Michael D. Green - Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation
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Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation
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Benedictin was prescribed to more than thirty-five million American women from its introduction in 1956 until 1983, when it was withdrawn from the market. The drugs manufacturer, Merrill Dow Pharmaceuticals, a major U.S. pharmaceutical firm, joined a list of other companies whose product liabilities would result in precedent-setting litigation. Before it was over, the Benedictin litigation would involve 2,000 claimants over a fifteen-year period. Michael D. Green offers a comprehensive overview of the Benedictin case and highlights many of the key issues in mass toxic substances litigation, comparing individual and collective forms of litigation, and illustrating the misunderstandings between scientists and lawyers about the role of science in providing evidence for the legal system.
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The Challenges of Mass Toxic Substances Litigation
Michael D. Green
Page iv
Copyright 1996 by the University of Pennsylvania Press All rights reserved Printed in the United States of America
Library of Congress Cataloging-in-Publication Data
Green, Michael D., 1950 Bendectin and birth defects : the challenges of mass toxic substances litigation / Michael D. Green. p. cm. Includes bibliographical references and index. ISBN 0-8122-3257-7 (alk. paper) 1. Products liabilityDrugsUnited States. 2. Toxic torts United States. 3. Complex litigationUnited States. 4. BendectinToxicology. 5. Abnormalities, Human. I. Title. KF1297.D7G74 1996 346.7303'8dc20 95-42306 [347.30638] CIP
Page v
To my children, ABBY, BRETT, and ROSS for whom I am endlessly grateful
Page vii
Contents
Preface
ix
Acknowledgments
xi
1 A Birth Defect Child Is Born
1
2 Locating Bendectin within the Mass Toxic Landscape
4
3 The Science of Determining Toxic Causation
26
4 The Food and Drug Administration
44
5 The Wm. S. Merrell Company
61
6 A Mother's Quest
96
7 The Mekdeci Case
121
8 The Unraveling of Mekdeci
148
9 The Proliferation of Bendectin Litigation
159
10 Litigating a Multidistrict Case
167
11 The Withdrawal of Bendectin
180
12 Forging a Mass Toxic Substances Trial
189
13 The Settlement and Unsettlement of MDL-486
207
14 The MDL-486 Trial
226
15 Aggregative Procedure in Mass Toxic Substances Litigation
237
16 The Third Phase of Bendectin Litigation: Oxendine, Richardson, and the Individual Trials
273
17 The Legacy of Bendectin for Toxic Causation Law
299
18 The Lessons and Non-Lessons of Bendectin Litigation
328
Selected Bibliography
353
Index
361
Page ix
Preface
When Bendectin litigation first emerged, with allegations that it caused birth defects, I was a young law professor who was teachingand learningproducts liability law. I took notice of the litigation as well because a dear friend had suffered from severe morning sickness during her first pregnancy, and I knew that she had used Bendectin to help quell her nausea and vomiting. The emerging concerns about birth defects posed a quandary for me as to whether I should alert my friend about these developments during her next pregnancy. I chose the uncourageous path, consoling myself that I really didn't know whether there was any truth to the claims.
Later, in the mid-1980s, while working on a Products Liability casebook, I was reading Bendectin cases that reached conflicting outcomes, which further piqued my curiosity. How could these cases be resolved differently? What was the situation with regard to the evidence of Bendectin's connection with birth defects? The early stages of asbestos litigation had been characterized by similar differing results, and I decided that it might be interesting to investigate Bendectin litigation. I was lucky enough to have a job that permitted me to do so. Around that time, Peter Schuck published his splendid account of the Agent Orange litigation and that book served as a model for my effort. Schuck's work stands as a standard for an increasing number of in depth chronicles of prominent case congregations.
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