The Clash of Medical Evidence and the Law in the Breast Implant Case

Marcia Angell, M.D. W.W. Norton -- 256pp -- $27.50

About a year ago, I started receiving mailings from Dow Corning Corp., one of the primary manufacturers of breast implants and the target of hundreds of thousands of lawsuits from women who have gotten them. Unsurprisingly, the clippings contained articles that denied any connection between breast implants and the terrible diseases they were accused of causing. At first, I shrugged the material off as company propaganda. But it wasn't much later that scientific articles and a wave of news reports led me to begin to question the accusations being made against implants.

Dr. Marcia Angell, the author of Science on Trial, began her questioning back in 1992. That's when Dr. David A. Kessler, head of the Food & Drug Administration, banned breast implants--ostensibly because there was not enough scientific evidence to prove they were safe. He submitted an article to the New England Journal of Medicine--where Angell is executive editor--outlining his reasons for the ban. After reviewing the manuscript, Angell realized that politics, public opinion, and the law played as great a role in Kessler's decision as science. Then, in 1994, just weeks after besieged implant manufacturers, including Dow Corning, had agreed to set aside $4.2 billion to meet the claims of women with breast implants, doctors from the Mayo Clinic submitted the first epidemiological study to the journal finding no link between implants and connective-tissue disease.

In Science on Trial, Angell tells a tale that is becoming increasingly familiar. Fearing that new technology, ranging from medical devices to cellular phones, may be inherently harmful, the public and courts are quick to find fault without waiting for scientific evidence. With breast implants, courts awarded multimillion-dollar judgments based on heart-rending anecdotes, unsubstantiated theories, and debatable expert opinion. But the scientific studies were nowhere to be found.

The cost of these actions is staggering. Implant manufacturers have spent hundreds of millions on claims so far. Dow Corning--an international supplier of silicone adhesives and other products, where implants made up just 1% of the business--filed for bankruptcy. At this point, the settlement is in a shambles as a result of that bankruptcy.

Angell's book highlights the dissonance between the culture of science and that of the legal world. Perhaps the biggest problem with science in the courtroom, according to Angell, is that it cannot provide absolutes. In the case of breast implants, for example, the Mayo Clinic study set out to test the hypothesis that implants increase the risk of connective-tissue disease. But researchers ``could not find an association between implants and the diseases and symptoms they studied. If they had said that implants do not cause connective-tissue disease, they would have gone beyond what their data could support. The study did not rule out a connection.''

In science, as more and more studies back up a hypothesis, it becomes accepted as a powerful or even reigning theory--but rarely as undeniable fact. (The connection between smoking and cancer is regarded as nearly incontrovertible--but only after 30 years of painstaking research.) In the hands of an adroit lawyer, however, such scientific caution is forgotten, as theories become powerful arguments for causation. Some so-called expert witnesses steamroll over complex scientific evidence--instead spinning theories that they say are supported by their experience or unspecified research. In reality, these experts often do not have relevant experience, says Angell, and their research may be unpublished or out of the mainstream. ``The result,'' she writes, ``is a growing gap between scientific reality and what passes for it in the courtroom.''

The public is quick to believe courtroom explanations in the case of implants, argues Angell, because of growing anti-science sentiment in the U.S., a topic to which she devotes a chapter of the book. Coming in for particular scrutiny are ``anti-science feminists'' who embrace the idea that implants are deadly and, according to the writer, dismiss value-free research as a delusion fostered by a male-dominated profession that ignores ``intuitive, multi-faceted thinking.'' As a result, these feminists, as well as the people who have given in to speculation and mysticism, ``...could believe that implants caused disease because they `knew' it.''

Other chapters are devoted to the history of breast implants, a primer on scientific evidence, and an illuminating look at who is profiting from breast-implant litigation: a suspect group of doctors, expert witnesses, and inevitably, lawyers, Angell argues. At times, she is too strident in her defense of scientific method: A ``reliance on concrete evidence distinguishes science from all other human endeavors,'' she writes. But given that she is an editor at a premier scientific journal, this can be forgiven. And Science on Trial is extremely well-documented, even though, at times, Angell relies too heavily on press reports--especially from The New York Times--instead of original research.

Science on Trial is an important book that makes a strong case for bringing well-documented science into the courtroom as the best deterrent against such legal circuses as the breast-implant controversy or looming cases involving a variety of medical-device makers. Have a look, counselor.

By Naomi Freundlich


Updated June 14, 1997 by bwwebmaster
Copyright 1996, Bloomberg L.P.
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