. The errors can be found by reviewing the cites. The reviewers may expand the problem by not checking the cites and letting the errors slip by them. • “What Do Peer Reviewers Do?,” 263 JAMA 1341 (1990).



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A study found less than two hours were spent by a reviewer reviewing a manuscript. Sometimes this may differ depending on the specialty. “Editorial Peer Review in U.S. Medical Journals,” 263 JAMA 1344 (1990). Thorough study on peer review used by journals. Anonymous review was used by almost all journals. Interestingly, in articles that have statistics, statistical review is not used in even half of them. Of these, statistical reviewers were most often used when the original reviewer questioned the statistics. “Letters,” 264 JAMA 3142 (1990). These letters address the time supposedly involved in reviewing. It is suspected that reviewers who have a lot of experience in the field and a lot of experience as a reviewer do not need as much time. Peer review cannot accomplish all of its goals unless medical students and physicians are educated on the important elements of what goes into the peer review process. “Policy of AMA Journals Regarding Release of Information to the Public,” 265 JAMA 400 (1991). “Flaws Documented, Reforms Debated at Congress on Journal Peer Review,” 270 JAMA 2775 (1993). What a reviewer should look for is discussed. Readability of an article is not made better by peer review. Through all of its bias, peer review appears to have no sexual bias. There is no information on racial bias. Some feel peer review will disappear with electronic publishing. “More Peering Into Editorial Peer Review,” 270 JAMA 2856 (1993). Opponents feel peer review is a dictatorship, reviewers are self-serving, its too secretive, there are no clear standards, it suppresses innovation, its expensive, ideas are stolen, publishing is delayed, and it still does not guarantee a good article. Even so, it is the only thing out there and blind review makes it even better. There is a need for standardized review and education on how to review appropriately. “The Second International Congress on Peer Review on Biomedical Publication, and Structural Transformations of the Sciences and the End of Peer Review,” 272 JAMA 91, 92 (1994). Peer reviewing in electronic journals will be called “collaborating.” A group will be working collectively in the same area, competing and reviewing each other’s work. “Peer Review and Evaluating Peer Reviews,” 272 JAMA 96, 98 (1994). Deficiencies of how peer review is designed are reviewed: (1) inadequately controlled; (2) biased, and (3) inadequately defined. “Peer Review is an Effective Screening Process to Evaluate Medical Manuscripts,” 272 JAMA 105 (1994).



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Peer review is effective to screen out bad medical manuscripts, but not so much in other fields. Most of the articles rejected were not accepted by other medical journals. Those that were, had at least a year delay. This study was conducted by the American Journal of Surgery and those articles submitted to it. “Do Readers and Peer Reviewers Agree on Manuscript Quality?” and “Effects of Peer Review and Editing on the Readability of Articles Published in Annals of Internal Medicine,” 272 JAMA 117, 119 (1994). Fifteen percent of articles sent to Annals of Internal Medicine are published. Peers and readers are more satisfied with an article’s final product than experts are. Clinical relevance needs to be concentrated on more in the peer review process. Peer review makes an article more readable for readers, but the articles seem to remain in the very difficult to read range. “Effect of Institutional Prestige on Reviewers Recommendations and Editorial Decisions;” “Is There Gender Bias in JAMA’s Peer Review Process?;” “The Effects of Blinding on Acceptance of Research Papers by Peer Review;” “A Citation Analysis of the Impact of Blinded Peer Review;” “Multiple Blinded Reviews of the Same Two Manuscripts;” “How Well Does a Journal’s Peer Review Process Function?;” “Ethics, Economics, and the Publication Policies of Major Medical Journals;” “Peer Review in Journals Indexed in Index Medicus,” 272 JAMA 137, 139, 143, 147, 149, 152, 154, 156 (1994). The prestige of the institution submitting the article had no effect on the decision to publish. Women reviewers are more likely to reject a manuscript than men reviewers. There was no correlation between rejection or acceptance rate between genders. Despite the blinding process approximately _ of the reviewers were able to identify the author. Double blinding is where the authors and reviewers are anonymous to each other. Single blinding is when the reviewer knows the author, but not vice versa. Double blinding seems to be better than single blinding. English manuscripts are accepted more than other languages, even if the content is the same. Editors and reviewers have a higher opinion of the peer review process than the authors. Editors that do not have a background in a certain area may give the article to the wrong people to review. Not all journals publish their peer review policies or guidelines, so that authors know what the process and the criteria are in advance. “Instructions for Authors,” 276 JAMA 19 (1996). First reviewed by editor then sent to outside experts. Experts identities are confidential and author identities are not. “Institutional Review Board Approval and Publication of Human Research Results,” 277 JAMA 909 (1997).


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What editors of peer reviewed journals should do to guarantee proper approval of human research for papers. The Lancet • “Conflict of Interest,” 341 Lancet 742 (1993). Conflict of interest can be financial, personal, academic, or intellectual. Peer reviewers should disqualify themselves from reviewing papers that they will have a conflict of interest with. These conflicts should be revealed so that the editor can analyze them. • “Peer Review 1993,” 342 Lancet 735 (1993). Best reviewers are from centers of academic excellence and are blinded to author’s identification. Daubert has forced peer review to be the guideline for legitimate scientific research. • “The Ingelfinger Rule, Embargoes, and Journal Peer Review: Part I,” 347 Lancet 1382 (1996). Letters to journals may report new data, but are not subject to peer review. There is little data on when peer review actually rejects an article — since not all journals require peer review a rejected article may be published elsewhere. Peer review is not cost effective. Peer review isn’t always external and readers are not informed whether review is internal or external. Part II reiterates Part I with a little bit stronger conviction. • “Ruling Out Ingelfinger?,” 347 Lancet 1423 (1996). At certain times when concerned with public health, the peer review process may be speeded up. Peer review is a good filter, but it is not foolproof. The New England Journal of Medicine • “Journal Peer Review,” 312 New Eng. J. Med. 654 (1985). Peer review overall seems to work well. One improvement is to select a reviewer with a different perspective on the topic instead of always choosing those with the same perspective. Each reviewer is different. Some are more lenient than others. If rejected by one journal, many authors go to another and get published. Costs of peer review. • “Letters in Response to Reviewer Status and Review Quality,” 313 New Eng. J. Med. 269 (1985). Low status reviewers may accept more papers from a high status professional so as to gain favor when they want to publish. High status reviewers may give their assignment to an assistant who does not do a thorough job of reviewing, so the article gets rejected. • “Fraud in Biomedical Research,” 318 New Eng. J. Med. 1462 (1988).



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Peer review is supposed to self-correct fraud in research papers, but it is much too heavily relied upon. • “The Journal’s Peer-Review Process,” 321 New Eng. J. Med. 837 (1989). The New England Journals of Medicine’s process: (1) assistant editor chooses two outside reviewers for each article; (2) both scientific and non-scientific articles may be sent out; (3) editors make the decision to reject or accept; (4) rely on reviewer’s comments more to improve article rather than on decision to accept or reject; (5) anonymous review; and (6) authors are known to reviewers. • “How Good is Peer Review?,” 321 New Eng. J. Med. 827 (1989). Peer review cannot be relied upon to guarantee the validity or honesty of scientific research. • “The Publication of Sponsored Symposiums in Medical Journals,” 327 New Eng. J. Med. 1135 (1992). Peer reviewed journals that publish symposiums sponsored by drug companies may not follow their regular peer review processes. Journals should publish what review process was followed in the symposium. The FDA should also become involved. Science • “Conflict of Interest,” 249 Sci. 109 (1990). Peer review needs to be done by a specialist in that field, no matter what the field, even if conflict of interest is a possibility. These specialists are the only ones that know enough to make an editorial review. Scientists are basically doing this pro bono, so they are not benefitting economically. • “Conflict Over Release of Clinical Research Data,” 251 Sci. 374 (1991). Sometimes information in a study is released if the findings are important enough and safe enough to save lives without requiring the information to be published and go through peer review. Peer review can cause an article to be published only up to a year after being written. • “Conflict of Interest Policy,” 257 Sci. 595 (1992). Referees are often selected to be sure there is no conflict of interest. At other times editors have reason to choose opponents of an idea or proponents of an idea. Science’s policy is for the reviewer to reveal all conflicts of interest whether the reviewer thinks she can be impartial and let the editor make the final decision. • “Simplicity and Complexity in Conflict of Interest,” 261 Sci. 11 (1993). May be hard to find a referee/reviewer that is not a direct competitor of the author because of frequent changes in interest and jobs. Need to have a conflict of interest policy, but it must be used wisely to protect everyone involved.


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• “Peer Review Goes Under the Microscope,” 262 Sci. 25 (1993). Statistics are a big problem in peer reviewing. Some journals have no statistical reviewer on hand and some statistics are too complex for many to understand, so these statistics just fly by the reviewers. Symposium or supplements may have good science, but some studies show more often than not that symposium papers are biased. One example is tobacco company symposiums. Additionally, symposium papers often do not have a method section explaining how the study was done. Studies show that the best reviewers have fellowship training with a doctorate or advanced degree in public health, graduated from a prestigious school, have a lower ranking job, and are less than 40 years old. • “Peer Review in Cyberspace,” 266 Sci. 967 (1994). Trying peer review in journals on the Internet (physics journal). Reviews will not be anonymous as are paper journal reviews. Part of it is voluntary. An author does not have to have peer review scoring. Those people submitting comments on the paper will not necessarily be heard. Author reads comments first and then decides whether or not to publicize it. • “Electronic Preprints Point the Way to Increase Author Empowerment,” 271 Sci. 767 (1996). The Internet is a good publishing option because of its much lower cost. The physics journal that publishes on the net has two types of articles: (1) non-peer reviewed pre-print abstracts; and (2) the peer reviewed journal. The first can still be peer reviewed because anyone can send in their written commentary. • “Should non-peer-reviewed Raw DNA Sequence Data Release Be Forced on the Scientific Community?, 274 Sci. 534 (1996). Discussion of whether portions of the DNA/genome project should be released on the web as it is completed without peer review or should wait to be published in peer review journals when finished. Technology Review • “Truth, Beauty, and Peer Review,” 93 Tech. Rev. 5 (1990). Do not use peer review for fear it will turn away a new, important invention. One problem with peer review is that no two journals define it the same or have the same peer review process. One journal may reject a paper and it will be published in another. Miscellaneous Journal Articles • “An Editor’s Perspective of the Future for Peer-Reviewed Traditional Surgical Journals,” 161 Abstract Am. J. Surgery 309 (1991).



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• “Conflict of Interest and Financial Disclosure: Judge the Science, Not the Author,” 112 Chest 865 (1997). This journal’s policy is to reveal any conflicts of interest in footnotes. Peer review process should take care of any bias in study or article. • “To Publish or Not to Publish,” 19 Hastings Center Rep. 2 (1989). Peer review began in 1600s. It was, at that time, a casual collegial, refereeing of papers. Now it is very complicated and there are no uniform standards. Bias in peer review may be good or bad. If a person has a conflict of interest, he or she may have a very useful critique or may be overly harsh. If a person does not have a conflict of interest, he or she may not be critical enough. • “Delays That Can Cause Death, and Is Science Censored?,” Newsweek, Sept. 14 (1992) at 62, 63. Peer review overall does avoid mistakes. It must be remembered that studies for papers also go through their own peer review system. The peer review process may slow down the dissemination of important life saving information. • “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” Pub. Health Rep. 253 (1997). The requirements suggested would make all journals have a standardized system for submitting articles. The guidelines govern everything from technical requirements (e.g., double spacing) to ethical responsibilities to citing to mailing format. The guidelines also give general suggestions for peer reviewers and editors on how to do their jobs. • “Revision of Manuscripts for Scholarly Publication,” 69 Radiologic Tech. 47 (1997). Most manuscripts that are sent back to writers to be revised will be published if the revisions are made. • “Peer Review Under Fire,” 139 Sci. News 394 (1991). Specialty journals have higher acceptance rates and use less reviewers than generalized journals. The first reviewer’s decision often is the editor’s decision. In medical and psychiatric journals an author often gets published in another journal if rejected by another. Suggestions to include peer review: (1) have three specialized reviewers for each article; (2) allow author anonymity; (3) have reviewers sign critiques; (4) reward reviewers for a good job; and (5) provide training for reviewers. • “Editorial Policy and Peer Review Process,” 43, Tech. Comm. 222 (1996). Review process: (1) editor gets review coordinator (member of editorial advisory board); (2) review coordinator gets two peer reviewers who have knowledge in the field the paper discusses; (3) author is not


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revealed; (4) reviewer recommends accept, accept with revisions, revise and resubmit, or reject; (5) if two reviewers do not agree, a third reviewer is found; and (6) reviewers are given specific criteria they must review. Article Citations from the 1997 International Congress on Biomedical Peer Review and Global Communications, September 18, 1997* • Susan van Rooyen et al., “What Makes a Good Reviewer and What Makes a Good Review?,” 1997 Int. Congress on Biomedical and Global Comm. • Gretchen P. Purcell1 and Frank Davidoff, “Changes During Peer Review: Characterizing the Evolution of a Clinical Paper,” 1997 Int. Congress on Biomedical and Global Comm. • Annette Flanagin et al., “Honorary Authors, Ghost Authors, and Medical Writers in Peer-Reviewed Medical Journals,” 1997 Int. Congress on Biomedical and Global Comm. • Sheldon Krimsky, “Financial Interest and Disclosure in Scientific Publications,” 1997 Int. Congress on Biomedical and Global Comm. • Richard M. Glass and Mindy Schneiderman, “A Survey of Journal Conflict of Interest Policies,” 1997 Int. Congress on Biomedical and Global Comm. • Tom Jefferson et al., “Evaluating the BMJ Guidelines on Economic Submissions: Prospective Audit of Economic Submissions to the BMJ and the Lancet,” 1997 Int. Congress on Biomedical and Global Comm. • Dorothy L. Lebeau et al., “A Survey of Journal Editors Regarding the Review Process for Original Clinical Research,” 1997 Int. Congress on Biomedical and Global Comm. • Michael L. Callaham and Joseph Waeckerle, “Consistency of Reviewer Ratings and Impact on Editor Manuscript Decisions,” 1997 Int. Congress on Biomedical and Global Comm. • Fiona Godlee et al., “The Effect on the Quality of Peer Review of Blinding Reviewers and Asking Them to Sign Their Reports: A Randomized Controlled Trial,” 1997 Int. Congress on Biomedical and Global Comm. • Amy C. Justice et al., “Masking Author Identity in Peer Review: Does It Improve Peer-Review Quality?” 1997 Int. Congress on Biomedical and Global Comm. • Douglas G. Altman et al., “The Nature of Statistical Input in Medical Research,” 1997 Int. Congress on Biomedical and Global Comm.” * These articles are available on the JAMA Web site at http://www.ama-assn.org



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• Dominique Broclain et al., “An International Survey of Quality Control Procedures in Independent Drug Bulletins,” 1997 Int. Congress on Biomedical and Global Comm. • Paul M. Woodcock and Hamish A. Cameron, “Commercial and Scientific Conflict in Biomedical Publishing: The Perspective of an International Pharmaceutical Company,” 1997 Int. Congress on Biomedical and Global Comm. • Robert Goldberg and James E. Dalen, “Reviewers’ Attitudes Toward an Enhancement of the Peer-Review Process,” 1997 Int. Congress on Biomedical and Global Comm. • Timothy C. Fagan, “Time Trends for Publication of International Manuscripts in Leading U.S. Medical Journals,” 1997 Int. Congress on Biomedical and Global Comm. • Jean-Pierre Pierie et al., “A Structured Review of the Literature on Peer Review,” 1997 Int. Congress on Biomedical and Global Comm. • Ellen J. Weber et al., “Characteristics of Unpublished Research and Reasons for Failure to Publish,” 1997 Int. Congress on Biomedical and Global Comm. • Ann M. Link, “Papers Submitted from Outside and Inside the United States: An Analysis of Reviewer Bias, 1997 Int. Congress on Biomedical and Global Comm. • Andrew Herxheimer, “Data on File Cited in Pharmaceutical Advertisements: What Are They?,” 1997 Int. Congress on Biomedical and Global Comm. • Edzard Ernst and Karl-Ludwig Resch, “Peer-Reviewer Bias Against Unconventional Medicine,” 1997 Int. Congress on Biomedical and Global Comm. • Karl-Ludwig Resch et al., “Does Peer Review Favor the Conceptual Framework of Orthodox Medicine?,” 1997 Int. Congress on Biomedical and Global Comm. • Ian G. Roberts, “Medical Editors Trial Amnesty,” 1997 Int. Congress on Biomedical and Global Comm. • Robert S. DeWoskin, “Quality Criteria That Support ComputerAssisted Retrieval and Review of Scientific Data,” 1997 Int. Congress on Biomedical and Global Comm. • Richard Smith, “Are Medical Journal Editors Singing More Loudly and Preaching More?,” 1997 Int. Congress on Biomedical and Global Comm. • Linda Wilcox, “Authorship: The Coins of the Realm, the Source of Complaints,” 1997 Int. Congress on Biomedical and Global Comm. • David McNamee, “What is the Lifespan of a Manuscript after Submission?,” 1997 Int. Congress on Biomedical and Global Comm.


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• Christopher L. Hatch and Steven N. Goodman, “The Perceived Value of Providing Peer Reviewers With Abstracts and Preprints of Related Published and Unpublished Papers,” 1997 Int. Congress on Biomedical and Global Comm. • Donna F. Stroup et al., “Characteristics of Meta-Analyses Submitted to a Medical Journal,” 1997 Int. Congress on Biomedical and Global Comm. • Michael Clarke and Iain Chalmers, “The Quality of Discussion Sections in Reports of Controlled Trials Published By Five Leading General Medical Journals,” 1997 Int. Congress on Biomedical and Global Comm. • Philip C. Swain, “Closing Some Legal Loopholes in the Peer-Review Process, 1997 Int. Congress on Biomedical and Global Comm. • John M. Budd and Mary Ellen Sievert, “Phenomena of Retraction: Reasons for Retraction and Citations to the Publications,” 1997 Int. Congress on Biomedical and Global Comm. 2001 September Peer-Review Conference Program: Peer Review Congress (September 14–16, 2001) Barcelona, Spain* Note: The papers presented in Barcelona will eventually be published in the Journal of the American Medical Association (JAMA). Consult their Web site to track publication, online and in printed form (http://www.jama-amaassn.org/). The Fourth International Congress on Peer Review in Biomedical Publication, on behalf of JAMA and the BMJ Publishing Group, was held in Barcelona for the Fourth International Exhibit and Congress on Peer Review in Biomedical Publication. The initial sponsors were Pfizer Inc, Aventis Pharma, Merck and Co., Eli Lilly and Company, Lasker Foundation, Amgen Inc. and Medscape. The following is a list of some of the important papers that were presented. • “A Multi-Journal Authorship Database: Variation in Author Contributions by Byline Position,” Christine Laine, Anthony Proto, Frank Davidoff (United States). • “Authors Define Their Own Contribution to Articles: Who Fulfills the Criteria for Authorship?” Lydia E. Vos, A. John, P. M. Overbeke (The Netherlands). • “What Makes an Author? A Comparison Between What Authors Say They Did and What Editorial Guidelines Require,” Susan van * Abstracts of these articles may be found at the JAMA Web site at http://www.ama-assn. org/public/peer/peerhome.htm. The full articles will be published in JAMA in Spring 2002.



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Rooyen, Sandra Goldbeck-Wood, Fiona Godlee (United States, United Kingdom). “Survey of Contributorship in Cochrane Reviews,” Graham Mowatt, Jeremy M. Grimshaw, on behalf of the Survey of Contributorship in Cochrane Reviews Project Team (Scotland, United Kingdom). “Corporate Authorship: Problems with Current Systems for Indexing and Citation,” Kay Dickersin, Roberta Scherer, Michelle Gil Montero (United States). “The Hidden Research Paper: Evidence of Suppressed Opinion, Censored Criticism, and Serious Bias among Contributors,” Richard Horton (United Kingdom). “Is the Reporting Quality of Randomized Controlled Trials an Adequate Measure of Their Methodological Quality?” Karin Huwiler, Peter Jüni, Matthias Egger, Christoph Junker (Switzerland, United Kingdom). “Misleading Publications of Major Mammography Screening Trials in Major General Journals,” Peter C. Gotzsche, Ole Olsen (Denmark). “Discussing Trials in Context: Have the Islands Found Their Continents?,” Mike Clarke, Iain Chalmers (United Kingdom). “Reporting Number Needed to Treat and Number Needed to Harm in Randomized Controlled Trials,” Denise Chang, Joy Melnikow, Jim Nuovo (United States). “Extrapolation of Association Between Two Variables in Four General Medical Journals,” Yen-Hong Kuo (United States). “The Nature of Statistical Input Into Medical Research,” Douglas G. Altman, Steven N. Goodman (United Kingdom, United States). “Association of Journal Quality Indicators With Methodological Quality of Clinical Research Articles,” Kirby Lee, Marieka Schotland, Lisa A. Bero (United States). “Quality of Systematic Reviews of Economic Evaluations in Health Care and What They Are Telling Us,” Vittorio Demicheli, Tom O. Jefferson (United Kingdom). “Graphics in Journal Pharmaceutical Advertisements: Are They Truthful and Are They Adequately Detailed?,” Richelle J. Cooper, David L. Schriger, Roger C. Wallace, Vladislav J. Mikulich, Michael S. Wilkes (United States). “Published Peer Review Policies: Determining Journal Peer Review Status From a Non-Expert Perspective,” Marieka Schotland, Erin VanScoyoc, Lisa A. Bero (United States). “Effect of Feedback on Quality of Reviews,” Michael L. Callaham, E. John Gallagher, Robert K. Knopp (United States). “Peer Reviewer Opinions About Manuscript-Specific Acknowledgment,” Michael Berkwits, Frank Davidoff (United States).


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• “Peer Review in Small and Big Medical Journals,” Ana Marusic, Ivan Kresimir Lukic, Matko Marusic, David McNamee, David Sharp, Richard Horton (Croatia, United Kingdom). • “Effect of Statistical Review on Manuscript Quality in Medicina Clinica,” Catalina Arnau, Erik Cobo, Francesc Cardellach, Joseph Maria Ribera, Albert Selva, Agustin Urrutia, Vincente Fonollosa, Celestino Rey-Joly, Miquel Vilardell, J. Lluis Seg (Spain). • “Editorial Peer Review for Improving the Quality of Reports of Biomedical Studies: A Cochrane Review,” Phil A. Alderson, Frank Davidoff, Tom O. Jefferson, Phillipa Middleton, Elizabeth Wager (United Kingdom, United States). • “Measuring the Quality of Editorial Peer Review,” Tom O. Jefferson, Elizabeth Wager, Frank Davidoff (United Kingdom, United States). • “Paper or Screen, Mother Tongue or English: Which Is Better?,” Pl Gulbrandsen, Torben V. Schroeder, Josef Milerad, Magne Nylenna (Norway, Denmark, Sweden). • “Comparing the Quality of Review Articles Published in PeerReviewed and Throwaway Journals: Should We Be Throwing Away the Throwaways?,” Paula A. Rochon, Lisa A. Bero, Ari M. Bay, Jennifer L. Gold, Julie M. Dergal, Malcolm A. Binns, David L. Streiner, Jerry H. Gurwitz (United States, Canada). • “Media Coverage of Scientific Meetings: Too Much, Too Soon?,” L. Baczek, Steven Woloshin, Lisa M. Schwartz (United States). • “Comparison of Editorial Peer Review Practices among Indexed Health Sciences Electronic Journals,” Ann C. Weller (United States). • “Much Ado About ‘Nothing’? Looking for Evidence on Harm Resulting From Health Information on the Internet,” Anthony George Crocco, Miguel Villasis-Keever, Alejandro R. Jadad (Canada, Mexico). • “How Aware are Health Professionals and Consumers of Resources to Find Peer-Reviewed Evidence on the Internet?,” Christopher Sigouin, Alejandro R. Jadad (Canada). • “Publishing Protocols Electronically: A Way to Reduce or Introduce Bias?,” Chris A. Silagy, Phillipa Middleton, Sally Hopewell (Australia, United Kingdom). • “Publication Bias in Editorial Decision Making: Assessment of Reports of Controlled Trials Submitted to JAMA,” Carin M. Olson, Drummond Rennie, Deborah Cook, Kay Dickersin, Annette Flanagin, Joseph W. Hogan, Qi Zhu, Jennifer Reiling, Brian Pace (United States, Canada). • “Speed of Publication for Submitted Manuscripts by Direction of Study Results,” Carin M. Olson, Drummond Rennie, Deborah Cook, Kay Dickersin, Annette Flanagin, Qi Zhu, Jennifer Reiling, Brian Pace (United States, Canada).



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• “Benefits of Financial Disclosure in Published Trials: Absence of Associations Between Funding Source, Trial Outcome, and Quality Score,” Tammy J. Clifford, David Moher, Nicholas Barrowman (Canada). • “Financial Conflict of Interest and Industry Support in Published Research in Biomedical Journals: A Study of Research Outcomes and Adherence to the Uniform Requirements,” Anu R. Gupta, Cary P. Gross, Harlan M. Krumholz (United States). • “Failure to Report Ethical Approval in Research Related to Child Health,” Howard Bauchner, Joshua Sharfstein (United States). • “Reporting of Ethics Committee Approval and Informed Consent in Clinical Trials: Have Journals Improved?,” Veronica Yank, Drummond Rennie (United States). • “Editorial Independence at Medical Journals Owned by Professional Associations: A Survey of Editors,” Ronald M. Davis, Marcus Millner (United States, Austria). • “Confidentiality of Manuscripts Submitted to Medical Journals for Peer Review: Legal Lessons from an Ongoing Case,” Debra Parrish, David Bruns (United States). • “Work of the Committee on Publication Ethics (COPE),” Mike Farthing, Richard Horton, Richard Smith, Alex Williamson (United Kingdom). • “Publication Bias and Other Characteristics Predicting Citation by Other Authors of a Cohort of Original Research Papers in PeerReviewed Journals,” Michael L. Callaham, Robert L. Wears, Ellen J. Weber (United States). • “How Important Is the Size of a Reprint Order?,” Sally Hopewell, Mike Clarke (United Kingdom). • “The Correspondence Column: How Important Is Post-Publication Criticism in Shaping Clinical Knowledge?,” Richard Horton (United Kingdom).

Endnotes 1. “The End of our Foundation is the knowledges of Causes, and secret motions of things; and the enlarging of the bounds of Human Empire, to the effecting of all things possible.” See Brian Vickers (ed.), Francis Bacon: A Critical Edition of the Major Works (Oxford Authors Series, 1996), at 489. 2. See Brian Vickers (ed.), Francis Bacon: A Critical Edition of the Major Works (Oxford Authors Series, 1996), at 486–487. Also see Francis Bacon’s grand plan for a comprehensive reformation of science’s goals plus a series of specific investigations or “histories” to be conducted across all scientific lines, from the “History of the Heavenly Bodies” to the “History of Rainbows.” Bacon,



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3. 4.

5.

6. 7.

8.

Novum Organum (1620) (Translated and edited by Peter Urbach and John Gibson, Open Court Press, 1994). S. Shapin and S. Schaffer, Leviathan and the Airpump (Princeton, 1985). Ibid. at 14. Also see Barbara J. Shapiro, “Law and Science in Seventeenth Century England,” 21 Stanford L. Rev. 727 (1969); Barbara J. Shapiro, Probability and Certainty in 17th Century England: A Study of the Relationship between Natural Science, Religion, History, Law and Literature (Princeton, 1983). Steven Shapin and Simon Schaffer, Leviathan and the Air Pump (Princeton, 1985), at 23–24. English experimentalists of the mid-seventeenth century and afterwards increasingly took the view that all that could be expected of physical knowledge was ‘probability,’ thus breaking down the radical distinction between ‘knowledge,’ and ‘opinion.’ Physical hypotheses were provisional and revisable; assent to them was not obligatory, as it was to mathematical demonstrations: and physical science was, to varying degrees, removed from the realm of the demonstrative. The probabilistic conception of physical knowledge was not regarded by its proponents as a regrettable retreat from more ambitious goals; it was celebrated as a wise rejection of a failed project. By the adoption of a probabilistic view of knowledge, one could attain to an approximate certainty and aim to secure legitimate assent to knowledge-claims. The quest for necessary and universal assent to physical propositions was seen as inappropriate and illegitimate. It belonged to a ‘dogmatic’ enterprise, and dogmatism was seen not only as a failure but as dangerous to genuine knowledge. See, e.g., Gina Kolata, “Who Owns Your Genes?,” New York Times, May 15, 2000. See, e.g., “FDA Proposes A New Public Disclosure Rule for Gene Therapy and Xenotransplantation Clinical Trials,” U.S. Department of Health and Human Services, HHS News, PO1-02, January 17, 2001; Andrew Pollack, “FDA Plans New Scrutiny in Areas of Biotechnology,” New York Times, January 18, 2001; Francis S. Collins and Victor A. McKusick, “Implications of the Human Genome Project for Medical Science,” JAMA, 285, (5), February 7, 2001. Robert Hookes, Micrographia or Some Physiological Descriptions of Minute Bodies Made by Magnifying Glasses with Observations and Inquiries Thereon: Preface to the Royal Society, (1664). The offering of scholary books and articles as support for an expert’s opinion, has been a mainstay of expert testimony since the early days of common law trials. In Spencer Cowper’s Trial, tried in England in 1699, the ongoing skirmish between courts and expert witnesses can be seen in the following exchange: Dr. Crell: Now, my lord, I will give you the opinion of several ancient authors Baron Hatsell: Pray, doctor, tell us your own observations.



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Dr. Crell: My lord, it must be reading, as well as a man’s own experience, that will make anyone a physician, for without the reading of books of that art, the art itself cannot be attained to. Besides, my lord, I conceive that in such a difficult case as this we ought to have a great deference for the reports and opinions of learned men. Neither do I see why I should not quote the fathers of my profession in this case as well as you gentlemen of the long robe quote Coke upon Littleton in others (13 How. St. Tr. 1106, 1163 [1699]). 9. Hookes, supra n. 9. 10. Green, “The Duty Problem in Negligence Cases,” 28 Colum. L. Rev. 1014, 1018 (1928). “‘Legal evolution’ is the gradual process of judicial refinement of the verbalization of a new legal idea, both operationally and semantically. The original core idea ensconced within the new rule statement is honed, elucidated, and brought to its functional fruition by way of a long series of decisions involving varied applications of the core idea in whole or part.” T. Kiely, “The Art of the Neglected Obvious in Products Liability Cases: Some Thoughts On Llewellyn’s The Common Law Tradition,” 25 DePaul L. Rev., 914, 923 (1975). 11. Charles Babbage, Reflections on the Decline of Science in England, and on Some of its Causes, Irish University Press [Reprint] at ix (1830). 12. State courts that retain the Frye general acceptance language structure all follow the basic ideas of Daubert reliability, in the sense of where to look for scientific support and what there is to see. There is nowhere else to look and modern courts, as those in the 19th century realized it. The avalanche of law review articles on the subject of the Daubert law and science makes it appear that law professors still do not. 13. See Arielle Emmet, “Biotech Startups, Must a Biotech Entrepreneur Travel A Golden Mile to be Successful?” Scientist 14 (13): 1, June 26, 2000; Kate Devine, “A Converging Market For Biotech,” Scientist 15 (2): 29, January 22, 2001; Ken Howard, “The Bioinformatics Gold Rush,” Scientific American, July 2000. 14. The discussion to follow does not examine the totally neglected subject of in-house, proprietary studies, keenly sought in hotly contested discovery practice. See, Chapter 8, Science and Pretrial Discovery. 15. 70 NYUL Rev. 100, 113 (1995). 16. Litigators are beginning to realize the potential for ethical challenges to scholarly literature raised as a bar to Frye general acceptability or Daubert reliability. See Jean Hellwege, “Undisclosed Industry Ties of Scientific Authors Undercut Credibility,” Trial, (July 2001): 16, which discusses recent findings in this respect by university researchers. See also “Conflict of Interest Policies in Science and Medical Journals: Editorial Practices and Author Disclosures,” 7 Sci. Engineering Ethics 205 (2001). 17. See Chan, supra.


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18. See, Chapter 1, Science in American Litigation and Chapter 2, Science, Products Liability and the Courts. 19. Frye v. United States, 54 App.D.C.46 293 F. 1013 (1923); Daubert v. Merrell Dow Pharmaceuticals, 509 U.S.579, 113 S.Ct.2786 (1993); General Electric v. Joiner, 118 S.Ct.512, 522 U.S.136 (1997); Kumho Tire Company, Ltd. v. Carmichael, 119 S.Ct. 1167 (1999). 20. See, Lawrence S. Pinsky (Comment), “Use of Scientific Peer Review and Colloquia to Assist Judges in The Admissibility Gatekeeping Mandated by Daubert,” 34 Hous. L. Rev. 527 (1997). 21. See, Effie J. Chan, “The ‘Brave New World’ of Daubert: True Peer Review, Editorial Peer Review, and Scientific Validity,” 70 NYUL Rev. 100 (1995). 22. Id. at 101. 23. See, Chapter 1, Science in American Litigation. 24. 509 U.S.579, 113 S.Ct.2786 (1993). 25. Ibid. at 2796–98. 26. Daubert at 582. 27. Shanna Helen Swan, who received a master’s degree in biostatistics from Columbia University and a doctorate in statistics from the University of California at Berkeley, was chief of the section of the California Department of Health Services that determines causes of birth defects and had served as a consultant to the World Health Organization, the Food and Drug Administration, and the National Institutes of Health. Stuart A. Newman, who received his bachelor’s degree in chemistry from Columbia University and his master’s and doctorate in chemistry from the University of Chicago, was a professor at New York Medical College and had spent over a decade studying the effect of chemicals on limb development. The court found the credentials of the others were similarly impressive. See, Daubert at 583, n. 2. 28. Daubert at 2792. 29. 727 F.Supp., at 575. 30. 951 F.2d 1128 (1991). 31. Ibid. at 1130–1131. 32. Id., at 1131. 33. Citing S. Jasanoff, “The Fifth Branch: Science Advisors as Policymakers,” 61–76 (1990): It is true that open debate is an essential part of both legal and scientific analyses. Yet there are important differences between the quest for truth in the courtroom and the quest for truth in the laboratory. Scientific conclusions are subject to perpetual revision. Law, on the other hand, must resolve disputes finally and quickly. The scientific project is advanced by broad and wide-ranging consideration of a multitude of hypotheses, for those that are incorrect will eventually be shown to be so, and that in itself is an advance. Conjectures that are probably wrong



34. 35.

36. 37.

38. 39. 40. 41. 42. 43.

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45. 46.

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are of little use, however, in the project of reaching a quick, final, and binding legal judgment — often of great consequence — about a particular set of events in the past. We recognize that, in practice, a gatekeeping role for the judge, no matter how flexible, inevitably on occasion will prevent the jury from learning of authentic insights and innovations. That, nevertheless, is the balance that is struck by Rules of Evidence designed not for the exhaustive search for cosmic understanding but for the particularized resolution of legal disputes (Daubert at 597). Citing Horrobin, “The Philosophical Basis of Peer Review and the Suppression of Innovation,” 263 JAMA 1438 (1990). Daubert, at 596. The court cited J. Ziman, “Reliable Knowledge: An Exploration of the Grounds for Belief in Science,” 130–33 (1978); A.S. Relman and Marcia Angell, “How Good Is Peer Review?” 321 New Eng. J. Med. 827 (1989). Id. 118 S.Ct.512, 522 U.S.136 (1997) The District Court had ruled that there was a genuine issue of material fact as to whether Joiner had been exposed to PCBs, but nevertheless granted summary judgment for petitioners because there was no genuine issue as to whether Joiner had been exposed to furans and dioxins, and that the testimony of Joiner’s experts had failed to show that there was a link between exposure to PCBs and small-cell lung cancer. The court believed that the testimony of respondent’s experts to the contrary did not rise above “subjective belief or unsupported speculation.” 864 F.Supp. 1310, 1326 (N.D.Ga.1994). Their testimony was therefore ruled inadmissible. Joiner, at 516. See 90 Stat.2020, 15 U.S.C. § 2605(e)(2)(A). Joiner at 518. The court observed that Joiner was an adult human being whose alleged exposure to PCBs was far less than the exposure in the animal studies. 864 F.Supp., at 1324. Joiner at 522 U.S.145. Bertazzi, Riboldi, Pesatori, Radice, and Zocchetti, Cancer Mortality of Capacitor Manufacturing Workers, 11 American Journal of Industrial Medicine 165 (1987). J. Zack and D. Musch, “Mortality of PCB Workers at the Monsanto Plant in Sauget, Illinois,” December 14, 1979 (unpublished report), 3 Record, Doc. No. 11. Joiner, at 519. Ronneberg, Andersen, and Skyberg, “Mortality and Incidence of Cancer Among Oil-Exposed Workers in a Norwegian Cable Manufacturing Company,” 45 British Journal of Industrial Medicine 595 (1988). Kuratsune, Nakamura, Ikeda, and Hirohata, “Analysis of Deaths Seen Among Patients with Yusho: A Preliminary Report,” 16 Chemosphere 8/9: 2085 (1987).


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48. Joiner at 522 U.S.146. 49. Id. 50. 119 S.Ct. 1167 (1999). See, Chapter 2, Science, Products Liability and the Courts, for a more detailed discussion of the Daubert, Joiner, and Kumho Tire cases, as respects the total generally acceptable vs. reliablity standards debate. The use here is limited to an analysis of the extent to which those cases provide guidance on the peer-review component of the Daubert reliability requirement. 51. Kumho Tire, at 1178. 52. Citing Stephen Bobo, “Tire Flaws and Separations, in Mechanics of Pneumatic Tires,” 636–37 (S. Clark (ed.), 1981); C. Schnuth et al., “Compression Grooving and Rim Flange Abrasion as Indicators of Over-Deflected Operating Conditions in Tires,” presented to Rubber Division of the American Chemical Society, October 21–24, 1997; J. Walter and R. Kiminecz, “Bead Contact Pressure Measurements at the Tire-Rim Interface, presented to Society of Automotive Engineers,” February 24–28, 1975. Id. at 1178–1179. 53. 19 F.Supp.2d 592 (D.Ct. S.D. West Virginia 1998). 54. Id. at 594. 55. Id. at 594–595. 56. Id. at 600. The court cited Effie J. Chan, “The ‘Brave New World’ of Daubert True Peer Review, Editorial Peer Review, and Scientific Validity,” 70 NYUL.Rev. 100, 113 (1995). The court noted with approval that the balance of the article highlighted significant problems with the entire process of editorial peer review. 57. 19 F.Supp.2d 592 at 600. 58. 70 NYUL.Rev. 100, 113 (1995). The court noted with approval that the balance of the article highlights significant problems with the entire process of editorial peer review. 59. Id. at 117. 60. Citing Chan, supra at 113 (“The body of published scientific literature is the most visible and prevalent forum through which modern-day scientific claims are communicated to the global audience of scientists. Journal articles are ‘temporal statements in an ongoing debate’ and their publication is a starting point for the open discourse of true peer review.” [emphasis added]). Id. at 601. 61. 184 F.3d 1300 (11th Cir.Ct.App 1999). 62. Federal Rule 104(a) provides: “Preliminary questions concerning the qualification of a person to be a witness, the existence of a privilege, or the admissibility of evidence shall be determined by the court, subject to the provisions of subdivision (b). In making its determination it is not bound by the rules of evidence except those with respect to privileges.”



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63. The court noted at the outset, that despite 3M/McGhan’s bandying about of terms such as “junk science” and “science for hire,” that the district court was careful to note the impeccable qualifications of the experts it was reviewing and that the court had before it sufficient record to adequately assess the Daubert issues. 64. 184 F.3d at 1313. 65. Daubert, 509 U.S. at 593, 113 S.Ct. 2786. 66. Id. 67. 184 F.3d at 1313. The court found Gershwin failed to explain the correlation of the results of Lightfoote’s rat studies in which the rats were directly injected with silicone to symptoms in a human patient where the inner lumen of the implants had remained intact. Similarly, the court found that Gershwin failed to convincingly extrapolate data from the human retinal studies to cases involving unruptured implants. The court specifically noted extrapolation or “leap” problems with Gershwin’s collagen antibody studies having a causal connection to systemic disease. Ibid. at 1314. 68. Id. at 1314. 69. See, L.K. Kayler et al., “Breast Implants Increase the Risk of Arthralgias: An Epidemiological Meta-Analysis,” 43 J. Investigative Med. 129 (1995); S. Friis et al., “Connective Tissue Disease and Other Rheumatic Conditions Following Breast Implants in Denmark,” 39 Annals Plastic Surgery 1 (1997); Eric J. Giltay et al., “Silicone Breast Prostheses and Rheumatic Symptoms: A Retrospective FollowUp Study,” 53 Annals Rheumatic Diseases 194 (1994); Charles H. Hennekens et al., “Self-Reported Breast Implants and Connective-Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study,” 275 JAMA 616 (1996). The trial court found the Kayler study unreliable because it was a reanalysis of other studies that had found no statistical correlation between silicone implants and disease. It found the Friis study irrelevant because it specifically scrutinized muscular rheumatism, not systemic disease. Similarly, the Giltay study found correlations between implants and increased risk of joint pain, a complaint which Allison did not have. While the study did support Allison’s claim for burning eyes, the court noted that the women participating in the study were aware of the hypothesis, a factor which could have created bias, skewing the results and ultimately making its conclusions suspect. The court found that the Hennekens study, which had the most significant statistical correlation of silicone and increased ANA, had a relative risk of only 1:24, a finding so significantly close to 1.0 that the court thought the study was not worth serious consideration for proving causation. 184 F.3d at 1313, 1315. 70. Daubert, 509 U.S. at 593–94, 113 S.Ct.2786. “[C]onclusions and methodology are not entirely distinct from one another. Trained experts commonly extrapolate from existing data. But nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may


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72. 73.

74. 75.

76. 77. 78.

79. 80. 81. 82. 83. 84.

85. 86. 87.

Science and Litigation: Products Liability in Theory and Practice conclude that there is simply too great an analytical gap between the data and the opinion proffered.” Id. Also see, Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594, 598 (9th Cir.1996). A court may properly scrutinize anomalous conclusions and reject expert opinion if the expert fails to identify and defend the reasons why his scientific methodologies yielded novel results. Daubert, 509 U.S. at 593, 113 S.Ct. 2786. See Daubert, 509 U.S. at 591, 113 S.Ct. 2786. “‘Fit’ is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes.” 705 N.E.2d 539 (Ct. App. Ind. 1999). Dr. Kaplan testified that the protocol for the test was the following: a) to drive a vehicle (with outriggers) in a 12-foot lane at a predetermined speed (usually 35–50 mph in 5 mile increments) as close to an obstacle (traffic pylons) which block a lane of traffic before imputing steer to the left (in a left avoidance maneuver) to avoid the pylons; and b) as the vehicle clears the barrier (pylons), input steering back to the right to correct the first steer; and c) then input a third steer to straighten the vehicle back into the original lane of travel; and d) make all inputs as quickly as possible; but e) picking off cones with outriggers is not a negation of a test, nor does picking off the cone with the vehicle itself necessarily negate the test. The protocol is to “avoid and correct.” R. at 5960–62. 705 N.E.2d at 549–550. 705 N.E.2d at 552. Id. at 554. See Daubert, 113 S.Ct. at 2797 (noting that well-grounded but innovative theories may not be published while some propositions are too particular, too new, or of too limited interest to be published). Id. at 558. Id. 184 F.R.D.304 (Dis. Ct. Missouri 1998). Id. at 305–306. Id. at 307. Id. None of the crash tests performed by General Motors demonstrated the forces on the break pedal at the time of frontal impacts, nor how far rearward the break pedal is thrust when the test van impacts the barrier wall. Daubert, 509 U.S. at 593, 113 S.Ct.2786. Id. at 308, FN3. Id. Also see, Oddi v. Ford Motor Company 234 F.3d 136 (3rd Cir.Ct.App. 2000), where a truck driver filed a products liability action, after he was injured when his truck struck a guardrail and a bridge abutment pierced floor of cab. The Court of Appeals ruled expert testimony claiming that the truck was not



88. 89.

90.

91.

92.

93. 94. 95. 96.

97. 98. 99.

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crashworthy due to the defective design of the front bumper and cab floor was properly excluded under Daubert. Since plantiff ’s expert conducted no tests and failed to attempt to calculate any of the forces on Oddi or the truck during this accident, he used little, if any, methodology beyond his own intuition. Hence, there was nothing here to submit to peer review, and it was impossible to ascertain any rate of error for Noettl’s assumptions about the forces that caused Oddi’s horrific injuries. Clearly, the Court of Appeals ruled, the district court did not abuse its discretion in excluding Noettle’s proffered expert opinion testimony. 149 F.3d 294 (4th Cir.Ct.App. 1998). Id. at 297. The court noted that Dr. Anderson’s findings in a series of tests on carpet samples caused considerable public concern and spurred numerous attempts by the public and private sector to examine and replicate her results. (See “Potential Health Risks from Carpets and Carpeting Material: Hearing Before the House Subcommittee on Environment, Energy, and Natural Resources,” 103d Cong. lst Sess. 1 (1993), attached to B. Richard Dudek, “Affidavit as Exhibit 2,” pp. 1–2.) “ORD Carpet Study, Toxicology Report: Evaluation of Off-Gassed Carpet Sample Atmospheres,” August 6, 1993, at p. I, attached to Dudek Affidavit as Exhibit 1. Id. at 298–299. In addition to the EPA study, defendants relied on the studies of two private corporations, Monsanto Company and Dow Chemical Company, that also were unable to replicate Dr. Anderson’s findings of toxicity and neurotoxicity in mice exposed to carpet samples. The most common criticisms of Anderson Labs’ methodologies and procedures related to its failure to insure a “blinded” study, its failure to perform necropsies or autopsies on the deceased mice in the studies and irregularities in recording indications of sensory and pulmonary irritation. 149 F.3d at 299. 432 Mass. 304, 733 N.E.2d 1042 (Mass.Sp.Ct. 2000). Id. at 306–307. Dr. Accetta was certified by the American Board of Allergy and Immunology. He was a private practitioner, a consultant in allergy at New England Medical Center, the secretary of the New England Society of Allergy, and had served on the board of directors for both the New England Society of Allergy and the Massachusetts Allergy Society. Id. at 1046. Id. at 313–14. Id. at 314–15.



Science and Legal Causation: A Primer on Proximate Cause

4

MR. BERGER: Thank you, Your Honor. May it please the Court. Plaintiffs allege in this case that the drug Parlodel caused a myocardial infarction or MI of the plaintiff, Mrs. Kittleson, and our motion is brought to show the Court that plaintiffs have failed to demonstrate under Daubert either general causation that Parlodel can cause MI or coronary vasospasm, which is what they say caused the MI, and for purposes of this motion we don’t dispute that, or specific causation that even if Parlodel could cause MI and coronary vasospasm, that it did so in her case. I have some bullet points up here, Your Honor, which review the evidence or lack of evidence with respect to the proposition. There is no epidemiology showing Parlodel causes MI, there are no controlled clinical trials showing that Parlodel causes MI or coronary vasospasm. There are no animal studies — THE COURT: Are there any controlled clinical studies that show that a bullet shot into the temple of a person causes their death? — Kittleson v. Sandoz Pharmaceuticals, 2000 WL 562553 (USDC D. Minn. 2000)

Introduction: A Primer on Proximate Cause This chapter analyzes a wide variety of causation theories and mechanisms and their accompanying verbal formulas. The concepts discussed include such familiar formulations as the “natural, probable consequence” test and the “substantial factor test.” It also focuses on subsets of causation theory utilized in products liability cases employed as analytical tools to reach such conclusions. The latter includes the theories, such as bellwether cases, centered in the use of differential statistics in mass tort settings, extrapolation theory often used in products liability causation debates, statistical analyses, and animal studies also used in products liability cases. Special attention is given to the device of differential diagnosis, which is utilized frequently in medical malpractice and products liability litigation. All of these seemingly complex ideas, used in different products liability, toxic tort, and other tort litigation settings, are simply attempts at providing a verbal formula for the determination of causation in civil and criminal law. 131


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It is essential to understand clearly that all of these various formulations are utilized in their varied settings to answer the same question: Did defendant “cause” the death or injury complained of by the plaintiff. As will be demonstrated in this chapter, the question of cause or proximate cause, discussed within any of the above-noted verbal tests, is always basically a question of facilitation — i.e., did this defendant have enough to do with facilitating the biological process that really caused the injury or death that they should be required to pay for it? People are injured or suffer respiratory failure or cessation of brain function as a result of natural biological causes. A manufacturer’s poor design of a drug or automobile or its failure to adequately instruct or warn a consumer cannot cause a death or injury in a real biological sense any more than a failure to stop at a stop sign can cause the death of the occupants in either vehicle in the event of an intersection collision. The question of causation, which continues to be the central law and science issue in products liability litigation, is and has always been strictly a policy-driven idea, albeit often being analyzed in the context of complex questions of toxicology or forensic pathology. In pragmatist terms we may even be able to say that A caused B because on a policy basis we believe that A should be liable for its facilitation of the series of events leading to the initiation of natural biological processes that resulted in death or injury. Facilitation is at the heart of all modern tort litigation. It is very close to the old criminal law idea of accessory before the fact or modern theories of accountability, where one who did not actually commit the crime may be guilty of it due to having aided or abetted the activities of the perpetrator before the commission of the crime. Causation or proximate causation is always an essential element in all tort areas. The complex scientific, commercial, and political aspects of causation present in modern products liability cases are communicated to a jury by way of a narrow range of linguistic standards for jury instructions on proximate causation which cover a wide variety of alleged social sins committed by companies. This context must be understood as a necessary preliminary step in getting a sense of the place, meaning, and utility of contemporary efforts to establish a one-size-fits-all definition of causation, let alone one idea of determining generally acceptable or reliable scientific method. Along with all other evidence on the right and wrong of the issues, a causation requirement is, nonetheless the linchpin which enables the eventual allocation of legal responsibility due to the defendant’s facilitation of the plaintiff ’s injury or death. Obviously, there must be some physical, real-time connection between the actual plaintiff and the defendant or his goods or services.1



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Any state’s single linguistic standard for causation, translated to jurors via a very succinct and noncommunicative jury instruction,2 both mask and encompass a wide variety of alleged social sins committed by companies and doctors in products liability, environmental, and medical malpractice settings. The criticism that proximate cause arguments and decisions are really grounded in policy merely state the obvious — of course they are. Once we admit that no defendant, civil or criminal, can ever be personally responsible for any combination of physics and/or biological processes that actually caused a real world death or injury — which is the reality in every case — then we see that we must take several steps back from any such eventuality to think of reasons, nonetheless, to hold a defendant responsible for them. The impact of genetically based pharmaceuticals and gene therapies will simply require fewer steps backwards from the result in litigation, but step back we must. In criminal cases, where the issue is focused on personal injury or death, the state must prove, beyond a reasonable doubt, the defendant’s facilitating acts in bringing about such physical results.3 As in products liability cases the defendant cannot be responsible for the natural processes that result in death or injury, but only for facilitating the initiation of those processes for a socially unacceptable reason. Interestingly, the question of the appropriate language to use in communicating this very complex idea in criminal cases typically has been resolved by simply using slight variations on the civil side of the question, where totally different factors are at play.4

The Varieties of Cause: The Case of Dennis D. When we closely examine the idea of proximate cause, we see that it is really a concept composed of three intimately related ideas: • Actual cause • Legal cause • Proximate cause These separate but related ideas can best be illustrated by using a causation problem, The Case of Dennis D., which will serve as a clear example of the tripartite nature of all causation issues. The observations to follow apply in full force to products liability, toxic tort, medical malpractice, or any other injury setting, including prosecutions under the criminal law. In each case that results in litigation, the defendant, whether a natural person, corporation or political entity has allegedly done or failed to do something that facilitates a death or injury. If it comes to litigation for


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resolution, the complaining party must point her finger at whatever it is that the defendant did or did not do that she feels justifies an imposition of liability. A legal theory, i.e., negligence or strict products liability must be chosen and the suspect act or omission must be specified as the cause or proximate cause of the injury. That may be a defective design or a failure to warn about the risks involved in using a manufactured product or in ingesting a pharmaceutical. The same applies to a simple accident case alleging a failure to yield the right of way or the release of a genetically misdesigned drug. The act or omission set out in the complaint is the focus of the proximate cause analysis. The discussion of the Dennis D. case to follow will illustrate all of the key points of any proximate cause issue. It will be set forth at this point in this chapter as a means of introducing and clarifying the above-noted three aspects of the causation question by way of an example based on a series of actual products liability cases. It will also serve as an introduction to the reallife implications of causation issues in actual products litigation. Following the Dennis D. analysis we will turn to an examination of a series of the most recent products liability cases centered in causation or proximate cause issues. The Case of Dennis D. Dennis D. is a 32-year-old male, residing in the northern woodland area of the midwest. He has been diagnosed with cancer of the left kidney, which was surgically removed. His right kidney is revealed to be “dwarfed” by the same disease process that resulted in the removal of the left kidney. It is unknown at this time whether the right kidney will also have to be removed, necessitating lifelong dialysis treatment. The Mayo Brothers Clinic staff has concluded that the malignant tumor in Dennis’s left kidney was “phenacetin-induced.” By this is meant that the scarring pattern on the tumor was most consistent with a conclusion that the kidney tissue was gradually compromised by long-term ingestion of pain killers (analgesics) containing the chemical phenacetin, a central component of all analgesic pain relievers from the turn of the century, until that component was banned by the Food and Drug Administration in the United States in the early 1990s (after a 10-year battle with the drug companies with respect to phenacetin’s deleterious effect on the normal functioning of the human kidney). From the ages of 19 to 31, a 12-year period, Dennis D. ingested increasing amounts of analgesic pain-killers, as a result of two major accidents suffered in the course of his employment. When he was 19, he fell off of a roof, suffering a broken neck, a condition that later resulted in the necessity of neck-fusion surgery, which operation left him in constant and recurring neck and head pain. In addition to the fall, several years later he suffered a serious



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head injury when a truck tire he was mounting blew off of the rim, causing a severe blow to the forehead bone which added to and increased his ongoing pain levels due to the previous neck injury. Dennis D. resides in a small community in the far northern reaches of a midwestern state called Woodland. The primary employment in this area involves various aspects of the logging industry and Dennis D. operated a “skidder,” a small vehicle used to drag cut trees from the logging camp sites for further processing. The town of Woodland had a small hospital, Woodland Community Hospital and the Woodland Medical Clinic, a private facility operated by Drs. Richard Mason and Donald Sloan. There is also one pharmacy in town, the Woodland Pharmacy, owned and operated by Dennis Corey, a registered pharmacist. To relieve his constant pain problems, Dennis D. has been under the care of both Drs. Mason and Sloan over the 12-year period noted above. Both doctors agreed in their conclusion that Dennis’s pain problems were permanent, continuing and should be treated with analgesic pain relief therapy. Accordingly, Dennis was prescribed regular allotments of two analgesic pain killers, Nopain, a powerful prescription drug classified as a controlled substance under the law, and Compound X, also a prescription analgesic drug, but considered much less potent. In fact, Dennis D. was prescribed Compound X as a balancing factor in his pain relief regimen to counteract some of the more serious and ongoing side effects of a regular ingestion of Nopain. The sum and total of all of this was that for a total of 12 years, in increasing dosages, Dennis D. ingested very large amounts of phenacetincontaining analgesics, with the result, according to the Mayo Clinic staff, of inducing a malignant tumor in his left kidney and permanent, and perhaps, ongoing damage to the right kidney. It is important to note that, with the exception of a several week period, the prescriptions received for each of the two drugs was within the recommended dosage set by the manufacturers. The fact that he was prescribed two analgesics to be taken at the same time is a problem that must be addressed later in this exercise. Nopain was prescribed over the entire 12-year period and was manufactured by the E.I. Dubois Company. Dennis D. was prescribed Compound X, manufactured by Lawson Laboratories, for 8 of the 12-year period. For the next three-year period, the pharmacist, with the doctor’s permission, substituted a generic drug, Ruby propoxyphene compound, manufactured by Ruby Laboratories, for the Compound X. For the last eight months, the pharmacist substituted Zeno Propoxyphene Compound for the Ruby product. Dennis D. has only a seventh grade education. His current medical situation will not allow him to engage in any further work in the logging industry, which is all he has ever known. Due to the uncertainty of his future as respects the prospect of surgical removal of his remaining kidney and the


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accompanying lifetime need for dialysis, and his current ongoing pain and unemployment, Dennis D. has attempted suicide on two occasions and is in a generally depressed state. His future medical, psychological and incomeproducing capacities are uncertain at best. Physical, psychological and employment rehabilitation will clearly be required. Dennis D. is married and has a 14-year-old daughter. General Liability Analysis Medical research reveals that, beginning in Germany, shortly after 1948, concern was expressed in a few medical journals about the general deleterious effect that “analgesic powders” containing phenacetin may have on the normal functioning and health of the human kidney. Over the ensuing years, this general concern was expressed in an increasing number of prestigious medical journals, in Scandinavia, Scotland, Great Britain and Australia. By the year 1989, there were a total of 745 articles, which with increasing stridency, opined that phenacetin-containing analgesics receive enhanced warnings by the pharmaceutical houses or be outright outlawed due to the mounting clinical evidence of damage to the human kidney. The majority of the articles addressed overall kidney deterioration. However, beginning in the late 1970s, an increasing number of articles (approximately 27 in number, a small percentage of the total, but a larger percentage if clustered into the final 15-year period of scholarly articles on the subject) addressed the risk of kidney tumor as a result of long-term ingestion of phenacetin-containing analgesic pain killers. American medical journals were some of the last to express these concerns, beginning in the mid- to late 1980s and into the 1990s. All manufacturers of phenacetin-containing analgesics, including the companies noted above, provided a uniform, FDA-approved warning to physicians in their package inserts and the Physician’s Desk Reference, which provided under the heading “Precautions” as follows: “Phenacetin has been reported to damage the kidneys when taken in excessive amounts for a long time.” Beginning in the later 1970s, the FDA requested that the manufacturers enhance the warning to include concern over tumor formation and to place such warning in a “black box,” considered to be the most enhanced of warnings to physicians. The manufacturers refused, arguing that the medical literature did not support the need for such a dramatic and focused increase in warning. These warnings were never implemented and became moot when the manufacturers “voluntarily” eliminated phenacetin as a component of analgesics after a 10-year battle, when it became clear that the FDA would mandate such removal. It should also be noted that while the medical literature is nowhere as extensive or prestigious as noted above, that there is literature suggesting that



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the type of scarring pattern endemic to Dennis D.’s kidney tumor could also have been caused by one of three factors, none of which have anything to do with phenacetin-containing analgesics: 1. Smoking cigarettes (Dennis has been a heavy smoker all of his life); 2. Long-term exposure to the resin of the type of trees that Dennis D. has worked with all of his adult life; 3. Long-term, close-up exposure to gas and oil fumes (Dennis has an avid interest in stock car racing and has served in the capacity of ground crew at race weekends for most of his teenage and adult years. More will need to be said about all of this). Dennis D. has consulted a law firm that has agreed to represent him in an action for personal injuries against all of the manufacturers, the hospital, the clinic, the individual physicians and the pharmacist. What will follow is a breakdown of any potential action against these defendants, with special focus on the causal relation issues unique to each and common to all. It is here that the central task of this article sets out for itself — i.e., a structured analysis of the different types of causation involved in tort litigation and an analysis of the very different conceptual and evidentiary environments that each inhabits. Once this has been set out, more general, statements will be made as to the need for a fundamental reorientation in the way we currently think about, teach and most importantly, litigate causation issues in modern tort litigation. Causal Relation Identification and Analysis The first thing that needs to be done is to map out the potential defendants and assess the range of acts or omissions on the part of the numerous potential defendants that may qualify for selection as candidates for allegations of proximate cause. Starting with the four manufacturers of the suspect drugs, each may be said to have failed to warn the medical profession, including Dennis D.’s physicians, of the increasing risk of kidney cancer with increased and longer term prescription of the phenacetin-containing analgesics involved. The same may be said of the pharmacist. The hospital and clinic’s liability would rest on vicarious liability due to staff privileges being granted to the two physicians. The physician’s situation is more complex. Negligent failure to warn Dennis D. by way of failing to engage independent medical research on the dangers of prescribing such drugs on an increasing amount over a long period of time is certainly one choice. However, malpractice in overprescribing these drugs is perhaps the primary condition of choice, a choice that will surely be characterized as liability ending intervening cause by all other defendants.


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As to the manufacturers, the primary financial targets of the suit, many causal relation issues, separate in nature and degree are central to the complex cause issues in this case. They must initially be broken down with respect to defendants claim that phenacetin did not cause Dennis D.’s tumor and those that state that their failure to warn physicians was a cause of that same medical anomaly. The considerations, both factually and conceptually are separate and distinct and driven by entirely different policy and evidentiary focal points. Defendant’s No Cause-In Fact Argument The major issues include the determination of whether the evidence points to the phenacetin or the smoking, resin, or gasoline fumes being the “cause” of the tumor. The only choice, as with the “failure to warn,” is to consult the medical literature as interpreted by expert witness at trial. Here, however, the question to be resolved is: Did the phenacetin cause the tumor or did Dennis’ lifestyle choices cause it? It is a question of attacking defendant’s bad judgment in failing to heighten cautions to the medical professions as to a risk associated with the use of their pharmaceuticals. The literature in defendant’s column is much less in numbers, but much more focused than the gradual rise of concern over the deleterious effects of phenacetin-based analgesic powders. In fact, there is significant disparity in the 742 articles available on the failure to warn counts as to samples, methodology and the like. The failure to warn counts focus on very different factual and policy issues. Here it is not a simple “did it or did it not,” but rather, “should or should not have.” The defendant’s social failing, if any, was in exercising bad judgment in not focusing attention on a serious health risk to patients. The “learned intermediary” rule limits their communicative responsibilities to physicians, not the mass patient pool. Accordingly, a whole set of considerations must be examined to determine if such a failing “caused” Dennis D.’s kidney tumor — an attenuated connection under the best of circumstances. Having examined a practical application of the three aspects of proximate cause, it will be of value to take a closer theoretical look at actual, legal and proximate cause. Actual Cause Actual cause, in the author’s frame of reference, means the requirement that the plaintiff prove that his real-life physical problem, was “caused by” the defendant, in the sense that something defendant did or did not do resulted in a process of physics or biology that caused the physical condition that has brought about the lawsuit. It is essential at this stage to recall that the real-life harm that plaintiffs suffer is always the result of some biological or physical process over which



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the defendant has absolutely no control and could not conceivably be held responsible for. In the Dennis D. case, the biological interaction of phenacetin with the nephron of the human kidney causing malignant cell growth is totally outside of the control or responsibility of any pharmaceutical manufacturer. The same can be said for the physical result of a portion of the human body being crushed by weight in an auto collision or tissue burned by fire in the same incident. The actual real-life physical damage is caused by laws of nature, however clearly or not clearly understood. So, the need for close analysis and initial conceptualization of causal relation begins here, at the most basic level of physical proof of injury, upon which the theoretical basis for liability traditionally rises. In a legally neutral fashion, counsel must identify the manner in which the defendant facilitated the injury by bringing together the plaintiff and the forces of biology and or physics that combined to produce the purely physical problems he has suffered. This, in the Dennis D. case would be utilizing phenacetin in its analgesic products, marketing them in Dennis D.’s area and otherwise facilitating his ingestion of such product, thus allowing the biological forces to take their course. In our collision and burn example, it would be the simple proof of the act or omission of the defendant driver in facilitating the contact of the plaintiff ’s person with the gravitational force of his car and the deleterious effects of a fuel fed fire. A central problem here is the choices that often must be made as to the appropriate scientific tests to serve as a frame of reference for the tort system in the rare case where the defendants claim that there is no physical or biological connection between anything that they may have done and the real-life injury that plaintiff seeks to place at their doorstep. In our Dennis D. case, defendants choose smoking, tree resin and oil and gas fumes over phenacetin as the initiator of the biological processes resulting in Dennis D.’s kidney tumor. The controversy over the fetal injury potential of Bendectin, and the U.S. Supreme Court’s recent and controversial science decisions, highlight the ongoing stresses placed on the tort system in true actual cause controversies as to where to seek a real world test to aid the jury in determining the actual cause issue. Do they choose among the paradigms used by the science and industry involved? Which of the many utilized? Are scientific causal relation tests, such as statistics, what is needed to resolve legal issues? Legal Cause By legal cause, the author refers to those real-time, historical acts or omissions specified in the complaint, that the plaintiff wishes to be deemed a or the cause of the injury alleged. In the Dennis D. case, “failure to warn” about the risk of kidney cancer would be the central antisocial failing of all defendants. In the automobile collision and fire case we may allege excessive speed. These


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“causes” are the highest form of abstraction, since it is obvious that failing to warn about the risk of cancer or excessive speed are incapable, per se, of causing any physical injury to anyone. Laws of biology and physics cause real-life injury. Causation-in-fact is as much a legal fiction as any other that seeks to impose liability on otherwise legally neutral acts or omissions — i.e., the characterization or legal labeling of such conduct for purposes of imposing legally enforceable criminal or financial responsibility. The 19th century English philosopher Jeremy Bentham stated a useful construct that is of assistance in getting a clearer view of the legal or complaint stage of causation. Bentham posits what he calls a “continuum of necessary conditions,” each of which preceding condition is as necessary as any other in bringing about the transactional reality that we wish to examine. 5 In our Dennis D. setting, it was as necessary that the companies decided to manufacture any analgesics or even went initially into business as was the use of phenacetin in order to bring about our alleged injury. The invention of the automobile or the birth of our defendant driver would serve as like examples of conditions on the “continuum.” In our system of pleading a tort action, the plaintiff gets to pick which of the endless preceding conditions that he or she desires the tort system to characterize as a or the “cause” of his reallife injuries. That choice then focuses attention on that set of transactional facts, determines the scope of discovery, initiates the investigation and presentation of evidence, and the eventual analysis of relevant policy matters that will ultimately determine liability or the lack of it. This is all done through the linguistic vacuum of various causal relation tests-but for; greatly multiplies the chances; natural and probable consequences or today’s favorite, the Restatement of Torts Second “substantial factor” test. Proximate Cause The idea of proximate cause looks less to the injury-producing event and defendants contribution to the initiation of physical and biological forces against the plaintiff, than it does to the future ramifications of such events. It tends to focus on the ramifications in plaintiff ’s life that are resultant from the injury-producing event. Plaintiff ’s prospective physical and psychological problems and attending rehabilitative costs; injury to his income producing capacity and the reality of his or her pain and suffering, must be examined as to their legitimacy in terms of how far a defendant’s liability can morally extend. It then must be ultimately translated into a finite amount of damages that can withstand the scrutiny of a remittitur (a judicial reduction of the award total) analysis. Proximate cause is perhaps the most policy-driven of our triparte cause types, as it must examine each ring emanating from the stone being thrown in the plaintiff ’s personal pond.



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The liability theory chosen to process the case will have a direct bearing on the degree and extent of the science to be examined. As noted in Chapter 2, Science and the Courts, the theories of liability for the allegedly harmful side effects or other injury-producing effects of the commercial applications of scientific theory are well settled and the outlines of that theory are quite clear. Even recent pressures for “tort reforms” in the products liability area and the latest version of the Restatement of Torts, Sec. 402A, basically shift or change burdens of proof, cap damages or otherwise make it more onerous and less interesting financially to pursue these matters. There has been no retrenchment or serious calls for the elimination of potential tort responsibility for product mishaps. What is the theoretical difference between cause-in-fact and proximate cause? Is there really any, especially when we realize that the jury instruction for proximate cause is only one of the verbal tests for cause-in-fact? There really isn’t any difference other than this basic policy question: Do defendants have to pay for every injury or repercussion to plaintiff that was “in fact caused” by something that defendant did or did not do? If plaintiff has some real life repercussion due to contact with defendant’s product and that repercussion was “caused” by the defendant under one of the causation tests noted above, then why shouldn’t defendant have to pay for it? The answer is that as a matter of compensation policy, we are required as a fair society to put some limit on just how much a defendant will have to pay for “butting in” to somebody else’s life and facilitating serious injury. We have developed a cluster of policy considerations that are supposed to help us figure out when “enough is enough!”

The Language of Cause To get a solid understanding of the proximate cause idea, it must be distinguished from the various language formulations used over the years to express the cluster of policy ideas in which it is centered. It is also important to realize that the often lengthy discussions of proximate cause in appellate decisions stands in stark contrast to the terse epigrammatic language typically provided to the jurors in jury instructions that are allegedly designed to guide a jury to a proximate cause finding.6 Proximate cause is an overarching requirement in all law cases, which very fact creates problems when a question of its existence is raised in such a wide variety of settings. The problem is an old one in the common law and has been debated since the early days of the formulation of modern tort theory. Nicholas St. John Green, the first professor of torts at Harvard, addressed it in his book,


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Essays in Tort and Crime, published in 1876. He clearly saw the interconnectedness of all prior and subsequent “conditions” relative to any ultimate proximate cause finding: In as many different ways as we view an effect, so many different causes…can we find for it. The true, the entire, cause is none of these separate causes taken singly, but all of them taken together. There is no chain of causation consisting of determinate links ranged in order of proximity to the effect. They are rather mutually interwoven with themselves and the effect, as the meshes of a net are interwoven. As the existence of each adjoining mesh of the net is necessary for the existence of any particular mesh, so the presence of each and every surrounding circumstance, which, taken by itself we may call a cause, is necessary for the production of the effect…The same cause and effect which would be considered proximate in one class of [legal] actions, the attendant circumstances being unchanged, would be considered remote in others. The meaning of the terms, proximate and remote, is contracted or enlarged, according to what is the subject-matter of the inquiry.7

As noted by the great American torts scholar Leon Green: Causal relation is the universal factor common to all legal liability. On the other hand, the constituents of the other elements of legal liability change with every type of action. In assault they are different from what they are in crime. They constitute the universal variants. But causation is as much an element in an accident as in a battery; in a breach of contract as in a murder. And it is exactly the same problem wherever found and is soluble by the same process. It is only in the rarest instances that it offers any difficulty. It seldom gets to the surface. It is made difficult only because of the attempts to translate foreign problems into causation terms.8

The pragmatic purpose of a causation requirement, i.e., to enable the allocation of legal responsibility due to the defendant’s facilitation of the biological processes actually resulting in plaintiff ’s injury or death, must be expressed in language sufficient to communicate its function. This goal has been historically thwarted by the confusion inherent in relying on terse legal formulations as a substitute for the judging process and responsibility. Leon Green stated it clearly nearly three-quarters of a century ago: Under whatever guise it has been undertaken, the search for a language technic which would solve the difficulties of government has been the falsest hope of legal scholarship…It is not that a scientific language device is not desirable. It is merely that too much emphasis has been put upon it, and too much expected of it. The attempt has been made and still is made to make language do the service of judging itself.9



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Language changes with its use in law and all other areas of life. In law, like science, the language is shaped by the legal process within which it functions and accordingly raises the risk of losing the trees in the forest. The rules of civil practice necessitate the capsulization of the basic facts of a case and require the plaintiff to state how he wishes the court or jury to officially characterize the defendant’s conduct. This preliminary unofficial labeling sets in motion the plethora of litigation-related rules, including proximate causation, which determine the manner and pace at which the problem is to be channeled through the process to eventual resolution. It is here that legal theory enters and serves as the major catalyst in the process of structural metamorphosis of the historical event giving rise to the litigation. 10 Causation, like all legal ideas, is subject to change, both linguistically and operationally, due to the process of legal evolution over centuries of use. There have been a series of verbal formulations of the cause-in-fact or proximate cause idea developed and utilized by Anglo-American courts over the years. Some of these verbal tests, like the famous “but for” or sine qua non (“without which not”) test, which was popularized by the early 17th century philosopher Francis Bacon, have been around for many years. All of these verbal formulations, what we may call verbal referential tests serve as the legal definition of the facilitation idea and are the theoretical standard within which to judge the transactional facts involved in a particular case. In some cases, the formulas are used without reference to any subspecies of methodology used to get to the verbal goal in particular areas of our scientific or commercial life, such as differential diagnosis, bellwhether inferential statistics predictive modeling, or extrapolation from blocks of scientific literature, epidemiological studies, animal studies and the like. These discipline or context specific models are often used to supply the grist for the verbal referential mill, resulting in a finding of a natural probable consequence, substantial factor and the like. The pure verbal tests reference only the explicit commonsense of the case connections established or not established by the parties. These linguistic formulations have remained as the endgoal of legal history’s ongoing causation debates. It is the same formulas used to determine liability for fires caused by railroad sparks, inadequate product designs or warnings or, in the immediate future, products liability focused on genetic bioengineering. It is new wine in old bottles, a phenomenon recognized by Justice Holmes nearly 120 years ago: A very common phenomenon, and one very familiar to the student of history, is this. The customs, beliefs, or needs of a primitive time establish a rule or a formula. In the course of centuries the custom, belief, or necessity disappears, but the rule remains. The reason which gave rise to the rule has been forgotten, and ingenious minds set themselves to inquire how it is to be accounted for. Some ground of policy is thought of, which seems to


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Science and Litigation: Products Liability in Theory and Practice explain it and to reconcile it with the present state of things; and then the rule adapts itself to the new reasons which have been found for it, and enters on a new career. The old form receives a new content, and in time even the form modifies itself to fit the meaning which it has received.11

Here is a list of the most commonly used verbal formulas for cause, within which any discipline specific subset of causation theory, such as extrapolation are employed: • But for Test: But for the act or omission of the defendant, the injury would not have occurred12 • Greatly Increases the Chances Test: The act or omission of the defendant greatly increased the chances of the injury happening13 • More Probable than Not Test: The act or omission of the defendant made it more probable than not that the injury would occur14 • Natural, Probable Consequence Test: The death injury was the natural, probable consequence of the act or omission of the defendant 15 • Substantial Factor Test: The act or omission of the defendant was a substantial factor in bringing about the death or injury16 Each of these verbal formulations have been used over the years in different jurisdictions to accomplish the same goal: to provide courts and juries with a language formula within which to discuss the relevant political, philosophical, scientific, economic or moral factors that assist in the jury’s finding or not finding “proximate cause,” i.e., sufficient facilitation on defendant’s part to warrant a criminal or civil verdict against her. The material to follow will examine recent case law utilizations of the range of causation formula utilized in American tort law, in particular, those currently used in products liability litigation.

Working Theories of Cause Verbal Referential Tests Nunez v. Commercial Union Insurance Company,17 decided in 2000, illustrates the use of differing tests of the purely verbal, nonreferential type, here, combining the but for and substantial factor tests to reach a decision on the adequacy of facilitation in a serious automobile collision case. The court pointed out the basic necessity of an initial causal determination: The first inquiry in the duty risk-analysis is cause-in-fact. Cause-in-fact is a ‘but for’ inquiry, that is, if the plaintiff ’s harm would not have occurred



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but for the defendant’s substandard conduct, then it is a cause-in-fact. When multiple causes are present, a defendant’s conduct is a cause-in-fact when it is a substantial factor in generating a plaintiff ’s harm.18

After reviewing the evidence, the court found that it was reasonable for a jury to find that the conduct of two state troopers in failing to take control of an intersection immediately after a deputy sheriff asked to be relieved, was a cause-in-fact of the accident occurring. However, the court continued, it was unreasonable for the jury to conclude that the actions of Deputy Pierotti in leaving the intersection unmanned were not a cause-in-fact of the accident. Both of these actions were substantial factors in causing the collision between the Nunezes and Garrett. In Trull v. Volkswagen of America, Inc.,19 a 2000 products liability case, plaintiff alleged two defective designs in a Volkswagen van: (1) the van was constructed in such a way that it lacked sufficient protection against a frontal impact; and (2) it was defective because the rear bench seats, on which two children were seated, did not have shoulder safety belts as well as lap belts, resulting in enhanced injuries to the occupants. The Supreme Court, Nadeau, J., held that in crash worthiness cases20 where injuries sustained are separate and divisible, burden of proof remains solely upon plaintiff, including burden of proving “enhancement,” and that in crash worthiness cases involving indivisible injuries, plaintiffs must prove that a design defect was a substantial factor in producing damages over and above those which were probably caused as a result of original impact or collision. At such point, the burden shifts to defendants to show which injuries were attributable to the initial collision over which the defendant had no control of responsibility for, and those allegedly enhanced by the suspect designs. These cases illustrate the most typical utilization of formal causation theory. In these cases the tests simply reference the case facts without the interposition of any type of discipline specific subset of causation analysis such as extrapolation or differential diagnosis as a means to get to the ultimate causation determination. In the factually more complex world of products liability the causation argument often involves questions of the reliability of analytical devices that are part and parcel of the work of scientists in the field out of which the litigation arises. The discussions to follow will examine those settings, beginning with cases involving the use of the analytical technique known as differential diagnosis.

Differential Diagnosis The concept known as differential diagnosis is widely used in the field of medicine as a basis of eliminating potential known causes of a type of injury,


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in the hope of reducing the treatment options to a meaningful level of treatment.21 In the case of products liability litigation, courts must be aware of the use of this process to identify what has happened to an injured party for purposes of assessing treatment from the use of it to determine the cause of the injury for purposes of determining legal responsibility. In medicine, differential diagnosis refers to the identification of the patient’s illness based on examinations of medical history, physical fitness, and clinical tests. The physician attempts to match the patient’s symptoms to those associated with a known disease in order to identify, through the process of elimination, the condition that best fits the patient’s symptoms. The conclusion from the differential diagnosis determines the best course of treatment. In toxic tort cases, a physician called as an expert may rely on the method of differential diagnosis when considering the underlying cause or causes of an illness. Differential diagnosis has also been referred to as ‘differential etiology’ due to its causal component. …A physician diagnosing a patient may revise the course of treatment throughout the process of identifying the illness. However, as the Supreme Court noted in Daubert, scientific testimony in the legal setting attempts to resolve particular legal disputes, and therefore cannot be perpetually revised. The plaintiff only has one attempt to prove his case, unlike the doctor diagnosing the patient.22

The difficulties inherent in confusion over the medical and legal uses of the idea of the medical concept of differential diagnosis, was recently addressed in the second edition of the Federal Judicial Center’s Reference Manual on Scientific Evidence: Perhaps because medical testimony is so common and yet not entirely accessible to the lay public, courts have come to use certain medical terms, such as ‘differential diagnosis’ and ‘differential etiology’ in ways that differ from their common usage in the medical profession. For example, although environmental and occupational health physicians may use the term ‘differential diagnosis’ to include the process of determining whether an environmental or occupational exposure caused the patient’s disease, most physicians use the term to describe the process of determining which of several diseases is causing a patient’s symptoms. Expert witnesses and courts, however, frequently use the term “differential diagnosis” to describe the process by which causes of the patient’s condition are identified, particularly causes external to the patient…. For the sake of clarity and consistency, this reference guide uses the term ‘differential diagnosis’ in its traditional medical sense, that is, referring to the diagnosis of diseases, and refers to the process of identifying external causes of diseases and conditions as ‘determining cause,’ ‘determining external cause,’ or some similar phrase, as the circumstances warrant.23



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The discussion to follow focuses on several recent products liability cases questioning the wisdom of utilizing differential diagnosis, used to eliminate the potential causes of an illness as a means to the choice of a treatment plan, as also, a means of establishing legal causation. In Turner v. Iowa Fire Equipment Company,24 the plaintiff, who was diagnosed with respiratory disorder following exposure to a discharge from a fire extinguisher at her place of employment, brought an action against a fire equipment company that had inspected her employer’s fire suppression equipment. The fire equipment company brought a third-party action against the manufacturer of the extinguisher. The United States District Court for the Western District of Missouri entered summary judgment for defendants. The Court of Appeals held that the requirement of a Daubert analysis applied to the treating physician’s causation opinion, and that such opinion, based upon a proper differential diagnosis, was sufficiently reliable to satisfy Daubert. The court also found that the trial court, however, had not abused its discretion in excluding, under Daubert, the treating physician’s opinion that plaintiff ’s exposure to baking soda caused her hyperactive airway disorder. Without the physician’s causation opinion, plaintiff could not prove her claims under Missouri law. The parties deposed a Dr. Hof, who proffered his opinion that plaintiff ’s reactive airways disease (RAD) was caused by her exposure to the chemicals from the fire extinguisher discharge. He based his opinion in part upon the medical history he obtained from the plaintiff, indicating that she had not suffered respiratory problems prior to the fire extinguisher incident, and in part upon the temporal relationship between the fire extinguisher incident and the onset of symptoms. The doctor conceded that he had not determined whether any other factors may have caused or contributed to her respiratory problems, such as repetitive exposure in the workplace to flour dust or ammonia-based cleaning products (both of which were shown to be potential causes for OA 25), or repetitive exposure to fumes, chemicals, or cigarette smoke at home. Dr. Hof also conceded that he had made no direct effort to determine what caused plaintiff ’s medical condition, or what specific ingredient in the extinguisher could have caused any such reactive airway disorder: Q.

Is it a fair statement that as a treating provider you’re not nearly as concerned as to what caused specifically the respiratory complaints to initiate, rather, you are in the role of someone who is trying to treat and limit or eliminate the complaints; is that right?

Hof: That’s correct. …



148 Q.

And what you’re telling us today is that you made no specific effort to look at, for example, the ingredients in the product to see which of those ingredients might have caused airway or respiratory irritation to Turner, correct?

Hof: No, I did not. … Q.

Is there some reason that you haven’t … undertaken any kind of analysis to determine whether the ingredients in this product have ever been shown to produce OA or RADs?

Hof: That’s not my job definition. Q.

And that’s because you’re the treating physician as opposed to someone who is charged with ascertaining the cause of the complaints; is that right?

Hof: You’re very astute.26

Dr. Hof did proffer the opinion that baking soda could have caused the reactive airway disorder until his deposition (March 1999). Until then, he had only once identified a specific substance as the likely cause of plaintiff ’s condition. In an earlier letter to the workers’ compensation insurer, Dr. Hof stated: I have reviewed your note of March 17, listing several of the agents to which [the plaintiff] was exposed in January. The NH4H2PO4 appears to be the agent that would be most likely to injure her airways, releasing both a phosphorous acid and ammonia, which can be quite irritable to the lining of the airways, combining with the water of the lining, producing an acid burn topically, which could cause enough chronic inflammatory injury to result in her present problems.

Dr. Hof had relied upon a Material Safety Data Sheet (MSDS) sent to him by the workers’ compensation insurer, which, however, applied to an extinguisher manufactured by Ansul Fire Protection, not the Kidde-Fenwal extinguisher involved in this case. After an initial mistake as to the chemical components of the extinguisher at issue, he changed his position on the precise cause of the plaintiff ’s ailments. The only other thing I could also think that I haven’t said is that I would think common baking soda in a large enough concentration could probably combine with the airway water and produce carbonic acid that could be irritating to the surface.27



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Experts testifying on behalf of Iowa Fire and Kidde-Fenwal indicated that baking soda never becomes acidic when mixed with moisture (but rather weakly alkaline), and that baking soda would not burn or irritate tissue when mixed with moisture. Iowa Fire and Kidde-Fenwal brought a motion to strike Dr. Hof ’s opinion that baking soda caused Delores Turner’s reactive airway disorder, on the basis that Dr. Hof ’s opinion was not scientifically reliable under the Daubert requirements. Plaintiffs finally argued that Daubert did not apply to Dr. Hof ’s causation opinion because he was a treating physician/fact witness, and that even if it did apply, his opinion was based on a differential diagnosis and therefore should be admitted. Plaintiffs also proffered scientific literature that purportedly established a sufficient link between baking soda and respiratory problems, thereby scientifically supporting Dr. Hof ’s opinion. The causal basis for the scientific link between baking soda and respiratory problems, were argued from a Poisondex reference for sodium bicarbonate which stated that “[p]ulmonary irritation may occur following inhalation.” Plaintiffs also presented an abstract of two case reports which suggested a link between reactive airway disorders (RADs) and exposures to high levels of “nonimmunogenic irritants.” Last, the plaintiffs offered a Material Safety Data Sheet (MSDS) for the Kidde-Fenwal fire extinguisher, which said “[b]reathing dust may irritate the noise [sic] and throat and cause coughing and chest discomfort.” This MSDS also stated that “respiratory disease including asthma and emphysema” were medical conditions “generally aggravated by exposure.” Defendants pointed out that Dr. Hof did not rely upon any of those items to form his opinion that baking soda caused Delores Turner’s reactive airway disorder.28 The court began its lengthy analysis of the causation issues in this products liability case, by rejecting plaintiff ’s argument that, as a treating physician, his opinion was not subject to a Daubert review. The court, citing the Supreme Court’s Kumho Tire decision,29 held that a treating physician’s expert opinion on causation was subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for purposes of litigation. Turner also contended that because Dr. Hof performed a differential diagnosis to support his causation opinion, and that a differential diagnosis was a scientific methodology or technique that did satisfy Daubert, it thus satisfied Daubert. The court here acknowledged that most federal circuits had ruled that a reliable differential diagnosis satisfies Daubert and provided a valid foundation for admitting an expert opinion. Those courts argued that a differential diagnosis was a tested methodology that had been subjected to peer review publication, did not frequently lead to incorrect results, and was


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generally accepted in the medical community.30 The Turner court agreed that a medical opinion about causation, based upon a proper differential diagnosis, is sufficiently reliable to satisfy Daubert. In the current case, however, the court noted that Dr. Hof acknowledged that the differential diagnosis he performed was for the purpose of identifying Delores Turner’s condition, not its cause: He admitted that he made no attempt to consider all the possible causes, or to exclude each potential cause until only one remained, or to consider which of two or more non-excludable causes was the more likely to have caused the condition…. As a treating physician, Dr. Hof wanted to identify Delores Turners’ condition so he could treat it. Dr. Hof ’s diagnosis was, we believe, one which the medical community more properly identifies as ‘differential,’ [citations omitted] (identifying differential diagnosis as a systematic comparison of symptoms to determine which of two or more conditions is the one from which a patient is suffering), rather than the type of causal diagnosis which the legal community calls ‘differential,’ see, e.g., Westberry, 178 F.3d at 262 (identifying differential diagnosis as a technique that identifies the cause of a medical condition by eliminating the likely causes until the most probable cause is isolated).31

Unlike his diagnosis of condition, the court continued, Dr. Hof ’s causation opinion was not based upon a methodology that had been tested, subjected to peer review, and generally accepted in the medical community: Significantly, Dr. Hof did not systematically rule out all other possible causes. He was clearly more concerned with identifying and treating Delores’s condition than he was with identifying the specific substance that caused her condition. Dr. Hof arrived at his opinion about baking soda more as an afterthought, in an ad hoc manner, only after being informed that he had misidentified NH4H2PO4 as one of the extinguisher’s ingredients. Therefore, although recognizing that a causation opinion based upon a proper differential diagnosis (one that systematically rules out other possible causes) satisfies Daubert, we conclude that the district court did not abuse its discretion in excluding Dr. Hof ’s particular causation opinion in this case.32

Turner also argued that Dr. Hof ’s causation opinion should be admitted because reliable, scientific literature has established a causal link between baking soda and respiratory disease, citing the Poisondex reference for sodium bicarbonate, a case report abstract, and the MSDS for the Kidde-Fenwal extinguisher. The court held that they did not believe that a medical expert must always cite published studies on general causation in order to reliably conclude that a particular object caused a particular illness. 33 The court stated



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that first several victims of a new toxic tort should not be barred from having their day in court simply because the medical literature, which will eventually show the connection between the victims’ condition and the toxic substance, had not yet been completed: If a properly qualified medical expert performs a reliable differential diagnosis through which, to a reasonable degree of medical certainty, all other possible causes of the victims’ condition can be eliminated, leaving only the toxic substance as the cause, a causation opinion based on that differential diagnosis should be admitted.34

In this case, the court noted, Turner relied on a Poisondex reference that indicates “[p]ulmonary irritation may occur following inhalation [of baking soda].” However, the court observed, Dr. Hof did not rely upon the Poisondex reference in formulating his opinion. Moreover, they concluded, the Poisondex reference was not specific enough to establish a causal link between Delores Turner’s hyperactive airway disorder and baking soda. As to the case report abstract that suggested a link between RADs and exposures to high levels of “nonimmunogenic irritants,” the court again noted that Dr. Hof had not relied upon that case report abstract to form his opinion, and thus did not discuss what the abstract identifies as “nonimmunogenic irritants.” Turner had presented no evidence demonstrating that baking soda could be considered a “nonimmunogenic irritant.” The court also observed that case reports were generally not considered reliable evidence of causation.35 A similar result was had in Wynacht v. Beckman Instruments,36 a 2000 case decided by the Eastern District Court in Tennessee. In Wynacht, plaintiff brought a products liability action against the manufacturer of a lab analyzer, alleging that she suffered fibromyalgia, chronic fatigue syndrome, toxic encephalopathy, and other health problems as result of her exposure to chemicals present in wastewater released from the lab analyzer. The District Court held that Grace E. Ziem, M.D., a clinical treating physician, was not qualified to testify as to medical causation. Dr. Ziem opined that plaintiff ’s exposure to the chemicals discharged from the Beckman CX-7 Analyzer caused her medical conditions, diagnosing Wynacht as suffering from some 18 medical conditions.37 Plaintiff informed the trial court that Dr. Ziem’s testimony would be based on her role as a clinical treating physician, not just as a hard scientist, based on her examination and testing of plaintiff, her experience in treating hundreds of other patients with toxic injuries, and the “hundreds of hours” Dr. Ziem had spent involved in plaintiff ’s care and well-being. The court, after careful review of the affidavits presented determined that Dr. Ziem’s testimony fell “well short” of the standard for scientific reliability pursuant


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to Rule 702 and Daubert.38 As in Turner, above, the court stressed the difference between a medical diagnosis and a scientific determination of causation: First and foremost, there is a fundamental distinction between Dr. Ziem’s ability to render a medical diagnosis based on clinical experience and her ability to render an opinion on causation of Wynacht’s injuries. Beckman apparently does not dispute, and the Court does not question, that Dr. Ziem is an experienced physician, qualified to diagnose medical conditions and treat patients. The ability to diagnose medical conditions is not remotely the same, however, as the ability to deduce, delineate, and describe, in a scientifically reliable manner, the causes of those medical conditions.39

Secondly, the court continued, to provide a reliable expert causation opinion, Dr. Ziem was required to demonstrate a connection, based on a reliable scientific methodology, between the chemical spill and the various medical conditions that she has diagnosed for Wynacht. Dr. Ziem’s opinion was that the exposure to the combination of irritants from the CX-7 induced plaintiff ’s reactive airways disease (RAD), and that the combination of neurotoxic agents as well as entry into the brain of agents that would not otherwise be neurotoxic were the factors that induced plaintiff’s chronic permanent brain damage, or toxic encephalopathy. The record contained a listing, compiled by Beckman experts, derived from the laboratory records, of the chemicals in use in the Synchron CX-7 at Columbia Southern Tennessee Medical Center on the date in question. Dr. Ziem stated in her deposition that she utilized this listing in determining that Wynacht was exposed to chemicals. The court found the bases of Dr. Ziem’s opinion to be totally inadequate: Dr. Ziem does not, and apparently cannot, state through a reliable scientific methodology how these various chemicals caused toxic encephalopathy, fibromyalgia, chronic fatigue syndrome, and the other conditions she has diagnosed for Wynacht. In short, Dr. Ziem’s opinion that the chemicals present in the Synchron CX-7 caused Wynacht’s fibromyalgia, chronic fatigue syndrome, toxic encephalopathy, and other health problems, is based solely on the temporal relationship between the January chemical spill, burning sensations reported by Wynacht, and Dr. Ziem’s subsequent diagnosis of 18 maladies. Given the complex nature of the facts giving rise to this litigation, this perceived temporal connection, especially given Dr. Ziem’s failure to identify any biochemical, medical, or toxicological principles or studies supporting it, falls well short of the Daubert reliability standard [Citations omitted]… Dr. Ziem’s methodology simply does not reflect the intellectual rigor required of experts pursuant to Rule 702.40

Not only had Dr. Ziem not personally undertaken any testing that would support her conclusion that the wastewater ingredients caused Wynacht’s



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ailments, but she also stated that she was unaware of any testing of these chemicals by others. The court also noted that Dr. Ziem stated in her deposition that she is not familiar with studies of the effects of these chemicals, although she conceded that such knowledge would be possible to access, helpful, and illustrative. In addition, she stated that she did not know of any other scientific or medical literature in support of her causation opinion: Consequently, there has been neither verification through testing of Dr. Ziem’s conclusions, nor have they been subject to peer review, nor has Dr. Ziem identified any rate of error. Without testing data or support in scientific or medical literature, the Court cannot say with any confidence whether her reasoning would have any acceptance in the medical or scientific communities.41

In contrast, the court observed, an entire field of scientific research, toxicology, was concerned with examining and identifying the effects of chemicals on organisms and organ systems.42 In general, the court noted, toxicologists and physicians specializing in occupational medicine undertook a series of inquiries in determining whether a chemical exposure is capable of causing a disease or other impairment.43 Key to these investigations the court found, was the identification of the level of exposure and how it interacted with various organs or body systems (“dose–response”), both in terms of how the chemical was initially distributed through the organism as well as how it ultimately produced a specific ill-effect. By contrast, the court observed, Dr. Ziem did not offer any informed assessment of how the chemicals interacted with Wynacht’s body systems (other than describing them as having initial “irritant” effects) and how they led to Wynacht’s myriad diseases and conditions. Although Rule 702 did not require Dr. Ziem to undertake massive toxicological research in developing her causation opinion, the fact that such principles were well-known and regularly employed bolstered the Court’s conclusion that her reasoning did not display the intellectual rigor required of experts testifying before the federal courts.44 A like result was also had in Goeb v. Tharaldson,45 a 2000 Minnesota Supreme Court decision, where plaintiff parents brought a products liability action against Timothy Tharaldson d/b/a Duluth Quality Pest Control (Tharaldson), and Dow Chemical Company, d/b/a DowElanco (Dow), alleging that they and their son were permanently injured by their exposure to the insecticide Dursban. Dow sought to exclude several of plaintiff ’s expert witnesses, and moved for summary judgment on the issue of medical causation. The district court excluded appellants’ experts on the basis that their methodology failed a Daubert scrutiny, and without that support plaintiff was unable to prove medical causation.


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On March 31, 1990, defendant Tharaldson applied various insecticides to control an ant infestation at an uninhabited rental home. One of the insecticides was Dursban, which was manufactured by Dow 46 and contained the active ingredient chlorpyrifos. At noon on Monday, April 2, 1990, plaintiffs arrived at the house to begin the process of moving in, and immediately noticed “a strong pungent, chemical smell” that caused their nose and throat to burn. The owner/renter of the house assured plaintiffs that open windows would quickly eliminate the problem. A subsequent health department memo concluded that the medical problems experienced by plaintiffs since moving out of the house could not be attributed to the chlorpyrifos exposure. Studies indicated that the halflife for the chemical in the body is 27 hours. Given this, it did not seem possible that 15 to 20 minute daily periods in the house or contact with the items removed from the house would be sufficient to prevent ongoing declines in the tissue concentration of chlorpyrifos in the affected individuals. Plaintiffs identified two expert witnesses who would testify that appellants had permanent damage to their health caused by their exposure to Dursban. Dr. Sherman, a medical doctor for over 30 years, was licensed to practice in four states and was board certified in internal medicine. Prior to medical school, she worked as a chemist and biologist in several laboratories and had lectured on toxicology and occupational and environmental medicine for over 20 years. Dr. Sherman was also the author of numerous articles on pesticide toxicology, including ones in peer-reviewed journals that discuss chlorpyrifos. She had been recognized as an expert in her field, and had testified before Congress and acted as a consultant to the EPA on Dursban and other insecticides. Dr. Sherman, after examining the plaintiff family and taking their medical history, concluded that the three Goeb family members had permanent brain damage and peripheral neuropathy caused by their exposure to Dursban. Dr. Sherman based this conclusion on her interviews with plaintiffs, some pre-exposure medical records, the St. Louis County Health Department report, other relevant scientific research and literature, and her career expertise. In her affidavit in response to Dow’s motion to exclude her testimony, Dr. Sherman in the course of laying out the extensive amount of material used explaining her reasoning in her affidavit stated that she employed the technique of “differential diagnosis in ruling out other likely causes of their illnesses, correlation with known adverse effects in other similarly exposed patients, and scientific, governmental and Dow Chemical Company reports.”47 The second expert witness for appellants, Dr. Kilburn, was also renowned in his field and had published extensively in peer-reviewed medical journals on a variety of medical topics. His expertise lays in neurotoxicological testing and its use in evaluating chemical exposure. A medical doctor for over



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40 years, he was a professor of medicine at the University of Southern California School of Medicine and had served on a number of medical advisory committees and was a member of the editorial boards of several medical journals. Dr. Kilburn had also been accepted by federal and state courts as an expert in various fields including environmental toxicology.48 Dr. Kilburn had met with and examined plaintiffs and his assistants performed a series of neurophysiological and neuropsychological tests on the family. In his affidavit, Dr. Kilburn also indicated that he employed the technique of differential diagnosis to reach his conclusion that exposure to Dursban were the cause of plaintiff ’s alleged injuries.49 Dow contended that Drs. Sherman and Kilburn both acknowledged that they did not estimate the exposure levels in the home, and neither attempted to incorporate an exposure level into their analyses. Dow’s experts argued that reliance on a temporal relationship between the date of exposure and the onset of symptoms was not a generally accepted or reliable methodology and that neither Drs. Sherman or Kilburn had the training, education, or experience in neurology, clinical neuropsychology, or toxicology to be qualified to testify as experts in those fields. Dow further noted that, contrary to the assertions in his affidavit, Dr. Kilburn testified during his deposition that he had not requested or received plaintiff ’s medical records nor otherwise reviewed them. In addition, he was not able to identify any published studies to support the premise underlying his conclusions that persons who had normal cholinesterase tests results during or shortly after exposure could in any event exhibit chronic illnesses attributable to the exposure as long as six years later. Finally, contrary to her affidavit, Dr. Sherman admitted during her deposition that she did not review all of the appellants’ pre-exposure medical records. The Minnesota Supreme Court, echoing the Daubert reliability standard, stressed that the proponent of scientific evidence had the burden to establish the proper foundation for the admissibility of the test by showing that the methodology used was reliable and in the particular instance produced reliable results. They observed that plaintiffs, in response to reliability concerns raised by Dow as to both Dr. Sherman’s and Dr. Kilburn’s affidavit, failed to directly counter such concerns: [Plaintiffs] had merely simply argued her[Dr. Sherman] credentials and referred the court to her affidavit. Appellants do not point to any independent validation of her methodology or otherwise bolster its reliability by addressing the particular concerns raised by Dow. As the record supports the district court’s determination, we hold that it was not an abuse of discretion to exclude Dr. Sherman’s testimony for lack of reliabilty.50


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Dr. Kilburn’s position was found equally unacceptable: However, in contrast to his affidavit, he admitted at his deposition that he did not review appellants’ pre- or post-exposure medical records. Instead Dr. Kilburn relied solely on questionnaires completed by the appellants to rule out any other causes as to their current claimed illnesses. The selfreporting of a plaintiff ’s medical history in preparation for litigation, without additional independent confirmation, is inherently unreliable.51

Also, and again in contrast to other statements he made, Dr. Kilburn stated at his deposition that he based his conclusion as to causation exclusively on the neuropsychological and neurophysiological tests he conducted on appellants six years after their exposure to Dursban. He allegedly developed this particular limited battery of tests to assess chemical exposures and was unaware of any other researcher who also uses these tests. In addition he conceded that his battery of tests has not been peer-reviewed. Given those concerns with Dr. Kilburn’s methodology, the district court concluded that Dr. Kilburn had made too great a leap to get from “mere exposure of an unquantified amount of Dursban” to his conclusions about appellants’ illnesses. Here, the appeals court concluded that the district court’s ruling was clearly supported by the record. Appellants hads merely argued Dr. Kilburn’s qualifications and the assertions in his affidavit. The court here concluded that the district court did not abuse its discretion in determining Dr. Kilburn’s methodologies were unreliable.52 Because the court affirmed the district court’s exclusion of plaintiff s’ experts, the court concluded that the district court properly granted summary judgment to Dow on the issue of medical causation. Theresa Canavan’s case,53 a 2000 Massachusetts Supreme Court decision addressed the recurring problem of determining causation in products liability cases, here, in the context of a diagnosis of the controversial condition referred to as multiple chemical sensitivities (MCS). Here, a self-insured employer appealed from a decision of the Industrial Accident Reviewing Board which had upheld an administrative judge’s finding that this workers’ compensation claimant was temporarily unable to work due to MCS and that her medical treatment was reasonable and necessary. The plaintiff began a full-time position as a nurse in the hospital’s recovery room where she worked until June, 1990, when she began working as a nurse in the hospital’s operating room. As an operating room nurse, she was responsible for the safe care of patients during surgery, including preparing the room for surgery, caring for the surgical instruments, and assisting the surgeons. She testified that, while in the operating room, she was subjected to various chemicals including ethylene oxide, formaldehyde, and diesel fuel. After several months working in that capacity, she claimed that she experienced severe



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headaches, nasal congestion, dizziness, fever, and swelling of her nose and right cheek. After arriving at the hospital for work, she was referred to Dr. Arthur M. Laurentano who confirmed her symptoms and prescribed a course of antibiotics. At that time she was diagnosed as having chronic sinusitis and was determined to be disabled. The hospital accepted her medical condition and paid her workers’ compensation benefits.54 Dr. Laurentano, whose antibiotic treatment proved only slightly effective for the employee, referred her to Dr. N. Thomas LaCava. The employee first met with Dr. LaCava in June 1994, who concluded that the employee suffered from arthritis, paresthesias, organic brain syndrome, chemical-induced headaches, immunodeficiency, and multiple chemical sensitivities (MCS) secondary to chemical poisoning. Dr. LaCava believed that this plethora of illnesses was caused by exposure during her employment at the hospital. He became her treating physician and provided, by deposition, the expert medical testimony on her behalf at the workers’ compensation hearing.55 Dr. LaCava was a private practitioner, an instructor in pediatrics at the University of Massachusetts Medical School, a staff pediatrician at Holden District Hospital, St. Vincent Hospital, Worcester Hahnemann Hospital, and the Memorial Hospital, and was on the medical staff at University of Massachusetts Hospital. He was certified in pediatrics by the American Board of Medical Specialties and was also certified in environmental medicine by the American Board of Environmental Medicine, a field not recognized by the American Board of Medical Specialties. Dr. LaCava conducted an extensive medical examination of the employee, took her medical history, performed an examination and conducted a number of diagnostic tests. Dr. LaCava testified that: MCS is a systemic reaction of the body with multiple symptoms to multiple kinds of chemicals, which may be chemically unrelated, which are commonly present in the every day working and living environment where that environment has not been meticulously cleaned up and had the chemical sources removed.56

Dr. LaCava testified that the employee’s injury was caused by chemical poisoning at her work environment and that MCS rendered her totally disabled. Dr. Donald D. Accetta testified by deposition for the hospital. He was certified by the American Board of Allergy and Immunology, was a consultant in allergy at New England Medical Center, the secretary of the New England Society of Allergy. He was also a private practitioner who had served on the board of directors for both the New England Society of Allergy and the Massachusetts Allergy Society. Dr. Accetta examined the employee on two occasions. He opined that the employee’s condition was not caused by chemicals present in her work environment and that MCS is was “not accepted as


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a diagnostic disease by mainstream allergists/immunologists and occupational medicine physicians.” He also was of the opinion that the employee was suffering from chronic nonallergic rhinitis caused by nonspecific stimuli that existed in the every day environment. He also felt that her symptoms had a psychogenic component. The hospital argued that the methodology used by Dr. LaCava to reach his opinion regarding MCS and its cause was not generally accepted in the medical field and was not otherwise reliable and therefore his opinion was inadmissible. The Massachusetts Supreme Court stated the obvious, but too often judicially misunderstood, reality that the validity of a scientific theory was not always certain. This has been a standard working principle in the world of science since the mid-17th century. As noted by Professors Steven Shapin and Simon Schaffer: A discarded theory remains a theory. There are ‘good’ theories and ‘bad’ theories — theories currently regarded as true by everyone and theories that no one any longer believes to be true. However, when we reject a matter of fact, we take away its entitlement to the description: it never was a matter of fact at all.57

The process of constant scientific testing, over time, the court observed, validated certain theories and discredited others. A decision by an appellate court that as a matter of law a certain scientific theory or method was reliable or unreliable might freeze perceptions concerning the evidentiary usefulness of the theory or method without accounting for the evolving state of scientific knowledge: Moreover, when considering novel scientific testimony there is often limited literature for an appellate court to examine to determine whether a scientific theory or method is reliable. This is part of the rationale for abandoning exclusive reliance on general acceptance under the Frye test. We recognized in the Lanigan case that a scientific method or theory could be so novel that it has not yet had time to appear in the scientific literature and thus to have gained general acceptance in the relevant scientific community but could nonetheless be sufficiently reliable to be the basis of admissible expert testimony.58

The court held that there was no logical reason why conclusions based on personal observations or clinical experience should not be subject to the Daubert analysis. Observation informed by experience was but one scientific technique that was no less susceptible to a Daubert type analysis than any other types of scientific methodology. The gatekeeping function was the same



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regardless of the nature of the methodology used: to determine whether the process or theory underlying a scientific expert’s opinion lacks reliability to the degree that the opinion should not reach the trier of fact. If the proponent can show that the method of personal observation was either generally accepted by the relevant scientific community or otherwise reliable to support a scientific conclusion relevant to the case, such expert testimony was admissible.59 Here, the court noted, Dr. LaCava referred to “the literature” as confirming the existence of MCS and had asserted that based on the examination and tests he conducted the employee had symptoms highly suggestive of environmental sensitivity. However, the court stressed, Dr. LaCava did not identify any specific studies that showed the existence of MCS based on specific symptoms and did not identify any tests that could be performed to prove that a patient suffers from MCS. Indeed, on cross-examination, the court emphasized, he admitted that there was a dispute in the medical community regarding the very existence of MCS. Thus, the only evidence on the record tending to show that the employee suffered from MCS was Dr. LaCava’s assertion. The court concluded that on this record it was an abuse of discretion for the judge to admit Dr. LaCava’s diagnosis testimony. Because understanding medical causation was beyond the knowledge of the ordinary layman, proof of if it must rest upon expert medical testimony. The causation question in this case, the court continued, was whether exposure to a variety of chemicals including ethylene, diesel fuel, and formaldehyde caused the employee to be “highly reactive to low levels of environmental chemicals.” Because the judge below did not conduct a Daubert analysis to determine whether Dr. LaCava relied on a reliable methodology to determine that chemical exposures caused the employee’s MCS, it was also an error to admit the opinion.60 Differential diagnosis continues to be a major causation component in the effort to provide a substratum of scientific or medical technique to support a finding of a natural or probable consequence, a substantial factor or other verbal referential test used as the theoretical conclusion of a complex causation litigation effort.61

Bellwether Cases and Inferential Statistics The rise of mass tort cases based upon injuries to large groups of persons exposed to alleged toxic exposure has required the courts to search for litigation strategies to enable them to find some solid basis for settlement. The federal courts’ Manual for Complex Litigation provides a suggested solution, grounded in the use of inferential statistics, referred to as “bellwhether” cases.


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Extrapolation Theory Extrapolation theory, a causation technique commonly utilized in both science and products liability cases, come in several forms. It is important to recall that utilization of the causation theories previously discussed and those to be discussed below, serve to provide methodologies for reaching one of the overarching verbal causation endpoints such as “substantial factor” or “a natural, probable consequence.” Whether the focus be differential diagnosis, inferential statistics used in mass tort bellwether settings, or the use of extrapolation theory for examining disparate scientific or medical studies to reach some causation consensus, they all are directed toward the same goal. That goal is establishing or not, sufficient facilitation of the death or injury involved by the defendant to warrant a jury determination of cause or proximate cause. The use of statistical methodologies for data analyses and the use of extrapolation theory, in the area of epidemiological and animal studies, are of central concern in products liability. The current second edition of the Reference Manual on Scientific Evidence, published by the Federal Judicial Center in 2000, devotes no fewer than four chapters to statistics62 and an equal number to subjects grounded in whole or in part in extrapolation theory.63 The stated purpose of the use of what is referred to as bellwether theory is to reach some consensus in mass tort settings of the probable liability and damages estimations in a large number of cases, by examining the results of the trial of a “representative” number of the whole. The idea is that if trial court and counsel agree to try a select number, say 15 out of several thousand actual cases, that all parties can get a good sense of how liability will fall and in what monetary amounts, and thereby have a solid basis upon which to reach a satisfactory settlement of the whole. It is understood that the parties in those cases that do go to trial are bound by the results reached in their cases. However, the remaining cases are not affected, other than by agreeing to examine the results of the completed trials in attempting to settle their own. There is a growing body of literature devoted to this most complex causation-centered complex litigation technique.64 Extrapolation cases utilizing statistical methods, come in many packages,65 ranging from the consideration of a small number of scientific articles in a single case as a basis for a causation finding, to thousands of separate cases where the trial of a statistically significant number is sought to be used as the basis for liability of the total in a mass tort setting. The typical mass tort extrapolation scenario involves a defendant with hundreds, or even thousands, of product liability or toxic tort lawsuits pending in one court. Instead of trying each case, the court conducts a limited number of representative trials (designated as bellwether trials). Statisticians are



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employed to testify that, although individual transactional facts of each case differ, the bellwether cases contain a statistically accurate cross-section of plaintiffs, allowing for the extrapolation of the results of the sample trials to all of the remaining cases. Thus, as noted by Glickstein, if 50 bellwether trials were conducted — and the defendant won defense verdicts in 25 of the trials, lost $20,000 verdicts in 15 trials and lost $200,000 verdicts in 10 trials — the court would assume that the defendant would have lost an average of $46,000 per case to the remaining plaintiffs and so enter judgment in all the remaining cases.66 The practical effect of the idea behind bellwhether extrapolation techniques, is to relieve plaintiffs of their obligation to prove individual causation and damages. There is good news and bad news with this idea. Plaintiffs with low-value or invalid claims, including those who neither used or were exposed to the suspect product, would nonetheless recover whatever is the statistical average. Those with more substantial proof and significant higher losses, would have the amount of their recovery lowered to comport with the statistical average emanating from the selected bellwhether trials. Plaintiffs who have agreed to statistical results, thereby waiving their individual claim profiles, have the advantages of a class action, such as limited and focused discovery opportunities and a significant resolution by agreed upon settlement pathways. Defendants typically oppose bellwhether statistical extrapolation proposals, arguing quite correctly, that such procedures deny them their right to a jury trial in each case brought against them, as well as the protection of the general proof requirements that must be met in all like cases in individual trials. Plaintiffs, however, argue that those rights are substantially protected as long as the defendant is provided with a jury trial in the statistically chosen bellwhether cases and a full hearing is provided for to debate and present evidence as regards the statistical accuracy of the extrapolation. 67 In the important bellwether case of In re Chevron U.S.A., Inc.,68 decided by the Federal Fifth Circuit Court of Appeal in 1997, the former owner of property used for a crude oil storage waste pit, on which residential development was built, brought suit against defendant for injuries to homeowners. Defendant Chevron petitioned for writ of mandamus seeking relief from order of the United States District Court for the Southern District of Texas containing a trial plan for litigation pertaining to plaintiffs’ and interveners’ allegedly contaminated property. The Court of Appeals held that the 30 cases selected for use in the district court’s “unitary trial” lacked the requisite level of representativeness so that any results could permit the court to draw sufficiently reliable inferences about the whole that could, in turn, form a basis for judgment affecting cases other those selected 30. It was determined that


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before a trial court may utilize results from bellwether trials for purposes that extend beyond any individual cases tried, it must, prior to any extrapolation, find that the cases selected for trial were representative of the larger group of cases or claims from which they are selected. The case arose out of the alleged injuries suffered by over 3000 plaintiffs and interveners (“plaintiffs”), who alleged damages for personal injuries, wrongful death, and/or property contamination allegedly caused by Chevron’s acts and omissions in the course of maintaining a crude oil storage waste pit. When Chevron ceased using the property as a tank farm, it allegedly failed to take appropriate measures to secure the site, thereby allowing other waste to be deposited on the land. Later, plaintiff’s claimed, Chevron sold the property for residential development knowing that the land was contaminated.69 The district court approved a trial plan that provided for a unitary trial on the issues of “general liability or causation” on behalf of the remaining plaintiffs, as well as the individual causation and damage issues of the selected plaintiffs, and ordered the selection of a bellwether group of 30 claimants, 15 to be chosen by the plaintiffs and 15 to be chosen by Chevron. Chevron contends that the goal of the “unitary trial” was to determine its liability, or lack thereof, in a single trial and to establish bellwether verdicts to which the remaining claims could be matched for settlement purposes. It was this selection process which Chevron argued would not result in a representative group of bellwether plaintiffs. The court began its analysis by concurring with the district court that this was indeed properly categorized as complex litigation, justifying an examination of the application of the procedures for such cases. 70 The mere fact that there were potentially some 3000 claimants in and of itself complicated traditional dispute resolution. Additionally, the court continued, when large numbers of claimants assert both property damage claims and claims for personal injury as well as claims for injunctive relief, it removes any question that may linger regarding the great difficulty of such cases for court and counsel: This case is a classic example of a non-elastic mass tort, that is, the universe of potential claimants are either known or are capable of ascertainment and the event or course of conduct alleged to constitute the tort involved occurred over a known time period and is traceable to an identified entity or entities. When compared to an elastic mass tort where the universe of potential plaintiffs is unknown and many times is seemingly unlimited and the number of potential tortfeasors is equally obtuse, the task of managing the non-elastic mass tort is infinitely less complex. In the non-elastic context, the necessity for the obtainment of maturity as reflected by a series of verdicts over time is not required in order to test the viability of plaintiffs’ claims or the defendant’s defenses.71



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The district court, after designating the case as complex, then articulated the goals of its trial plan, which structured the trial by selecting the 30 plaintiffs. All chosen plaintiffs were be adults, to the exclusion of minor children, unless the children were part of a household represented by at least one adult. Each individual would be counted as a single plaintiff, as opposed to a household as a single plaintiff. Finally, the trial would focus on the individual claims of each of the selected plaintiffs and on the issue of the existence or nonexistence of liability on the part of Chevron for the pollutants that, allegedly, give rise to all of the plaintiffs’ claims. Accordingly, a unitary trial on the issues of general liability or causation as well as the individual causation and damage issues of the selected plaintiff was to occur. 72 Of the many problems discussed by the Fifth Circuit Court of Appeals, the court noted what they referred to as the “obvious,” fact that the plan did not identify any common issues or explain how the verdicts in the 30 selected cases were supposed to resolve liability for the remaining 2970 plaintiffs: It is impossible to discern from the district court’s order what variables may exist that will impact on both the property and personal injury claims in this litigation. Similar litigation typically contains property issue variables that are related to time, proximity, and contamination levels of exposure to any pollutants that may be present, and personal injury claims that contain a mix of alleged exposure related maladies that also may be affected by time, proximity, and exposure levels. We, however, may not speculate on the homogeneity of the mix of claims, the uniformity of any exposure that may have existed and what diseases, if any, may be related to that exposure. Instead our review is restricted to the record and to an examination of the district court’s order.73

The court then proceeded to discuss the general issue of utilizing so-called bellwether trials in such complex products liability litigation. The court observed that the term “bellwether” was derived from the ancient practice of belling a wether (a male sheep) selected to lead his flock, the ultimate success of which was determined by whether the flock had confidence that the wether would not lead them astray, and so it was in the mass tort context. The notion that the trial of some members of a large group of claimants might provide a basis for enhancing the prospects of settlement or for resolving common issues or claims, the court continued, was a sound one that had achieved general acceptance by both bench and bar and references to bellwether trials had long been included in the Manual for Complex Litigation: The reasons for acceptance by bench and bar are apparent. If a representative group of claimants are tried to verdict, the results of such trials can be


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Science and Litigation: Products Liability in Theory and Practice beneficial for litigants who desire to settle such claims by providing information on the value of the cases as reflected by the jury verdicts. Common issues or even general liability may also be resolved in a bellwether context in appropriate cases.74

However, the court continued, the trial contemplated by the district court’s order here was not a bellwether trial. Rather, it was simply a trial of 15 of the “best” and 15 of the “worst” cases contained in the universe of claims involved in the litigation. There was not even a pretense that the 30 cases selected were representative of the 3000 member group of claimants: A bellwether trial designed to achieve its value ascertainment function for settlement purposes or to answer troubling causation or liability issues common to the universe of claimants has as a core element representativeness — that is, the sample must be a randomly selected one of sufficient size so as to achieve statistical significance to the desired level of confidence in the result obtained. Such samples are selected by the application of the science of inferential statistics. The essence of the science of inferential statistics is that one may confidently draw inferences about the whole from a representative sample of the whole. The applicability of inferential statistics have long been recognized by the courts [citations omitted]…The selected thirty (30) cases included in the district court’s “unitary trial” are not cases calculated to represent the group of 3,000 claimants. Thus, the results that would be obtained from a trial of these thirty (30) cases lack the requisite level of representativeness so that the results could permit a court to draw sufficiently reliable inferences about the whole that could, in turn, form the basis for a judgment affecting cases other than the selected thirty.75

While this particular sample of 30 cases was lacking in representativeness, statistical sampling with an appropriate level of representativeness had been utilized and approved.76 The court concluded that before a trial court could utilize results from a bellwether trial for a purpose that extended beyond the individual cases tried, it must, prior to any extrapolation, find that the cases tried were representative of the larger group of cases or claims from which they are selected. Typically, they suggested, such a finding must be based on competent, scientific, statistical evidence that identified the variables involved and that provided a sample of sufficient size so as to permit a finding that there was a sufficient level of confidence that the results obtained reflect results that would be obtained from trials of the whole. It was such findings that provide the foundation for any inferences that might be drawn from the trial of sample cases. Without it, no inferences



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could be drawn from such results that would form the basis for applying such results to cases or claims that have not been actually tried:77 We recognize that in appropriate cases common issues impacting upon general liability or causation may be tried standing alone. However, when such a common issue trial is presented through or along with selected individuals’ cases, concerns arise that are founded upon considerations of due process. Specifically, our procedural due process concerns focus on the fact that the procedure embodied in the district court’s trial plan is devoid of safeguards designed to ensure that the claims against Chevron of the non-represented plaintiffs as they relate to liability or causation are determined in a proceeding that is reasonably calculated to reflect the results that would be obtained if those claims were actually tried. Conversely, the procedure subjects Chevron to potential liability to 3,000 plaintiffs by a procedure that is completely lacking in the minimal level of reliability necessary for the imposition of such liability.78

Similar concerns were expressed in the case of Cimino v. Raymark Industries, Inc.,79 also decided by the Fifth Circuit Court of Appeals in 1998, one year after their decision in In re Chevron. In Cimino, personal injury and wrongful death class actions were brought against several manufacturers of asbestos-containing insulation products and some of their suppliers. 80 The complex litigation trial plan ultimately implemented consisted of three phases. Phase I comprised a complete jury trial of the entire individual cases of ten class representatives and also a class-wide determination of issues of product defectiveness, warning, and punitive damages (including a multiplier as to each defendant). Phase II, addressing exposure on a craft and job site basis, was dispensed with on the basis of a stipulation. In Phase III, 160 different individual cases (“sample cases”), some from each of the five different allegedly asbestos-related diseases included in the entire group of cases, were tried to two other juries to determine only each of those individual sample case plaintiffs’ respective actual damages from their asbestos-related disease. Thereafter, followed a one-day bench hearing on the basis of which the court determined that in each disease category the 160 sample cases were reliably representative of the cases involving the like disease among the remaining 2,128 cases. The court ruled that each of these remaining 2,128 cases (the “extrapolation cases”) would be assigned by the court to one of the five disease categories and each would be entitled to judgment based on an amount of actual damages equal to the average of the verdicts rendered in those of the 160 sample cases involving the same disease category. Punitive damages in each case would be essentially based on the Phase I verdict.


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This plan was also rejected, as was the less complicated bellwether plan in In Re Chevron: While the majority opinion (one judge specially concurred) contains language generally looking with favor on the use of bellwether verdicts when shown to be statistically representative, this language is plainly dicta, certainly insofar as it might suggest that representative bellwether verdicts could properly be used to determine individual causation and damages for other plaintiffs…To begin with [the court stated], no such question was before that Court, as the trial plan contemplated that individual causation and damages issues would not be controlled by the thirty individual bellwether verdicts, which would be used to encourage settlement. Moreover, what we did — our holding — was to prevent any preclusive use of the unitary trial results (whether for general causation or individual causation or otherwise) in cases other than those of the thirty selected plaintiffs.81

The court concluded that under Texas law causation must be determined as to “individuals, not groups,” and, the Seventh Amendment gave the right to a jury trial to make that determination. Here, there was no such trial determination made, and no jury determined, that exposure to Pittsburgh Corning’s products was a cause of the asbestos disease of any of the 160 Phase III plaintiffs. Nor did the stipulation determine or establish that. Accordingly, the judgments in all the 143 Phase III cases were reversed and remanded. Turning to the extrapolation cases, it was obvious that the conclusion reached in respect to the Phase III cases applied a fortiori to the extrapolation cases. In those extrapolation cases there was no trial and no jury determination that any individual plaintiff suffered an asbestos-related disease. Indeed, the court stressed, in the extrapolation cases there was no trial at all — by jury or otherwise — and there was no evidence presented. Accordingly the court reversed the judgments in the five extrapolation cases before them.

Extrapolation Theory In Duran v. Cullinan,82 a 1997 Illinois appellate court decision, an infant and parents brought a medical malpractice action against physicians and a medical group alleging that the oral contraceptive Ovulen-21, prescribed to the mother caused the infant’s birth defects.83 The trial court granted summary judgment for defendants, ruling that the plaintiffs’ experts’ opinions as to causation were inadmissible. The Appellate Court held that the extrapolation from studies to conclude that defects not actually mentioned in the proffered scientific literature were caused by oral contraceptive was a technique sufficiently



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established to have gained general acceptance in scientific field such that opinions were admissible. A number of physicians testified on both sides of the issue. The Duran case is an excellent example of one of the most common problems facing litigators in products liability cases centered in chemistry or pharmacology, i.e., the absence of sufficient amounts of quality scientific literature to support causation claims. The absence of literature dealing with the precise causation issue involved, whether at all or in sufficient numbers, is commonly encountered in the initial litigation questioning a drug’s safety.84 In such cases, expert witnesses use extrapolation theory to link the methodology and conclusions of disparate studies to offer a causation opinion in the case at hand. Duran is not only a clear example of the use of such a process, but approved the use of extrapolation based causation opinions under the right set of circumstances. Dr. Paul Wong, the infant’s treating physician, who was board certified in pediatrics and medical genetics, testified with a reasonable degree of medical certainty that Ovulen-21 did not cause her birth abnormalities. He based his opinion on the absence of medical literature linking Ovulen-21 to the types of birth defects suffered by the infant. Dr. Wong also stated that it was significant that the infant had two siblings with birth defects and that she may have inherited a genetic disorder herself. Dr. Joe Hoo, an expert in medical genetics, also one of the infant’s treating physicians, also testified in his deposition that birth defects were probably not caused by birth control pills, and further stated that he was not aware of any link between Ovulen-21 and the type of birth defects suffered by the infant. Although he was not able to determine the actual cause of her condition, he stated that the cause could have been genetic.85 Dr. Eugene Pergament, also testifying for the defense, was board certified in clinical genetics and cytogenetics. He testified that he had access to the most recent scientific literature and medical opinion regarding the teratogenic impact of various agents. He also stated that prior to his deposition he had checked the databases for information on whether the chemical agents that comprise Ovulen-21 are capable of causing the type of birth defects involved here and determined that there was no teratogenic risk to children from exposure to the chemical agents comprising Ovulen-21. Dr. Melvyn Bayly, an obstetrician and gynecologist, also testifying for the defense, stated that, based on his review of the literature and his experience the birth defects were not caused by the mother’s ingestion of birth control pills during pregnancy. He opined that the mother’s history of having children with abnormalities was more significant than the ingestion of Ovulen21 in determining the cause of the defects.


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The court was careful to note the contents of plaintiff ’s answers to the standard interrogatories asking the name of experts to be called and the basis for their opinion: They briefly described the time frame of Ellen’s pregnancy and the ingestion of contraceptives, the ordinary development of the nervous system during pregnancy, and a Federal Drug Administration (FDA) rule promulgated in 1977 requiring patient warnings with progestational agents. The essays then stated that [a]dditional supporting data for the causal connection between oral contraceptives and this unfortunate child’s birth defects are extrapolated from a wide variety of defects appearing in the literature.86

The defendants argued in their summary judgment motion that the “extrapolation” method used by the plaintiffs’ experts in reaching their opinions on causation was not generally accepted in the scientific community as is required by Frye. The defendants attached the affidavit of Dr. Thomas Shepherd, a board-certified pediatrician with expertise in teratology, who opined with a reasonable degree of medical certainty that Ovulen-21 did not cause the birth defects exhibited by the infant. He also stated that the plaintiffs’ experts’ attempt to interpret the scientific articles to support a causal relationship between Ovulen-21 and the birth defects would be contrary to accepted scientific principles and methodologies used by the scientific community to determine a causal relationship between a potential teratogen on human fetal development. Plaintiff ’s countered with the affidavit of Stuart A. Newman, Ph.D., a professor of biology and anatomy with expertise in teratology 87 and embryology, who stated that he was familiar with the methodology scientists employ in determining probable relationships between exposure to drugs, such as oral contraceptives, and abnormalities of fetal development. In his view, the methodologies used by the plaintiffs’ experts in their answers to the interrogatories were commonly used not only by the scientific community but the FDA, the EPA, and numerous other governmental agencies such as the National Institute of Health (NIH) to assess probable relationships between potential teratogens and human fetal development.88 Based on the foregoing pleadings, depositions, and affidavits, the trial court granted the defendants’ motion for summary judgment. In its written opinion explaining its decision, the court noted that no study specifically showed Ovulen-21 to cause birth defects of the type found in Lindsay. Rather, the plaintiffs’ experts had relied on some 43-odd epidemiological studies involving birth defects not of the type found in Lindsay. The court then stated that the plaintiffs’ experts’ opinions did not rest on the 43 studies directly, but on “extrapolation” from them, and thus the general acceptance of the



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“extrapolation” technique must be tested under Frye. The court then concluded that, because the plaintiffs’ methodology in reaching their conclusion was not generally accepted in the scientific community, a genuine issue of material fact did not exist and therefore summary judgment was appropriate. In reaching its conclusion, the court relied upon the fact that the plaintiffs’ methodology was not peer reviewed. The appellate court, in rejecting defendant’s arguments, noted that, in contrast to the Daubert line of cases, where studies showed that the drug at issue had no teratogenic effect, the instant plaintiffs rely on 43 studies showing oral contraceptives to have a teratogenic effect: … we do not believe that the plaintiffs were required to present an epidemiological study showing the exact type of defect as long as the plaintiffs’ experts’ methodology in reaching their conclusions as to causation was sound. In reaching that conclusion, we note that some of the defects described in the scientific literature appear to be similar if not identical to Lindsay’s congenital defects. For example, the Lorber study identifies growth retardation and mental retardation, two defects present in Lindsay, as being caused by the ingestion of the hormones found in oral contraceptives.89

The appeals court also observed that defendants apparently did not challenge the notion that Ovulen-21 was for all intents and purposes properly categorized as a progestional that is essentially the same as those causing the defects in the studies. Rather, the court stated, defendants relied on the fact that the literature did not mention the exact defects suffered by Lindsay: The defendants maintain that the scientific community does not accept extrapolation from the studies to conclude that other defects are caused which are not mentioned in the literature and that this is so because the extrapolation method has not been peer reviewed. However, if, as the plaintiffs’ expert’s affidavit suggests, extrapolation is a technique commonly used by the scientific community, it does not appear that the extrapolation method would be a likely subject for a scientific article. Similarly, the defendants would not be able to point to a scientific article discussing the dangers of extrapolation.90

The court took as true the plaintiffs’ expert’s affidavit asserting that the extrapolation method was commonly used by the scientific community as well as various federal agencies. The court also noted the similarity between some of the defects described in the scientific literature and those exhibited by Lindsay Duran. The court found that the trial court abused its discretion in finding that the plaintiffs’ extrapolation from the studies was not a technique sufficiently established to have gained general acceptance in this particular scientific field.


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Thus, the court concluded, the plaintiffs’ experts could give their opinion as to causation and the weight to be afforded those opinions were matters for the jury to resolve. The fact that plaintiffs’ experts, under the circumstances of the case at bar, had to “extrapolate” from various studies in arriving at their opinion rather than rely on a specific epidemiological study affected the weight of the testimony and not its admissibility. 91 Accordingly, the court ruled that the trial court erred in granting the defendants’ motion for summary judgment. In Donaldson v. Central Illinois Public Service Company,92 a 2000 Illinois appellate case, cancer victims and their parents brought an action seeking compensatory and punitive damages for negligence and nuisance relative to the remediation of a nearby, former coal gasification plant. The Circuit Court entered jury verdict in favor of plaintiffs and against the public utility company for $3.2 million. The Appellate Court held that the trial court’s failure to hold a Frye to determine the admissibility of the proffered testimony of toxicology and epidemiology experts was not an abuse of discretion and that the experts’ opinions that coal tar could have caused neuroblastomas were admissible. The court also ruled that the experts’ causation testimony was not inadmissible simply because it was couched in terms of probabilities. Four Taylorville, Illinois, families filed suit seeking compensatory and punitive damages for negligence and nuisance from Central Illinois Public Service Company (CIPS). Hanson Engineers, Inc. (Hanson). Parsons Engineering Science, Inc. (Parsons ES), and Haztech, Inc., growing out of the remediation of a particular area located in Taylorville (Site) that formerly was a gas manufacturing plant. All four families had a child afflicted with neuroblastoma, a cancer of the peripheral nervous system. All parties were in agreement that the number of neuroblastoma cases in Taylorville is statistically above normal. The cause of those neuroblastomas was the focal point of this case. However, statistically, 9 out of every 1,000,000 children born develop neuroblastoma. In 1988, Christian County, where Taylorville is located, registered 520 live births. The court found that the fact that four Christian County children developed neuroblastoma within the span of a little over two years was overwhelming. At the time of this case and as of yet, there was no established precise cause of neuroblastoma. Neuroblastoma is a type of cancer, and as stated above, that involves the peripheral nervous system. Plaintiffs alleged that the statistical excess of neuroblastoma cases for the area could only be connected to the contaminants released at the site. They offered three experts to connect the neuroblastomas and the site: an epidemiologist specializing in childhood cancers, a toxicologist who also specialized in molecular biology, and a medical doctor specializing in occupational and environmental medicine. Defendants provided numerous experts,



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including the children’s treating physicians, to testify that since the cause of neuroblastoma remains uncertain, they could not testify within a reasonable degree of medical certainty that toxic exposures from the site caused these particular neuroblastomas.93 The court found that the Duran case discussed above was controlling: …we find that Duran is controlling. Plaintiffs’ toxicology and epidemiology experts cannot specifically link neuroblastoma to the carcinogens involved. However, they are able to point to numerous studies directly linking those same carcinogens to other forms of cancer. Extrapolating from these studies, the experts conclude that, logically, the carcinogens could have caused the neuroblastomas at issue in this case. While obviously these are not terribly strong opinions, they are causation opinions utilizing the accepted extrapolation method and are therefore admissible under Frye. As the appellate court stated in Duran, the fact that the experts must resort to extrapolation instead of pointing to a single epidemiological study ‘affects the weight of the testimony and not its admissibility.’94

On the central issue of proximate cause, defendant CIPS initially argued that plaintiffs were required to prove both generic and specific causation within reasonable certainty, defining generic causation as that causal link between the substances at the site and neuroblastoma. CIPS defined specific causation relative to the facts of this case as plaintiffs’ requirement to show that exposure to site chemicals and substances actually caused plaintiffs’ neuroblastomas. The court, noting the obvious relationship between actual cause/cause-in-fact and proximate cause summarily rejected any such distinction: We have reviewed CIPS’s authority on this subject. What CIPS is referring to is nothing unique to toxic tort litigation but is the stuff learned by all first- year law students regarding tort law — to establish negligence, the plaintiff must prove both causation and proximate causation. Therefore, there are no heightened causation rules applicable to the plaintiffs in this case.95

CIPS next argued that plaintiffs’ experts’ testimony was inherently unreliable and should not have been admitted. The court ruled that contrary to CIPS’s argument, an expert’s causation testimony was not inadmissible simply because it was “couched in terms of probabilities or possibilities based upon certain assumed facts.”96 The court stated that the plaintiffs correctly argued that the state of Illinois law that when the cause or etiology of a specific disease is not known, or is otherwise unclear, proof of causation was not quite as stringent. The cases citing this rule originated in worker’s compensation law,97 but had not been limited to such cases.98


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The court found the oft-cited case of Ferebee v. Chevron Chemical Co.,99 to be of particular significance with respect to the paucity of direct scientific affirmation of the causal claims in these neuroblastoma claims. Richard Ferebee had worked for an agricultural research center, and was repeatedly exposed to paraquat, a herbicide exclusively distributed in the United States by Chevron Chemical Co. (Chevron). Richard Ferebee contracted pulmonary fibrosis and eventually died. In his products liability suit, at issue was whether Richard Ferebee’s pulmonary fibrosis was caused by long-term skin exposure to paraquat. Ferebee’s experts testified to a causal relationship between his paraquat exposure and his pulmonary disease, while Chevron’s experts testified that paraquat was toxic, but only acutely, and since Ferebee’s last paraquat exposure was 10 months prior to his pulmonary diagnosis, causation could not be presumed.100 In concluding that the testimony of Ferebee’s experts was properly admitted, the appellate court had stated: [A] cause-effect relationship need not be clearly established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound … products liability law does not preclude recovery until a ‘statistically significant’ number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical … That Ferebee’s case may have been the first of its exact type, or that his doctors may have been the first alert enough to recognize such a case, does not mean that the testimony of those doctors, who are concededly well qualified in their fields, should not have been admitted.101

The Donaldson court held that, as in Ferebee and following established Illinois law, that they did not believe that plaintiffs were required to prove with 100% certainty that neuroblastoma was caused by the carcinogens to which plaintiffs were exposed. What was clear was that many components of coal tar were toxic and carcinogenic in nature. Coal tar has not been specifically linked to neuroblastoma. Expert testimony during this trial supported and disputed the causal link. We conclude that plaintiffs’ experts were correctly allowed to testify to a causal link despite the lack of a statistical number of others with neuroblastoma and a history of coal tar exposure. Worldwide, there is a limit to funding for the research into the causes of many fatal and otherwise debilitating diseases. Just because presently there is no study connecting coal tar to neuroblastoma does not exclude coal tar as the cause. Coal tar is known to cause cancer. Coal tar could very easily have caused the neuroblastomas at issue in this case. The jury was presented with testimony as to each possibility. As stated



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previously, the lack of studies connecting the two is something that the jury had to weigh in considering the expert testimony. The weight of the testimony simply does not affect its admissibility. To hold otherwise unfairly penalizes injured parties.102

The court observed that in Illinois, an expert also did not need to quantify the specific level of exposure to environmental chemicals,103 and that testimony of dust’s existence throughout a plant sufficed to prove occupational exposure without regard to individual exposures. Turning to the facts of this particular case, the court, in upholding the $3.2 million verdict against the defendants, saw a combination of factors sufficient to support a jury finding on causation. Initially the court noted, for two years beginning in April 1987, which followed the immediate removal action, particulate air emissions from the open site were essentially uncontrolled and unmonitored and left open for a period of two years. The area had not been backfilled until April and May of 1989. Exposures were not limited to the two months of excavation but also could have occurred until the spring of 1989 backfilling, with some contaminated soil remaining unremediated.Without testing the soil, CIPS represented to the EPA that the soil was not contaminated, even though after the surface soil was removed and transported, it was found to contain coal tar at levels that were even higher than those found at subsurface levels. The court stressed the fact that because it was not known that the soil was contaminated, any calculations regarding air emissions based upon the lack of soil contamination could not have been accurate. The court also addressed the general conjoining of surrounding knowledge that would support the jury’s verdict: Much damage can occur to prezygotic mothers and fathers with the parentto-be appearing healthy. But the child, ultimately conceived from the damaged ovum or sperm, may not be as healthy. Developing fetuses are much more sensitive to carcinogenic exposures. Experts testified regarding studies on prepregnancy maternal exposure as increasing the cancer risks to the later-conceived child…. Plaintiffs concede that they cannot quantify individual exposures. At trial, there was testimony that the affected radius was four miles from the Site. All plaintiffs lived within four miles of the Site. Furthermore, some of the plaintiffs testified that they frequented Manners Park, as well as nearby homes and businesses. Additionally, there was undisputed testimony at trial that particulate matter can travel hundreds of miles from its origin. To summarize and simplify, all plaintiffs fall into the realm of possible exposures. We therefore conclude that there was adequate evidence of causation with respect to plaintiffs’ exposures to the carcinogens involved.104


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One of the most useful recent decisions on causal relations issues revolving around the cancer causing potentials of chemical exposures is the 2000 Florida appellate decision in the case of E.I. Du Pont De Nemours & Co. v. Castillo.105 Here, a pregnant woman was exposed to an agricultural fungicide (Benlate) when it was sprayed on a field and later gave birth to a child with a rare birth defect. Castillo’s expert witness testified that fetal exposure to benomyl (an active ingredient in the fungicide) at a concentration of twenty parts per billion in the maternal bloodstream would cause microphthalmia in humans. He based his conclusion on two sources, rat gavage studies, and laboratory experiments on both human and rat cells. The defendant objected to this testimony on the ground that the expert’s methodology for determining whether and at what level Benlate could cause birth defects in humans was not generally accepted in the scientific community and thus the testimony was inadmissible. The court concluded that where plaintiffs wished to establish a substance’s teratogenicity in human beings based on animal and in vitro studies, the methodology used in the studies, including the method of extrapolating from the achieved results, must be generally accepted in the relevant scientific community.106 The court’s extensive remarks were preceded by a series of key scientific definitions that bear extensive repetition here. The court initially observed that the scientific evidence in the case encompassed the fields of toxicology, 107 medicine and pathology, and was primarily concerned with teratology, the specialized study of the causation of birth defects. The general causation question at issue in the Castillo case addressed whether Benlate had the capacity to cause the birth defect microphthalmia in humans, and the specific causation inquiry related to whether Benlate actually caused John Castillo’s microphthalmia.108 This science, the court continued, involved three primary types of evidence that might contribute to an inference of legal causation: epidemiology (studies to observe the effect of exposure of a single factor upon the incidence of disease in human populations), in vivo testing (animal toxicology), and in vitro testing (analysis of effects of suspected substances on isolated cell systems). The court observed that epidemiological studies were frequently described, in both scientific literature and case law, as the “best source” of information about human responses to toxic substances exposure and their potential teratogenic effects. Unfortunately, the court noted, epidemiological evidence was often unavailable regarding substances that were not actually designed for human consumption (such as Benlate). The court observed that large population groups were necessary to ensure the strength of statistical associations in epidemiological studies and that scientists “uniformly consider it unethical to test potential toxic substances on humans.”109



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In addition, the court continued, or in lieu of epidemiological evidence, researchers often relied upon animal studies to gauge the toxicity of chemical substances and that though many species were used as subjects, mammals are preferred: While primates such as rhesus monkeys are favored due to their biological similarity with humans, the predominant species used in animal toxicity studies are white rats and mice. Animal studies, which are experimental, have several advantages over epidemiological studies. Researchers can control the environment, reduce the likelihood of biases affecting the results, and administer large doses of an agent over a short period of time. However, a causal inference from an animal study to a similar effect in humans is more tenuous than with epidemiology because of physiological variations between the species (such as size, life span, metabolism and the ability to accommodate exposure to toxic substances), and because of the uncertainties associated with extrapolation both from animals to humans and from high to low doses.110

In vitro studies, the court noted, were considered useful in identifying the potential target organ toxicity and mechanisms of toxic action. In vitro teratogenic testing involved the transplantation of fetal cells into a medium where they are subjected to agents to study the effect on the transplanted tissues. However, the court stated, the mediating metabolic influence of the mother and the placenta were absent in those tests, resulting, according to the scientific literature in “a layer of uncertainty with regard to extrapolation to humans.”111 The Castillo court observed that many cases involving extensive epidemiological studies, which had shown over several years that there was no association between a chemical and a birth defect or disease, had held that contrary epidemiological studies were deemed necessary to prove causation and that animal and in vitro studies were held inadmissible to prove causation. Other factors that courts considered in weighing scientific evidence in the absence of positive epidemiology were the failure of experts to publish or submit their studies for peer review, and the fact that tests were performed solely for the purpose of litigation.112 DuPont’s primary argument concerned the methodology used by Dr. Howard in reaching his conclusion that Benlate was a human teratogen which caused John Castillo’s microphthalmia. The court noted that while DuPont appeared to acknowledge that in vivo and in vitro tests were generally accepted methods for analyzing the toxicology of a chemical such as Benlate, it nonetheless contended that Dr. Howard’s direct extrapolation of data from the in vivo and in vitro testing to conclude that Benlate was a human teratogen was


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not generally accepted science. DuPont argued that plaintiffs had not identified any scientific or legal authority to validate Dr. Howard’s assumption that a substance can be considered a human teratogen based solely on rat gavage studies, maintaining that positive results in animal and in vitro cellular tests were not accepted as proof of human developmental hazards. 113 The court agreed with DuPont that more was required of plaintiff ’s experts before their extrapolation methodology could be found generally accepted in the scientific community: We do not conclude that epidemiological studies are a mandatory prerequisite to establish a toxic substance’s teratogenicity in human beings. We do, however, conclude that where, as here, plaintiffs wish to establish a substance’s teratogenicity in human beings based on animal and in vitro studies, the methodology used in the studies, including the method of extrapolating from the achieved results, must be generally accepted in the relevant scientific community. In the present case, plaintiffs’ experts conceded at the Frye hearing that the direct extrapolation method they used in their study was new and that they were unaware of any scientific study that has ever purported to determine a human teratogenic exposure level in this manner. Plaintiffs’ experts further admitted at trial that no scientific, governmental, or academic publication had ever before relied on direct extrapolation from in-vitro test results to determine a teratogenic exposure level in a living being.114

The Court was aware that waiting until an association found in one study was confirmed by others could mean that early claimants would be denied a recovery. They also acknowledged that history demonstrated that the scientific community had always been slow to accept valid research and its results. The court quoted the decision in Merrell Dow Pharms., Inc. v. Havner, 953 S.W.2d 706 (Tex.1997), cert. denied, 523 U.S. 1119, 118 S.Ct. 1799, 140 L.Ed.2d 939 (1998): While these observations are true, history also tells us that valid and reliable research and theories are generally accepted quickly within the scientific community when sufficient explanation is provided and empirical data are adequate…. Our legal system requires that claimants prove their cases by a preponderance of the evidence. In keeping with this sound proposition at the heart of our jurisprudence, the law should not be hasty to impose liability when scientifically reliable evidence is unavailable. As Judge Posner has said, ‘[l]aw lags science; it does not lead it.’115

Based on the record in the case, the court ruled that plaintiffs’ scientific evidence should have been excluded, because the methodology used to obtain



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any conclusions from it, was not generally accepted in the relevant scientific community. In the absence of such evidence plaintiffs failed to offer any proof of causation.116 There are limited uses of the extrapolation methodology in criminal cases, primarily in drunk driving cases.117 The typical use of causation theory in criminal law are the facilitation-based verbal formulas, such as the “natural and probable consequence” or “substantial factor” discussed at the beginning of this chapter.118

The Parlodel Controversy This chapter concludes with a detailed discussion of the recent Parlodel controversy, the first significant products liability causation debate of the 21st century. Parlodel is alleged to have caused strokes in postpartum women who took the drug for antilactation purposes. Novartis introduced Parlodel in 1978 and in 1980, the FDA approved Parlodel for use in preventing postpartum lactation. Parlodel accomplishes this goal by blocking the production of the hormone prolactin, which acts upon the breasts to induce secretion of milk in postpartum women. Parlodel’s active ingredient is the chemical substance called bromocriptine mesylate (bromocriptine). 119 In 1994 the FDA proposed to revoke its earlier approval of Parlodel for inhibiting postpartum lactation, concluding that the possible harm from using Parlodel (including the possibility of seizures and strokes in certain atrisk women) outweighed its limited benefit as a lactation suppressant. 120 The ongoing and hard fought Parlodel controversy will serve as a guide to understanding the significant causation issues that will continue to be involved, at increased rates of complexity in the 21st century products cases. Here, the defendant corporation argued that there simply could not be any cause-in-fact or causal connection between the type of injury suffered by the plaintiff and the drug Parlodel. This is what has been referred to as actual causation earlier in this chapter and is also frequently labeled general causation. The basic idea is that under no set of scientific circumstances could the suspect chemical contained in the product alleged as causative actually be causative. Hence, the argument, untypical in products cases, does not rest on a debate over questionable design choices, inadequate or absent warnings, or instructions or material misrepresentations in marketing literature. We will now examine the 2001 case of Siharath v. Sandoz Pharmaceuticals Corporation,121 a lengthy and superb analysis of the place and function of the causation components in modern products liability litigation. The arguments in these cases are straightforward: migrating silicone cannot cause autoimmune



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system damage, Bendectin cannot cause birth defects, long-term exposure to PCBs cannot cause cancer, and here, bromocriptine mesylate (bromocriptine), the suspect chemical in Parlodel, cannot cause stroke in any postpartum mothers. In Siharath, patients in two cases122 who suffered hemorrhagic strokes after taking Parlodel as an antilactation drug for new mothers, brought products liability actions against the drug manufacturer. The court stated the problem in the simplest of terms: In each case, a postpartum woman suffered a stroke after taking a prescription drug manufactured by the Defendant. In its simplest form, the question presented is did the drug cause the strokes? Or, is the temporal association of taking the drug and a subsequent stroke merely coincidental? To begin to answer those questions, the Court must address the recurring issue of what is the quantity and quality of scientific evidence that a plaintiff must present on the issue of medical causation in a world of imperfect scientific knowledge.123

In this case, the latest in a string of Parlodel opinions falling on either side of the causation question, we may see a discussion of most all of the components of the “causation” argument that are available to litigators in this most contentious of products liability case issues. These components are: • • • • •

Expert witness qualifications profiles Epidemiological studies Anecdotal case reports Extrapolations from nonspecific studies of related areas Extrapolation from animal studies.

As discussed throughout this book, especially in the actual or general causation cases, there simply are rarely any peer-reviewed studies that address the causation issue. The level of scientific knowledge as respects health risks required for FDA approval is typically well below what the scientific community requires as a basis for a responsible analysis of causation issues. The result is all too often an absence of peer-reviewed studies of the challenged chemical as safe or not safe for its intended purposes. In the early days of a drug’s release the bulk of the risk data about a prescription drug is contained in proprietary reports protected as trade secrets by the pharmaceutical manufacturers, thus effectively removing any meaningful outside examination. The recent disclosure of widespread ethical and financial improprieties in the publication of academic peer-reviewed articles adds to the problem of court and counsel being able to avail themselves of sufficiently reliable materials upon which to argue and resolve actual



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causation problems. This problem will be exacerbated in the ensuing decade as pharmaceutical houses rush to market drugs and other products emerging from the worldwide explosion of genetic and other biomedical advances. In Siharath, the district court granted the defendant’s motion to exclude plaintiff ’s expert’s causation testimony as insufficiently reliable. The Court held a three-day Daubert hearing at which it heard evidence and argument from both sides regarding medical causation. At the hearing, Plaintiffs presented testimony from two of their experts, Dr. Maurice N.G. Dukes and Dr. Kenneth Kulig. Defendant presented testimony from three of its experts, Dr. James Martin, Dr. Karl Engelman and Dr. David Buchholz. Both sides, the court noted, took full advantage of the opportunity to cross examine the other side’s experts. In addition to the Daubert hearing, the Court reviewed what it referred to as the “the massive volume of documentary evidence (in all, about 575 exhibits, depositions and affidavits)” that addressed plaintiffs’ expert testimony on medical causation. Defendant argued that Plaintiffs’ experts must be excluded from testifying in this case on the grounds that their expert testimony on medical causation was inadmissible as being unreliable under the Daubert reliability standard.124 Here the court ruled, the five experts that plaintiff ’s sought to use were qualified by experience and training to testify on scientific and medical causation issues.125 However, on the crucial issue of the reliability of their proffered causation opinions, their testimony was inadequate. The court analyzed each component of the experts basis for their conclusion that Parlodel could be and was a cause of the plaintiff ’s strokes, and found them wanting in reliability. The court, prior to its step-by-step analysis, set forth the plaintiff ’s experts’ argument regarding medical causation, i.e., that Parlodel caused plaintiffs’ seizures and hemorrhagic strokes: The argument underlying their conclusion of medical causation is the following causal chain: (1) Parlodel(R)’s active ingredient, bromocriptine, prevents lactation from occurring by blocking the hormone that causes it. (2) Bromocriptine is a member of the ergot alkaloid class of drugs. (3) With respect to circulation, ergot alkaloids can cause vasoconstriction (narrowing of the blood vessels) and hypertension (high blood pressure). (4) Vasoconstriction can lead to seizures and even ischemic stroke (strokes caused by decreased blood flow to the brain). (5) If vasoconstriction can lead to ischemic strokes, it also likely causes hemorrhagic strokes (strokes caused by a rupture to the vessel). (6) Paroldel(R), therefore, caused plaintiffs’ hemorrhagic strokes.126

In short, the court observed, the chain of plaintiffs’ argument was that Parlodel’s active ingredient was bromocriptine, which was an ergot alkaloid.


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Ergot alkaloids were a class of drugs that can cause hypertension, seizures and ischemic strokes and, therefore, likely also cause hemorrhagic strokes. The question before the Court was whether their methodology in constructing this causal chain was based on scientific knowledge that was sufficiently relevant and reliable to assist the trier of fact; or whether plaintiffs’ causal chain required “leaps of faith” and was no more than a hypothesis not adequately supported by the scientific method.127 The court began its detailed analysis of the causation argument by examining plaintiff ’s epidemiological studies evidence. The initial Daubert criterion was whether the theory of causation utilized has been tested. The court recognized that epidemiology was the medical science devoted to determining the cause of disease in human beings and that epidemiologists employ cohort studies, case-control studies, and ecological studies to determine whether individuals exposed to an agent have a greater risk of developing the disease in question.128 The court recognized that while the existence of relevant epidemiological studies could be a significant factor in proving general causation in toxic tort cases, such support was lacking here. The court noted that four epidemiological studies had been conducted to investigate a possible association between Parlodel and stroke. 129 The court concluded that any meaningful statistical relation between Parlodel and stroke was simply not there: In short, neither the ERI study, the HCIA study, nor the Herings-Stricker study shows any statistically significant relationship between Parlodel and stroke. The unpublished Witlin study found that bromocriptine was negatively associated with postpartum stroke, but it is unpublished and questions surround its actual intended purpose. As Dr. Kulig stated, ‘there is no good epidemiology on the subject’ (transcript of Daubert Hearing, at 281). Plaintiffs’ experts concede that no epidemiological study shows a statistically significant association between Parlodel and stroke. The epidemiological studies either show no relationship or a negative relationship between the drug and stroke. Unable to rely upon the epidemiological studies as support for their causation opinions, plaintiffs’ experts predictably are critical of the conclusion that the studies prove Parlodel is safe for postpartum women. None of the epidemiological studies are perfect; all have their flaws. It is important to recall, however, that the burden is on plaintiffs to show that well-conducted epidemiological studies do show a statistically significant relationship between Parlodel and seizures and stroke. It is not defendant’s burden to show the lack of such relationship.130

The court noted that plaintiffs’ offered well-taken criticisms of those epidemiological studies. Nonetheless, such criticisms did not satisfy their burden of proof.131



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The Siharath court noted that the absence of epidemiological support raised the question of whether the causation opinions of plaintiffs’ experts were merely speculative and not based on scientific knowledge. The lack of epidemiological studies supporting plaintiffs’ claims created a high bar for plaintiffs to surmount with respect to the reliability requirement, but it alone was not automatically fatal. If other reliable scientific knowledge existed, claimants might overcome this considerable evidentiary gap in their proof of causation. The court recognized that epidemiology often was difficult to conduct and that considerable ethical issues were involved. The court cited the court’s observation in the case Globetti v. Sandoz Pharms. Corp.,132 a 2000 Alabama federal district court decision, where that panel stated that “[O]ne cannot ethically experiment on human beings, exposing them to near certainty of some number of deaths, simply to satisfy some evidentiary standard.” Consequently, the Siharath court continued, it would look not only to the existence of epidemiology but also the other forms of causation evidence, such as case studies, animal studies and extrapolation from related studies, that Plaintiffs might offer in totality to support their case.133 The court next directed its attention to the subject of case studies of the type offered by plaintiffs here. In the absence of statistically significant epidemiological studies to support their general causation theories. Plaintiffs’ experts relied heavily on case reports. Case reports, the court explained, were a form of anecdotal evidence where one event was reported as following another.134 Defendant’s response to the case reports was twofold. First, it argued that the specific case reports relied upon were not cases where Parlodel caused hemorrhagic stroke in postpartum women, and second, that case reports in general do not satisfy the requirements of the scientific method sufficient to establish general causation. The court agreed on both counts. Dr. Dukes, plaintiffs’ own principal adverse drug reactions expert, had emphasized in his affidavit a number of Sandoz case reports as evidence for his opinion that Parlodel caused strokes. Some of these case reports involved women well past childbearing age. Others only spoke in terms of a possibility that Parlodel was causally related to her hypertension and incoordination. Mere possibility, the court noted, did not establish medical causation. Although an adverse case report was not required to “rule out” every other possibility to have some reliability, it should do more than just fail to rule out the alleged cause. Rather, it should provide a source for “ruling in” the alleged cause. A finding that Parlodel “probably” caused a particular adverse event may add needed evidence to a causation theory. A finding that it only “possibly” caused the adverse event did not.135 The court ruled that the adverse drug reports in this case lack the requisite quantity, nature and content:


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Science and Litigation: Products Liability in Theory and Practice From 1980 to 1994 millions of women took Parlodel. The modest number of case reports associating the drug with stroke or even postpartum hypertension is not what would be expected if there was a significant increased risk. Only one report exists that links Parlodel to a stroke, and in that case the patient suffered from an underlying condition that itself can cause stroke. No other patient in any case reports suffered any form of stroke. The other patients instead suffered noncerebral effects such as hypertension and myocardial infarction. Many of the case reports cited involved patients who were not postpartum. One case report involved a patient who was dechallenged but continued to suffer from hypertension for another four to five days. In short, plaintiffs’ have not pointed to a single case report involving a postpartum woman who suffered a hemorrhagic stroke. Accordingly, even if case reports could be used to establish general causation, the Court would have to conclude that they are insufficient to do so in this case. The case reports simply lack the quantity, nature and content that Dr. Dukes himself claims is necessary for case reports to provide reliable scientific information about causation.136

The fact of the matter, the court concluded, was that even if relevant case reports existed, they could not alone establish general causation.137 Adverse reaction reports and other case reports, the court observed were generated by the clinical process of “differential diagnosis.” Differential diagnosis was described as a “patient-specific process of elimination” that medical practitioners used in an attempt to identify the “most likely” cause of a set of signs and symptoms from a list of possible causes. Differential diagnosis, however, the court emphasized, did not by itself unequivocally prove the cause, even for a particular patient. Nor could it be used alone to establish general causation.138 Indeed, differential diagnosis assumes that general causation has been proven for the entire list of possible causes that are eliminated one-by-one: The process of differential diagnosis is undoubtedly important to the question of ‘specific causation.’ If other possible causes of an injury cannot be ruled out, or at least the possibility of their contribution to causation minimized, then the ‘more likely than not’ threshold for proving causation may not be met. But it is also important to recognize that a fundamental assumption underlying this method is that the final, suspected ‘cause’ remaining after this process of elimination must actually be capable of causing the injury. That is, the expert must ‘rule in’ the other suspected cause as well as ‘rule out’ other possible causes. And, of course, expert opinion on this issue of “general causation” must be derived from scientifically valid methodology. With respect to general causation, the relevant scientific field is epidemiology or toxicology and not clinical medicine.139

Plaintiffs’ experts also relied on adverse effects of drugs other than bromocriptine, but within the same class, to support their theory that Parlodel



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causes seizures and stroke. They argued that the effects of bromocriptine were similar to those of other ergot alkaloids, a family of naturally occurring and semi-synthetic compounds.140 The court cited Mitchell v. Gencorp, Inc., 165 F.3d 778, 782 (10th Cir.1999), where the plaintiffs’ experts sought to testify that exposure to the defendant’s chemicals caused the decedent to develop chronic myelogenous leukemia. The plaintiffs’ experts had attempted to support their conclusion with various published works that link exposure to benzene and certain types of leukemia. The plaintiffs’ experts, however, did not possess any information suggesting that the decedent had ever been exposed to benzene. The district court found that the plaintiffs’ experts’ opinions lacked sufficient scientific validation to withstand the demands of Daubert. The Tenth Circuit affirmed, ruling that while the record contained some testimony about the similarities between benzene and defendant’s products, it was bereft of testimony explaining exactly what these similarities were and how the similarities caused the human body to respond to defendant’s chemicals in a manner similar to benzene. Nor did the literature presented support the notion that chemicals similar to benzene would affect the body in a manner similar enough to cause the same response as benzene.141 The Siharath court came to a similar conclusion: Plaintiffs’ experts in this case cannot show that bromocriptine, the active ingredient in Parlodel, affects the body in a manner similar to other ergot alkaloids. Plaintiffs’ argument in this regard is as follows: Parlodel’s active ingredient is bromocriptine. Bromocriptine is a semi-synthetic ergot alkaloid. Ergot alkaloids are a class of drugs that can cause vasoconstriction. Vasoconstriction can lead to hypertension, seizures and ischemic strokes. Hemorrhages are another type of stroke, so it is possible that they also are caused by Parlodel. As in Mitchell, this argument suffers from a number of flaws. As mentioned above, bromocriptine cannot be assumed to cause the same effects as other ergot alkaloids. Bromocriptine differs physically from the other ergot alkaloids in several respects, most notably the addition of a bromine atom. It is accepted in the scientific and medical community that bromocriptine is not always a vasoconstrictor. It can be a vasodilator depending upon vascular tone. No evidence exists that other ergot alkaloids cause such peculiar effects. This scientific fact supports both the finding that small differences in chemical structure often have significant consequences and the conclusion that testimony about similar drugs often does not meet Daubert’s requirements of reliability.142

Additionally, even if scientific support did exist for the plaintiffs’ conclusion that bromocriptine acted like other ergot alkaloids, plaintiffs had not presented any evidence that ergot alkaloids could cause hemorrhagic strokes.


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Plaintiffs’ argument that the fact of the FDA’s withdrawal of permission to use Parlodel as an antilactation gave support to a causation finding was readily rejected. Plaintiffs contended that the withdrawal statement by the FDA supported the reliability of their experts’ testimony. However, the court stressed, plaintiff ’s argument ignored the lower standard of proof for agency determinations based upon a risk-utility analysis than the standard of proof required for the imposition of tort liability. Such methodology by a government agency resulted from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances. A federal regulatory agency’s threshold of proof was reasonably lower than that appropriate in tort law, which traditionally made more particularized inquiries into cause and effect and required a plaintiff to prove that it was more likely than not that another individual has caused harm. In this case, the court emphasized that the lower standard was indeed reflected in the FDA’s August 24, 1994, order itself: The August 24 order fails to state affirmatively that a connection exists between bromocriptine and the type of injuries suffered in these cases. Instead it states that the evidence received by the FDA only ‘calls into question bromocriptine’s safety,’ that bromocriptine ‘may be an additional risk factor in patients who are already at risk for seizures and stroke,’ and that the FDA had obtained new evidence ‘suggesting that therapeutic use of bromocriptine for the prevention of physiological lactation may lead to serious adverse experiences….’ 59 Fed.Reg. 43348, 43351 (Aug. 24, 1994). This language does not suggest that the FDA concluded that bromocriptine causes seizures and stroke. It merely indicates that in light of the limited social utility of bromocriptine for suppression of lactation, the availability of alternative therapy, and reports of possible adverse effects, the drug should no longer be used for that indication.143

The court next addressed plaintiff ’s experts evidence derived from animal studies. Plaintiffs’ experts also relied on animal studies to support their causation opinions. Defendant also challenged the reliability, or “fit,” of those studies. Defendants argued that extrapolations from animal studies to human beings were generally not considered reliable in the absence of a credible scientific explanation of why such extrapolation was warranted. The court noted that there was considerable support in case law for defendant’s position.144 In the Reference Manual on Scientific Evidence’s Reference Guide on Epidemiology, also cited by the court, authors Green, Freedman and Gordis write that the use of animal studies to prove causation in human beings had two distinct disadvantages: First, animal study results must be extrapolated to another species-human beings-and differences in absorption, metabolism, and other factors may



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result in interspecies variations in response…. The second difficulty with inferring human causation from animal studies is that the high doses customarily used in animal studies require consideration of the dose–response relationship and whether a threshold no-effect exists. These matters are almost always fraught with considerable, and currently unresolvable, uncertainty.145

After careful review of the animal studies at issue, the Court concluded that plaintiffs had not met the necessary standard for reliability. There were basically three animal studies relied upon by plaintiffs as evidentiary support for their theory that Parlodel caused hemorrhagic strokes. These were a Sandoz study conducted on the hind limb of a dog to determine bromocriptine’s vasoconstrictive properties; a Sandoz study that assessed the effect of bromocriptine on the carotid artery of three mongrel dogs; and a group of Sandoz studies performed on pithed animals. The court stressed that none of the studies established that Parlodel caused stroke in humans — or even in animals. Furthermore, the court stated, all of the animal studies had methodological flaws that prevented any conclusion that they “fit” with plaintiffs’ causation theory. Because causation must be based on scientific knowledge allowing for a reasonable degree of medical certainty rather than mere “leaps of faith,” the Court felt compelled to conclude that the animal studies did not assist plaintiffs in satisfying the Daubert reliability requirements. The plaintiffs’ reliance on a disparate number of medical treatises was also found to be inadequate support for their causation theory. The excerpts from the treatises did not provide sufficient support for plaintiffs’ causation theory. The statements in the treatises were clearly based on case reports and, therefore, provided no more support than the case reports themselves. In conclusion, the courts recognized that plaintiffs had indeed produced an enormous mass of evidence about Paroldel, that prior to Daubert, would in all likelihood would have been submitted to a jury to evaluate the relevance and reliability of plaintiffs’ expert testimony. The command of Daubert, however, was that scientific testimony must be based upon reliable scientific methodology. In concluding that Parlodel causes seizures and hemorrhagic strokes, plaintiffs’ experts had not relied upon reliable scientific methodology: It would be a different case if there was at least some support for the causal hypothesis in the peer-reviewed epidemiological literature, a predictable chemical mechanism, general acceptance in learned treatises and other scientific literature of a causal relationship, a plausible animal model, and dozens of well-documented case reports involving postpartum women with no other risk factors for stroke. In such a case, the totality of the evidence would be enough to satisfy the demands of Daubert. In this case, no epidemiological studies support plaintiffs’ causation theory. Plaintiffs have not


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Science and Litigation: Products Liability in Theory and Practice established that all ergot alkaloids cause vasoconstriction and strokes. Although the FDA has removed its indication of Parlodel for postpartum lactation, this decision was based upon a risk-utility analysis rather than a finding using scientific methodology that Parlodel causes strokes…The animal studies that plaintiffs rely on do not “fit” because the reliability of extrapolating them to the human situation has been forcefully and effectively challenged by defendant. The excerpts from learned treatises that plaintiffs cite are merely based on case reports and, therefore, provide no more assistance than the case reports themselves. The case reports do not establish that Parlodel causes hemorrhagic stroke in postpartum women. Additionally, case reports do not establish general causation. In short, none of the types of evidence that plaintiffs offer — individually or collectively — establish a prima facie case that Parlodel causes stroke.146

In short, the court concluded plaintiffs’ case was not based on reasonable medical certainty, or “probabilities,” but instead merely on “possibilities.” The Siharath case is an excellent example the ongoing struggle faced by 21st century courts and counsel in the struggle to meld legal and scientific orders of proof in the complex area of actual causation. 147 The problem in many respects is a result of trying to equate an ex post facto litigation process to the many factors involved in what is essentially an examination of the commercial application of science. This is the basic assumption on which Part I, Science and Legal Theory, has been based. The ways and whys of how scientists do science and the ways and whys of how world corporations adapt science to business is essentially different in method and purpose from the nation’s litigation system. We are always involved in exercises to determine if one citizen, here corporations, has sufficiently facilitated a death or injury so as to impose social responsibility in the form of money damages. That goal is not likely to jell easily with both scientific and commercial cultures. This ends the discussion of Part I of this book, which has concentrated on law and science history, the response of the United States Supreme Court to the scientific reliability concern, the highs and lows of the central scientifically validating factor of peer-review publication and here, the considerable difficulties of resolving causation debates. Part II, Science and Litigation Practice, will examine in considerable detail, the various aspects of the American civil litigation system that must be utilized in the hands-on attempt to actually prosecute or defend a products liability case. The theory cannot be divorced from the practical measures provided to litigants to effectuate it. All legal theory has been developed, explicated, honed and studied to serve the need of our laws as social control devices. Legal ideas are designed, directly or indirectly, to be used in our changing society. Litigation is a major device for the both the clarification and implementation of legal theory, including the tough products liability causation issues.



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Scientific issues here begin in laboratories, wend their way through whatever corporate processes are used to give them their commercial value, and eventually run the gauntlet of the litigation process. Each stage leaves its stamp on the final decision. Part II, Science and Litigation Practice, concentrates on those key subjects. Part II addresses the subjects of the essential pretrial scientific and business research required in all products liability cases and the central subject of the use of expert witnesses. It will also deal extensively with the nuts and bolts of the search for and use of the business documentation that is the grit and gristle of products litigation. This important subject will be followed by an analysis of pretrial discovery principles and practice that is the driving force of products cases. Finally, the appendix will offer final thoughts on some of the issues likely to be raised over the next several decades and provide an extensive list of available research sources for the products liability lawyer.

Endnotes 1. There are, of course, cases where an innocent third party is injured by a manufactured good or manufacturing process without an commercial connection by way of commercial distribution. 2. Illinois Pattern Instruction–Civil Instruction 15.01, a typical verbalization, defines the term ‘proximate cause’ as follows: 15.01 Proximate Cause — Definition[:] When I use the expression ‘proximate cause’, I mean [that] [a] [any] cause which, in natural or probable sequence, produced the injury complained of. [It need not be the only cause, nor the last or nearest cause. It is sufficient if it concurs with some other cause acting at the same time, which in combination with it, causes the injury].” 3. See People v. Ehlert, 274 Ill.App.3d 1026, 654 N.E.2d 705 (1995) and People v. Caldwell, 295 Ill.App.3d 172, 692 N.E.2d 448 (1998) for lengthy causal relation issues in two homicide cases. The Ehlert case focuses on whether a baby was born alive and the Caldwell case where an elderly releative in the hospital, as a result of defendant’s assault, decides to remove a respirator and dies. The “facilitation” reality of causal relation is clearly seen in these two fascinating decisions. 4. See, People v. Martin, 266 Ill.App.3d 369, 640 N.E.2d 638 (Ill.App.4th 1994), where the court noted that although the Illinois Criminal Pattern Jury Instruction Committee took no position on the propriety of using IPI–Civil Instruction 15.01, the committee did note that, as a general proposition, courts have treated the concepts of legal causation in criminal cases and tort cases in a similar manner. 5. See generally, William Twining, Theories of Evidence: Bentham & Wigmore (Stanford University Press, 1985).


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6. Some of the many classic statements of the causation issue in American law, still relevant to the new issues that will be raised in genetic-based products cases, are Green, Rationale of Proximate Cause (Rothman Reprints, 1927); Hart and Honore, Causation in the Law, 2d ed. (Oxford, 1985); Leon Green, “The Causal Relation Issue in Negligence Law,” 60 Mich. L. Rev. at 543 (1962) and Wex Malone, “Ruminations on Cause-In-fact,” 9 Stanford L. Rev. 60 (1956). 7. Nicholas St. John Green, “Proximate and Remote Cause” (1870), Essays and Notes on the Law of Torts and Crime (Menasha, Wis. George Banta, 1933), 13,15. 8. Green: Rationale of Proximate Cause (Rothman Reprints, 1927), at 132–133. 9. Leon Green, “The Duty Problem in Negligence Cases,” 28 Colum. L. Rev. 1014, 1018 (1928). 10. T. Kiely, “The Art of the Neglected Obvious In Products Liability Cases: Some Thoughts On Llewellyn’s The Common Law Tradition,” 25 DePaul L. Rev., 914, 921 (1975). 11. Holmes: The Common Law (1881, Dover reprint, 1991) at 5. 12. See Perkins v. Texas and New Orleans Ry. Co., 243 La. 829, 147 So. 2d 646 (1962). 13. See Reynolds v. Texas & Pac. Ry. Co., 37 La.Ann.694 (1885). 14. See Kramer Services, Inc. v. Wilkins, 184 Miss.483, 186 So.2d 625 (1939). 15. See Kirincich v. Standard Dredging Co., 112 F.2d 163 (3rd Cir. 1940). 16. See Coburn v. Lenox Homes Inc., 186 Conn.370, 441 A.2d 620 (1982). 17. 774 So.2d 208 (La.App.3.Cir. 2000). 18. Nunez, at 217. 19. 761 A.2d 477 (Sp.Ct.N.H. 2000). 20. The crash worthiness doctrine “extends the scope of liability of a manufacturer to the situations in which the construction or design of its product has caused separate or enhanced injuries in the course of an initial accident brought about by an independent cause.” Bass v. General Motors Corp., 150 F.3d 842, 847 (8th Cir.1998). 21. See, e.g., Mabry v. County of Cook and Cook County Hospital, 733 N.E.2d 737 (Illinois 2000). Doctor violated standard of care by not performing a proper DD on patient. Physician expert testified that there is a sort of “spiral of failure” to diagnose a problem, and each doctor went along in that spiral by assuming that her underlying problem was asthma and never pursuing any other diagnostic possibilities. Tsoukas v. Lapid, 733 N.E.2d 823 (Illinois 2000). Based upon expert’s differential diagnosis, plaintiff had had a total occlusion of the artery to the leg and foot resulting in gangrene. The testimony by the treating emergency room physicians who misdiagnosed revealed that their misdiagnosis was based solely upon plaintiff ’s medical history; Williams v. Patel, 104 F.Supp.2d 984 (Illinois 2000). Physician expert testified that the



22. 23.

24. 25. 26. 27.

28.

29.

30.

31. 32. 33.

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standard of care at least requires the general practitioner to perform a DD as to what may cause the blurring vision and at the very least make a referral. R. Wade Marionneaux and Voris E. Johnson, Jr., “Differential Diagnosis: The Next Daubert Frontier,” 15 No. 6 Mealey’s Litigation Reports, Apr. 2000. Reference Manual on Scientific Evidence, 2d ed., Mary Sue Henifan, Howard M. Kipen, and Susan R. Poulter, Reference Guide on Medical Testimony, at 443–444 (Federal Judicial Center, 2000). See Anderson v. Quality Stores, Inc., 181 F.3d 86 (4thCir. 1999). A properly performed differential diagnosis coupled with a compelling temporal relationship, without any further hard scientific evidence of general causation, renders an expert’s opinions reliable. 229 F.3d 1202 U.S.Ct.App. 2000). OA generally refers to any asthmatic condition caused by exposure to sensitizing agents in the workplace. 229 F.3d 1206. Both Kidde-Fenwal and Ansul extinguishers are composed primarily of baking soda, and neither contained NH4H2PO4. The Ansul MSDS listed NH4H2PO4 under “Physical Hazards” (agents that are incompatible with the fire extinguisher’s ingredients). Dr. Hof apparently misread the Ansul MSDS and concluded that NH4H2PO4 was an ingredient, rather than a hazardous combinant. Only when Dr. Hof was confronted with the mistake during his deposition did he conclude that exposure to baking soda could cause respiratory problems. Id. at 1207. The district court had concluded that Dr. Hof ’s causation opinion did not satisfy Daubert ‘s standards of scientific reliability, and granted the motion to strike the opinion. Since no other evidence established a causal connection between the extinguisher exposure and Delores Turner’s injuries, the court granted summary judgment and dismissed all of the Turners’ claims. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S.137, 151, 119 S.Ct.1167, 143 L.Ed.2d 238 (1999) (holding that Daubert applies even when an expert’s opinion relies on skill- or experience-based observation). See, e.g., Westberry v. Gislaved Gummi AB, 178 F.3d257, 262–63 (4th Cir. 1999) (collecting cases). But also see Moore v. Ashland Chem., Inc., 151 F.3d 269, 277–79 (5th Cir.1998) (en banc), cert. denied, 526 U.S. 1064, 119 S.Ct. 1454, 143 L.Ed.2d 541 (1999) (concluding that the district court did not abuse its discretion in excluding causation opinion based on differential diagnosis). Turner, at 229 F.3d 1208. Id. Citing Heller v. Shaw Indus., Inc., 167 F.3d 146, 155 (3rd *1209 Cir.1999). Also see Westberry, 178 F.3d at 262 (a reliable differential diagnosis alone provides valid foundation for a causation opinion, even when no epidemiological studies, peer-reviewed published studies, animal studies, or laboratory data are offered in support of the opinion).


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34. Turner, at 1209. 35. See, e.g., Willert v. Ortho Pharm. Corp., 995 F.Supp. 979, 981 (D.Minn.1998); Casey v. Ohio Med. Prod., 877 F.Supp. 1380, 1385 (N.D.Cal.1995); Schmaltz v. Norfolk & Western Ry. Co., 878 F.Supp. 1119, 1122 (N.D.Ill.1995). 36. Wynacht v. Beckman Instruments, 113 F.Supp.2d 1205 (E.D. Tenn. 2000). 37. These ailments included, toxic encephalopathy, impaired detoxification, adrenal insufficiency, pancreatic enzyme deficiency, reactive airways disease, angina, immune deficiency characterized by decreased secretory IgA, nutritional deficiencies, impairment of energy metabolism, impairment of neurotransmitter metabolism, neurogenic inflammation of the respiratory system, neurogenic inflammation affecting the bladder, recurrent urinary tract infections, changes in lipid composition of cell membranes, arrythmias, chronic fatigue syndrome, fibromyalgia, and heightened sensitivity. 38. Wynacht, at 1209. 39. Id. 40. Id. 41. Wynacht, at 1209–10. 42. Citing, See David L. Eaton and Curtis D. Klaassen, “Principles of Toxicology,” in Casarett and Doull’s Toxicology: The Basic Science of Poisons 13, (5th ed., Curtis D. Klaassen, 1996) (hereinafter Casarett and Doull’s Toxicology); Frank C. Lu, Basic Toxicology: Fundamentals, Target Organs, and Risk Assessment, 3–9 (2d ed., Taylor & Francis, 1991). Research in this field includes inquiries into the effects of chemicals on the occupational environment, see Robert R. Lauwerys, “Occupational Toxicology,” in Casarett and Doull’s Toxicology, 987–1007, as well as studies of the effects of the interactions of several chemicals, see Edward J. Calabrese, Multiple Chemical Interactions, 21–91 (Lewis Publishers, 1991). 43. See, e.g., Bernard D. Goldstein and Mary Sue Henifin, Reference Guide on Toxicology, in Federal Judicial Center Reference Manual on Scientific Evidence 181, 201–12 (1994); Clifton T. Hutchinson and Lee Davis Thames, “Guide to Toxicology,” in Expert Evidence: A Practitioner’s Guide to Law, Science, and the FJC Manual 117, 123–38 (Bert Black and Patrick W. Lee eds., 1997). 44. Wynacht, at 1211. 45. Goeb v. Tharaldson, 615 N.W.2d 800 (Sp.Ct.Minn. 2000). 46. In April 1994, appellants amended their complaint for the first time to add Dow as a defendant, and add claims for negligent manufacture, marketing, and sale, and failure to provide adequate warnings and instructions for use. The complaint was amended a second time in June 1994 to add a claim for misrepresentations by Dow. Dow moved for partial summary judgment, arguing that claims regarding warnings and label instructions were preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 (1994), which requires manufacturers to register pesticides with the U.S. Environmental Protection Agency (EPA) and subjects them to



47. 48. 49.

50. 51.

52. 53. 54. 55. 56. 57. 58. 59.

60.

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specific regulations regarding the labeling and packaging of pesticides. Goeb, at 803. Goeb, at 806. Goeb, at 807 Dow’s experts explained that the generally accepted methodology to determine a cause and effect relationship between chemical exposure and illness involves a four-step process: (1) identification of the substance at issue and the duration and levels of exposure; (2) determination of the dose of the exposure received by the person; (3) analysis of relevant scientific and medical literature for valid proof of a causal relationship between a dose and a medical condition (dose–response); and (4) a differential diagnosis to rule out other possible causes. Id. at 808 Goeb, at 816. See, In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 762 (3rd Cir.1994) (excluding expert opinions as to whether illnesses were caused by PCB exposure that were based “solely on the plaintiff ’s self-report of illness in preparation for litigation,” when not confirmed by medical records or examinations, as unreliable). Goeb, at 816. 432 Mass. 304, 733 N.E.2d 1042 (Mass.Sp.Ct. 2000) . Id. at 305–306. Id. at 306. Id. at 307. Shapin and Schaffer, Leviathan and the Air Pump (Princeton, 1985) at 23. 432 Mass.304, 311–12. “That a person qualifies as an expert does not endow his testimony with magic qualities.” Boston Gas Co. v. Assessors of Boston, 334 Mass.549, 579, 137 N.E.2d 462 (1956). Also see, Mattis v. General Electrical Products, 114 F.Supp.2d 888 (Dist.Ct.D. South Dakota Sept. 2000), a products liability action against the manufacturer of polyvinyl chloride (PVC) cement to recover for reactive airways dysfunction syndrome (RADS) he allegedly acquired as result of his exposure to cement vapors. The court ruled that an expert’s opinions that plaintiff ’s RADS was caused by his exposure to vapors constituted admissible scientific knowledge and the court denied defendant’s motion for summary judgment. The court stated that although there was an analytical gap between the clinical studies of RADS and the particular solvents in the instant case which allegedly caused the condition, it was not fatal to the opinions of the experts. The gap between clinical cases of RADS and this particular cement was bridged by the testimony of the defendant’s own witness, who admitted that in high enough concentrations the solvents in the cement can cause RADS as evidenced in the Brooks study and heard from the plaintiff ’s experts.


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61. Also see, Michael B. Kent, Jr., “Daubert, Doctors and Differential Diagnosis: Treating Medical Causation Testimony as Evidence,” 66 Def. Couns. J. 525 (Oct. 1999); “Differential Diagnosis Sufficient Basis For Expert Opinion,” 8 (5) Mealey’s Emerging Toxic Torts 14 (June 1999), at 4; “Opinion Based on Differential Diagnosis is Reliable,” 4th Cir. Rules, 8 (6) Mealey’s Emerging Toxic Torts 25 (June 1999); “4th Cir. Lets Doctor Pass Daubert Test With Only Differential Diagnosis,” 21 (10) Andrews Asbestos Litigation Reporter 5 (June 1999). See also, Mattis v. General Electrical Products, 2000 WL 1473447 (Dist. Ct. D. South Dakota Sept. 2000), expert’s opinions that plaintiff ’s reactive airways dysfunction syndrome (RADS) was caused by his exposure to vapors constituted admissible scientific knowledge; Hannan v. Pest Control Services, Inc., 734 N.E.2d 674 (Indiana 2000), plaintiff ’s physician experts’ testimony were properly excluded since none of them performed any testing that would rule out alternative causes of the ailments. Differential diagnosis testing is important to rule out potential causes; Cox v. Depuy Motech, 2000 WL 1160486 (S.D.Cal.), Product liability case involving spinal implantation devices. Neither of the plaintiff ’s experts provided a sufficient methodology to establish causation nor performed a differential diagnosis to rule out other possible causes. 62. In Reference Manual on Scientific Evidence, 2d ed., (Federal Judicial Center, 2000), see David H. Kaye and David A. Freedman, “Reference Guide on Statistics,” at 83; Daniel L. Rubinfeld, “Reference Guide on Multiple Regression,” at 179; Shari Seidman Diamond, “Reference Guide on Survey Research,” at 229; Robert E. Hall and Victoria A. Lazear, “Reference Guide on Estimation of Economic Lossses in Damages,” at 277. These excellent chapters are required reading for all lawyers engaged in products liability, toxic tort or medical malpractice cases in state or federal courts. 63. In Reference Manual on Scientific Evidence, 2nd ed. (FJC, 2000), see Michael D. Green, D. Mical Freedman and Leon Gordis, “Reference Guide on Epidemiology,” at 333; Bernard D. Goldstein and Mary Sue Henifin, “Reference Guide on Toxicology,” at 401; Mary Sue Henifin, Howard M. Kipen and Susan Poulter, “Reference Guide on Medical Testimony,” at 439; David H. Kay and George F. Sensabaugh, Jr., “Reference Guide on DNA Evidence,” at 485. These excellent chapters are also required reading for all lawyers engaged in products liability, toxic tort or medical malpractice cases in state or federal courts. 64. See, e.g., “Mass Torts Problems and Prosposals: a Report to the Mass Torts Working Group,” 187 F.R.D. 328, 368+ (1999); “The Mechanics of Motion Practice Before the Judicial Panel on Multidistrict Litigation,” 175 F.R.D. 589, 589+ (1998); “Aggregated Claims — Bellwether Trial — Selection of Sample Cases,” 12 (6) Fed. Litigator 174, 175+ (1997); “The Judicial Coordination of Drug and Device Litigation: a Review and Critique,” 54 Food and Drug L.J. 325, 345+ (1999); “How Many Times Must the Question Be Answered? The Application of the Learned Intermediary Doctrine in the Norplant Contraceptive Products Liability Litigation,” 30 Golden Gate U.L.Rev. 331, 377+



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(2000); “The Limits of Sampling and Consolidation in Mass Tort Trials: Justice Improved or Justice Altered?” 22 Law and Psychol. Rev. 43, 66 (1998); “Too Many Probabilities: Statistical Evidence of Tort Causation,” 64 Law and Contemp. Probs. 191, 212+ (2001); “Ethical Constraints on Aggregated Settlements of Mass-Tort Cases,” 31 Loy. L.A.L. Rev. 395, 408 (1998); “Class Certification and Mass Torts: Are ‘Immature’ Tort Claims Appropriate for Class Action Treatment?” 29 Seton Hall L. Rev. 213, 234+ (1998); “Building a Better Mousetrap? A New Approach to Trying Mass Tort Cases,” 29 Tex. Tech L. Rev. 779, 810+ (1998); “Beyond Maturity: Mass Tort Case Management in the Manual for Complex Litigation,” 148 U.Pa.L.Rev. 2225, 2261+ (2000); “Mass Lawsuits and the Aggregate Settlement Rule,” 32 Wake Forest L. Rev. 733, 780 (1997); “Utilizing Statistics and Bellwether Trials in Mass Torts: What Do the Constitution and Federal Rules of Civil Procedure Permit?” 8 Wm. and Mary Bill Rts. J. 199, 216+ (1999); “Toxic Tort Litigation at the Millennium,” SD67 ALI-ABA 35, 100+ (1999). 65. John M. Kobayashi, “Killing Them Softy with Your Song: Problems with Proof of Causal Relationship by Statistical Methods and Probability Theory and Expert Opinions with Suggested Methods for Analysis and Cross-examination, and Notes about Epidemiological Studies and Animal Data as Causation Evidence,” 363 PLI/Lit 37 (1988), “Practising Law Institute, Litigation and Administrative Practice Course Handbook Series,” Litigation, November 1, 1988, “Preparation and Trial of a Toxic Tort Case,” 1988. 66. See, Steven Glickstein, “Statistical Extrapolations and ‘Bellwether’ Trials,” 17 Prod. Liab. L. and Strategy 1(4) (1998), for an excellent summary discussion of these issues. 67. On the difficulty of using extrapolation theory in the context of bellwether cases, see In re Fibreboard Corp., 893 F.2d 706, 709 (5th Cir. 1990), trial court constructed a three-phase trial of close to 3000 asbestos cases. The order resulted in the trial of 41 plaintiffs’ cases considered to be statistically similar, with the results to be extrapolated to all 3000 plaintiff cases. The Fifth Circuit reversed, that defendants’ due process rights denied by the procedure, since state law required that a plaintiff prove both causation and damages, requirements not able to be met when the trial focus was on groups of statistically grouped cases; Cimino v. Raymark Industries Inc., 151 F.3d 297(5th Cir. 1998), ruling that extrapolated the trial results in 160 “sample” asbestos cases to 2128 other asbestos cases that were not tried, reversed; In re Chevron U.S.A. Inc., 109 F.3d 1016 (5th Cir. 1997), judgment establishing defendant’s liability for 3000 cases on the basis of a trial involving only 30 claimants — 15 selected by the plaintiffs and 15 selected by the defendant, reversed on basis that the 30 cases selected for trial were not truly representative of the group of 3000 claimants. But see, Hilao v. Estate of Marcos, 103 F.3d 767 (9th Cir. 1996), [class action on behalf of 10000 Philippine nationals killed, kidnaped or tortured by Philippine President Ferdinand Marcos. The court accepted the


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68. 69.

70. 71. 72. 73. 74. 75.

76.

77.

78. 79.

Science and Litigation: Products Liability in Theory and Practice argument that statistical sampling had been appropriately employed and approved the use of extrapolation to determine the number of valid and invalid claims, while not addressing whether extrapolation to determine aggregate damages was permissible. 109 F.3d 1016 (5th Cir.Ct.App. 1997). Various developers filled these waste pits without remediating the land. Plaintiffs claimed that the hazardous substances which were stored in the waste pits had migrated into the environment, including the drinking water supply for the Kennedy Heights section. As a result, plaintiffs claimed personal injuries and property damage. Subsequent to the federal suit being filed, Chevron removed the state court cause of action to federal court, which was consolidated into this case. See Manual for Complex Litigation 33.27–.28 (3d ed., Federal Judicial Center, 1995). In re Chevron, at 1018. In re Chevron, at 1019 Id. Id. In re Chevron, at 1019–20. On the acceptability of the use of inferential statistics in a variety of settings, see, e.g., Castaneda v. Partida, 430 U.S.482, 97 S.Ct.1272, 51 L.Ed.2d 498 (1977), using statistical data to prove discrimination in jury selection; Capaci v. Katz and Besthoff, Inc., 711 F.2d 647, 653–57 (5th Cir. 1983), using census data in gender discrimination case; Exxon Corp. v. Texas Motor Exchange, Inc., 628 F.2d 500 (5th Cir.1980), using statistical sampling in trademark infringement suit; Ageloff v. Delta Airlines, Inc., 860 F.2d 379 (11th Cir. 1988), using evidence of life-expectancy tables to determine damages; G.M. Brod and Co., Inc. v. U.S. Home Corp., 759 F.2d 1526, 1538–40 (11th Cir. 1985), using expert testimony as to profit projections based on industry norms; United States v. 449 Cases Containing Tomato Paste, 212 F.2d 567 (2nd Cir.1954), approving inspector’s testing of samples, rather than requiring the opening of all cases. The court cited the Ninth Circuit, “[i]nferential statistics with random sampling produces an acceptable due process solution to the troublesome area of mass tort litigation.” In re Estate of Marcos Human Rights Litigation, 910 F.Supp.1460, 1467 (D. Haw.1995), aff ’d. sub. nom. Hilao v. Estate of Marcos, 103 F.3d 767 (9th Cir. 1996), holding that the random sampling procedures used by the district court do not violate due process. Id. at 1020. See Michael J. Saks and Peter David Blanck, “Justice Improved: The Unrecognized Benefits of Aggregation and Sampling in Mass Torts,” 44 Stan. L.Rev. 815 (1992). In re Chevron, at 1020. Cimino v. Raymark Industries, 151 F.3d 297 (5th Cir.Ct.App. 1998).



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80. This was the same set of cases addressed in In re Fibreboard, 893 F.2d706 (5th Cir.1990), but the judgments now before the court resulted from a trial plan modified following that decision. 81. Cimino at 318. 82. 286 Ill.App.3d 1005, 677 N.E.2d 999 (1997). 83. The infant Lindsay was born on December 2, 1983, with multiple birth defects, including mental retardation; hearing, speech, and vision impairments; developmental delay; and facial dysmorphic features (i.e., bilateral blepharophimosis and unilateral nystagmus). Ellen, the mother, had previously given birth to two other children who had birth defects. 84. Much of the actual laboratory data is in the form of proprietary studies never released to the public, which data is often considerably less than required by the FDA or other federal agency whose marketing approval is necessary. All too often in this new century we have also seen the baneful influence of the manufacturers themselves in sponsoring scientific studies without attribution to themselves or the publication in leading medical or science peer-reviewed journals of basically ghost-written publications signed by academics eager to receive research grants. See, Chapter 3, Science and Peer-Review. Also see discussions in Chapter 5, Science and Pretrial Research, and Chapter 9, Science and Pretrial Discovery. 85. Duran, at 1007. 86. The remainder of each essay consisted of general descriptions of 43 different studies identified by the author’s last name and the year the study appeared in print. Some of the types of birth defects identified by the various studies included central nervous system defects, including memingomyelocele or hydrocephalus; anencephaly; spina bifida; neural tube defects; neurological disorders; cardiovascular defects; cardiac anomalies; VACTEL syndrome (vertebral, anal, cardiac, tracheal, esophagal, and limb defects), osseous abnormalities; micrognathia; cleft palate; and dysmorphic features, including growth retardation, mental retardation, peculiar facies, umbilical eversion, sacral pit, and hypospadias (Lorber study). The essay concluded by additionally noting that animal studies indicated that oral contraceptives have significant teratogenic potential. Duran, at 1002 . 87. Teratology is the branch of medicine and of developmental biology which deals with congenital defects and abnormal formations (New Shorter Oxford English Dictionary, Oxford). 88. Duran, at 1009. 89. Duran, at 1010. 90. Id. 91. Also see, In Ferebee v. Chevron Chemical Co., 736 F.2d 1529, 1534 (D.C.Cir.1984), where the court dealt with an issue on the “frontier of current medical and epidemiological inquiry,” whether paraquat exposure caused


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92. 93. 94. 95. 96.

97.

98.

99. 100. 101. 102.

Science and Litigation: Products Liability in Theory and Practice pulmonary fibrosis. The court concluded that the plaintiffs’ expert was properly allowed to offer his opinion on causation. The court noted: “[A] causeeffect relationship need not be clearly established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound, … [the] law does not preclude recovery until a ‘statistically significant’ number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical” (Ferebee, 736 F.2d at 1535–36). But see, Harris v. Cropmate Company, 706 N.E.2d 55, 67 (Ill. App. Ct 4th 1999), where farm operators who suffered damage to their crops sued company which had sprayed herbicide on adjacent tract of property, and its employee, alleging that negligent spraying of herbicide containing 2,4-D had caused damage. The court concluded that the causation testimony did not constitute “scientific” evidence where the experts reached their conclusions that exposure to 2,4-D had caused the injuries to the crops by combining their generalized knowledge of agriculture, including crops and weeds, their firsthand experience with and observations of the effects of exposure to 2,4-D upon cucurbits, and the type of deductive process that was common to everyone. 313 Ill.App.3d 1061, 730 N.E.2d 68 (2000). Donaldson, at 1067–68. Donaldson, at 1075. See, Duran, 286 Ill.App.3d at 1013, 222 Ill.Dec. 465, 677 N.E.2d at 1004. Donaldson, at 1076. See, McKenzie v. S K Hand Tool Corp., 272 Ill.App.3d 1, 8, 208 Ill.Dec. 918, 650 N.E.2d 612, 617 (1995); see Holton v. Memorial Hospital, 176 Ill.2d 95, 108, 223 Ill.Dec. 429, 679 N.E.2d 1202, 1211 (1997). See Quaker Oats Co. v. Industrial Comm’n, 414 Ill. 326, 111 N.E.2d 351 (1953); Mechanics Universal Joint Division, Borg-Warner Corp. v. Industrial Comm’n, 21 Ill.2d 535, 173 N.E.2d 479 (1961); U.S. Steel Corp. v. Industrial Comm’n, 32 Ill.2d 68, 203 N.E.2d 569 (1964); National Castings Division of MidlandRoss Corp. v. Industrial Comm’n, 55 Ill.2d 198, 302 N.E.2d 330 (1973); Dixon v. Industrial Comm’n, 60 Ill.2d 126, 324 N.E.2d 393 (1975). See Robinson v. Chicago Transit Authority, 69 Ill.App.3d 1003, 26 Ill.Dec. 539, 388 N.E.2d 163 (1979); Swartz v. Sears, Roebuck and Co., 264 Ill.App.3d 254, 201 Ill.Dec. 210, 636 N.E.2d 642 (1993). 736 F.2d 1529 (D.C.Cir.1984). See Ferebee, 736 F.2d at 1535. Ferebee, 736 F.2d at 1535–36. Cited in Donaldson at 1077. Donaldson, at 1078. “Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define.



103. 104. 105. 106. 107.

108.

109. 110.

111.

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Somewhere in this twilight zone the evidential force of the principle must be recognized.” Frye v. United States, 293 F. at 1014. See La Salle National Bank v. Malik, 302 Ill.App.3d 236, 240–43, 235 Ill.Dec. 755, 705 N.E.2d 938, 941–43 (1999). Donaldson at 1079. 748 So.2d 1108 (Fla.App. 2000). Id. at 1120. Toxicology classically is known as the science of poisons. A modern definition is the study of the adverse effects of chemicals on living organisms. “Although it is a very old science, it has only fairly recently become a discipline distinct from pharmacology, biochemistry, cell biology, and related fields.” See, Bernard D. Goldstein and Mary Sue Henifin, “Reference Guide on Toxicology,” Reference Manual on Scientific Evidence 2nd ed., 401 (Federal Judicial Center, 2000). This is the division of causation into general and specific causation rejected in the Donaldson case discussed above. This artificial distinction is often argued and accepted as working principles in products cases centering in a basic actual cause/cause-in-fact issue. Castillo at 1116. Castillo at 1116–17. Rats, the court observed, considered the least appropriate mammalian test species, were nonetheless used in 90% of long-term animal bioessays due to pragmatic concerns such as availability, size, cost ($3.50–30.00 as compared to up to $10,000 for a pregnant primate), short lifespan and lack of a vomiting-reflex. Citing, Jack L. Landau and W. Hugh O’Riordan, “Of Mice and Men: The Admissibility of Animal Studies to Prove Causation in Toxic Torts Litigation,” 25 Idaho L.Rev. 521, 532–49 (1988); Michael D. Green, “Expert Witnesses and Sufficiency of Evidence in Toxic Substance Litigation: The Legacy of Agent Orange and Bendectin Litigation,” 86 NW. U.L.Rev. 643, 654–57 (1992). See, Bernard D. Goldstein and Mary Sue Henifin, “Reference Guide on Toxicology,” Reference Manual on Scientific Evidence (2nd ed.), 410 (Federal Judicial Center, 2000), “Extrapolation from Animal and Cell Research to Humans.” The court noted the initial and ongoing importance of the causation decisions in the famous case of In re “Agent Orange” Prod. Liab. Litig., 611 F.Supp.1223 (E.D.N.Y.1985), affirmed on other grounds, 818 F.2d 187 (2d Cir.1987), where the trial judge entered summary judgment against several plaintiffs based on the conclusion that affidavits submitted by their experts failed to present credible evidence of causation: “[L]aboratory animal studies … are generally viewed with more suspicion than epidemiological studies, because they require making the assumption that chemicals behave similarly in different species.” Dr. Silbergeld further notes that “[a]nimal studies are aimed at discovering a dose–response relationship, while epidemiological


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studies show an association between exposure and disease.” Id. at 1241 (quoting Hall and Silbergeld, “Reappraising Epidemiology: A Response to Mr. Dore,” 7 Harv. Envtl.L.Rev. 441–43 (1983) (citation omitted). 112. Castillo, at 1118. The court cited numerous decisions supporting that finding. See, e.g., Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194 (5th Cir.1996); Brock, 874 F.2d at 315, “Assuredly, one day in the future, medical science may have a clearer understanding of the mechanics of tissue development in the fetus. However, that is not the case today, and speculation unconfirmed by epidemiologic proof cannot form the basis for causation in a court of law;” Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 832 (D.C.Cir.1988), “Bendectin … has been extensively studied and a wealth of published epidemiological data has been amassed, none of which has concluded that the drug is teratogenic. Uniquely to this case, the law now has the benefit of twenty years of scientific study, and the published results must be given their just due;” Lynch v. Merrell-National Labs., Div. of Richardson-Merrell, Inc., 830 F.2d 1190 (1st Cir.1987); Wade-Greaux v. Whitehall Labs., Inc., 874 F.Supp.1441, 1451 (D.Vi.1994), “Regardless of the particular articulation of the teratology community’s methodology, positive human epidemiologic studies are always required to reach a conclusion as to whether a specific agent is teratogenic in humans;” Cadarian v. Merrell Dow Pharms., Inc., 745 F.Supp.409, 412 (E.D.Mich.1989), “in vivo and in vitro animal studies … are insufficient to prove causation in human beings in the absence of confirmatory epidemiological evidence.” 113. Id. 114. Castillo at 1120. Also see, Rodriquez v. Feinstein, 2001 WL 830630 (Fla.App. 3 Dist. 2001), where a patient and child brought a medical malpractice action against a doctor alleging failure to warn that the patient not become pregnant while taking medication. The court engaged in an extensive causation discussion involving the full range of related topics such as animal studies and extrapolation theory. See also, Heller v. Shaw Industries, 167 F.3d 146 (3rd Cir. 1999), where a homeowner who suffered respiratory illnesses after a carpet was installed in her home sued carpet manufacturer for breach of warranty, failure to warn, negligent and intentional misrepresentation, defective design, and violations of state consumer protection laws. The Court of Appeals ruled that the evidence did not support doctor’s reliance on temporal relationship between the onset of the illness and the carpet installation and that the exclusion of the doctor’s testimony that volatile organic compounds (VOCs) emitted by carpet caused homeowner’s illness was not abuse of discretion. The court expressed no opinion as to whether extrapolation back in time, using known levels of compounds and a scientifically valid mathematical formula for the extrapolation, would meet the standards of Rule 702 and Daubert. 115. Havner at 953, S.W.2d at 727–28.



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116. See Ruiz-Troche v. Pepsi Cola of P.R. Bottling Co., 161 F.3d 77, 85 (1st Cir.1998), approving a back-extrapolation and half-life methodology that “has been subjected to, and survived, the rigors of testing, publication, and peer review, and … appears to have won significant (if not universal) acceptance within the scientific community.” Here, the court concluded, however, that it is clear that plaintiff ’s expert’s formula for his extrapolation was based on speculation and estimation that was subject to gross error. 117. On the use of retrograde extrapolation in criminal DUI cases, see State v. Daniel, 132 Idaho 701, 979 P. 2d 103 (Sp. Ct. Idaho). Also see, Mark J. Reasor, Mark R. Montgomery, “Driving under the Influence: Is Retrograde Extrapolation of Blood Alcohol Scientifically Valid?” 9-FEB W. Va. Law. 14 (1996); Nicholas Bostic, “Alcohol-related Offenses: Retrograde Extrapolation after Wager,” 79 Mich. B.J. 668 (2000). For informative discussions of the place of statistics in a wide variety of cause-related legal issues, see, Fred S. McChesney, “Statistics: the Language of Science (Part I),” 9-FALL Kan. J.L. and Pub.Pol’y 75 (1999); Fred S. McChesney, “Statistics: the Language of Science (Part II),” 9-FALL Kan. J.L. and Pub.Pol’y 49 (1999); D.H. Kaye, “Statistical Decision Theory and the Burden of Persuasion: Completeness, Generality, and Utility, International Journal of Evidence and Proof,” Vol. 1, 1997, pp. 313–15. 118. See, e.g., People v. Ehlert, 274 Ill.App.3d 1026, 654 N.E. 2d 705 (1995); People v. Nathaniel Caldwell, 295 Illl. App. 3d 172, 692 N.E. 2d 448 (1998). Also see People v. Mark Martin, 266 Ill.App.3d 369, 640 N.E. 2d 638 (1994), for interesting discussion of the basic identity of proximate cause verbal formulas in civil and criminal cases. 119. See Glastetter v. Novartis Pharmaceuticals Corporation, 252 F.3d 986, 988 (U.S.Ct. App 8th Cir. 2001). In 1980 the drug was approved for use to suppress postpartum lactation. Approximately 9 million women in the United States have taken the drug to suppress postpartum lactation. 120. See, 59 Fed.Reg. 43,347 (Aug. 23, 1994). The FDA later revoked its approval of Parlodel after Novartis waived a formal hearing. Courts use the terms “bromocriptine” and “Parlodel” interchangeably in the cases. 121. 131 F.Supp.2d 1347 (N.D. Georgia 2001). For additional cases providing extensive actual or general causation discussions, see, Kuhn v. Sandoz Pharmaceuticals, 270 Kan. 443, 14 P. 3d 1170 (Sp.Ct.Kan. 2000); Brumbaugh v. Sandoz Pharmaceuticals Corp., 77 F.Supp.2d 1153 (D. Ct. Montana 1999); Willert v. Ortho Pharmaceuticals Corp. 995 F.Supp. 979 (D.Ct. Minn. 1998). Especially see, Warren v. Sandoz Pharmaceuticals Corp., 783 So. 2d 735 (Ct.App.MO. 2000), alleging discovery abuses by Sandoz. The case contains an interesting colloquy between judge and counsel on the discovery problems inherent in extensive multi-state filings as exist in the national Parlodel litigation. Also see, Globetti v. Sandoz Pharmaceuticals Corp., 111 F.Supp.2d 1174 (U.S.D.Ct.Al 2000).


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122. The other patient was Bonnie Joyce Rider, whose action was consolidated with Siharath. Both cases were discussed under the Siharath title. 123. Siharath, 131 F. Supp. at 1349. 124. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S.579, 594, 113 S.Ct.2786, 125 L.Ed.2d 469 (1993). 125. Dr. Kenneth Kulig was a physician who is board certified in toxicology and emergency medicine, Dr. Dennis Petro was a board-certified neurologist, Dr. Subir Roy was a reproductive endocrinologist who served as a professor in the Department of Obstetrics and Gynecology at the University of Southern California (USC) School of Medicine, Dr. Anthony Guarino was a pharmacologist and toxicologist, Dr. Maurice N.G. Dukes testified that he was an “adverse drug reaction scientist.” While there was no board certification for such a discipline, Dr. Dukes had extensive years long experience as a researcher for pharmaceutical manufacturers. 126. Siharath at 1334–35. The court noted that the “vascular tone” of plaintiffs’ cerebral arteries at the time of their strokes was completely unknown. 127. See In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 745 (3d Cir.1994), “Daubert’s requirement that the expert testify to scientific knowledge — conclusions supported for good grounds for each step of the analysis — means that any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony unreliable.” [emphasis in original]; Allison v. McGhan Med. Corp., 184 F.3d 1300, 1314 (11th Cir.1999), “Daubert decisions in other courts warn against leaping from an accepted scientific premise to an unsupported one.” 128. Citing Bailey, et al., “Reference Guide on Epidemiology,” Reference Manual on Scientific Evidence, 340–45(Federal Judicial Center, 2000). In epidemiological terms, the court noted, the difference in risk of getting the disease was the “relative risk.” A relative risk of 1.0 meant that the agent has no effect on the incidence of disease. When the relative risk reached 2.0, the agent was responsible for an equal number of cases of disease as all other background causes. A relative risk of 2.0 implied a 50% likelihood that an exposed individual’s disease was caused by the agent in question. See, e.g., Hall v. Baxter Healthcare Corp., 947 F.Supp.1387, 1403 (D.Or.1996); Reference Manual, at 348–49. Thus, in the world of epidemiology, the threshold for concluding that an agent was more likely than not the cause of a disease is a relative risk greater than 2.0. Siharath, at 1356. 129. See, Kenneth Rothman, An Epidemiologic Evaluation of the Possible Relation Between Bromocriptine, Puerperal Seizures and Strokes (Epidemiologic Resources, 1988); HCIA Inc., Postpartum Complications and Parlodel (R) (October 1995); R.M.C. Herings and B.H.C. “Stricker, Bromocriptine and Suppression of Postpartum Lactation,” Pharmacy World and Sci. 17: 133–37 (1995); Andrea D. Witlin, et al., “Postpartum Stroke: A Twenty-Year Experience.” This study was accepted for publication by the American Journal of



130.

131.

132. 133.

134.

135. 136. 137.

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Obstetrics and Gynecology, but the offer was later withdrawn. The study, however, has been subjected to some peer review. Siharath v. Sandoz Pharmaceuticals Corp., 131 F.Supp. at 1358. No evidence had been offered of an increase in postpartum strokes after the drug was approved for suppression of lactation and no evidence had demonstrated a decrease in postpartum strokes after the approval for suppression of lactation was withdrawn. Also see Glastetter v. Novartis Pharmaceutials Corp., 107 F.Supp.2d 1015, 1044 (E.D.Mo.2000), “In the absence of their own epidemiological evidence supporting the conclusions of their experts that Parlodel can cause an ICH (intracranial hemmorrhage), the best plaintiffs can do is attack defendant’s studies;” Brumbaugh v. Sandoz Pharmaceutical Corp., 77 F.Supp.2d 1153, 1156 (D.Mont.1999), “The plaintiff criticizes certain aspects of these studies, but she produced no epidemiological study, or other reliable scientific proof that does make the causal link between Parlodel and her condition, or any related condition. Plaintiff ’s lawyers attack on defendant’s studies does not meet the law’s requirements. She must come forward with reliable scientific evidence of her own to defeat a summary judgment motion when her case is based on the expert’s proof.” 111 F.Supp.2d 1174, 1180 (N.D.Ala.2000). “Opinions of any kind are derived from individual pieces of evidence, each of which by itself might not be conclusive, but when reviewed in its entirety are the building blocks of a perfectly reasonable conclusion, one reliable enough to be submitted to a jury along with the tests and criticisms crossexamination and contrary evidence would supply.” Joiner v. General Elec. Corp., 78 F.3d 524, 531 (11th Cir. 1996), rev’d on other grounds, 522 U.S.136, 146–47, 118 S.Ct.512, 139 L.Ed.2d 508 (1997). See, David H. Kaye and David A. Freedman, “Reference Guide on Statistics,” Reference Manual on Scientific Evidence (Federal Judicial Center, 2d ed. 2000), at 91.” Typically, the reports are obtained haphazardly or selectively, and the logic of “post hoc, ergo procter hoc” does not suffice to demonstrate that the first event causes the second. Consequently, while anecdotal evidence can be suggestive, it can also be quite misleading.” Siharath at 1360. Siharath at 1361. [C]ase reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group; do not isolate and exclude potentially alternative causes; and do not investigate or explain the mechanism of causation.” Casey v. Ohio Medical Products, 877 F.Supp.1380, 1385 (1995). There are a large number of authorities cited by the Siharath court supporting their conclusion. See, e.g., Glastetter v. Novartis Pharms. Corp., 107


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138.

139. 140.

141.

Science and Litigation: Products Liability in Theory and Practice F.Supp.2d 1015, (E.D.Mo.2000) (concluding in Parlodel case that case reports did not support the reliability of plaintiffs’ expert testimony); Hollander v. Sandoz Pharms. Corp., 95 F.Supp.2d 1230, 1235–38 (W.D.Okla.2000) (noting that “case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation”); Brumbaugh v. Sandoz Pharm. Corp., 77 F.Supp.2d 1153, 1157 (D.Mont.1999) (concluding that testimony in Parlodel case was inadmissible because the expert was relying only on case reports of possible adverse drug reactions); In re Breast Implant Litig., 11 F.Supp.2d 1217, 1228 (D.Colo.1998) (“To the extent there are case or anecdotal reports noting various symptoms or signs in breast implanted women, without controls, these suggest only a potential, untested hypothesis that breast implants may be their cause.”); Willert v. Ortho Pharm. Corp., 995 F.Supp. 979, 981 (D.Minn.1998) (concluding that case reports are not sufficient evidence of causation because they do not exclude other alternative explanations); Pick v. American Med. Sys., 958 F.Supp. 1151, 1161–62 (E.D.La.1997) (noting that “courts have frequently rejected case studies as an insufficient basis to decide causation when they lack control groups” and that “the individual reports cited must be shown to be independently reliable under Daubert before they can be admitted”); Hall v. Baxter Healthcare, 947 F.Supp. 1387, 1411 (D.Or.1996) (“[C]ase reports and case studies are universally regarded as an insufficient scientific basis for a conclusion regarding causation because case reports lack controls”); Haggerty v. Upjohn Co., 950 F.Supp. 1160, 1165 (S.D.Fla.1996) (“[W]hile case reports may provide anecdotal support, they are not a substitute for scientifically designed and conducted inquiry.”), aff ’d, 158 F.3d 588 (11th Cir.1998); Muzzey v. Kerr-McGee Chem. Corp., 921 F.Supp. 511, 519 (N.D.Ill.1996) (stating that anecdotal reports may be an incentive for more careful investigation, but are not reliable bases to form a scientific opinion about a causal link); Wade-Greaux v. Whitehall Labs., 874 F.Supp. 1441, 1453 (D.Vi.1994) (“[Case] reports record nothing more than a temporal association between an exposure and a particular occurrence. Because of individual confounding factors, one cannot draw causation conclusions from such anecdotal data. Epidemiologists use their population studies to eliminate the chance associations and confounding factors, which inherently affect anecdotal reports, to determine whether a statistically significant positive association exists.”) See generally Michael B. Kent, Jr., “Daubert, Doctors and Differential Diagnosis: Treating Medical Causation Testimony as Evidence,” 66 Def. Couns. J. 525, 532 (1999) (discussing differential diagnosis and general causation). Siharath at 1362–63. See Brumbaugh v. Sandoz Pharm. Corp., 77 F.Supp.2d 1153, 1157 (D.Mont.1999); accord Schudel v. General *1364 Elec. Co., 120 F.3d 991, 996–97 (9th Cir.1997); see generally Daniel J. Capra, “The Daubert Puzzle,” 32 Ga. L.Rev. 699, 715 (1998). 165 F.3d 778, 782 (10th Cir.1999).



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142. Siharath at 1364–65. 143. Id. at 1366. Also see Hollander v. Sandoz Pharmaceuticals Corp., 95 F.Supp.2d 1230, 1234 n. 9 (W.D.Okla. 2000), and Glastetter v. Novartis Pharmaceuticals Corp., 107 F.Supp.2d 1015, 1036 (E.D.Mo. 2000) recognizing that the FDA’s decision was motivated not simply by concerns with bromocriptine, but also by the relative risks and benefits of available alternatives. 144. See, in support, Hall v. Baxter Healthcare Corp., 947 F.Supp. 1387, 1410 (D.Or. 1996); Turpin v. Merrell Dow Pharmaceuticals, Inc., 959 F.2d 1349, 1360 (6th Cir. 1992) (excluding testimony where the record failed to make clear how animal studies were sufficient to show that Bendectin causes birth defects); Richardson v. Richardson-Merrell, Inc., 857 F.2d 823, 830 (D.C.Cir. 1988) (excluding animal studies of Bendectin because of the overwhelming body of contrary epidemiological evidence and the admissions of the expert that animal studies merely raise a suspicion of causation in humans); Lynch v. Merrell-National Labs., 830 F.2d 1190, 1194 (1st Cir.1987) (excluding animal studies of Bendectin in the absence of significant confirmatory epidemiological data); Viterbo v. Dow Chemical Co., 826 F.2d 420, 424 (5th Cir. 1987) (excluding evidence where there was only a single animal study and it showed a link to a disease completely different than plaintiff ’s diseases). 145. Michael D. Green, D. Michael Freedman and Leon Gordis, “Reference Guide to Epidemiology,” Reference Manual on Scientific Evidence, 2d ed. (Federal Judicial Center, 2000), at 346. 146. Siharath v. Sandoz Pharmaceutical Corporation, 131 F. Supp.2d at 1371. 147. Also see Glastetter v. Novartis Pharmaceuticals Corp., 252 F.3d 986, 988 (U.S.Ct.App 8th Cir. 2001). This decision reaches the same no causation finding of Siharath, but in a much more limited fashion. The Parlodel controversy continues, with the cases shifting towards the defendant’s position.



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II



5

Science and Pretrial Research

For the several employments and offices of our fellows, we have twelve that sail into foreign countries under the names of other nations (for our own we conceal), who bring us the books and abstracts, and patterns of experiments of all other parts. These we call merchants of light. — Francis Bacon, The New Atlantis (1626)

Introduction Modern day “merchants of light” surf the Internet and access the increasing number of online databases available to study world knowledge. Products liability and other science-centered litigation require specialized research planning and techniques. This is especially so if the lawyer intends to utilize online computer information databases and/or Web sites as the primary source for needed data. The amount and complexity of the facts involved in products liability prosecution or defense typically require the investment of significant amounts of time, energy, and expense. The keys to the most efficient and cost effective planning, settlement, and trial of these cases are computer-aided research and database management. The use of computeraided research to meet the complex goals of products liability case preparation will constitute the major focus of this book. The case preparation undertaking is centered in the chemical or mechanical aspect of the suspect product that actually caused the client’s injury. A wide-ranging series of research tasks will emanate from this central factor. The actual injury may have occurred as a result of ingesting over-the-counter or prescription drugs, using an engineered product, or being exposed in a variety of fashions to some form of toxic chemical. It is essential to determine with exactitude the aspect of product design or formulation that physically contributed to that injury. Considerable legal research and analysis is required in these cases on a multiplicity of issues. The major thrust of the preparation effort, however, involves complex state of the art, industry, company, and product specific research. This wide-ranging research is indispensable to prove that the product 207


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was in a “defective condition unreasonably dangerous”1 on the date of the injury producing event. Initial Planning The first important planning task is achieving a sense of the broad context within which research will be conducted. There are three basic subject areas involved in products liability research: • Technical product related research • Regulatory research • Industry and company research Each of these areas of inquiry has unique aspects to it which will be addressed in detail in the subsequent chapters of this book. The preparation of a products liability case will consist of the detailed product, regulatory, industry and company research needed to answer five basic questions: • What mechanical or chemical aspect of defendant’s product actually caused plaintiff ’s injury or death? • How did it do that? • Was defendant aware of that injury-producing potential? • Could defendant have done something to have eliminated or minimized that risk and still have aggressively competed in its chosen market? • If it could have, why didn’t it? A significant amount of complex information must be accumulated and mastered to answer these essential questions. Consequently, prior to initiating extensive computerized technical and company research, it is important that the lawyer-researcher construct and implement a basic case preparation plan. There are a set of recurring difficulties typically encountered by inexperienced the lawyer-researcher in these cases, that are a direct result of inadequate case preparation planning: • Assessing the extent of the total time and financial commitment that will be required to manage the case • Achieving sufficient technical background to accurately identify product defects in the complaint • Achieving sufficient technical expertise to draft comprehensive and technically accurate interrogatories and document requests



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• Achieving sufficient technical expertise to subsequently enforce discovery rights and take productive depositions • Minimizing the potential for skyrocketing expert witness costs associated with the locating, accessing and synopsizing of the technical and company information that serves as the framework for all aspects of case preparation and trial An efficient case preparation plan can significantly reduce these problems to manageable proportions and allow for an orderly, quick and cost-efficient litigation. Any such plan has three basic components: • Identifying the major investigative focal points that will serve as the basis for detailed research in a variety of specific areas • Construction of a topical checklist delineating the specific areas of inquiry within each major focal point, wherein detailed research will be required • Constructing a detailed plan for initiating computerized research to expedite specific investigative tasks Categorizing the broad areas within which detailed research will be required, is the first major step in initiating the extensive fact investigations typically required in products liability and other science-centered centered litigation. A very large amount of specialized data will be reviewed over the many months of case preparation. It is essential that you be able to determine where all information evaluated fits into the overall investigative and legal requirements of the case. Having a basic evaluative framework constantly at hand, with which to accurately assess both the legal and investigative significance of the material, will facilitate this responsibility. The old adage about not seeing the forest for the trees has direct relevance to this preliminary research work. A detailed topical checklist will facilitate the next stage of case planning by providing a detailed breakdown of the actual investigative ingredients resident in the broad case focal points noted above. That breakdown will pigeonhole defined areas for specific research tasks and serve as a guideline for the computerized information database planning that constitutes the third and final phase of the basic case preparation plan. Producing a detailed plan for initiating computerized research will set the stage for locating and accessing the required technical, regulatory and company information. Once you have this plan in place, case preparation will move into high gear. The bulk of the extensive information required to complete case preparation, other than internal corporate documents available only through discovery, can be gathered in a matter of days.


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Defining the Research Context The ultimate goal of products liability research can best be achieved by analyzing the historical information under investigation from the perspective of the impact any such data had on the decision-making processes of the defendant corporation over the case time frames. This important viewpoint requires that you have a sense of the manner and timing within which information was available to the company from either the outside world or from its own internal processes. It is important to maintain this perspective for all key activities occurring over the course of the product’s development, manufacture and marketing. It is critical to eventually appraise with precision the impact that all such data had on the decision-making processes of corporate management. Achieving an early understanding of this important framework can best be had by categorizing information at the time it was generated as being internal or external to the corporate processes themselves. External and Internal Events Corporate decisions are based on the analysis of objective data generated internally by corporate employees or generated by sources external to the company. The influx of such information to managers is an ongoing, multiyear process extending over the entire case time frame. This information serves as the backdrop to estimate the appropriateness of the defendant’s final decisions as to product design and manufacture. The lawyer-researcher for both sides must identify that body of information and determine its availability in computerized and print form. They must then pinpoint its historical interplay in the overall process of the defendant’s design, testing, manufacture, marketing and postmanufacturing activities with respect to the suspect product. That considerable task constitutes the heart of case preparation in the products case. Unless the lawyer-researcher has a severe statute of limitations problem, the bulk of the research addressing the points discussed in this chapter, should be well toward completion prior to filing the complaint. This not only facilitates the drafting of an accurate and comprehensive pleading but, equally important, equips the lawyer-researcher with the necessary information to both initiate and engage in aggressive discovery. Internal processes such as product design and testing should be reflective of the company’s awareness of relevant technological developments in the world outside of the company. Failure on the part of managers to either incorporate or adequately weigh such data is the principal factor establishing liability. The lion’s share of the material to follow in this book will analyze the vast number of computer databases that delineate the external



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product-related data available to managers over the product development and manufacturing cycle. Estimating Preliminary Time Frames A principal research task is calculating the historical period within which to seek out such information. This decision will determine the chronological boundaries of the investigation and ultimately define the period of corporate life within which the lawyer-researcher will seek discovery. The discovery time frame should, if possible, also serve as the evidentiary time frame for the introduction of trial evidence. Most products cases involve several time frames that can vary in length from 1 to 40 years, operating simultaneously over the course of case preparation and trial. Time frames will also vary with the defect types identified and the theories of liability specified in the complaint. The introduction of a manufactured good into the stream of commerce is typically the result of a number of years of planning and testing. New products are rarely made of whole cloth. Subsequent models in a preexisting line of goods are normally not significantly altered in their basic design configurations. You must accordingly ascertain the relevant historical antecedents of the suspect product unit. The number of years in an investigative time frame will vary, depending upon the focal point of a particular investigative task. A relatively short period of time may be segregated to achieve a specific, limited investigative goal, such as determining the relationship between one company and another. Greater periods may be required for more ambitious tasks such as identifying and tracking authoritative articles addressing the design component, drug or chemical under scrutiny. Generally speaking, an expansive investigative time frame will be required to provide sufficiently flexible delimiters for discovery and later evidentiary offerings. You may choose any time frame you wish for purely investigative purposes. The historical periods chosen for your own investigations will alternatively expand and contract as familiarity with the technical, governmental and company source material indicates new leads or nullifies others. Typically, you will quickly gauge the appropriate period of time that will yield profitable research shortly after serious research begins. Technical Information Initial planning for the technical aspect of state-of-the-art research, involves identifying the area of science or technology wherein scholarly discussions are likely to have been had relative to the product design or chemical formulation under scrutiny. It is important to realize that authoritative literature


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is rarely, if ever, product specific. The literature will normally speak to design modes or chemicals per se, rather than their incorporation in a specific manufactured good. For example, of the over 700 articles discussing the risk of severe kidney damage resulting from the long-term ingestion of phenacetin-containing analgesic pain killers, less than a handful refer to identifiable products such as Percodan or Darvon. This fact requires that one first focus on the broad technology utilized by the defendant in designing the suspect product, rather than the incorporation of that technology in their product. If the issue is the adequacy of a drug warning, the spotlight must be on the chemical or chemicals in the drug formulation, such as phenacetin, that actually caused the harm to the client. If the issue, for example, is the propriety of failing to provide an automatic tipover shut off switch in a low-priced space heater, the focus will be on the electronic engineering literature addressing the design, functionality and cost of shut-off switches per se. Regulatory Information Undertaking research to identify major governmental information sources is much less onerous than conducting technical investigations. The lion’s share of all products cases will involve either the Food and Drug Administration (FDA) for pharmaceuticals and medical devices; the National Highway Traffic Safety Administration (NHTSA) for automobiles and the Consumer Product Safety Commission (CPSC) for an increasing number of home use or truly “consumer goods” such as electronics. The Occupational Safety and Health Administration (OSHA) is also a common source of products liability regulatory research in cases involving industrial machinery or exposure to toxic chemicals. The Environmental Protection Agency (EPA) is the focal point for an enormous amout of information on the environmental impact of the commercial use of chemicals. Each of these agencies has rule-making, investigative and purely information gathering functions. Each of the latter functions generate a wealth of informative material that can be of significant value in early research. The identification of the relevant agency and its available information should be a priority. A large portion of the noninvestigatory information is available by simple request. However, a significant amount, especially that gathered or generated pursuant to the agencies’ investigation powers, can only be obtained as a result of a Freedom of Information Act (FOIA) request. Federal agencies are notoriously slow in responding to such requests. It is wise to issue FOIA requests as early as possible, and supplement them as research progresses and information requirements are identified with more precision.



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Research Focal Points Identifying the Product Defect Once the lawyer-researcher has identified the theoretical category or categories of defects within which the case falls, the precise technical cause of the injury-producing event must be determined. In the unit case, this necessitates an investigation into the specific cause of product malfunction. In the packaging case, the particular design feature of the package that physically led to the injury must be identified. Likewise, in the instruction and warning cases, the physical aspect of the product that actually caused the injury must be technically isolated as a prerequisite to a contextual analysis of the propriety of defendant’s communications to the consumer. The overall design case as well, requires a precise technical investigation of the cause in fact of the injury. Finally, the physical aspect of the product causing the injury must be segregated in the misrepresentation case as the technical frame of reference for arguments as to the falsity of advertising literature. Identifying the precise nature of the injury-producing technical problem is essential to the successful litigation of a products case involving any of the five generic defect types. Assessing the Product’s Injury Potential Once the underlying technical causes of the injury have been tentatively identified, you must then determine how extensive the problem has been for consumers of the suspect or comparable products. Outside of the unit case, the quantitative extent of the problem can have a dramatic bearing on the success or failure of the lawsuit. When the legal focus is on a design or communicative aspect of product safety for an entire line of goods, a relatively insignificant injury history makes proof that the product was in a “defective condition unreasonably dangerous”2 difficult to establish. While the broader based design-defect category of cases do balance numerous factors in the effort to judge the social acceptability of defendant’s conscious design choices, the cold figures delineating the product’s injury history are often the decisive point in the analysis. This is particulary so in drug cases. A related area of inquiry is the severity of the range of injuries associated with the design or chemical formulation of the product under investigation. An injury profile of a severe magnitude can counterbalance a statistically low injury base. In instances where an actor can foresee statistically insignificant, but catastrophic, injuries potentially materializing from his acts or omissions, the law has always required that the party best able to minimize or eliminate the risk take precautions not normally required of the reasonably prudent


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person.3 This holds equally if not more true here, given the strong consumer oriented policy base of product liability law. Locating the Authoritative Literature Constructing a detailed plan for the utilization of computer information databases and Web sites is the final stage of initial case planning. Once this has been completed, prefiling case preparation will proceed rapidly, in an efficient and cost-effective fashion. The topical checklist, discussed below, will serve as a basic outline of the subject areas in which needed information will be required. However, conducting successful products liability research is much more than merely locating information that appears to fit the slots on a preliminary checklist. Products research must be focused along several important lines that will provide the lawyer-researcher with answers to the central question of how risk-related data impacted on corporate decision-making processes. Once the lawyer-researcher has identified the technical defect and its range in terms of quantity and severity, he must determine the extent to which authoritative sources have recognized that a problem actually exists. Equally important is the determination of the steps that have been recommended to minimize or eliminate the risks associated with the problem. This research constitutes the heart of what is commonly thought of as the “state-of-the-art” research. The sources shedding light on this question are rarely product, and on occasion, not even industry specific. The lawyer-researcher, with the aid of an expert, must estimate the general technology utilized in the suspect product and study all historical sources addressing that technology. Careful tracking of the technological antecedents of the suspect product is essential to provide the lawyer-researcher, the court, and ultimately, the trier of fact, with a context within which to gauge the propriety of the corporation’s product development choices. This requires concentrated study in fields far removed from the professional fare of the average lawyer. Nonetheless, a firm grasp of this material is a sine qua non for effective complaint drafting, discovery, and trial. Tracking Regulatory Activity It is rare today to encounter a manufactured good that is not subject, in some respect, to a proposed or existing federal agency regulation. The existence or prospect of such regulations has had a dramatic effect on the entire product development and manufacturing philosophies of American companies. Whether testing requirements, reporting requirements, product performance standards, or packaging or labelling specifications, these regulations, if present, affect every stage of the product litigator’s research effort.



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The law is clear that performance standards are to be considered minimum standards only and do not affect an injured consumer’s right to bring an action for injuries arising out of design features which are the subject of a regulation.4 Corporate compliance with such regulations however, as in cases where there is uniform industry adherence to a single voluntary design standard, tends to shift the case analysis to the regulation as the “reasonable” standard. Corporations that have made a substantial investment in compliance tend to view such requirements as the upper limit of their obligation to design safe products. In product cases where defendant has complied with such a regulation as a prerequisite to selling the good, both plaintiff’s and defendant’s cases tend to center around the pros and cons of the relevant regulation. Product planning is often centered around the effective date of a regulation, which in turn generates further documentation. Aside from the effect of such regulations on internal corporate processes, the evolution of governmental responses to a perceived product safety problem is a reflection of the state-of-the-art as respects the affected technology. The tracing of the evolution of agency action in regard to an industry is often also a window into corporate thinking and can clarify and highlight the internal documentation received during the course of discovery. Industry Information Comparative product analysis is a key component in the total research effort in the products case. Conformity to industry design standards does not legally constitute due care as a matter of law.5 However, proof by defendant that all others in the industry producing comparable goods utilize the same basic design technology, is a powerful argument against allegations that their product is in a “defective condition unreasonably dangerous.”6 It is a powerful argument for two reasons. First, it requires the plaintiff to, in effect, challenge the acts or omissions of an entire industry, thereby putting the jury in a much more difficult posture in terms of judging the defendant’s specific product. Second, it significantly expands the negative or defensive thrust of the lawyer-researcher’s technical research and eventual presentation to the jury with respect to whatever technology he has proffered as a feasible alternative design. Comparative product analysis thus necessitates close familiarity with the industry of which the defendant is a part and detailed understanding of the technology of comparable or competing products. Not only does this research estimate the industry’s response to the technical problem but may as well, demonstrate a concentrated industry effort to impede utilization of safer design methodology. In either case, it is a basic component of product liability research.


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Company Information Computerized information covering virtually every aspect of major American industries, as well as individual domestic and foreign corporations, is increasing at a geometric rate. In the past, due to the proprietary nature of even organizational data, this type of research was the most difficult of the three main areas to complete. Due to the rapid adoption of computer technology among businessmen and professionals and the explosion of commercial database information services, this is no longer a serious research problem. Demands of investors and other segments of the business community have resulted in an amazing number of sources with which to obtain detailed industry and company specific data. Chapter 9 will discuss these sources in great detail. The products litigator has two major goals in conducting industry and company research: getting a sense of the scope, nature and major participants in the industry within which the defendant does business and gathering as much information as is possible about the history, scope, management and profit profile of the target defendant. The body of computerized literature that is available to investigate these two areas is now comprehensive and readily accessible.7 Product cases usually involve a product and associated technology that stretch back over a relevant time frame of a decade or more. As technology changes so does the organization of the industry that utilizes it. New product technology creates new corporate divisions, committee structures and document generating processes. The corporate structure that is of importance to the lawyer-researcher in one period of research may not be present in another equally important time period. Technological developments, shifts in public tastes, the success or failure of long term marketing schemes, and changes in managerial and production philosophy, often have a noticeable effect on the way a corporation is organized to do business. In instances where the target defendant is a major corporation, tracing data through the labyrinth of corporate document and decision-making processes is very difficult. It is up to the plaintiff ’s lawyer-researcher to determine in what years and from what office, department, committee or individual relevant documentation of a wide variety of types were issued. Typically, protracted discovery is required to gain access to these vital materials. The key to successful discovery is having a solid sense of the types of documents likely to be present in the defendant’s files at various periods over the case time frames. Once in hand, considerable work is required to piece them together into an intelligible whole for necessary integration with the state-of-the-art materials gathered outside of the discovery process.



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Similar Litigation An essential element of the overall research effort is identifying the litigation history of the suspect or comparable product. Identifying all settlements, jury verdicts and appellate decisions in either respect is of great importance on several fronts. Initially, identifying prior litigation will acquaint the lawyer-researcher with other lawyers who have had experience with the product, company, expert witnesses and associated research. In addition, an examination of settlements and verdicts synopses and the reported decisions will acquaint the lawyer-researcher with the range of legal issues associated with the contemplated litigation and the judicial attitudes towards them. Requesting a search for prior and pending litigation or inquiries on your case product or technology from the Association of Trial Lawyers of America (ATLA) Exchange, should be one of the first tasks to complete in your initial case preparation plan.

Research Topical Checklist The next major step in preparation planning is to organize the cluster of research tasks inherent in each of the investigative focal points discussed above into a detailed checklist. The checklist will translate these overarching research goals into a clear set of initial planning guidelines. The items on the checklist discussed below, will be essentially the same regardless of the product or industry involved or the side being represented. This checklist may be easily customized to include the detailed product specific research tasks required in a particular case. Injury Producing Event The status of the injured party in the vertical chain of distribution of the product will determine which of the legal defects and accompanying theories of liability are available to process the case. The failure to instruct, warn and misrepresentation counts are limited to foreseeable consumers and/or users of the product. The injured bystander is generally relegated to unit defect or defective design counts. There are four primary product related investigative concerns that center in the injuring producing event: • Locating and establishing, if possible, a tight chain of custody for the product unit involved • Gathering detailed circumstantial evidence of product failure in the event that the product unit has been destroyed or damaged to an extent that would eliminate the chance for detailed technical analysis


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• Building the factual basis for establishing causation • Gathering occurrence information to eliminate a defense of misuse or comparative fault These factors will bear heavily on the nature and scope of the lawyerresearcher’s technical and company research as the preparation effort moves into its more detailed stages. The exact manner in which plaintiff received his injury is the cardinal fact question controlling the issue of proximate causation. Proximate causation is still a mainstay of the defense bar in products cases. 8 Product Defects The most difficult “cause” related inquiry, around which the bulk of the preparation effort revolves, is determining the precise chemical or engineering aspect of defendant’s product that, at the purely physical level, actually caused the plaintiff ’s injuries. This elemental fact issue will inform the entire case and be the prime catalyst in case preparation. It is central to every products case that has been or ever will be litigated. What is in the drug Coumadin that caused muscular necrosis and the subsequent amputation of plaintiff ’s legs? What is it that causes asbestos workers to develop asbestosis? What is about the design of the fuel system on plaintiff ’s subcompact car that caused the gas tank to explode at a low or medium rear end impact? What is it about the chemical dioxin that causes birth defects in children? The resolution of these “physical cause” issues requires early expert assistance and a steady, well-coordinated research effort on the part of the lawyerresearcher on both sides of the issue. Answers to the bulk of the questions flowing from the physical cause issue may now be quickly, efficiently and economically resolved by the use of computer-aided research. Theoretical Defects It is very important to make the distinction between the actual physically or chemically induced cause of injury and the theoretical “cause” of the injury alleged in the complaint, such as failure to instruct or warn or a defective design. Theoretical or legal “defects” are relatively easy to isolate from an examination of how the consumer was intended by the manufacturer to interact with the product according to its intended purposes. Product shortcomings are generally characterized as unit or manufacturing defects, or as falling within a range of design related defects. The legal characterization of the actual product problem in one of these legal categories, however, does not resolve the basic question of exactly what was wrong



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with the product and how it got to be that way. The categories of legal defects cognizable under American products liability theory are: • • • • •

Defective unit Defective packaging Inadequate instructions Absent or inadequate product warnings Defective design

A material misrepresentation of fact in marketing or promotional literature is also the basis for action in all states. It is important to realize at the outset of case preparation and planning that these types of “defects,” being legal abstractions, are incapable of actually causing harm to a human being. The above-noted defect categories are simply doctrinal devices to characterize, for liability purposes, a years-long series of conscious technological and business decisions of the manufacturer that resulted in the product being the way it was on the day of the injury producing event. The key to actually resolving the factual and legal issues in these cases, lies in a detailed understanding of the technical context within which the suspect product was planned, designed, manufactured, and marketed. These facts will explain how the suspect product could have actually caused the type and nature of the injury suffered by the plaintiff. Legal theory will ultimately determine the development and resolution of the entire case. However, the major part of the lawyer-researcher’s task in preparing products cases is essentially divorced from the specifics of legal theory. Each of these generic defect types has unique research requirements. The typical products case will often involve several defect modes operating simultaneously. For example, in virtually every drug products case, the legal cause of the injury alleged in the complaint is a failure to warn of adverse reactions to the drug. The same applies generally to toxic chemicals that plaintiff is exposed to or otherwise comes into contact. In instances of engineered products, the range of legal causes can encompass all of the noted categories. Product Profile An extensive series of research tasks are centered around the necessity to construct a thorough profile of the suspect product. In essence, the entire preparation effort expands from and is centered in this endeavor. As with all research associated with products cases, computer aided research is available to simplify and speed up this key aspect of case preparation. Chapters 4 through 9 of this book will provide detailed discussions of the database currently available to conduct product specific research.


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Intended Use Identifying the range of functions that arguably fall within the intended use of the product is a key element in the preparation plan. The primary information sources in resolving this issue are the advertising and material accompanying the product. The boundaries of the manufacturer’s stated uses can be legally extended by other reasonably foreseeable uses technically falling outside of the formal intent of the manufacturer.9 In most instances, the scope of intended use is obvious and clearly circumscribed. In others, however, especially chemical and pharmaceutical products, the lines are much less clearly drawn. In the drug and chemical cases, one must track down every use to which the suspect design, pharmaceutical formulation, or chemical has been put. This is necessary to determine the effect that any product problems in those other respects should have had on the utilization of such technology or chemical in the instant case. For example, new products are about to be released that allegedly promote new hair growth. Some of these products are based in a chemical that has long been associated with the relief of high blood pressure and has had serious associated risks when used in that context. This tracking of intended uses can sometimes, unavoidably, lead the lawyer-researcher far astray from the general type of product involved in the case. However, information about the basic chemical or design configuration that serves as the antecedent or basis for the suspect product unit, must be followed wherever it leads, if case preparation is to be thorough. Composite Materials The offending chemical or design component in the suspect product must be isolated. However, a good working knowledge of the product as a whole, including a close understanding of the materials or chemicals incorporated in its construction or formulation, is essential. Achieving a firm grasp of the total product is important in several key respects. Initially, it is necessary to judge the feasibility of alternative designs on the total products’ utility, cost, maintenance, and marketability. These factors must all be considered in resolving the feasibility of alternative designs or chemical formulations. The spate of recent federal and state proposals for product liability reform place that very burden on the complaining party. Aside from the increasing pressures on plaintiff ’s, the lawyer-researcher to meet that burden, it is simply good trial practice. Manufacturing Process A familiarity with manufacturing techniques for products of the type under investigation is also an important element in the prediscovery research plan.



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A key factor here is determining the existence of internal or externally recommended voluntary standards and/or government regulations that impact on the manufacturing process. Identifying and mastering the complexities of past, current or proposed materials, or performance standards is a central part of early preparation planning. Public and Private Technical Standards The most pervasive influence on the standardization of manufacturing practices for engineered items, is the work done by the American National Standards Institute (ANSI) committees. ANSI standards either already exist or are being formulated for products as disparate as lawn mowers, coffee pots, and computer software languages. These standards often provide the lawyerresearcher with a state-of-the-art frame of reference with which to gauge the propriety of defendant’s conscious design choices. Additionally, the history of any such standard will indicate the development of authoritative perspectives on the design feature under scrutiny over the several years of the case time frame. Determining the existence of past, proposed or existing federal regulations addressing test procedures, and/or product performance standards is also a central part of the preparation of any products liability case. Such regulations, especially proposed regulations, are a very important focal point for the entirety of pretrial research as well as the actual trial itself. The issuance of a proposed testing or performance testing regulation generally brings an immediate response on the part of the corporations in the affected industry. Current manufacturing practices rarely comply with the testing or performance level mandated by such proposals. Typically, an intense flurry of activity can be noted in all related sections of a company in an attempt to determine their technical, financial, and marketing ability to comply with any such proposal in the event it becomes effective. This type of activity generates a wealth of discoverable internal corporate documentation of inestimable importance to both plaintiff and defense the lawyerresearcher. This type of material is generally the most focused data that the lawyer-researcher will encounter in the search for corporate documents illuminating the defendant’s actions respecting the chemical formulation or design under investigation. There is typically considerable correspondence between the affected companies and the issuing agency following the issuance of a proposed regulation for industry comment. A Freedom of Information Act Request (FOIA) requesting the file on such interchange can often yield important insights into management’s position as well as copies of corporate documentation normally not accessible until the completion of protracted discovery. This is especially the case where an agency defect investigation has been initiated.


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Federal Agency Reporting Requirements It is important that the lawyer-researcher achieve a good working knowledge of the general procedures of federal agencies having jurisdiction over the target industry. This is in addition to identifying the fine points of whatever testing or performance standards may have been proposed or are currently in effect. It is particulary important to identify any procedures that mandate notification to the agency of information received by the manufacturer outlining injuries to consumers associated with the normal use of the product. For example, the FDA requires that communications to drug manufacturers from health care providers expressing concern over the risk potential of their pharmaceuticals be forwarded to the FDA within 15 days of receipt. Production History Determining how long the defendant has manufactured the subject product and/or comparable product lines, is important in several respects. This time period will establish tentative limits on the time frame within which investigation and discovery will proceed. Authoritative literature searches, comparative product analyses, and agency regulatory studies are definitely in order for this period of time. The latter type of inquiries should actually extend several years previous to this period. It is a principal focal point for all prediscovery investigation. Production of Suspect Unit The date of manufacture of the product unit involved in the case is a key date in both factual and legal analysis. In defective design counts, it is arguably the terminal date beyond which advances in technology have direct bearing on the propriety of defendant’s conscious design choices. The incorporation of postmanufacture design changes leaves open the issue of the feasibility of any such designs prior to this terminal date. Nonetheless, it is usually proffered as the discovery and evidentiary cutoff point by defense the lawyerresearcher. This date also has important bearing in failure-to-instruct and failureto-warn counts. The manufacturer has an affirmative duty to provide such additional instructional material and/or warnings as are merited by their receipt of data respecting the risk potential of their goods. The date of manufacture provides a clear dividing line with respect to state-of-the-art and comparative product information in that important respect. This date is also important in determining when product specifications were frozen, often many months previous to the actual date of manufacture. For all intents and purposes, the date at which materials selection and manufacturing specifications were finalized is the “date of manufacture.”



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Other Product Lines It is important that the lawyer-researcher identify the other product lines manufactured by the defendant that have technological or chemical similarities to the product unit under investigation. Basic design configurations, materials and parts, tend to be common among generically similar product lines. This is especially the case in the area of engineered products. As an example, in the automobile industry, basic designs respecting seat belts and fuel system integrity are very similar, if not identical in various categories of vehicles such as full size, compact and subcompact vehicles. In cases of pharmaceutical and chemicals, a new formulation often incorporates chemical ingredients that have existed in other product lines and remained unchanged for decades. This reality has particular importance in achieving thorough discovery. Corporations do not waste money by duplicating research and development and testing programs respecting generic design components that will be incorporated in various product lines. The data obtained from across-theboard design and component studies or chemical analysis are simply incorporated into programs targeted towards specific product lines. Accordingly, testing and financial data from formally separate product lines are often directly relevant on both discovery and trial evidence. Marketing Strategy The lawyer-researcher on each side must develop a clear understanding of the way in which defendant marketed and continues to market the suspect product or comparable product lines. This would include instructions, warnings, advertising and all other promotional literature. The way in which the manufacturer communicates information regarding the product’s intended use, performance level and risk potential, is a central focal point for the entire case preparation. The misrepresentation count requires that plaintiff prove a material misrepresentation of fact about product performance levels, intent that the consumer relied upon it and justifiable reliance.10 Marketing literature is the primary source for the information needed to successfully establish such a count. Second, the history and present status of instructional materials and warnings is vital to the failure to instruct and warn counts. The history of a drug manufacturers’ submissions to the Physician’s Desk Reference may serve as a prime example. A growing number of computer databases that are currently accessible allow tracking of virtually every key aspect of marketing schemes utilized by major American corporations, from Physician’s Desk Reference entries to advertisements of more than a quarter-page in over 200 publications. 11


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Comparative Products Comparative product analysis is one of the most important aspects of products liability case preparation. Conducting successful comparative product analysis requires the lawyer-researcher to become totally conversant with all products similar to the suspect product in the market within which defendant does business. This will require that the lawyer-researcher identify the comparable design features or chemical formulation of competing products. It will also require identification of the instructional, warning and promotional output of all competing companies over the case time frame. Comparative product analyses provide the lawyer-researcher with several key pieces of information. First, it delineates in a clear way the variances in product features, performance levels and consumer communications among competing manufacturers. This information gives the lawyer-researcher a ready frame of reference within which to estimate the sufficiency of the defendant’s efforts and choices in those respects. It also provides the lawyerresearcher with a very practical yardstick to determine the market cost effect of the addition or subtraction of isolated product features that may be central to the case. The latter ability is often a godsend when attempting to make sense of internal corporate documents that assign numerous purely accounting costs to the development or incorporation of alternative designs, chemical formulations or consumer directed literature. Manufacturing practices and materials selection tend to be quite similar within specific industries. Most voluntary standards, as well as proposed or mandated federal agency testing and/or performance requirements, are not company specific. All of these standards are industry oriented. This results in a significant degree of testing and manufacturing parity among companies doing business within the effected industries. This is especially the case in the area of product performance testing procedures. Once the lawyerresearcher has learned the design, testing, production and marketing procedures of the target defendant, it is relatively easy to obtain information and identify important variances in those respects among competing manufacturers. Injury History Identifying the existence or absence of injuries associated with the suspect product is an important early goal in case preparation. The quantitative extent of injuries of the type involved in the case is a key element in establishing defendant’s knowledge of danger. The existence of a similar injury history is strong circumstantial evidence that the product was in a defective condition. This factor is of acute concern in cases involving adverse reactions



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to drugs and other failure to warn settings. The length and extent of a product’s injury history is also a prime factor in proving a punitive damage count. Litigation History An important adjunct to the injury data associated with the suspect product is its litigation history. The primary benefit of this research is contact with other litigators who may be able to provide important information on various aspects of case preparation. Experienced lawyer-researchers can save the new litigator an enormous amount of time and expense as well as minimize the inherent frustration of attempting to obtain full discovery from large scale manufacturing concerns. An inquiry directed to the Association of Trial Lawyers of America (ATLA) Information Exchange is a valuable first step in obtaining this vital information. Company Documents The key to success in prosecuting or defending a products case lies in the comparison of defendant’s decision-making processes with the state-of-theart referred to above. In essence, it requires that the lawyer-researcher for either side determine, to the extent possible, what the defendant knew about the risk at issue in the lawsuit, when they knew it, and what they did with the information once that had it. Aggressive discovery by plaintiff is necessary to effect this level of analysis. Computer-aided research of the type to be discussed in the remainder of this book is essential to plan and enforce discovery rights. It is also indispensable to making sense of the voluminous, but disjointed documents that the lawyerresearcher will obtain after protracted discovery.12 Identifying Potential Defendants Timely identification of the corporate entities involved in the manufacture and vertical chain of distribution of the suspect product is an essential element of initial case planning. Given the complex nature of the modern American and multinational corporation, this is often a challenging aspect of initial case preparation. Complicated joint venture and distributorship arrangements with foreign producers have multiplied, resulting in the massive influx of foreign goods. These factors bring increasing pressure to bear to both identify the responsible parties and to avoid any claims of legal malpractice for having failed to do so. Splitting the question into segments that reflect the typical breakdown of corporate participation in the American market is an important


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preliminary step in the resolution of whatever quandary may exist in this regard. In most instances, identifying the actual manufacturer of the suspect product is a relatively simple exercise. In many cases, however, it can be an initial nightmare, resulting in the expenditure of significant amounts of time and money. Where the statute of limitations looms on the horizon, it can develop into a fundamental case crisis in regard to service of process. Foreign Corporations In cases where the primary manufacturer is a foreign corporation, all too common in the late 20th and early 21st centuries, unique preparation problems immediately arise. Aside from fundamental questions related to service of process, the concern must lay with several key preparation components. The primary concern is locating sources with which to assess the industrial and competitive context within which the target defendant does business. As will be illustrated in Chapter 9, a wealth of information on every aspect of American manufacture is available for searching on a variety of commercial computer databases. Less information is accessible with respect to foreign manufacturers. Additionally, significant amounts and varieties of information on foreign companies is becoming increasingly available on several new databases. Successor Corporations Due to a total purchase of assets by another corporation, the target manufacturer may no longer be in business at the time of initial case preparation. While rare, this is a prospect that warrants special attention. This situation creates unique research problems for plaintiff. The criteria used by courts to determine if the successor entity will stand in the shoes of the actual manufacturer requires the gathering and analysis of several categories of information not normally accessible outside of discovery: • Whether the purchaser intends to utilize the seller’s trade name • Whether the purchaser intends to use the seller’s original product designs or chemical formulations • Whether the purchaser intends to employ significant numbers of the seller’s key personnel • Whether significant stock transfers were part of the transfer agreement These factors are balanced by the courts in determining the ultimate issue of whether Corporation B, the purchaser, succeeds to the original potential liability of Corporation A, the seller, for purposes of the lawsuit. 13



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Corporate Status It is critical to identify as clearly as possible the exact corporate status of any company targeted as a potential defendant. When dealing with major or multinational corporations, this can be more difficult than one would assume. The absence of discovery rights prior to filing leaves the lawyerresearcher at his own devices in the task of unscrambling the complex interrelations among wholly owned subsidiaries and divisions of large American and foreign manufacturers. Computerized research now provides the lawyerresearcher with several comprehensive databases containing numerous information sources with which to clarify this issue. Accomplishing this goal is important in several respects. The company at the top of the corporate pyramid is generally responsible for the activities of those companies they own. In turn, the separate corporate entities owned by them bear full responsibility for their own activities. Nonetheless, due to the overlap of responsibility among the various layers of the total corporate entity, it is extremely important to have discovery access to the corporate documents of all participating entities within that complex relationship. Component Parts and Materials Suppliers Component parts manufacturers and materials suppliers also generally bear separate responsibility for injuries associated with the parts or materials they supply to the ultimate manufacturer. Determining the relationship between the ultimate manufacturer and its materials and parts suppliers is a key investigative goal. All of the participants in getting the suspect product to market must be clearly identified and evaluated for both their investigative and legal significance. This is especially the case with firms not legally associated with the central manufacturer. It is difficult, but nonetheless possible to get an adequate fix on this important aspect of case planning without discovery rights. Computerized nonlegal research can also greatly assist in this key factual injury.14 Wholesalers, Distributors and Retailers Identifying the scheme of distribution for the suspect product line is also an important early case preparation goal. Wholesalers and distributors bear the same responsibility as primary manufacturers in most states. The discovery information these parties often provide on the issues of demographics, instructions and warnings and injury history can be invaluable. Given a foreign manufacturer and a large scale distribution scheme, these defendants may be the most attractive targets available. The identity of the retailer is rarely a problem in these cases. They legally bear full responsibility with the other entities involved in the manufacture


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and vertical chain of distribution of the product. In instances where the retailer is a major chain or a significant participant in the manufacturer’s vertical scheme of distribution, much valuable information on sales figures, comparative product analysis and injury history can often be obtained in discovery. In cases of small job manufacturers, often the case in toys or specialty items, the retailer may be the only viable candidate from a financial standpoint. Industry Information Gaining a solid working knowledge of the industry within which all targeted defendants do business is a central part of the initial preparation of the products liability case. Conformity to industry custom in the design, testing, production, marketing, or vertical distribution of a product does not mean that the suspect product was not defective or negligently produced in any of those respects. Nonetheless, it is a powerful factual defense that manufacturer’s, the lawyer-researcher, must prepare and plaintiff ’s, the lawyerresearcher, be adequately prepared to meet. There are a cluster of important information points with respect to the industrial context of the suspect product: • The similarities and differences among competing or similar product features, instructions, warnings, marketing and cost • The period of time over which the basic design or chemical or chemical formulation has been utilized in the industry • The various product applications in which the basic design or chemical has been utilized in the industry • The injury history of products or chemicals or pharmaceuticals of the general type involved in the case • The litigation history of products or chemicals or pharmaceuticals of the general type involved in the case Identifying, locating, accessing and organizing this category of data is an imposing task. A wealth of computer databases and Web sites now exist to facilitate this vital component of case preparation in a timely, cost-effective fashion. Punitive Damages The legal requirements for the imposition of punitive damages are uniform in most states. Plaintiff must generally prove a longstanding knowledge of a substantial risk to the consumer and demonstrate a callous, reckless and willful disregard towards that risk. In the products field, such activity is also generally associated with the desire for corporate profit.



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The presence of a punitive damage count is generally supportive of the lawyer-researcher’s arguments in favor of a more extensive discovery time frame. The longer the period of time that defendant was aware of a risk, the greater the opportunity to characterize inaction as callous and reckless. This is particularly the case where there has been a steady or increasing injury and litigation history arising out of the normal use of the product. Proving the punitive damage count requires more than establishing mistaken or even deliberate decisions affecting product safety. Large scale manufacturers and pharmaceutical houses rarely finalize product decisions in a careless or haphazard fashion. All decisions are generally the result of careful review and analysis by management of the data generated by technical staff. Comprehensive computer-aided research often reveals expressed authoritative concerns of many years standing as well as revealing aspects of company or industry activity that lend credence to the punitive damage count. 15 The remainder of this chapter will concentrate on the utilization of online computer databases and Web sites to conduct the detailed research needed to economically and efficiently initiate and finalize case preparation. Online information systems, such as Dialog, are and will continue dramatically altering the way complex litigation is conducted, from initial research to jury verdict. The rapid growth in the number and sophistication of the Web sites available on the Internet has further enhanced the potential for solid pretrial research in the science-centered case. The developments in this field have been rapid and spectacular.

Research In Depth There are four broad evidentiary requirements that serve as the focal points for the preparation of the plaintiff ’s product liability design case: • Objective data demonstrating corporate knowledge of product defects and feasible alternative designs. • Socially unacceptable management decisions in light of such knowledge. • Proof that one or more of the identified defects in fact caused the death or injury to the client. • Proof that one or more of the feasible alternative designs, warnings or instructions would have minimized or eliminated such death or injury. The process of satisfactorily addressing each of these factors involves the gathering and analysis of large amounts of data. A substantial portion of that material is quite technical in nature. The information must be first located


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and then thoroughly digested and organized. This work is essential if the lawyer-researcher is to have any real chance of competing with the vast array of technical, investigative and legal resources typically available to the corporate defendant. At times, the breadth and complexity of such data can be staggering to to the lawyer unfamiliar with the rigors of product liability litigation. In essence, the greater part of the lawyer’s job in this area of practice is effective data management. Reconstructing the cause of the death or injury in its total historical context is the purpose of pretrial investigation. The story that must be reconstructed in the products case is complex and multifaceted, stretching over many years in most cases. A significant part of that story is available to the lawyer-researcher prior to the filing of a complaint and engaging in discovery through analysis of the state of the art literature, government agency files, and the wealth of publicly accessible information about the defendant corporation. Thousands of pages of company documents are available through discovery, that range over the entire period from the earliest activity towards product development to the date of the injury producing event. The development of effective and economical methods to locate such materials and efficient analytical and organizational systems to evaluate them once in hand, are the keys to successful product liability litigation. The greatest part of the material to follow in this book will address those overriding practical concerns. Initial Investigative Concerns At the outset of every product liability litigation, the lawyer-researcher is required to address a wide range of questions that must be satisfactorily answered through the course of prefiling research and investigation. Answering these questions will require many hours of study of sources normally unfamiliar to other than experienced specialists in the products field. Even then, new products and industries invariably raise a host of new questions. How is the product made? What is it made of? How do its design and materials composition compare to competing products in the same market? What is the price differential among similar products with enhanced safety features? What share of the market does this product have? How does its instructions and warnings compare to competing products given the apparent risks involved? Is there an identifiable defect that was remediable prior to or subsequent to manufacture? What does the authoritative literature say about this defect or range of defects? Is it well documented in authoritative sources? Has the defendant company ignored clearly expressed and authoritative concerns about this defect? Do all competing products have the same basic problem to a greater, same or lessor degree? What are the leading studies



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in this area? Who are the recognized authorities? Is the problem essentially one of manufacture, packaging, instructions, warnings or design? Is it a combination of them? What are the statistics regarding product failure and resultant death or injury? Are there government regulations in effect or proposed that have a direct bearing or can be used by analogy? Have there been government imposed recalls or defect investigations in the past? Is there company documentation available in agency files that are accessible prior to discovery through a Freedom of Information Act request? Has there been a concerted effort by the industry and this defendant to water down or impede safety regulations? How do existing or proposed performance standards compare to thinking in the scientific community regarding the relevant performance feature? What companies are involved in supplying materials or component parts? Who are involved in the vertical chain of distribution of this product? Is a foreign corporation involved? Has there been a sale of the manufacturer creating a successor liability problem? How is the defendant organized? What are their assets? Has this defendant and product been involved in previous litigation? These and a host of other questions face the products litigator at the beginning of each products undertaking. The answer to the lion’s share of such inquiries can normally be acquired at a modest cost prior to discovery by comprehensive and tightly organized prefiling research. What follows is a basic overview of that research and the points of interest upon which it should concentrate. Investigative and Legal Significance of Research Data It is important in every aspect of both pre- and post-filing product research that the lawyer-researcher maintain a dual perspective toward each item of information gathered and analyzed. Those perspectives are the investigative and legal significance of the data under study. The greatest amount of information reviewed by the lawyer-researcher will yield its primary value in respect to its investigative importance. What does this information tell me about this technology, industry or corporation that I did not know before? In what direction does it point for additional research? Hard choices that must be made at the conclusion of research and discovery to convert the massive accumulation of data into a controllable as well as communicable case for jury presentation. The bulk of the information that the lawyer-researcher will be required to marshal may not be admissible under the rules of evidence. Accordingly, the lawyer-researcher must be able to determine the unique value that each item of information will have to both the investigation and formal legal requirements of the planned lawsuit. This dual perspective will be referenced throughout this study.


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Research Points of Reference Prefiling research should be viewed as an attempt to isolate a series of informational and legal focal points that will place the suspect product in its business, technical, regulatory and litigation contexts. This preliminary approach will provide a solid backdrop of research against which the lawyerresearcher may effectively analyse and organize the data that appears to be of particular concern to the potential litigation. It is essential for the subsequent accessing and analyzing of corporate documentation. The suspect product is normally one of a generic type of manufactured good produced in an industry which draws on a traditional pool of academic, scientific and professional data. It is often subject to some form of government regulation, and, with respect to the design type under review, more often than not has an injury producing history. Preliminarily examining the suspect design in the manner to be discussed below, facilitates smoother and more comprehensive specialized research in later stages of the preparation effort. Given the expansive nature of the research undertaking in the typical products case, achieving an early understanding of this broad context is essential to economy and efficiency in each ensuing stage of the planned litigation. The first point of reference, around which the remaining research will revolve, is the identification of the type of defect or defects that may be attributed to the suspect product unit. The first thing that the lawyer-researcher will need to do is determine just what it is that is wrong with the product in common sense terms. Was there some flaw in the product unit that caused the injury not present in other units sold by the defendant? Was the client injured by the product packaging and not the product itself? Is it a question of misleading instructions or inadequate or nonexistent warnings? Is there something wrong with the basic design of the product in a particular respect? Prior to purchase, was the client misled by some material misrepresentation about the product that he relied upon to his detriment? Are more than one of these problems involved? Product shortcomings are generally classified in legal parlance as being either manufacturing or design defects. Regardless of the broad classification of product defects or the overarching theory of liability utilized in any one count of a complaint, the defect or defects actually involved in a particular case will fall within one of the following categories: Manufacturing • Unit defects • Packaging defects • Instructions defects



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Design • Warnings defects • Overall design defects • Misrepresentation It is these generic defect types that set the scope of prefiling research, and in large part determine the limits of discovery and the acceptability of trial evidence. Each of these generic defect types has unique research requirements. The typical products case will often involve several defect modes operating simultaneously. It is important, nonetheless, for both legal and investigative purposes, to keep each defect type as a separate research project, although in reality, they are very much related to each other. Unit Defects Unit defects are those which involve an actual flaw in the unit of the product purchased and used by the injured party. The focus is on that one product unit that is dangerously different from the other units in the same product line sold by defendant. In such cases, defendant’s own specific product line is the major frame of reference that will reflect the defective nature of the suspect unit. The lawyer-researcher is not required to do extensive prefiling state-of-the-art research in unit defect cases. That research would be necessary in cases involving the other generic defect types, noted above, in order to demonstrate inappropriate conscious design choices by the defendant. Strict liability is limited in the unit or manufacturing defect case. The liability is strict in the sense that state-of-the-art defenses are unavailable to the defendant. Arguments that the defendant has the latest equipment and the best quality control system in the industry are not a defense. The unit defect case does not concern itself with the question of how the unit became flawed. Nor is it concerned with the question of industry custom in designing such goods. The focus is on the causal relation between a demonstrated flaw and plaintiff ’s injury. It is necessary, however, to conduct product research relative to the basic design, materials composition and production of the product to initially determine if it is truly a flawed unit. Such research is also necessary to give the lawyer-researcher a technical context with which to process all necessary steps in the litigation, especially discovery. Nonetheless, in instances where the lawyer-researcher can confidently identify the defect as a true flaw in the client’s unit, extensive prefiling research of the type required for the design defect categories is generally unnecessary.


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Packaging Defects Packaging defect cases are of the design category classification of product defect and thereby question the propriety of the packaging design of the entire line of defendant’s good. This is opposed to focusing the inquiry on a single unit as in a true manufacturing defect setting. In these instances, the focus is not on the product unit itself or all other units in the specific product line of which it is a part. The packaging case centers on the consumer’s physical access to the actual product. The gist of such cases is that the packaging is so designed that the end user is exposed to unacceptable risk in reasonable attempts to use the product. Here, the focus is on the design, materials composition, instructions or warnings relative to the package itself. The integrity of the unit or the propriety of the conscious design choices made by the defendant in creating or marketing the actual good are of subsidiary interest. Being of the design defect category, however, full study of the state-of-the-art, regulatory and company data sources is required to the degree that they shed light on the defendant’s packaging design criteria. These cases typically involve both the primary manufacturer and the packaging supplier. Failure to Instruct Cases involving inadequately drafted instructions, like packaging defect cases, do not directly question the integrity of the client’s product unit per se or the conscious design choices that were made by defendant relative to the particular product line. The instructions case centers around the sufficiency of the literature regarding intended use that accompanies the client’s product unit. Since instructional materials, like packaging, are generic to product lines, the instructions case questions the adequacy of defendant’s educational literature for that entire line of goods. The basic thrust of the case is that a reasonably prudent user could follow such instructions to the letter and nonetheless be subject to unacceptable levels of danger. It is quite common and normally appropriate for the instructions count to be brought in league with an overall design and failure to warn count. Since the case is generic in nature, the lawyer-researcher will be required to do extensive prefiling research relative to the state-of-the-art of drafting instructional materials, as well as probe the internal history of defendant’s policy and experience in that regard. From a research standpoint, there is often only a very fine line between the failure to instruct case and those specifically centered around a failure to warn. In turn, the presence of either gives strong indication that an overall design problem is present.



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Failure to Warn The failure to warn cases likewise challenge an entire manufacturing undertaking by the defendant. These cases are centered in the defendant’s failure to warn the consumer about a known risk or only doing so in an unclear or misleading manner. Focusing as it does on a risk of injury inherent in the product design itself, the failure to warn cases requires extensive research. The technical nature and history of the perceived risk, governmental or industry imposed labelling requirements and comparative product warnings must all be thoroughly studied. In such design category cases, where the applicable time frame for the examination of relevant data can easily reach back a decade, the research can be quite extensive. Typically, the failure to warn count often goes hand in hand with counts grounded in failure to instruct and overall design defects. Overall Design Defects The overall design defect case focuses on the inadequacies inherent in the design of the injury producing unit itself. As with packaging, instructions and warnings cases, the entire line of goods of which the offending unit is a part is subject to scrutiny. The overall design defect case is, in many respects, the most complex of the five types of product cases to research. While the technical and legal issues involved in processing the other generic types can be and normally are extensive, the overall design case routinely requires expansive research of a most exacting nature. Misrepresentation Cases grounded in misrepresentation under Section 402B of the Restatement of Torts 2d, rest upon a false or misleading statement of fact about the product’s features made in defendant’s advertising or other marketing literature. The focus of the case is the misrepresentation itself, with the product design feature associated with the injury serving as a frame of reference for what is essentially a communicative tort. This does not relieve the lawyer-researcher of the obligation of doing basic product research to gain a technical and industry perspective with which to process the case. However, the task is to demonstrate the falsity of the misrepresentation, the client’s justifiable reliance and resulting proximate causation. The right or wrong of the product feature under review is of no relevance. It is the fact that defendant, with intent that the consumer rely upon it, made a representation that was simply not true. This factor and not the propriety of the product design is the central issue.


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Accordingly, the main research effort will be towards a technical comparison of product performance to the representation made in regard to it. Of the five generic defect types, the misrepresentation case is the least onerous in terms of lawyer time and expense.

Research Points of Reference Identification of the Technical Problem Once the lawyer-researcher has estimated the general category or categories of defects within which the case falls, the precise technical cause of the injuryproducing event must be determined. In the unit case, this necessitates an investigation into the specific cause of product malfunction. In the packaging case, the particular design feature of the package that physically led to the injury must be identified. Likewise, in the instruction and warning cases, the physical aspect of the product that actually caused the injury must be technically isolated as a prerequisite to a contextual analysis of the propriety of defendant’s communications to the consumer. The overall design case as well, requires a precise technical investigation of the cause in fact of the injury. Finally, the physical aspect of the product causing the injury must be segregated in the misrepresentation case as the technical frame of reference for arguments as to the falsity of advertising literature. Identifying the precise nature of the injury-producing technical problem is thus essential to the successful litigation of a products case involving any of the six generic defect types. Depending upon the particular defect type involved in the case, the technical aspects of the product will have varying degrees of importance to the litigation. However, as with any tort action, a primary factual issue is whether or not defendant’s act or omission in fact caused the subject death or injury. The principal goal of the lawsuit is to determine if defendant will be legally responsible for the injury that he in fact caused. Establishing cause in fact is no less a central investigational goal for the product’s litigator. Quantitative Extent of the Technical Problem Once the underlying technical causes of the injury have been tentatively identified, the lawyer-researcher must then determine how extensive the problem has been for consumers of the suspect or comparable products. Outside of the unit case, the quantitative extent of the problem can have a dramatic bearing on the success or failure of the lawsuit. When the legal focus is on a design or communicative aspect of product safety for an entire line of goods, a relatively insignificant injury history makes



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proof that the product was in a “defective condition unreasonably dangerous” difficult to establish. While the broader based design defect category of cases do balance numerous factors in the effort to judge the social acceptability of defendant’s conscious design choices, the cold figures delineating the product’s injury history are often the decisive point in the analysis. This is particulary so in drug cases. Qualitative Extent of the Technical Problem A related area of inquiry is the severity of the range of injuries associated with the technical design defect of the product under investigation. An injury profile of a severe magnitude can counterbalance a statistically low injury base. In instances where an actor can foresee statistically insignificant, but catastrophic, injuries potentially materializing from his acts or omissions, the law has always required that the party best able to minimize or eliminate the risk take precautions not normally required of the reasonably prudent person. This holds equally if not more true here, given the policy base of product liability law. Evolution of State-of-the-Art Responses to the Technical Problem A central investigative goal in the products case, once the lawyer-researcher has identified the technical defect and its range in terms of quantity and severity, is to determine the extent to which authoritative sources have recognized that a problem actually exists. Equally important is the determination of the response that has been made to minimize or eliminate the risks associated with the problem. This research constitutes the heart of what is commonly thought of as the state-of-the-art research. The sources shedding light on this question are rarely product, and on occasion, not even industry specific. The lawyer-researcher, with the aid of an expert, must estimate the general technology utilized in the suspect product and study all historical sources addressing that technology. A common occurrence in discovery and trial is the objection of the defendant that research that is not product specific has no relevance to the proceeding. Careful tracking of the technological antecedents of the suspect product is essential to provide the lawyer-researcher, the court and, ultimately, the trier of fact with a context within which to gauge the propriety of the product under scrutiny. This requires concentrated study in fields far removed from the professional fare of the average lawyer. Nonetheless, a firm grasp of this material is a sine qua non for effective complaint drafting, discovery and trial. Evolution of Governmental Responses to the Technical Problem It is rare today to encounter a manufactured good that is not subject in some respect, to a proposed or existing federal agency regulation. The existence or


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prospect of such regulations has had a dramatic effect on the entire product development and manufacturing philosophies of American manufacturers. Whether testing requirements, reporting requirements, product performance standards, or packaging or labelling specifications, these regulations, if present, affect every stage of the product litigator’s research effort. The law is clear that performance standards are to be considered minimum standards only and do not affect an injured consumer’s right to bring an action for injuries arising out of design features which are the subject of a regulation. Corporate compliance with such regulations however, as in cases where there is uniform industry adherence to a single voluntary design standard, tends to shift the case analysis to the regulation as the “reasonable” standard. Corporations who have made a substantial investment in compliance tend to view such requirements as the upper limit of their obligation to design safe products. In product cases where defendant has complied with such a regulation as a prerequisite to selling the good, both plaintiff ’s and defendant’s cases tend to center around the pros and cons of the relevant regulation. More often than not, any such standard, being considered minimal, is in reality, just that. An added problem is that the certification testing system utilized by most agencies is a self-certifying one, with true compliance and adequate testing dependant upon the good will and veracity of the affected companies. All too often, that has been sorely lacking. The date of the issuance of a proposed regulation is a key one in the organization of materials, since such proposals generally generate a wealth of internal documentation analyzing the ability of the affected product lines to meet such standard as well as management’s philosophy towards compliance. Product planning is often centered around the effective date of a regulation, which in turn generates further documentation. Aside from the effect of such regulations on internal corporate processes, the evolution of governmental responses to a perceived product safety problem is a reflection of the state of the art with respect to the affected technology. Industries are given the opportunity to comment on proposals and to issue position papers with supporting documentation. With some exceptions, these historical materials are generally available to the lawyer-researcher prior to filing through a Freedom of Information Act request. This is often a prime source of information on the state-of-the-art, industry and corporate questions with which the lawyer-researcher is plagued at the outset of the case. The tracing of the evolution of agency action in regard to an industry is often also a window into corporate thinking and can clarify and highlight the internal documentation received during the course of discovery.



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Evolution of Industry Response to the Technical Problem Comparative product analysis is also a key component in the total research effort in the products case. Conformity to industry design standards does not legally constitute due care as a matter of law. However, proof by defendant that all others in the industry producing comparable goods utilize the same basic design technology, is a powerful argument against allegations that their product is in a “defective condition unreasonably dangerous.” It is a powerful argument for two reasons. First, it requires the plaintiff to, in effect, challenge the acts or omissions of an entire industry, thereby putting the jury in a much more difficult posture in terms of judging the defendant’s specific product. Second, it significantly expands the negative or defensive thrust of the lawyer-researcher’s technical research and eventual presentation to the jury with respect to whatever technology he has proffered as a feasible alternative design. Fortunately, it is often the case that other manufacturers, as well as the target defendant, utilize several levels of technology in different models of the base product that provide a ready frame of reference. The question of a corporation’s right to participate in various market levels is a complex one and will be addressed in detail later in this study. Suffice it to say at this point, that the the strongest basis for determining the feasibility of an alternate package, instruction, warning or design, is that either the defendant itself or others in the industry have actually incorporated it in a product line. Comparative product analysis thus necessitates close familiarity with the industry of which the defendant is a part and detailed understanding of the technology of comparable or competing products. Not only does this research estimate the industry’s response to the technical problem, but may as well demonstrate a concentrated industry effort to impede utilization of safer design methodology. In either case, it is a basic component of product liability research. Evolution of Defendant’s Organization and Processes In instances where the target defendant is a major corporation, tracing data through the labyrinth of corporate document and decision-making processes is very difficult. It is up to plaintiff ’s, the lawyer-researcher, to determine in what years and from what office, department, committee or individual relevant documentation of a wide variety of types were issued. Product cases often involve a product and associated technology that stretch back over a relevant time frame of a decade or more. As technology changes so does the organization of the industry that utilizes it. New product technology creates new corporate divisions, committee structures and document generating


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processes. The corporate structure that is of importance to the lawyerresearcher in one period of research may not be present in another equally important time period. Technological developments, shifts in public tastes, the success or failure of long term marketing schemes, and changes in managerial and production philosophy, often have a noticeable effect on the way a corporation is organized to do business. These changes can result in greatly increased difficulty for the products litigator attempting to isolate information flow within a company over an extended period. It also provides potent ammunition for the corporate deponent anxious to frustrate discovery through guarded or equivocal answers grounded in differences in organizational terminology. It is thus incumbent on the products litigator to establish the evolution of defendant’s organization and internal structures. A great deal towards this end can be accomplished prior to filing, but the fine points of internal decision and document generating processes can only be determined after careful document discovery and analysis. The defendant is aware of the totality of the nuances of corporate organization and reorganization. It is plaintiff’s burden to clarify that development and its relevancy to the court in discovery and ultimately to the jury at trial. Evolution of Defendant’s Response to the Technical Problem The heart of the products case is proof of defendant’s disregard of a known product problem in face of a feasible solution to it. In addition to placing the suspect design in the several contexts noted above, the lawyer-researcher must track defendant’s own internal responses to the technical problem with exactitude. This capability will only be present after protracted discovery has yielded sufficient documentation and deposition testimony. This effort, in many ways the central purpose of all of the research efforts proceeding it, is no simple accomplishment. Except in the rare case of General Motors, whose corporate organization is a subject of graduate business school textbooks, the detailed internal structure of most corporations is a closely held secret. Aside from the concern over product liability litigation, companies realize that the competitor who knows the fine points of company organization and the assignment of technical or managerial personnel is that much closer to knowing the competition’s product development, production and marketing plans. The internal processes of most companies must thus be assembled in bits and pieces from publicly accessible materials and, in the main, corporate documentation received in the course of discovery. There are hundreds of thousands of corporate documents generated over a period of several years. Only a small portion of them are of genuine concern to the litigator. However, the fact that the materials of concern to the lawyer-researcher were generated as part of an enveloping process of doing business, coupled with the inevitable



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organizational and personnel shifts noted above, make the task of determining the evolution of defendant’s response to the relevant technical problem extremely complex. It is one of the most difficult and frustrating aspects of product liability litigation. Evolution of Common Law Responses to Technical Problems A vital portion of the overall research effort is that directed towards the litigation history of the suspect or comparable product. Identifying all settlements, jury verdicts and appellate decisions in either respect is of great importance on several fronts. Initially, the location of prior litigation will acquaint the lawyerresearcher with other lawyers who have had experience with the product, company, expert witnesses and associated research. In addition, an examination of ATLA settlements and verdict synopses and the reported decisions will acquaint the lawyer-researcher with the range of legal issues associated with the contemplated litigation and the judicial attitudes towards them. Law library research now has the capability of providing the lawyerresearcher with valuable sources of technical data as well as the more familiar legal sources, through the growing number of product profile and litigation journals reaching most medium size law libraries. An especially valuable source of important nonlegal materials are the Lexis and Westlaw databases, which carry increasing amounts of data relating to government agency activity, corporations and modern technology. Overview of Defendant’s Materials Suppliers and Marketing Scheme Identifying suppliers of materials and component parts is also an essential part of the litigator’s total research responsibility. The importance of this data lies mainly in respect to identifying all participants in the process of getting the suspect good to market, preliminary to a finalization of parties defendant. The bulk of these important questions can be answered prior to filing a lawsuit. The remainder should be resolved in the early stages of discovery. This area of research, while not as difficult or exacting as the other areas discussed above, is nonetheless a crucial part of the overall research plan.

Introduction to Detailed Research The greatest amount of the material that must be examined in the products case falls within one of three broad categories: state-of-the-art materials, government agency activity and documents related to corporate organization


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and decision-making processes. While the material related to the occurrence facts may be substantial, these areas of inquiry account for the bulk of the lawyer-researcher’s investigative and analytical efforts. Accordingly, the lawyer-researcher must have a general feel for the nature and types of materials accessible in any one area, as well as their relation to each other. All must be examined as to their investigative and legal significance. It is necessary to briefly discuss these materials to provide a context for the more detailed analyses to follow. State-of-the-Art Research The concept of the state of the art has two separate but related meanings in the preparation of the products case. In a theoretical sense it refers to the standard of testing, design or performance against which the propriety of the suspect product design is to be judged. In that sense it is an elusive standard. It can only be determined the balancing of a wide-ranging pool of data from academic, professional and industry sources. These, in turn, must be analyzed in light of technological and financial realities and basic consumer expectations. In this more theoretical sense, the totality of the materials falling within all of the areas to be referenced below have a direct bearing on the jury’s final decision on the adequacy of the instruction, warning or design choice under examination. From a purely investigative standpoint, however, state of the art refers to the materials generated by authoritative sources in the scientific, engineering and industry sectors that reflect the past and present thinking on the propriety of conscious design choices of the type under scrutiny. The materials generated by such sources are, of the three broad areas under discussion, the most varied in format, content and perspective. They are quite typically voluminous. These materials include technical studies by university professors, professional organizations, government agencies and industry related bodies such as trade associations. They include an increasingly large and sophisticated body of statistical data as well as technical standards proposals generated by the growing number of standards setting organizations in a wide variety of scientific and engineering disciplines. They include, as well, materials addressing comparative design analyses of similar or competing products in the broader industry under investigation. A typical time frame for investigation can easily reach back a decade from the date of the injuryproducing event. The control and efficacious use of such a significant amount of material requires concentrated investigative and organizational methodologies from the outset of case preparation.



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Government Regulation It is rare today for a product litigator to encounter a product that is not the subject, in some respect, of an existing, proposed, or analogous federal agency performance and/or testing standard or regulation. Cases involving drugs cannot be processed without a close working knowledge of the intricacies of the FDA. The same applies to cases involving automobiles, subject to the jurisdiction of the NHTSA. The CPSC and the FTC are steadily expanding their overseeing functions with regard to an increasing variety of manufactured goods. The research materials associated with the regulation of American manufacturers are expanding at a steady rate as regulatory efforts by these agencies move into new areas or the agencies re-evaluate the regulation of existing industries within their jurisdiction. The performance or testing standards promulgated by such agencies are, along with the academic and industry studies referred to above, indicators of the reasonableness of the defendant corporation’s conscious design choices. While the federal legislation creating such agencies generally state that any standards issuing from such bodies are to be considered “minimum” standards only, they nonetheless are a central point of reference in any products litigation where they are applicable. The material designated under the heading of “regulatory data” typically involves the history of the relevant regulation, and equally important, the efforts of the affected industry to forestall or water down any such regulation. Documentation generated from both the agency and the defendant in the course of a defects investigation or recall campaign are of great importance to the products litigator. Agency activities in these respects are often a prime source of company documentation otherwise unavailable until the conclusion of protracted discovery efforts months and often years into the preparation of the case. Federal agencies collect and analyze data that can be of great value, ranging from special reports, statistical data collections and technical bibliographies. The public correspondence files, including consumer complaints and formal petitions for investigative or rule making activity, likewise provide valuable information at the early stages of the preparation effort. This type of information is often dispositive on the issue of punitive damages. Finally, the area of regulatory data will often include formal tests run by independent testing bodies at the behest of a relevant agency. Such tests are occasionally contracted for as a means of supplementing the technical profile of the design area under investigation, necessitated by the often selfserving materials submitted by the companies in the course of such defect inquiries.


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Company Research The third broad area of research essential to the products case is general information about the industry of which the defendant is a part, as well as information regarding the history, organization and operational structure of the defendant corporation. The decision-making processes of the modern corporation are extremely complex, involving hundreds of individuals and multilayered office, department and committee structures. In most instances, decisions are based on the consideration of technical, marketing and financial analyses generated by numerous subcommittees and individual employees over a several year period. Given this inherent complexity in corporate planning and decisionmaking, it is incumbent on the products litigator to learn as much as possible about the day to day as well as long-term workings of the company under investigation prior to filing. The identity of suppliers of materials and component parts is basic to initial filing decisions. A knowledge of the key personnel and committees over the relevant time frame is essential to effective discovery and especially deposition planning. A solid working knowledge of the corporate group, office, department, section and even smaller functional employee groupings is eventually needed to accurately trace the flow of information culminating in questionable management action. Financial profiles are of central importance on the issues of economic feasibility of alternative designs as well as the issue of punitive damages. Broad-based general information that sheds significant light on these issues is becoming increasingly available prior to discovery from a wide variety of sources. This is the result of the proliferation of online computer databases offering extremely comprehensive source materials on corporate organization, personnel, technical and financial planning and marketing. These materials range from collections of annual reports and public filings, such as Securities and Exchange Commission (SEC) 10k reports, to professional and technical management studies. Until very recently, company and industry information was the most difficult of the three categories to locate prior to discovery. These materials are now readily available and nearly as voluminous as those in the state of the art and regulatory areas. Discovery will yield an even greater volume and specificity of materials ranging from detailed drawings and materials specifications to test reports, complex technical and financial analyses and organization charts not otherwise available from public sources.

Focal Points for State-of-the-Art Research It is important that the lawyer-researcher delineate a set of informational focal points before engaging in concentrated state-of-the-art research. Given



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the wide variety of information accessible in this area, the lawyer-researcher should attempt to concentrate his efforts on focal points that cut across the types of data likely to be encountered over the course of this significant undertaking. This is necessary to evaluate the legal significance of all material studied as well as estimating its primary investigative value. The most effective way of later accessing this data for purposes of estimating its legal significance with respect to strict liability theory is, as much as is possible, to delineate investigative categories that relate to the individual components of that theory. Keeping a close eye on the forest while examining the trees is the most efficient use of the lawyer-researcher’s time at this important stage of case preparation. The sections to follow will address some of the more important focal points in that process. Time Frames One of the most important decisions that the litigator will make in the total product liability undertaking is the determination of the historical points in time within which to gather product, regulatory and company information. This decision will eventually determine the boundaries of the historical within which the lawyer-researcher will ask the court and trier of fact to assess the legality of defendant’s conscious design choices. While for purely research purposes the lawyer-researcher may choose any period considered of background importance, the selection of time frames has central importance on the extent of discovery as well as the later introduction of evidence at trial. It should be stressed at this point that the typical products case normally involves several time frames that can vary in length from one to 40 years, operating simultaneously over the course of case preparation and trial. The introduction of a drug or manufactured item into the stream of commerce is typically the culmination of several years of planning and testing. Most products are rarely made of whole cloth. It is more often the case that the broad outlines of the product are determined by pre-existing technology both within and without the company. The task for the litigator is to determine the relevant historical antecedents of the suspect product unit, both in the company proper and the more extensive state of the art context of the type of manufacture under consideration. The precise identification of time frames cannot usually be determined with precision until the conclusion of discovery depositions. The catch-22 is that the lawyer-researcher is unable to effectively engage in prefiling research or discovery without some fairly firm idea of just what those time frames may be. The reason for this anomaly in the discovery area is that it is the lawyerresearcher’s responsibility to initially designate the time frames in preliminary discovery requests, normally the first set of interrogatories to defendant. This is effected, for example, by requesting the identification of all tests of a


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particular type for the years 1985–2000. The greatest degree of subsequent argument over the “relevancy” of plaintiff ’s discovery requests is grounded in the claim that the information sought in the designated historical period has little or nothing to do with the case at hand. The court, in ruling on the scope of proper discovery and the introduction of trial evidence, will eventually set boundaries on the several time frames involved. However, this is normally the result of protracted debate over the entire course of plaintiff ’s discovery efforts. Obtaining sufficiently expansive time frames in those regards is the key to successful products litigation. Hence, a major goal of prefiling research is to delineate the historical periods wherein state of the art, regulatory and company information will have probative value on the conscious design choices engaged in by the defendant in getting the suspect good to market. The material to follow will analyze in more detail the factors that must be considered prior to the lawyerresearcher’s initial decisions in this crucial aspect of case preparation. Criterion for Selection of Time Frames The selection of both investigative and evidentiary time frames will involve the analysis of several distinct but clearly related factors: • The generic type of defect or defects involved in the case, whether unit, packaging, instructions, warnings or overall design • The theoretical basis of the lawsuit, whether negligence, strict liability or misrepresentation • The status of the defendant in the scheme of manufacturing, distributing or marketing the suspect product • The model year of the product unit involved in the instant case • The approximate date that product planning was initiated by the primary manufacturer • The approximate date that knowledge of the relevant technology and associated problems became current in the state of the art literature and the subject industry The number of years in any particular time frame will vary according to the reason that period of time is selected out for study. A truncated period of time may be isolated to achieve a select investigative goal, while more expanded periods will be required to serve as predictable delimiters for discovery and later evidentiary offerings. The lawyer-researcher may delineate any time frame he or she chooses for investigative purposes. As research progresses, that time frame will expand and contract as familiarity with the technical, governmental and company



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source material indicates new leads or nullifies others. Eventually, the lawyerresearcher will have a feel for the appropriate period of time that will yield profitable research. The initial research conducted in the products case serves to educate the lawyer-researcher as to the location and nature of relevant source materials and to familiarize him with the broad outlines and terminology of the relevant technology and industry. It also serves to put in historical context the defendant manufacturer’s utilization of that technology and its general organizational and marketing schemes. The ultimate impact of time frames in the products case, however, is the controlling effect they have on discovery and proffers of evidence. The initial legal impact of the selection of time frames begins with the filing of plaintiff ’s first set of interrogatories. It is here that plaintiff designates the period of time within which he seeks information about corporate processes and the existence of documents. The designation of a request such as “List the title, date, requesting individual and subject vehicle for all fixed barrier, moving barrier or car-to-car crash tests conducted to determine windshield retention on the Ford Pinto sedan for the years 1969 to 1978,” initiates a long-term legal battle over the relevancy of any such materials. The difference between the meaning of relevancy for discovery, as opposed to evidentiary purposes, is a substantial one. The demarcation of time frames in discovery requests, in turn, have a significant bearing on the admissibility of evidence at trial. The materials subject to review in the discovery process are much broader, since the materials accessible in discovery are all materials that are relevant in an evidentiary sense plus those likely to lead to the discovery of relevant evidence (Fed. R. Civ.P. 26[b][1]). The latter concept allows for far reaching examination of materials in defendant’s possession or control. While large portions of investigative material may not qualify as admissible evidence, the time frame selected for investigative purposes does impact on discovery and the evidence that will be admissible at the trial. After initial research has been completed the investigative and discovery time frames tend to become identical. The selection of investigative and legal time frames requires careful planning, given the dramatic effect they have on the education of the litigator and, more importantly, the success of discovery and acceptability of trial evidence. Given their centrality to the entire products undertaking, time frames will be continually referenced in the remaining chapters of this book. The initial broad divisions to be considered in estimating the appropriateness of investigative and legal time frames are preproduction and postproduction activities. Once these are given preliminary consideration, more sophisticated divisions within each may be more profitably discussed.


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Preproduction Time Frames The preproduction research period includes corporate product development activity from the first preliminary thinking about product planning for a new product line. In instances of a preexisting line of goods, it would include planning and testing towards the refinement of a subsequent model year offering. In the latter respect, the basic design parameters of a later model will generally have been set in the first model year offering of the good. This results in the fact that corporate information associated with earlier models in the manufacturing cycle have direct bearing on the propriety of the design, instruction, warning or marketing decisions of the company with respect to the subsequently produced suspect product unit. This fact and the concomitant effect it has on decision-making and document generation within the company, is a major source of contention over relevancy throughout the discovery process. The preproduction stage also involves corporate testing programs, whether for internal performance standards or those standards currently or prospectively required by a federal agency. The major outlines of marketing strategies are also determined within this broad division of corporate activity as well as the corporation’s position relative to proposed government regulation. The success of the design case rests on a firm grasp of the intricacies of corporate document-generating and decision-making processes during this extended period of time. Postproduction Time Frames Corporate activity subsequent to the actual production of the suspect product unit has its central relevance in the failure to instruct, failure to warn, misrepresentation and punitive damage case. Activities included here are ongoing testing programs to meet the requirements of agency regulations that will take effect during course of the planned market life of the affected product line. It would also cover the development of advanced technology in comparable or new product lines. There is an increasing amount of case law allowing the admissibility of postmanufacture design changes and warnings on the issue of the feasibility of alternative designs.16 More recent case law holds that the bar against the introduction of postoccurrence change evidence is inapplicable to strict liability counts.17 Such data will be primarily scrutinized, however, for the light it sheds on defendant’s knowledge and accompanying duty to communicate, or not misrepresent, product dangers to the consumer. Further divisions of the two broad categories of pre- and postmanufacture must be made to clarify in the litigator’s mind the intricacies of corporate product development and manufacture and to delineate in a more focused



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way the direction that preliminary product research should take. It is also a necessary precursor to the choice of legal theories and the initial designation of time frames in the first round of discovery. Investigative and Legal Significance of Time Frames As with any aspect of research in the product liability case, the selection of time frames has both investigative as well as legal significance. From an investigative standpoint, the several time frames involved in the case set boundaries to the lawyer-researcher’s research responsibilities and thereby allow for a more focused and controllable research effort. In the early stages of research there may be numerous forays into the technical materials to follow through on a variety of investigative leads. Realistically, however, the generic defect types and legal theories tentatively identified as having applicability to the case will set the broad outlines for the relevant time frames. The rules of evidence and the need to cull out only the most telling as well as communicable data for jury presentation will eventually trim the data gathered in the larger time frame to more manageable proportions. Nonetheless, even a conservatively delineated time frame for investigative purposes will often generate a large volume of information that must be digested and efficiently organized prior to the final selection of material for inclusion in the case-in-chief. In cases falling within the design categories of defect, the lawyer-researcher’s research should preliminarily set the time frame to the earliest point when reference is had to the technology and/or design parameters involved in the case. Close attention should be given to the various periods of time where the lawyer-researcher is able to locate arguably relevant material on these subjects. A log containing the dates of all such materials with a brief description of their content and type will be very useful when later attempting to finalize the choice of time frame in plaintiff ’s initial discovery requests. The final choice of case time frames is a complex one, intimately related to the type of defects involved in the case and the theories of liability selected to channel it. Defendant’s knowledge of defect and feasible alternative designs, instructions or warnings is of central importance in these cases. As experts they are deemed to have knowledge of all such information. The chronological tracking of such data is thus a primary goal in the lawyerresearcher’s investigative plan. As the lawyer-researcher gains familiarity with the state-of-the-art materials relevant to his case, these time frames will become more obvious. Once the lawyer-researcher has completed his initial state-of-the-art research he should then organize this data by date to determine the periods of time indicating the most concentrated amount of discussion of the topics of concern to


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his case. This information will have great importance as focal points for the cross referencing of internal corporate activity. Defect Types The nature of the lawyer-researcher’s nonlegal research effort is directly related to the issue of the generic defect type or types applicable to the case. Each defect type requires the search for and examination of disparate blocks of state-of-the-art research materials. Important scientific and other technical literature is rarely company specific and often not directed towards a particular industry, let alone specific types of product design. While specialized publications aimed at the product litigator may organize selected blocks of technical literature around a particular product failing such as failure to warn, the bulk of the actual state-of-the-art materials are not so conveniently organized. Accordingly, the lawyer-researcher must conduct research with an eye towards the categories of data and their sources that have bearing on the defect type or types involved in the case. In the packaging case, the focus is on the development of packaging technology itself. The materials relevant to this subject will normally be far removed from the data normally accessed in cases addressing some aspect of actual product performance. Instructions and warnings cases often go hand in hand in product liability litigation. Poorly drafted instructions often mask an unknown or insufficiently clarified risk associated with the normal use of the product. Nonetheless, these theories of liability are sufficiently distinctive in focus that state-of-the-art data sources appropriate to the study of one will not necessarily be of value on the other. The materials addressing overall design defects, however, tend to be more cohesive and centered on the broad factual issues likely to be of interest to the lawyer-researcher. The perspective from which the suspect technology, design parameter or product type is discussed in the state-of-the-art literature is also important. Noting this perspective will provide the lawyer-researcher with a feel for the manner in which the authoritative sources view the risk potential inherent in the technology or design discussed. Such discussions may be limited to concerns over design problems or be focused along the lines of poor communication of product risks. Analyses may in turn center on purely marketing aspects of the subject. These various perspectives can delineate the degree to which the lawyerresearcher’s own analysis of the defect type or types deemed applicable to the case is actually supported in authoritative circles. While the research focus on the identification of applicable defect types is more apt to prove beneficial in the course of the lawyer-researcher’s legal research, it is nonetheless a perspective that also bears watching here.



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Information Sources State-of-the-Art One of the most debated issues in current judicial thinking on the subject of products liability law is the question of just what type of data actually constitutes the state of the art as the factual standard against which the defendant’s conscious design decisions are to be compared. However, there appears to be general agreement that risk information will generally emanate from three major sources: • Authoritative scientific literature • Government regulatory activities and routine data collections • Industry custom and industry directed literature The concept of the state of the art centers around several related legal and factual focal points. The state of the art from a purely legal perspective is the abstract standard against which the propriety of defendant’s conscious design or marketing choices are evaluated. The Restatement of Torts 2d, Section 402A, the accepted verbalization of the idea of strict liability for products prohibits the sale of products that are “in a defective condition unreasonably dangerous.”18 That admittedly vague standard is arrived at by reference to a combination of factual elements that will have developed over the period of the case time frame: • The development and current perspective of authoritative sources in the scientific community regarding the risk potential involved in the case • The development and current status of industry custom respecting the design or chemical formulation under scrutiny • The development and current status of voluntary or government proposed or mandated materials or performance standards The information issuing annually from these three major sources is immense. The actual material falling within any one broad state-of-the-art category is contained in thousands of books, articles, monographs and reports, published weekly. The individual sources themselves are published across the world in every conceivable language by thousands of book publishers and specialty journals. This reality must be added to the fact that the average historical investigative or discovery time frame for products liability cases 15 to 20 years. Accordingly, the products-science litigator is faced with



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a formidable task in attempting to locate, access, interpret and organize the relevant body of world literature necessary to successful case preparation. The great appeal of the rapid growth and development of online information databases and Web sites lies in the fact that all of these widely dispersed specialty books and journals sources may now be quickly and economically identified from several centralized sources. Access to the vast body of bibliographic databases is now easily available by modem on major database information services. Books Books and other printed materials will continue to be the mainstay of products liability case preparation and trial. The enormous amount of worldwide authoritative books and periodicals published each year, mandates the utilization of online database searching as the only efficient and cost effective method of identifying, locating and accessing such material. Once in hand, through library acquisition or purchase, the actual books, articles and reports may be studied in detail and integrated with relevant aspects of the legal and factual parameters in the case. Identifying treatises and other scholarly collections is essential to achieve a thorough understanding of authoritative thinking in the area of science, medicine or pharmacology under investigation, as well as to identify potential expert witnesses. Major library reference works, such as Books In Print, are now available online. In addition, a growing number of major universities have placed their entire library card catalogs online for searching by alumni or the general public. Popular Publications Popular publications covering a wide variety of interests are a principal early information source in products liability case preparation. There are literally hundreds of magazines devoted to the hobbyist or enthusiast in virtually every aspect of recreational or specialist endeavor. Consumer oriented magazines, such as Consumer Reports, are of special interest to the products litigator. This type of popular publication, while not intended to be authoritative in a scholarly or professional sense, can nonetheless provide the researcher with a number of items of information not likely to be located in any other single source. Listed below are some of the normal contents of these magazines that can be of considerable value at the early stages of case preparation: • A range of advertisements for products, providing a quick entre to comparative product analysis. Back issues will provide a historical



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record of the range of products available in the target defendant’s chosen market • The identity of trade associations or other national information sources addressing the broad interests of the readers of these such magazines, such as the Recreational Motor Vehicle Association or the National Ski Equipment Manufacturers Association • Product reviews, product announcements and price comparisons • Bibliographic references to more technically oriented materials One of the first tasks should be the identification of any such popular specialty magazines. A subscription to the publication and a close examination of the back issues covering the case time frame should be a top priority. Academic and Professional Journals Technical information contained in academic and professional journals are the most significant data in the entire case preparation effort that should be located, accessed and mastered. It is in this body of literature that most of the risk-associated data constituting the relevant state of the art of product design or chemical formulation is likely to be found. The number and variety of academic and professional journals, articles and monographs published across the world each year is immense. A significant amount of the literature from the worldwide scientific community of scholars, emanates from foreign countries. Fortunately, English has become the language of science. Accordingly, the greatest number of scholarly articles or monographs likely sought by the litigator, are available in English or English-language abstracts. The appendix herein will provide many leads to these sources. Identifying the scholarly publications relevant to case preparation can be accomplished in several ways. One method is to consult the scholarly bibliographic databases accessible on Dialog, Northern Light, Medline, or Compendex, or a host of similar comprehensive bibliographic resources. A large number of such sources are provided in the appendix, such as A Research Guide to the Science-Based Case, that utilize a group of related publications as the source material for an enormous number of bibliographic citations and abstract listings. Academic and Professional Conferences and Exhibits An important component of early case preparation is the identification of the annual academic or professional conferences conducted throughout the world by scholars working in the fields relevant to the technology under investigation. The numerous conferences held each year typically address the most current issues or developments in that field through the presentation of papers and the


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conducting of seminars, colloquia and workshops. The importance to the products litigator lies in the fact that these papers are normally published in annual proceedings collections which are accessible for review and study. Conferences typically attract the leading scholars in their respective disciplines. Accordingly, the papers presented not only provide counsel with the most contemporary discussions of the pressing issues but also a list of potential experts. While the bound copy of the conference proceedings may not be available in most public libraries, they are normally accessible from university collections. Several online databases now exist that provide the products litigator with complete information on the schedule, content and, often, the publications issuing from this important source of state-of-the-art information. Trade and Professional Associations Another very important research goal in the early stages of case preparation is the identification of the trade associations identified with the industry within which the target defendant does business. Trade associations are not only a valuable source of industry and product specific information. In some instances, they may well qualify for inclusion as a party defendant. They regularly serve as lobbyists for their respective industries. These organizations typically publish journals that supply the products liability litigator with several important classes of current and historical data: • The industry’s position on proposed government agency performance and/or test performance or recordation standards • New product reviews, often providing a historical analysis of industry design developments • Schedules of professional meetings and trade shows • Statistics and other reports on injuries associated with the range of company types that compromise the industry • The schedules for trade shows or exhibits, which provide a tremendous opportunity for actual comparison of current product lines and the collecting of sales and promotional literature generally unavailable from any other central source Trade associations exist for virtually every industry that counsel is likely to encounter in the course of a products liability practice. In many instances, several trade associations exist to serve as lobbyists and information gatherers for a single industry. It is important to study back issues of these journals to gain a historical perspective for case research and to reference current issues to track significant ongoing developments in the industry or company under investigation.



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Dissertations and Masters’ Theses It is a rare situation when counsel is unable to identify and access technical materials related to the product involved in the case being prosecuted or defended. However, in instances of new technology, or the development of new chemical or pharmaceutical formulations, counsel may be at a loss to find sufficient data with which to gauge the potential of the suit or adequately prepare it once the decision has been made to file. An important potential source of information in these settings are the wealth of doctoral dissertations and masters’ theses completed each year in universities throughout the world. The ability to identify relevant dissertations or theses has the additional value of providing complete background studies of case expert witnesses when preparing for depositions or the cross-examination of expert witnesses at trial. This information has recently become available on optical disk. Government Publications The number of books, booklets, pamphlets and reports published each year by the various agencies of the United States government is tremendous. These publications are normally free of charge, or available at a very low cost. The range of subjects addressed in this literature covers the gamut of topics likely to be of interest to products liability litigators. Information U.S.A. and the Federal Database Finder, with which one can check books in print and cite web pages, are essential sources for tracking the information available from the federal government. These two volumes should be in the library of every lawyer, regardless of the areas of law in which he or she may practice. Information available from the federal government that will be of value to products litigators come in several forms: • Routine reports prepared by agency offices and departments • Books and pamphlets describing agency services and regulations • Articles, monographs and intermediate or final reports by private researchers doing work with federal grant or contract funding • Investigative materials available pursuant to a Freedom of Information Act request Research In Progress Due to the length of time typically associated with the progress of products liability litigation, it is important that counsel identify current research projects that address the technology or aspect of chemistry or pharmaceutical formulation involved in the case. In addition to the fact that the fruits of that


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research may be of value at later stages of case preparation or trial, it is good trial practice to leave no gaps in counsel’s knowledge of the scientific subjects in which the case is centered. The ability to identify and track the progress of ongoing scientific and medical research may also result in the location of expert witnesses in cases of injuries resulting from new technology or drugs. The number and variety of research projects underway in the world, at any one time, is enormous. It is virtually impossible to identify all of them. However, an increasing number of online databases now provide the ability to identify such research in many significant areas of interest to products liability litigators. Research Grants An additional method of insuring that counsel is aware of all current academic or other research activity with respect to the technology or chemistry under investigation, is to identify all research grants that have been allocated for work in those or related areas. This is especially important in new areas such as toxic torts or innovative areas of industrial manufacture. Identifying the character of prospective research will allow counsel to track contemporary thinking on the subject and to obtain any interim reports that may become available over the course of case preparation and trial. Research projects receiving funding from the United States government typically publish lengthy interim reports as part of the grant conditions. You should be aware of the scheduled dates for the issuance of any such reports and be in a position to immediately identify, locate and access them. The number and variety of funding bodies and funding proposals is significant. However, given the importance of the activity, very sophisticated methods have been developed to keep track of the more significant governmental and private granting bodies and their grant recipients. As noted, this important information is available on the Internet and listed in the appendix to this book. Insurance Industry Publications Journal articles published by various organizations in the insurance industry are a potential source of important safety related literature. This is especially the case in the area of automobile products liability litigation, where the Insurance Institute for Highway Safety publishes a steady stream of monographs addressing current safety issues in automotive design. Publications issuing from disparate sectors of the insurance industry can prove of value, if only for the citations to available reports addressing safety issues that counsel may yet have located during the course of case preparation.



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Statistical Publications and Data Banks Statistical data is gaining increasing importance in the trial of product liability cases. Statistics have always been a feature of this area of litigation, especially in cases involving prescription drugs and toxic chemicals.19 As plaintiff and defense counsel gain greater familiarity with statistical modeling and data gathering techniques, statistics will become an even more familiar component of products liability case preparation and trial. Earlier, it was noted that one of the types of information available on commercial or government databases was numerical or time series data. A significant amount of such data is statistical in nature. In addition to the availability of online statistical data, significant amounts of statistical information is available free of charge from numerous agencies of the United States government.20 The subjects covered range from the Fatal Accident Reporting System (FARS), maintained by the National Highway Traffic Safety Administration, to detailed statistics on aircraft injuries, demographics and a host of other subjects of keen interest to products litigators. Materials, Design and Performance Standards Government or industry-generated materials and performance standards are one of the primary focal points in the preparation and trial of the products liability case. It is unusual to encounter a manufactured good for which some recognized standards-issuing body or a government agency has not either proposed, recommended or mandated some standard. These standards are a constant point of reference in gauging the technological propriety of the construction or performance of the suspect product involved in the litigation. There is a significant body of existing government imposed or industry voluntary standards. In addition to American standards, there is an increasing amount of foreign standards that counsel must locate and master. All of these standards undergo continual revision. Proposals for new materials, design or performance standards are also continually emerging from agencies of the United States government or major private standards issuing bodies such as the American National Standards Institute (ANSI) or the American Society for Testing Materials (ASTM). Identifying, locating and accessing relevant materials, design or performance standards, is an extremely important research goal at the early stages of case preparation. Due to the development of online information databases and substantial improvements in the ability of the user to search through them on a keyword basis, this extremely versatile and complex body of knowledge is readily available to products litigators.



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In addition to the online database sources discussed below, significant amounts of standards information is available by directly contacting numerous technological centers maintained by agencies of the United States government. Consumer Groups and Publications An abundance of material on product safety is available to products litigators from an expanding number of organizations dedicated to the interests of consumers. They range from the more organized large-scale entities such as the Center for Auto Safety in Washington to small, diversified consumer interest groups. There is a wide variety of printed material and organizational expertise on which to draw in a range of products liability case preparation endeavors. Consumer groups are a central source for the identification and location of authoritative journal materials, monographs, government reports and pamphlets. Many such organizations maintain a network of experts who are available for consultation and/or deposition and trial testimony. These organizations are widely dispersed and not easy to locate through traditional sources such as phone directories. Fortunately, the growing number of online databases and Web sites have become available to provide counsel with ready access to these valuable research tools.

Endnotes 1. 2. 3. 4. 5. 6. 7. 8. 9.

10. 11. 12. 13. 14.

Restatement of Torts 3d, Section 402A (1998). Restatement of Torts 2d (1965), Section 402A. See, e.g., United States v. Carroll Towing Co., 159 F.2d 169 (2d Cir. 1947). See, e.g., Ferebee v. Chevron Chemical Co., 736 F.2d 1529, (D.C.Cir. 1984). Toyota Motor Co. v. Moll, 438 So.2d 192 (Fla.1983). Restatement of Torts 2d, Section 402A (1965). See Appendix, “Researching the Science Case.” See Chapter 4, Law, Science and Causation. See, e.g., Schultz v. Rockwell Mfg. Co., 108 Ill. App. 3d 113, 438 N.E.2d 1230 (Ill.App.Ct. 1982). Also see, Owen, “Defenses Based On User Misconduct,” 1983 SMU Products Liability Institute, at §§11.01–11.19. Restatement (2d) of Torts, §§402B. See advertising database cites on Dialog and Internet. See Chapter 7, Science and Business Practices. See, generally, Jerry J. Phillips, “Product Line Continuity and Successor Corporate Liability,” 58 N.Y.U. L.Rev. 906 (1983). See Appendix, “A Research Guide for the Science-Based Litigation.”



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15. See Appendix, “A Research Guide for the Science-Based Litigation.” 16. See, e.g., Ault v. International Harvestor Co., 13 Cal.3d 113, 117 Cal.Rptr.812, 528 P.2d 1148 (1974), Shelbauer v. Butler Mfg. Co., 673 P.2d 743 (Cal.1984). 17. See, Sanderson v. Steve Snyder Enterprises, 196 Conn. 134 (1985); Holmes v. Sahara Coal Company, 475 N.E.2d 1383 (Ill.App 5th, 1985); Caprara v. Chrysler Corporation, 52 N.Y.2d 114, 417 N.E.2d 545(1981). 18. Restatement of Torts 2d (1965), Section 402A. 19. See Appendix, “Researching the Science Case,” for statistical source data. 20. See Appendix, “Researching the Science Case.”



6

Science and Expert Witnesses

“When I use a word,” Humpty Dumpty said, in a rather scornful tone, “it means just what I choose it to mean–neither more nor less.” “The question is,” said Alice, “whether you can make words mean so many things.” “The question is,” said Humpty Dumpty, “which is to be master — that’s all.” — Charles Dodgson (Lewis Carroll), Through the Looking Glass

Introduction The central subject of expert witnesses has already been extensively discussed, in Chapters 1 through 4, in the context of science in litigation history, recent Supreme Court jurisprudence, the peer-review process, and causation theory. It is necessary now to address the subject in more practical terms. What expertise is needed? Where is it found? What must be in hand from a planning standpoint before any experts are sought? What should the key concerns be regarding qualifying at trial and trial experience? There are a multitude of considerations that this chapter discusses to assist the products litigator from the beginning of preparation through trial. Expert witness assistance and testimony is essential to successful product liability litigation. Counsel needs experts to provide both narrative testimony regarding the state-of-the-art context of the case as well as expert opinion on the primary issues of product defect, feasible alternative design and proximate causation. However, expert witness participation in the prefiling research and investigation, discovery, and motion-in-limine stages of the case is also central to the products undertaking. Hence, experts should become involved at the very early stages of case preparation. While the expert is a tremendous source of technical information and guidance and the centerpiece of trial testimony, the lawyer’s technical independence is essential. Gaining technical competence is a basic requirement

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for effective performance at every stage of the case, from drafting the complaint to engaging in discovery and conducting examinations at trial. Such competence also provides a substantial basis for counsel’s initial determination of expert witness needs as well as for the ensuing selection and utilization of expert witness support. Immersion by counsel in the broad range of materials discussed in Chapter 1 is of particular importance in all working encounters with the expert or experts eventually engaged. Some experts welcome the inadequately versed attorney as a source of extensive fees necessitated by the giving of technical tutorials. However, the best — and hence, the busiest and most sought after — will shy away from an attorney who appears not to possess basic knowledge of the technical area involved. The lawyer’s self-generated technical education will also go a long way toward minimizing often staggering expert witness expenses. Experts do not come cheap. Leading experts in various fields have complex support staffs and often command an average of $125 per hour and $1250 per day for deposition or trial testimony. It is essential that such expertise be used sparingly. Too many products litigators have seen otherwise closely shepherded expense funds gradually whittled away by unnecessary phone calls and conferences with their experts. The problem is exacerbated if, as is increasingly the case, more than one expert is engaged to assist in the litigation. Comprehensive prefiling research of the type discussed throughout this book can greatly lessen expert witness costs by reducing purely educational contacts to a minimum.

Determining Expert Witness Needs The question of expert witness needs should be analyzed from the dual perspectives of counsel’s legal and investigative requirements, the same as with any other aspect of the total preparation effort. The expert has much to offer in the purely investigative aspects of case preparation, especially in the identification of occurrence facts that may be determinative on the crucial issue of proximate causation. The selection of the expert is one of the most important decisions that will be made throughout the entire case. In many ways it is one of the most difficult due to counsel’s initial unfamiliarity with the range of technical issues involved. Once that initial determination is made, however, the utilization of experts should be prioritized according to the sequence in case investigation when such assistance is required. Several categories of experts need not be utilized until counsel is ready to initiate discovery, while others need not be called upon to any significant degree until the case approaches trial. The ever



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present need to control expert witness costs requires close planning regarding the actual uses of the expert. The following discussion addresses several approaches that may be utilized to resolve the important threshold issue of pinpointing the range of counsel’s requirement for expert witness assistance. Categorizing Expert Witness Needs The primary guide to the determination of the overall extent of the need for expert assistance is counsel’s preliminary research on the broad state-of-theart context of the case. This will indicate the specific technical areas generally involved in cases of the type under investigation. As preliminary legal, state of the art, regulatory, and company research proceed, counsel will see the general outlines of the technical areas central to the resolution of the broad legal issues that will control the pending litigation. Counsel should categorize those technical areas that appear to be arguably separate fields, as a first step towards the final determination of expert witness needs over the entire course of the litigation. A case involving the crash worthiness of an automobile fuel system will serve as an illustration. Counsel may initially determine that the following categories of expertise may be involved: general automotive design; fuel system design in particular; automobile crash testing methodology; metallurgy; accident reconstruction; National Highway Traffic Safety Administration regulatory processes; corporate documentation and decision-making processes; corporate accounting principles; and statistical analyses. Once the gamut of expert witness types has been sketched out, counsel should then make a determination of what additional specialized expertise, if any, may be required by the particular facts of the case under investigation. All such categories of expertise should then be prioritized with respect to when such experts need be contacted for investigative, discovery, or trial purposes. The actual retention and utilization of these experts should be staggered accordingly. Case Analysis Each case, while involving a broad range of technical issues, is generally centered around several that actually will be determinative of the outcome of the case. The key legal and technical issues are those specifically related to defect, feasible alternative design, and proximate causation. The occurrence facts must be placed in the general state-of-the-art context having compelling relevance to the resolution of the totality of the legal and technical issues involved. However, counsel must further refine those considerations and identify the unique occurrence facts that lie at the heart of the death- or


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injury-producing event. He must pinpoint the precise technical causes of the injury-producing event. In the fuel system hypothetical discussed above, counsel may determine that the company’s overall fuel system design and general testing procedures fall well below acceptable standards. Eventually he will determine that the precise problem in the case at hand is the inadequate gauge of the metal used in the fuel tank and the method of spot welding of both the tank halves and the floor pan sheet metal. It would be those precise technical failings which contributed to tank puncture and the entry of fuel into the passenger compartment. Once the precise technical shortcomings have been isolated, counsel can then proceed to classify additional areas of expertise having less immediate impact on such basic issues. ATLA Inquiry The Association of Trial Lawyers of America (ATLA) Exchange is an excellent source for a full range of information relating to the potential products case. A primary purpose of the ATLA Exchange is supplying members with focused product research and bibliographies. It is also a valuable source in assisting counsel in determining the scope of their expert witness needs by supplying the names of lawyers involved in similar litigation. While ATLA does not formally keep a list of the types of experts required in classes of product liability cases, nor a list of approved experts, the data supplied by them is of great assistance in obtaining a feel for the areas of expertise involved as well as pinpointing leading experts in the relevant fields. The list of attorneys engaged in similar litigation is a valuable source for initiating contacts with those who have been through the difficult process of finalizing expert witness assistance in such cases. While an excellent source of information, the ATLA Exchange should be only one of several avenues of approach taken in the important search for the right expert or experts. As the data expands and becomes more sophisticated, it will be a much more complete fund of expert witness information. At the present time, the ATLA Exchange serves as only one of the primary sources of information on expert witness availability. Other Lawyers Consultation with other lawyers involved in similar litigation is a tremendous source of information on every aspect of case preparation. This is especially so with respect to the determination of the scope of expert witness assistance. Once counsel has begun broad-based prefiling research and made a thorough analysis of his case, these contacts can be focused along the specific needs of



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counsel’s planned litigation. The other lawyers can review the general technical areas of expertise involved, the unique features of counsel’s particular case, and supply the names and qualifications of experts and organizations known to them who may be contacted for further, more focused inquiries.

Prioritizing Expert Witness Needs The corporate defendant will routinely hire a multitude of outside experts from varied fields to both initiate and finalize case preparation. A large number of highly trained technicians are also employed for the execution of routine corporate processes who can and often are called upon to join in the overall defense effort. This latter factor gives even greater urgency to plaintiff counsel’s decision regarding the nature and extent of expert witness assistance to be utilized in the case. The financial and technical imbalance between plaintiff and defendant is a major concern in this type of litigation. Carefully prioritizing expert witness needs is one way to rectify this financial disparity. Technical expertise on product defect, feasible alternative design, and proximate causation is counsel’s primary concern. The case cannot proceed — let alone have any hope of success — without it. Any one category of expertise is generally ill-equipped to speak to the totality of concerns involved in the case with any degree of confidence. Contracting with more than one expert is rapidly becoming common practice for plaintiff’s counsel in products cases. In some instances this results in an obvious but necessary overlap in expertise. In addition to purely technical experts, the employment of several nontechnical products experts of one type or another is becoming an increasing fact of life for the products litigator. This makes the prioritization process and its concomitant financial impact of central concern throughout the litigation. The material to follow will address the categories of experts potentially involved in the products case.

Choosing the Expert: General Considerations Expert Witness Research Services It is important to briefly note the range of research and initial diagnostic services that expert witnesses, in particular, the larger expert witness service corporations, are increasingly able to provide. It is essential that counsel maintain relative parity with the expert witness in regard to the history and current status of the applicable state-of-the-art, as well as specific aspects of design or technology particularly relevant to the case. Delegating that responsibility almost completely to an expert witness can be very counterproductive


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as well as exorbitantly expensive. Counsel’s subsequent attempts to gain control of the range of technical and legal issues confronting him can be significantly impeded by any such wholesale delegation of technical research. Expert witness service corporations are ready and willing to do that basic research for the products litigator. They will make an initial diagnostic evaluation of the case with preliminary opinions as to general technical liability, proximate causation, general prospects of success, and a complete breakdown of steps needed to initiate a full-blown investigation of the case. Preliminary research on the general and specific state-of-the-art will be provided as well as profiles of the structure and regulations of relevant government agencies. A complete search will be made through all available technical and governmental data sources. All materials will be cataloged and indexed. Reports summarizing and integrating such data with the occurrence facts will also be provided as research progresses. It is not the intent of this section to demean the value of such services or the professionalism and organization that go into providing them. The concern that lies in any extensive utilization of such broad-based preliminary research services is twofold. The first concern is the tremendous expense that such work entails. The second, with the most negative long-term impact, is the effect that too heavy reliance on such services will have on counsel’s ability to meet his individual responsibilities in virtually every subsequent stage of case preparation. These services require a considerable time investment by those providing them and very quickly can involve enormous expense. In addition, it can never be forgotten that no matter how experienced experts are in the litigation of products cases, they are not lawyers. Counsel’s undue reliance on a nonlawyer to choose the materials within which he will ground his case is risky at best. Other Nontechnical Services There are a number of other contributions that the more experienced experts can make that fall under the general category of nontechnical services. Many of these can be of lasting significance to counsel over the course of the preparation effort. Experts who have had experience with the corporation under investigation can quite often supply valuable information regarding the technical context of defenses available and/or currently used by the defendant. They are often primary sources for information respecting defendant’s corporate structure and processes, the identity of key employees and the relative strengths and weaknesses of the experts that defendant will or may engage in their defense. In addition, such experts often have in their possession documents of the defendant not subject to a protective order, that were



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obtained in the course of working with other lawyers in similar litigation. The latter can be of inestimable value to counsel in preparing interrogatories and requests for the production of documents. Expert Witness Clearing Houses Another, more recent, source of information on the availability and location of expert witnesses is the expert witness clearing house. Initially developed for the medical field, this type of organization now exists to cover virtually every field of interest to the products litigator. These organizations serve as registries for experts who are sole practitioners or associations of experts in related fields. Regardless of the degree of affiliation between the registry and the experts they serve, such organizations can be of great assistance to the products litigator, by initially screening counsel’s perceived needs and then putting the lawyer in contact with a selection of experts who meet his or her qualifications. An increasing number of such clearing houses regularly advertise in the pages of Trial Magazine, the monthly magazine published by ATLA.

Choosing the Expert: Organizational Factors Organizational Factors The bulk of the information that counsel needs to resolve his expert witness selection problem, should be obtained from the experts under consideration themselves. On occasion, due to the limited number of experts able to speak to a particular subject or the preeminence of a certain expert, counsel’s choices may be limited. In such instances, counsel should nevertheless conduct a thoroughgoing interview with the prospective expert. The expert witness business is a business like any other, with each party to the initial negotiation attempting to sell the other. The image of the expert witness as the absent-minded professor with pipe ashes on his pants is increasingly becoming the realm of fiction. Today’s expert witnesses, especially those associated with the burgeoning number of expert witness service corporations, are a far cry from the academics whose services were called upon almost exclusively in the early days of product liability litigation. In addition to the interview with the prospective expert, counsel should definitely consult with attorneys who are currently using the expert or have done so in the recent past. Counsel should also be sure to consult attorneys with whom the expert has worked that are not on the expert’s list of formal references. Such attorneys can provide invaluable insights into virtually every area of concern to the product litigator faced with the difficult task of engaging a particular expert witness.


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The ensuing discussion will provide a detailed analysis of focal points for the selection of expert witness assistance. Counsel must obtain sufficient data with which to make an informed decision on whether or not the structure, services and qualifications provided by the organization or individual under consideration fit the specialized needs of his case. Sole Practitioners There has been a dramatic change in the pattern of expert witness participation in product liability cases over the past decade. That change is the result of the rapid growth of expert witness service corporations of increasing size and complexity. This has resulted in the concomitant displacement of the sole practitioner or several member organization as the key figures in the preparation and trial of the products case. The classified section of Trial Magazine and other more formal sources of expert witness availability still advertise the skills of single or small groups of individuals able to testify and do technical research on a bewildering number of subjects. The fact remains, however, that increasingly today, such individuals are being supplanted as the primary source of expertise in the products field. Accordingly, an initial discussion of the advantages and disadvantages of the sole practitioner vs. the expert witness service organization is in order. It should first be recalled that counsel may not have a choice due to his or her being the first to bring a suspect product type to litigation. In those areas, the fields of expertise may be such that the large expert witness organizations are simply unable to supply or subcontract with an individual possessed of sufficient background to meet counsel’s broad requirements. Admittedly, this hypothetical situation is becoming a rare phenomenon, due to expert witness service organizations constantly expanding the range of experts working for them. Disadvantages of Sole Practitioners The past decade has seen rapid progress in the field of laboratory technology for both product evaluation and accident reconstruction. Corporations have continually increased the amount of money spent in these cases to avail themselves of such technology. Due to this reality, a sole practitioner may have to be passed by due to a lack of technical facilities with which to take advantage of the most recent scientific methods for product and occurrence evaluation. The increasingly hierarchical nature of expert witness service corporations, with their highly refined areas of responsibility, wealth of scientific equipment, extensive support staffs and expanding areas of expertise, put great strain upon the sole practitioner in attempts to compete with the well-financed and supported corporate defendant.



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Another potential drawback to the sole practitioner is the lack of accessibility. In addition to the increasing technological inadequacies of the sole practitioner, there is the important factor of available time as a central consideration. The sole practitioner, especially in the fields relevant to engineered products, has little or no backup support and — if effective in their field — are generally constantly on the go, studying accident sites, and product units across the country. Their unavailability in instances where time is of the essence can have harmful, and at times long-lasting, negative effects on the prosecution of a products case. Advantages of Sole Practitioners Given the above concerns, there are nevertheless several advantages to using the sole practitioner if counsel is confident that he has the technological capability of competing with defendant’s expert witness support team. Initially, the opportunity exists for counsel to develop a personal relationship and shared commitment to the case and the client, important factors often sorely lacking when utilizing the services of an assigned employee of a large expert witness corporation. Many a lawyer who has called his organization expert has been put off by the highly structured nature of the parent organization and their less than personal touch in dealing with attorney contacts. These are not factors that should be lightly brushed aside, given the realities of a commitment of several years and untold energy to a very complex and personally frustrating undertaking. Another advantage to working with the sole practitioner is the possibility of more flexible fee schedules and payment arrangements. The fee schedules of the expert witness corporations are rigidly adhered to and bills processed and mailed with great efficiency. Computers are utilized for billing as well as product analysis and technical research. Finally, counsel must consider the expertise of the expert witness as a witness proper. The witness whose skills at communication and handling rigorous cross-examination are deficient and no bargain, regardless of the level of technological support possessed by the organization with whom he is associated. Staff Support The greater number of employees and areas of expertise, as well as the purely technological support available to the large scale organization, increases the flexibility of it in responding to counsel’s needs. These factors allow for greater input into the final determination of defect modes, proximate causation, overall technical strategy and the like. This extended capability has obvious advantages over the more limited capabilities of the sole practitioner.


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This should be a major consideration for counsel, given the fact that defendant will be able to draw on similar if not greater technical resources in the course of preparing an overall defense. Some of the larger organizations have staffs with as many as seven levels: principal; principal consultant; supervising engineer; senior engineer; staff engineer; engineer; associates; and consulting specialists. Likewise, the same organization may have its purely technical staff further divided into subdivisions. A common structure may include: senior technologist; senior technician; technician or laboratory assistant. Other organizations will have less complex staff classifications. Counsel should be very aware of the organizational structure and exactly to what degree, if any, the expert witness who originally attracted him to the service will be actively involved in his particular litigation. In large scale organizations built around the reputation of one or more preeminent experts, the chances of such persons getting deeply involved in any one litigation are relatively slim. There is, however, a great negotiating value in being able to represent that such an individual or organization are on plaintiff’s team. Aside from the overall quality and efficiency of such organizations, defense counsel is aware that you are capable of competing in regard to any technological aspects of the case. Technical Facilities Counsel should make detailed inquiries about the specifics of laboratory equipment owned or available to the expert. Counsel’s preliminary research and discussions with other lawyers should provide a basic grasp of the type of equipment needed to conduct the basic, as well as the more sophisticated, scientific analyses that may be involved in the course of the litigation. This technical understanding is very important to making an effective decision. The potential expert witness should be thoroughly interviewed on the subject of their technological support.

Choosing the Expert: Individual Factors Range of Past and Current Projects An examination of the current and past projects of the expert or organization, as well as the professional background of the principals and senior staff, provides counsel with important data regarding the true capability of the expert under consideration. Such information will also go a long way towards the determination of any such person’s ability to qualify to testify on key aspects of the case several years down the road.



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This is a central concern for counsel, who should take with a grain of salt any representations that later qualification to testify are of minimal concern. An additional focal point is the degree to which the expert or organization testifies for corporations or plaintiff ’s counsel. If the information indicates that a substantial amount of the energies of the expert has been and is devoted to the defense of corporations, counsel, given the option, may wish to look further. Qualifications An important factor impacting on qualification and credibility at trial is the extent of his or her professional associations and publications. Counsel should obtain a complete listing of all books, articles and other professional papers written by any expert that may be a potential deposition or trial witness in the anticipated litigation. These should be readily available and will provide counsel with valuable information as to the range of expertise actually possessed by the individual under consideration as well as reveal any areas of inconsistency that may create troublesome cross-examination problems later in the case. References As with any other potential professional relationship, references should definitely be obtained. Quite naturally, counsel cannot expect the expert to give him names of attorneys who have had an unsatisfactory relationship with him as formal references. It is counsel’s responsibility to obtain a list of all attorneys requiring comparable skills that have engaged the expert under consideration and make his own inquiries. It bears repeating that these lawyers can provide vital information in virtually every area of concern in this extremely important decision in the products case. It is here that the ATLA Exchange can provide valuable guidance. Accessibility and Work Product Counsel should definitely inquire as to both the nature and frequency of receipt, of technical materials, reports and updates to be forwarded pursuant to the general outlines of the service agreement entered into. Additionally, for service organizations, counsel must determine the policy of the corporation regarding the accessibility of assigned experts as well as any policy relative to the substitution of personnel at any stage of the preparation effort. Experienced experts should be able to provide counsel with a list of tasks to be performed, the work product issuing from them and an estimate of the lead time necessary to complete the task and prepare and forward written


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materials. Their inability to do so should be considered an important negative factor in their possible inclusion on the expert witness team. Expert witnesses are no different than lawyers in regards to giving their closest attention to files in which the prospect of trial is imminent. Counsel should realistically expect a certain amount of delay in receiving materials, even a degree of frustration in attempts to contact the expert for answers to important questions, it may be better to set times for conferences. Delays and unanswered phone calls, beyond what is to be expected as the result of the cluttered schedule of any busy professional, can have serious repercussions on the overall preparation of the case. Other lawyers experienced with the witness and/or the organization of which he is an employee can be invaluable in gauging this extremely important component of expert witness assistance. Here, as with the other selection criteria discussed, getting the subjects on the table at the beginning will be of great value in assisting counsel in arriving at his or her final decision. Fees and Billing Procedures Retainers, fee schedules and billing procedures are primary areas of inquiry in the interview process. Counsel must get a broad estimate of the categories of services that will likely be employed as well as those that are optional, given the range of expertise capable of being utilized for any aspect of case preparation. If the expert is sufficiently experienced, these broad figures should be readily available. Experts, like airlines, have preparation packages ranging from “no frills” to “first class.” Counsel should inquire as to the capabilities of the expert relative to specific aspects of the preparation effort, the options that may be exercised for any one stage — for example, accident reconstruction — and the accompanying costs. Another cost-related area of inquiry when dealing with the expert witness service corporation is the general operating procedures for the levels of staff participation in the overall effort and how those procedures translate into costs to the lawyer. The possibility of double or triple billing due to an assignment being bumped from one staff level to another is a real one, and should be investigated during the course of initial interviews. Indemnification Agreements Counsel should make very specific inquiries about the nature of any indemnification agreement that the organization may wish him to execute. A recent development on the expert witness scene is the gradual proliferation of indemnity agreements as a condition precedent to counsel’s utilization of the expert witness organization’s services.



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These agreements provide that counsel will purchase insurance for or will personally undertake to cover the defense of the expert in any action brought against them resulting from their participation or work product in the contemplated litigation. Counsel must additionally agree to pay all costs, including attorney’s fees, and the amount of any judgments entered against them as a result of alleged negligence on their part. These hold-harmless agreements not only cover allegations of expert witness malpractice, but also include any death or personal injury that may result from any service or work product supplied by them during the course of the litigation. The steady growth of the large expert witness service corporation will no doubt result in the increased presence of such agreements. Counsel should think long and hard before executing any such indemnification contract. Current Case Load and Schedule An important aspect of the working relationship between the lawyer and expert, in particular the lead technical expert, is the ability to communicate and develop the technical ends of the case along parallel lines. Counsel should determine the current and projected case load and typical travel and testimonial schedule of any individual under consideration. He should get an estimate of the effect of any such schedule on work product output and general availability. While it would be unrealistic to determine these factors two to three years down the road, the expert should be able to provide a broad sketch of his professional activities in the upcoming year. This information is of great value in determining whether or not any one individual, regardless of his technical skills and resources, is capable of supplying expertise when counsel estimates it will be required. Methodological Preferences It is important to note that while the expert may have various levels of analysis available, they most likely have professional preferences that their experience has shown to be the most efficacious in regard to the technological needs under discussion. Counsel should be sure to get a detailed overview of both the available and preferred methodologies, their demonstrative value from the expert’s perspective, and the relative costs of any one analytical model as compared to the others. Once counsel is familiar with the range of services and preferred methodologies of the expert under consideration, he should inquire of the expert regarding alternative methodologies available to achieve similar results and the expert’s rationale for choosing those he plans to utilize in the instant


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litigation. The variance in costs among available methods of analysis can be enormous. Counsel must be confident that the analytical method selected by the expert is actually needed, at least in the early stages, to achieve desired results. Counsel’s general research and consultations with other products litigators can put the expert’s methodological preferences in an informed context within which the difficult retention decision may be reached. Working with Other Experts As noted earlier, the employment of more than one expert witness is fast becoming the reality for the products litigator. Given that state of affairs, it is important to determine the perspective of any expert under serious consideration with regard to those experts with whom he has worked and respects professionally. Equally important, counsel should determine the identity of those fellow experts or organizations that he does not respect and with whom he would not feel comfortable working — or would refuse to work with at all. Over the years many products litigators have wasted valuable time serving as a referee in the midst of recurring personal or professional clashes among experts. Differing analytical philosophies, methodological preferences, or disparities in technical support among experts may not, in the long run, be complementary and end up substantially detracting from an otherwise cohesive analysis and trial presentation. Relative parity in scientific philosophy, methodology, and technological capability should be a central point of reference for counsel in selecting the members of the expert witness team in cases of overlap of areas of expertise. Competition is stiff in the expert witness field and, increasingly, the expert witness organization is urging counsel to leave all matters of expertise to them. In any particular case, given an available range of expertise within company ranks, that may be the most efficient and economical course. Since that is not always the case, concern over the working relationship among experts is a real one and must be thoroughly investigated. Testimonial Experience Regardless of the technological sophistication of the expert or the organization of which he is a member, it is essential for counsel to realize the vital importance of the “witness” aspect of expert witness assistance. The heavy cost of expert witness support is to little avail if the expert lacks sufficient communicative skills or is unable to withstand the rigors of cross-examination. The inexperienced expert is an unknown quantity whose ability to undergo often searing cross-examination by a skilled adversary may not be estimated until a stage is reached in the litigation when it is not realistically possible to effect a substitution.



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Equally vulnerable is the long-term expert witness whose extensive prior trial or deposition testimony provides a field day for defense counsel in search of inconsistencies and other impeachable material. Given these two overriding concerns, there are a series of important considerations that counsel should ponder in estimating the witness potential of an expert under consideration. Initially, it should be determined just how many years and in what general categories of products cases the witness has been testifying professionally. It is important as well to determine the extent to which his work has been for the plaintiff or defense side of the case. Additionally, counsel should inquire as to any major changes in direction the expert has undergone over the course of his career as an expert witness regarding the technological or methodological subjects involved in the instant litigation. Extensive theoretical shifts on the part of an expert witness provide a prime source for defense crossexamination. Finally, counsel should seek information relative to the expert’s current case load and whether or not he will be testifying in the near future, to allow for a possible personal estimation of the expert’s testimonial skills. The latter is of particular importance, in the case of the relatively inexperienced witness, where lawyer feedback is limited. The professional career of an expert witness with extensive experience is an open book to the more sophisticated defense firms. The bulk of such witness’ professional writing and trial and deposition testimony is carefully cataloged and indexed, providing defense counsel with a ready source of material with which to attempt to lessen such expert’s effectiveness in the eyes of the jury. It is especially important to determine the extent of such prior testimony and if possible, to make a detailed study of available recent transcripts. It is important to also seek counsel from attorneys who have used the expert, regarding his capabilities on both direct and cross-examination. Qualifying at Trial The ability of the expert to qualify on all subject areas that counsel feels are essential to the success of the case is essential. This is equally, if not more, important than the expert’s communicative and testimonial skills. All too often, experts bill themselves as technological renaissance men, capable of testifying on a seemingly unlimited number of scientific subjects. Expenditures of time and money are to no avail if the expert is unable to testify or is so marginally qualified that he falls victim to a sophisticated cross-examination by a technically well-versed defense team. Experts of this type are of as little utility as the expert whose technological range is unduly circumscribed and narrowly centered on a specific subject within the broad range of topics that must be addressed during the course of the trial.


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Counsel should obtain a complete list of the subjects — and their extent — on which the expert has qualified, those on which he was found not qualified, those where there were serious questions raised by the court, and those on which the expert has not heretofore testified but feels professionally qualified to do so. Finally, those areas in which the expert feels that he is not qualified to testify should be determined, as well as those with which he would not feel comfortable. Getting these matters clarified at the outset is essential for the smooth functioning of the totality of the expert witness’ participation in the products undertaking.1

Categories of Experts Technical Expertise The range of purely technical expertise that is available to the products litigator is extensive. There is virtually no area of state-of-the-art engineering, drug, or chemical analysis that is without the reach of the corps of modern expert witnesses. It should be noted, however, that while the number and range of experts has increased dramatically in the past decade, competent, experienced, accessible, and affordable expert witness assistance is still somewhat at a premium. In certain instances, especially in cases involving new drugs or areas of manufacture where counsel is breaking new ground, there may even be a dearth of qualified persons who fit both of counsel’s expert and witness needs. The problem of availability is exacerbated each year, as corporations increasingly place the most competent and experienced authorities on retainer or engage the services of the more sophisticated expert witness service corporations on a full-time basis. The lion’s share of the expert witness burden in any products undertaking falls to the technical expert. Accordingly, he or she will be the lead expert on the team eventually assembled for the preparation and trial of the case. Detailed analysis of the suspect product’s design and material composition, overviews of the state-of-the-art context of the product, the feasibility of alternative designs, interpretation of defendant’s technical response to the perceived problem, and resolution of the overarching issue of proximate causation, all fall on the shoulders of the technical expert. Whatever the final composition of the expert witness team, counsel’s greatest number of working encounters, as well as expense, will be had with the technical expert. Given the central place of such an individual in the entire preparation effort, the choice is a crucial one. Once the technical expert is chosen and work begun, it is not realistic to substitute personnel. Defect modes are determined, strategies set, and technical planning is finalized. A change in



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technical expert even at the early stages of prefiling research can result in case preparation disruptions and added expense in starting over with another expert. Counsel will thus ordinarily have to live with his or her initial selection of lead technical expert, making that decision one of the most important in the entire preparation undertaking. Nontechnical Expertise The determination of areas of nontechnical expert witness needs is also of central, if less pressing, importance to the litigator. Nontechnical assistance is increasingly seen as being of great assistance in providing both counsel and jury with a fundamental understanding of the totality of issues involved in the case and their relationship to and among each other. As the categories of information considered admissible by the defendant expands, the nontechnical expert becomes increasingly important to the successful prosecution of products cases. The more frequent appearance of this category of nontechnical expert is further swelling the ranks of expert witnesses involved in the products undertaking, and thereby significantly adding to plaintiff ’s overall financial burden. However, the unique contribution that such an expert can make to the total preparation effort may result in any added expense being very cost effective. Management Principles and Corporate Processes A category of nontechnical expert witness participating much more frequently in the products arena is one who speaks to overall corporate operations. The subjects addressed by such an expert would include general principles of good management regarding safety and the more specialized subjects of corporate organization, routine document generation, and management decision-making processes. Product litigators have come to value the contribution that such an expert can make in placing the corporation’s acts or omissions in an understandable context for their own needs as well as that of the jury. The complexity of the modern corporation and the labyrinthine nature of corporate processes provide defense counsel with great opportunity to delay and frustrate discovery, as well as to cloud the issues of responsibility and chain of command at the trial of the case. This is especially so in cases involving a typical time frame stretching as far back as a decade or more. Specifically, the corporate-managerial expert can explain the general process through which a product proceeds from the idea stage to the inventory shelf. He can also shed light on marketing considerations in product design and testing, as well as the effect of regulatory activity on the entire process of development and production. This type of expert has tremendous value in revealing where safety as a factor is placed in responsible management systems.


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Having a firm grasp of the literature relative to safety management and practical knowledge about the intricacies of corporate decision-making, such an expert can supply counsel with a path through the thicket of documentation that he must master to complete discovery. It must be noted that literally hundreds of thousands of documents may be generated over the course of a product’s development and market life. Only a relatively small portion of such documentation is of any real concern to the products litigator, whether from an investigative or legal standpoint. The managerial expert can give counsel a qualitative yardstick with which to initially locate and subsequently evaluate such materials. In addition to their clarifying function, such experts are also becoming increasingly involved in the discovery and motion-in-limine stages of products cases. This takes the form of providing affidavits in counsel’s efforts to enforce legitimate discovery requests, to prevent the entry of debilitating protective orders or the granting of comprehensive defense motions-in-limine. Such experts also contribute to proof of the punitive damage case. This is especially so in regard to establishing the long-term impropriety of managerial disregard for overall safety concerns and the inadequacy of their technical responses to recurring information indicating product dangers. Regulatory Agency Procedures and Policy Another category of nontechnical expert witness appearing more frequently in product liability cases is the expert who is able to speak to the intricacies of government regulation of major industries. It is becoming increasingly rare today for the products litigator to be involved with a product that is not touched by some aspect of federal regulation. Lobbying efforts directed toward the watering down or elimination of safety standards are a central part of such encounters. The expert, normally a former government official, can lend great assistance in interpreting the sufficiency of defendant’s compliance with agency requirements. They can also effectively counter defense claims that a particular agency’s performance testing regulations are the nadir of the state-ofthe-art. Such experts are often a fertile source of information during the data gathering stages of case preparation as to the categories and types of potentially relevant data available to counsel from agency files. The lack of candor of many corporations in responding to government testing, reporting, or record-keeping requirements, is often a prime source for data with which to establish plaintiff’s punitive damage count. This is especially the case during the course of defect investigations or recall inquiries. This category of expert, being adept at the realities of corporate contacts with the relevant agency, can provide the same clarifying function as the managerial expert noted above. Experts of this type are available to speak to



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virtually any regulatory agency that counsel may encounter in the course of investigation. As with the managerial expert, they also are a source of affidavit support in the discovery and motion-in-limine stages of case preparation. Finally, this category of expert can provide counsel with useful insights into the growing statistical data banks generated by federal agencies which increasingly serve as a major pillar of the corporate defense strategy. Statisticians The statistician is rapidly becoming a permanent fixture on the products scene. Corporations are increasingly using statistics as a basis for supporting the action they took relative to design or warning or as a means of justifying nonaction in either area. The increase in statistical data banks, whether issuing from government agencies or private research bodies, multiplies the defendant’s opportunity to muddy the waters by sophisticated statistical analyses. Thus, knowledge of statistical theory, methodology, data input criterion, and data interpretation are additional complex topics requiring expert assistance and concomitant expense. Statistical analysis is as much a part of plaintiff ’s case as it is defendant’s. The relevant state-of-the-art materials in any product case are filled with statistical data and interpretation. Statistics are a potent weapon for defusing plaintiff ’s arguments relative to the quantitative extent of the technical problem associated with the normal use of the suspect product. They are also often used by defense counsel to demonstrate the nonfeasibility of alternative designs offered by plaintiff as a solution to the alleged defect. Facility with the varied models of statistical analysis, the effect on such analyses of the data gathering criterion for the materials subjected to analysis and the complex mathematics involved in data interpretation, all require a level of expertise that is more often than not beyond the capabilities of most product litigators. In products cases centered in a failure-to-warn count, statistics may be determinative of success or failure. This is especially so in the prosecution of a drug case. Whether or not counsel decides to actually use a statistician at trial, at some point in the preparation effort, a statistical tutorial will likely be required to some degree. As experience is gained in the understanding of statistical analysis and the trial performance of statisticians, this category of expert will join ranks with the technical expert as a central figure on plaintiff ’s expert witness team. Corporate Accountants A category of expert infrequently used, but having great utility, is the expert familiar with corporate accounting procedures. They can provide valuable


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information regarding internal cost allocations over the entire course of product development and how such costs translate into retail cost equivalents. A central issue in products cases is the economic as well as technical feasibility of alleged alternative designs. The typical corpus of corporate documents received during the course of discovery contain numerous sets of bewildering figures that place costs on varied aspects of research, development and production. Typical cost figures are piece cost, facilities costs, lifetime costs, and design costs. Counsel needs to know the relation that any one or all of such costs have to defendant’s actual ability to incorporate the alternative urged by plaintiff and still realistically compete in their target market. The corporate accountant can greatly assist plaintiff ’s counsel in understanding such figures and provide clear direction as to how the corporation translates internal cost allocations into actual manufacturing expense and ultimate cost to the consumer. The juggling of internal corporate cost allocations is a major device used by corporate deposition or trial witnesses in attempts to blunt plaintiff ’s alternative design arguments. It is also a major defense tactic in attempts to explain away damaging management decisions that appear to place corporate profits over human safety. The corporate or industrial accountant can contribute significantly to counsel’s and the jury’s grasp of this most important aspect of corporate product development. In addition to shedding light on the monetary allocations made to various aspects of research and development, such expertise can provide needed insight into corporate cost-benefit analyses. Such analyses are routinely submitted to government agencies in attempts to minimize regulatory intrusion into the manufacturing process. Cost-benefit and cost-effectiveness analyses are a permanent part of a corporation’s operating philosophy and regulatory strategy. Plaintiff ’s counsel can thus ill-afford a lack of knowledge on the subject of product development cost allocations. Marketing and Advertising Experts in the area of marketing and advertising are seldom used in the trial of product cases, but should be given serious consideration in cases revolving around allegations of failure to instruct, failure to warn, and especially misrepresentation. The relationship between marketing and product development is a close one. Marketing concerns are given primacy in debates over alternative product design, formal instructions and warnings, and advertising campaigns and copy. Marketing concerns significantly color and to a large degree control the concept, development, and eventual production of manufactured goods of all varieties.



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At trial, such experts can provide the jury with a clear picture of the relationship between profitability projections and research, development and testing. This perspective may have a significant effect on the success of a punitive damage count. Narrative v. Opinion Witnesses An important consideration involved in the entire issue of the nature and extent of expert witness assistance is the extent to which any expert consulted will be put relative to deposition or trial testimony. Quite often, experts are engaged solely to provide guidance to counsel during initial preparation or to acquaint the jury with the general state-of-the-art context of the suspect product. Thus the question of which witnesses will be engaged to provide narrative testimony and which will give opinions is central to the expert witness aspect of case planning. Counsel may wish to put one or more experts on retainer strictly for purposes of gaining a negotiating edge or for deposition testimony. Counsel may wish to reserve the bulk of available funds for closer working encounters with their lead technical expert. Given the limited resources available, the optimal situation is to have the experts engaged provide both narrative and opinion testimony, as required. This, however, is not always possible, especially in cases where the schedule or fees of a preeminent expert in a field do not allow for the close relationship with the case normally required of those offering opinions.

Initial Utilization of the Expert Defect Determination In litigation involving an engineered item, the primary task of the expert at the initial stage of participation is to examine the defective product unit, if available, to determine the existence within it of one of the range of potential defects that preliminary study has indicated may be causative factors in the death or injury giving rise to the case. Pinpointing the right defect or defects is crucial to guide subsequent investigation and study along productive lines. It is essential as well, in providing the basis for drafting a sufficiently detailed complaint that will serve as the focal point for all later arguments relative to discovery, motionsin-limine, and the introduction of trial evidence. Counsel must keep close tabs on the chain of evidence involving the suspect unit. This applies equally to all expert witness contact with it. Counsel should determine what destructive testing may be necessary to enable the expert to make his initial defect determination and pay especially close attention to any proposed testing that


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may later detract from the integrity of the unit as a trial exhibit. If there is any doubt in counsel’s mind in the latter respect, destructive testing should only be conducted under the auspices of a court order. Counsel should also inquire as to the nature and degree of any destructive testing that defendant may have grounds for requesting in the course of its discovery, and potential arguments against any such request. Alternative Design or Warnings An additional expert witness contribution at the defect determination stage is the indication of the range of feasible alternative designs that may have eliminated or minimized the resulting death or injury. Counsel should be concerned with those alternatives having direct applicability, as well as those of a more arguable nature. The latter may very well prove to have a much more direct bearing on the case once investigation and discovery near completion. It should be determined which scientific theories or methodologies led the expert to his conclusions on the defect and its feasible alternatives. Counsel should also ask the expert to identify authoritative materials that may be studied to develop a sufficient degree of expertise with which to support those conclusions throughout the remainder of the case. Counsel should also determine the major arguments that can be utilized by the defense to question the theoretical basis of the expert’s conclusions with like recommendations of literature to gain familiarity with that position. Proximate Cause A primary task of the expert in the initial stages of investigation is to pinpoint the precise aspect of the suspect design that contributed to the client’s death or injury. Equally important is identifying those factors which indicate the viability of a feasible alternative that would have avoided or minimized such a result. Identification of a defect that caused the injury and an alternative design that would have eliminated it, are requirements in the proof of any products case. In many respects, these tasks are the most important ones that the expert will perform in the entire undertaking.2 They provide the technical framework for all ensuing research, discovery and trial efforts. It is normally the area given the greatest attention by defense counsel and one that all too often gets insufficient attention in the midst of the multiplicity of concerns facing the products litigator. State-of-the-Art Context An expert can be of great value in helping counsel refine his or her preliminary grasp of the authoritative literature in the fields relevant to the case.



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He can also clarify any remaining uncertainty in counsel’s mind about the precise technical details involved in the several issues at hand. The focal points for prefiling research discussed in Chapter 1 can serve as guidelines for productive educational conferences with the expert. The broad outlines of defendant’s likely state-of-the-art and specific technical defenses may also be profitably analyzed with the expert. This can provide counsel with a firm basis upon which to initiate discovery planning and practice and ensuing corporate document analysis. Counsel should also inquire about any relevant studies in progress, whether under private or government auspices, that may bear watching over the several years duration of the suit. Bibliographies should be obtained as a means of cross-referencing as well as supplementing materials gleaned from counsel’s own literature search. It should be determined which authoritative materials the expert has relied upon in the past when opinions were given in a similar area. Counsel should also determine what other literature the expert feels may be sufficiently authoritative and current to rely upon in supporting his opinion in deposition or trial testimony in the current case. Early familiarity with such literature can avoid cram courses and possible errors in the utilization of such materials as the case progresses to its conclusion. Discovery Planning Once counsel has a firm grasp of the technical end of his case and filed his complaint, the next major undertaking is the initiation of discovery planning.3 By this stage in the case, counsel should have a clear understanding of his or her discovery goals and the most efficacious manner of achieving them through the traditional discovery devices available. Counsel should outline for the expert his general thinking on discovery planning and express exactly what he hopes to gain as a result of it. The experienced expert witness can be of great value in correcting any misdirections in such plan and in refining counsel’s understanding of the broad technical information that is realistically available. The perspective that the experienced expert can bring to the estimation of what significant technical data is likely in defendant’s possession, is of great value in accomplishing a fruitful plan of discovery. The expert can also be of considerable assistance by reviewing counsel’s interrogatories and production requests for overall technical accuracy and the correctness of terminology employed in such requests. This is especially important in regard to the comprehensiveness of counsel’s coverage of testing methodologies. An additional and very important perspective is the expert’s estimation of the sufficiency of the time frame chosen by counsel within which all such


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requests will operate. Determining the correct time frame is one of counsel’s most vital preliminary decisions. The expert can, by the above means, help to clarify discovery goals and assist in eliminating or minimizing potential pitfalls in the discovery process. The expert can thus add greatly to the productivity of the discovery stage of the case by reviewing with counsel those items of information likely to be in defendant’s possession that are essential to a convincing demonstration of the defective nature of the product and pinpointing defendant’s technical shortcomings in putting it in the stream of commerce. Summary Much remains to be said regarding the participation of the expert witness in the products case. Chapter 7, Science and Business Documentation, and Chapter 8, Science and Pretrial Discovery, will deal at some length on the place of the expert in supporting plaintiff counsel’s attempts to enforce compliance with discovery requests, the role served by the expert witness affidavit in opposing the entry of broad-based protective orders and motions-inlimine and the assistance they can provide in making final selections of the documentary component of the case-in-chief. There are a number of recent post-Kumho Tire articles4 aimed toward the needs of court5 and trial lawyers6 on the central position and importance of the products liability expert witness.

Endnotes 1. See, Gammil v. Jack Williams Chevrolet, 972 S.W.2d 713 (Sp. Ct. Texas 1998), where two experts’ testimony was stricken for failure to qualify; Lytle v. Ford Motor Company, 696 N.E.2d 465 (Ind.Ct.App. 1998), seatbelt expert fails to qualify; Ruffin v. Shaw Industries Case, 149 F.3d 294 (4th Cir.Ct.App. 1998), report of laboratory president who analyzed sample of carpet was not reliable and was inadmissible. But see, Ford Motor Company v. Aguiniga, 9 S.W.3d 252 (Ct.App.Texas 1999), (experts qualified re: automobile electrical system), for excellent examples and discussion of the important requirement of assuring that all witnesses qualify before trial. 2. See Chapter 4, Science and Causation. 3. See Chapter 8, Science and Pretrial Discovery. 4. The recent U.S. Supreme Court Kumho Tire decision has spawned a torrent of law review articles, comments, case notes, and a rash of plaintiff and defendant newsletter publications. See, e.g., Michael H. Graham, “The Expert Witness Predicament: Determining ‘Reliable’ under the Gatekeeping Test of Daubert, Kumho, and Proposed Amended Rule 702 of the Federal Rules of Evidence,” 54 U. Miami L. Rev. 317 (2000); Practical Litigator, January (2000);



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Jerold S. Solovy, Joel J. Africk, “Use of Experts in Federal Courts in the Wake of Kumho Tire,” 11 (1) Prac. Litigator 23 (2000); Paul Giannelli, Edward Imwinkelried, “Scientific Evidence: The Fallout from Supreme Court’s Decision in Kumho Tires,” 14-WTR Crim. Just. 12 (2000); Joseph P. H. Babington, “They Need to Hear from the Trenches (Or How a Young Trial Lawyer from Mobile, Ala. Came to Argue Kumho Tire v. Carmichael before the U.S. Supreme Court),” 48 La. B.J. 115 (2000); D. Michael Risinger, “Defining the ‘Task at Hand’: Nonscience Forensic Science after Kumho Tire Co. v. Carmichael, 57 Wash. & Lee L. Rev. 767 (2000); Michael J. Saks, “Banishing Ipse Dixit: The Impact of Kumho Tire on Forensic Identification Science,” 57 Wash. & Lee L. Rev. 879 (2000); Robert J. Goodwin, “The Hidden Significance of Kumho Tire Co. v. Carmichael: A Compass for Problems of Definition and Procedure Created by Daubert v. Merrell Dow Pharmaceuticals, Inc.,” 2 Baylor L. Rev. 603 (2000). 5. See, e.g., Gerson H. Smoger, J.D., Ph.D., “From Rule 702 to Daubert to Joiner to Kumho Tire: A Review of the Supreme Court’s Analysis of the Admissibility of Expert Testimony,” 4 (4) Andrews Diet Drugs Litig. Rep. 9 (2001); Marilyn J. Holifield, “Deposing Expert Witnesses in Products Liability Cases,” 12 (2) Prac. Litigator 31 (2001); Gary M. Paul, “The Trial of Damages in a Muscle Sprain Case: Dealing with the Biomechanical Expert,” (Winter) ATLACLE 149 (2001), Lisa Palmer O’Donnell, “Trial of Damages in a Substantial Damages Case: As a Matter of Fact-Qualifying and Using Vocational Experts to Maximize Damages,” (Winter) ATLA-CLE 259 (2001); 7 (17) Andrews Med. Devices Litig. Rep. 5, January 26, 2001, “Breast Implants: PA Judge Rules out Expert Testimony on Effects of Gel,” Toledo v. Medical Eng’g Corp; 16 (4) Andrews Tobacco Indus. Litig. Rep. 7, January 12, 2001; “Johns-Manville Trust: Judge Weinstein Keeps Tobacco Cos. From Using Plaintiffs’ Experts, Falise v. American Tobacco Co.”; Federal Litigator January (2001); “Discovery, Work Product, Protection, Testifying Experts, and Draft Reports,” 16 (1) Fed. Litigator 18; Eliot G. Disner, “The Trouble with Experts,” 12 (1) Prac. Litigator 27, January 2001; Geoffrey M. Howard, Elizabeth A. Ybarra, “Courtappointed Experts,” 12 (1) Prac. Litigator 55, January 2001. Also see, Judge Harvey Brown, “Eight Gates for Expert Witnesses,” 36 Hous. L. Rev. 743 (1999); “Procedural Issues under Daubert,” 36 Hous. L. Rev. 1133 (1999), the second of a two-part analysis of the admissibility of expert witness testimony after Daubert v. Merrell Dow Pharmaceuticals, Inc. and its progeny. These are two excellent collections of cases and analysis by an experienced judge. Also see, Gail Troutwine, Wayne R. Spivey and Daniel S. Weinstock, “Proving Defect in Medical Device and Pharmaceutical Litigation,” 2 Ann. 2000 ATLA-CLE 2335 (2000). 6. See, e.g., Michael C. Smith, “The Effect of Kumho Tire and Amended Federal Rule of Evidence 702 on Daubert Challenge Procedure,” (Winter) ATLACLE 455 (2001); (Winter) ATLA-CLE 295; Hon. John H. Whitfield, “An Overview of the Test for Determining the Admissibility of Scientific Evidence: Frye, Daubert, and Kumho (Winter) ATLA-CLE 295 (2001); Ronald Simon,


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Science and Litigation: Products Liability in Theory and Practice “Re-reading Daubert, Joiner, and Kumho: Pitfalls, Potholes, and/or Avoiding Being Off-track,” 2 Ann. 2000 ATLA-CLE 2723 (2000); Gerson H. Smoger, J. D., Ph.D., “From Rule 702 to Daubert to Joiner to Kumho Tire: A Review of the Supreme Court’s Analysis of the Admissibility of Expert Testimony,” 4 (4) Andrews Diet Drugs Litig. Rep. 9 (2001).


Science and Business Documentation

7

It is quite a three-pipe problem, and I beg that you won’t speak to me for fifty minutes. — Sherlock Holmes to Dr. Watson, A Study In Scarlet (Arthur Conan Doyle, 1887)

Introduction A fundamental requirement for success in the products case is the procurement and comprehension of internal company documentation reflecting knowledge of defect, feasible alternative designs, and irresponsible management decisions. All such materials are studied in light of the defendant company’s relevant scientific knowledge, whether it be centered in engineering, chemistry, pharmacology, or, in this new century, bioengineering, bioinformatics, or other offshoots of genetics. There are several complex investigative and legal issues facing the product litigator with respect to this subject: • How to determine the type of company documents are generally contained in corporate archives • Which of those are available in discovery • How to both identify and locate defendant’s documents during discovery • How to enforce discovery rights with respect to such documents • How to organize and analyze them once plaintiff has received them • How to rate the investigative or legal significance of any one document with an eye toward including it in the documentary component of plaintiff ’s case-in-chief The defendant has no legal obligation to voluntarily identify and hand over all “relevant” documentation conveniently packaged and arranged chronologically by document type. The burden is on plaintiff ’s counsel to find

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out what he needs, determine how to get it, and to make sense of it once in his possession. Virtually no attention has been paid in the literature to this central aspect of product liability preparation. It is plaintiff ’s major stumbling block in most cases and the context for the hardest fought pretrial exchanges between plaintiff and defense counsel. It is the purpose of Chapters 5, 6, and 7, to eliminate the confusion and difficulty that has inundated this crucial aspect of case preparation. The analyses and methodologies discussed in those chapters will provide counsel with effective and expeditious means for identifying, accessing, and utilizing internal corporate documentation. It is first necessary to identify and discuss at length the categories of internal corporate documentation not normally available to the product’s litigator during prefiling research, but generally accessible during the course of discovery. Once this has been completed, a detailed analysis of discovery planning and drafting and discovery motion practice can be made more profitably. The discussion that follows serves as a close examination of any case involving an engineered item, regardless of the generic defect type or types involved in the case or the theory or theories of liability chosen. The lion’s share of the analysis also has general applicability to drug and environmental settings. The goal here is to have the reader realize and internalize the highly structured way in which modern corporations engage in the business of the commercial application of science theory. This is essential if a litigator is to engage in vigorous and productive discovery in products liability cases.

The Generation of Corporate Documents It is important that counsel not forget that the types of documentation discussed below are generated by a corporation bent on maximizing profits, not providing the safest product that technology will allow. This factor colors the entire document-generating process from start to finish. It is normally a solid basis upon which to interpret seemingly incongruous management decisions in the face of inapposite technical research conducted by experts both within and without the corporation. Counsel, immersed in the hundreds or thousands of documents received in discovery, too often overlook this basic reality in the difficult task of attempting to see the forest for the trees. Products of whatever type are developed within an organizational structure that is roughly equivalent in most large corporations. There are hundreds of ways for a company to organize product development and manufacture. In reality, American companies, especially intra-industry, tend to follow a



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small number of classic organizational formats in the process of getting the good from the idea stage to the inventory shelf. One typical stage leads predictably to the next until the product is available to the consuming public. Corporations are organizational creatures of habit. Due to their complexity, their actions, from product development through manufacturing and marketing, are normally governed by standard operating procedures and set forms of documentation. This makes for consistency in operations and document generation that greatly assists the product litigator in his or her attempt to ferret out relevant material during the course of reconstructing this central aspect of the case. Information is generated according to set formats and analyzed and acted upon within well-coordinated committee structures. It is relatively difficult for a corporation to effect a cover-up of questionable manufacturing practices. This is due to the fact that sensitive documentation was generated pursuant to standard operating procedures in set forms of documentation and distributed along well-established lines of communication. These organizational facts of life are of central importance in planning and finalizing the document discovery portion of the product liability undertaking. Stages of Document Generation Regardless of the type of product being manufactured and whether or not it is a new offering or a subsequent model in a preexisting line of goods, there are routine stages or steps that are followed in the corporation to meet each task as it arises. Each stage or step in this ongoing process is further broken down into equally repetitive components or subsets that consistently generate routine types and forms of documentation. These materials, in turn, are channeled along fairly fixed lines of distribution within the company. This is especially so in intra-industry settings. An overriding investigative goal is the identification of the types of documentation consistently generated at any one stage or substage of the total product development, manufacturing, and marketing process and the manner in which that documentation is disseminated throughout the organization. Understanding this process and its documentary significance can go a long way in eliminating costly and time-consuming discovery motion practice and allow for efficient and effective discovery and trial planning. At this point it will be of value to briefly set forth the broad areas of corporate activity within which the body of documentation of concern to the litigator in the products case is actually generated. While experienced litigators may differ in terminology, the major stages along the product development and manufacturing continuum in large corporations, are basically four in number:



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Basic Stages • • • •

Design Testing Production Marketing

These broad categories can be further subdivided for analytical purposes by a functional breakdown of the activities that are generally the primary focus of corporate energies in each such category: Design • • • • • • • • •

Overall product planning Marketing feasibility studies Technical feasibility studies Financial feasibility studies Tooling studies Regulatory review Detailed component studies Prototype testing Project approval

Testing • • • • •

Prospective regulatory testing Alternative design testing Detailed component testing Certification testing Production validation testing

Production • Finalization of specifications • Production runs • Quality control activities Marketing • Marketing campaigns • Instructions and warnings • Complaint processing



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These broad categories will serve as a central paradigm in the planning and drafting of interrogatories, requests for the production of documents and the preparation of discovery depositions. They will serve as well as key focal points for the organization, analysis and synthesis of all materials received as a result of counsel’s discovery efforts. Overlap in Document Generation Each of the above-noted stages has a separate and distinct function from the others in the long process of getting the product to market. As indicated, each has within it identifiable, progressive steps each of which, in turn, will normally generate routine types and set forms of documentation. It is very important to realize at the outset, that there is a continuing overlap and interaction among the various stages and substages of the product development and manufacturing process. This is the case even though each stage is primarily concerned with a specific aspect of the total product development and manufacturing undertaking. This functional overlap, with its accompanying effect on the chronological generation of internal documentation, is due to the fact that the contemplated good is targeted for a particular market, in a milieu of government regulation, by a company actively involved in the planning, production and marketing of a series of products. All of the concerns that are centered in any one stage for major concentration are present from the inception of a product development concept. Product development work, in particular, cannot function in isolation from other prospective production, marketing, and regulatory concerns of the central corporate plan. Planning for overall spending, research projects, facilities availability, production time, personnel, marketing, and government regulation is at the heart of the successful corporate entity. Accordingly, while each particular stage along the line has specific tasks to meet, each must be considered in its effect on the organization’s total functions. Decisions on a particular design aspect of a specific model line are routinely made with an eye to other planned corporate activities that may be affected. This reality is further complicated by the fact that broad decisions, especially with respect to regulatory policy, are made across model lines. This causes great confusion as to the relevancy, in both a discovery and evidentiary sense, of the documents generated along the course of development of the product and design parameter of interest to the litigator (see Chapter 7). The entire product development effort, whether directed towards a new product or a subsequent model in a preexisting line of goods, is centered on the goal of entering the target market in a competitive position with the goal of realizing substantial financial rewards. Given the primacy of profit in the entire product development and manufacturing process, it is vital for the


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product litigator to never lose sight of the importance of costs and marketability in efforts to understand and synthesize technical documentation generated at any one stage of the total corporate undertaking. The factor of overlap in corporate document generation will receive extended attention in the more detailed discussion of routine document types to follow. Introduction to Document Types While there may be differences of opinion over nomenclature, the categories of documents likely to be generated over the course of a product’s development and manufacturing effort in any one company, at any one stage, tend to be repetitive in nature. This is so with respect to the chronology of their appearance in the corpus of company documents, the type of information they generally contain and even the way they are formatted and distributed. Document generation and output tend to follow set patterns within large corporations. By “document types,” the author means those memoranda addressing selected aspects of the product development and manufacturing scheme that are staples of the documentary output of large American manufacturing concerns. Corporations are organizational and documentary creatures of habit. Not only does their complexity require a tight set of standard operating procedures, but set forms of documentation and channels of communication as well. Stages of product development and manufacture not only give rise to predictable substages of activity, but also to predictable types of documents and routine systems for their dissemination. This repetitive manner of generating, recording, distributing, and using information is one of the features of corporate life that is of great value to the product litigator. It will, in its various aspects, be referenced throughout the material to follow. Counsel, from the inception of work on the case, must view each item of information brought to his or her attention from both an investigative and legal perspective — this is especially the case in regard to corporate documentation. Getting a fix on just how the suspect product moved its way along the corporate processes and was released to the consumer in a “defective condition unreasonably dangerous,” is akin to putting together all of the pieces in a huge jigsaw puzzle. The thousands of documents actually generated in this process need not and cannot be scrutinized by plaintiff ’s counsel. It is very important that counsel, prior to discovery, have a sense of the types of documentation likely to be in the company files at any one point over the case time frames that may have investigative or legal bearing on the preparation and eventual trial of the case. The greatest investigative problem faced by the product litigator is in the proper identification and procurement of internal corporate documentation. Defendant knows what is there and, quite properly, is reluctant to give it up.



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Plaintiff is at a severe disadvantage if he has only the faintest concept of what it is he is seeking. This is especially so, given the fact that discovery is a onetime proposition, not reopened as counsel feels his way through the intricacies of the case. Understanding what is normally found in company files and the routine corporate processes utilized to get them there is of central importance in several respects. A firm grasp of document generating processes and the specific significance of recurrent document types is essential with respect to understanding, synthesizing, and organizing such materials once in hand (see Chapter 6.) Not the least of plaintiff ’s difficulties is making order out of the documentary chaos presented to him by the defendant. Document submissions do not come packaged by year, document type, or degree of importance in the product development and manufacturing scheme. There is no set of instructions as to how the pieces fit. That is plaintiff ’s burden. A good working knowledge of how, why, and when various documents are generated in a corporation and their investigative and legal significance will allow for expeditious analysis and organization of such materials. It will also facilitate their eventual integration into the corpus of stateof-the-art and occurrence facts that give them meaningful context. A good grasp of the format, style, general informational content, and distribution lists of the various document types generated over the entire product development, manufacturing and marketing process is one of the greatest weapons in the arsenal of the product liability litigator.

Design Documentation Design Stage Documentation generated at the early stage of concept origin and preliminary research and development is of prime importance in developing the engineering or pharmaceutical design case. This is especially so in instances where counsel feels that a punitive damage count may be appropriate. It bears repeating that while this initial stage, as with the others to be discussed, can be isolated with confidence, nonetheless, there will be a degree of functional and documentary overlap with the other stages at any one point in time. This is due to the aforementioned need for advance planning and coordination and the fact that the entire process is being initiated with successful marketing as the central goal. Keeping in the foreground the defects identified through preliminary research and the design aspect of the product within which such features technically function, counsel can often reap rich rewards in the examination of documents generated at this seminal stage. Initially, this stage will typically


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involve discussions by the highest levels of management as to the marketability of the proposed product line. These analyses often set broad limitations on just what can be done in subsequent development efforts by the technical staff, especially as relates to safety levels or features. Cross-referencing broad-based design decisions, especially those with subsequently generated technical materials, is of great value in assessing the feasibility of both the design and punitive damage count. Market presence and prospective profitability are the key considerations in management’s thinking at this point. Safety concerns, while not dismissed as unimportant, have significantly less priority. Safety considerations are rarely, if ever, directly addressed in these documents. This is a telling point for plaintiff ’s counsel, who should be alert to the fact that what these documents fail to discuss is as, and often, more, important than what they do discuss. Virtually all of the key product development and manufacturing offices of the corporation are likely to be involved to some degree at this initial development stage. The corporation must seek information from nontechnical staff to determine not only the marketing feasibility of the proposed product, but also the availability of production facilities, funds, materials, and component parts at the point in the future when the proposed manufacture is to begin. This same prognostication involves a close look at the potential for government agency regulation at that future date. All of these preliminary questions generate large amounts of documentation of great value to the product litigator. Only a relatively small amount of the corpus of documentation spawned over the entire course of the product development and manufacturing process is of investigative or legal interest to plaintiff ’s counsel. The choices made in determining the documents of value are centered around the defect modes identified during prefiling research and the design aspect of the total product within which such defects technically function. It is important to recall that corporations make design and agency compliance decisions across model lines. Government agency regulations do not address particular model lines of an affected industry and thus also apply across model lines. For example, Federal Motor Vehicle Safety Standard 301 required that all passenger vehicles be able to withstand a 30 mile-per-hour moving barrier rear collision without leaking more than one ounce of fuel for the first five minutes following impact. The documentary impact of this regulatory scheme is that material of particular interest to the product litigator, which will often be found within documents that, at first examination, appear unrelated to the specific investigative matter at hand. For example, the fuel system integrity policy applicable to a Ford Pinto would be found in documents addressing the entire



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line of Ford Motor Company automobiles, with the Pinto line not necessarily even being referenced by name. More will be said on this topic in the discussion of motions-in-limine and the trial document selection process. The early design-related documentation generally sets the tone for what follows in subsequent years in the process of getting the suspect good to market. Product development projects are rarely haphazard undertakings. Considerable thought goes into the management decision to initiate the expensive and time consuming process of product development. As a result, key decisions affecting the ultimate design are, more often than not, finalized at this early stage. This is not necessarily the result of careless analysis. It is a reality mandated by the need for tight corporate planning. This fact lends great importance to the range of early documentation under discussion. It is here that decisions are made that can lock in the involved company divisions, offices and departments and set up virtually unpassable barriers to subsequent reevaluations of safety-related design issues by the technical staff. The range of documents generated at this initial stage will indicate the degree of attention or nonattention given to the general issue of safety in the overall product development process. Estimates will be made of the broad design costs relative to the proposed product as well as alternative designs. The degree to which existing parts will be incorporated in the new product will be assessed. The company’s attitude toward compliance with proposed agency regulation will be found, as well as their position respecting alternative designs that would bring the proposed product into compliance. In connection with the latter topic, discussion may be had as to the company’s in-house safety levels for various design features as well as those of competing products in the market place. Division, office, department, and section participation in the development project and the names of participating personnel can be gleaned from an examination of the varied document types generated at this early date. This information is essential to latter decisions by counsel as to the appropriate parties to depose as well as to the difficult process of tracking the dissemination of important documents throughout the company. Preliminary assumptions regarding the above concerns will be made by the participating technical and managerial personnel on the basis of technical, financial, and marketing data currently in company files. This will facilitate counsel’s efforts to trace back the documentary antecedents of the product development project under investigation. This latter data allows for a precise adjustment of the relevant time frames involved in the case, which is of inestimable value in subsequent arguments at the motion-in-limine and trial stages of the case.


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The first block of document types to be specifically discussed are those routinely generated at the earliest stage of product development. It bears repeating that what follows is not an attempt to mirror the exact document output of any one manufacturing concern or industry. It is, however, a study of corporate document generating processes and document types that have been and continue to be routinely encountered by product liability litigators. The discussion to follow will concentrate primarily on the development and manufacture of engineered products. The bulk of the analysis, however, has equal applicability to the broad processes and accompanying document generation of companies engaged in the development and sale of drugs and chemicals. Product Concept New product ideas generally originate on a high management level and are rarely the result of sudden flashes of insight on the part of any one employee. It is essential to realize that while product ideas often originate with the technical staff, it is more often the case that top management is the primary source of broad product development and planning. Technical feasibility studies and preliminary detail work are normally effected within the confines of predetermined management guidelines. Like every other important task in corporate life, product conceptualization is the result of relatively structured group, usually committee, activity. Most large American manufacturing concerns have product planning committees, whose primary function is to advance broad product development and marketing strategies. The marketability of an idea takes precedence over its technical feasibility at this early point. Documentation generated at this stage may consist of broad product and marketing goals, accompanied by discussions of competing products already present or likely to be present in the near future. Documents generated here often indicate the negative light in which technically viable and safer designs are viewed, if deemed too costly with respect to the anticipated entry price into the target market. If an idea is considered worth developing, broad outlines for the product’s features will be made. Requests will be issued to draftspeople or artists to provide preliminary sketches or plans illustrating these seminal ideas. These, in turn, will generate comment and evaluation by product planning committee personnel and affected support staff. The documentation generated here is of central importance to the litigator in numerous respects. Initially, these materials will identify the company divisions, offices, departments, and sections actively involved in the early planning of the suspect product. Documents also routinely indicate what person is sending the data from what office or department to what other person in a designated



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office or department. This is a tremendous aid in attempting to place individuals in their respective locations in the corporation over a multiyear time frame. Corporate organization charts are normally of little or no assistance in this latter important respect, limited as they are to bare descriptions of corporate line responsibility. Additionally, many documents of set types are routinely distributed to other employees, not necessarily involved in the immediate work around which the memoranda revolve. These may be employees who, for a variety of reasons, are placed on a distribution list for materials or projects of the general type involved. Hence, while the actual content of any one document may appear to have little substance from a legal perspective, they are all of inestimable value in counsel’s continuing investigative efforts to learn the information exchange process within the corporation and the identity of knowledgeable personnel. Preliminary Marketing Studies Marketing memoranda developed at the early stages of the design process are of great importance to the product litigator for a variety of reasons. Given the fact that companies develop and manufacture goods to reap a profit, the marketability of a new idea is perhaps the most important preliminary consideration investigated by product planning committees. Marketing staff generally have a good grasp of what will sell and what will not. Product ideas are developed primarily as marketing efforts, not to develop the state-of-theart of engineering or chemistry. Well before any significant resources are expended to determine the technical feasibility of a proposed addition to the company’s product lines, the marketing potential of any such idea is thoroughly explored. It is important to note that the law allows corporations to enter domestic markets of their choosing. The law does not mandate market entry levels or a specific range of product lines within any one target market. Automobile manufacturers can make Pintos as well as Lincoln Continentals. Likewise, a company can market a $22 and an $85 electric space heater. Rarely, if ever, does the legal issue in a products case center on the defendant’s right to participate in a particular targeted market. The controlling issue is whether or not the defendant could have made the suspect product safer and still compete in that market. This allows for what is at times a striking variance in quality among products lines, in many instances, developed and manufactured by the same company. This reality should caution counsel from attempts to impose a level of safety on a product line that does not comport with the pricing structure of the market within which the product is sold.


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These materials bear close examination for the immediate effect that they may have on the first leg of the technical feasibility efforts by planning personnel. They also shed continuing light on the central investigative issues of information flow and employee participation. In instances of a new product line, marketing staff are very sensitive to those features that will attract consumer interest. Historically, enhanced safety features have not been found to be a viable core around which to develop a multiyear marketing strategy. Accordingly, these considerations dramatically effect the technical planner’s perspective on just what features the proposed product line will possess. Technical and other purely designrelated ideas that do not add to or that actually detract from the central purpose of marketing, are normally jettisoned by planning staff. The documentation related to marketing thus has great bearing on how the suspect product got to the plaintiff in the condition it did. These materials are often of tremendous value in the punitive damage setting. Personnel serving as marketing liaisons to central planning committees and subcommittees are often a potent source of information during the taking of discovery depositions. Preliminary Costing Studies Materials falling under the heading of preliminary costing documents encompass a wide variety of information. Once a central planning committee has decided to expend funds for detailed technical feasibility studies, requests are made of select manufacturing and accounting offices to provide rough figures as to the actual cost to the company to produce such an item. Appropriate offices in manufacturing, as well as in product development, are queried about broad design costs, piece costs, labor costs, facilities costs, and materials costs. The cost of each of the several components of an anticipated design are often spelled out in great detail. Examination of these materials add to the ongoing education of counsel as to participating offices, departments, sections and individuals, obtained as a result of the study of the format of such documents and their distribution lists. More importantly, they serve to acquaint counsel with the internal costaccounting categories utilized by the company in general planning and in eventually placing a retail price on the proposed product. It is of central importance that counsel understand this internal cost allocation system. It is necessary to interpret the figures referenced in any one document as to its actual relation to the retail price of the planned product. It is also necessary for successfully deposing key company personnel. This is especially the case when counsel is attempting to obtain an accurate picture of the marketing realities of the company with respect to the suspect



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line. This is an area of activity where the assistance of a corporate cost accountant may be necessary. The proposed product is not available in even prototype form at this stage. Accordingly, reference must be had by planning committees to cost figures established on preexisting lines of products that bear broad generic similarity to the product or product component being discussed. This necessary fact of corporate life is of great importance to plaintiff in any relevancy arguments that may surface at various stages of the pretrial and trial processes. Counsel should make special note of each instance where the defendant has referenced preexisting financial or technical data as a basis for specific decisions or cost estimates for the new product under consideration. Relevancy under FRE 401 is grounded in the logical and experiential relationships among facts. This common corporate practice provides plaintiff ’s counsel with internal support for his arguments regarding the relevancy of materials that formally address distinct, although generically similar, product lines produced by the defendant. Defense counsel are hard put to deny the relevancy of such material when their client routinely uses the same data as a basis for hard decisions regarding formally separate product lines or model years. Finally, these materials may provide counsel with valuable information regarding the subject of commonality of parts as well as materials and component parts suppliers. Preliminary Tooling Studies It is important to know to what degree parts already tooled and stocked will be utilized in the new product. Tooling is a very expensive process and companies attempt to use current stocks in packaging a new product line. If the company has utilized existing stocks or designs for the design parameter of concern to plaintiff, it has a strong argument indicating the performance of such parts in arguably distinct model lines are fair game for discovery. These historical materials will directly reflect the actual performance of any such components in the suspect model. The traditional use of common parts, especially within differing model years of the same product line, requires that counsel identify and study those with a superior performance history utilized in other generically similar product lines. This is especially important with respect to those that could have been actually incorporated in the suspect product. For example, in Ford Pinto cases, the fact that a smooth face differential housing cover without sharp edges was used in other small car lines raises questions about the necessity for a more dangerous, sharp edged, cover on the Pinto line of subcompacts.


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Alternative Design Studies A routine part of initial technical feasibility studies is the drafting of design options for the major components of the proposed product. These efforts will normally attempt to follow the broad guidelines set by management planning personnel. Numerous documents will be generated at this stage that delineate the various features of these design options. They are often accompanied by detailed cost differentials and marketing pluses and minuses. The alternative design documentation found here may be very general in nature or specifically focused on a particular design aspect of the proposed product. In either case, this documentation has important investigative and legal significance for plaintiff ’s counsel. Initially, such material reveals additional office, department, and individual participation in the total product development project, adding to counsel’s knowledge about who was involved in what aspect of development at what point in time. As noted above, while any one document may appear to have minimal legal significance, each adds to counsel’s knowledge in this most important respect. Counsel should also be sensitive to the effect that broad marketing goals may have on this process. Alternative design documentation can date the corporation’s initial discussions and attitude toward the design alternative at a time when design decisions were stll fluid. There are a limited number of ways that a product can be redesigned and still remain the same product. As government or competitive pressures increase over the life of a product line, especially as regards to safety features, alternatives are dusted off and reconsidered. A design change at the heart of a “voluntary” recall engaged in after years of litigation and regulatory agency investigation, may often have been considered and rejected in this early stage for financial and/or marketing reasons. This eventuality has great bearing on the punitive damage count. Finally, alternative design documentation serves as objective technical data upon which management level personnel exercise their policy defining role. As with any other type of objective data, whether design, financial, or marketing in nature, this type of material must be addressed in some fashion by managers. Often, management documents analyzing such data has profound legal as well as investigative significance. The initial rejection of a safer, feasible design alternative at this early stage may have foreclosed any serious efforts by technical staff to rectify safety problems over the course of the remainder of the total development project. Competitive Product Studies New or updated products are targeted for a selected market normally populated by other firms. Technical as well as marketing analyses are routinely made of competing goods as a necessary step in achieving the company’s



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overall goal of carving out a competitive niche in such market. At each of the above-noted stages culminating in the manufacture of the suspect product, counsel will find references to the product or products serving as the defendant’s major competition. In Chapter 1, the importance of comparative product analysis was noted as a central part of state-of-the-art research. It is an equally important aspect of understanding the defendant’s internal choices and accompanying actions relative to the suspect product. The products already in that market are specifically examined as a means of determining the most productive program to achieve both marketing parity and a competitive edge. Competitive product studies can be quite thorough and, on occasion, result in the actual performance testing of competing goods. Documents generated here may include a variety of document types, ranging from comparative marketing and financial analyses to technical profiles. These are all of value to the product litigator, especially in those instances where discussion is had of superior product design features incorporated in potentially competing goods of the type that are of interest to counsel. Technical Feasibility Studies Once initial planning decisions have progressed to the point where funding is approved for detailed technical research and development work, the documentary output usually increases dramatically. Technical feasibility studies normally address every aspect of the proposed product design, with accompanying cost and regulatory analyses, where appropriate. Depending upon the complexity of the company and the proposed product, this output can be voluminous. The majority of these materials will have only peripheral legal interest to counsel. They can have considerable investigative value, however, for the light they will shed on the identity of involved offices and personnel. Corporations with model lines of products generically similar to the product under study, will often use existing product components, technical analyses, and financial breakdowns as the frame of reference for the drafting of feasibility studies for the proposed good. This not only requires knowledge of just what those analogous goods might be, but also raises the continuing problem of applying the discovery relevancy rules to the realities of such a common manufacturing practice. Given the magnitude of documents that surround the several key issues in the case, it is difficult for counsel to properly assess the logical bearing that many of the materials generated at this crucial stage may have on the preparation and eventual resolution of the lawsuit. Experts can be of great assistance in this respect by identifying those technical aspects of existing


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products that will surely be referenced in these initial technical feasibility investigations. The actual document types encountered at this stage can include both laboratory and test track reports, materials and component parts availability studies, facilities and labor estimates, analogous regulatory assessments and broad-based cost and financial estimates. It cannot be overemphasized that the bulk of these materials may not specifically address the suspect product. It is a generic design component, such as fuel systems, that often serves as the springboard for the gathering and analysis of the subject data. It is a point that plaintiff ’s counsel will have to stress time and again in the discovery, motion-in-limine, and trial stages of the litigation. All of these documents will shed continuing light on the identity of participating offices, departments, sections, and individuals in the overall development and manufacture of the product. Given the size and complexity of the typical corporate organization charts received in discovery, this factor alone justifies the examination of as many documents generated at this juncture as is legally and practically feasible. Cycle Plan Studies Each product developed by a corporation is intended to have a multiyear market life. In some instances, such as drugs, that market life or cycle can extend over decades. In most instances, the actual market life of a good is directly related to its acceptability and profitability in the target market. Nonetheless, due to the need for tight corporate planning and coordination of effort, each product that receives the go-ahead for development and manufacture does so in the context of a tentative cycle. Products are not developed without some fairly detailed planning regarding their future market life. This is especially the case in industries such as the automobile industry, where the introduction of a new model is an integral part of the marketing scheme for goods of that type. By whatever name such plans are designated, the fact remains that they are generally an integral part of the total marketing, product development, and manufacturing process. They are of great value to the product litigator and bear close examination. Products are initiated with the intent of carving out a place in the target market and gradually gaining ascendancy in it. To keep competitive, companies must look to the future of that market and anticipate design and marketing adjustments that will be necessary to maintain a foothold. Extensive planning is engaged in by corporations as to the changes through which a particular model line will go for a predetermined number of years or product cycle. It is extremely important to understand that the basic design configuration of the product is normally set in the first model year of the anticipated



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run of the product. The product may, accordingly, experience little significant design change in subsequent model year offerings. Testing, engineering, and financial analyses of the suspect design feature for ensuing model years thus have direct relevancy to the defendant’s knowledge of defects or alternative designs in the previously marketed suspect unit. This is especially the case where later test parameters are conducted at more severe levels and fail. Documents of this category and their supporting studies, will normally reference any government regulation that will take effect during the course of the new product’s market life. They often spell out, in some detail, those technical changes that will be necessary to achieve compliance at such future date. The alternative designs needed to accomplish any such changes are often available to the company for incorporation in the first model year, but are delayed on a cost savings basis. In some instances they have already been successfully tested and show a clear solution to technical shortcomings in the initial offering of the product to the public. This factor is telling evidence on the issue of the feasibility of alternative designs as well as the defendant’s attitude toward safety with respect to punitive damages. Additionally, these plans reinforce counsel’s arguments regarding the discovery and trial relevancy of documentation formally addressed to model years preceding and subsequent to the particular model year involved in the case at hand. Such materials are often proof that the basic design configurations for the product are set and maintained from the first model year of the product’s life. If the specific design configuration of concern to plaintiff is one of the basic features of the product that is not scheduled for significant change until later in the product cycle, these documents can be of great value. Preliminary Timing Studies Another integral component of the corporate product development and manufacturing process is the establishing of timing charts for each leg of the process up to the actual shipping of the goods for sale. Documents of this type are important in several respects. First, they give counsel a feel for the actual time spent on each stage of the process and allow for the isolation in specific time frames of performance testing and related projects so important on the issues of safety. Getting a feel for the typical scheduling of projects of the type under investigation will allow counsel to be sensitive to any acceleration in the process that may have required shortcuts. Documentation indicating a variance from the normal amount of time allotted for such projects, should receive special attention. Accelerated schedules often result in a dangerous attenuation of safety testing and related


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analyses. Products that are rushed to market have a greater chance of being flawed and dangerous to the user. Comparing typical timing charts with those configured for the suspect product is an important aspect of counsel’s investigative responsibilities. Preliminary Regulatory Review The prospect of an agency regulation applicable to either data recording or performance testing for products under development is a prime mover in the generation of documentation. This is especially the case in regulations requiring levels of safety performance. A wide variety of documentation types are generated at the development stage in response to the company’s concern over the prospect or effective date of any such regulation. Preliminary regulatory reviews are a staple of the design stage of the product development process. While many of the document types generated at this stage are produced because of regulatory pressures, there are documents that are more properly termed “regulatory analyses.” The safety office or its equivalent in most large corporations keep constant tabs on the prospects for legislative or regulatory activity. A primary function of such offices is to inform management of the likelihood of passage of and severity levels of performance testing requirements. These reviews typically discuss strategies to be used in campaigns to water down or eliminate any such measures. Learning the organization and identity of the staff in this central office is essential to a full understanding of the early document generation processes as they relate to safety concerns. It has been the experience of many product litigators that regulatory reviews set in motion by such offices account for the bulk of both technical and financial material addressing safety performance issues. Management Committee Support Studies One of the most important tasks that the product litigator must accomplish is the identification of the committee and subcommittee structure of the defendant. Corporate design decisions are both grounded in and finalized by the work of committees, not any one individual. Many committees are established on a permanent basis with set personnel. Others, however, are established on a functional basis for the carrying out of specific tasks and may not appear on corporate organization charts. On occasion, even permanent committees whose reporting links can be traced on a line responsibility chart may, on a task basis, report to an office or division head that technically crosses reporting lines. The identification of functional as well as line responsibility for all committees actually involved in the design and manufacture of the suspect product is



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one of the most important investigative goals of the product litigator. Such identification is complicated by the fact that, in instances where counsel has a multiyear time frame, the committees will invariably change names, focus, and personnel. This is a common feature of corporate life as the company adapts to the nature of its market and inevitable changes in technology. The precise identification of relevant committees and personnel is no easy task. Technical and financial information generated at each stage in the development and manufacture of a product serves as the foundational material for management decisions regarding each aspect of the proposed product. Hard data is generated at the request of committees who serve as organizational arms for management. This data in turn may be filtered through additional lower level committees who analyze it according to the broad outlines set by top managers. Each examination or synthesis of the data serves as the basis for a continuing series of reports or summaries that eventually end up as supporting data on a high-level management committee meeting agenda. Managers at various levels of ascendancy will review and digest such material as a prerequisite of the decision-making process. Documents generated at different times by disparate offices often serve as appendices for the presentation of a policy position paper at a top level management meeting. This can occur months or even years after the actual document was drafted. Documents received in discovery do not reflect the actual uses to which they were eventually put. Determining the true significance of any one document in respects to its impact of management decisions is one of the most difficult investigative tasks facing the products litigator. The resolution of such issues can only follow very close organization and analysis of all such materials. All of these memoranda, reports, and synopses are of great value to the litigator in both an investigative and legal sense. The set format of most of these materials, especially their distribution lists, further acquaint counsel with the important committees and personnel involved in generating significant material for management consumption. Management committee studies, whether technical, financial, or policy based in nature, are generally a central part of plaintiff ’s proof of knowledge of defect and feasible alternative designs. Incorporating and referencing as they do documents of a more technical cast, these materials are a significant aid in counsel’s attempt to identify which of the mass of underlying data was actually considered significant and/or determinative by management. This is of tremendous value when counsel is rating and selecting documents for use in depositions and in the selection of documents for use in the documentary portion of the case-in-chief (see Chapter 6).


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Management Committee Decisions Technical and financial data generated by corporate personnel with respect to a new product or new model in an existing line is generated as a basis for the exercise of management judgment. Management committees will eventually make hard decisions about final product design configurations, cost allocations, timing schedules, marketing strategies, conformity or lack of conformity to government regulations, and a host of other conclusions necessary to move the product along to the stage of actual manufacture. Not all of these decisions are necessarily made by the same committee on a detailed basis although there is generally overall accountability to more centralized management bodies. Counsel must isolate those committees having jurisdiction over those aspects of the product of concern to him and determine the chain of command through which such committees function. As with most other document types in corporate life, management committee decisions tend to be issued to affected offices in a standard form and hence are normally identifiable as such. In some instances such directives are even given a special color to highlight their nature. These documents will often reference the meeting where the decision delineated in the document was made and note any prior management decisions that are superseded. They generally contain a distribution list, thereby adding to counsel’ store of information regarding knowledgable offices, departments, sections, and individual personnel. Documents reflecting management decisions are the culmination of numerous committee meetings analyzing large amounts of technical and financial data generated by disparate arms of the corporation. Such documents are central components of plaintiff ’s case in chief. Corporate deponents and trial witnesses invariably raise the evolutionary nature of the corporate decision-making process when pressed on the issue of who made what decisions at what point in time. While such decisions are the result of long-term effort on the part of management support staff, nonetheless, decisions are eventually made by some group or individual and put into effect. Documents of this type provide clear evidence of hard decisions. They also provide counsel with a key date that will serve as a focal point in the examination of corporate activity that preceded and followed it in the process of getting the suspect good to market. In a related context, this knowledge of how to generate policy documentation, is of great importance in arguments over the discovery of documents. As noted above, documents that discuss or set company policy relative to the exact product unit and design parameter of concern to plaintiff, may never mention that product by name or only in a peripheral way. This is the result of the fact that corporations with multiple lines of generically similar products, such as automobile manufacturers, make policy decisions, especially



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those involving conformity to proposed government regulation, across model lines. This documentary reality is often encountered in attempts to get fair compliance from the defendant in discovery. For example, auto manufacturers have one standard for fuel system integrity safety levels for all of the cars they make. Given the broad similarity of basic design features such as fuel tank placement and related matters, tests conducted to aid management in developing or setting policy may be conducted on representative car sizes. Tests may be conducted on full-size, compact, and subcompact models. Those tests and the accompanying technical evaluations of them will serve as the basis for management policy on all specific model lines falling within those broad automobile size categories. This system can result in the fact that an entire series of documents having direct and compelling relevance to the particular model of automobile involved in the case at hand, may never mention it. This common corporate “across model lines” decision-making process provides defense counsel with potent arguments against the relevancy of such materials to the litigation. Understanding this system and the effect that it has on the generation of policy-oriented documentation is extremely important to efficient and efficacious discovery. Continuing Studies of All Types Documents of the types discussed in the preceding sections, as well as those analyzed below, are generated on an ongoing basis. Marketing, materials and parts analyses, cost breakdowns, regulatory reviews, design and alternative design configurations, test requests and reports, committee meeting memoranda, and the like are generated continually. Initial documents foster reactions and further output as the overall project progresses to the point in time when production is initiated. Given an extensive time frame, the resulting amount of documentation that counsel must access and review can be substantial. Once counsel has a feel for the materials received in discovery, he or she can generally track each document type over the course of the selected time frame and integrate them into the corpus of other types of material that give them meaning and context. The value of a more general grasp of document types prior to discovery lies in the edge such insight provides to counsel in estimating the scope of interrogatories and documentary requests.

Testing Documentation Testing The documents available to counsel with respect to the company’s testing program will often reap rich rewards. They are a key source in efforts to


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prove defendant’s knowledge of defects and feasible alternative designs. The testing conducted prior to the initial market offering of the product are good predictors of later testing involving more stringent test parameters. Several important clusters of facts will be found in these materials. Initially, counsel will discover the performance testing methodology utilized by the defendant and be able to compare it to the methodologies considered necessary by experts to adequately determine appropriate safety levels. In addition, counsel will become aware of the standard operating procedures within the company that control performance testing. The number of tests actually run to determine the performance level of the product in respect to the design feature under investigation can be determined. Test reports will also further reveal the identity of the office, section, department, and specific individuals actively involved at that stage of the product development process. They are an invaluable investigatory tool with respect to determining the dissemination of test results throughout the company. These tests, whether conducted on prototype models or production samples, normally tell the tale as to whether plaintiff has an arguable basis for recovery. Testing programs, test request forms, and intermediate and final test reports, are essential components in the proof of the products case. Aside from their important technical content, such tests are often filmed and/or photographed, thereby providing dramatic and often decisive viewing later at trial. Testing is an ongoing activity in the complex process of getting the product to market. Responsible companies will engage in testing to determine the upper safety limits of their product for each of their central design features. Unfortunately, this is too often the exception and not the rule. Counsel should always have the performance testing requirements of the federal agency having jurisdiction over the suspect company and product. More often than not, that standard — considered a minimum standard by the law — sets the upper standard for safety testing by the affected corporations. Counsel should also pay close attention to the dates that such tests were conducted, since, depending upon the model year of the offending unit, there may have been ample time and opportunity for the company to initiate needed design changes before final product specifications were frozen. This is vital information, especially in the punitive damage setting. Performance testing of products and/or product components is an integral part of the product development and manufacturing process. While the bulk of performance testing occurs in the early stages of product development, tests are also a staple feature of the manufacturing stage. Production validation and other quality control testing programs are a common feature of large scale manufacture.



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In instances where an annual new model introduction is a marketing requirement, as in the automobile industry, such testing may be conducted relative to those design features that distinguish the new model offering. In settings where the product is planned to maintain its basic design or chemical composition throughout its market like, testing may be dormant for years. In these latter instances, counsel must nonetheless be conversant with current performance testing methodologies in the field. Defendant’s failing may be its ignorance or purposeful ignoring of the increased opportunity that such methods would offer to determine product defects. Test reports are thus a central component of the product liability case, both from an investigative and legal standpoint. Performance testing tells the tale regarding the safety of the product. They also indicate, by examination of the test parameters, those safety levels considered adequate by the company. Agency regulations have their initial impact on companies with respect to their testing programs, given the fact that the greater number of precise agency regulations address performance testing and the recording and reporting of test results. The testing of the product is the culmination of the long term planning and detailed analyses of the types discussed in the discussion above. Every corporation tests their products to some degree, whether accomplished inhouse, as with the larger companies, or through the agency of independent testing organizations. Given the primacy of testing and test results in the product liability case, it is important that counsel be familiar with the range of testing methodologies utilized in the affected industries for goods of that type. In many ways, performance tests are the centerpiece of the entire product development and manufacturing story that counsel must communicate to the jury. All of the preceding effort by technical staff and the planning and decision-making of management culminate in the construction of a prototype or production model of the product. Testing provides hard data as to product performance which must be addressed by management in their subsequent technical and policy-setting activities. Management committees address test results in the context of company policy toward marketing, government regulation, and overall safety issues. This type of documentation is thus generally determinative of defendant’s liability or the lack of it. Test Logs One of the more important corporate documents associated with testing programs that counsel must request in discovery is the central log of tests performed on the suspect and generically similar products. It is necessary to determine the range of tests performed on all similar products, even those formally run to determine the performance level of components technically unrelated to the subject design parameters.


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The importance of a test log lies primarily in the historical frame of reference it gives counsel respecting the testing priorities of the defendant at select periods over the time frame. An examination of such a document often reveals only minimum testing of features that are rife with danger to the consumer and extensive testing of less onerous but more attractive marketing features of the product. In addition, counsel can get a feel for the periods of time when testing was of concern to the defendant and when it was not. From an investigative standpoint, the isolation of such facts can often shed new light on the generation of other documentation during the same time periods. Finally, possession of test logs by plaintiff ’s counsel aids in determining the veracity of defendant’s representations about the extent of testing with respect to the product and design feature at issue in the case. Testing Standards The actual performance testing standards utilized by the company, with respect to the type of product and feature being tested, are important materials for counsel to obtain and study. More often than not, these standards are ones issued by the American National Standards Institute (ANSI) or other formal standards issuing body. These standards are voluminous; they address materials testing, materials composition, and performance testing and are readily accessible for study during prefiling investigation. The examination of defendant’s internal testing procedures is necessary to determine the degree of compliance with such standards and recommended test severity levels. While voluntary in nature, these standards are generally mirrored in performance testing standards issued by federal and state agencies. In-house test specifications also tend to mirror these standards. Variances in test severity levels are generally the bone of contention in analyses of the propriety of such standards and defendant’s obligation to adhere to them. It is important to note that the funding for standards setting organizations such as ANSI come in large part from industry, who are well represented on the committees and subcommittees actually formulating such standards. In instances where recommended practices are not followed by a corporation in its testing program, it is of value to determine defendant’s representative on the aforementioned committees. The latter information can have compelling importance in punitive damages settings. Test Requests As noted throughout this chapter, corporations tend to standardize the manner in which various corporate activities are initiated, carried out, reported, and communicated. The same holds true for its testing programs. The testing



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of product performance is costly and therefore carefully thought out before funds are expended. Tests, like other significant expenditures of corporate resources, are initiated by request. The test parameters and test object or purpose are generally spelled out in specific terms. The obtaining and analysis of test request forms can, in some instances, be as important or more important than the test results themselves. Why a particular test or series of tests are being conducted sheds light on management’s product concerns at that time. As noted, a substantial amount of testing in modern corporations are the direct result of pressures created by government agency regulations that mandate it. Attention must be given to the possibility that a formal test report may misrepresent the actual purpose for which the test was run. Government certification testing programs are basically self-certifying systems where corporations that are subject to a particular regulation conduct their own tests according to agency standards and submit the required reports to the agency. Such self-certifying testing systems have great potential for abuse by those companies subject to government regulation. Government agencies do not require that the corporation submit every test conducted on a product prior to agency approval or certification. Generally, such agencies do not require that the corporation submit tests conducted to determine how improvements can be made in their overall testing program. Likewise, agencies generally do not request tests conducted to provide general information about the overall design of the product or design features that are either outside the scope of the applicable regulation or the jurisdiction of such agencies. However, tests conducted to determine the ability of a relevant design feature to meet the standards of a regulation, must be submitted for agency scrutiny, including those which indicate an inability to achieve compliance. It is in the latter instances where possession of test request forms are of importance. It has been the case that corporate management has requested testing to determine regulatory compliance and where such tests fail, have altered the formal test report to reflect a test type or purpose that falls without the submission requirements of the relevant agency. The possibility of such a questionable practice is something counsel should be alert to in the process of examining defendant’s documents addressing its testing program. The test request form normally indicates the actual purpose of any test to be conducted. These should be carefully compared to the test object set forth in all formal test reports. Test request forms, like all other document types studied, will also shed further light on the identity of knowledgable offices, departments, sections, and individuals at that specific stage in the product development or manufacturing process.


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Informal Test Reports Formal test reports written in the format mandated by corporate standard operating procedures are not the only form in which test results are recorded and communicated. In the larger corporations, formal test reports are often written by in-house technical writers. In some instances, these formal reports are not prepared for weeks or even months after the subject test was conducted. Formal test reports often set out the date that the test was requested, the date that it was conducted and the date of the report. In instances where there is a time gap between the running of the test and the date of the formal report, counsel must be alert to the existence of informal memoranda that communicated the test results to management personnel in the interim. Informal memoranda delineating test results normally do not follow any set format regarding the content of such memoranda. Certain personnel may only be interested in certain aspects of the test, resulting in a summary description of that test data of interest to the party requesting it. In discovery, counsel should specifically request any and all summaries, synopses, or other recordations of test results including, but not limited to, the formal test reports that eventually reside in the company’s technical archives. These informal memoranda, both those requesting such synopses and those providing them, often reveal concerns about product performance and management policy that would not be included in the formal test reports drafted by a professional writing staff. Corporations are much more careful in the way formal test reports are written, given the fact that such tests are routinely submitted to federal agencies and are a staple of the discovery process. It is common practice for corporate lawyers to instruct engineers on the dangers of loose or alarmist statements placed in the more descriptive sections of test reports. These memoranda can assist counsel in delineating corporate activity when there is a noticeable time gap in the more formal testing documentation generated during that period. Formal Test Reports Formal test reports are essential documents in establishing the legal requirements of the products case. They are also important from an investigative standpoint, due to the fact that they contain a wealth of information of great value to the products litigator with respect to the document generating and decision-making processes of the company. The actual number of test reports and related documentation will vary significantly from case to case, depending upon the nature of the product, the frequency of introduction of updated or new models, if any, and the type of testing mandated by a relevant government agency. In some instances, the entire body of testing materials may have been generated at the design stage,



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with the product not being subject to any further testing for years. In other cases, testing can be a continuous process, accounting for a significant amount of the technical material that must be mastered by counsel. Counsel must be thoroughly versed in the testing methodology considered state-of-the-art for products and/or design features of the type being evaluated. The corporation’s failing may lie in its lack of diligence in utilizing modern testing methods, rather than a failure to test at all. In some instances the fault may lie in the defendant’s failure to follow all recommended practices even though they do utilize the basic approach considered appropriate by technical standards issuing bodies. Close familiarity with state-of-the-art testing methodologies applicable to the industry, product and design features involved in the case, provide counsel with a technical frame of reference with which to assess the reasonableness of defendant’s testing program. The information contained in formal test reports, regardless of the type of product being tested, would normally include the following: • • • • • • • • • • •

• • •

•

Test identification number Date that the test was requested Date that the test was run Date that the report was issued Product or product feature being tested in the event of laboratory testing of separate design components Test object or purpose Government regulation to which the test is configured, if any Author of report Office, department, and/or section in the company where the author works Name and office, section, and/or department of the individual requesting that the test be conducted List of corporate personnel to whom the test report will be distributed, and in some instances, the office, section, or department in which such individuals work ANSI or other test standard that serves as the guideline for the test methodology Special conditions, if any, under which the test was run, such as alternative design features or test severity levels Categories of data generally recorded in tests of that type and specific descriptions of the resulting data generated by the particular test in such categories Number and in-house identification number of any still photographs or films that may have been taken


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• A narrative synopsis of the overall test result relative to the test object or purpose • A narrative synopsis of the results per the categories in which data is recorded Each of the above categories of illustrative test data are typically important informational and organizational focal points in the analysis, synthesis, and selection of documents for deposition and trial use. Prototype Tests Prototype testing is a staple of the testing program for new products or new product models in an existing line of goods. Prototypes are customized models of the planned product. They are either constructed from whole cloth or through the adaptation of existing products to the planned specifications. Prototype testing, occurring as it does prior to the fixing of final design parameters for the product to be mass produced, provide information of considerable investigative and legal significance. Initially, counsel should be alert to references to code names for the product development project resulting in the manufacture of the suspect product. There is nothing improper in the use of such project code names. They are used in attempts to keep research work private or simply serve as a temporary product label until marketing staff and managers decide on a permanent designation. The importance of such code names lies in the clue they may provide regarding the existence of a body of early documentation that may not be referenced in initial interrogatories or document requests and thus provide a solid basis for supplemental discovery.1 A central focal point in assessing the value of a prototype test is the date that final product specifications were set preliminary to the start of the first production run. In some instances, prototype testing may in reality only be pro forma. If conducted shortly prior to the finalization of production specifications, it may indicate an arguable disinterest in the actual performance of the product or design parameter being tested. Project documentation generated prior and immediately subsequent to the request for the tests may reveal firm decisions regarding marketing campaigns, material and component parts purchasing, facilities allocations and the like, that the same conclusion may be said to follow. Formal testing is, in many respects, the culmination of a great part of the corporate activity preceding it. It is, nonetheless, only one important part of it. Other considerations of the type noted above may have resulted in the drawing of fast project lines that, from the total corporate organizational point of view, mandate that negative test results be essentially ignored. Such a situation has compelling interest in punitive damages settings.



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It is normally at the prototype testing stage for new products or new model lines that alternative designs are considered. This is especially the case where proposed government regulations or the effective date of a finalized regulation put pressure on the company to meet a specified performance level. In this respect, counsel should review the prototype test reports and the documentation preceding the running of any test, for references to earlier test results or technical and managerial analyses that may be mentioned in them. To whatever degree the overall or specific feature of the new design is unique, corporations must nonetheless rely on preexisting technical data obtained from the testing of generically similar products or design components. This body of information serves as a basis for preliminary assessments regarding the probable performance of the new design, pending the receipt of hard data from the actual prototype tests to be run. The fact that corporations necessarily and consistently rely on preexisting technical and evaluative data at the early design and prototype testing stage allows for the accessing of such materials by counsel in the course of initial and supplemental discovery. This routine corporate process provides an effective basis to counter defense objections to the production or use of such materials on the basis that their “differences” militate against their relevancy in a discovery or evidentiary sense. Comparative Product Tests Manufacturers will often conduct tests on competing products to provide data for comparative performance evaluations and future design planning for their own goods. In other instances, the defendant may possess the results of tests performed on competing products while not engaging in testing themselves. In either event, counsel should be aware that comparative product tests are a routine part of the product development and manufacturing processes of most large American manufacturers. The request for and examination of such test reports or evaluations is important in several respects. Initially, in the event that the competing product has a superior design of the type of interest to counsel, it bears directly on defendant’s knowledge of a feasible alternative to the suspect design feature. Second, in instances where the competition’s design is equally inadequate, it reinforces defendant’s knowledge of danger. In cases where the suspect design is one generally adopted by the industry at large, the defendant will normally argue industry custom as a major factor militating against a finding of defect. The fact that everyone in a particular industry has adopted a similar design does not legally require a finding that the product was not in a “defective condition unreasonably dangerous.” It is nonetheless a powerful factual defense. Such a defense, in effect, requires


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plaintiff to find fault with the entire industry. This information, otherwise unavailable from the competing companies, provides counsel with an opportunity to assess how he will meet the “industry custom” argument of the primary defendant. Finally, examination of documents addressing competitive designs may reveal an industry-wide agreement on test severity levels in attempts to counter agency efforts to impose a higher level of performance. In many instances trade association submissions to a relevant government agency, containing valuable comparative testing data, may be located in defendant’s files and be discoverable. Certification Tests Certification testing to government standards is an ongoing process in major American industries, such as automobile and drug manufacturing and it may account for the greatest amount of testing actually conducted by the company. Certification testing encompasses tests run to determine the ability of the affected industry to meet the requirements of proposed regulations as well as those regulations that have been adopted and will be prospectively mandated. Certification testing requirements are performance oriented. The regulations do not by their terms, require any particular design of the product features touched by them. Rather, they require that the product, however designed, perform to a level specified in the regulation. In the automobile industry, for example, Federal Motor Vehicle Safety Standard 301 requires, beginning with the 1977 model year, all vehicles sold in the United States not leak more than one ounce of fuel per minute for the first five minutes following a rear-end collision of 30 miles per hour. During the years preceding the effective date of FMVSS 301, automakers conducted rear-end crash tests on vehicles representative of their model lines to assess the ability of such vehicles to withstand such a crash within the requirements of the regulation. Similar testing is required for all future model lines and yearly updates. Given the increase in the number of federal performance testing standards, certification testing and related documentation are a major subject for the products litigator’s discovery, analytical, and organizational efforts. The testing and reporting requirements of the FDA alone, mandate the generation of copious amounts of documentation of central concern to the litigator preparing the drug-based products case. Production Validation Tests Production validation tests are conducted on production units of the product to determine whether the mass produced version of the good complies in



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the same manner as prototype models with internally or externally mandated performance standards. These tests generally adhere to the same test parameters and are requested and reported according to the form for such activities normally adhered to in the company. Production validation tests serve as a check on the company’s adherence to required test severity levels. They also indicate the degree to which production models may vary from prototypes with respect to such requirements. Production testing often occurs years after the initial prototype tests that served as the basis for management decisions to proceed with production. Current testing methodologies may be capable of revealing enhanced dangers not easily recognized in earlier testing activity. Counsel should thus keep pace with the state-of-the-art of testing and carefully cross-check the data capable of being generated under newer testing systems. Production validation testing may have failed to incorporate recent technology or methods. Laboratory Tests Laboratory testing is central to the premanufacturing processes of the drug and chemical industries. It also accounts for a significant percentage of the testing conducted by companies outside those fields. Even automakers, who use large-scale crash testing tracks to conduct the bulk of their testing, utilize laboratory facilities for a respectable amount of their testing agenda. In companies manufacturing outside of the automobile and heavy equipment industries, laboratory testing comprises the bulk of their efforts. This testing may be conducted in-house or through the agency of private testing facilities such as Underwriters Laboratory. Quite often, it is a combination of both methods. It is incumbent upon counsel to familiarize himself with the testing methodologies utilized by the industry within which the defendant corporation does business. Understanding what those methodologies are and their recommended use, allows counsel to anticipate the types and number of documents associated with such testing procedures when both planning and executing discovery requests. The above discussion of agency recommended or imposed performance testing requirements applies equally to testing centered in laboratories. Documentation Relating to Testing Program The documentation associated with a company’s testing program is voluminous, and actually encompasses a significant amount of the documentary output relative to any one product. This is especially the cases in industries such as the automobile and drug industries who are subject to numerous performance testing and/or test reporting regulations issuing from federal agencies. The type of documentation referred to here includes all of the types


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noted above, ranging from engineering analyses to financial and management decision data. Tests are a catalyst for much of the documentation encountered in a product liability case.

Production Documentation Production Stage The stage of actual mass production of the suspect product bears close attention. While the bulk of the documentation that will determine defendant’s liability will have been generated well before this stage, nonetheless, a certain amount of material generated here can be of great value in the total preparation effort. Production validation test requests and reports, discussed above, are one area for investigation. Production activity is the culmination of the multitude of planning components preceding it that further serve to put the extent of defendant’s failings into perspective. Production, like any other corporate activity, is well planned. It is here that documents will be found that discuss in detail the future of the product line of which the offending unit is a part. This is particulary so with respect to materials that discuss design changes that may be made at subsequent dates in the ensuing production cycle for that product line and model. In the design categories of case, the documents generated at this stage offer the least amount in quantity and quality. However, there are several document types that bear examination. Production timing charts give counsel a feel for the average amount of time it takes to get a product of the type under consideration from the idea stage to an actual production run. A truncated timing schedule should be a red flag for plaintiff ’s counsel. This may be encountered in cases where the company experiences a sense of urgency in entering the target market. An abbreviated timing schedule requires that certain steps normally taken along the way must be eliminated or watered down to meet the stated deadline. What generally suffers in the increased tempo of product development is alternative design and general safety testing. The rush to market by the defendant can have great impact on plaintiff ’s punitive damage count. Documentation addressing production runs can often yield valuable information. Quality control standards and the number of flawed units noted by them can be important in some cases where it is difficult to determine if the case truly revolves around a design category or a manufacturing defect. This data will also acquaint counsel with the number of units produced over the relevant time frames, a needed block of information when attempting to gauge the amount of punitive damages that plaintiff is seeking.



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Finally, this data will assist counsel in determining if any materials specifications or last minute design changes were made during the course of the several production runs. It will also aid in the attempt to trace the offending unit to a particular point in the actual production process. The discussion to follow will examine the investigative and legal significance of several of the more commonly encountered production processes and their documentary output. Production Specification Manuals Production specification manuals or “product books” are those sets of documents that freeze all specifications for the actual manufacture of the good. These documents reference data ranging from the type and supplier of materials and component parts to the exact measurement and place of every item to be incorporated in the good. At some point in time, in every company, for every product, these decisions are eventually made. Due to the complexity of coordinating all of the corporate bodies necessary to initiate a production run, these decisions are made well in advance of the date that actual production is to commence. Here, as with all other stages central to getting the good to market, planning and final decision-making may lag one or more years behind the event toward which they are directed. The date at which product specifications are frozen is a central focal point for investigative and legal analysis. The specific contents of such manuals also provide a set of control parameters against which the prior and subsequent efforts to test alternatives can be assessed. Materials and Component Parts Specifications Counsel should be alert to documentation in such books, or elsewhere, that delineate the source of materials or component parts that make up the particular design aspect of the suspect product. This is generally determinative as to whether newly tooled parts were used or those from existing stocks utilized on other product lines within the company. The process of finalizing parts and materials is a long and complex one. It accounts for a significant amount of the documentation that counsel will review. Reviewing this material, couched as it is in internal codes and vocabulary, is laborious and time consuming. It is nonetheless often worth the effort, especially in instances where documents reveal the substitution of inferior parts or materials for those originally or normally used. These materials may also reveal actual design changes in the course of a production run deemed necessary to avoid cost overruns.


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Production Statistics and Runs Production statistics are important in isolating two important blocks of information: the actual numbers of units produced over the cycle of a product line, and the point in time when the suspect product unit was actually produced. The former figure is important to the initial determination of punitive damages, providing, as it does, a necessary figure for the estimation of gross corporate profits with respect to the product line of which the offending unit was a part. The latter figure is needed to isolate the point in time when the suspect unit was produced. This is required to place the date of manufacture of the suspect unit in the precise production run out of which it originated. While this is not always possible, it can be of value with respect to materials, parts, or design changes that may have occurred during the course of the production run of which the offending unit was a part. Quality Control Procedures The examination of quality control procedures is important in many products cases. This is especially so in instances where it is uncertain if the suspected flaw is the result of a manufacturing or design defect. Examination of the methods utilized to check for product flaws during production runs and the figures for the number of units that failed to meet the defendant’s quality control standards, can often assist in resolving this technical quandary. By isolating the production run wherein the offending product unit was manufactured and examining the quality control statistics for that run, counsel will be better equipped to address this issue.

Marketing Documentation Marketing Stage The marketing aspect of product development and manufacture is, like testing, an ongoing process. It begins at the inception of thinking about the product line. Since the product is being made to sell, marketing issues are of central concern to managers and are often determinative of product design parameters and safety performance levels. Recommendations of the technical and engineering staffs are always viewed by those on the management level with an eye toward competition and anticipated profits. Design features that significantly detract from either are quickly scuttled. Only those that conform to the managerial vision of the product’s market potential are seriously considered.



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Documentation generated here is generally very revealing as to the initial commercial considerations that may restrict the extent of research and development efforts by technical staff. Counsel often find memoranda criticizing suggested design configurations that fail to comport with company strategy relative to market entry price, long range advertising campaigns, future model line changes or estimates of competitive activity. The factor of market price requires brief analysis. The central idea of strict liability for products does not require that manufacturers be insurers of their products. Plaintiff must prove that the suspect product was in a “defective condition unreasonably dangerous” (Restatement of Torts 2d §§ 402A). The policy underlying strict liability recognizes the reality of a varied American market structure. A Pinto is not a Lincoln Continental or a Mercedes Benz, and product liability theory does not require that it be so. Producers have the right to reach out to disparate markets in the complex system of modern American manufacture within which they function. This fact requires counsel to have the financial realities of defendant’s target market close at hand when analyzing the suspect product against the state-of-the-art, generically similar products and expert witness evaluations. The primary focus is appropriate safety levels in the target market. What could the defendant have done to make the suspect product safer according to the dictates of the state-of-the-art and still remain competitive in the market in which it chooses to sell. Counsel must beware of attempting to impose levels of safety that are not realistically obtainable by the defendant in that target market. This factor underscores plaintiff ’s need to conduct a thorough comparative product analysis and to develop an expertise in the corporate process of translating design, tooling, facilities, and production costs into retail price equivalents. This is a major factor in determining the economic feasibility of alternative designs technically available to the defendant. It is determinative on the resolution of the ultimate issue of whether or not the product as sold was in a defective condition that was unreasonably dangerous. Counsel will encounter documents that set out what appears to be a minimal cost figure to accomplish a needed change that would provide a more responsible level of safety for the design configuration under investigation. What is not always clear to the novice products litigator is that cost may be only one type of cost logged in the course of the complex corporate accounting systems of most large American manufacturing firms. The cost figure under study may be designated a design cost. That cost must be added to other internal costs normally logged by the company such as tooling, piece, facilities costs, and the like. All such costs must be considered to


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approach an approximation of how they, in total, translate to a dollar figure on the retail shelf or showroom floor. Corporate cost allocations and production accounting procedures are extremely complex and require close study. Many a products litigator has suffered frustration and dismay at the degree of obsfucation that this factor generates in deposition and trial testimony by corporate witnesses. It is a primary basis for defense efforts to convince the court and jury that the suspect product is not, based on economic realities, in a defective condition unreasonably dangerous. The overriding importance of marketing considerations in the planning, design, testing, and ultimate manufacture of products, has been emphasized numerous times in this book. It bears repeating that those concerns color the entire process of getting a good to market. The concept of “marketing” encompasses the ongoing references to marketing concerns found along the product development path. It refers as well to the type of materials to be discussed in the ensuing material that are more traditionally associated with that topic. Documents Relating to Marketing Concerns Documents addressing the marketing of a product will be encountered at virtually every stage of a product’s planning, development, and manufacture. Marketing concerns address much more than sales campaigns and advertising literature. They also include documentation issuing from management at any specific stage of development that serve as checks against engineering or regulatory concerns that detract by any significant degree from the original profile of what makes the proposed product attractive in management’s eyes. The difficulty encountered by product litigators in this respect, is that such concerns are rarely directly stated as the reason for management opposition to changes perceived as necessary by the technical staff. Memoranda issuing from marketing wings of management that ride rough shod over engineers are unlikely to be found even at the earliest development stages. There, as throughout the entire product development and manufacturing process, those restrictions loom as assumed factors that set limits to internally or externally proposed innovations that would alter the marketing vision. Counsel should attempt to determine the effect that the design, instructional, or warnings changes deemed desirable would have on the total functionability as well as marketing attractiveness of the product under study. In particular, he should isolate any marketing focal points that clash with the alternative designs that will be fostered throughout the case. As an example, in the Ford Pinto litigation, very early documentation is encountered reject-



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ing proposals to place the fuel tank in a protected area above the rear axle due to its impingement on trunk space. As noted many times throughout this book, what is not said in corporate documents is often more important than what is said. The seeming incongruity of management decisions in light of testing and other scientific studies indicating product hazards is often a result of previously determined marketing and other financial considerations. Understanding this reality will go a long way in honing counsel’s understanding of how a dangerous product was released to the consuming public. The determination of just what those financial and marketing goals were is one of the central investigative tasks facing plaintiff ’s counsel. Advertising and Marketing Literature Advertising and related marketing literature lie at the heart of the 402B misrepresentation case. They are also extremely important evidentiary components of failure to instruct and/or warn counts. It cannot be forgotten that while such cases concentrate on communications from the manufacturer directly to the consumer, they are nonetheless grounded in a technical product failing. Technical documentation of the type heretofore discussed will serve accordingly as a necessary backdrop to cases grounded in these theories. Misrepresentation, failure to instruct, or failure to warn cases are centered in the absence of or misstatement of product information known to the defendant corporation but not accessible by the consumer. Advertising and marketing offices within a corporation do not operate in a vacuum and are normally aware of product failings. Corporate counsel carefully scrutinize such literature for its litigation potential. It is important to identify those offices or departments within the company that directly address the communicative aspects of product marketing. Equally important is the system of information dissemination that channel data indicating knowledge of product hazards to such offices. Advertising Copy Once this information is obtained, counsel should determine what the memoranda issuing from such offices to outside advertising agencies say or do not say about preexisting product defects. In this respect, counsel should closely scrutinize not only the particular language utilized in proposed advertising copy but its physical layout and graphics as well. This category of documentation is too often overlooked by product litigators. This type of material would encompass the communications and proposals passing to and from offices within the company and those issued


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to the advertising agencies selected to mount the formal campaign that reaches the consumer. Each large corporation has offices within it that specialize in the creation of guidelines for, as well as final selection of, formal advertising copy. This activity is, in many ways, the culmination of years of technical and financial planning. It is a vital part of the overall product development and manufacturing process. This essential activity, as with all others of importance in corporate life, is the result of significant planning. Often this work precedes the actual advertising campaign by one or more years. Drafts of advertising copy developed by defendant’s advertising agency and in-house advertising liaison office are important in these types of actions. Advertising, as with any stage of the entire product development and manufacturing process, must dovetail with managerial aspirations regarding the suspect product. Corporate memoranda normally exist that evaluate the merits or demerits of advertising copy in light of management’s product policy. These memoranda can be very informative as to the company’s concern over known design defects and their attitude towards public awareness of them. This consideration applies equally to text and graphic representations. Preliminary advertising copy as well as the finished materials should be carefully examined in this light. Comparing advertising to research and development budgets to the costs required to incorporate needed design changes often dramatically highlight the defendant’s questionable priorities. Once again, the issue of appropriate time frames is important. Advertising that fails to keep current with or ignores technical knowledge of product dangers, whether gleaned through company or outside sources, is a prime source of evidence on both compensatory and punitive damage counts. These documents are generally present to some degree in corporate archives and can potentially fulfill several important components of counsel’s investigative and legal requirements. This is especially the case in instances where the litigation is grounded in 402B misrepresentation. Instructions and Warnings Product warnings and instructions accompanying the good are the result of careful and long-term planning as with every other significant aspect of product development and manufacture. In many instances they are based on materials of many years standing, especially in cases where the suspect product has experienced a long market life without alteration. The same would be true for a new model of an engineered item which incorporates the same basic technology as in preceding model years.



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Counsel should be aware of the organizational structures and document generating processes that shed light on the development of warnings and instructional materials. He or she must also identify the personnel primarily charged with their development and final issue. Due to the significant impact of federal legislation in this area, especially in the drug field, counsel will no doubt observe the active participation of the type of “safety” office referred to earlier in this study. Instructions Instructions for use accompanying the product are also the result of an evolutionary process within the company. As with other aspects of the product development process, they often reveal a disparity among the views of the technical, marketing, and managerial staffs. The examination of drafts of instructional materials and the various memoranda generated in response to them, will acquaint counsel with the internal processes for the development, approval, and publication of product instructions. Comparative product analysis, along with in-house documentation illustrating defendant’s awareness of product defects, will place the suspect instructions in a revealing light. Documentation relating to instructional materials can fall into several categories. Initially, there are drafts of instructions prepared for the specific product under scrutiny as well as all generically similar goods produced by the defendant. As noted, the time frame for such documentation grounded in these theories can be, and often is, of significant length resulting in large amounts of relevant material for study. In addition to specific instructional materials, there are often company guidelines for the drafting of them. Counsel will also normally find memoranda passing to and from the various levels within the appropriate office and to and from management personnel evaluating their suitability. Given the centrality of the communicative aspects of instructions, counsel should be alert to standard procedures applicable across the company’s product lines that address the subject of graphic displays, print size, and print enhancement features of instructional materials and warnings. The way in which important material is communicated to the consumer is of equal importance to what is actually communicated. Inadequately formatted instructional materials can nullify the impact of the subject matter of the communication. The timing restrictions faced by personnel charged with the task of completing instructional materials should also be determined and compared to the normal time allotments for the completion of such tasks. This important work, like design efforts, suffers from truncated timing schedules.


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Warnings The observations noted above regarding instructional materials has equal applicability to documentation addressing product warnings. The way in which major companies instruct or warn and the processes utilized to do so, are normally governed by set operating guidelines, committee structures and timing schedules. This constant feature of corporate life bears repeating here. Drafts of warnings must be examined in light of their intended audience. Given the fact that a very large number of drugs are available by prescription only, the appropriateness of a warning to a physician will vary greatly from one primarily directed to the consuming public. Company guidelines respecting the drafting of warnings for such disparate audiences bears close examination. It is important to compare each draft of a warning with both the final issue by defendant and those issued by manufacturers of similar goods. Counsel can expect to find memoranda exchanged among the staff specifically charged with this work as well as documentation evaluating such materials issuing to and from management personnel at the highest levels. It is essential that counsel cross-reference warnings and instructional materials with historical and contemporary state-of-the-art literature respecting known or suspected hazards. This is a base requirement in establishing knowledge of defect and proximate causation.

Regulatory Documentation Documents Related to Government Regulation The existence or expectation of government regulation, whether addressed to record-keeping, reporting, or performance testing requirements, has a dramatic effect on the generation of routine corporate documentation at every stage of the product development and manufacturing process. A disproportionate number of documents addressing product safety are generated in direct response to management concerns over the details of a prospective federal agency regulation. Since such regulations affect to some degree virtually every aspect of a product’s development, production, and sale, they are a continuing source of technical and financial evaluation, and managerial study and decisionmaking. The existence or prospect of precise performance testing requirements prompts technical analyses and tests to determine the ability of the affected product to comply with the regulation. A host of other materials will normally be generated to assess the additional costs and other ramifications associated with such compliance.



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In the event that current or planned design parameters fail to meet anticipated regulatory specifications, alternative design testing and cost analyses are generated. These objective materials are then scrutinized by management to review current company policy and to prepare a response to the relevant federal agency. A standard feature of such research and associated studies are political assessments of the likelihood that such regulations will become effective. While not every product involved in product liability litigation will be subject to existing or proposed regulations, it is becoming increasingly rare to process a product liability case that is not touched to some degree by federal regulatory activity. The amount and variety of document types associated with the corporation’s concern over pending federal regulation is thus a central source of the data needed to fulfill the legal requirements of the products case. The subject of government regulation also encompasses the corporation’s ongoing contacts with the federal agency having jurisdiction over various aspects of the product’s development, manufacture, and marketing. The processes of the National Highway Traffic Safety Administration (NHTSA), the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the Consumer Product Safety Commission (CPSC), are the source of ever increasing amounts and types of corporate documentation of keen interest to the product’s litigator. This is the result of the constant interchange between the company and the relevant agency required by agency regulations of varying types. These contacts may be necessitated by reporting requirements as with the FDA or performance testing requirements such as are increasingly issued by NHTSA and the CPSC. Each type of contact can generate significant amounts of documentation. They are often available to counsel through a Freedom of Information Act request. The initial discussion will focus on the range of documentation generally found as the result of the issuance of proposed performance testing regulations by a federal agency. As noted, an inordinate amount of the safety testing and related documentation generated by companies is a direct result of the issuance of proposed performance testing requirements. This reality lends strong support to the commonly held position of consumer advocates that corporations pay inadequate attention to safety concerns until they are faced with the prospect of government regulation. Performance testing regulations do not directly impose any particular design configuration on a company. Rather, they posit a level of performance in a particular respect that the company’s design must reach in any way that they chose. Performance standards are, by law, deemed minimal standards


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only. They serve as a forced incentive to companies to improve the design parameter addressed by the regulation. These minimum standards, however, are generally considered by the affected industries as the upper limit of performance in corporate planning. At trial, they will take the position that such standards are the true state-of-the-art. The existence or specter of government regulation generates input, and hence, documentation, from virtually all key divisions and offices in the company that are involved with the product line and feature affected by the regulation. The greater number of government regulations for engineered products involve performance testing standards. These may require the redesign of the affected components as a necessary effect of compliance. Companies faced with the promulgation of a safety performance testing requirement must seek information from technical staff as to whether the proposed safety level can be met within current or planned design parameters or whether redesign is deemed necessary. Quite often, testing is required to answer this question. The test results are by no means determinative of what the company actually intends to do regarding compliance. Input from manufacturing offices is needed to gauge the assumed cost of any needed changes relative to design, tooling, facilities, and labor. It must be determined if needed parts can come from current stocks or whether the goal of commonality of parts will have to be forgone and retooling initiated. Estimates must be made as to how any needed changes will effect forward company plans relative to overall model line development, marketing strategies, future budget allocations, and a host of related financial and planning considerations. It is during this process that the corporation’s political liaison office’s become increasingly important. Most major corporations have an office whose primary function is to keep abreast of agency activity and to serve as liaison between the product development and manufacturing divisions of the company and the relevant agency. Often these offices are designated “Safety Office.” This is misleading at best. The central purpose of the greater number of these safety offices is to stave off or water down agency regulations and to apprise management of the likelihood and extent of regulation in the future. In many instances, counsel will find that the safety office is the prime mover in the document generating process with respect to design parameters that are the focal point of government scrutiny. Since the safety office requires hard data to prepare its case against regulation or to seek a delay in enforcement, it is a major source of requests for testing and technical evaluation. The disparity between the technical analyses generated by such requests and the conclusions reached by the office in their submission to the agency enforcement office is often striking. The differences between what the internal documents actually show and the company’s position



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that the regulation is too onerous or unnecessary, serve to highlight plaintiff ’s punitive damage count. In the course of a defects investigation, agencies will normally submit a series of interrogatories to the company requesting information relative to a broad range of product development, manufacturing and marketing subjects. They also normally request copies of all documentation relevant to such questions currently located in company files. A comparison of documents obtained during the course of discovery and those submitted by the defendant to the agency pursuant to this process, often show glaring omissions by the company. This all-too-common corporate practice can go a long way in convincing the court or jury of the propriety of a punitive damage count. The agency process of proposing, reevaluating, mandating or, in many instances, eventually abandoning a regulation is a lengthy one. Accordingly, the amount of corporate documentation of all categories addressing the regulation — especially at the earlier design and testing stages — can be, and quite typically is, voluminous. It is important that counsel determine the exact nature of the corporate documentary submissions required by the appropriate agency in the certification process. These agencies do not require copies of every document generated within the company that addresses the design configuration. This point lies at the heart of regulation. Unless the agency is in the midst of a formal defects investigation, they generally only require documentation of tests that were run specifically to test product performance against the regulation. They do not require the submission of test materials, even those directly reflecting product performance of the type of concern to the agency, if such tests were formally conducted for other corporate purposes, such as general design or testing guidance. More importantly, agencies do not normally require submission of the multitude of documents that typically precede and follow the actual conducting of performance or adverse reaction tests. The importance of this fact lies in the almost total lack of scrutiny exercised by regulatory agency over the criterion utilized by the company in assessing and determining corporate policy respecting the level of product safety of concern to it. This system provides an opportunity for the affected industries to engage in unnecessary delays under the guise of technical research, or in some instances, outright falsification and the withholding of negative test results. The latter type of activity has resulted in more than one substantial punitive damage award.2 Product Performance Levels Three major factors color the entire document generation process and bear close watching when the suspect product is the subject of a proposed or


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existing agency regulation. The first is the company’s internal, desired level of product performance. The second is the actual performance level the product can technically meet at any one point in time. The third is the product performance level mandated by the proposed or prospectively mandated agency regulation. These three factors are inextricably intertwined with the regulatory process. The type, amount, and character of documentation relative to the above three factors is determined at any one stage of the product development process by whether any such regulation is not present in any form, is only proposed by the agency or has actually been adopted with a prospective date for implementation. Absence of Agency Activity When there has been no agency activity regarding the suspect design feature, counsel will generally note a more staggered documentary output relative to the alleged product failing of concern to him. Significant amounts of documentation indicative of corporate concern over the safety aspects of product design are not likely to be encountered in the absence of outside pressure. In some instances, the fact that a product in development fails to meet internally desired product performance goals is not considered cause for alarm or a sufficient reason to require major modifications of the complex planning surrounding the product. There is a casualness about these matters not seen in instances where outside forces threaten to rock the entire corporate boat. Proposed Agency Regulations In instances where an agency regulation has been communicated to the affected industries as a serious proposal, counsel should expect to see a proliferation of documentation clustered around the date of issuance of such proposal. The company will marshal its technical and managerial forces in an effort to determine its technical and financial ability to meet any such regulation on the assumption that it will become effective at the time and in the form in which it is proposed. The dates on which proposed agency regulations are promulgated are thus central focal points in counsel’s system of document organization and analysis. Being realists, companies must develop design, production, and marketing scenarios on the assumption that the proposed regulation will take effect on the stated date. This is in spite of the fact that their intent may be to do all in their power to delay enforcement or eliminate any such regulation. Accordingly, the various design changes that must be incorporated for compliance are analyzed, tested, and costed at an early date. This is necessary



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to adequately assess the technical and financial realities of such compliance. Equally important, it is required to supply the safety office with the hard data it needs to adequately assess the situation and construct an effective lobbying position. This process generates a wealth of documentation of importance to plaintiff ’s counsel. The primary reason why such activity is necessary is the failure of the affected industries to engage in safety research and development work to achieve a degree of safety that comports with the performance level addressed by the regulation. The disparity between internal product performance levels and those deemed to be minimum requirements for public safety is often pronounced. The company will be required to review its overall corporate product development plans and timing cycles to determine the degree of interference to long range planning resulting from such an eventuality. This evaluative process typically increases as political assessments of the regulation’s likely implementation become less optimistic. Pressure from government agencies will significantly alter the focus of corporate activity, but rarely its information-gathering methodologies, document types, and formatting, or its information dissemination procedures. It bears repeating that the organized way in which companies act is one of the great assets possessed by counsel in his efforts to construct a successful product liability case. Mandated Agency Regulations In instances where corporate efforts to prevent a regulation from taking effect have failed, the company will concentrate its efforts towards compliance by the effective date. This effort involves most of the same processes and accompanying documentary output encountered by counsel when a regulation was only a proposal. A noticeable increase in activity and resulting documentation addressing the development, costing, and timing of alternative designs is often noted during the period immediately following the agency’s adoption of the standard. Cost-Benefit Analyses and Related Documentation Cost-benefit analyses are a staple in corporate planning. Assessing whether a new product’s projected developmental and initial implementation costs justify the long-term financial benefits is a necessary exercise for any business. When a corporation engages in a cost-benefit exercise, they are necessarily comparing dollar values. This fact creates an anomaly due to company’s efforts to apply this type of analysis to an agency safety proposal. The “cost” from the agency’s perspective is death, injury, and/or property damage. The “benefit” is the minimization or elimination of such losses. In order to utilize


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cost-benefit analyses, the corporation must place a dollar value on human and societal costs and compare those dollar values to the financial burden inuring to it if required to develop and implement the technology necessary to comply with the regulation. Cost-benefit analyses are to be found in corporate documentation in two basic contexts. In a broad sense, the bulk of management and technical staff studies analyzing the cost impact of compliance with regulatory measures utilize the method. Increased costs are always gauged against the backdrop of existing corporate cost assessments, long term financial plans and profit projections. These are normally straightforward financial analyses, with little or no discussion of the human loss associated with perceived product failings. In a more focused sense, they are utilized in submissions to regulatory agencies, as supporting the company’s negative view of proposed performance requirements. Cost-benefit analyses of this type can be of great interest to the products litigator. Initially, they highlight in a direct way what is perhaps the essential underlying issue in the field of strict liability for products. To what degree do corporate concerns over profits allow for the marketing of a good with a death- or injury-producing potential? More importantly, they demonstrate a stark difference in attitude toward the entire subject of safety related regulation. Proponents of regulatory action take the position that once a need for a regulation of the type under discussion has been demonstrated, the only choice open to the corporation is to find the most cost-effective method of achieving the specified performance level. There is no debate about whether it will be done. Affected companies take the position that if the costs associated with such regulation put them at a distinct competitive advantage in their chosen market, they should not be required to comply. The actual figures used to financially quantify the social losses are often taken from the government’s own figures generated for other purposes. An example would be the figures from the Bureau of Labor Standards assessing the average value to surviving family members of the loss of support due to the death of a breadwinner. Independent scholarly sources also may supply such figures. Whatever their source, cost-benefit analyses can be very effective in focusing a jury’s attention on the issue of the extent to which a corporation can place corporate profit over human life and safety.

Organizational Documentation Corporate Organization and Document Generating Processes The effort to master the complexities of corporate documentation requires close analysis of the overall organizational, document generating, and decision-



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making processes of the defendant company. Counsel must be able to estimate the types of documentation in company archives that will be of investigative and legal interest to him. He must be able to assess to the degree possible, both prior to and especially subsequent to discovery, where certain activity occurred in the corporation at varying periods over the case time frames. He must determine which individuals in what offices, departments, sections, and committees both generated and evaluated relevant product data. The identification and tracking of data through the ever changing labyrinth of corporate organization over a multiyear time frame is a significant investigative undertaking. As noted in Chapter 5, prefiling research can provide counsel with sufficiently detailed information regarding the broadest levels of corporate structure. Major divisions, groups within any one division, central offices within a group, and, to a degree, the structure of central staff and major supporting offices can be determined prior to discovery. The major task following the close of discovery is to isolate the technical and managerial activity within the lower echelons of the corporate structure and trace it back up to a sufficiently high level of management. Conversely, counsel must also be able to isolate germinal design guidance directives from central planning bodies and trace the implementation of such ideas down the corporate managerial and technical ladder. An initial topdown analysis of corporate organization charts should be the first effort in this central and complex investigative undertaking. Organization Charts Organization charts are an important component of counsel’s initial request for documents. The charts mapping line responsibility for large corporations are typically voluminous. They can create an investigative nightmare for the litigator unless they are initially studied from the broadest corporate structure down to the most specific. In major companies, the majority of the offices and departments in existence over the course of the relevant time frame will be of little or no concern to the litigator. The difficult task is to cull out of this multiplicity of related offices, those offices, departments, and sections having central investigative importance to the case. The ensuing goal is to trace the flow of relevant product data through such entities. This knowledge is essential for the effective conducting of discovery depositions and the analysis and organization of documents received in discovery. It is also essential to meet counsel’s obligation of clarifying this movement of data and its significance, to the court and jury. While the mastering of these materials will not supply counsel with all of the pertinent


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organizational information that will be needed to finalize the investigative and legal obligations, the approach discussed below will go a long way towards achieving that goal. Counsel should initially examine the materials obtained both prior and subsequent to discovery to determine the number of corporate divisions within the company. He should then determine the major grouping of offices within those divisions and the succeeding levels of specific offices within any one overall grouping. Once this has been accomplished, counsel should next attempt to isolate the departments within any one office within a group and attempt to identify the sections or other functional groupings within such departments. A very common functional designation for clusters of large offices within a corporation is the “group.” “Product Development Group,” “Manufacturing Group,” and “Sales Group” are three common designators found among American manufacturing concerns. The term “group” refers to a number of offices whose general activities are centered around various stages of the product development, manufacturing, and marketing efforts of the company. These groups are composed of a number of separate offices which are further subdivided into departments which may in turn be split into sections. Smaller functional groupings, often referred to as “activities” in many companies, may only exist for the completion of set tasks at varying periods over the case time frame. A major complicating factor in the analysis of corporate organization charts is the fact that the composition of very important committees or activities often cut across division, office, and departmental lines. Precise information about them is not normally accessible by reference to corporate organization charts. In addition, while committees may be composed of set individuals from a variety of offices and departments, quite often the personnel on any such committee at any one point in time will vary, depending upon what task is being analyzed. Committee personnel also often cut across division lines. Committees, like activities, may be limited, task-oriented bodies, as opposed to long-term standing committees or other functional groupings. There may be offices or departments from separate divisions who have functional reporting obligations to an office or committee in a separate division that would not be traceable as a line responsibility on an organization chart. Identification of these functional groupings is the result of close analysis of the distribution lists of documents received in discovery and carefully planned depositions of corporate personnel. Central Staff The composition of those offices comprising the central staff of the company, is generally not difficult to identify in broad outline. Often this component of corporate structure can be readily determined from annual reports and several of the readily accessible business related sources discussed in



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Chapter 1. The identification of the bodies having liaison functions between top management and the key product development and manufacturing offices is an important investigative step in tracing important materials back up the corporate ladder. It is also important in tracing high level planning decisions down through the implementing divisions and offices spread throughout the company. In the latter respect, it is common to find safety offices at this central staff level. In addition to central staff offices and their subdivisions, it is important to determine the identity of the major committees functioning at this high level. Major corporations often have product planning committees that initiate broad development concepts for new product lines. There are also committees composed of top level managers from the central offices in each division that set company policy with respect to agency regulation and a host of other topics. Offices, Departments, and Sections The procurement of a sufficient number of organization charts covering the entire time frame for the case may be one of the central points of contention in the course of discovery practice. The structure of corporations will change over the years in response to many factors. Changes in organizational philosophy and the nature of the company’s markets are major factors. The completion of a particular product development project over a several year cycle in the company can result in offices and their departments being disbanded and reformed. This organizational fluidity can cause major investigative snags, when counsel loses the thread of information generation and distribution from year to year. This is especially the case where counsel has a time frame stretching back several decades. The major groupings of offices in a division and the top offices within any one group generally have more staying power than offices, departments, and sections lower down on the corporate scale. Periodic changes in the name of these bodies are a primary basis for defense counsel’s delay tactics in discovery. This is often the case where counsel has learned the name of an important office or committee but does not realize that particular designation had a limited life in the company. A request for materials issuing from the product planning committee will not produce data from the engineering product planning committee. Careful drafting of interrogatories and document requests can minimize the defendant’s opportunity to take advantage of this recurrent fact of corporate life. The careful notation of the name of the requesting as well as receiving office and individual is a very useful method of building a list of relevant bodies that may then be searched for on more comprehensive organization charts. By noting every reference to an office, department, section, or activity


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that occurs in a document, counsel will be able to construct a customized organization chart highlighting those bodies having direct participation, at any one point in time, in matters of concern to him. Committees The identification of important committees is a central investigative goal for the product litigator. Committees, not individuals, normally initiate significant work by technical staff. They also analyze and make decisions based on the resulting engineering and financial data. Discovery requests that center on the identity of individuals who made key decisions or are knowledgable about them should be avoided. They only provide an opportunity for defense counsel to object to such requests as unduly burdensome or to respond by simply providing the names of nonessential personnel. The precise identification of relevant committees, as with offices, departments, and sections, is only achievable through carefully drafted interrogatories and the close examination and organization of materials received pursuant to document requests. Committees request and review materials through the information generating processes of the standard office and department chain of command. The result is that the committee or committees which may be centrally involved and the motive force for those processes, may not be referenced in the documents being generated for their consumption. The precise identification of committee activity and the materials actually reviewed by them is the result of a close organization of all document types dated at select time periods, especially those making technical or financial analyses of test data. Functional Groupings As noted above, it is a common practice for large corporate offices to create small functional groups for the implementation of varying tasks, either on a long- or short-term basis. On occasion, these groupings will appear on corporate organization charts. More often than not, they must be located through carefully constructed interrogatories and close study and organization of documents received in discovery. Depositions of corporate personnel are a major source of specific information about these employees and their responsibilities.

Operational Documentation Standard Operating Procedures Select standard operating procedures (SOPs) should be considered in formulating documentary requests. The full complement of such materials



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would be unnecessary and unwieldy in cases involving major companies. Counsel should select out those activities that have direct bearing on issues central to the overall preparation effort. In particular, counsel should examine those SOPs delineating test requesting, testing, and test reporting procedures for the design parameter involved in the case. These procedures tend to be fixed as opposed to information gathering and distribution processes which are more difficult to access in any one period over a lengthy time frame. Close examination of such procedures can greatly assist counsel in piecing together the multitude of documents received in the course of discovery. They can be of considerable assistance in the planning and taking of depositions of corporate personnel and in constructing the outlines of the documentary case-in-chief. Record Retention Policies Accessing corporate record retention policies is one of the most important aspects of the discovery process. They are of particular importance in cases having extended time frames. The continuing process of document generation in corporations requires systems for the periodic elimination of records. Every corporation has procedures that govern what types of documents will be retained and which are destroyed. It is incumbent upon the product litigator to determine how those policies may effect his attempt to gather and analyze relevant materials for case preparation. Record retention policies will vary according to the type of documents under consideration and are subject to shifts in record retention and destruction philosophy. The computerization of data and the increasing economy of mass computer storage media has had its effect on this issue. Research and development data and related documentation have more staying power than less essential materials. Counsel needs to know what generic types of documents, at selected periods over the case time frame, were potentially affected by these policies. This information is essential to gauge the veracity of claims that certain requested documentation no longer exists or cannot be found. An organizational fact intimately related to the records retention issue is the company’s procedures for the storage of document archives. This would include information on how and where such data is stored and the systems utilized by the company for its retrieval. These are subjects that require close attention in the drafting of interrogatories and requests for documentation. Customer Relations An area of great importance is customer relations. In the author’s frame of reference, this concept encompasses product complaints issuing from consumers as well as retailers and distributors. It also encompasses the internal


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corporate procedures and accompanying documentation involved in processing such complaints. While the corporate designation of such activities will differ, each corporation nonetheless has standard operating procedures for addressing such complaints. Information respecting these processes is essential to the litigator’s full knowledge and proof of product defect. Customer and retailer complaints are as significant as negative test results on the issue of defendants knowledge of risk associated with the normal use of the product. Isolated complaints about product performance may be an insufficient basis to establish knowledge of defect. However, a steady stream of repetitive customer or retailer complaints can often serve as the basis for punitive damages if ignored in the planning of forward models. The same holds for a company’s failure to initiate a voluntary recall. Summary This chapter has addressed a variety of topics related to the documentary component of the products case. The goal has been to acquaint the reader with the range of materials in the possession of the defendant. The ability to access and master the relevant documentary output of the defendant is perhaps the greatest challenge facing the litigator. All of the hard won knowledge gained as a result of prefiling state-of-the-art, regulatory, and company research comes together as a backdrop for the discovery, analysis, and organization of this extremely important material.

Endnotes 1. For example, during the 1960s development of the Ford Pinto, the project was initially called “Phoenix” then “Special Maverick” and finally the “Pinto”. 2. Stanton v. Astra Pharmaceutical Products, Inc., 718 F.12d 553 (3d Cir.1983).


8

Science and Pretrial Discovery

“Then you should say what you mean,” the March Hare went on. “I do,” Alice hastily replied; “at least I mean what I say, that’s the same thing you know.” “Not the same thing a bit!” said the Hatter. “Why, you might just as well say that “I see what I eat” is the same thing as “I eat what I see!” — Charles Dodgson (Lewis Carroll), Alice in Wonderland

Introduction Discovery planning is central to the successful prosecution of any litigation. It is especially important in product liability cases. The inherent complexity of tracing the development of a product over a multiyear time frame and the large amount of corporate documentation attendant on such a process mandate an intensive discovery effort. Careful planning and thorough prefiling research are required to counter defense tactics designed to delay and frustrate discovery.1 Discovery is viewed today as liberal in nature. It is felt by the courts to be the most effective way to streamline the search for the truth and to allow counsel to bring the full range of his or her professional skills to the analysis of the facts underlying the claim. Liberal discovery, however, cannot operate in a factual vacuum. Without adequate prefiling research and analysis, the only party involved in the case who has detailed knowledge of the nature and extent of those facts is the corporate defendant. This gives the trial court little choice but to lean toward corporate counsel’s perspective as to the appropriateness of discovery requests. The greatest amount of time and frustration encountered by plaintiff’s counsel in preparing these cases occurs in the discovery process. Adequate discovery is the key to a successful settlement or verdict. It is important to remember that counsel has only one opportunity to conduct discovery. Plaintiff has the right to supplemental discovery after study of the materials received pursuant to the original issuance of discovery requests. However, he does not have the prerogative of starting fresh if the original discovery was insufficiently thought out and drafted. Getting started 339


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on the wrong foot can be fatal to the successful prosecution of these cases. It is essential that the discovery phase of product liability litigation receive close attention before any discovery requests are issued to defendant. The material to follow will concentrate on effective strategies for both the planning and drafting of discovery requests. It will also address the complexities of motion practice attendant to the discovery phase of product liability litigation. The initial topic to be analyzed is the scope of discovery.

Discovery Planning Relevancy in the Discovery Process The legal standard used to determine the information available to the parties in the course of discovery is stated in Federal Rule of Civil Procedure 26(b)(1): (b) Discovery Scope and Limits. Unless otherwise limited by order of the court in accordance with these rules, the scope of discovery is as follows: (1) In General. Parties may obtain discovery regarding any matter, not privileged, which is relevant to the subject matter involved in the pending action, whether it relates to the claim or defense of the party seeking discovery or to the claim or defense of any other party, including the existence, description, nature, custody, condition and location of any books, documents, or other tangible things and the identity and location of persons having knowledge of any discoverable matter. The information sought need not be admissible at the trial if the information sought appears reasonably calculated to lead to the discovery of admissible evidence (Fed. R. Civ.P §26(b)(1)).

The definition of relevance is provided by Federal Rule of Evidence 401, which defines relevant evidence as “information having any tendency to make the existence of a fact that is of consequence to the action more probable or less probable than it would be without it.” By providing for the discovery of data that may reasonably be calculated to lead to formally admissible evidence, both federal and state courts have provided for a very expansive discovery scheme. As noted by Justice Powell of the United States Supreme Court, writing for a unanimous court: …The key phrase in this definition — ‘relevant to the subject matter involved in the pending action’ — has been construed broadly to encompass any matter that bears on, or that reasonably could lead to other matter that could bear on, any issue that is or may be in the case [citations omitted].



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Consistently with the notice-pleading system established by the Rules, discovery is not limited to issues raised by the pleadings, for discovery itself is designed to help define and clarify the issues [citation omitted]. Nor is discovery limited to the merits of a case, for a variety of fact-oriented issues may arise during litigation that are not related to the merits.2

A request for discovery should be considered relevant if there is “any possibility” that information sought may be relevant to the subject matter of the action. The primary focal point to determine the actual scope of discovery relevancy is the plaintiff ’s complaint. This point was stressed in the important decision in Roesberg v. Johns-Manville Corp.:3 …The detail in the complaint specifies the necessary relevance of the interrogatories…The burden now falls upon GAF, the party resisting discovery, to clarify and explain its objections and to provide support therefor.4

The allegations of each count in the complaint determine the broad subject matters involved in the case.5 However, relevance is to be measured, not strictly according to the specific fact issues raised by the pleadings, but by reference to the broader logical parameters of those facts. 6 Arguments over the practical impact of this liberal discovery scheme constitute the bulk of defense efforts to delay or otherwise frustrate discovery. Arguments over the documentary significance of the right to broad discovery in the products case is the focal point for the lion’s share of pretrial practice. A working knowledge of the technical context of the case and the general contents of corporate archives at any one point over the designated case time frames is essential to successfully meet these standard defense strategies. Finalizing Choice of Time Frames The major objections raised by defendant to plaintiff ’s discovery requests are grounded in the extent of the time frames within which counsel seeks to obtain corporate documentation. The primary basis for objection lies in the claimed irrelevancy of requested materials outside of the model year of the product unit involved in the case. While specific objections will reference differences in basic design features among model years, the crux of these blanket objections is directed toward significant blocks of time. Normally these are the years preceding and following the manufacture of the suspect unit. The appropriate periods of history within which case investigation is relevant is not an issue until plaintiff files his first set of interrogatories. Until that time, prefiling technical, agency and company research is strictly a matter of personal choice dictated by the preliminary investigative goals that have


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been set. Formal discovery, however, requires that plaintiff indicate the historical periods within which he expects documentation to be forthcoming from the defendant corporation. These dates serve to guide both discovery and the subsequent introduction of trial evidence. These periods are often unavoidably extensive due to the nature of the suspect product or technology at issue. For example, in asbestos and DES cases, a time frame stretching back as far as 40 years is necessary to prepare and present the case responsibly. In other cases such as those involving Jeep CJ-5 type vehicles, where the basic design has remained constant, counsel may legitimately argue for a time frame that begins in the early 1940s when the Jeep was developed and widely used in the armed forces. In the Jeep cases, however, the necessity for such a lengthy time frame is less obvious. The rollover problems with the Ford Explorer is another example of a systemic problem existing over a multimodel and multiyear span of a product’s life. The finalizing of discovery time frames is one of the most important decisions that counsel will make in the overall preparation of the product liability case. Unit Defects The unit defect case involves the most truncated time frame, generally running from the date that plaintiff purchased the good to the date of the injuryproducing event. This is the only category of defect where strict liability truly exists. Here the product unit with which the client had contact is flawed in a real sense. Due to this flaw or defect, the unit is dangerously different from other units in the same line manufactured by the defendant. In most instances the flaw can be identified with some precision and the product unit isolated from the general line of similar goods manufactured by the defendant. In this category of defect, true strict liability principles control the information flow in the trial. In these settings, the basic public policy underpinnings of strict liability have full force and effect. The time, effort and money spent by defendant to prevent mismanufactured units from reaching the inventory shelf, the inherent merits of its design or its relative position when examined in reference to the state of the art, are all irrelevant to the analysis. Plaintiff need only prove the absence of alterations or modifications within the anticipated range of intended use of the product, the existence of the flaw or defect and proximate causation. The legal focus is the single offending product unit. Defendant’s specific product line is the frame of reference that reflects the defective nature of this unit. Hence, the key time frame involved in the unit or manufacturing defect case is the period of time from the date that the suspect product unit left the hands of the manufacturer to the date of the injury producing event.



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Actions brought under negligence, strict liability, or misrepresentation theory involving any defect type must establish that the product at the time of the injury was in substantially the same condition that it was when it left the hands of the manufacturer. In manufacturing defect cases, the elimination of product alteration or misuse is the major focal point. This is not to say that counsel need not engage in product research relative to the basic design, materials composition and production of the product. Initially, this information is required in any unit defect case to determine if it is truly a flawed unit. It is also required to give counsel a technical context with which to process all necessary steps in the litigation, especially discovery. However, the long periods over which technical research must be conducted in the typical design category case is not present here. The right or wrong of defendant’s conscious design choices prior to marketing the good have no bearing on the overriding issue of the integrity of the offending product unit. 7 Overall Design Defects Defect types falling within the design categories have their starting point at the initial references in the authoritative literature to the technology or design parameter involved in the case. The time frame begins at that period and arguably ends at the point in company history when the specifications for the suspect design were frozen. There are several focal points for the determination of the appropriate investigative and legal time frames in cases involving a defect type falling within the design category. The selection of time frames in any design category case will initially require that counsel concentrate on three important factors: • The model year of the product unit • Whether the suspect design has been utilized in earlier model year offerings of the same or comparable product lines • The period of time within which design technology of the type under scrutiny has been addressed in the authoritative literature and/or been current in the industry within which defendant does business While the model year of the suspect unit may be an arguably terminal date in the design case, it is by no means determinative of the relevant time frame reaching back from that date. The technological and managerial antecedents of any manufactured good typically go back at least several years. In instances of a technology basic to an industry, comparable products of many years standing, or a preexisting line of goods of which the offending unit is a part, the relevant historical time frame can be substantial.


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State-of-the-art materials and internal company documentation often antedate the model year of the suspect unit a decade or more. This fact greatly expands counsel’s research base. It is the basis for ongoing relevancy arguments from defense counsel at virtually every stage of the litigation. There are important factors in making this determination. The length of time that prefiling research indicates that the suspect design parameter or technology inherent in it has been current in the industry of which defendant is a part is a primary investigative focal point. Equally important is the extent to which this technology has been the subject of authoritative literature in the supporting scientific disciplines. In the early stages of the design case, there is often a substantial difference between the length of the historical period or periods appropriate for investigative purposes and those for discovery. The latter will normally be a much more truncated period, based on both legal and practical considerations. However, the realities of long-term corporate planning and the utilization of basic technologies require lengthy discovery time frames in these cases. In the design defect counts, plaintiff is necessarily challenging the propriety of defendant’s conscious design choices for the entire line of goods of which the offending unit is a member. The initial examination of the technology in the literature normally sets the beginning of the time frame. The company, being considered an expert, is deemed to have constructive knowledge of such material.8 The starting point for an investigative and legal time frame in a design category case is accordingly directly related to the existence of the relevant technology as a subject in the authoritative literature. It is also determined by the use of such technology by the industries of concern to the litigator. Thus it is not possible to set a starting point for the appropriate discovery time frame in the design case until a fair amount of preliminary prefiling research has been conducted. The outside scope of time frames can be estimated with greater precision. That issue is determined by the confines of legal theory and not the development of technology and its gradual utilization by industry. The broad terminal point of the time frame in design cases is the date at which the subject design was finalized for mass production. This is assuming that further changes were foreclosed during actual production runs. Since the focus is on the propriety of the conscious design choices resulting in the suspect design, once those design parameters are fixed, further legal scrutiny of such configuration is technically foreclosed. This technical outer limit is subject to substantial expansion. Counsel can successfully argue for the discovery of documents addressing subsequent technological developments to the extent they indicate the existence of a feasible alternative design prior to the point when the specifications of the



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suspect design were frozen for production purposes.9 Additionally, recent case law, upholding the traditional ban against the admissibility of subsequent remedial measures, has no applicability to strict liability cases. 10 Failure to Instruct or Warn Cases involving failure-to-instruct and failure-to-warn counts have time frames that run from that same starting point up to the date of the injuryproducing event. This is due to the fact that while the technical legal focus is on the absence or inadequacy of the instruction or warning accompanying the product, the heart of the case lies in defendant’s knowledge of danger. Prior to manufacture that knowledge is reflected in the history of the literature and commercial utilization of the design feature containing the risk. The terminal point of the time frame, however, is the date of the injuryproducing event. Defendant’s duty to warn or instruct adequately is ongoing and not dependant on internal company guidelines as to finalization of product specifications for production purposes. In these instances, the legal focus is on the defendant’s knowledge of risk. All data, whether internal or external to the company that is indicative of such knowledge, is subject to discovery and admissible at trial. This would include all testing and related documentation on the basic design feature at issue in the case generated after the release of the suspect unit for sale. In instances of goods experiencing little or no change after their original introduction into the stream of commerce, the amount of discoverable post-production data can be substantial. 11 Misrepresentation In the 402B or misrepresentation case, the start of the relevant discovery time frame, as with all design cases, begins with the first inklings in the literature relative to the design technology under study. Inasmuch as a design flaw lies at the heart of the defendant’s misstatement, it determines the starting point for analysis. The same considerations applicable to instruction and warning cases apply with respect to the terminal point of the time frame in the misrepresentation case. In all three instances, the focus is on the form and nature of communications that were made to the consumer in marketing literature as opposed to technological considerations proper. In the misrepresentation case, however, the time frame is generally considered to be terminated at the date of purchase, inasmuch as the central legal focal point is justifiable reliance on a misstated inducement to buy. Looked at strictly in that context, the terminal point of the time frame can be substantially shorter than in counts grounded in failure-to-instruct or failure-to-warn.


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Focal Points for Finalizing Time Frames Several additional factors bear on the question of the final selection of time frames for discovery purposes. The primary initial guideline on the resolution of this issue is the generic type or types of defect involved in the case. As noted, each defect type has an identifiable block of time associated with it that bears directly on the issue of relevancy in both a discovery and evidentiary sense. During prefiling research, counsel should follow whatever historical leads are presented within those broad time periods, with respect to the technology, industry, and company under investigation. This initial familiarization is counsel’s primary task at the early stages of prefiling research. This will allow him to get a feel for the scientific and business context of the litigation and to preliminarily identify the range of relevant technical issues that may be involved. Once this is accomplished, however, he must then attempt to identify with greater precision those times in the life of the defendant corporation when documents addressing those central technical issues were likely generated. A central point of reference in assessing the latter issue is when the defendant introduced the suspect product or another good having roughly comparable design parameters. Given the reality of advance corporate planning and the time normally taken in the product development process, these dates can safely be antedated by several additional years. Hard choices must be made prior to discovery to reduce to a manageable level an otherwise appropriate investigative time frame that covers a span of many years. This is so even in instances where a punitive damage count, which usually addresses more substantial periods of time in corporate life, is considered a viable option. A practical consideration in this respect is the investigative work load that counsel will face if such large amounts of material are found to be accessible by the court. Mastering and effectively organizing corporate documentation involves tremendous investments of time and energy. While counsel needs to gain a complete understanding of the defendant’s perspective toward — and utilization of — the relevant technology, there is a limit as to the material actually needed to accomplish that goal. Another factor that bears close consideration is that requests for documentation over very extensive time frames may provide defense counsel with the opportunity to divert both plaintiff and the court from efforts to identify and access important blocks of data that are central to the case. Protracted arguments over documentation that has little direct bearing on the dispositive technical and managerial aspects of defendant’s activity often only serve to obfuscate discovery. Counsel needs to provide the trial court with a clear



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picture of the central documentary context of the case. This effort should be unencumbered with highly disputed requests for data having minimal impact from either an investigative or legal standpoint. At the onset of the discovery stage the trial court is unaware of the intricacies of the defendant’s business and how documents are generated or for what purposes. The court is equally unaware of the technical bases for plaintiff ’s claim and just how that may relate to corporate document-generating processes. In the face of claims by defense counsel that requests are overbroad and potentially cover hundreds of thousands of totally irrelevant documents, the court will look to plaintiff for guidance. Organization and Drafting of Discovery Requests Interrogatories and requests to produce address the same corpus of corporate documentation and should be planned with a consistent method. There are a series of important focal points in this organizational effort that should serve as the bases for the actual drafting of any such requests. Whether counsel is planning interrogatories or document requests, the following components should be incorporated in them: • Case time frames • Identifiable stages of product development and manufacture within which time frames documents were likely generated • Identifiable activities occurring within any one stage in that overall process • Types of documents likely generated at any one point in time as a result of such activities. • Offices, departments, sections, and individuals involved in those document generating activities • Active committees and their membership during those periods • Defect mode or modes identified as applicable to the case • Existence of proposed or pending government regulations over any period within the case time frames Planning requests around those factors facilitates a structured approach to discovery that lends itself to cohesive responses to the inevitable refusal of the defendant to honor broad-based discovery requests. Concentrating on routine document generating processes over designated time periods and grounding requests in the document types logically associated with the defect modes involved in the case provide organizational clarity. This clarity substantially minimizes the defendant’s opportunities to divert the court’s attention from the underlying documentary reality of the case. Discovery requests


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obtained from form books not only make for a poor impression, but are simply inadequate. Closely considered customized requests are the most effective devices for achieving success in these cases. Incorporating the above factors, where appropriate, in each interrogatory or document request will guarantee that each inquiry is centered in the corporate processes and document types logically relevant to the broad factual context surrounding the defects alleged in the complaint. This will reduce defense arguments respecting the extent of discovery over the time frame to questions of “relevancy” or privilege. It will eliminate opportunities to object based on the alleged vagueness or uncertainty of the requests. The latter objections are commonplace and can be eliminated by structured drafting methods. The initial consideration in planning a set of interrogatories or document requests to be issued to any one defendant is estimating the categories or blocks of data that logically should be in that party’s possession. Once the this major block of material has been preliminarily identified, counsel should attempt to estimate with greater precision the document types that would constitute the actual makeup of such blocks of information. This assessment should be followed, in turn, by an analysis of the likely chronology of the generation of such document types over the selected case time frames. This analysis will yield differing results depending upon whether the interrogatories or document requests will be directed to the primary manufacturer, materials or component parts suppliers, or one of the participants in the vertical chain of distribution. Each of these parties has different information to offer and the interrogatories and document requests directed to them should clearly reflect that reality. It is also important to recall that discovery requests, like the complaint itself, serve an important educational function in providing the trial court with a clear grasp of the documentary significance of counsel’s overall discovery scheme. The ability to clearly define discovery goals for the court in face of the inevitable barrage of defense arguments in support of noncompliance, is central to the efficient and expeditious accessing of corporate documents. Logically organized, precisely drafted and structurally focused interrogatories and requests for production are the key to successful discovery practice.

Interrogatories Organizing the Interrogatories A fairly recent development affecting the organization of interrogatories is the limitation on the permissible number of interrogatories being set by state



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and federal courts.12 Permissible numbers range from 20 to 50 interrogatories.13 The emergence of these rules is in direct response to long-standing squabbles resulting from the practice of too many plaintiffs’ lawyers issuing 100 or more poorly thought-out and unstructured interrogatories. While such limitations may cause hardship in cases involving significant time frames, they are nonetheless being rapidly adopted and are an important factor in the overall quality of the drafting process. Special requests for additional interrogatories will be entertained, but are not routinely granted. Regardless of the number of interrogatories set by local rule, a reasonable number of subsections are allowed as long as they are logically related to the central subject matter of the root question. Careful wording and well-structured subsections should allow for adequate coverage under any limitation scheme. Accordingly, careful planning and economy of language are central considerations in the actual drafting process.14 In many ways, interrogatories serve as an organizational paradigm for the entire discovery effort. If constructed according to the focal points discussed above, they will roughly reflect the chronology of relevant documentary activity in the corporation and isolate the document-generating activities involved in the defendant’s overall product development and manufacturing scheme. The bulk of the documentation in a products case will come from the primary manufacturer, and to a lesser degree, materials and component parts suppliers. Wholesalers, distributors and retailers will have valuable vertical chain information respecting marketing demographics, instructions, warnings and product performance. However, the actual volume of related documentation obtainable from them will pale in comparison to that possessed by the manufacturer and major suppliers. Counsel should attempt to structure the interrogatories, as much as is possible, around the four broad stages of design, testing, production, and marketing, through which the product progresses on its way to the inventory shelf. This is an especially efficient organizational methodology with respect to the primary manufacturer and component part and material suppliers. These rough stages may serve as an organizational shell for the drafting of discovery requests, even factoring in the inherent documentary overlap among them. It can be of great assistance in attempts to comply with limitations on the number of interrogatories set by local rule. Assuming an average limitation of 30 interrogatories, that only allows approximately 7 questions for each of these essential steps along the product development and manufacturing spectrum. This is not including several additional essential blocks of data such as complaint processing and record retention policies that must be accessed in these cases. Even though interrogatories with subsections are permitted, counsel is nonetheless hard pressed to achieve adequate coverage of necessary topics.15


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In product liability cases with lengthy time frames, interrogatories actually serve more to determine the existence of large blocks of information rather than to provide detailed answers to specific questions. The information supplied by plaintiff in response to defendant’s interrogatories is, on the contrary, quite specific in nature. This is due to the very limited information, such as medical and employment data, that plaintiff is able to provide. Interrogatories are primarily issued by plaintiff in these cases to assess the blocks of information contained in corporate archives that may have investigative or legal significance. They serve to pave the way for comprehensive document requests. Organizing interrogatories around the types of information likely to have been generated during each of the four major periods of activity involved in getting the good to market will allow for comprehensive coverage of those areas. Careful drafting will also leave questions available to address other important aspects of corporate life that transcend the activity occurring within any one of those periods. Areas of interest in the design stage would include documentation relating to the original product concept, comparative product analyses, preliminary marketing, financial and technical feasibility studies, preliminary product specifications and prototype building and testing. The testing stage would encompass testing procedures, test requests, test reports, and all associated documentation evaluating such test results from a marketing, financial, technical, and regulatory perspective. Interrogatories with respect to production would address intermediate and final production specification manuals, any design, materials or component parts alterations during actual production runs, production numbers, quality control procedures, and production validation testing. Marketing considerations would include inquiries respecting marketing image studies, the processes involved in preparing and approving drafts of instructions and warnings, and subjects related to advertising strategies. An additional group of topics that must be addressed in all products cases are general questions respecting corporate organization, record retention policies, complaint processing, prior and current litigation and information respecting liability insurance and witnesses to the injury producing event. Finally, Federal Rule of Civil Procedure 26, allows for interrogatories directed towards the identification of expert witnesses the opposing party plans to call as an expert at the trial:16 Except as otherwise stipulated or directed by the court, this disclosure shall, with respect to a witness who is retained or specially employed to provide expert testimony in the case or whose duties as an employee of the party regularly involve giving expert testimony, be accompanied by a written



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report prepared and signed by the witness. The report shall contain a complete statement of all opinions to be expressed and the basis and reasons therefor; the data or other information considered by the witness in forming the opinions; any exhibits to be used as a summary of or support for the opinions; the qualifications of the witness, including a list of all publications authored by the witness within the preceding ten years; the compensation to be paid for the study and testimony; and a listing of any other cases in which the witness has testified as an expert at trial or by deposition within the preceding four years.17

While the answers to this type of interrogatory is generally vague at best, it is important and must always be included. After constructing a particular question, counsel should place himself in the position of corporate counsel who seeks to find any possible basis for refusing to answer it. Each interrogatory should be critically examined to determine the degree to which defense counsel could refuse to answer on the grounds of relevancy, vagueness, or undue hardship. The optimal drafting methodology should allow only for relevancy or privilege as the sole bases for objection. Any objections based on an alleged lack of clarity in the question should be eliminated during the drafting process. A brief selection of interrogatories from a hypothetical products liability litigation involving the rollover of a Jeep-type vehicle with resulting structural failures that addresses various aspects of the product development and manufacturing process will now be briefly analyzed. Assume that Main Motors, the parent company, owns Fourwheel Motor Company who actually manufactures the vehicle. Another company, Rollbar, Inc. manufactured the rollbars to specification. The selections to follow are directed to the parent, Main Motors, and do not purport to cover all of the necessary focal points for discovery discussed above. An important initial question would address the subject of corporate organization: INTERROGATORY NO. 1: State for the years 1985 to 2000, the names of the Main Motors Corporation (hereinafter referred to as MMC) divisions, groups, or offices having primary responsibility for the design, testing, production or marketing of the Fourwheel Models line of utility motor vehicles and the names of the offices, departments, sections or other functional employee groupings within such divisions, groups or offices. Also state the names, title, and current company position, if any, of the individual employees managing such group, office, department, or section for each of the designated years.


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A question directed to the Main Motors Corporation committee structure demonstrates another important topic to be addressed in the interrogatories: INTERROGATORY NO. 2: State the names of the MMC committee or committees having primary responsibility for the review of and/or the making of corporate decisions regarding any aspect of the design, testing, production or marketing of the Fourwheel model line of utility motor vehicles for the years 1985 to 2000, as well as the names, title, and current company position, if any, of the members of such committee or committees for each of the designated years.

These two questions seek blocks of information which will provide counsel with a structural context for accessing and analyzing management documents evaluating testing and other purely technical materials generated at the staff level. It is essential to get some sense of the pipeline through which the commercial application of science decision passed through on the way to market. Chapter 7, Science and Business Documentation, sets out a typical scenario for the stages of corporate documentation generation. At this stage of discovery, determining how and when generic types of documents were both generated and later evaluated by corporate personnel is of much greater importance than the specific substantive content of any one document. Information accessed through questions such as these is of inestimable value in subsequently piecing together the story of defendant’s malfeasance from the thousands of pages of materials received as the result of ensuing document requests. Interrogatories directed to Main Motors Corporation respecting testing materials may serve as examples of questions with a more specific, but still generically oriented focus: INTERROGATORY NO. 12: State, for the years 1985 to 2000, whether tests were conducted on vehicles or separate components in the Fourwheel line of utility vehicles, whether on a test track or in a laboratory, to determine in whole or in part, the following:

1. 2. 3. 4 5.

Rollbar materials strength Rollbar effectiveness in the event of rollover Utility vehicle rollover potential Windshield attachment stability in the event of rollover Adequacy of occupant restraint systems



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If the answer to this Interrogatory is in the affirmative, state:

1. 2. 3. 4. 5. 6. 7.

The test number The requesting office, department, section, committee or individual The name of the testing organization The make and model of the vehicle tested The purpose of the test The test conditions and vehicle configuration The request date, test date, final report date and the current location of every such test INTERROGATORY NO. 14:

State whether, for the years 1970 to 1985, tests were conducted by MMC or anyone on their behalf, whether conducted on a test track or in a laboratory, to determine the feasibility of alternate designs other than those eventually incorporated in the production models of the Fourwheel line of utility vehicles to determine in whole or in part, the following:

1. 2. 3. 4. 5.

Rollbar materials strength Rollbar effectiveness in the event of rollover Utility vehicle rollover potential Windshield attachment stability in the event of rollover Adequacy of occupant restraint systems

If the answer to this Interrogatory is in the affirmative, state: 1. 2. 3. 4. 5. 6. 7. 8.

The test number The test title The requesting office, department, section, committee or individual The name of the testing organization The make and model of the vehicle tested The purpose of the test The test conditions and vehicle configuration The date and the current location of every such test

Interrogatories of this type are directed to several important blocks of data. Initially, they solicit information on the core testing program respecting the suspect product unit in the context of the defect modes identified as having causal relevance to the case. Second, they focus on the offices, departments, sections, committees, and individuals involved in that process over


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the case time frame. Finally, such questions lend themselves to focused argument respecting their scope in ensuing debates over defendant’s obligation to respond. A question formulated along these lines should leave little doubt as to the nature of the information that it seeks and should eliminate needless argument over the essential technical context of the case towards which it is directed. Information relative to the defendant’s relationship with federal regulatory agencies is also a primary subject for discovery. Interrogatories addressing this issue should also be concentrated along the lines of corporate organization rather than being directed towards detailed information. INTERROGATORY NO. 9: State, for the years 1970 to 1985, the name of the individual or individuals employed by MMC, whether operating officer on the central staff level, product development or manufacturing group vice president or other applicable MMC organizational title, as well as the offices, departments or sections, having primary responsibility for liaison between MMC and the National Highway Traffic Safety Administration, Federal Trade Commission or other federal regulatory agency having jurisdiction over any aspect of the design, testing, production or marketing of the Fourwheel line of motor vehicles. INTERROGATORY NO. 10 State, for the years 1985 to 2000, whether MMC has made either formal or informal responses to complaints filed with the National Highway Traffic Safety Administration or its predecessor the National Highway Traffic Safety Board or the Federal Trade Commission, alleging safety related problems with the Fourwheel line of utility motor vehicles or its advertising or promotional literature. If the answer to this interrogatory is in the affirmative, state the name of the individual or group filing such petition or complaint, the date or dates of the same and a brief description of all MMC submissions, including supporting attachments, made in response to such petitions or complaints.

The important issues of record retention policies and customer complaints may be addressed through several structured inquiries. INTERROGATORY NO. 17: Identify by reference to standard operating procedure or other applicable MMC organizational designation, the record retention and record destruction policies of MMC, relative to the retention or destruction of records of



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all types, including but not limited to financial memoranda, engineering memoranda, test reports, and customer, retailer, or service representative complaints regarding the safety or performance of the Fourwheel line of utility vehicles. INTERROGATORY NO. 18: State whether MMC has received any notification or complaints relative to the safety of the Fourwheel line of utility vehicles, from any source, with respect to rollover problems, rollbar failure, occupant restraint systems, windshield framing materials, design, and attaching apparatus. If the answer is in the affirmative, state the following for each of the years 1985 to 2000:

1. The total number of such complaints by reference to the above categories 2. The name and address of the individual, group or company making such complaint 3. The MMC office, department, section, committee, or individuals processing such complaints The above selections serve as examples of a structured approach to drafting that focuses in greatest part on the identification of the document generating processes of the corporation and the organizational and individual participants in those processes. Rather than seeking specific facts more appropriately and efficiently obtained through document requests and depositions, interrogatories should seek to determine the structure of corporate processes for producing and evaluating relevant data over the case time frame. The answers to interrogatories in the products case can serve as a rough road map through the intricacies of the thousands of pages of material accessed through requests for documentation. Requests to Admit Fact or the Genuineness of Documents Requests to admit facts under Rule 36 (Fed.R.Civ.P Rule 36) are generally not recommended for use in the products case. Any use of this discovery device is sure to result in time consuming motion practice due to defense objections. They are the least utilized of available discovery devices. 18 The opportunities are great for skilled defense counsel to supply evasive answers to allege inability to admit or deny. Most importantly, any such facts that do stand admitted are generally not subject to proof at trial.19 This can result in gaps in the dynamic presentation of the case that must be filled by the reading of the dry admission responses themselves.


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Rule 36 does have utility with respect to requesting that defendant admit the genuineness of documents. This method of document authentication is particularly beneficial when counsel has been able to procure internal corporate documentation from other litigators. Requiring defendant to admit that attached materials are true and correct copies of documents contained in corporate archives saves time at trial. It also allows free use of such materials in the course of discovery depositions. This aspect of Rule 36 also has considerable tactical advantages with respect to the courts grasp of and attitude towards plaintiff ’s discovery efforts. Careful selection of the stock variety of the document types that plaintiff will be seeking in large doses will acquaint the court with the physical reality of such materials and supply an informed context for plaintiff ’s enforcement efforts. In addition, the inclusion of “smoking gun” documents obtained from other lawyers will provide the court with a more realistic perspective with which to estimate the veracity and sincerity of defendant’s objections to discovery.20

Requests for the Production of Documents Organizing Requests for Documentation As the interrogatories and requests for documentation both address the same corpus of material, they should follow the same organizational pattern and be grounded in the same focal points. As with interrogatories, requests for documentation are directed towards large blocks of data composed of a variety of routine types of documentation generated in stages over the case time frames. Requests pursuant to Rule 34 (Fed.R.Civ.P. Rule 34) or a state equivalent, are best made by reference to generic document types. The requests should be centered in the defect modes referenced in the complaint or directed towards corporate organizational or operational guidelines. Drafting the Requests for Documentation A brief selection of document requests addressed to the hypothetical Main Motors Corporation will serve to illustrate examples of a structured approach to this vital stage in the discovery process. REQUEST FOR PRODUCTION The Plaintiff John Q. Consumer, Pursuant to Rule 34 of the Federal Rules of Civil Procedure, requests that the Defendant Main Motors Corporation, produce and permit Plaintiff John Q. Consumer and his representatives to inspect and copy all documents in the possession, custody or control of the



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Defendant, their subsidiaries, agents or attorneys, which are relevant to the claims and defenses asserted by the parties in this matter or appear reasonably calculated to lead to the discovery of relevant information, which documents are specified more particularly to include the following: I. Definitions

1. “Document” shall be defined as that term is used in Federal Rule of Civil Procedure 34, and shall include data recordations in any form, including, but not limited to any and all computerized records and storage medium. 2. “Incident” refers to the events of January 1, 1985, alleged in rhetorical paragraph 10 of Pleading Paragraph I of the Plaintiff ’s complaint. 3. “Defendant” refers to the Main Motors Corporation (hereinafter referred to as MMC). II. Documents to be Produced

1. Corporate organization charts or other applicable listings of Main Motors Corporation (hereinafter referred to as MMC) for the years 1985 to 2000, including, but not limited to any and all Divisions, Groups, Offices, departments, sections, committees, and any other MMC functional employee group designation for those employees having any responsibility, either independently or in conjunction with offices of the Fourwheel Corporation, or Rollbar, Inc., for the design, testing, production, or marketing of the Fourwheel Corporation line of utility motor vehicles. 2. The names, company position or title and current company position, if any, of the vice presidents or managers of the above-noted MMC organizational entities and the members of any such committees for each of the years 1985 to 2000. 3. Any and all documents, memoranda, summaries, synopses, graphs, computer printouts, or other data recordations in any form, either generated or reviewed by the MMC organizational entities referred to in Request No. 1, for the years 1985 to 2000. This is to include such documents relative to any aspect of the design, testing, production or marketing of the Fourwheel line of utility vehicles, for the years 1985 to 2000, including, but not limited to financial and engineering documents addressing center of gravity and track


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4. 5. 6.

7.

8.

9.

width design and testing; rollbar materials selection, design and testing; windshield materials selection, design and testing; and occupant restraint systems. MMC Annual Report to stockholders for the years 1985 to 2000 MMC 10K and 8K filings with the Securities and Exchange Commission for the years 1985 to 2000. Any and all documents, memoranda, summaries, synopses, graphs, computer printouts, or other data recordations in any form, either generated or reviewed by the MMC entities referred to in Request No.1, for the years 1985 to 2000, relative to any aspect of the design, testing, production, or marketing of the Fourwheel line of utility vehicles for use by the United States military, for the years 1985 to 2000, including, but not limited to, financial and engineering documents addressing center of gravity and track width design and testing; rollbar materials selection, design and testing; windshield materials selection, design and testing; and occupant restraint systems. MMC corporate organization charts or other applicable listings stating the name of the office, department, section, committee, or other applicable MMC organizational entity having any liaison responsibility with Fourwheel Corporation regarding the relationship of the Fourwheel Corporation with the National Highway Traffic Safety Administration relative to Federal Motor Vehicle Safety Standards, defect investigations, recalls or other matters involving the Fourwheel line of motor vehicles, for each of the years 1985 to 2000. Provide as well, documents setting forth the names, title and current company position, if any, of the individual members of such offices, departments, sections, committees, or other applicable MMC organizational entity for each of the designated years. MMC corporate organization charts or other applicable listings indicating the name of the office, department, section, committee, or other applicable MMC organizational entity and the name of the individual or individuals employed by MMC, having primary responsibility for liaison between MMC and the National Highway Traffic Safety Administration, Federal Trade Commission or other federal regulatory agencies having jurisdiction over any aspect of the design, testing, production or marketing of the Fourwheel line of motor vehicles for the years 1985 to 2000. Any and all submissions, correspondence, or other submissions, or any other formal or informal responses to complaints filed with the National Highway Traffic Safety Administration or its predecessor



10.

11.

12.

13.

14.

15.

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the National Highway Traffic Safety Board or the Federal Trade Commission, or the United States military relative to safety related allegations with respect to the Fourwheel line of utility motor vehicles or its advertising or promotional literature. Any and all engineering or styling design layouts, specifications, blueprints, models, mathematical analyses, or other renderings of original, intermediate, alternative or final designs of the Fourwheel line of utility motor vehicles, including, but not limited to: designs relative to rollbar materials specification, rollbar configuration; rollbar placement and attaching apparatus; windshield framing configuration and attaching apparatus; vehicle center of gravity and track width; and occupant restraint systems for the years 1985 to 2000. Any and all final or intermediate test reports, test requests, test summaries or test synopses in any form, for the years 1985 to 2000, of tests conducted on the Fourwheel line of utility vehicles, whether on a test track or in a laboratory, to determine in whole or in part, the following: 1. Rollbar materials strength 2. Rollbar effectiveness in the event of rollover 3. Utility vehicle rollover potential 4. Windshield attachment stability in the event of rollover 5. Adequacy of occupant restraint systems Any and all documents respecting the record retention and record destruction policies of MMC, for the years 1985 to 2000, relative to the retention or destruction of records of all types, including, but not limited to, financial memoranda, engineering memoranda, test reports and customer, retailer or service representative complaints regarding the safety or performance of the Fourwheel line of utility vehicles. Any and all complaints in any form relative to the safety of the Fourwheel line of utility vehicles, from any source, with respect to rollover problems, rollbar failure, occupant restraint systems or windshield framing materials, design and attaching apparatus. [Standard occurrence witness statements, drawings photographs, etc.] Any and all documents, notes, sketches or photographs resulting from any inspection of the Fourwheel model 2 utility vehicle involved in the instant action, with respect to the mechanical and/or physical condition of such vehicle. Any statements in any form of witnesses to this occurrence or photographs of the scene or vehicles involved.


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This sampling of document requests, as with the interrogatories preceding it, concentrate on process and document types over content. Constructing document requests along the lines suggested above will insure that counsel receives adequate material with which to prepare for depositions and construct a comprehensive documentary component of the case-in-chief. Physical Examination of Requested Documentation Once the first round of discovery motions have run their course, counsel will have an opportunity to examine the corpus of requested documentation. This will normally take place either at corporate headquarters or the offices of defense counsel. Counsel will be required to examine these materials and indicate which document he wishes defendant to copy. This process has benefits for defense counsel as well as plaintiff. The obvious benefit to plaintiff is the chance to peruse these important materials. The advantage to defendant lies in the fact that the documents selected for copying are a clear indication of what plaintiff knows. Defendant can accurately gauge the level of plaintiff ’s sophistication with respect to the nuances of corporate documents and processes and the central technical issues in the case. Defendant’s examination of the materials selected for copying can have a significant impact on the remainder of discovery and ensuing settlement negotiations. What plaintiff wants is an indication of what he knows. Like poorly organized and drafted discovery requests, fumbling at this point can create the impression that plaintiff is not an adversary to be taken seriously. It is therefore essential that counsel have a solid grasp of the significance of each document type he will be reviewing. There are several additional observations to be made respecting the initial examination of corporate documentation. It is important to realize this is not an occasion for the close reading of documents. There are several practical reasons for this conclusion. Initially, due to the typically high volume of such submissions, counsel’s primary task is to mark those documents he wishes copied and delivered to his offices. Counsel simply does not have the time to carefully pour over each individual document to make a detailed assessment of its investigative or legal value. Also, these materials are rarely chronologically organized by document type. More often than not they are packaged according to the particular interrogatory or request for documentation that led to their inclusion. A significant number of these documents, generated at different dates, may have served as attachments in support of presentations at committee meeting at various levels in the company over the case time frames. These documentary submissions are usually spread out over time, making it difficult to assess the true significance of any one document.



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Counsel’s best approach is to limit his examination to the construction of a rudimentary indexing system, pending the opportunity to closely examine and organize the documents once in hand. Recording the date, title, subject matter, document type, and number of attachments and pages is generally all that can be efficiently accomplished at this time. Getting a general feel for the types of documentation generated over the case time frames and the nature of the information contained in each type is about the limit of what can be accomplished. This simple system may consume several days due to the amount of material that must be examined. Supplemental Discovery Federal Rule of Civil Procedure 2621 and comparable state provisions impose a continuing duty to supplement any incomplete discovery responses and correct any inaccuracies. While counsel should insist on these requirements, it is unwise to do so in lieu of comprehensive supplemental interrogatories and requests for documentation. It must be recalled that the right to supplemental discovery does not mean that counsel can start over if defendant’s submissions show serious flaws in plaintiff ’s original discovery plan. During the course of counsel’s close examination of the documents received in the initial phase of discovery, numerous questions will arise that could not have reasonably been anticipated prior to having had the opportunity to review these materials. In addition, these materials will normally reveal the existence of large amounts of additional documentation, with which counsel will need to fill the documentary gaps that will be encountered after the initial document analysis. Rule 26(e) allows for supplemental discovery and counsel should take full advantage of it. Counsel will discover activities at varying points over the case time frames that warrant detailed attention in supplementary interrogatories. This can range from theretofore unknown committee activities to a series of tests and test evaluations on related product lines having great bearing on the defendant’s knowledge of defect. There may be veiled references to documentation reflecting an aspect of committee activity that should have been produced under good faith compliance with the original submission of interrogatories. Supplemental interrogatories serve two general purposes in these cases. First, they allow counsel to obtain additional information on company structures such as committees and committee membership that are first seen in sharp outline after close document analysis. Second, they allow counsel to access additional listings of documentary materials such as test reports, engineering or chemical analyses, financial studies, and the like, the existence of which first becomes apparent as following the same process of document review.


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Whether or not counsel issues additional interrogatories, supplemental requests for documentation will definitely need to be served. As opposed to the necessarily generic or categorical format of initial document requests, supplemental requests for documentation tend to be very specific. The bulk of the new material that counsel will seek will have been referenced in some fashion in the materials in hand. This may be the fourth attachment to a memo noted in the primary document but not supplied. It may be the remainder of a series of memoranda that simple logic indicates are present. For example, counsel may have received a document entitled “Fuel System Integrity Status Report #12.” Counsel is entitled to the eleven reports preceding it and any that may follow. Other instances may arise where less specific references are made to other documentation. A particular document may state: “The following draft assessment is made pursuant to the guidelines published by Mr. Smith on April 15.” Wherever additional documentation is referenced directly or indirectly, counsel should make detailed notes and request such materials. The supplemental request for documentation should note the primary documents title, date, and the page where such material is mentioned. It should also quote the sentence in the document that references the new material. These specific requests leave defendant little basis for objection on the basis of relevancy. Relevancy issues will have been fully argued and resolved prior to the first submission of material by defendant.

Depositions Deposition Planning A primary purpose in deposing corporate staff is to fill in the remaining gaps in counsel’s knowledge after close study of the documentation received in discovery. In planning depositions it is important that counsel classify his remaining investigative and legal needs and estimate the most likely corporate deposition candidates to resolve them. There are several basic focal points in planning the depositions of corporate personnel: • Resolving remaining questions about corporate decision-making processes • Resolving remaining questions about individual documents or a related series of documents • Identifying the corporation’s state of the art defense strategy • Identifying the corporation’s defense strategy with respect to its’ overall processes in designing the product • Identifying the corporation’s interpretation of key documents • Identifying the corporation’s proximate cause defenses



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Preparing the depositions of corporate staff and defense experts around these focal points should insure that the bulk of counsel’s remaining investigative and legal needs will be met. Selection of Corporate Deponents Depositions of corporate staff should follow counsel’s organization and analysis of the materials received in the original and supplemental requests for documentation. Close familiarity with corporate processes and documents reflecting key activities over the case time frames is essential to the effective deposing of corporate personnel. Little will be accomplished in the course of deposing personnel who have had years of experience in these matters without this level of preparation. Depositions, like the other major tools of discovery, are allowed once. Federal Rule of Civil Procedure 30(b)(6)22 allows a party to request that a corporation designate one or more individuals to be deposed respecting relevant subject matters specified in the deposition notice. The purpose of the rule is to allow for depositions on these matters when counsel is unable to adequately identify knowledgeable individuals at the time when the deposition is requested. While this and comparable state provisions have great utility in a wide variety of settings, they should be used as a last resort in product liability litigation. Most major corporations have engineers and other scientists whose sole function is to work with the legal staff in defending these cases. A primary part of their employment is to represent the corporation in 30(b)(6) depositions. These individuals are totally familiar with all of the documentation involved in the case. They are very adept at leading inexperienced counsel astray or providing little or no valuable information during the course of a deposition. If plaintiff’s counsel issues 30(b)(6) notices prior to detailed study of corporate documentation he is doing himself and the client a great disservice. This is especially so if these are the only depositions of corporate staff that counsel intends to take. The organization and analysis of corporate documentation will identify key personnel who were actively involved in the product development and manufacturing processes of primary concern to counsel. These are the employees who have the most to offer. While these persons will be well prepared by defense lawyers, they are not professional witnesses. Counsel is much more likely to gain important testimony from them than from employees whose job description includes the obfuscation of discovery. Specifying Subjects and Documents in Notice It is essential to this effort that counsel carefully consider the subject matters and specific documents that he will use as the basis of his interrogation of


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these individuals. Counsel should specify in the deposition notice and in letters to defense counsel those subject matters and documents that he expects the deponent to be prepared to discuss. By specifying these matters in the deposition notice, counsel is not revealing anything that is strategically vital to the defendant. Defense counsel are well aware of those periods over the case time frames where documentation may be harmful to it. This is especially so in cases where there is a significant litigation history associated with the suspect product. These materials were received from defendant in the first instance. Accordingly, they are very familiar with all of the nuances of this material. It is plaintiff ’s counsel who must achieve that degree of familiarity prior to trial. The particular deponent may not really be equipped to recall sufficient detail without focused study. Deponents may take the opportunity to feign lack of recollection, even if well versed in these materials. If counsel has been careful enough to avoid the use of 30(b)(6) depositions and adequately prepared himself, the chances are that he will have a more detailed working knowledge of these subjects than a potential deponent. Most personnel have not have seen or thought about these matters in years. This is especially the case where lengthy case time frames are involved. Therefore, it is important that counsel do all in his power to see to it that any deponent is prepared. The purpose of the deposition is to obtain detailed information. If that level of information is not achievable, it is important to make a record that counsel has done all in his power to focus the deposition along productive lines. Deposing Technical Staff The bulk of the questions directed to technical staff will concentrate on important aspects of product design, materials selection, testing, and test evaluation. This type of deposition should be preceded by consultation with plaintiff ’s expert witness to refine both the organization and substance of such questions. It is essential that counsel attempt to achieve parity with the deponent, at least with respect to the technical context within which the deponent exercised his professional work for the defendant company. The deposing of defendant’s technical staff should concentrate on corporate decision-making processes as much as the more purely scientific aspects of product development. The extent of corporate knowledge resulting from testing and analyses by lower echelon employees is a direct result of the testing and analytical guidelines set by managers in the first instance. It is rarely the case that technical staff are given carte blanche authority to test products and simply pass that information up the corporate ladder. Technical work on product development and testing programs are highly structured and controlled by management committees. The central questions of what



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management personnel knew and when they knew it are directly related to the information requested by them. The constraints placed on technical staff by management guidelines, whether from a timing, financial or scientific standpoint, should also be major areas of inquiry in the depositions of these employees. Managerial staff in these cases consistently claim that engineers and scientist have extensive flexibility in altering design parameters if deemed necessary. Experienced litigators know that this is far from the reality. Counsel should conduct extensive questioning to identify and determine the source and extent of any such constraints. An additional important area of inquiry in deposing technical staff is the manner in which technical information, in particular test results, were disseminated to management personnel. In major corporations, the formal test reports that go into corporate archives and are produced in discovery, are often written by professional technical writers, weeks or even months after the actual date of the test. It is important that counsel determine the informal methods utilized to channel this information. Deposing Management Personnel Important focal points in deposing management staff are the identification of the company’s defenses. This includes their overall case strategy, their explanation of specific documents reflecting corporate knowledge of defect or feasible alternative designs, the rationale for important committee decisions, and theory of proximate cause. Considerable preparation is needed to adequately accomplish these goals. In many respects, deposing management personnel is more difficult than technical staff. Management often has extensive technical as well as managerial expertise. They are considerably more adept than lower level employees at explaining away negative technical materials. Counsel will need a solid grounding in corporate information-generating and decision-making processes to effectively depose these individuals. The systems for document organization and analysis discussed in Chapter 6 should adequately equip counsel for this important aspect of discovery. A primary focal point in these depositions is establishing the precise chain of command for varying activities over the case time frames. It is important to track decision-making to the highest levels possible. Corporate line charts tell only part of the story. Specialized reporting formats are often at the heart of the development of new product lines. These would not normally appear on standard organization charts. These unique organizational structures are also often utilized for the resolution of short-term corporate goals. It is also common practice for managers to establish various


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“activities,” task forces, or other functional groupings to carry out important work. Counsel must specifically identify any such organizational processes and involved entities to adequately assess the exact nature and extent of corporate knowledge. It is important to determine the manner in which varying product development and manufacturing costs are allocated and the extent to which they reflect an actual increase in the market price of the product. In this respect it is particularly important that counsel elicit management’s interpretation of documents detailing cost increases required to enhance product safety. Whether the figures in such documents appear high or low, it is necessary to determine how they were arrived at and their potential impact on the retail cost of each product unit. The concept of feasibility of alternative designs is as much a question of dollars as it is technical dexterity. Finally, it is important to focus on the company’s response to and attitude towards government regulations. This would include those having an impact on the suspect product’s design that were proposed or became effective over the case time frames. Detailed questions should be asked respecting company lobbying campaigns and the offices and individuals involved in them. This is an area where corporate documentation is typically inadequate to provide counsel with a sharp outline of these activities. This information can have compelling relevance to a punitive count. Deposing Defense Experts The deposition of the defense expert is one of the most crucial in the entire series of depositions that will be taken. The members of defendant’s technical and managerial staff deposed by plaintiff may not be called to testify. The expert, however, not only possesses valuable information, but will also likely be a major defense witness at trial. While gauging the testimonial competence of any deponent is an important goal of deposition practice, it is especially important here. The greater number of experts deposed in these cases will be technical experts. Accordingly, the majority of this section will be addressed to experts of that type. The thrust of the testimony of this expert will center around the state of the art and proximate case defenses. The technical expert generally has little to offer in the way of details of defendant’s document-generating and decision-making processes. Their main contribution is to testify that defendant’s packaging, instructions, warnings, or overall design reflected the highest level of the state of the art. They will testify that the suspect design met this standard when examined in light of either the authoritative literature in the field or the customary practice of the industry. The other key aspect of their testimony is that the feature of defendant’s product involved in the case was not the proximate cause of plaintiff ’s death or injury.



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Addressing these two primary aspects of the expert’s testimony requires significant preparation. Counsel should consult with his expert prior to this deposition to assess the most fruitful lines of inquiry to take regarding the issues of state of the art and proximate cause. Plaintiff ’s expert can also indicate the weak points of the deponents analytical methodology gleaned from the review of prior deposition or trial testimony. Study of the deponent’s prior trial and deposition testimony is essential to adequately prepare for this type of witness. Those materials can generally be gathered from lawyers identified through the ATLA Exchange. The deposition of the defendant’s technical expert will reveal the substance of the defendant’s state of the art, documentary, and proximate cause strategies. It will also indicate, in broad outline, the basic format and manner in which it will be communicated to the jury. Expert witnesses for both sides are the center of attraction in these cases. The success of the litigation generally stands or falls on the quality of their testimony. A significant part of the value of an expert to the lawyer is his skill as a communicator. The manner in which the expert communicates, or as the case may be, fails to communicate important information, is often of equal value to the substance of their testimony. Identifying, accessing and mastering internal corporate documentation is the key to success in product liability litigation. It is one of the most difficult aspects of this type of case. The material to follow discusses techniques for the organization, cross-referencing, and analysis of these materials. It also provides guidelines for the difficult task of winnowing down the mass of documentation to a cohesive and communicable amount for presentation to the jury. The organization, integration, and analysis of materials gathered prior and subsequent to discovery is an essential step in the total preparation effort. In essence, it is the culmination of the preparation phase of the products case. At the conclusion of the information-gathering process, counsel is faced with the task of making sense of it all, for herself initially, and subsequently, for the court and jury. In the typical products case the amount of such material can be voluminous. Efficient and productive organizational and analytical systems are vital at this stage of case preparation. The material to follow addresses practical methods for accomplishing these goals. The discussion will center on the design of manual indexing and analytical methods that lend themselves to subsequent transfer to a microcomputer litigation support systems. It is important to note that the analytical steps to be discussed in this chapter must be followed whether or not counsel wishes to place the litigation on computer. In fact, those very same steps are prerequisites to doing just that. The task of organizing and analyzing corporate documentation is one of the more time consuming that counsel will encounter in case preparation.


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The sheer volume of such materials and the unfamiliarity of counsel with industry terminology are two major factors inherent in the task. The problem is exacerbated by the fact that counsel’s collection of documentation is by no means complete. What has been received in discovery is only a small portion of the actual documentation generated with respect to the product. As such, this body of material is considerably disjointed. Counsel must be able to construct a pattern of corporate activity out of it that has both legal and investigative significance. It is necessary to extract as much of the big picture as is possible from the limited amount of documentation in counsel’s possession. This can be accomplished by tight organization and the utilization of the series of indexing and cross-referencing schemes to be discussed below. There are three basic goals that counsel must work towards at this stage of case preparation: • Identification of the committees and personnel involved in central aspects of the product’s design and manufacture • The points over the case time frames when important data was generated and key decisions were made • The common sense meaning of terms consistently used in all such materials. Achieving these basic goals requires close study of the variety of document types received in discovery. Counsel can then draw upon his familiarity with the total body of document types to answer any questions that may arise in subsequent phases of case preparation or trial.

Focal Points for Organization and Analysis Rating Corporate Documents An important related task in the preparation of the products case is the selection of corporate documents for use at trial. This is a difficult process since those choices must be made from thousands of pages of corporate materials gathered in discovery. The documentary component of the casein-chief is a central part of the story that must be communicated to jurors. However, even in punitive damage settings, where long-term disregard for known dangers must be established, jurors cannot be expected to absorb large amounts of these materials. No more than 25 to 50 documents should be presented to the jury for their consideration. The closer counsel can get to the lower number, the better.



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This task is complicated by the fact that each of the documents in counsel’s possession has some investigative and legal significance. Initially, effective systems must be developed to rate each document according to the potential uses to which it may be put at trial. The ensuing task is the selection of a sufficiently small number of the most highly rated documents to serve as the documentary centerpiece of the case. The value of each document should be gauged according to its usefulness in proving one or more of the following essential requirements in the products case: • • • •

Knowledge of defect Knowledge of feasible alternative design Irresponsible management decisions Proximate cause

The utility of any document for such purposes should then be assessed with respect to its contribution to each of the three basic phases of the trial: • Primary liability in case-in-chief • Cross-examination • Rebuttal The final rating and actual selection of documents can only follow counsel’s mastery of all of the documentary material involved in the case. These two essential functions, however, must be preliminarily considered as counsel begins the initial analysis and organization of the discovery materials. The rating of any single document constitutes an assessment of its legal significance or its value as a means of jury education. Documents should be evaluated on some form a sliding scale, such as A+ to C. The rating of documents requires a set of criteria that impact on those two important considerations. Corporate documentation should be reviewed from a rating standpoint that includes consideration of the following factors: • • • • •

The number of years in the time frame The presence of a punitive damage count The degree of complexity of the technical issues involved in the case The degree of complexity of the defendant’s corporate organization The requirements of each legal theory according to the defect types involved • The ease or difficulty with which the document can be understood • The clarification of defendant’s document generating processes • The clarification of defendant’s decision-making processes



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• • • • • •

The document’s length The topical concentration of the document The controvertibility of the document by defense counsel The foundation requirements for the document The authentication requirements of the document Whether the expert witness will utilize a document in support of testimony • Whether the document is needed as underlying support for trial exhibits • Proximate cause considerations • Trial relevancy considerations This checklist should be kept in the foreground as counsel sets out to organize and analyze her collection of documentation. The rating given to a document is also a point of interest or “field” that should be included as part of the breakdown of every category of document encountered in the products case. Focal Points for Organization and Analysis The analysis of selected document types to follow leans more toward cases addressing engineered product lines. The discussion is nonetheless intended to be applicable in its general terms to any product liability undertaking. The observations herein may easily be adopted to product liability litigation involving the drug and chemical industries. Organization is the key to the mastery of corporate documents and the mass of other data that counsel will accumulate in a product liability case. It is very easy to lose control of this material as the volume mounts in orders of magnitude. This is particularly so at the conclusion of discovery. The largest block of material that counsel will need to master is defendant’s internal documentation. Counsel is faced with the initial task of bringing legal and investigative order to thousands of pages of material spanning an extensive time frame and incorporating a wide variety of document types. The first order of business, prior to any attempt to master the entire body of such data, is to physically arrange the documents into related categories and familiarize himself with the organization and substantive content of each. Indexing and Analysis by Document Type Chapter 7, Science and Business Documentation, discussed selected types of documentation typically encountered in products cases. Such documents are generated during one of the typical stages of activity found along the product development and manufacturing spectrum. It is essential that counsel understand those stages and the likely subsets of activity occurring within any one



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of them. Most importantly, he must have a grasp of the nature of the document generating processes in each. The chronological steps historically followed in getting the good to market is one of the most important processes to identify in these cases. This process must be sketched out in detail prior to any attempts to manipulate document data across the years of the case time frames. The most time-saving and effective method for accomplishing this initial goal is to divide up all of the documentation according to its type. Any one document is a reflection of some consistent corporate activity with respect to the suspect product at any one point in time. Organizing documents by document type gives counsel a feel for the extent and nature of that particular activity over the entire case time frame. It also allows for quick familiarity with the terminology, involved personnel, and substantive results of such activity over that period. This will facilitate the informed construction of sophisticated indexing, cross-referencing, and information retrieval systems addressed to all of the materials in counsel’s possession. The first step is to establish a classification system for all of the documents received from the defendant in discovery. Due to the organizational and operational habits of major corporations in generating documentation, this is a relatively simple, if time-consuming, task. Document types tend to be repetitive in the major stages of product development and manufacture. Labeling documents by type is a function of determining the degree to which any one document reflects a continuing type of activity with respect to product development or manufacture. The number of document types encountered in a case will depend upon the degree of complexity of the defendant corporation and the suspect product itself. When in doubt, it is good practice to carve out more document types rather than less. Since the ultimate goal is to put them all together in chronological order, regardless of type, a very detailed document classification system can do harm. It will often result in a better understanding of the realities of corporate activity over the case time frames. Continuing the engineered product example utilized above, and following our discussion of document-request planning, a typical document-type classification system could include the following: Design: • • • • •

Product concept studies Marketing studies Cost studies Facilities availability studies Tooling studies



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• • • • • • • • •

Alternative design studies Competitive product studies Technical feasibility studies Component parts and materials studies Cycle plan studies Timing studies Regulatory reviews Management committee studies Management committee decisions

Testing • • • •

Test logs Testing standards Test requests Test reports

Production • • • • •

Production specification manuals Quality control procedures Production statistics Post-production design or materials changes Timing charts

Marketing • Advertising studies • Instructions and related documentation • Warnings and related documentation Regulation • • • •

Agency performance standards memoranda Agency reporting requirements memoranda Political appraisals of regulatory activity Cost-benefit analyses and related documentation

Company Organization • Organization charts • Committee charts



• • • •

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Functional employee grouping charts Standard operating procedures Record retention policies Complaint processing procedures

Companies tend to be corporate creatures of habit. Standard operating procedures (SOPs) are essential to the orderly functioning of any large scale business. Accordingly, different documents exist for many different functions. They also tend to look alike, in the sense of recording the same type of information in prearranged forms. This overall corporate fact of life lends itself to the construction of a document type indexing system that is made for insertion into a database manager. We might call it a geography of documents. Once all documents have been placed in their appropriate categories, counsel should arrange each separate grouping in chronological order. This will allow for close study of the historical generation and nuances of the documents in each category. Counsel will quickly become conversant with their technical and organizational context. He or she will also be in a position to construct effectively a master document list encompassing all document types and be able to conduct a thorough historical analysis of the entire range of corporate documentation in possession. The latter eventually supplies a clear look at the periods over the requested time frame where the defendant has not supplied materials that would appear to be called for in discovery requests. Standard Informational Content When initially examining any one type of document it is important to determine the type of information contained in it. This allows counsel to determine in what category certain information is likely to be contained. It is of particular value in deposing corporate officials, who often use the complexity of corporate documentation as a means of hedging on questions respecting information flow within the company. This information mapping is a necessary prerequisite to identifying the items of interest to counsel that are routinely encountered in documents of any one type. The latter function is the key to the construction of a successful manual or computerized indexing and information retrieval system. Identifying Document Points of Interest Counsel must determine just what it is that is interesting about any one category of documentary material. Once that has been established all of the recurring points of interest contained in each of the different document


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categories must be put into an accessible organizational system. It is necessary to cross-reference these points of interest across document categories at any point over the case time frames. This is also necessary to allow counsel to precisely identify how many documents of each type reflect the proof requirements in these cases. These broad requirements are set out below: • Objective data demonstrating corporate knowledge of product defects and feasible alternative designs. • Socially unacceptable management decisions in light of such knowledge. • Proof that one or more of the identified defects in fact caused the death or injury to the client. • Proof that one or more of the feasible alternative designs, warnings or instructions would have minimized or eliminated such death or injury. An entire range of questions will arise for each document type of data in counsel’s possession. Analyzing test reports in a products case resulting from the fuel tank explosion of an automobile23 may serve as an illustration. Automobile crash test reports, quite common in automobile products liability cases, is one of the major categories of documents that would typically be present in such a case. We will assume a series of crash tests conducted by the defendant, Main Motors Corporation, on a compact family automobile that has had a basically identical fuel system design over a number of model years. These tests would have been conducted to determine the ability of the fuel system design to prevent the gasoline from escaping when the car is impacted from the rear by a test barrier or other vehicle at varying rates of speed. Given a time frame of 10 years, there could be as many as 100 crash tests addressing this issue. There are a number of points of interest that must be isolated for this single document type. They must then be recorded in some fashion if counsel is to subsequently determine the legal and investigative significance of any one test in the series. These types of corporate documents tend to record the same classes of information. Typical questions out of the hundreds that will arise as the preliminary review of such tests progresses, would include the following: • What was the average speed of all rear barrier tests run between 1980 to 1985? • What was the highest test speed? • What offices, departments and individual employees were heavily involved in the testing phase of this product development project?



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• How many test reports did John Smith receive? How many did he request be run? • On what committee or committees did he serve? • When managers sat down to discuss the issue of fuel system integrity on April 22, 1980, what tests had been completed and what did they show regarding the integrity of the fuel system? • What did the engineering support staff have to say about these tests? • When did they say it? • What design alternatives were tested between one key date and another? • What did they show regarding the problem of tank puncture by the differential housing? • When was a successful filler pipe alternative ever referenced in a management document? • What authoritative monographs were published during this period that should have affected the engineer’s or manager’s thought processes respecting this design? • When were production specifications frozen? • What design changes were made in the course of the production runs occurring between one date and another? Ad infinitum. The logging of essential points of interest with respect to each of these crash tests is a necessary prerequisite to any attempt to get answers to the above questions. The recording of the data for each point of interest contained in every test in counsel’s possession must be followed by the integration of that data into an efficient cross-referencing system. Counsel must master the terminology, substantive content and chronology of each arguably separate category of data. He must also put the data selected from all document categories into chronological order and be able to manipulate it across categorical lines over the period of the case time frames. This detailed analysis is essential to proving that the suspect product was in a defective condition on the date of the injury-producing event. A sampling of the points of interest contained in each of the 100 tests noted above might very well include the following: • • • • • • •

Test number Date the test was requested Date the test was actually conducted Date that the test was formally reported Office which requested that it be run Department within that office Individual in that department



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• Government regulation, if any, to which the test was referenced • Vehicle tested • Type of test being conducted, i.e., moving barrier, fixed barrier, or car to car • Speed of the test • Any special components qualifying as alternative designs • Actual results of the test respecting the various components of the fuel system: tank contact, tank puncture, filler pipe pullout, dynamic sheetmetal crush, static sheetmetal crush, tank and floor pan seam weld performance, amount of leakage, if any. • Names of the corporate personnel on the distribution list for the test • Relationship of the test results to the proximate cause of the case • Relevancy of the test, in whole or in part, to the legal requirements of the theories in the complaint • General notes, thoughts, or ideas that each test brings to mind Each of these topics are data categories that would be present in each crash test reviewed by counsel and have significant investigative and legal importance to the case. Testing materials, however, are only one of a large variety of document types that counsel must master. There are also engineering analyses, engineering financial analyses, management engineering analyses, management financial analyses, planning documents, production specification manuals, drafts of instructions and warnings, advertising copy and a host of other categories of document types.24 Each one of these additional categories may have hundreds of separate documents falling within it that may run to a thousand or more pages. Taking as an additional example a block of documents falling into the category of management engineering analyses, a new list of points of interest must be isolated. A sample list of such points would include the following: • • • • • • • • • • •

Document title Document date Subject matter Precise document type Office to which it is directed Department to which it is directed Individual to whom it is directed Office generating the document Department generating the document Author of the document Names of personnel on the document’s distribution list



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• • • • • • • • • • • • • •

Any committees referenced Any committee meetings referenced Vehicles discussed in the document Model years of all vehicles discussed Any crash tests discussed Any alternative designs discussed All references to knowledge of defect All references to feasible alternative designs All cost figures All references to production cycles All references to suppliers Any references to government standards Proximate cause aspect of all or part of the document Relevancy of all or part of the document to the legal requirements of the case theories • General thought, observations, or ideas respecting the document

The points of interest contained in any one document type could be much more extensive than the two samples set out above. Multiplying the points contained in these two examples by the total number of document categories involved in the typical products case will give an indication of the tremendous amount of facts that counsel must comprehend. It is essential to understand that it must be done in some fashion to master the terribly disjointed number of documents received after arduous and expensive discovery. The proposed system easily lends itself to entry into database records that allow total control over the documentary aspect of the litigation. Indexing of All Corporate Documents Once counsel has closely analyzed the individual documents falling into any one category and recorded their points of interest, he should then index all corporate documents in his possession in chronological order, regardless of their type. A simple master index of all documents can reveal patterns of activity that shed considerable light on many of the questions noted by counsel during the study of each document category. Subsequent close analysis of all of these documents, in the order in which they were actually generated in the company, will answer most others. This master index should contain, for each document entered, the title, date, document type, and subject matter. Recording this minimal information for each document is necessary to achieve the next level of understanding, which is the reconstruction of the entire product development and manufacturing processes over the case time frames. These entries will allow for a virtually unlimited number of cross-referencing


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exercises that will greatly facilitate counsel’s mastery of these materials for all purposes, not the least of which are depositions and cross-examination. Reviewing all corporate documents in the order in which they were generated in the company allows counsel to accurately trace the life of the suspect product. The first several entries on the index may be planning committee memoranda, followed by a series of tests, followed in turn by engineering studies and additional committee meetings. Whatever the actual chronological flow of documentation is, counsel will have a clear perspective on the reality of corporate activity over the case time frames. In large part, this is the result of her prior close study of the individual documents falling within any one document category. This level of knowledge will enable counsel to effectively utilize the more sophisticated analytical methods to be discussed in the sections to follow. Indexing of All Documentary Materials Once counsel has constructed the master index, the most significant stateof-the-art, regulatory, and company research in possession should be incorporated. Not all of this voluminous data need be included. However, key state-of-the-art studies, agency performance or reporting requirements, and important events in defendant’s corporate history should definitely be added to the index. The incorporation of these classes of materials will flesh out the historical context within which corporate managers made the policy decisions that lie at the heart of the case. For example, the expanded index may reveal that corporate testing only began several weeks after the issuance of a proposed agency regulation. The external events represented by these documents, especially federal agency activity, generally have a significant impact on the product development and manufacturing processes of the affected corporation. The publication of authoritative studies and agency proposals always bring reaction in the industries touched by them. This reaction comes in the form of documentation that will include most of the document types encountered in these cases. It is important to trace the effect of these external events on corporate processes. In one form or another, counsel must do this. The following is the easiest and most efficient method of tracing this documentation — companies also follow this method. Terminology Each set of documents is likely to have terminology peculiar to it. Other terms will apply across document types. Certain terms have industry-wide acceptance while others are unique to the corporation being studied. In either event, it is important that counsel make a note of each term he does not



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understand and consult his expert or other authoritative source as to its meaning. This is not only necessary to gain a full understanding of all of the documents under study but also to maximize the depositions of corporate personnel. Isolating Activity over the Time Frame The chronological indexing of each document type in counsel’s possession is valuable in several key respects. Initially, this allows counsel to isolate the activities that that group of documents addresses, over the entire case time frame. It also facilitates the precise determination of the nature and extent of such activities at any one point over that same period of time. Assuming the group under study is vehicle crash tests, counsel can quickly estimate how many tests, if any, where conducted under what conditions between May 1st and August 30th in 1987. Counsel may find that tests were not run to determine a certain performance level or that certain feasible design alternatives were not tested or were rejected at select points over the time frame. Preliminary study of document types is the most efficient and productive method for eventually mastering defendant’s product development and manufacturing processes. Whatever the category of document type under study, counsel has an opportunity to determine the exact nature of the activity they describe and familiarize himself with the terminology and other important features of the type to be discussed below. Determining the Pattern of Documentation One of counsel’s more important goals in the analysis of documents is the ability to pinpoint the pattern of various corporate activities with respect to the suspect product over the entire case time frames. This is a necessary prerequisite to answering the numerous questions that typically arise in the course of preparing these cases. The resolution of questions raised at one stage will spawn a more sophisticated series at the next. The answer to most all of such inquiries is contained in the documents. Methods must be designed to efficiently and expeditiously extract the necessary data to answer them. Any number of inquiries may be readily answered if counsel has a firm grasp of the patterns of documentation over the case time frames. Examples of typical inquiries are set out below. • • • • •

When was this product concept first discussed by planning committees? Who was involved in that process? What was their position in the corporation? What relevant tests preceded these planning meetings? What did those tests specifically show with respect to the broad design parameters being discussed?


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• What work was done by technical staff at the direction of these committees? • What did it show about possible product problems? • What effect did this technical input have on the planning process? • When was the suspect product approved for detailed research and development work? • What tests and evaluations — whether technical, financial, or marketing in nature — followed this level of approval? • When was this product in its present form, given final approval. • When were the majority of performance tests run prior to final approval? • How many were run after it? • What was the response of management to poor test performance or outright test failures? • What offices, departments, and individuals were involved at key stages along this product development and manufacturing spectrum? • How did the scientific literature relevant to the industry factor in, if at all? • What was the company reaction to agency performance testing proposals? • How many alternatives were tested? • How were they costed? • When were they tested? • What was the manufacturing cycle within which this product was to be produced? • What was the timing schedule for this project? • How many documents of each type do we have in selected periods over the time frame? • At what period of time did the greatest amount of activity, with respect to any one aspect, seem evident? • To what extent did purely marketing concerns impact on design work? • At what stage? • In what respect? The above questions are only a small sampling of the host of questions that will be raised over the course of case preparation. The defendant generally has the answer to most of them. It is essential that counsel achieve parity with defense counsel in this respect. Overrepresentation of Document Types In addition to identifying the broad outlines of document generation over the case time frames, counsel must isolate those periods when key corporate



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activities may have been intensified. Even a cursory examination of the documents listed on a master index will reveal the pattern of corporate activity for any select period of time. A good rule of thumb in making this important analysis is to search for over representation of document types in any one period. For example, in cases involving a product introduced over a number of model years, such as an automobile, the master index will normally show a concentration of performance testing in the several years preceding the original introduction of the product. Testing of basic design features may be nonexistent or at a minimum in later years. In instances where the market for the product is not linked to a model year format, such as drugs and much of industrial and home products, there may be no subsequent testing. Another review may reveal a flurry of top management meetings respecting compliance with agency regulations at one period of time, with little or no reconsideration of policy thereafter. The overrepresentation of any document type in any period is a reflection of corporate priorities with respect to the activity underlying the generation of such documents. Intensified activities are generally an indication of pressures of one sort or another. These periods often reveal questionable management priorities. Their isolation and study can contribute significantly to counsel’s understanding of materials generated much later in the process of getting the goods to market. Underrepresentation of Document Types As important as noting overrepresentation of document types over the case time frames is being aware of the underrepresentation of document types. The absence or minimal presence of select document types, such as testing materials, at periods when they would be normally expected to have been generated, can shed important light on corporate processes. The absence of certain document types are an indication that policies have been set respecting the aspect of product development or manufacture represented by such materials. It is a clear indication of corporate priorities at such times. This factor is of great importance in arguments over the relevancy of documents at the motion-in-limine trial stage of the case. Decisions may have been made in the past that will govern detailed corporate activity in the future. Documents whose date antedates the model year of the product unit involved in the case by many years may have compelling relevancy to the litigation. Examination of the master index from this perspective contributes to the identification of key documents that may control design policy far into the future life of the relevant product line.


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Gaps in the Generation of Documents Counsel should search out the master index for contiguous periods of time when no documents of any type are represented. A gap in documentation of a month, say, for any period over the case time frame, is also a cause for concern over the sufficiency of defendant’s good faith compliance with discovery requests. This is an important point with respect to supplemental requests for documentation. It is necessary to determine if document types underrepresented or not present in any one period were or were not actually generated. The more common scenario is that defendant, for whatever reason, failed to produce them pursuant to initial discovery requests. This question must be resolved to assure the integrity of plaintiff ’s body of corporate documentation. Any significant gap in documentation should be carefully noted and made the subject of inquiry in supplemental requests for documents. In areas where intensified activity of various types has been identified, even small documentary gaps may warrant close scrutiny. Gaps in documentation may be the result of the record destruction policies of the company, especially during the early years of corporate activity with respect to the suspect product. Such gaps in documentation may indicate the need for more questions over the adequacy of defendant’s compliance with discovery. In some instances they may reflect a purposeful destruction of harmful materials. This is seldom encountered due to the difficulty of any attempt by a corporation to effect a documentary cover-up. At the time when the now-sensitive documents were generated, they were done so according to the routine corporate processes in place at such time. Their absence at a later date from the normal flow of documentation is relatively simple to identify but very difficult to explain away.

Specialized Indexing and Cross-Referencing Cross-Referencing Focal Points Once close familiarity with the various individual document categories has been achieved and the master index prepared, counsel should plan and implement a detailed cross-referencing system. No one corporate document is generated as an isolated act. Each document is part of a series of information generating activities the purpose of which is to provide objective data for management policy-making bodies. As such, it is necessary to identify the beginning and end of such processes and the precise nature of the activities occurring within them. Sophisticated cross-referencing will provide counsel with the means to delineate these processes with great particularity. The previous recording of the points of interest for each category of document



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in counsel’s possession will facilitate this important aspect of case preparation. Cross-referencing involves centering document analyses around a series of analytical focal points. They are applied to the entire corpus of documentation in counsel’s possession. These exercises will facilitate detailed profiles of corporate activity on a wide variety of important subjects over the entire period of the case time frame. The dates included in the master list provide the starting point for any of such exercises. A comprehensive cross-referencing system would include the following focal points. This would be the case regardless of the nature of the industry or product under investigation. The bulk of the detailed questions counsel will have revolve around the following central topics: • • • • • • • • • • • •

Key meetings Key tests Agency proposals Key offices Key individuals Authoritative studies and reports Preexisting cycle plans Final product specifications Legal theories Proximate cause Relevancy Document ratings

Knowledge of Defect Documentation indicating knowledge of product defect will cover the gamut of document types encountered in a products cases. The degree to which any one document will reflect this knowledge will vary dramatically. Some may simply reference reported test failures or engineering analyses discussing product problems. Others will reflect knowledge of defect only by implication in that the document date simply follows negative test results and accompanying engineering evaluations. The degree and manner in which any one document indicates knowledge of defect is one of the central criterion in the process of selecting documents for use at trial. The ability to extract this information at any period over the case time frames has tremendous value for numerous aspects of case preparation. Knowing which documents in each category demonstrate this knowledge allows counsel to accurately gauge the nature and extent of corporate knowledge of defect at any one point over the case time frame. The extent


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to which each of the document categories demonstrates this knowledge is determinative of the strength of counsel’s case. Knowledge of Alternative Design The above observations also apply to documents reflecting knowledge of feasible alternative designs. Instances of this knowledge may range from the obvious, as in test reports and evaluations, to mere notation of a test having been completed. It may only reside in the fact that the discussion postdates the running of such tests. The strength of counsel’s case is grounded in the defendant’s rejection of safer feasible alternative designs. The reasons why a particular design alternative was rejected should be carefully recorded. The basis for such a rejection can range from genuine concern over technological inadvisability to purely financial or marketing reasons. Legal Theories and Relevancy It is important that counsel be able to determine the strength of each count of the complaint at any point over the case time frame. The beginning and terminal point of corporate activities that meet the elements of each of the case theories should be pinpointed. Accordingly, as counsel reviews the individual documents in each category, their applicability to the several theories of liability involved in the case should be noted. This will enable counsel to estimate which of his chosen theories has greater or less support based on the corporate documentation currently in his possession. This cross-referencing focal point will also facilitate the selection of documents for use at trial. Proximate Cause It is important that counsel have a detailed understanding of the product failings that significantly contributed to the client’s death or injury. It is also essential to determine the exact manner in which they so contributed. This is absolutely required prior to the organization and close analysis of corporate documents. The ultimate investigative significance of any one document lies in the degree to which it gives direction to counsel’s search for facts that support his legal theories. This is especially so with proximate cause. Establishing proximate cause is a pivotal investigative and legal focal point. It must follow the identification of documents reflecting defendant’s knowledge of defect and rejection of feasible alternative designs. This requires a clear showing that one or more of the identified defects caused the injury and that one or more of the alternative designs would have prevented or minimized the injury.



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The relevance to the proximate cause issue of any one document will vary significantly, depending upon which of the several counts in the complaint is being considered. A document having no clear relevancy to a design or failure to warn count may have compelling relevancy to a misrepresentation or punitive damage count. Counsel should examine each document for its potential contribution to proof of the proximate cause issue for each count of the complaint. Requesting Offices and Departments The greatest number of corporate documents examined will contain references to the office, department and individual who requested the data, as well as the same information regarding the information suppliers. This very common “to–from” notation is of great importance in counsel’s attempts to determine the identity of knowledgeable corporate personnel and the levels of management requesting, generating, and evaluating product performance data. Corporate organization charts will delineate the broad organizational structure of the company for each year in the time frame. However, they will not indicate the activity of any individual offices, departments, or individuals with respect to the suspect product. This detailed information is not contained in any one corporate document. It must be painstakingly reconstructed by counsel. Recording this information for each document reviewed will facilitate the construction of customized organization charts. These charts, in turn, facilitate the cross-referencing of personnel activities over the case time frame. This is essential information for the deposing of technical and managerial staff. Understanding the structure utilized by the company to initiate and complete evaluative processes is as important as the materials generated the processes themselves. Counsel must identify the offices and departments having significant involvement with the product over the course of its development and manufacture. This perspective is essential to place the information contained in the documents in the organizational context out of which they arose. Cross-referencing and indexing documents by office and department can achieve this goal. This process is greatly facilitated by counsel’s having previously recorded this data for each document reviewed as a standard point of interest. This can be a difficult task in litigation involving major corporations and lengthy case time frames. Corporate organization is constantly shifting, with offices changing names and functions, or even being eliminated, in response to a number of factors. The organization charts for each year in the time frame received in discovery are useful in providing a top-down view of


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the line responsibility in the company. The entities noted on such charts are associated with particular activities with respect to the suspect product. Such disembodied listings are of little assistance in developing a close working knowledge of the offices having significant impact on the manufacture of the suspect product. To achieve this degree of proficiency, counsel must be able to determine, at any one point over the case time frames, what offices and department generated, received, and evaluated relevant product-related data. Creating indexes arranged by office and department that link individual documents to them, accomplishes this goal. It is a necessary task whose value will far outweigh the time and effort consumed in effecting it. Requesting Individuals A list of the individuals requesting as well as receiving product-related information is important for several purposes. It will supply counsel with the identity of select employees actively involved with the product over the case time frame. This list can serve as a valuable reference for the subsequent selection of candidates for deposition. It will also provide counsel with an inkling of the corporate personnel that defendant will be required to draw upon in the event the case goes to trial. Finally, this listing will greatly assist counsel in placing personnel whose name, but not location in the company, may appear on a document distribution list. While committees exercise the greatest influence on the shaping and making of company policy, their work is the result of significant input from individual technical and managerial personnel. Some may be of value strictly for their technical knowledge of the product. Others are important for the light they can shed on management priorities and knowledge of product defects and alternatives. As noted above, the two major sources of information for the identification of key personnel are the “to–from” notations and distribution lists for each document studied in a category. Those actually involved in the requesting and generating of information are of greater importance in this respect that those individuals whose names only appear on a lengthy distribution lists. Cross-referencing documents by individual names requires indexing each person with the documents that he requested, wrote, concurred in or simply received. This is a laborious but important investigative exercise. Distribution Lists The distribution list or “cc:” notation is a common feature of corporate documentation. In many instances a distribution list can contain as many as 30 names. These are normally disembodied listings that do not indicate the



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group, office, or department where the designated individuals work in the company. Making that determination for each person on the countless number of such lists likely to be encountered is no easy task. It is nonetheless important if counsel is to gain a complete working knowledge of the involvement of key personnel in getting the product to market. This process is complicated by the constant movement of personnel through the company and the elimination, restructuring, or renaming of offices over the case time frame. The fact that John Smith worked in a certain department in a certain during in one year is no guarantee that he or the office and department can be located the next. The fact that a name is on a distribution list does not necessarily mean that that person was actually involved in activities of concern to counsel. Often an individual will receive a document because he is on a list of employees who are to routinely receive all documents of that type. Conversely, the fact that someone’s name does not appear on a distribution list does not mean that they did not receive and act upon it. It is common practice among the highest levels of management to see to it that their names do not appear on any documentation. There are two basic sources that counsel can use to attempt to identify individuals on these lists. The most fruitful is an internal telephone directory. This directory will normally list the office and department where any one person listed works. These directories should be included in counsel’s document request for each year of the case time frame. In cases involving lengthy time frames, however, directories may not be available for each year. In that event, counsel can piece together the offices and departments referenced in the “to–from” portions of each document and try and match that information to the names on the distribution list. This latter process is very time consuming, but in many instances may be the only effective method to complete this important investigative task. Asking corporate deponents to place these individual more often than not elicits little information. Committees and Committee Meetings It is very important to identify all of the committees involved in generating and evaluating technical and financial data over the case time frame. Committees are the major source of corporate decisions affecting product development and manufacture. Individual personnel do not normally make important corporate policy decisions, at least without significant prior committee study and evaluation. This is especially the case in large corporations. Much of the individual documentation that counsel will review will have been generated at the behest of a committee. The identification of relevant committees and the position of committee members is a central goal of counsel’s interrogatories and requests for


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documentation. In cases involving extensive time frames, the defendant may be unable to adequately supply this information from existing documents in its archives. This item of information should, accordingly, be a standard point of interest when reviewing each document type. Once all of the various document types have been analyzed counsel should be able to piece together the references to committee involvement in them. Counsel can then assess the extent to which one or more of them influenced important policy decisions impacting on the suspect product. Counsel will invariably encounter memos of committee meetings where product failings and feasible alternatives were discussed or important policy decisions reached. It is important that counsel identify the range of corporate activities preceding and following such meetings. This information is necessary to gauge the propriety of any course of action formulated by such committee. The activities preceding such meetings should be reexamined with the goal of precisely identifying the details of preexisting knowledge of defects and feasible alternative designs. This gives counsel, and subsequently the jury, a very accurate picture of the realities of the decision-making process on any one date over the case time frames. This is especially so with respect to performance tests and test evaluations. Key Tests The review of test reports will reveal a certain number that will have significant impact on the trial of the case. These will normally show design defects inherent in the product as marketed and safer feasible alternative designs that were rejected by the defendant. As with important committee meetings, counsel should track the corporate activities preceding and following the running of such tests. Testing activities are normally the result of a preexisting evaluative process. They, in turn, are the catalyst for the generation of a wide variety of additional documentation. They are utilized by engineers to gauge the need for additional design work. They are also used to estimate the cost of alternative designs. Marketing staff will reference test data to estimate the effect of needed design changes on the marketing potential of the product. Management committees evaluate test reports in the process of planning future technical activity or in finalizing company policy in some respect. An inordinately large number of performance tests are conducted to determine the company’s ability to comply with proposed or existing federal agency regulations. This means that many of the tests of interest to counsel will have been conducted as part of an ongoing compliance study. The data generated by this coordinated activity results in the setting of company policy policy. Numerous offices and departments are involved in the process of finalizing these policy decisions. Tracking company activity with respect to



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government regulation is one of counsel’s most important investigative undertakings. Centering the analysis around the date of key performance tests is a very effective method for accomplishing this task. Government Regulations The largest part of the documentation addressing safety-related aspects of product design are generated in response to concerns over compliance with a proposed or existing agency performance regulation. The issuance of a proposed regulation is the catalyst for a flurry of documentary activity in a corporation. If the companies had been designing up to the performance level contained in the regulation it would never have been proposed. Accordingly, the affected corporations must conduct investigations to determine the ability of affected product lines to comply, pending a final decision by the agency. This activity draws upon all of the resources of the company from design centers to financial and marketing experts. A significant amount of documentation falling within all document types is generated in the course of this process. Prefiling investigation will identify those agency regulations that were proposed and/or took effect at any point over the case time frame. Every reference to any such regulation should be logged as a point of interest for each category of documentation analyzed. Doing so will enable counsel to later determine how much of any one activity with respect to the product was the result of independent safety concerns and how much the result of agency pressure. This is a telling point in educating jurors as to the actual place served by customer safety in product development and manufacture. It can be dispositive on the issue of punitive damages. Product Planning Cycle or production plans are a staple of corporate life. It is important that counsel identify the long-term plans formulated by the company with respect to the suspect product. Design changes will be staggered according to these planning components and not on the basis of their urgency from a safety standpoint. Safety-related product enhancements are often scheduled according to the effective date of government performance standards. In the absence of government pressure, they may not be scheduled at all. The willingness to effect design changes deemed necessary by technical staff is directly related to whether they can be accomplished within current planning cycles. The chances for any significant design change occurring “out of cycle,” regardless of its life-saving potential, is generally negligible. Comparing the date at which product defects and/or feasible alternatives were known to the defendant with the controlling corporate planning documents is an important cross-referencing exercise. This is especially so in


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cases involving products such as automobiles, which have an annual model year marketing scheme. The date on which product design specifications were frozen prior to manufacture is a central cross-referencing focal point. At some point, specifications must be frozen if production is to be initiated in an efficient manner. Determining the date when final specifications for the product were set is necessary when assessing the impact of tests and related materials generated prior to that date. A comparison of final specifications against the findings and recommendations in such data often serve as a forceful demonstration of corporate disregard of known dangers and feasible alternative designs. Counsel should also determine the degree of flexibility that existed to make any design changes prior to and during production runs. Complaints Customer, dealer, or, in the case of drugs, health care provider complaints are an important source of knowledge regarding defects. While they do not carry the authority of formal test reports and evaluations, they do represent information that the company should have acted upon. In some settings, such as pharmaceuticals, they must be forwarded to the Food and Drug Administration (FDA). It is well worth counsel’s time to cross-reference the timing of customer and dealer complaints with subsequent activity in the company. This is especially so in cases where there has been a significant amount of such complaints. If the substance of these allegations dovetail with the findings of the technical staff in internal testing programs, they provide significant support to the punitive damage count. The same cross-referencing could profitably be made with any litigation history involving the suspect product. The ability to quickly access the wide variety of information contained in these materials can make the difference between success or failure in these cases. Multiple indexes and cross-referencing exercises of the type discussed above give counsel that ability. Whether counsel chooses manual or computerized systems to organize these materials, well-planned structures should be in place before any significant investment of time is made in reviewing them. Pretrial Motion Practice Pretrial motion practice in all litigation, particularly product liability and other science-based cases, consists of three major components: • Enforcement of discovery rights. • Arguments in opposition to requests for protective orders. • Arguments in opposition to motions-in-limine.



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The defendant corporation typically will object to most interrogatories and requests for documents. It will also seek encompassing protective orders in attempts to prevent counsel from gaining assistance from more experienced counsel. It will also file broad-based motions-in-limine aimed at the major components of plaintiff ’s case. Success or failure in the product liability case is directly related to the quality and aggressiveness of plaintiff counsel’s efforts at this crucial phase of the long discovery and pretrial process. The material to follow will analyze each of the major aspects of pretrial motion practice. It will discuss practical methods for successfully meeting defense motions. Every approach to be discussed, however, assumes a level of planning and prefiling research of the type discussed in the preceding chapters. The lawyer who has done little or no preparation has limited opportunities for success at this vital stage of case preparation. The initial discussion will center on discovery, the most involved and important aspect of pretrial motion practice.

Defense Objections to Discovery Objections to Discovery Requests The most difficult phase of counsel’s case preparation is the effort that must be expended to force the defendant corporation to comply with discovery requests. It is a very time consuming and frustrating exercise. Every interrogatory and document request will be hotly contested by corporate defense lawyers. This stage of case preparation typically requires numerous trips to the courthouse and the extensive drafting of motions, memoranda, and supportive affidavits. Discovery motion practice in these cases can be a dangerous pitfall for the plaintiff ’s lawyer who has failed to do extensive pretrial research. The amount of any fair settlement or a victory at trial are directly related to the quality and aggressiveness of counsel’s work at this point. It is the time when the defendant can accurately assess the quality of its opposition and thereby determine how seriously to take the case. Typically, defendants raise five objections as bases for their refusal to provide information to plaintiff: • Information sought is not relevant nor likely to lead to the discovery of relevant evidence • Request is vague • Request is overbroad • Request is oppressive or burdensome • Information sought is privileged from discovery


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In order to meet these standard objections sufficiently, counsel must have a firm grasp of the defendant’s document-generating processes, the likely content of defendant’s archives and the relationship between those factors and the specific allegations of the complaint. The discovery and relevancy rules, as well as supporting case law, merely serve as window dressing for what are essentially complex factual arguments. Counsel must be equipped to specifically address the actual documentary impact of his complaint and discovery filings. Relevancy The definition of relevance is provided by Federal Rule of Evidence 401, which defines relevant evidence as information having any tendency to make the existence of a fact that is of consequence to the action more probable or less probable than it would be without it. Using this standard as the base definition, the federal rules also allow for the discovery of data that may be reasonably calculated to lead to the accessing of such information. Both federal and state courts have consistently supported very liberal discovery pursuant to this standard. Objections to relevancy constitute the major component of the corporation’s refusal to honor plaintiff ’s discovery requests. Defendants will usually allege that materials arguably contained in the categories of information that counsel seeks have no logical bearing on any of the factual issues raised by the complaint. The stock response to many, if not all, of plaintiff ’s interrogatories and document requests states: Defendant objects to this request on the grounds that it is overbroad, unduly burdensome and seeks information which is neither relevant nor reasonably calculated to lead to the discovery of admissible evidence.

This is typically accompanied by claims that it does not understand the terms used by plaintiff to describe relevant aspects of the technology or corporate processes involved in the case. The defendant also generally refuses to accept the definition of any terms set out in the preamble to discovery requests. These stock responses will be encountered by product liability litigators in virtually every case they file. In cases involving products that have a model year associated with them, defense arguments tend to center around the year of manufacture of the suspect unit. Data preceding and following that model year are alleged to be irrelevant and hence nondiscoverable. Where the marketing of the product is not tied to a periodic change in model year, as in drug and industrial equipment cases, arguments tend to concentrate more on the categories of documentation sought by plaintiff and the nature of the information likely



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to be contained in it. Even here, the thrust of defendant’s argument is necessarily tied to the logical inapplicability of both pre- and post-production data to the legal and factual issues involved in the case. These arguments rest on the assumption that the precise design feature at issue was not existent in the company in earlier years and was significantly changed soon after the date of production of the suspect unit. The only way that defendant can hope to succeed in this argument is to convince the court that the general design features involved in the case were short lived at or around the date of manufacture of the suspect unit. This is a difficult position to argue with any degree of credibility. Plaintiff ’s should maintain a two-fold position in this respect. First, that the general design features inherent in the suspect unit have not changed to any significant degree over the case time frame. Second, that even if the precise specifications have been significantly altered, the overarching design principles are still current in the company. Accordingly, technical and financial analyses bearing on that particular design feature or the more encompassing design theory, would shed light on the performance of the suspect unit. It would also reflect the corporation’s attitude toward known product dangers or alternatives associated with such design principles. The key to overcoming the relevancy objection lies in analyzing the corporate data that would be logically related to the defect allegations in the complaint that support each individual request. Vagueness of Request Corporate defendants often claim that the vagueness of the requests prevents them from identifying the documents to which they are purportedly addressed. Discovery requests must be sufficiently broad to encompass all arguably relevant information and sufficiently informative to indicate the information they seek to access. To achieve this degree of clarity, the interrogatories and document requests must be centered in the defect allegations of the complaint. Discovery requests that mirror that degree of specificity will deprive defendant of the opportunity to use this stock objection. Allegations in the complaint that the product was “not properly designed,” “not safe,” “not adequately tested,” “defective,” or that defendant “failed to issue proper warnings or instructions” are simply inadequate. Accompanying discovery requests seeking “any and all documents related to the safety of the product” or “memoranda of all meetings with respect to the product” are equally faulty. They quite properly subject plaintiff to objections of vagueness. Noncommunicative defect allegations and related discovery requests are of little or no assistance to a court attempting to assay the extent of plaintiff ’s right to discovery.


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Burdensome and Oppressive Requests Objection that plaintiff ’s quests are burdensome and oppressive is a permanent member of the litany of discovery objections raised by corporate defendants. As with most other standard objections, these are typically unsupported by factual allegations or affidavit. Hence, they do not qualify as a valid answer and may constitute a waiver of objection. 25 Rule 33 of the Federal Rules of Civil Procedure requires that corporations furnish such information as is available from the corporation itself or from sources under its control.26 The number and detailed nature of the interrogatories and requests for documents are not sufficient reasons for disallowing them unless they are “egregiously burdensome or oppressive.” 27 Equally unavailing is the fact that answering them will require the corporation to expend considerable time, effort, and expense, even to the point of interfering with their company business.28 The bare allegation of oppressiveness is patently insufficient to warrant a refusal to answer. In the case of Altech Industries v. Al Tech Specialty Steel,29 the defendant objected that compliance would cause undue burdens and oppression. The objection was unsupported by factual allegations or affidavit. In rejecting that objection as insufficient, the court emphasized the statutory requirement of specific factual allegations to support such a claim: …A second objection of the defendant is that it would be unduly burdensome for it to respond more fully than it has to interrogatory 4 of the first and third sets. In objecting to augmenting its answer…defendant alleges that to do so would be burdensome in that ‘plaintiff seeks information concerning possible meetings involving hundreds of present and former employees of GATX and the company maintains no separate records as to any such meetings involving such persons.’ Similarly, defendant’s objection to augmenting the answers which it has supplied to interrogatory 4…is that this too would be burdensome since plaintiff ‘seeks information concerning possible communications or conversations involving hundreds of present and former employees of GATX and the company maintains no separate records as to any such communications or conversations involving such persons.’ The defendant has provided no evidence to support its objection of burdensomeness. Consequently, no validity can be attributed to it.30

In the case of F.D.I.C. v. Mercantile Nat. Bank of Chicago,31 Judge Marovitz, in the face of a similar objection, stated: …Concerning Mercantile’s argument that compliance with plaintiff ’s interrogatories will be unduly burdensome, the Court begins with the proposition that the fact that a party will be put to some trouble and expense in the process of answering interrogatories is not alone a sufficient ground for



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objection…An objection to a set of interrogatories on the ground that compliance would be unduly burdensome will only be sustained if the objecting party establishes that the burden upon him outweighs the benefit the information would provide to the party submitting the interrogatories.32

Costly and Time-Consuming Research The objection that responding to a particular discovery request will result in costly and time-consuming research is a variation on the burdensome and oppressive argument. It is equally unavailing if not supported by sufficient factual allegations. In this and the burdensome and oppressive objections, corporate defendants attempt to use the fact of their size and complexity to frustrate legitimate discovery. To the extent any factual support is provided, it generally rests on the claim that defendant does not archive its records in a manner that would facilitate compliance or that interviews with hundreds of present and former employees would be required. This argument, based on inconvenience rather than inability, finds little support in the case law. 33 Attorney–Work-Product Privilege The work-product doctrine generally requires that the relevant information a party seeks to protect actually be prepared in anticipation of litigation. 34 Defense counsel often takes the position that any ideas contained in evaluative materials generated by corporate personnel that are subsequently incorporated by the lawyer into his theory of the case entitle such material to protection as work product. This argument was rejected by the Illinois Supreme Court in Consolidation Coal Co. v. Bucyrus Erie.35 The court was asked to determine whether a metallurgical report could be characterized as appellant’s attorney’s work product. The court concluded that the report was actually a notebook that contained objective and material information consisting of mathematical computations, formula, tables, drawings, photographs, industry specification tables, and the like. The court concluded that such a document did not reflect or disclose the theories, mental impressions or litigation plans of the attorneys and was not protected material. The court reasoned that the metallurgist never communicated with the legal department prior to preparing the material nor was he advised by his superior as to what the theories or plans of the attorney were relative to the litigation. Accordingly the materials did not thereby become the attorney’s work product simply because he thereafter requested the report and adopted the ideas and notations in it as part of the theory of his case. Courts in virtually every jurisdiction have offered a variety of formulas for the necessary nexus between the creation of work product material and the process of litigation. These various pronouncements state that there must


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be a “substantial probability that litigation will occur,” that the commencement of any such litigation be “imminent,” that the prospect of litigation must be “identifiable,” or that the litigation must “reasonably have been anticipated or apprehended.”36 The pivotal factor, however, is not whether any particular litigation has actually begun. Materials prepared with an eye toward litigation will most likely be protected. This is very common in corporations who anticipate numerous filings associated with a product line. The likelihood that the litigation will occur must be substantial before a document will be deemed to be in anticipation of litigation. The mere likelihood that some particular litigation might occur is not a sufficient showing.37 Work-product documents prepared incident to litigation do not normally lose their protected status upon the termination of that particular litigation. This is of some importance in product liability cases, where it is common practice for defendants to conduct a series of tests to replicate the injury-producing event. There may be a rather large block of objective data about product performance that is not accessible due to the reason for which such tests were originally conducted. Defense counsel take the position that since the test parameters were specified by them to aid in their evaluation, that those materials remain work product. Accordingly, they do not lose the qualified immunity extended to them and are generally not discoverable in subsequent litigation.38 Attorney–Client Privilege The attorney–client privilege is available to corporations as well as to natural persons.39 The attorney–client privilege protects only communications made by or to the attorney’s “client.” A corporation, as a purely legal entity, has no operational existence aside from its employees and agents. Hence, a problem arises as to which of these agents acts for the corporation in the attorney–client relationship so as to enjoy the status of a client. Two principle tests have been applied by the federal and state courts to determine which corporate communications are within the attorney–client privilege. The most widely accepted is the “control-group” test. There, an employee’s statement is within the privilege if he is a member, an authorized, body or group that has authority respecting the action the company may take upon the advice of the attorney.”40 Another more expansive formula utilized by the courts is the “subject matter” test. Under this test, the privilege can be asserted even though the employee is not a member of the control group where the employee makes the communication at the direction of his superiors in the corporation and the subject matter of the communication is the performance by the employee of the duties of his employment.



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In the case of Consolidation Coal v. Bucyrus Erie Co.41 noted above, the Illinois Supreme Court was asked to determine the scope of the attorney– client privilege as it applies to a corporation. The Consolidation court adopted a modified control-group test. They expanded the privilege to cover not only those communications made between top level managers, but also communications made by certain lower level employees. Employees whose advisory role to top management in a particular area is such that a decision would not normally be made without their advice or opinion, and whose opinion forms the basis of a final decision by those with actual authority, are considered part of the “control group.” The court’s decision to adopt this rationale was based in part on its desire to accommodate modern corporate realities where decision-making within a corporation is a “process rather than a act.”42 Documentary Significance In one form or another, corporate counsel routinely raise the attorney–client and work-product privileges to support their refusal to comply with discovery in products cases. Initially, as with most all objections, defendants typically fail to state any specific facts warranting the application of any recognized privilege. Like the others, such an unsupported objection constitutes no answer and a waiver of objection.43 Bare allegations that a particular inquiry “seeks information protected from disclosure by the work product doctrine and attorney–client privilege,” or that “this interrogatory might seek information concerning tests performed at the direction of counsel or preparation for other litigation,” are inadequate. The party raising privilege as a bar to discovery has the burden of establishing the existence of the privilege relative to the material sought. 44 The mere existence of the attorney–client relationship does not raise a presumption of confidentiality.45 The filing of an affidavit stating sufficient facts to justify the privilege is a “minimum” requirement.46 It is most important that counsel makes clear to the court the distinction between the information he wants and the form in which he wants it. In general, reports prepared for defense counsel by the corporation on any area of the technical or managerial aspects of product history are subject to protection. It is equally clear that any relevant objective or evaluative documentation generated in the normal course of business is fair game in discovery. Defense counsel routinely requests and receives broad overviews of the product development and manufacturing history of the suspect product. These are normally accompanied by the body of relevant documentation from the corporate archives attached as appendixes. It is also common practice for defense counsel to receive significant numbers of document summaries and


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indexes from corporate staff. These summaries, indexes, and evaluations are clearly protected. However, the documents which underlie such indexes, summaries or evaluations are discoverable by plaintiff. The simple fact that someone has summarized or evaluated a document for defense counsel or that it has been done by the attorney, does not mean that the underlying documentation itself is unavailable in discovery. The key distinction lies between objective or evaluative data generated by the corporation in the normal course of business, and objective or evaluative material generated by it or its staff lawyers in connection with or in anticipation of litigation. Counsel may access any relevant materials generated during the regular course of business. He may not obtain summaries or evaluations of such material generated in connection with the instant or earlier litigation. In effect, counsel has the right to access and analyze the identical corporate documentation that the defense lawyers’ study. The difference is that defense counsel gets the data delivered to him on a silver platter. Plaintiff ’s counsel must get it the hard way, through protracted discovery.

The Motion to Compel Discovery Legal Components of the Motion to Compel The legal support for the motion to compel discovery is grounded in discovery and relevancy theory. These arguments, however, are essentially window dressing for what is, in essence, a series of complex factual arguments. The real issue here is not the question of plaintiff ’s rights to “relevant” corporate material or what relevancy means in a theoretical sense. Those issues have been settled for years. The real problem is identifying the actual documents in defendant’s archives that arguably fall within those broad discovery concepts. The legal standard to determine the extent of plaintiff ’s discovery rights is whether the information sought is relevant in an evidentiary sense or likely to lead to the discovery of such formally relevant material. 47 This standard is very liberally construed.48 The sole legal source for making that determination is the specific allegation of the complaint.49 In this respect, it is important to note that if the complaint is legally sufficient, the propriety of the list of alleged product defects delineated in the several counts of the complaint are not subject to question during the discovery practice stage. No matter how fanciful they may appear to the defendant, the trial court does not have the option of striking any of these allegations. They will stand as drafted until the court issues rulings on motions-in-limine or trial evidence. Relevancy is a logical as opposed to a legal concept. The cluster of exclusionary policy factors constituting legal relevancy serve as a bar to the admission



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of otherwise logically probative and material evidence. Federal Rule of Evidence 403 delineates the most often utilized “legal relevancy” rules. The 403 factors, mainly prejudice, confusion of issues, misleading the jury, undue consumption of time, and needless presentation of cumulative evidence, are grounded in basic concerns over fundamental fairness and trial efficiency. They have no real applicability to the discovery stage of the case when the trial is far distant. Likewise, the other major “legal relevancy” exclusionary principles — post-occurrence change evidence,50 statements made in the course of settlement negotiations, 51 offers to pay medical expenses, 52 insurance53 and hearsay,54 — address themselves to the fair trial question and have little or no bearing on the general purposes of discovery. When the inevitable arguments do arise over the relevancy of plaintiff ’s discovery requests, the only option open to the court is to determine if the requests bear a logical, experiential relationship to the defects alleged in the complaint. While that issue is a complex one, the court must look to those allegations for primary guidance on the relevancy issue. Clearly drafted allegations of product defect will more often than not result in a favorable discovery ruling for plaintiff. Specificity of Objections The stock discovery objections raised by corporate defendants are rarely, if ever, supported by detailed facts. Typically, there is nothing but the bare allegation that the information sought is not relevant or likely to lead to such, is overbroad, vague, unduly burdensome, or protected. In instances where some factual base for the objection is provided it generally amounts to no more than than meaningless generalities unsupported by affidavit. There is really very little that can be said in support of defendant’s refusal to comply with respect to the greatest amount of material sought by plaintiff. Counsel should aggressively insist upon full factual support for each objection to each request, as his first line of argument. Federal Rules of Civil Procedure 33 and 34 set forth the requirements relative to the serving and answering of interrogatories and requests for the production of documents. If the party receiving the same objects to any inquiry contained therein, the reasons for such objection “shall” be stated. Federal courts have been uniform in holding that the objections must point to specific facts supporting the objection and that a simple reiteration of “irrelevant,” “oppressive,” “burdensome,” or “privilege” constitutes no answer and a waiver of objection.55 In the leading case of Roesberg v. Johns-Manville Corp. (85 F.R.D.292, 296–297[E.D.Pa.1980]), the court stated: …Finally, GAF objects generally to this interrogatory as ‘overly broad, burdensome, oppressive, and irrelevant’, a complaint which GAF echoes with


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Science and Litigation: Products Liability in Theory and Practice virtually every other interrogatory. To voice a successful objection to an interrogatory, GAF cannot simply intone this familiar litany. Rather, GAF must show specifically how, despite the broad and liberal construction afforded the federal discovery rules, each interrogatory is not relevant or how each question is overly broad, burdensome, or oppressive [citations omitted] by submitting affidavits or offering evidence revealing the nature of the burden.(citations omitted). The court is not required to ‘sift each interrogatory to determine the usefulness of the answer sought.’ [citations omitted]….56

In the case of In Re Folding Carton Antitrust Litigation, (83 F.R.D.260, 264[E.D.Il.1979]), the court, as in Roseburg, condemned the practice by corporate defense counsel of rubber stamping each discovery request with an unsupported litany of stock objections: …Objections to interrogatories must be specific and supported by a ‘detailed explanation’ why the interrogatories are improper. General objections may result in waiver of the objections….Plaintiff ’s catch-all objection named every conceivable ground including that the interrogatories are duplicative, not relevant to the subject matter of the litigation, oppressive, and overly vague. Plaintiff ’s response was so broad as to be meaningless….57

Corporate objections to plaintiff ’s discovery requests in products cases are very often a mirror image of the responses found totally lacking in the cases cited above. In response to virtually every interrogatory and request for the production of documents, defense counsel will set forth the litany of stock objections and supply one or two line statements in the place of complete answers or specific facts justifying the objections. Rule 37, addressing sanctions for failure to make discovery, states “Evasive or Incomplete Answer. For purposes of this subdivision, an evasive or incomplete answer is to be treated as a failure to answer.”58 If the purposes of discovery are to be met and needless waste of court time avoided, answers to relevant, structured, and specific discovery requests must be responsive. The imposition of an order compelling discovery and the awarding of expenses and attorneys’ fees are the appropriate responses to this type of purposely dilatory behavior. The corporation’s attempt to circumvent the above-noted rules by the supplying of bits and pieces of nonresponsive information must also be attacked. Answers to interrogatories and document requests must be complete, explicit, and responsive. If a corporation cannot furnish details, it must, under oath, state why it is unable to do so and set forth the efforts used in a good faith attempt to obtain the requested information.59 Also, a party cannot answer one interrogatory or request to produce documentation simply by referring opposing counsel to another equally unresponsive answer.60



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Defendant’s claim that certain portions of plaintiff ’s requests do not comport with its record-keeping or organizational practices is an equally inadequate response. If the corporations do not classify data in the manner requested, it must seek out the information by whatever reasonable means are available to it. This may be by personal observation, interviews of corporate personnel, or otherwise (see Equal Employment Opportunity Commission v. Hickey-Mitchell Co., 372 F.Supp.1117 [D.C.Mo.1973]). Factual Components of the Motion to Compel The ability to quickly educate the court as to the corporate realities behind document requests will go a long way in getting discovery on the right track. It is the goal of defense counsel to muddy the discovery waters by obscuring the factual bases for plaintiff ’s requests. They will trade on the complexity of the technical issues and defendant’s size and organization. It is plaintiff counsel’s obligation to constantly clarify and simplify these complex fact patterns for the court. This ongoing educational and clarifying function will give plaintiff a competitive edge throughout the long course of discovery. In state courts in major population centers, this educational effort may have to be made twice, for the judge to whom the case is later assigned for actual trial, is often not the same judge handling discovery and other pretrial matters. There are several educational goals that counsel must achieve in drafting and arguing the memoranda in support of the motion to compel discovery. These are basically as follows: • • • • • •

The nature of the defect or defects involved in the case The validity of the case time frames The nature of defendant’s document-generating processes The nature of defendant’s decision-making processes The document types involved in those processes The factual issues logically flowing from each defect allegation in the complaint • The appropriateness of each interrogatory and request to produce in light of the above factors

The first thing that counsel will need to do is to educate the court as to just what it is that is wrong with the product in common-sense terms. Was there some flaw in the product unit that caused the injury not present in other units sold by the defendant? Was the client injured by the product packaging and not the product itself? Is it a question of misleading instructions or inadequate or nonexistent warnings? Is there something particularly wrong with the basic design of the product? Prior to purchase, was the client


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misled by some material misrepresentation about the product that was relied upon to the client’s detriment? Are more than one of these problems involved? Regardless of which category of defect is involved in the case, plaintiff must be able to relate that category to the particular technology involved and state the technical problem in the simplest of terms. Providing technical tutorials for the court without being patronizing is a difficult task. Nonetheless, it is essential to overcome the barrage of alleged complexities offered to the court by defense counsel. Equally, if not more important, is the task of convincing the court of the validity of the case time frame. This can only be accomplished by educating the court as to the broad similarity of the basic design parameters involved in the case over that period of time. Every one of counsel’s requests is necessarily centered in that design technology and the routine processes followed by the defendant in addressing it. It is here that the affidavit of an expert witness has great utility. The factual issues logically flowing from the defect allegations of the complaint should serve as the focal points for counsel’s supporting memoranda. Any analyses of these factors should be preceded by a brief but comprehensive sketch of defendant’s organization and documentgenerating and decision-making processes. Corporate Processes It is a difficult task to succinctly describe the defendant’s document-generating and decision-making processes in the memoranda supporting the motion to compel. This is another area where an expert witness affidavit has great importance. In the memoranda counsel should attempt to illustrate the logical connection between defendant’s processes and the nature of the documentation requested. This component of the memoranda must be broadly focused on both pre- and post-manufacture documentation. Defect Allegations It is important to recall that at this stage of the case that defendant may not challenge the plaintiff ’s right to allege particular defects. The sole issue is whether or not defendant has in its possession materials that shed light on the factual issues logically flowing from such allegations. Examining several allegations from the Main Motors complaint example, discussed in Chapter 4, will serve as illustrations. In the complaint, the defendants were Main Motors Corp., (MMC) the parent company of the Fourwheel Corp., the actual manufacturer of the Model 2 utility vehicle, and Rollbar, Inc., the manufacturer of the rollbar installed in the Model 2 line. The lawsuit is based on the rollover of a fourwheel utility vehicle in which the owner was severely injured. Plaintiff John Q.



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consumer alleges the following with respect to the design of the suspect vehicle: (a) Designed said Fourwheel Model 2 with an unreasonably dangerous center of gravity that adversely affected the stability of said motor vehicle in foreseeable highway operation, thereby greatly increasing the propensity of such motor vehicle to rollover.

This single allegation is centered in a claim that the vehicle is designed so that it has a strong tendency to roll over in the course of foreseeable turning maneuvers in both normal on- and off-road use. The factual issues emanating from this allegation would be those facts that bear on the general question of vehicle stability in turning maneuvers, in particular, track width and center of gravity. The documents to be discovered would be those in the archives of each of the three corporate defendants which would be relevant or likely to lead to the discovery of such formally relevant evidence on these logically related facts, such as: 1. Any and all tests that address the issues of track width, center of gravity, and related matters with respect to Fourwheel Model 2 utility vehicles. 2. Any and all tests that address these issues with respect to Fourwheel’s entire line of utility vehicles to the extent that they incorporate generically similar designs as the Model 2 line. 3. Any and all tests of Main Motors or Fourwheel vehicles not in the utility vehicle line, where these two factors were a subject of data recordation in a test run. 4. Any and all technical evaluations of such tests, including the analysis and costing of alternative designs. 5. Any and all management assessments of such tests and test evaluations, including policy decisions, marketing analyses, and reviews of pending agency regulations addressing the issue of vehicle rollover. 6. Organization charts or similar listings of the offices, departments, sections, and committees involved in generating and evaluating the above materials as well as the names and current company position of the involved personnel. 7. Any and all dealer or customer complaints with respect to rollover problems. 8. Any and all lawsuits that are completed by settlement or verdict or that are currently pending. This list, in turn, properly translates into interrogatories and requests for documents addressed to each of the three defendants.


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The discoverable documents listed for each defect would encompass each of the calendar years over the selected case time frames. Similar listings could be made from each of the remaining design defect allegations specifying design or failure to warn or instruct defects with respect to the rollbar material selection and design, windshield design, windshield attaching apparatus, seat belt anchorages, and the absence of upper torso harness belts. Utilizing Expert Witness Affidavits Expert witness affidavits have great utility as support for plaintiff ’s motion to compel discovery. Logical relevancy is the focal point of the arguments in these motions. It is important that the court have something other than swearing contests between lawyers that documents do or do not have a logical bearing on the factual issues raised by the defect allegations of the complaint. The expert’s affidavit can significantly add to the strength of plaintiff ’s argument. In fact, even assuming a counter-affidavit by a defense expert, the filing of a supportive affidavit by plaintiff ’s expert is generally sufficient to obtain an order mandating production of the disputed material. This is due to the fact that when two qualified experts disagree over the logical relevancy of the underlying documents to the discovery requests, the court has little choice but to grant the motion. Having no independent basis to disbelieve either expert, the court is forced to lean toward plaintiff, given the very liberal nature of civil discovery. Defendants generally make broad-based objections on relevancy grounds to the bulk of both pre- and post-manufacture materials. In planning the use of such affidavits, counsel should initially list the categories of information that defendant is unwilling to produce. A further division should be made respecting the periods over the case time frames within which such blocks of documentation fall. Once this has been completed, counsel should estimate the categories of experts needed to attest to the logical probity of the requested material. Depending upon the defect types involved in the case, as many as three or four affidavits may be necessary to adequately cover all of the document types covered by defendant’s blanket objections. In most cases, however, two will suffice. One expert will be needed to address the purely technical designrelated documentation. Another may be required to support counsel’s position respecting the manner in which documents are generated and policy decisions are made in the defendant corporation. The technical expert previously engaged can supply the affidavit respecting the technical issues. A former employee or expert in business organizations will be required to adequately address the corporate process issues. The technical expert is rarely equipped to speak to these latter issues.



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Drafting the Expert Witness Affidavit It is essential that counsel be the one to draft the affidavit for the expert’s review and signature. Too often, lawyers give the expert a vague idea of what they want and ask the expert to draft and forward the affidavit. This is poor practice in two respects. First, many experts are simply reluctant to do it. More importantly, they will rarely provide the type of well-considered and structured document that is needed in these instances. In drafting the affidavit, counsel should make sure that all categories of document types objected to are covered. Equally important is the need to structure the affidavit so that it flows logically and clearly from the general expertise of the affiant to the specifics of the disputed documents. The first portion of the affidavit should set out the experts qualifications. While a current resume will always be attached as an appendix, it is important to summarize that expertise in the preamble of the affidavit. In many instances, there will have been prior litigation wherein the expert has had the opportunity to review the precise documents that fall within the categories of information counsel is seeking to obtain. If there has been no such litigation or the expert was not involved, counsel can focus the affidavit on testing or corporate processes in general terms. Opposing Defense Affidavits Affidavits filed by defense experts can often be used to advantage. This is especially so with those alleging substantial dissimilarity of the design parameters in disputed test reports. The defense affidavit must be grounded in a detailed list of differences over the case time frames. Often the specified areas of difference tend to shore up plaintiff ’s position of substantial similarity. In many cases defense experts will emphasize very minor points of variance that are transparent attempts to make a distinction without a difference. In cases involving engineered products, for example, specifying design features in requested tests that were not incorporated in production models, demonstrates alternative design testing of the relevant design feature. Stressing the difference in testing methods and test parameters highlights the commonality of such testing practices. The dates of the documents cited by the affiant can lend support to the validity of the case time frames. In cases where the basic design feature at issue has not significantly changed in subsequent years, defense counsel is hard put to counter the affidavit of plaintiff ’s expert. Where there has been no change whatsoever, as in drug cases, the task is virtually impossible. Insisting on the allegation of specific facts in support of each defense objection and filing comprehensive expert witness affidavits, will generally result in a favorable ruling on the motion to compel discovery.


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Protective Orders A major hurdle that plaintiff ’s counsel must overcome is the defense motion for a comprehensive protective order. The entry of a protective order can significantly impede counsel’s efforts to achieve a detailed understanding of defendant’s document-generating and decision-making processes. The major goal of such orders is to deprive plaintiff ’s counsel of the opportunity to consult with more experienced lawyers. This consultation may take the form of document tutorials and/or the exchange of information. Corporate concern over the rippling effects of information sharing is the major factor in their routine requests for these orders. The motion for protective order has traditionally been viewed as a disfavored motion, with the burden on the moving party to show some plainly adequate reason for the order.61 Federal Rule of Civil Procedure 26(c) provides: Upon the motion of any party… and for good cause shown, the court… may make any order which justice requires to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense, including…that a trade secret or other confidential research, development, or commercial information not be disclosed…

The type of protective orders typically sought by corporate defense counsel typically read as follows: 1. All documents and materials which are produced and exhibited by the defendant in this action shall remain in the possession of the defendant’s counsel. 2. Any and all copies of said documents and materials made by or at the incidence of the plaintiff or his attorneys, shall remain in the physical custody, possession, and control of the plaintiff ’s attorneys, and each such item which is not admitted into evidence at trial shall be returned to the defendant’s counsel at the termination of this litigation. Moreover, each such item which is admitted into evidence shall be returned to the defendant’s counsel at the termination of this litigation. 3. All experts retained by the plaintiff and by the plaintiff ’s counsel are prohibited from making any copy of any item produced in this action by the defendant. The plaintiff, his counsel, and all experts retained by the plaintiff, or by the plaintiff ’s counsel are prohibited from, in any fashion, distributing or disseminating any documents or materials or copies thereof produced in this action by the defendant. 4. Any and all notes, whether handwritten, typed, or recorded in any form, and any copies or reproductions thereof, which are made by or at the instance of the plaintiff, his attorneys, or any experts retained by the plaintiff or by his attorneys from any documents and materials which are produced and exhibited by the defendant in this action or copies



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thereof shall be turned over to defendant’s counsel at the termination of this litigation. 5. The plaintiff, his counsel, and all experts retained by the plaintiff or by the plaintiff ’s counsel are prohibited from, in any fashion, distributing or disseminating any notes, whether handwritten, typed, recorded, or reproduced in any form made from any documents and materials which are produced and exhibited by the defendant in this action, or copies thereof. 6. Any contents of any documents or materials produced in this action by the defendant which deals with or concerns any matters other than the fuel storage and delivery systems may be excised and obliterated by the defendant prior to the production of said documents and materials.

The entry of an order along the above lines can seriously detract from counsel’s efforts to maximize knowledge of corporate documents and processes. Requirement of Specific Supportive Facts As with objections to discovery requests, the moving party must allege specific facts in support of the motion for a protective order. A bare repetition of the statutory grounds for such orders is inadequate. The party seeking the order must demonstrate good cause for its issuance. A showing of good cause requires facts demonstrating that disclosure of the information “will work a clearly defined and very serious injury.”62 Information Sharing Corporations view information sharing among plaintiff ’s attorneys as an unmitigated evil. Even assuming past or planned dissemination of discovery materials by plaintiff ’s counsel, corporate defendants seriously misconstrue the basic purposes of liberal discovery under the Federal Rules. That purpose is “to secure the just, speedy, and inexpensive determination of every action.”63 In the greatest number of cases, defendant’s primary concern in requesting protective orders is that attorneys for plaintiffs in other cases will be able to obtain the documents. Regardless of the stated reasons for requesting these orders, with the possible exception of trade secret, they are generally centered in concerns over information sharing. It is very difficult for a sole plaintiff to complete discovery in a complex products liability case when faced with a corporate opponent who has significant financial superiority and resources. Corporations should not be allowed to casually obtain a protective order without a showing of good and sufficient cause. This is particularly so when such action is in direct conflict with the spirit of state and federal discovery rules.


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In the leading case of Williams v. Johnson and Johnson (50 F.R.D. 31, 33 [D.D. N.Y. 1970]), the court stated: In this situation [where numerous similar suits had been filed] it is at least theoretically advantageous for plaintiffs in the various suits to share the fruits of discovery. They thus reduce the time and money which must be expended to prepare for trial and are probably able to provide more effective, speedy, and efficient representation to their clients…On its face, such collaboration comes squarely within the aims laid out in the first and fundamental rule of the Federal Rules of Civil Procedure…Thus there is no merit to the all-encompassing contention that the fruits of discovery in one case are to be used in the case only…

In rejecting defendant’s unsupported assertion that plaintiff ’s counsel would encourage litigation against it and otherwise seek to harass defendant, the court continued: It is difficult to draw a clear line between the legitimate educative activities of any attorney and the drumming up of business from those who might otherwise settle their disputes without the entanglements of litigation…It is impossible to draw that line sharply and distinctly when virtually no facts are presented to the Court. The only specific allegations defendants make in this respect is that plaintiff ’s attorneys may sell or may have sold the fruits of discovery in this case with other materials and information to attorneys engaged in similar cases. Without more, the charging of fees between attorneys collaborating in similar cases and the collaboration itself both seem reasonable on their face….64

In Johnson Foils v. Huycke Corp. (61 F.R.D. 405, 410 [1973]), the court echoed the ruling in Williams: …unless it can be shown that the discovering party is exploiting the instant litigation solely to assist in other litigation before a foreign forum, federal courts do allow full use of the information in other forums…Indeed, there must be some evidence of bad faith in the institution of the suit on the part of the discovering party before a Court will act to limit the discovery process….

Defense arguments relative to the evils of information sharing are increasingly rejected by state and federal courts. In the case of Earl v. Gulf & Western Manufacturing Company (366 N.W.2d 160 [1985]), the Court of Appeals of Wisconsin, in denying defendant’s motion for a protective order, held:



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The only reason advanced by Gulf & Western for the protective order is its fears that the Earls might pass the information along to other plaintiffs involved in litigation against Gulf & Western. This does not rise to the level of ‘good cause’ for a protective order. Gulf & Western has not shown that it has a legitimate interest in denying parties to other lawsuits access to the information. If the information is irrelevant to the issues raised in those cases, it will not be admissible against Gulf & Western; if it is relevant, the other plaintiffs can discover it from Gulf & Western in any event, and their obtaining it from the Earls will save Gulf & Western the trouble and expense of producing the same information several times over. Gulf & Western argues that there is no reason why the Earls should be allowed to disseminate the information ‘at will’ because doing so will not help their case. Gulf & Western misunderstands its burden on a motion for a protective order. The presumption is that no order is necessary; the movant must show a positive reason (i.e., ‘good cause’) for the entry of an order. It is insufficient merely to argue that no reason exists not to issue an order.65

The growing number of plaintiff–attorney support groups is often raised as empirical evidence of the extent and danger of information sharing. Organizations such as the tobbaco and breast implant groups make no secret of the fact that one of their primary goals is the dissemination of information of interest to its members in litigation. The growth of such organizations is increasingly seen by courts as a positive factor in achieving the goal of efficient dispute resolution. In the case of Patterson v. Ford Motor Company (85 F.R.D. 152 [D.C. Texas, 1980]), defendant sought the entry of a protective order on the basis that plaintiff ’s counsel were members of both state and national trial lawyers associations that engaged in information sharing among its members. In denying Ford’s motion, the court stated: For good cause shown, this Court will make any order which justice requires to protect Ford from annoyance, embarrassment, oppression, or undue burden, or expense. Rule 26(C), F.R.C.P. to show good cause, Ford asserts that counsel for Plaintiff are members of the Texas Trial Lawyers Association and the American Trial Lawyers Association, which collect and distribute information with regard to manufacturers. Such collaboration among plaintiff ’s attorneys would come squarely within the aims of the Federal Rules of Civil Procedure — to secure the just, speedy, and inexpensive determination of every action.66

Protection Against Fraud An additional reason for the courts to countenance information sharing is to prevent the fraud in the discovery process. The possibility of a corporate


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defendant falsifying responses to discovery requests by an individual claimant, who has no access to other sources of information, is very real. In the case of Rozier v. Ford Motor Company (573 F. 2d 1332 [1978]), defendant falsified its answer to one of plaintiff ’s interrogatories regarding the existence of a certain document. After a verdict for defendant, the subject document came to light and plaintiff was granted a new trial. In condemning such action, the U.S. Court of Appeals for the Fifth Circuit stated: …Through its misconduct in this case, Ford completely sabotaged the federal trial machinery, precluding the ‘fair contest’ which the Federal Rules of Civil Procedure are intended to secure. Instead of serving as a vehicle for ascertainment of the truth, the trial in this case accomplished little more than the adjudication of a hypothetical fact situation imposed by Ford’s selective disclosure of information. The policy protecting the finality of judgments is not so broad as to require protection of judgments obtained in this manner…67

In a similar context, in the 1978 Illinois case of Buehler v. Whalen,68 the company falsified answers to plaintiff ’s interrogations and otherwise failed to honestly honor requests for documents. As noted by the Illinois Supreme Court, only information sharing revealed the fraud: This was vital information which was withheld by defendant Ford Motor Corporation. Whalen’s attorney had obtained this Ford record from some litigation other than the instant one — a sad commentary on the effectiveness of the discovery here…69

Annoyance, Embarrassment, and Oppression Corporations routinely seek protective orders on the basis that they will suffer significant annoyance, embarrassment, and oppression if their documentation is not protected. Plaintiff counsel should insist that defense counsel point out those aspects of the documentation that would lead to those results. Due to the great risk of illustrating the strength of plaintiff ’s case in doing so, such arguments are rarely forthcoming. The greatest number of defense motions for protective orders based in these claims are grounded in fear of information sharing. They are also used as the basis for orders alleging that the documentation sought is commercially sensitive. Trade Secrets and Confidential Commercial Information In most instances, defendants cannot support trade secret as the basis for a protective order with any degree of credibility. The test for determining whether information qualifies as a trade secret is threefold:



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• Is the matter sought to be protected a trade secret or other confidential research, development, or commercial information entitled to protection? • Would disclosure cause a cognizable harm sufficient to warrant a protective order? • Has the party seeking protection shown good cause for invoking the court’s protection?70 The question of competitive disadvantage resulting from the disclosure of discovery materials is deemed to fall within the annoyance, embarrassment, and oppression factors of Rule 26(c).Id. at 890. The party seeking the order on this basis has a heavy burden to establish a sufficient basis for its entry.71 In the leading case of Parsons v. General Motors Corp. (85 F.R.D.724 [N.D.Ga.1980]), the plaintiff claimed injury as a result of burns suffered from a ruptured fuel tank in an Oldsmobile automobile. Plaintiff sought discovery of information from General Motors relative to fuel system design and certain crash tests results. General Motors objected to the discovery and moved for a protective order based upon the confidentiality of the information. In denying their motion, the court provided a close analysis of this important issue that warrants extended quotation: GM admits that this material is not a ‘trade secret’ but argues that it constitutes ‘confidential research, development or commercial information’, within the meaning of the Rule 26(c)(7). Fed. R. Civ. P.26 (c)(7). GM has asked the Court to enter a protective order which would prohibit plaintiff and her attorneys from reproducing the crash test results or fuel system design information and from disclosing the material to any third party without the Court’s permission…Restrictions of discovery are allowed for ‘good cause’ when disclosure of ‘a trade secret or other confidential research development or commercial information’ is involved. Fed.R. Civ. P. 26(c) (7). The Court interprets ‘good cause’ in the context of Rule 26(c) (7) to mean that the parties seeking the protective order must demonstrate that the material sought to be protected in confidential and that disclosure will create a competitive disadvantage for the party. The Court finds that the two Affidavits filed by GM do not establish that the information in question is confidential. One affidavit states that disclosure of crash test results and design information within GM is limited to the technical and engineering staffs of respective divisions. The affidavit does not reveal how many persons worked on their staffs, or how the secrecy of the reports is maintained. The second affidavit states that ‘initial distribution’ of reports of crash tests is limited to ‘only a few employees’. Circulation to others is permitted although reproduction of the reports of crash tests is controlled. The second affidavit



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mentions no specific controls on fuel system design information. Some of the information plaintiff seeks is ten years old; GM does not show that the information is still confidential after ten years. Moreover, GM admits that some of the information which plaintiff seeks must be disclosed to the government. GM has not attempted to show what specific information is already part of the public record and what information remains confidentially held at GM. GM has not made a particularized showing that the information sought is confidential as required by Fed. R. Civ. P. 26(c) (7) for entry of a protective order. Moreover, GM’s allegations of competitive harm are vague and conclusory when specific examples are necessary….72

Factual Components of the Argument in Opposition In United States v. International Business Machines Inc.,73 Chief Judge Edelstein of the Southern District of New York set forth the factual standards that should be considered to determine if commercial information warrants the protection of an order of confidentiality: 1. 2. 3. 4.

The extent to which such information is known outside the business The extent to which such information is known to those in the business Measures taken to guard the secrecy of the information The value of the information to the business and its competitors. (Id. at 46.)

The ultimate test, however, is whether disclosure will work a “clearly defined and very serious injury.”74 In drafting the memoranda in opposition to the motion for protective order, the argument should accordingly focus on the general availability of the technical processes that defendant seeks to protect. This will necessitate close study on plaintiff counsel’s part. The expert witness affidavit can be used to great advantage here. Counsel must educate the court as to the nature of the technology and research underlying defendant’ motion. Here, however, that tutorial is directed to the technology and manufacturing processes themselves, rather than the arguable relevancy of underlying documentation to the legal and factual issues in the litigation. Document Types and Case Time Frames Plaintiff ’s memoranda should concentrate on the four factors set out above. It should also delineate the categories of documentation for which protection is sought and the historical period in which they were generated. While the focus of the argument is on the commercial availability of the technology underlying the documents, that issue must be placed in the documentary



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context of defendant’s motion. As a general rule of thumb, defendant’s chances of success decreases in direct proportion to the length of time that has passed since the introduction of the underlying technology into the market place. Meeting the Arguments for Each Document Counsel should insist that defendant establish the basis of protection for each document covered by the motion. It is incumbent on the corporation to demonstrate both the degree and manner in which each would reveal the processes deemed commercially sensitive. Defense arguments directed to general document types are insufficient to warrant protection for the specific processes reflected in any one individual document. Counsel should also contact attorneys involved in prior or current litigation to check the status of protection in those cases. In many instances, corporations have been unsuccessful in obtaining protective orders in other similar litigation. Counsel should request an index of documents produced by defendant in all such litigation that was not subject to a protective order. Defendant’s argument for protection with respect to those particular documents will be unsuccessful. Even if all documents sought by plaintiff in the instant litigation were not produced in those cases, the resulting availability of technology underlying them provides solid support to defeat the motion. Utilizing the Expert Witness Affidavit Expert witness affidavits can also provide significant support for plaintiff ’s argument that the information reflected in the disputed documentation is not commercially sensitive. Counsel should isolate each area of technology for which protection is sought and consult with the expert to estimate the validity of defendant’s claim. Judge Edelstein’s four-step analysis should serve as the guidelines for this conference. The expert can inform counsel of the availability of the technology to those within and without the industry, whether resulting from publicly accessible studies or the introduction of product lines into the market place. He can also provide valuable input on the difficult question of the value of the underlying technology to the defendant’s business. Drafting the Expert Witness Affidavit The affidavit should begin with paragraphs delineating the expert’s close familiarity with the subject technology. A simplified description of that technology should follow. This should be followed, in turn, by a brief listing of the ways in which technology becomes current intra- and inter-industry. Once this context has been provided, the expert should demonstrate the


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general availability of the disputed technology according to those indicators. The affidavit should also briefly analyze selected documents chosen from the corpus of disputed materials to provide specific examples of the preceding discussion. Motions-In-Limine Relevancy is at the heart of the motion-in-limine stage of pretrial motion practice, as it is in the entire discovery process. At this stage, however, relevancy is governed by trial admissibility standards and is according more circumscribed than relevancy for discovery purposes. In addition, hearsay, subsequent remedial measures, and other legal relevancy objections can be raised. The specific defect allegations of the complaint provide the major source for rulings at this point as with arguments over the extent of discovery. Counsel should be prepared to respond to a barrage of motions addressing each document type over the entire case time frame. Counsel must have the documentary component of their case-in-chief well thought out to successfully meet these motions. This is essential not only to adequately respond to broad-based relevancy objections, but also to specifically address the numerous legal relevancy objections that are raised in these motions. Logical Relevancy The standard for determining relevancy for trial admissibility is that set forth in Federal Rule of Evidence 401: ‘Relevant evidence’ means evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.75

This definition has general applicability in both federal and state courts. Relevancy is a concept grounded in logic. The ‘any tendency’ rubric means any tendency in logic, common sense, and the historical connection between and among events. As with relevancy arguments at the discovery stage, the law of relevancy essentially serves as window dressing for what are essentially complex fact analyses. Here the focus is on the tendency of any disputed fact to establish an important element of plaintiff ’s or defendant’s case or its impact on the impeachment process. The absence of the ‘likely to lead to’ aspect of relevancy in the discovery stage requires much tighter analysis of proffered information. As at the discovery stage, the specific allegations of defect are not subject to question, absent a protracted evidentiary hearing that would establish their falsity. The exclusion on relevancy grounds at the motion-in-limine stage is



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generally based in a limitation of the case time frame, rather than the legitimacy of the defect allegations themselves. Well-crafted defect allegations can go a long way in helping counsel avoid restrictive rulings at this crucial pretrial juncture. Time Frame The central issue in arguments over logical relevancy is the extent of the time frame that will be used for trial purposes. The more expansive nature of discovery relevancy and the elimination of foundation requirements at that stage make the length of the time frame less critical. Setting the time frame for trial purposes is one of the most important decisions that must be made by the trial court. It will largely determine what evidence will be admitted at trial. Due to case management considerations, counsel will usually be willing to try the case on a more truncated historical period than deemed necessary for discovery. Legal Relevancy The concept of legal relevancy encompasses a series of policy-based exclusionary principles that constitute a bar to otherwise logically probative and material information. The basic posture of both state and federal courts is that all relevant evidence is admissible unless prohibited by the constitution, statute, or specific rule. F.R.Evid. 402. The so called “relevancy rules” are actually few in number. They address areas which have been historically perceived as problematic, whether from a basic fairness or trial-efficiency standpoint. Accordingly, evidence falling within these categories is only admissible if it qualifies for one of the stated exceptions. Rule 403 sets forth the broadest categories of exclusion. That rule provides that otherwise logically probative evidence can be excluded if its probative value is “substantially outweighed” by undue prejudice, confusion of issues, misleading the jury, undue consumption of time, or needless presentation of cumulative evidence (F.R.Evid. 403). The greatest number of defense motions-in-limine in the products cases are based on this provision. It is important to note that Rule 403 requires a showing by the movant that the probative value of the disputed evidence will be “substantially outweighed” by these factors. That very requirement is a recognition that they are all present to a certain degree in the trial of any case. This is especially so in complex litigation such as product liability actions. The other legal relevancy rules traditionally utilized in these cases are the prohibition against evidence of subsequent remedial measures and hearsay. The burden of establishing the applicability of any of these settings falls squarely on the movant. It is important that counsel for plaintiff insist upon


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detailed factual support for motions-in-limine based on any of the legal relevancy rules. Each these rules will be discussed in detail in the sections to follow. Undue Prejudice Rule 403 does not bar prejudicial evidence. The focus is on the tension between Rule 402 providing for the general admissibility of relevant evidence and the policy-based rules of exclusion. Any evidence presented by plaintiff will inure to the prejudice of the defendant. Indeed, that is one of the major reasons for introducing it. Rule 403 will only bar otherwise relevant evidence if its probative value is substantially outweighed by prejudice. This requires a strong likelihood of such a result by the defendant. Typically, corporate defense counsel ignores this crucial distinction. Plaintiff ’s counsel should insist that the defendant specify the basis for any claim of undue prejudice. There is good reason for defense lawyers to fail to provide specific supportive arguments in these instances. Discovery motions may be argued before a motion judge. Motions-in-limine, however, are argued before the trial court. A factually supported argument grounded in undue prejudice would require defense counsel to highlight corporate failings and argue that the jury could not give defendant a fair trial if aware of them. Defense lawyers are normally unwilling to acquaint the court with this type of information. Confusion of Issues and Distraction of Jury Motions-in-limine based on these issues must also establish that the probative value of the specified evidence would be “substantially outweighed” by such eventualities. In most motions-in-limine grounded in Rule 403, defendants are prone to make bare allegations, without specific supportive arguments. In this instance, plaintiff counsel’s first line of attack should be insistance that corporate counsel specify exactly what issues are likely to result in jury confusion and distraction and the basis for those claims. It is important that plaintiff stress that confusion and distraction is inherent to some degree in all complex litigation. Rule 403 is only concerned that those factors do not substantially outweigh the probative value of the proffered information. Counsel should sketch out a range of preliminary, cautionary, and final instructions that would minimize this alleged problem. It is important for plaintiff to argue that defendant’s position denigrates the court’s ability to control the flow of information through such instructions. In addition, counsel should point out that such arguments deny the ability of a jury to resolve complex matters, something that is accomplished by them in a wide variety of settings on a daily basis.



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Undue Consumption of Time and Needless Presentation of Cumulative Evidence To successfully meet motions-in-limine based on these factors, counsel must be in a position to inform the court of the trial plan. Counsel should be prepared to inform the court of an estimate of the time needed to present each item of evidence covered by the motion. Defense counsel should be forced to specify the time necessary for cross-examination and the presentation of direct evidence on those issues. There are few secrets at this point in civil litigation and counsel will lose little strategic advantage in discussing his anticipated presentation of the disputed evidence. Providing the court with a selected sketch of counsel’s trial plan is the only way to effectively counter these motions. Plaintiff can quickly deflate defense arguments that the trial will be inordinately long by methodically discussing how he will proceed and forcing defense counsel to do the same. The onus will be on defendant to demonstrate a comparable level of efficiency. Subsequent Remedial Measures Motions-in-limine seeking to bar the introduction of evidence of post-production design changes, are a central component in the defendant’s pretrial strategy. These are hotly contested issues and require significant briefing and supportive filings. Expert witness affidavits have great importance in countering these motions. State and federal courts uniformly recognize that the reasons for barring post-accident remedial measures are not applicable when evidence is offered to prove facts other than negligence or product defect. 76 When used as evidence of the feasibility of preventive measures, such material is normally admitted.77 Several jurisdictions have held that the basis for barring introduction of post-design change evidence has no applicability to the strict liability cases. Hearsay Motions-in-limine based upon hearsay are occasionally encountered in products cases. In large part these are directed toward the introduction of correspondence received from government agencies in the course of defect investigations and expert witness testimony. Letters or agency findings generally qualify for admission as nonhearsay since they are not offered for the truth of the matter asserted in them, but as a reflection of defendant’s knowledge of defect. Hearsay arguments centered around expert witness testimony normally focus on the introduction of state-of-the-art materials in support of such


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witness testimony. Federal Rule of Evidence 703 and related state and federal case law state that the expert may base his opinion in part on data reasonably relied upon by experts in that field. These materials need not be admissible in evidence.78 Motions-in-limine often request that a stated foundation be established before certain categories of evidence may be introduced. This normally takes the form of requesting that evidence of an alleged product defect be proceeded by foundation testimony that the defect was a proximate cause of the death or injury giving rise to the action. These motions are directed to categories of design defect. These motions are grounded in Rule 403 claims of undue prejudice. Defendants argue that exposing the jury to testimony respecting alleged defects that did not cause the injury involved in the case would not be relevant and would only serve to prejudice the defendant. There is a superficial appeal to these arguments. This position has its greatest strength when applied to evidence flowing from counts alleging defective product design. It appears logical and just to require that plaintiff establish causation preliminary to the presentation of full-blown evidence with respect to such defects. Nonetheless, it would impose defendant’s view of the proper order of proof on plaintiff. It also confuses the two separate issues of proof of defect and proof of proximate cause. For these reasons, this position has not been favorably viewed. 79 In the failure-to-instruct and failure-to-warn settings, the argument misconstrues the basic nature of defendant’s duty. It does so by confusing the essentially separate issues of duty and causation. The corporation has an affirmative duty to warn consumers of all known dangers associated with the normal use of the product. They also have an affirmative duty to clearly instruct consumers in the intended use of the product. The logical fallacy of defense foundation arguments in these respects is that according to its terms, the duty to warn or instruct would only become effective after a specified defect had caused injury. It is absurd to take the position that the only product defect that the consumer must be alerted to is the one that cripples or kills him. Redaction of Documents Another common feature of defense motions-in-limine is the request that portions of any admitted documents not relevant to any issue in the case be masked or otherwise omitted. This argument is normally grounded in the confusion of issues and distraction of the jury provisions of Rule 403. A major purpose of such motions is to dissipate the impact of admitted documentation by reducing it to a series of disjointed statements. Counsel should strenuously object to any such arguments.



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The nature of the policy-making processes in large corporations is such that decisions are made across model lines. For example, discussions of a federal agency regulation encompasses all product lines affected by it. It is rare to find corporate documents that are solely concerned with matters relevant to the issues involved in a particular case. Masking these arguably irrelevant portions not only results in a disjointed and incomprehensible document, but also conceals the broad corporate processes within which the decisions crucial to the case were made. Counsel should argue that the jury’s need to understand the corporate decision-making processes is as important as their understanding of the specific decisions resulting from such processes. In addition, if the trial court accepts the general principle of redaction, counsel should insist that defendant justify every line for which redaction is sought. Factual Components of the Motion in Opposition The basic structure for the factual components of the memoranda in opposition to defense motions-in-limine are the same as discussed with respect to the enforcement of discovery rights. As in that setting, the major thrust of motions-in-limine are grounded in the irrelevancy of the disputed documents. Counsel must educate the court as to the technology reflected by the documents. The arguments here are also centered around the defect allegations of the complaint. Utilizing the Expert Witness Affidavit The expert witness affidavit has great importance in counsel’s attempts to defeat broad-based defense motions-in-limine. The affidavit will primarily address the central issue of relevancy as at the discovery stage. The affidavit can also support counsel’s arguments respecting the feasibility of alternative designs evidenced by defendant’s post-manufacture design changes. Similar to the use of these affidavits during discovery, more than one expert may be required to achieve adequate coverage of the documents and subject matters for which exclusion is sought. Drafting the Expert Witness Affidavit The format for the expert witness affidavit here is roughly equivalent to that utilized at the discovery stage. The broad paragraphs establishing the affiant’s expertise would be identical as would the basic thrust of the experts attestations. Here, however, the documents are in hand and may be reviewed by whatever expert counsel has retained. The affidavit should reference each motion-in-limine and the specific documents to which they are addressed.


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Pretrial motion practice requires a significant amount of counsel’s time and energy. It is the most frustrating aspect of the preparation for these cases. The key to achieving success in product liability litigation is prefiling research. That research provides the basis for aggressive discovery and defeating defense motions for protective orders and debilitating motions-in-limine.

Endnotes 1. Detweiler Bros., Inc. v. John Graham & Co., 412 F.Supp.416 (E.D.Wash., April 1, 1976). Also see No. CIV. 75–79; E. C. Ernst, Inc. v. Manhattan Const. Co. of Texas, 551 F.2d 1026, 1031 5th Cir. (Ala. 1977); Insurance Co. of North America v. Town of Manchester, 17 F.Supp.2d 81, 86 (D.Conn. June 16, 1998); In re Folding Carton Antitrust Litigation, 83 F.R.D.251, 254 (N.D.Ill. Aug 28, 1978). 2. Oppenheimer Fund, Inc. v. Sanders, 437 U.S.340, 351(1978). See also Kansas Hosp. Ass’n v. Whiteman, 167 F.R.D.144 (D.Kan. 1996); In re Victor Technologies Securities Litigation, 792 F.2d 862 (9th Cir. 1986), Southern Ute Indian Tribe v. Amoco Production Co., 2 F.3d 1023 (10th Cir. 1993); Oscar Gruss & Son v. Geon Industries, Inc., 89 F.R.D. (S.D.N.Y. 1980). Also see “Identification of Trade Secrets During Discovery: Timing and Specificity,” 24 AIPLA Q.J. 191, 280+ (1996); “Electronic Discovery: Making Your Opponent’s Computer a Vital Part of Your Legal Team,” 21 Am. J. Trial Advoc. 293, 324 (1997); “Using the Freedom of Information Act as a Discovery Device,” 1994 Ark. L. Notes 59, 66 (1994); “Electronic Discovery in Federal Civil Litigation: Is Rule 34 up to the Task?” 41 B.C. L. Rev. 327, 358+ (2000). 3. 85 F.R.D.292, 296–297 (E.D.Pa.1980). 4. Ibid., at 297. 5. Sylgab Steel & Wire Corp. v. Imoco-Gateway Corp., 357 F.Supp.659 (N.D.Ill., May 16, 1973) (No. 71 C 1848). 6. Smith v. F.T.C., 403 F.Supp.1000 (D.C.Del.1975). 7. Obrien v. Muskin Corp., 463 A.2d 298 (N.J., 1983). Also see Feldman v. Lederle Laboratories, 132 N.J. 339, 625 A.2d 1066 (1993); Johnson v. Salem Corp., 477 A.2d 1246 (1984); Dewey v. R.J. Reynolds Tobacco Co., 121 N.J. 69, 577 A.2d 1239 (1990). 8. Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87 (2d Cir.1980). See also Krasnopolsky v. Warner-Lambert Co., 799 F.Supp.1342 (E.D.N.Y. 1992); Bravman v. Baxter Healthcare Corp., 794 F.Supp.96(S.D.N.Y. 1992); Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993); Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006 (N.Y. 1985). 9. See D.L. v. Heubner, 329 N.W.2d 890(Wis.1983); Schelbauer v. Butler Mfg. Co. 673 P.2d 743 (Cal. 1984). Also see Lane v. Hughes Aircraft Co., 93 Cal.Rptr.2d 60, 76+, 993 P.2d 388, 403 (2000); Thompson v. Friendly Hills Regional Medical



10.

11. 12. 13.

14. 15. 16. 17. 18. 19.

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Center, 84 Cal.Rptr.2d 51, 53, 71 Cal.App.4th 544 (1999). But also see Freiberg v. City of Mission Viejo, 39 Cal.Rptr.2d 802, 804, 33 Cal.App.4th 1484(1995). Sanderson v. Steve Snyder Enterprises, 196 Conn.134 1985); Holmes v. Sahara Coal Company, 475 N.E.2d 1383 (Ill.App 5th, 1985); Caprara v. Chrysler Corporation, 52 N.Y.2d 114, 417 N.E.2d 545(1981). See also Hall v. Burns, 569 A.2d 10 (Conn. 1990); Wagner v. Clark Equipment Co., Inc., 700 A.2d 38 (Conn. 1997); Gore v. People’s Sav. Bank, 665 A.2d 1341 (Conn. 1995); Hartmann v. Black & Decker Mfg. Co., 547 A.2d 38 (Conn.App. 1998); Ames v. Sears, Roebuck and Co., 514 A.2d 352 (Conn.App. 1986); Stanton v. Carlson Sales, Inc., 728 A.2d 534 (Conn.Super.1998); Casey v. Westinghouse Elevator Co., a Div. of Westinghouse Elec. Corp., 651 F.Supp.258 (S.D.Ill. 1986); Central Illinois Sav. & Loan Ass’n v. Dupage County Bank of Glendale Heights, 622 F.Supp.1493 (N.D.Ill. 1985); U.S. Home Corp. v. George W. Kennedy Const. Co.,Inc., 617 F.Supp.893 (N.D.Ill. 1985). See, LaBelle v. McCauley Indus. Corp., 649 F.2d 46 (1st Cir.1981). See S.L. Cohn, “Federal Discovery: A Survey of Local Rules and Practices in View of Proposed Changes to the Federal Rules,” 63 Minn.L.Rev.253 (1979). See, e.g., Federal Rules of Civil Procedure, Rule 33, Interrogatories to Parties: (a) Availability. Without leave of court or written stipulation, any party may serve upon any other party written interrogatories, not exceeding 25 in number including all discrete subparts, to be answered by the party served or, if the party served is a public or private corporation or a partnership or association or governmental agency, by any officer or agent, who shall furnish such information as is available to the party. Leave to serve additional interrogatories shall be granted to the extent consistent with the principles of Rule 26(b)(2). See R.Haydock and D. Herr, Discovery Practice (Boston: Little, Brown & Co., 1982), at 288–290. Ibid. at 290–294. FRCP 26(a)(2)(B) Disclosure of Expert Testimony. Id. See R. Haydock and F. Herr, at 375 et.seq. (b) Effect of Admission. Any matter admitted under this rule is conclusively established unless the court on motion permits withdrawal or amendment of the admission. Subject to the provision of Rule 16 governing amendment of a pre-trial order, the court may permit withdrawal or amendment when the presentation of the merits of the action will be subserved thereby and the party who obtained the admission fails to satisfy the court that withdrawal or amendment will prejudice that party in maintaining the action or defense on the merits. Any admission made by a party under this rule is for the purpose of the pending action only and is not an admission for any other purpose nor may it be used against the party in any other proceeding.


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20. See Ford Motor Company v. Ammerman, 705 N.E.2d 539 (Ct. App. Ind. 1999) a 1999 Indiana Court of Appeals case: Exclusion of Ford’s Evidence We also disagree with Ford’s second assertion that NHTSA’s report issued after an investigation of the Bronco II precludes a finding that Ford acted with the requisite culpability on which a finding of punitive damages may rest. In support, Ford cites cases from other jurisdictions which Ford contends stand for the proposition that compliance with federal regulations precludes a finding of punitive damages. We first observe the cases on which Ford relies do not support its position. In any event, at present there are no federal regulations concerning rollover characteristics. Thus there were no federal regulations with which Ford was bound to comply. Further, the record is clear that the NHTSA investigation was essentially limited to examining documents Ford provided the agency. The record is clear also that Ford did not provide the agency with the results of its prototype testing, including the live testing conducted at the Arizona Proving Grounds in May 1982. During one such test Bronco II engineering prototypes tipped-up when exposed to sufficient side force, and the testing was suspended because of the danger it posed to the drivers. R. at 8809–11. Consequently, we cannot say NHTSA’s conclusion would have been the same had Ford provided the agency with documentation concerning the prototype testing (Id. at 558). 21. (e) Supplementation of Disclosures and Responses. A party who has made a disclosure under subdivision (a) or responded to a request for discovery with a disclosure or response is under a duty to supplement or correct the disclosure or response to include information thereafter acquired if ordered by the court or in the following circumstances: (1) A party is under a duty to supplement at appropriate intervals its disclosures under subdivision (a) if the party learns that in some material respect the information disclosed is incomplete or incorrect and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing. With respect to testimony of an expert from whom a report is required under subdivision (a)(2)(B) the duty extends both to information contained in the report and to information provided through a deposition of the expert, and any additions or other changes to this information shall be disclosed by the time the party’s disclosures under Rule 26(a)(3) are due. (2) A party is under a duty seasonably to amend a prior response to an interrogatory, request for production, or request for admission if the party learns that the response is in some material respect incomplete or incorrect and if the additional or corrective information has not otherwise been made known to the other parties during the discovery process or in writing.



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22. (6) A party may in the party’s notice and in a subpoena name as the deponent a public or private corporation or a partnership or association or governmental agency and describe with reasonable particularity the matters on which examination is requested. In that event, the organization so named shall designate one or more officers, directors, or managing agents, or other persons who consent to testify on its behalf, and may set forth, for each person designated, the matters on which the person will testify. A subpoena shall advise a non-party organization of its duty to make such a designation. The persons so designated shall testify as to matters known or reasonably available to the organization. This subdivision (b)(6) does not preclude taking a deposition by any other procedure authorized in these rules. 23. This problem seems endemic to small car manufacture and most recently, in 2001, has been alleged in Daimler family vans. 24. See Chapter 7, Science and Business Documentation. 25. Cone Mills Corp. v. Joseph Bancroft & Sons Co., 33 F.R.D.318 (D.Del.1963). 26. Brunswick Corp. v. Suzuki Motor Co., 96 F.R.D.684 (E.D.Wis. 1983). See also Gerling Intern. Ins. Co. v. C.I.R., 839 F.2d 131 (3rd Cir. 1988); Perini America, Inc. v. Paper Converting Mach. Co., 559 F.Supp. 552 (E.D.Wis. 1983). 27. Wirtz v. Capital Air Service, Inc., 42 F.R.D.641 (D.Kan. 1967). 28. Also see In Re Folding Carton Antitrust Litigation, 83 F.R.D.260 (N.D.Ill. 1979); Krantz v. United States, 56 F.R.D.555 (W.D.Va. 1970). Also see Bloodstock Services Ireland, Ltd. v. U.S., 87 F.R.D.732, 31 Fed.R.Serv.2d 705 (E.D.Ky., Sept. 18, 1980). 29. 528 F.Supp.521 (D.Del. 1981). 30. Id. at 523–524. 31. 84 F.R.D.345 (N.D.Ill. 1979). 32. Id. at 348. 33. Altech Industries v. Al Tech Specialty Steel, 528 F.Supp.521, 523–524 (D.Del.1981). 34. Hickman v. Taylor, 329 U.S. 495 (1947). 35. 432 N.E. 2d 250 (1982). See also Midwesco-Paschen Joint Venture For Viking Projects v. Imo Industries, Inc., 638 N.E.2d 322 (Ill.App. 1994); Mlynarski v. Rush Presbyterian–St. Luke’s Medical Center, 572 N.E.2d 1025 (Ill.App. 1991); Claxton v. Thackston, 559 N.E.2d 82 (Ill.App. 1990); Archer Daniels Midland Co. v. Koppers Co., Inc., 485 N.E.2d 1301 (Ill.App. 1985); Caremark, Inc. v. Affiliated Computer Services, Inc., 192 F.R.D.263 (N.D.Ill. 2000); Samaritan Foundation v. Superior Court In and For County of Maricopa, 844 P.2d 593 (Ariz.App. Div. 1992). 36. Re Grand Jury Investigation, 599 F.2d 1224 (1979). See also Republic of Philippines v. Westinghouse Elec. Corp., 132 F.R.D.384 (D.N.J. 1990). 37. Bloodstock Services Ireland, Ltd. v. United States, 732 F.2d 705 (1979). See also, Miles v. Bell Helicopter Co., 385 F.Supp.1029 (1973); National Tank Co. v.


424

38.

39.

40. 41. 42. 43.

Science and Litigation: Products Liability in Theory and Practice Brotherton, 851 S.W.2d 193 (Tex. 1993). But see Implied Overruling Recognized by Abdallah v. Coca-Cola Co., 2000 WL 33249254, *4 (N.D.Ga. Jan 25, 2000). See also 23 Am. Jur. 2d “Depositions and Discovery’s,” 53, “Requirement of Anticipation of Litigation, Discovering Investigative Reports under the Work Product Doctrine,” 34 Baylor L. Rev. 156 (1982), “Rejecting a General Privilege for Self-critical Analyses,” 51 Geo. Wash. L. Rev. 551, 582 (1983). U.S. v. Leggett & Platt Inc., 542 F.2d 655 (1970); In Re Murphy, 560 F.2d 326 (1969); F.T.C. v. Grolier Inc., 462 U.S.19 (1983), Federal Sav. and Loan Ins. Corp. v. Schoenberger (E.D.La. 1990). See also “Attorney’s Work Product Privilege under Rule 26(b)(3) of the Federal Rules of Civil Procedure, As Applicable to Documents Prepared in Anticipation of Terminated Litigation,” 41 A.L.R. Fed. 123 (1979); “What Corporate Communications are Entitled to Attorney–Client Privilege: Modern Cases,” 27 A.L.R. 5th 76 (1995); “Determination of Whether a Communication is from a Corporate Client for Purposes of the Attorney–Client Privilege: Modern Cases,” 26 A.L.R. 5th 628 (1995), “What Persons or Entities May Assert or Waive Corporation’s Attorney–Client Privilege: Modern Cases, 28 A.L.R. 5th 1 (1995); “The Disruption of Mandatory Disclosure with the Work Product Doctrine: An Analysis of a Potential Problem and a Proposed Solution,” 73 Tex. L. Rev. 177, 207 (1994); “The Attorney Work Product Doctrine and Carry-over Immunity: An Assessment of Their Justifications,” 47 U. Pitt. L. Rev. 675 (1986); “Developments in Federal Court Practice: Rule 26(b)(3) and Attorney Work Product,” 11-Oct Utah B.J. 9, 11 (1998). Natta v. Zeltz, 418 F.2d 633 (Ill. 1979), SCM Corp.v. Xerox Corp., 70 F.R.D.508, 520 (D.Conn. 1976); Fisher v. United States, 425 U.S.391, 403 (1976); United States v. Goldfarb, 328 F.2d 280,281 (6th Cir.) cert. denied. 277 U.S. 976 (1964). See also McCook Metals L. L. C. v. Alcoa Inc., 192 F.R.D. 242 (N.D.Ill. 2000); Advanced Cardiovascular Systems, Inc. v. C.R. Bard, Inc., 144 F.R.D.372 (N.D.Cal.1992), McNeil–PPC, Inc. v. Procter & Gamble Co., 136 F.R.D.666 (D.Colo. 1991); “Discovery of Attorney Work Product Reviewed by an Expert Witness,” 85 Colum. L. Rev. 812 (1985); “The Work Product Doctrine in Subsequent Litigation,” 83 Colum. L. Rev. 412 (1983); “The Work Product Doctrine,” 68 Cornell L. Rev. 760 (1983); “Attorney-Client Privilege: The Eroding Concept of Confidentiality Should Be Abolished,” 47 Duke L.J. 853 (1998). In Re Grand Jury Investigation, 599 F.2d 1244 (3rd Cir. 1979). 432 N.E.2d 250 (1982). Id. Goodman v. Wagner, 553 F.Supp.255 (E.D.Pa.1982); Josephs v. Harris Corp., (3rd Cir.) 677 F.2d 985 (1982); Roseberg v. Johns-Manville Corp., 85 F.R.D.292 (1980); Stewart v. Foti, 1987 WL 16337, *1 (E.D.La. Aug 28, 1987) (No. CIV. A. 86-3793),; Hamilton v. Byrd, 2001 WL 290355, *2 (M.D.Pa. Feb 21, 2001) (No. CIV. 3:CV-98-0833), Bogue v. Vaughn, 1993 WL 497851, *12, 3 A.D.D. 976, 976, 5 NDLR P 102, 102 (E.D.Pa. Dec. 1, 1993) (No. CIV. A. 91-5046).



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44. Reeg v. Fetzer, 78 F.R.D.34 (D.C.Okl. 1976); Pleasant Hill Bank v. U.S., 58 F.R.D.97 (D.C.Mo. 1973). See also Westinghouse Elec. Corp. v. Schlesinger, 542 F.2d 1190 4th Cir.1976); Kerr v. U.S. Dist. Court for Northern Dist. of California, 511 F.2d 192 (9th Cir. 1975); U.S. ex rel. Stone v. Rockwell Intern. Corp., 144 F.R.D.396 (D.Colo. 1992); U.S. v. American Tel. & Tel. Co., 86 F.R.D.603 (D.D.C. 1979); Pierson v. U.S., 428 F.Supp.384 (D.Del. 1977); Smith v. F. T. C., 403 F.Supp.1000 (D.Del. 1975); Canal Authority of State of Fla. v. Froehlke, 81 F.R.D.609 (M.D.Fla. 1979); Culinary Foods, Inc. v. Raychem Corp., 150 F.R.D. 122 (N.D.Ill. 1993). 45. Sneider v. Kimberly-Clark Corp., 91 F.R.D.1 (D.C.Ill. 1980). Also see Feldman v. Pioneer Petroleum, Inc., 87 F.R.D.86 (D.C.Okl. 1980); SCM Corp. v. Xerox Corp., 70 F.R.D.508 (D.C.Conn. 1976); Heidelberg Harris, Inc. v. Mitsubishi Heavy Industries, Ltd., 1996 WL 732522, *3+ (N.D.Ill. Dec 09, 1996) (NO. 95 C 0673); Baxter Travenol Laboratories, Inc. v. Abbott Laboratories, 1987 WL 12919, *3+ (N.D.Ill. Jun 19, 1987) (NO. 84 C 5103). See also “The Attorney–Client Privilege in the Corporate Setting: Counsel’s Dual Role as Attorney and Executive,” 62 UMKC L. Rev. 549 (1994) 46. North Am. Mortg. Investors v. First Wisconsin Nat. Bank, 69 F.R.D.9 (D.C.Wis. 1975). 47. Fed.R.Civ.P 26(b)(1). 48. Oppenheimer Fund, Inc. v. Sanders, 437 U.S.340, 351 (1978). 49. Roseberg v. Johns-Manville Corp., 85 F.R.D.292 (E.D.Pa. 1980). 50. Federal Rule of Evidence 407. 51. Federal Rule of Evidence 408. 52. Federal Rule of Evidence 409. 53. Federal Rule of Evidence 411. 54. Federal Rule of Evidence 801. 55. Pressley v. Boehlke, 33 F.R.D.316 (W.D.N.C. 1963); Dellums v. Powell, 184 App.D.C.339, 566 F.231 (1977); Josephs v. Harris Corp. (3rd Cir.) 677 F.2d 985 (1982); Goodman v. Wagner, 553 F.Supp.255 (E.D.Pa.1982). 56. See also Trabon Engineering Corp. v. Easton Manufacturing Co., 37 F.R.D.51, 54 (N.D.Ohio 1964); Stanley Works v. Haeger Potteries, Inc., 35 F.R.D.551, 555 (N.D.Ill.1964); Klausen v. Sidney Printing & Publishing Co., 271 F.Supp. 783, 784 (D.Kan. 1967). 57. Also see United States v. 58.16 Acres of Land, 66 F.R.D.570, 572 (E.D.Ill.1975). 58. Fed.R.Civ.P Rule 37 (2)(b)(3). 59. Milner v. National School of Health Technology, 73 F.R.D.628 (D.C.Pa.1977). 60. Martin v. Easton Pub. Co., 85 F.R.D.312 (D.C.Pa.1980); Miller v. Doctors General Hospital, 76 F.R.D.136 (D.C.Okl.1977). 61. United States vs. Purdome, 30 F.R.D.338, 341 (D.C.MO. 1962); Glick v. McKesson and Robbins, Inc., 10 F.R.D. 477 (D.C.MO. 1950); Blankenship v. Hearst


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62.

63. 64. 65. 66.

67.

68. 69. 70.

71. 72. 73. 74. 75. 76. 77.

Science and Litigation: Products Liability in Theory and Practice Corp., 519 F.2d418 (C.A.9th, 1975); U.S. v. International Business Machines Corp., 66 F.R.D.186, 189 (D.C.N.Y., 1974); Davis v. Romney, 55 F.R.D.180 (D.C.Pa. 1972); Hunter v. International Systems and Controls Corp., 51 F.R.D.251 (D.C.MO. 1970). United States v. International Business Machines Inc., 67 F.R.D.40,46 (S.D.N.Y.1975); Reliance Insurance Co. v. Barrons, 428 F.Supp.200,203 (S.D.N.Y.1977); In Re Halkin, 598 F.2d 176,186,191 (D.C.Cir.1979). See also New Castle County v. Hartford Acc. and Indem. Co., 8 Fed.R.Serv.3d 506 (S.D.N.Y.1987); Andrew Corp. v. Rossi, 180 F.R.D.338 (N.D.Ill. 1998); Culinary Foods, Inc. v. Raychem Corp., 151 F.R.D.297 (N.D.Ill. 1993) State ex rel. Johnson v. Tsapis, 419 S.E.2d 1 (W.Va. 1992). Fed. R. Civ. P. 1. Id. at 33. Id. at 187. Id. See also Averbach v. Rival Mfg. Co., 879 F.2d 1196 (3rd Cir. 1989); Chemetron Corp. v. Business Funds, Inc., 682 F.2d 1149 (5th Cir.1982); Jordan v. Paccar, Inc., 97 F.3d 1452 (6th Cir. 1996); Bunch v. U.S., 680 F.2d 1271 (9th Cir.1982). Id. 1346. See also Delvecchio v. General Motors Corp., 625 N.E.2d 1022 (Ill.App. 1993); Oakes v. General Motors Corp., 628 N.E.2d 341 (Ill.App. 1993); DePaepe v. General Motors Corp., 33 F.3d 737 (7th Cir. 1994). 70 Ill. 2d 51, 374 N.E.2d 460 (1978). Id. at 467. Zenith Radio Corp. v. Matsushita Elec. Indus.Co., 529 F.Supp.866, 889 (E.D.Penn.1981). See also In re Adobe Systems, Inc. Securities Litigation, 141 F.R.D.155 (N.D.Cal. 1992); In re Agent Orange Product Liability Litigation, 98 F.R.D.539 (E.D.N.Y. 1983); Littlejohn v. Bic Corp., 851 F.2d 673 (3rd Cir. 1988); Publicker Industries, Inc. v. Cohen, 733 F.2d 1059 (3rd Cir.1984). Zenith Radio Corp. v. Matsushita Elec.Co., supra, n.84. Also see Vollert v. Summa Corp., 389 F.Supp.1348 (D.Hawaii 1975). Id. at 725–726. 67 F.R.D.40 (S.D.N.Y 1975). Id. F.R.Evid. 401. Dudley Sports Co. v. Schmitt, 151 Ind. App. 217, 279 N.E.2d 266 (1972). Chart v. General Motors Corp., 80 Wis.2d 91, 258 N.W.2d 680 (1977). See also D.L. by Friederichs v. Huebner, 329 N.W.2d 890 (Wis. 1983); Leverence v. PFS Corp., 504 N.W.2d 874 (Wis.App. 1993); Weynand v. Weynand Foster, 610 N.W.2d 512 (Wis.App. 2000); “Admissibility of Subsequent Remedial Measures Evidence in Diversity Actions Based on Strict Products Liability,” 53 Fordham L. Rev. 1485 (1985).



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78. Fed.R.Evid. 703. As noted in the case of Capital Improvements Bd. v. Public Service Commission, 375 N.E.2d 616, 626 (1978), analyzing the same issue under Indiana common law: 1. The opinion of an expert is not necessarily rendered inadmissible or incompetent because it may be based on knowledge of facts gained from hearsay sources. Any expert worthy of the name must of necessity assimilate prior learning derived from the experience of others. As an expert witness, he draws upon various sources of information whose credibility or trustworthiness he must determine in the light of his expertness. It would completely frustrate the use of expert witnesses if they were obliged to substantiate each single factor upon which their ultimate opinion must depend. Id. 79. See Millette v. Rodasta, 84. Ill. App.3d 5, 404 N.E.2d 823 (1980).


0017ZAppendixFrame Page 429 Wednesday, March 6, 2002 10:31 PM


This appendix serves to acquaint readers with the major Internet links to essential science, medical, and government information sources for purposes of preparing and monitoring science-based litigation. It is meant to serve as a source reference for detailed work in the extensive world of the sciences and their commercial progeny that are involved in products liability litigation. Hopefully, with the utilization of the information provided in the individual chapters of this book, the reader will be equipped to begin efficient, practical work in the fascinating world of products liability litigation. Given the central scientific core of the world of the forensic sciences and the potential for use by products liability litigators, an extensive research listing of such sources is provided below. In-Silico Biology Data Mining for Bioinformatics: Toward In Silico Biology (http://industry.ebi.ac.uk/datamining99/) Second Annual in Silico Biology (http://www.healthtech.com/conference/00isb/) In-Silico Biology Support (http://www.bioinfo.de/isb/support.html) Forbes Biology, in-Silico (http://www.forbes.com/forbes/98/0601/6111119a.htm) Computational biology-related journals (http://www.genetics.wustl.edu/compgen-disc/journals.html) Bioinformatics, computational biology (http://www.unl.edu/stc-95/ResTools/biotools/biotools4.html) Bioinformatics AMIA, Medical Informatics (http://www.amia.org/) Genome-wide expression (http://web.wi.mit.edu/young/expression/) Transcriptome (http://web.wi.mit.edu/young/expression/transcriptome.html) 429


430


Proteomics Web sites (http://genome.uc.edu/genome/proteomics.html) Bioinformatics, DNA Background (http://post.queensu.ca/~forsdyke/bioinfor.htm) Columbia University Bioinformatics Center (http://cubic.bioc.columbia.edu/) Bioinformatics Links in the World (http://evol.nott.ac.uk/cmelun/links.html) BioExchange.com (http://www.bioexchange.com/account/register.cfm) PDA, an international association for pharmaceutical science and technology (http://www.pda.org/) ISPE Online (http://www.ispe.org/) CombiGenix.com, biological sciences directory (http://www.combigenix.com/) Genome database (http://gdbwww.gdb.org/) European Bioinformatics Institute (http://www.ebi.ac.uk/ MGI 2.4, Mouse Genome Informatics (MGI) (http://www.informatics.jax.org/) Bioinformatics (http://bioinformatics.oupjournals.org/) Stanford Medical Informatics (http://www-smi.stanford.edu/) Glaxo Wellcome Inc. USA, corporate Web site (http://www.glaxowellcome.com/) Working Group Bioinformatics (http://transfac.gbf-braunschweig.de/) BIMAS (http://bimas.dcrt.nih.gov/) Bioinform, global bioinformatics news service (http://www.bioinform.com/) Bioinformatics links (http://www.ii.uib.no/~inge/list.html) Bioinformatics newsletter, The BioInformer — (European Bioinformatics Institute) (http://bioinformer.ebi.ac.uk/) Molecular biology information servers/bioinformatics (http://research.nwfsc.noaa.gov/bioinformatics.html)



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Google Web Directory, science > biology > bioinformatics (http://directory.google.com/Top/Science/Biology/Bioinformatics/) Articles page (http://www.bioplanet.com/Bioarticles.htm) Bioinformatics at Stanford, Expert Qualifiers (http://camis.stanford.edu/people/altman/bioinformatics.html) Science Sites BioEdge.Net (http://www.bioedge.net/) Scientific American (http://www.sciam.com/) HEI (http://www.healtheffects.org/) Issues in Science & Technology (http://www.nap.edu/issues/index.html) Scientist: The News Journal for the Life Scientist (http://www.the-scientist.com/) Smithsonian Institution, Science Service Historical Image Collection (http://www.americanhistory.si.edu/scienceservice/) Electronic Publication Initiative (http://www.embo.org/E_Pub_pages.html) SciNet Science Search Engine (http://www.scinet.cc/) National Institutes of Health, Center for Scientific Review (NIH, CSR) (http://www.csr.nih.gov/default.htm) Issues in Science & Technology (http://www.nap.edu/issues/) Yahoo! Science > Engineering (http://dir.yahoo.com/science/engineering/) ScienceNews.com (http://www.healthblast.com/cgi-bin/exec/page-display?page=sites/ sciencenews/home.html) Isis (http://www.journals.uchicago.edu/Isis/home.html) Yahoo, patent information sites (http://dir.yahoo.com/Government/U_S__Government/Executive_ Branch/Departments_and_Agencies/Department_of_Commerce/ United_States_Patent_and_Trademark_Office__USPTO_/) U.S. Patent and Trademark Office (http://www.uspto.gov/)


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NCBI (http://www.ncbi.nlm.nih.gov/) Drug approval application process (http://www.fda.gov/cder/regulatory/applications/default.htm) Society of Automotive Engineers (SAE) (http://www.sae.org/jsp/index.jsp) Public Citizen (http://www.citizen.org/) Nature (http://www.nature.com/nature/) Issues in Science & Technology (http://www.nap.edu/issues/) The Why Files (http://whyfiles.org/) Human Genome Project Information (http://www.ornl.gov/TechResources/Human_Genome/home.html) Smithsonian (http://www.si.edu/organiza/start.htm) Food and Drug Administration (http://www.fda.gov/) Library of Congress (http://lcweb.loc.gov/homepage/lchp.html) WWW Virtual Library (http://vlib.org/Overview.html) National Science Foundation (http://www.nsf.gov/) National Academies (http://www.nas.edu/) National Institutes of Health (http://www.nih.gov/) World Health Organization (http://www.who.int/) Medicine Sites CSM (http://www.ihs.ox.ac.uk/csm/) Internet guides (http://www.hsls.pitt.edu/intres/guides/statcbw.html) Centers for Disease Control and Prevention (http://www.cdc.gov/); see also (http://www.cdc.gov/other.htm) Consumer Product Safety Commission (http://www.cpsc.gov/)



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Illinois Department of Public Health (http://www.idph.state.il.us/) WWW Virtual Library: Statistics (http://www.stat.ufl.edu/vlib/statistics.html) Virtual Medical Center, Martindale’s Health Science Guide (http://www-sci.lib.uci.edu/~martindale/Medical.html) Department of Medical Statistics (http://www.medstats.dmu.ac.uk/) Medical Statistics (http://www.gla.ac.uk/Library/Depts/MOPS/Stats/medstats.html) Kearl’s Guide to Health Statistics and the Medical Establishment (http://www.trinity.edu/~mkearl/health.html) HIV InSite (http://hivinsite.ucsf.edu/) Public health research: Dr. Lucian L. Leape’s research interests, Harvard School of Public Health (http://www.hsph.harvard.edu/facres/leape.html) National Academy Press Catalog: To Err Is Human (http://books.nap.edu/catalog/9728.html) VAPAHCS/Stanford University Simulation Center (http://pkpd.icon.palo-alto.med.va.gov/simulator/simulator.htm) AMIA: Medical Informatics (http://www.amia.org/) CRI Registry (http://www.criregistry.com/) CenterWatch Clinical Trials Listing Service (http://www.CenterWatch.com/main.htm) Medical Matrix (http://www.medmatrix.org/) Galaxy: Medicine (http://www.galaxy.com/galaxy/Medicine.html) WWW Virtual Library: Biosciences: Medicine (http://www.ohsu.edu/cliniweb/wwwvl/) National Institute of Allergy and Infectious Diseases Home Page (NIAID), National Institutes of Health (http://www.niaid.nih.gov/) Alumni Medical Library (http://med-libwww.bu.edu/) Yale Library: Selected Internet Resources (http://www.med.yale.edu/library/sir/) WebMD (http://my.webmd.com/)


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ScienceNews.com (http://www.healthblast.com/cgi-bin/exec/page-display?page = sites/ sciencenews/sections/medicalnews/home.html&session_id = 314779764.8499.N001) American Medical News (http://www.ama-assn.org/public/journals/amnews/amnews.htm) Journal of the American Medical Association (http://jama.ama-assn.org/) American Medical Association (http://www.ama-assn.org/) Search MEDLINE: PubMed and Internet Grateful Med (http://www.nlm.nih.gov/databases/freemedl.html) New England Journal of Medicine On-line (http://www.nejm.org/content/index.asp) American Society of Law, Medicine and Ethics (http://www.aslme.org/) American Association for Cancer Research (AACR) (http://www.aacr.org/) Yahoo: Medical Journals (http://dir.yahoo.com/Health/Medicine/Journals/) Doxamed.com: e-hub for the Medical Device Industry (http://www.doxamed.com/) Labinternet Online Science Magazine (http://www.labinternet.com/) Medical journals (http://www.sciencekomm.at/journals/medicine/med-bio.html) Life science and medical journals (http://www.sciencekomm.at/journal.html) Science.komm (http://www.sciencekomm.at/advice/up2date.html) Biomedical and Biological Sciences Graduate School Directories (http://www.gradschools.com/medicalsearch.html) MedicineNet.com (http://www.medicinenet.com/Script/Main/hp.asp) CombiGenix.com Biological Sciences Directory (http://www.combigenix.com/) Mayo Clinic & Foundation for Medical Education and Research (http://www.mayo.edu/) Howard Hughes Medical Institute HHMI, biomedical research and science education (http://www.hhmi.org/) Canadian Institutes of Health Research (http://www.cihr.ca/welcome_e.shtml)



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Agency for Healthcare Research and Quality (AHRQ), formerly the Agency for Health Care Policy and Research (AHCPR) (http://www.ahcpr.gov/) National Institute for Medical Research (http://www.nimr.mrc.ac.uk/) United States Army Medical Research and Materiel Command (USAMRMC) (http://mrmc-www.army.mil/) C. Everett Koop Institute (http://koop.dartmouth.edu/) U.S. National Library of Medicine (http://www.nlm.nih.gov/) ClinicalTrials.gov, Linking Patients to Medical Research (http://clinicaltrials.gov/ct/gui/c/r) Government Agencies Food and Drug Administration (http://www.fda.gov/) Medical Devices Agency (http://www.medical-devices.gov.uk/) CPSC (http://www.cpsc.gov/) WWW Virtual Library: U.S. Government Information Sources, National Performance Review (http://www.nttc.edu/gov/independents/chemsafe.html) WWW Virtual Library: U.S. Government Information Sources, Consumer Product Safety Commission (http://www.nttc.edu/gov/independents/cpsc.html) WWW Virtual Library: U.S. Government Information Sources (http://www.nttc.edu/gov_res.html) Law Sites Association of American Law Schools (http://www.aals.org/) National Conference of Lawyers and Scientists (http://www.aaas.org/spp/dspp/sfrl/committ/ncls.htm) Cornell Legal Information Institute (http://www.law.cornell.edu/) Supreme Court of the United States (http://www.supremecourtus.gov/)


436


FindLaw (http://www.findlaw.com/) Oyez Oyez Oyez (http://oyez.nwu.edu/) LII: Supreme Court Collection (http://supct.law.cornell.edu:8080/supct/) Federal Judiciary, news and information about the federal courts (http://www.uscourts.gov/) Center for Law & Science (http://www.law.depaul.edu) Lexis.com(SM) (http://www.lexis.com/) Federal Judiciary Homepage (http://www.uscourts.gov/allinks.html) JURIST: The Legal Education Network (http://jurist.law.pitt.edu/) Clifford Law Offices (http://www.cliffordlaw.com/) Professor Kiely — Criminal Law Spring 2001 (http://www.law.depaul.edu/faculty/kiely/) Illinois State Bar Association (http://www.illinoisbar.org/) Welcome to Westlaw! (http://www.westlaw.com/) Forensic Information on the Internet There are a growing number of Web sites that provide lists of information sources, journals, experts, professional associations, international forensics organizations, newsletters, university programs, international police organizations, and the like. A general search using any of the Internet search engines, such as Yahoo, will bring up most of them. The best is Zeno’s Forensic Science Page from the Netherlands. It contains updated links to all there is to get with regard to forensics on the web. It may be found at http://forensic.to/forensic.html. A superb resource is a site sponsored by the American Academy of Forensic Science (AAFS) and the American Society for Testing Materials (ASTM), located at http://www.aafs.org, which allows searches of the index of Journal of Forensic Science, the preeminent scholarly journal in this field, from 1980 to the present. The site allows viewing of abstracts associated with each citation. Also see a comprehensive law and forensic science Web site, maintained by the Center for Law and Science of DePaul University



437

College of Law (http://www.law.depaul.edu/cls). Each of the chapters in this book note the most important Web sites for each of the forensic science areas discussed. Forensic Science and Related Web sites American Academy of Forensic Sciences (http://www.aafs.org) Northern Light Search (http://www.globalindex.com/search.htm) An interview with DNA forensics authority, Dr. Bruce Weir (http://www.accessexcellence.org/WN/NM/ interview_dr_bruce_weir.html) Federal Bureau of Investigation (http://www.fbi.gov) CRC Press LLC (http://www.crcpress.com/) Zeno’s Forensic Page (http://www.forensic.to/links/pages/) Office of International Criminal Justice (http://oicj.acsp.uic.edu/) Professor William Thompson’s DNA page (http//www.scientific.org/web_admin/links.htm) Shoe print and tire track exam (http://members.aol.com/varfee/mastssite/home.html) Forensic firearms identification, an introduction (http://www.geocities.com/~jsdoyle/) Forensic anthropology, PoundLab (http://web.anthro.ufl.edu/c.a.poundlab/poundlab.htm) China, FSER: Forensic Med in WCUMS (http://members.xoom.com/legalmed) International Association Forensic Sciences, 1999 (http://www.criminalistics.com/iafs-1999/) California State Coroner’s Association (http://www.coroners.org/) Forensic Chemistry Network (http://www.geocities.com/CapeCanaveral/4329/) Stranka Forensic Sciences, fiber imaging process (http://www.lim.cz/paa/text/forens_sci.html) Terminal ballistics (http://home.sprynet.com/sprynet/frfrog/terminal.htm)


438


Sciences of soils (http://www.hintze-online.com/sos/) Dog Genome Project (http://mendel.berkeley.edu/dog.html) DNA, Gene Almanac Page (http://vector.cshl.org/) Medical Examiners’ Page (http://www.thename.org/info/info.htm) FBI Laboratory’s Combined DNA Index System (CODIS) Program (http://www.euro.promega.com/geneticidentity/symposia/ symproc6/niezgod.htm) International Association for Forensic Phonetics (http://zeno.simplenet.com/iafp98/) Royal Canadian Mounted Police (http://www.rcmp-grc.gc.ca/html/bugs.htm) Forensic Entomology (http://www.missouri.edu/cafnr/entomology/index.html) Forensic Computing (http://www.forensic-computing.com/) Jerry C. Lyell (Forensic DNA) (http://www.dnalwyr.com/) Trace evidence page (http://www.adfs.com/trace.htm) Entomology, insect drawings (http://www.life.uiuc.edu/Entomology/insectgifs.html) Forensic and law enforcement Web sites (http://www.shadow.net/~noslow/forensic.html) Forensic directories and listings (http://www.hypernet.on.ca/quincy/dirbib.htm) MSU Forensic Science (http://www.ssc.msu.edu/~forensic/) U.S. Army Criminal Forensic Lab (http://www.randomc.com/~german/usacil.html) Alphonse Bertillon: “Measuring the Head” (http://www.cimm.jcu.edu.au/hist/stats/bert/head2.htm) Pathology and Forensic Medicine (http://www.mic.ki.se/Pathol.html) Forensic pathology (http://medic.med.uth.tmc.edu/publ/00000075.htm) Forensic entomology references (http://www.uio.no/~mostarke/forens_ent/references.html)



Law-Related Sites Court TV online (http://www.courttv.com/) Jurist: The Law Professors’ Network, the legal education portal (http://jurist.law.pitt.edu/) International commentary on evidence (http://www.law.qub.ac.uk/ice/) Westlaw (http://www.westlaw.com/) Lexis-Nexis (http://www.lexis.com/xchange/) Hieros Gamos, comprehensive law and government site (http://www.hg.org/hg.html) U.S. Court of Appeals, 7th Circuit (http://www.kentlaw.edu/7circuit/) U.S. Department of Justice (http://www.usdoj.gov/) U.S. District Court, Northern Illinois (http://www.ilnd.uscourts.gov/) ABA Net, Criminal Law (http://www.abanet.org/crimjust/home.html) Government information searches (http://www.gpo.ucop.edu/search/default.html) Search government (http://www.isleuth.com/gove.html) Food and Drug Administration (http://www.fda.gov/) Fedstats, one-stop shopping for federal statistics (http://www.fedstats.gov/index.html) ILRG’s legal indices and search engines (http://www.ilrg.com/indices.html) Illinois Supreme Court rules (http://www.illinoisbar.org/CourtRules/Article2/home.html) Illinois State Bar Association (http://www.illinoisbar.org) FindLaw, Internet legal resources (http://www.findlaw.com/) CataLaw, metaindex of law and government (http://www.catalaw.com/) ATLA NET (http://www.atlanet.org/)

439


440


Center for Law and Science (http://www.law.depaul.edu/cls/) U.S. Department of Justice (http://www.usdoj.gov/) U.N. Crime and Justice Information Network (http://www.ifs.univie.ac.at/~uncjin/uncjin.html) INREP, artificial intelligence and evidence (http://www.eurocongres.com/criminallaw/) International Commentary on Evidence (http://www.law.qub.ac.uk/ice/) WWW Virtual Library: Law: Criminal Law and Evidence (http://www.law.indiana.edu/law/v-lib/criminal.html) International Criminal Law sites (http://www.hg.org/crime.html) Association of American Law Schools (http://www.aals.org/) Evidence site (http://www.law.umich.edu/thayer/) International commentary on evidence (http://www.law.qub.ac.uk/ice/) INTERPOL (http://193.123.144.14/interpol-pr/Index.html) Organization of International Criminal Justice Conferences (http://www.acsp.uic.edu/oicj/confs.htm) FBI Laboratory (an investigation into laboratory explosives) (http://www.tncrimlaw.com/fbi_indx.html) U.S. Department of Justice (http://www.usdoj.gov/) Police Officer’s Internet Directory (http://www.officer.com/) Federal Judicial Center Home Page (http://www.fjc.gov/) Cornell Legal Information Institute (http://www.law.cornell.edu/)

0017ZIndexFrame Page 441 Tuesday, March 12, 2002 1:55 PM

Index

1997 International Congress on Biomedical Peer Review and Global Communications, 116–118 2001 September Peer-Review Conference Program: Peer Review Congress, 118–121

A Absence of agency activity, 330 Academic and professional conferences and exhibits, 253–254 Accelerated production schedules, 303–304 Accetta, Donald D., 103, 157–158 Accountants, as expert witnesses, 279–280 Actual cause, 138–139 Adams, Henry, 13, 14 Administrative process, 8 Adrian v. the Live Yankee, 25 Advertisements for products, 252, 280–281, 323–324 Affidavits from expert witnesses drafting, 405, 413–414, 419–420 opposing, 405 utilizing, 404, 413, 419 Agency regulations, see Regulations Agricultural fungicide, case involving, 174–177 Alice in Wonderland (Dodgson), 339 Allen v. Hunter, 20 Allison v. McGhan Medical Corporation, 94–99 Altech Industries v. Al Tech Specialty Steel, 394 Al Tech Specialty Steel, Altech Industries v., 394 Alternative designs, testing of, 59–60

American Journal of Public Health, 105 American National Standards Institute (ANSI), 221, 310 Analgesics, case involving, 134–137 Anderson, Rosalind C., 101–104 “And Now, Evidence Based Editing” (Br. Med. J. article), 106 Angell, Marcia, 51 Animal studies in Allison v. McGhan Medical Corporation, 95–96 in E.I. Du Pont De Nemours & Co. v. Castillo, 175–176 in General Electric v. Joiner, 50–51, 89–90 in Siharath v. Sandoz Pharmaceuticals Corporation, 184–185 Annoyance, as reason for seeking protective order, 410 ANSI (American National Standards Institute), 221, 310 Appellate decisions, researching, 225, 241 Arthritis, case involving, 156–159 Artwork destruction, case involving, 62–64 Asbestos, case involving, 165–166 Association of Trial Lawyers of America (ATLA), 264 Attorney-client privilege, 396–397 Attorney-work-product privilege, 395

B Babbage, Charles, 6, 13–14, 80–81 Bacon, Sir Francis, 3, 77–78, 79 Baking soda, case involving, 147–151 Barney et al., Parrot v., 25–26 Bayly, Melvyn, 167

441


442


Becker, Carl, 39 Beckman Instruments, Wynacht v., 151–153 Bellwether trials, 159–166 Cimino v. Raymark Industries, Inc., 165–166 origin of term, 163 overview, 159–161 In re Chevron U.S.A., Inc., 161–165 Bendectin, see Daubert v. Merrell Dow Pharmaceuticals Benet, Jon, 40 Benlate, case involving, 174–177 Benomyl, case involving, 174–177 Bentham, Jeremy, 140 Benzene, case involving, 183 Bioinformatics, researching, 429–431 Biology, researching, 429 “Biomedical Information, Peer Review, and Conflict of Interest as They Influence Public Health” (JAMA article), 108 Birth defects, cases involving Daubert v. Merrell Dow Pharmaceuticals, 46–50 Donaldson v. Central Illinois Public Service Company, 170–173 E.I. Du Pont De Nemours & Co. v. Castillo, 174–177 Blackmun, Justice, 48 Black v. Rhone-Poulenc, 92–94 Blinding process, in peer reviews, 83–84 Boiler for steamboat, case involving, 25 Books, as research tools, 252 Bourelle, Darla, 56 Bourelle v. Crown Equipment, 56–62 Brain damage, case involving, 153–156 Breach of contract action, 24 Breast implants, cases involving, 54, 94–97 Breyer, Justice, 51, 52 British Medical Journal, 105–106 Bromocriptine mesylate, case involving, 177–186 Bruce, Robert V., 12 Bryan et al. v. Stevens, 19 Bucyrus Erie Co., Consolidation Coal v., 395 Buehler v. Whalen, 410 Burdensome requests, 394–395 Business documentation, see Documentation, business “But for” test, 144–145

C Canavan, Theresa, 102–103, 156–159 Cancer, cases involving; see also Dennis D., Case of; General Electric v. Joiner Donaldson v. Central Illinois Public Service Company,, 170–173 E.I. Du Pont De Nemours & Co. v. Castillo, 174–177 Carmichael, Kumho Tire v., see Kumho Tire vCarmichael Carpet, case involving toxic injuries from, 101–104 Carroll, Lewis, 261, 339 Case of Dennis D., see Dennis D., Case of CASE Project (Court Appointed Scientific Experts), 53 Castillo, E.I. Du Pont De Nemours & Co. v., 174–177 Cataloguing of documents, see Indexing of documents Causation, legal, see Proximate cause Cause-in-fact general information, 41–42, 141 Nunez v. Commercial Union Insurance Company, 144–145 CCC (Chicago Conservation Center ), case involving, 62–64 Central Illinois Public Service Company (CIPS), case involving, 170–173 Central Illinois Public Service Company, Donaldson v., 170–173 Central staff, corporation, 334–335 Certification testing, 316 Chambers, Jasemine C., 10 Chan, Effie J., 85–86, 94 Charts, organization, 333–334 Chemical-induced headaches, case involving, 156–159 Chevron Chemical Co., Ferebee v., 172–173 Chicago Conservation Center (CCC), case involving, 62–64 Chicago Conservation Center, Frey v., 62–64 Chlorpyrifos, case involving, 153–156 Chronic fatigue syndrome, case involving, 151–153 Chronic myelogenous leukemia, case involving, 183 Cimino v. Raymark Industries, Inc., 165–166


Index CIPS (Central Illinois Public Service Company), case involving, 170–173 “Citation Analysis of the Impact of Blinded Peer Review” (JAMA article), 111 Classifying documents, see Indexing of documents Clearing houses, expert witness, 267 Clifford, Justice, 24 Coal gasification plant, case involving, 170–173 Code names, 314 Coffey, Judge, 58 College of the Six Days Work (fictitious institution), 77–78 Commercial Union Insurance Company, Nunez v., 144–145 Committees, corporate documentation by, 304–307 identifying, 336 indexing documents by, 387–388 organization of, 334 Communication, corporate, see Documentation, business Communications-related defects, 38–39 “Communities of Scientists and Journal Peer Review, The” (JAMA article), 108 Companies, see Corporations Comparative products, analysis and tests of, 224, 239, 300–301, 315–316 Complaints indexing documents by, 390 interrogatories regarding, 354–355 Component parts, 227, 319 Compound X (drug), case involving, 134–136 Conferences, academic and professional, 253–254 “Conflict of Interest” (Lancet article), 112 “Conflict of Interest” (Science article), 113 “Conflict of Interest and Financial Disclosure: Judge the Science, Not the Author” (Chest article), 115 “Conflict of Interest and the Peer Review Process” (JAMA article), 106 “Conflict of Interest Policy” (Science article), 113 “Conflict Over Release of Clinical Research Data” (Science article), 113 Confusion of issues, 416

443 Consolidation Coal v. Bucyrus Erie Co., 395, 397 Consumer expectation test, 37 Consumer groups and publications, 258 Consumer Product Safety Commission (CPSC), 212 Consumer Reports (magazine), 252 Consumption of time, undue, 417 Contraceptive, case involving, 170–173 Control-group test, 279–280, 396 Corporations; see also Committees, corporate; Departments, corporate; Documentation, business; Offices, corporate corporate process overview, 7–8 cost allocations, 321–322 evolution of organization and processes, 239–240 expert witnesses on operations of, 277–278 researching, 216, 225, 226, 244 response to technical problem, 240–241 status of, 227 “Correcting the Literature Following Fraudulent Publication” (JAMA article), 108 Costs versus benefits, documentation for, 331–332 of changes due to government regulations, 328 corporate allocations for, 321–322 determining how arrived at, 366 early decisions regarding, 296 expert witnesses, 262, 263, 269, 272 manufacturing and design, 279–280 preliminary studies, documentation for, 298–299 research services, 266 Cotton and wool card-making machine, case involving, 18–19 Court Appointed Scientific Experts (CASE Project), 53 CPSC (Consumer Product Safety Commission), 212 Criminal cases crime scene, 42 forensic evidence in, 42–44 Frye v. United States, 45–50 United States v. Taylor, 25


444


Crown Equipment, Bourelle v., 56–62 Crude oil storage waste pit, case involving, 161–165 Cullinan, Duran v., 166–170 Cumulative evidence, needless presentation of, 417 Customer relations, documentation for, 337–338 Cutter, Whittemore v., 18–19 Cycle plan studies, 302–303

D Damage, punitive, researching, 228–229 Data banks, 257 Database searching; see also Internet research academic and professional conferences and exhibits, 254 books and journals, 252, 253 Federal Database Finder (publication), 255 materials, design and performance standards, 258 Date of defect determination, 389–390 Date of product specification finalization, 390 Daubert v. Merrell Dow Pharmaceuticals, 46–50 and Allison v. McGhan Medical Corporation, 95 and Bourelle v. Crown Equipment, 58, 60 effect on peer review, 85–86, 87–88 and Ford Motor Company v. Ammerman, 98, 99 and Frey v. Chicago Conservation Center, 62, 63, 64 and General Electric v. Joiner, 51, 91 and Kumho Tire v. Carmichael, 52–53, 91–92 and Pillow v. General Motors, 100, 101 and Ruffin v. Shaw Industries, 103–104 and Theresa Canavan’s case, 158 and Turner v. Iowa Fire Equipment Company, 147, 149–150 Day, Goodyear v., 21 Deception test, see Frye v. United States Defects, 213, 218–219, 233; see also Daubert v. Merrell Dow Pharmaceuticals; Design defects allegations of, 402–404

defect types, 250 and expert witnesses, 281–282 and hearsay arguments, 418 knowledge of, 383–384, 389–390 manufacturing, 232 packaging, 38, 234, 250 unit, 233, 342–343 use of term, 37, 38–39 Defendants, identifying potential, 225–226; see also Corporations Defense experts, deposing, 366–368 “Delays That Can Cause Death, and Is Science Censored?” (Newsweek article), 115 Dennis D., Case of, 134–136 and actual cause, 138–139 causal relation identification and analysis, 137–138 general liability analysis, 136–137 and legal cause, 139–140 no cause-in fact argument, 138 and proximate cause, 140–141 Dental compound formula, case involving, 20 Departments, corporate indexing documents by, 385–386 structure of, 335–336 Depositions, 362–368; see also Document production requests; Interrogatories defense experts, 366–368 management personnel, 365–366 overview, 362–363 selecting deponents, 363 specifying subjects and documents in notice, 363–364 technical staff, 364–365 Design changes, 222, 282, 417 costs, 279–280 knowledge of alternatives to, 384 standards, 257–258 Design defects; see also Misrepresentation and pretrial discovery, 343–345 researching, 234–235 types of, 233 use of term, 39 Design documentation, 293–307, 371–372 alternative design studies, 300 competitive product studies, 300–301


Index continuing studies, 307 costing studies, 298–299 cycle plan studies, 302–303 design stage, 293–296 management committee support studies, 306–307 marketing studies, 297–298 product concept, 296–297 regulatory review, 304 technical feasibility studies, 301–302 timing studies, 303–304 tooling studies, 299 Differential diagnosis, 145–159 in Goeb v. Tharaldson, 153–156 in Siharath v. Sandoz Pharmaceuticals Corporation, 182 Theresa Canavan’s case, 156–159 in Turner v. Iowa Fire Equipment Company, 147–151 use of term, 145–146 in Wynacht v. Beckman Instruments, 151–153 Discovery, pretrial, 339–427; see also Depositions; Document production requests; Indexing of documents; Interrogatories; Motion to compel discovery; Objections to discovery; Research, pretrial discovery planning, 340–348 discovery requests, 347–348 document points of interest, 373–377 and expert witnesses, 283–284 failure to instruct or warn, 345 finalizing time frames, 341–342, 346–347 misrepresentation, 345 organization and analysis, 370 overall design defects, 343–345 overview, 339–340 rating corporate documents, 368–370 relevancy issues, 340–341 standard informational content, 373 unit defects, 342–343 Dissemination of information, early, 84 Dissertations and masters’ theses, 255 Distraction of jury, 416 Distribution lists, 386–387 Distributors, researching, 227–228

445 Documentation, business, 287–338; see also Design documentation; Document production requests; Indexing of documents; Interrogatories; Marketing documentation; Regulatory documentation; Testing documentation determining pattern of, 379–380 generation of, 289–293, 382 genuineness of, 356 operational documentation, 336–338 organizational documentation, 332–336 organization and analysis, 370 overrepresentation of document types, 380–381 overview, 287–288 points of interest, 373–377 production documentation, 318–320 rating, 368–370 redaction of, 418–419 standard informational content, 373 underrepresentation of document types, 381 Document production requests, 356–362; see also Depositions; Interrogatories drafting, 347–348, 356–360 organizing, 347–348, 356 over very extensive time frames, 346–347 physical examination of, 360–361 supplemental discovery, 361–362 Dodgson, Charles, 261, 339 Donaldson v. Central Illinois Public Service Company, 170–173 “Do Readers and Peer Reviewers Agree on Manuscript Quality?” (JAMA article), 111 Double blinding, in peer reviews, 84 Dow Chemical Company, 153–156 Doyle, Arthur Conan, 287 Dukes, N.G., 179 Duluth Quality Pest Control, 153–156 Duran v. Cullinan, 166–170 Dursban, case involving, 153–156

E E.I. Du Pont De Nemours & Co. v. Castillo, 174–177 Edelstein, Judge, 412


446


“Editor’s Report: Scientific Misconduct and the Responsibility of Journal Editors” (Am. J. Pub. Health article), 105 “Editorial: The Paper Route for Submissions to the Journal and Annotation: Seven Fatal Flaws in Submitted Manuscripts” (Am. J. Pub. Health article), 105 Editorial peer review, 86 “Editorial Peer Review in U.S. Medical Journals” (JAMA article), 110 “Editorial Policy and Peer Review Process” (Tech. Comm. article), 115–116 “Editors and Auditors” (JAMA article), 107 “Effect of Acceptance or Rejection on the Author’s Evaluation of Peer Review of Medical Manuscripts” (JAMA article), 109 “Effect of Institutional Prestige on Reviewers Recommendations and Editorial Decisions” (JAMA article), 111 “Effects of Blinding on Acceptance of Research Papers by Peer Review, The” (JAMA article), 111 “Effects of Peer Review and Editing on the Readability of Articles Published in Annals of Internal Medicine” (JAMA article), 111 Electromagnetic telegraphs, case involving, 21 “Electronic Preprints Point the Way to Increase Author Empowerment” (Science article), 114 Embarrassment, as reason for seeking protective order, 410 End of Science: Facing the Limits of Knowledge in the Twilight of the Scientific Age, The (Horgan), 3, 55 England, scientific knowledge during 1800’s, 13 “Ensuring Integrity in Biomedical Publication” (JAMA article), 106 Environmental Protection Agency (EPA), 101–104, 212 Ergot alkaloids, case involving, 177–186 Essays in Tort and Crime (St. John Green), 142

“Ethics, Economics, and the Publication Policies of Major Medical Journals” (JAMA article), 111 European scientific knowledge, 12–13 Evidence, needless presentation of cumulative, 417 “Evolution of Editorial Peer Review, The” (JAMA article), 107–108 Exhibits, academic and professional, 253–254 Expert witnesses, 261–286; see also names of individual cases; Peer review affidavits from drafting, 405, 413–414, 419–420 opposing, 405 utilizing, 404, 413, 419 basis of challenging, 41 categories of, 276–281 choosing general considerations, 265–267 individual factors, 270–276 organizational factors, 267–270 technical experts, 276–277 costs of, 262, 263, 269, 272 credibility of, 22 deposing, 366–368 determining needs, 262–265 and hearsay arguments, 417–418 history of, 16–18, 19, 21 initial utilization of, 281–284 overview, 261–262 prioritizing needs, 265 services for, 268–270 sole practitioners as, 268–270 use of scientific literature, 42, 55, 56 Extrapolation theory, 160–166, 166–177 Donaldson v. Central Illinois Public Service Company,, 170–173 Duran v. Cullinan, 166–170 E.I. Du Pont De Nemours & Co. v. Castillo, 174–177

F F.D.I.C. v. Mercantile Nat. Bank of Chicago, 394–395 Facilitation, see Proximate cause Facilities, technical, 270 Failure-to-instruct and hearsay arguments, 418


Index pretrial discovery, 345 researching, 222, 234 Failure-to-warn, 38–39; see also Bourelle v. Crown Equipment Case of Dennis D., 137, 138, 139–140 expert witness opinions on, 282 and hearsay arguments, 418 pretrial discovery, 345 researching, 222, 235 use of term, 38–39 False statements, 39, 409–410 FDA (Food and Drug Administration), 212 Feasibility studies, 301–302 Federal agency regulations, see Regulations Federal Database Finder (publication), 255 Federal government, see Government Federal Judicial Center, 8 Federal Motor Vehicle Safety Standard 301 (FMVSS 301), 316 Federal Rules of Civil Procedure Rule 26, 340, 350–351, 361, 406 Rule 30, 363–364 Rule 33, 394, 399 Rule 34, 399 Rule 36, 355–356 Rule 37, 400 Federal Rules of Evidence Rule 104, 94 Rule 401, 340, 392, 414 Rule 402, 415, 416 Rule 403, 399, 415, 416, 418 Rule 702, 48, 49, 53, 153 Rule 703, 418 Ferebee v. Chevron Chemical Co., 172–173 Fetal malformations, see Birth defects Fibromyalgia, case involving, 151–153 Fire extinguisher, case involving, 147–151 “First Principles of Mechanics” (Scientific American article ), 16 Flaws, see Defects “Flaws Documented, Reforms Debated at Congress on Journal Peer Review” (JAMA article), 110 FMVSS 301 (Federal Motor Vehicle Safety Standard 301), 316 FOIA (Freedom of Information Act) requests, 212, 221 Food and Drug Administration (FDA), 212 Foote v. Silsby, 20–21 Ford Motor Company, Patterson v., 409

447 Ford Motor Company, Rozier v., 410 Foreign corporations, researching, 226 Forensics, 42–44, 435–436 Forklift accident, case involving, 56–62 Formal test reports, 312–314 Fraud, protection against, 409–410 “Fraud in Biomedical Research” (New Eng. J. Med. article), 112–113 Freedom of Information Act (FOIA) requests, 212, 221 French et al. v. Rogers et al., 21 Frey v. Chicago Conservation Center, 62–64 Friction matches, case involving, 19 Frye v. United States, 26, 45–50 Fulton, Robert, 14 Functional groupings, corporate, 336 Fungicide, case involving, 174–177

G Gencorp, Inc., Mitchell v., 183 General acceptability rule in Allison v. McGhan Medical Corporation, 95, 96 in Daubert v. Merrell Dow Pharmaceuticals, 48 emergence of, 46 in modern times, 80 General causation, 138–139 General Electric v. Joiner experiments and studies, 89–92 general information, 45–51 General Motors, case involving, 99–101 General Motors, Pillow v., 99–101 General Motors Corp., Parsons v., 411–412 Geography of documents, 373 Gershwin, Eric, 94–97 Girard, Stephen, 16 Globetti v. Sandoz Pharms. Corp., 181 Goeb v. Tharaldson, 153–156 Goods, use of term, 38 Goodyear v. Day, 21, 22–24 Government agencies, researching, 429–431 Government publications, 255 Government regulations, see Regulations Grants, research, 256 “Greatly increases the chances” test, 144 Green, Leon, 80, 142 Grier, Justice, 22


448


“Guardians of Science: Fairness and Reliability of Peer Review” (Br. Med. J. article), 105–106 Gulf & Western Manufacturing Company, Earl v., 408–409

H Hanson Engineers, Inc., case involving, 170–173 Havner, Merrell Dow Pharms., Inc. v., 176 Hawkins, Olcott v., 19–20 Haztech, Inc., case involving, 170–173 Hearsay, 417–418 Herbicide, case involving, 172–173 Historical period of interest, in cases, 40 History of science and litigation, 11–18 differences between ideas of science and of technology, 12 European scientific knowledge and United States, 12–13 expert witnesses, 16–18 growth of science related to growth of country, 14 inventions, 14–16 lack of government support for science, 13–14 reluctance to challenge scientific community, 11–12 Holmes, Justice Oliver Wendell Jr., 9, 143–144 Hoo, Joe, 167 Hooke, Robert, 9–10, 79–80 Hooker, Robert, 97 Horace, 77 Horgan, John, 3, 55 “How Blind is Blind Review” (Am. J. Pub. Health article), 105 “How Good is Peer Review?” (New Eng. J. Med. article), 113 “How Well Does a Journal’s Peer Review Process Function?” (JAMA article), 111 Hunter, Allen v., 20 Huycke Corp., Johnson Foils v., 408 Hydraulic power, case involving, 19

I Ice-cutting machine, case involving, 19 Immunodeficiency, case involving, 156–159 Indemnification agreements, 272 Indexing of documents committees and committee meetings, 387–388 complaints, 390 corporate, 377–378 cross-referencing focal points, 382–383 distribution lists, 386–387 documentary materials, 378–382 by document type, 370–373 government regulations, 389 initial, rudimentary indexing, 361 key tests, 388–389 knowledge of alternative design, 384 knowledge of defect, 383–384 legal theories and relevancy, 384 product planning, 389–390 proximate cause, 384–385 requesting individuals, 386 requesting offices and departments, 385–386 India rubber process, case involving, 21, 22–24 Industry custom argument, 315–316 Industry information, researching, 215, 228, 244 Inferential statistics, see Bellwether trials Informal test reports, 312 Information sharing, 407–409 Information sources, 251–258 academic and professional conferences and exhibits, 253–254 academic and professional journals, 253 books, 252 consumer groups and publications, 258 dissertations and masters’ theses, 255 government publications, 255 insurance industry publications, 256 materials, design and performance standards, 257–258 popular publications, 252–253 research grants, 256 research in progress, 255–256 state-of-the-art, 251–252


Index statistical publications and data banks, 257 trade and professional associations, 254 Information U.S.A. (publication), 255 Infringement cases, patent, see Patent litigation “Ingelfinger Rule, Embargoes, and Journal Peer Review, The: Part I” (Lancet article), 112 Injury history, researching, 217–218, 224–225 Injury potential, assessing, 213–214 In re: Silicone Gel Breast Implant Products Liability Litigation, 54 In re Chevron U.S.A., Inc., 161–165 In Re Folding Carton Antitrust Litigation, 400 Insecticide, case involving, 153–156 In-silico biology, researching, 429 “Institutional Review Board Approval and Publication of Human Research Results” (JAMA article), 111–112 Instruct, failure to, see Failure-to-instruct Instructions, documentation for, 324–326 “Instructions for Authors” (JAMA article), 111 Insurance industry publications, 256 Intended use of product, researching, 220 International Business Machines Inc., United States v., 412 International Congress on Biomedical Peer Review and Global Communications, 116–118 “International Congress on Peer Review in Biomedical Publication, The” (JAMA article), 107 Internet research academic and professional conferences and exhibits, 254 bioinformatics, 429–431 books and journals, 252, 253 effect on peer review, 84 forensics, 435–436 government agencies, 429–431 in-silico biology, 429 law, 435–436, 439–440 materials, design and performance standards, 258 medicine, 429–431 science Web sites, 429–431

449 Interrogatories, 348–356; see also Depositions; Document production requests limitation on number of, 348–349 organizing, 348–355 requests to admit fact or the genuineness of documents, 355–356 supplemental, 361 Inventions, see Patent litigation Investigation, see Discovery, pretrial; Research, pretrial Iowa Fire Equipment Company, Turner v., 147–151 Isaac Newton, The (breach of contract action), 24 “Is There Gender Bias in JAMA’s Peer Review Process?” (JAMA article), 111

J JAMA (Journal of the American Medical Association), 106–112 Johns-Manville Corp., Roesberg v., 341 Johnson and Johnson, Williams v., 408 Johnson Foils v. Huycke Corp., 408 Joiner, General Electric v., see General Electric v- Joiner Joiner, Robert, 50 “Journal’s Peer-Review Process, The” (New Eng. J. Med. article), 113 Journal of Science, 25 Journal of the American Medical Association (JAMA), 106–112 Journal of the Franklin Institutes (scientific journal), 25 “Journal Peer Review” (New Eng. J. Med. article), 112 Journals, scientific, see Scientific literature Jury distraction of, 416 role of, 10–11

K Kaplan, Michael, 97–99 Kelsey, H. Boulter Jr., 99–101 Kidney damage, case involving, see Dennis D., Case of King, Patrick B., 62–64 Kittleson v. Sandoz Pharmaceuticals, 131


450


Knowledge of defect, 383–384 Knowledge of risk, 338, 345 Kumho Tire v. Carmichael, 5, 51–54 and Bourelle v. Crown Equipment, 58 peer review issue, 91–92

L Laboratory equipment, 270 Laboratory tests, 317 LaCava, N. Thomas, 103, 157, 158, 159 Lamm, Steven H., 47, 87 Lancet, The (journal), 112 Lanigan test, 103–104 Launching of Modern American Science, The (Bruce), 12 Laurentano, Arthur M., 103, 157 Law, researching, 435–436, 439–440 Learned Hand, Judge, 35, 52 Legal cause, 139–140 Legal relevancy, 415–416 “Letters” (JAMA article), 110 “Letters in Response to Reviewer Status and Review Quality” (New Eng. J. Med. article), 112 Leukemia, case involving, 183 Leviathan and the Air Pump (Shaplin and Schaffer), 40, 78–79 Lexis and Westlaw databases, 241 Libraries, in early America, 13 Lieberman, Allan D., 101 Literature, scientific, see Scientific literature Litigation researching history of, 225, 241 use of term, 43 Live Yankee, Adrian v., 25 Logical relevancy, 414–415 Logs, test, 309–310 Lung cancer, case involving, see General Electric v. Joiner

M Magazines, as research tool, 252–253 Malpractice, 273 Management staff committee support studies, 306–307 deposing, 365–366 Mandated agency regulations, 331 Manual for Complex Litigation, 163–164

Manuals, production specification, 319 Manufacturing costs of, 279–280 defects from, 37, 38, 232 researching process, 220–221 Marketing decisions regarding product potential, 296 expert witnesses on, 280–281 researching strategy, 223, 227, 241 Marketing documentation, 320–326 advertising and marketing literature, 323–324 documents relating to marketing concerns, 322–323 instructions and warnings, 324–326 marketing stage, 320–322 preliminary studies, 297–298 types of, 372 Market life, planning regarding, 302–303 Marovitz, Judge, 394–395 Mason, Richard, 135 Masters’ theses, 255 Materials, design and performance standards, 257–258 Materials specifications, 319 Materials suppliers, 227, 241 McGhan Medical Corporation, Allison v., 94–99 MCS (multiple chemical sensitivities), case involving, 156–159 Medicine, researching, 429–431 Memoranda, see Documentation, business Mercantile Nat. Bank of Chicago, F.D.I.C. v., 394–395 Merrell Dow Pharmaceuticals, see Daubert v. Merrell Dow Pharmaceuticals Merrell Dow Pharmaceuticals, Daubert v., see Daubert v- Merrell Dow Pharmaceuticals Merrell Dow Pharms., Inc. v. Havner, 176 Methodology, scientific; see also names of individual cases and choice of expert witnesses, 273–274 Microphthalmia, case involving, 1 74–177 Miller, Stanley, 55 “Minimizing the Three Stages of Publication Bias” (JAMA article), 108


Index Misrepresentation pretrial discovery, 345 researching, 223, 235–236 use of term, 39 Mitchell v. Gencorp, Inc., 183 Mitchell v. Tilghman, 21, 24 Model testing, 314–315 “More Peering Into Editorial Peer Review” (JAMA article), 110 “More probable than not” test, 144 Motions-in-limine, 414 confusion of issues and distraction of jury, 416 drafting expert witness affidavit, 419–420 factual components of, 419 hearsay, 417–418 legal relevancy, 415–416 logical relevancy, 414–415 redaction of documents, 418–419 subsequent remedial measures, 417 undue consumption of time, 417 undue prejudice, 416 utilizing expert witness affidavits, 419 Motion to compel discovery, 398–420; see also Motions-in-limine; Protective orders corporate processes, 402 defect allegations, 402–404 drafting expert witness affidavit, 405 factual components of, 401–402 legal components of, 398–399 meeting arguments for each document, 413 needless presentation of cumulative evidence, 417 opposing defense affidavits, 405 specificity of objections, 399–401 time frame, 415 utilizing expert witness affidavits, 404 “Multiple Blinded Reviews of the Same Two Manuscripts” (JAMA article), 111 Multiple chemical sensitivities (MCS), case involving, 156–159 Myelogenous leukemia, case involving, 183

N N.L.R.B. v. Standard Oil Co., 35 Narrative witnesses, 281

451 National Highway Traffic Safety Administration (NHTSA), 212 “Natural, probable consequence” test, 144 Needless presentation of cumulative evidence, 417 Negligence theory, 37 Neuroblastoma, case involving, 170–173 Neuropathy, case involving, 153–156 New Atlantis (Bacon), 77–78 New England Journal of Medicine, 51, 84, 112 “New Inventions” article in Scientific American, 16 Newman, Stuart A., 168 “New Requirements of Authors: Signed Statements of Authorship Responsibility and Financial Disclosure” (JAMA article), 107 NHTSA (National Highway Traffic Safety Administration), 212 Nitroglycerine explosion, case involving, 25–26 Nontechnical expert witnesses, 277 Nopain (drug), case involving, 134–136 Nunez v. Commercial Union Insurance Company, 144–145

O Objections to discovery, 391–398 attorney-client privilege, 396–397 attorney-work-product privilege, 395–396 burdensome and oppressive requests, 394–395 costly and time-consuming research, 395 documentary significance, 397–398 objections to requests, 391–392 relevancy issues, 392–393 vagueness of request, 393 Occupational Safety and Health Administration (OSHA), 212 Office of Research and Development (ORD) study, 101–104 Offices, corporate indexing documents by, 385–386 structure of, 335–336 Oil storage waste pit, case involving, 161–165 Olcott v. Hawkins, 19–20 On Biomedical Peer Review and Global Communications


452


Online searching, see Internet research Operating procedures, standard (SOPs), 336–337 Operational documentation, 336–338 Opinion witnesses, 281 Oppression, as reason for seeking protective order, 410 Oppressive requests, 394–395 ORD (Office of Research and Development) study, 101–104 Organic brain syndrome, case involving, 156–159 Organizational documentation, 332–336 OSHA (Occupational Safety and Health Administration), 212 Overall design defects, 235 Ovulen-21 (contraceptive), case involving, 170–173 Ozone’s effect on artwork, case involving, 62–64

P Pacheco, Daniel, 57–61 Packaging defects, 38, 234, 250 Pain relievers, case involving, see Dennis D., Case of “Paper science”, 3, 38, 55, 56, 59–60 Paraquat, case involving, 172–173 Paresthesias, case involving, 156–159 Parker v. Stiles, 19 Parlodel controversy, 177–186 Parrot v. Barney et al., 25–26 Parsons v. General Motors Corp., 411–412 Parts specifications, 319 Patent litigation, 12 Allen v. Hunter, 20 Bryan et al. v. Stevens, 19 early patents issued, 14–15 expert witnesses, 16–18 Foote v. Silsby, 20–21 French et al. v. Rogers et al., 21 Goodyear v. Day, 21, 22–24 Mitchell v. Tilghman, 21, 24 Olcott v. Hawkins, 19–20 Parker v. Stiles, 19 Whittemore v. Cutter, 18–19 Wyeth v. Stone, 19 Patterson v. Ford Motor Company, 409

PCBs (polychlorinated biphenyls), see General Electric v. Joiner Peer review, 77–129 2001 September Peer-Review Conference Program: Peer Review Congress, 118–121 in Allison v. McGhan Medical Corporation, 94–99 article citations from 1997 International Congress basic process, 82 in Black v. Rhone-Poulenc, 92–94 characteristics of ideal individuals to conduct, 83 criticism of, 81–85 in General Electric v. Joiner, 89–92 journal articles about, 105–116 in Kumho Tire v. Carmichael, 91–92 overview, 77–81 in Pillow v. General Motors, 99–101 Ruffin v. Shaw Industries, 101–104 Supreme Court peer review discussions, 85–92 “Peer Review: Reform or Revolution?” (Br. Med. J. article), 106 “Peer Review 1993” (Lancet article), 112 “Peer Review and Evaluating Peer Reviews” (JAMA article), 110 “Peer Review Goes Under the Microscope” (Science article), 114 “Peer Review in 18th-Century Scientific Journalism” (JAMA article), 109 “Peer Review in Cyberspace” (Science article), 114 “Peer Review in Journals Indexed in Index Medicus” (JAMA article), 111 “Peer Review is an Effective Screening Process to Evaluate Medical Manuscripts” (JAMA article), 110–111 “Peer Review Under Fire” (Sci. News article), 115 Performance levels, product, 329–330 Performance standards, 257–258 Pergament, Eugene, 167 Pesticide toxicology, case involving, 153–156 Phenacetin, case involving, see Dennis D., Case of


Index “Philosophical Basis of Peer Review and the Suppression of Innovation, The” (JAMA article), 107 Pillow v. General Motors, 99–101 Plagiarism, 84 Pointer, Sam C. Jr., 54 “Policy of AMA Journals Regarding Release of Information to the Public” (JAMA article), 110 Political maneuvering, in peer reviews, 83 Polychlorinated biphenyls (PCBs), see General Electric v. Joiner Postmanufacture design changes, 222 Postproduction time frames, 248–249 Powell, Justice, 340–341 Prejudice, undue, 416, 418 Preproduction time frames, 248 Pretrial research, see Research, pretrial “Principles of a machine” concept, 18–19 Prior litigation, identifying, 217 Private technical standards, 221 “Problems Identified by Secondary Review of Accepted Manuscripts” (JAMA article), 109 “Process of Peer Review of Scientific Manuscripts, The” (JAMA article), 107 Production documentation, see Documentation, business Production history, researching, 222 Production schedules, 303–304, 318; see also Time frames Production specification manuals, 319 Production statistics and runs, 320 Production timing charts, 318 Production validation tests, 316–317 Product lines, researching, 223 Product performance levels, 329–330 Product planning, indexing, 389–390 Products, use of term, 38 Professional associations, 253 Professional conferences and exhibits, 253–254 “Promoting Research into Peer Review: An Invitation to Join In” (Br. Med. J. article), 105 Property damage cases, 25–26 Protection against fraud, 409–410 Protective orders, 406–407

453 annoyance, embarrassment, and oppression, 410 document types and case time frames, 412–413 drafting expert witness affidavit, 413–414 factual components of argument in opposition, 412 information sharing, 407–409 protection against fraud, 409–410 requirement of specific supportive facts, 407 trade secrets and confidential commercial information, 410–412 utilizing expert witness affidavits, 413 Prototype testing documentation, 314–315 Proximate cause, 41–42, 131–204; see also Dennis D., Case of; Bellwether trials; Differential diagnosis; Extrapolation theory; Parlodel controversy and actual cause, 138–139 case example, 134–136 and cause-in-fact, 141 expert witness opinions on, 282 indexing, 384–385 language formulations related to, 141–144 and legal cause, 139–140 overview, 131–133 verbal referential tests, 144–145 “Publication of Sponsored Symposiums in Medical Journals” (New Eng. J. Med. article), 113 Publications; see also Documentation, business; Scientific literature academic and professional journals, 253 books, 252 consumer, 258 government, 255 insurance industry, 256 popular, 252–253 Public technical standards, 221 Pulmonary fibrosis, case involving, 172–173 Punitive damages, researching, 228–229

Q Qualifications of expert witnesses, 271 Quality control procedures, 320


454


“Quotational and Reference Accuracy in Surgical Journals” (JAMA article), 109

R Ramsey, Jon Benet, 40 Rational Basis of Legal Institutions (Holmes), 9 Raymark Industries, Inc., Cimino v., 165–166 Reactive airways disease (RAD), case involving, 147–153 Records, see Documentation, business Redaction of documents, 418–419 Reference Manual on Scientific Evidence (Federal Judicial Center), 8, 146, 160 References of expert witnesses, 271 Reflections on the Decline of Science In England and Some of Its Causes (Babbage), 6, 80–81 Regulations; see also Regulatory documentation applicability across model lines, 294–295 corporation’s attitude toward, 366 determining attitude of company towards, 295 expert witnesses on, 278–279 indexing, 389 interrogatories regarding, 354 preliminary regulatory review, 304 researching, 237–238, 243 for testing, 311, 315–316 tracking regulatory activity, 214–215 Regulatory documentation, 326–332 absence of agency activity, 330 cost-benefit analyses and related documentation, 331–332 documents related to government regulation, 326–329 mandated agency regulations, 331 product performance levels, 329–330 proposed agency regulations, 330–331 types of, 372 Regulatory review, preliminary, 304 Rehnquist, Chief Justice, 91 Relevancy issues and defense objections to discovery, 392–393 in the discovery process, 340–341

legal relevancy, 415–416 logical relevancy, 414–415 Reliable science, use of phrase, 80 “Reporting Provocative Results” (JAMA article), 106–107 Requests for documents, see Document production requests; Interrogatories Requests to admit fact, 355–356 Research, pretrial, 207–259; see also Discovery, pretrial; Information sources; State-of-the-art research; Technical problems assessing product’s injury potential, 213–214 bioinformatics, 429–431 company documents, 225 company information, 216 company research, 244 comparative products, 224 component parts and materials suppliers, 227 composite materials, 220 corporate status, 227 defendant’s materials suppliers and marketing scheme, 241 defendant’s organization and processes, 239–240 defining research context, 210 estimating preliminary time frames, 211 external and internal events, 210–211 failure to instruct, 234 failure to warn, 235 federal agency reporting requirements, 222 foreign corporations, 226 forensics, 436–438 government agencies, 432–435 government regulation, 243 identifying potential defendants, 225–226 identifying prior litigation, 217 identifying product defect, 213 industry information, 215, 228 initial investigative concerns, 230–231 initial planning, 208–209 injury history, 224–225 injury producing event, 217–218 in-silico biology, 429 intended use, 220


Index investigative and legal significance of research data, 231 law, 435–436, 439–440 litigation history, 225 locating authoritative literature, 214 manufacturing process, 220–221 marketing strategy, 223 medicine, 432–435 misrepresentation, 235–236 other product lines, 223 overall design defects, 235 packaging defects, 234 product defects, 218 production history, 222 production of suspect unit, 222 product profile, 219 public and private technical standards, 221 punitive damages, 228–229 regulatory information, 212 research points of reference, 232–233 science sites, 429–431 services for, 265–266 successor corporations, 226 technical information, 211–212 theoretical defects, 218–219 tracking regulatory activity, 214–215 unit defects, 233 wholesalers, distributors and retailers, 227–228 Respiratory disorder, case involving, 147–151 Restatement (Second) of Torts, Section 402A, 36, 37 Retailers, researching, 227–228 “Revision of Manuscripts for Scholarly Publication” (Radiologic Tech article), 115 Rhone-Poulenc, Black v., 92–94 Rhone-Poulenc’s Institute, case involving, 92–94 Risk, knowledge of, 338, 345 Risk-utility test, 37 Roesberg v. Johns-Manville Corp., 341, 399–400 Rogers et al., French et al. v., 21 Rozier v. Ford Motor Company, 410 Rubber process, case involving, 21, 22–24 Ruffin v. Shaw Industries, 101–104 Rule 702, 48

455 Rules of Civil Procedure, see Federal Rules of Civil Procedure Rules of Evidence, see Federal Rules of Evidence “Ruling Out Ingelfinger?” (Lancet article), 112

S Safety offices, 328 Safety precautions early decisions regarding, 297–298 preliminary regulatory review, 304 in target market, 321 St. John Green, Nicholas, 141–142 Saloman’s House (fictitious institution), 77–78 Sandoz Pharmaceuticals, Kittleson v., 131 Sandoz Pharmaceuticals Corporation, Siharath v., 177–186 Sandoz Pharms. Corp., Globetti v., 181 Scatted, Sam, 94 Schaffer, Simon, 40, 78–79, 158 Schecter, Arnold, 89 Schedules, production, 303–304, 318; see also Time frames Schrager, Thomas, 93 Science; see also History of science and litigation use of term, 3–5, 17 Web sites about, 429–431 Science (journal), 113–114 Scientific American (periodical), 14–16 Scientific literature in Allison v. McGhan Medical Corporation, 95–97 in Bourelle v. Crown Equipment, 59–60 in Daubert v. Merrell Dow Pharmaceuticals, 87–89 in General Electric v. Joiner, 89 in Kumho Tire v. Carmichael, 53 locating for research, 214 peer reviewing by, 82–83 in In re: Silicone Gel Breast Implant Products Liability Litigation, 54 reliance on in history, 20–21, 22, 25 in Turner v. Iowa Fire Equipment Company, 150–151 Scientific methodology, see Methodology, scientific


456


Scotti, Joseph, 92–94 “Second International Congress on Peer Review on Biomedical Publication, and Structural Transformations of the Sciences and the End of Peer Review, The” (JAMA article), 110 Sections, corporate, 335–336 Self-certifying testing systems, 311 Sellers, use of term, 38 Settlements, researching, 225, 241 Shanklin, Douglas, 94 Shapin, Steven, 40, 78–79, 158 Sharing information, 407–409 Shaw Industries, Inc., case involving, 101–104 Shaw Industries, Ruffin v., 101–104 Shepherd, Thomas, 168 Sherwin Williams Company, case involving, 101–104 “Should non-peer-reviewed Raw DNA Sequence Data Release Be Forced on the Scientific Community?” (Science article), 114 Siharath v. Sandoz Pharmaceuticals Corporation, 177–186 Silicone breast implants, case involving, 94–97 Silsby, Foote v., 20–21 “Simplicity and Complexity in Conflict of Interest” (Science article), 113 Simpson, O. J., 40 Single blinding, in peer reviews, 83–84 Sloan, Donald, 135 Sole practitioners, as expert witnesses, 268–269 SOPs (standard operating procedures), 336–337 Special Liability of Seller of Product for Physical Harm to User or Consumer, 36 Specifications finalization of, 222, 390 materials and component parts, 319 Specific supportive facts, requirement of, 407 Speculation in Bourelle v. Crown Equipment, 59–60 in Frey v. Chicago Conservation Center, 63–64 Spencer Cowper’s Trial, 16–17

Staff, corporate; see also Depositions structure of, 334–335 Staff support, of expert witness services, 269–270 Standard Oil Co., N.L.R.B. v., 35 Standard operating procedures (SOPs), 336–337 Standards materials, design and performance, 257–258 technical, 221 testing, 310 State-of-the-art research, 242, 244–250 defect types, 250 time frames, 245–250 Statistical publications and data banks, 257 Statisticians, as expert witnesses, 279 Statistics, production, 320 Steamboat boiler, case involving, 25 Stevens, Bryan et al. v., 19 Stiles, Parker v., 19 Stone, Wyeth v., 19 Story, Justice Strokes, case involving, 177–186 Study In Scarlet, A (Doyle), 287 “Subject matter” test, 396 “Substantial factor” test, 144, 145 Suppliers, researching, 227–228, 241 Supreme Court key cases, 44–54 Frye v. United States, 45–50 General Electric v. Joiner, 45–51 Kumho Tire v. Carmichael, 51–54 Systolic blood pressure deception test, see Frye v. United States

T Technical expert witnesses, 276–277 Technical facilities, 270 Technical feasibility studies, 301–302 Technical problems extent of, 236–237 identification of, 236 responses to, 237–241 Technical staff, deposing, 364–365 Technology, history of, see History of science and litigation Technology Review (journal), 114 Teitelbaum, Daniel, 89 Telegraphs, case involving, 21


Index Testimonial experience, of expert witnesses, 274–275 Testing documentation, 307–318 certification, 316 comparative product tests, 315–316 documentation relating to testing program, 317–318 formal test reports, 312–314 indexing, 372, 388–389 informal test reports, 312 laboratory, 317 production validation tests, 316–317 prototype, 314–315 testing standards, 310 test logs, 309–310 test requests, 310–311 types of, 372 Testing of products, 221, 224, 243 for defect determination, 281–282 and time frames, 245–250 Tharaldson, Goeb v., 153–156 Tharaldson, Timothy, 153–156 “The Authorship and Fate of International Health Papers Submitted to the American Journal of Public Health in 1989” (Am. J. Pub. Health article), 105 Theoretical defects, researching, 218–219 Theories, indexing, 384 Theses, masters’, 255 Through the Looking Glass (Dodgson), 261 Tilghman, Mitchell v., 21 Time frames, 245–250 in design defect cases, 343–345 expert witness opinions on, 284–285 in failure to warn cases, 345 finalizing choice of, 341–342, 346–347 and logical relevancy, 415 in misrepresentation cases, 345 Timing charts, production, 318 Timing studies, documentation for, 303–304 Tire explosion, case involving, see Kumho Tire v. Carmichael Toluene Drying System, case involving, 92–94 Tooling studies, documentation for, 299 “To Publish or Not to Publish” (Hastings Center Rep. article), 115 “To the American Public” (article in Scientific American), 15–16

457 Toxic encephalopathy, case involving, 151–153 Trade and professional associations, 253, 254 “True peer review”, 85–86 Trull v. Volkswagen of America, Inc., 145 “Truth, Beauty, and Peer Review” (Technology Review article), 114 Turner v. Iowa Fire Equipment Company, 147–151

U Undue consumption of time, 417 Undue prejudice, 416, 418 “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” (Pub. Health Rep. article), 115 Unit defects, 233, 342–343 United States, early scientific knowledge, 12–13 United States, Frye v., 26 United States Supreme Court, see Supreme Court United States v. International Business Machines Inc., 412 United States v. Taylor, 25 United States v. Taylor, United States v., 25

V Validation tests, production, 316–317 Van, case involving, 145 Van Orsdel, Judge, 46 “Variation in Journal Peer Review Systems” (JAMA article), 109 Verbal referential tests, 143, 144–145 Verdicts, researching, 225, 241 Volkswagen of America, Inc., Trull v., 145 Volkswagen van, case involving, 145

W Warnings; see also Failure-to-warn on analgesics packages, 136 documentation for, 324–326 Wastewater, case involving, 151–153 Water & Light Department, see General Electric v. Joiner Web, World Wide, see Internet research Webster, Daniel, 22, 23


458


Webster, Noah, 13 Wendling, Rhonda, 56 Whalen, Buehler v., 410 “What Can and Should Be Done to Reduce Publication Bias?” (JAMA article), 108 “What Do Peer Reviewers Do?” (JAMA article), 109–110 “What Makes a Good Reviewer of Manuscripts?” (Br. Med. J. article), 106 Whittemore v. Cutter, 18–19 “Who are the Peer Reviewers and How Much Do They Review?” (JAMA article), 108 Wholesalers, researching, 227–228 Williams v. Johnson and Johnson, 408 Winterbottom v. Wright, 36

Witnesses, expert, see Expert witnesses Wong, Paul, 167 Woodworking machine, case involving, 19–20 World Wide Web, see Internet research Wright, Winterbottom v., 36 Wyeth v. Stone, 19 Wynacht v. Beckman Instruments, 151–153

Y “Your Letter Failed to Win a Place” (Br. Med. J. article), 106

Z Ziem, Grace E., 151–153

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