Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case

Overview

When the FDA banned silicone gel-filled breast implants in 1992, it was responding to mounting concerns that they caused autoimmune and connective tissue disease. The ban triggered a torrent of litigation, as women by the thousands sued breast-implant manufacturers. Sympathetic juries awarded huge damages, leading to a $4.25 billion class-action settlement that still wasn't large enough to cover all the claims. Shockingly, rigorous scientific studies of breast implants then began to show that there is no ...
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Overview

When the FDA banned silicone gel-filled breast implants in 1992, it was responding to mounting concerns that they caused autoimmune and connective tissue disease. The ban triggered a torrent of litigation, as women by the thousands sued breast-implant manufacturers. Sympathetic juries awarded huge damages, leading to a $4.25 billion class-action settlement that still wasn't large enough to cover all the claims. Shockingly, rigorous scientific studies of breast implants then began to show that there is no significant link between breast implants and disease. Why were the courts and the public so certain that breast implants were dangerous when medical researchers were not? The answer to this question reveals important differences in the way science, the law, and the public regard evidence - and not just in the breast-implant controversy. As our society becomes ever more dependent, at all levels, on science and technology, misconceptions about scientific evidence become an increasing danger to the public good - with consequences that extend far beyond the question of whether silicone gel-filled breast implants are safe.

Discusses breast implants, what they are, who has them, the FDSA ban, litigation, scientific evidence, where we stand.

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Editorial Reviews

Publishers Weekly - Publisher's Weekly
Angell, executive editor of the New England Journal of Medicine, explores here a preposterous situation: an industrial giant, Dow Corning, forced into Chapter 11 bankruptcy by numerous lawsuits filed on behalf of recipients of Dow's silicone breast implantsdespite the fact that medical evidence to date shows no link between implants and autoimmune disorders, cancer or any other disease. In a style that ranges from gently didactic to plodding, Angell describes the events leading up to the FDA's ban on implants, the torrent of lawsuits that followed and the implications of the verdictsoverwhelmingly favorable to the plaintiffs and often carrying cash awards in the millions of dollarsfor science and industry. Manufacturers have threatened to stop producing heart valves, shunts and other vital medical devices because of the threat of liability; further, suppliers of raw materials for these devices often refuse to sell to American companies for fear of ending up in an American courtroom. The author gives a clear explanation of the way science calculates risk by considering populations, not individuals and ably contrasts this with our judicial system, where the focus is on the individual seeking restitution. Angell is an effective champion of the scientific method and does a good job of exposing the chaos caused by a runaway tort system, but she offers no resolution to the state of affairs she describes. July
Library Journal
Angell, executive editor of the New England Journal of Medicine, addresses the controversy over silicone breast implants, which were banned and the subject of huge lawsuits despite dubious scientific evidence of harm. She suggests that lawyers and journalists have misinterpreted scientific results and ignored evidence, leading to the public's growing mistrust of science and the scientific method. Replacing cynicism with a more balanced ability to view scientific results critically is crucial to our health, notes Angell. But her case for scientific objectivity is disappointingly murky. She sweepingly dismisses the validity of controversial ideas only now being thoroughly researched (e.g., alternatives to technological medicine, criticisms of male biases in science), which undermines her credibility. Still, this remains a compelling book. Recommended for public and academic libraries.Constance A. Rinaldo, Dartmouth Coll., Biomedical Lib., Hanover, N.H.
William Beatty
Angell, executive editor of the "New England Journal of Medicine", explores the roles of the media, the medical and legal professions, and the public in the long-running silicone breast implants story. She frankly admits that her social and political outlooks had initially prepared her to go along with the thousands of women and their lawyers who claimed implants had caused connective tissue disorders and other medical problems. As a physician and editor, however, she realized that that relationship had to be based on scientific evidence rather than popular opinion. That meant evidence had to be sought, evaluated, and compared with the claims of the victims and their lawyers. Angell shows that scientific studies suggest there is no such connection. She concludes with suggestions for improving legal procedures: no contingency fees for lawyers and tort trials by a judge since juries are not scientifically qualified, with neutral expert witnesses to be appointed by the judge. She condemns physicians who appear as expert witnesses but do not use scientific evidence.
Kirkus Reviews
A well-crafted demonstration of how differently the law, the public, and science regard evidence, using the breast implant controversy as a case in point.

When the FDA banned silicone-filled breast implants in 1992, lawsuits by women who claimed to have been damaged by them skyrocketed. Eventually the implant manufacturers, having lost one case after another, agreed to the largest class-action settlement ever ( billion), despite the fact that as yet there is no scientific evidence that implants cause connective tissue disease. For Angell, executive editor of the New England Journal of Medicine, the breast implant story has several major themes: goverment regulation and its role in American society, excessive litigation within a flawed tort system, the public's lack of understanding of scientific evidence, the role of so- called expert testimony in the courtoom, greed and corruption, and the media's alarmist approach to medical news. When Angell, a self-described feminist and liberal Democrat, began researching the breast implant story, she was prepared to find corporate greed at its core. What she found was that the shortcomings of big business paled in comparison with those of three professions: law, medicine, and journalism. As for the law, she outlines problems and suggests reforms in our tort system and calls for raising scientific standards in the courtroom, especially in the use of expert witnesses. She castigates doctors who have lucrative arrangements with lawyers to provide their clients with dubious diagnoses, and journalists who stir up health scares in a gullible public.

An exceptionally clear explanation of the nature of scientific evidence, and a powerful plea for broader public understanding of it.

Wall Street Journal
“An indispensable guide to the breast implant madness—litigation that will forever stand as a monument to the inability of our civil justice system to sort out latter-day Ptolemies from Galileos.”
New York Times
“[A] sober and rigorous examination of the controversy over silicone breast implants . . . an important statement, not just about silicone implants, but about other matters at the intersection of law, science, and opinion. [Dr. Angell’s] book is . . . a warning that rationality, like much else in the fragile porcelain of society, can be weakened by lack of vigilance.”
Shirley M. Hufstedler
“Marcia Angell's outstanding book explains clearly and fairly the combination of greed, fear, ignorance, junk science, and media hype that created this national litigation nightmare. Everyone interested in the tort system, science, and medicine should heed the lessons that Dr. Angell teaches.”
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Product Details

  • ISBN-13: 9780393039733
  • Publisher: Norton, W. W. & Company, Inc.
  • Publication date: 6/1/1996
  • Edition number: 1
  • Pages: 256
  • Product dimensions: 5.81 (w) x 8.51 (h) x 1.02 (d)

Meet the Author

Marcia Angell is the executive editor of the New England Journal of Medicine.

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Table of Contents

Preface 9
Acknowledgments 15
1 The Breast Implant Story: Once Over Lightly 19
2 Breast Implants: What They Are and Who Has Them 33
3 The FDA Ban on Implants: Regulation in Modern America 50
4 The Rush to Court: Litigation and More Litigation 69
5 Scientific Evidence: What It Is and Where It Comes From 90
6 Science in the Courtroom: Opinions without Evidence 111
7 Greed and Corruption: All That Free Money 133
8 Americans and Health News: The Alarm of the Day 154
9 Breast Implants and the Rejection of Science: Other Ways of Knowing 177
10 Where We Stand ... and for How Long 192
Notes 211
Index 247
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