BMJ No 7068 Volume 313

Medicine and Books Saturday 23 November 1996


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

M Angell
W W Norton, £22 (to be published January 1997), pp 256
ISBN 0 393 03973 0

A trend in American litigation has important implications not only for those who practise medicine but also for those who purchase and organise it and for those who make equipment that clinicians use. By describing one particular case in the United States courts, this book focuses on the clash between medical and legal definitions of evidence that has received little attention hitherto but which is relevant world wide.

The story itself is relatively simple. A few women claimed that health problems, notably connective tissue disease, had resulted from their breast implants. A few "expert" witnesses asserted that this was the case and propounded theories about how such a causal relation might operate. There was not, and never has been, any strong evidence based on good epidemiological research that breast implants actually cause connective tissue disease, using conventional criteria for defining a causal relation. On the basis of no good evidence the major manufacturers agreed to pay $4.25 billion to women with breast implants, a billion dollars being explicitly earmarked for the lawyers. Some 440 000 women, as many as a third of all women with breast implants, were involved in the class action. For many of them their lives and health will never be the same again.

It is a fantastic story, well told by Marcia Angell, the executive editor of New England Journal of Medicine. But within this simple story a number of disturbing issues emerge, some, but not all, peculiar to the United States because of its legal system. Angell has six main themes: the place of regulation in American life today; the impact of litigation on American life, doctors, and lawyers; the "marginal and ambiguous role of scientific evidence"; the management of science in the courtroom; "the pervasive effect of the profit motive on so much of our public life"; and the way in which the media present medical issues to the public. All of these are relevant and important beyond the shores of the United States.

Of greatest interest to readers of the BMJ will probably be the two themes on science in the courtroom and "the marginal and ambiguous role of scientific evidence in our society." Those involved in the future of public policy will find much of interest in Dr AngelI's discussion on the place of regulation in a market economy and the profit motive; I doubt that Dr Angell will have voted Republican this fall, but her opinions are balanced and she reveals her biases sufficiently to allow the reader to adjust for them without distorting her account of events.

She makes clear how clever lawyers or lobby groups can find "an expert" with a story to tell and make them an influential public figure and a witness that juries find credible. Some of the descriptions of lawyers make the blood run cold. The role of the "expert witness," on whom so much hinges, is surely a topic worthy of serious study by lawyers and doctors on both sides of the Atlantic.

One of the popular columns in a Glasgow weekly paper, the Weekly News, was called "Stories from the Police Courts." Perhaps the BMJ needs to collect some more stories from the medicolegal courts, harrowing experiences of doctors and patients, and reports of the manipulation of science by lawyers. These would make compelling reading and build up a body of evidence that would allow us in health care to change the way in which science is managed in court. The need for this in the United Kingdom has been highlighted recently by the president of the Royal Statistical Society, who lambasted the legal profession in his presidential address. He quoted one ruling on evidence of a statistical nature: "'Evidence of the Bayes theorem or any similar statistical method of analysis in a criminal trial plunged the jury into inappropriate and unnecessary realms of theory and complexity, deflecting them from their proper task.... their Lordships.... had very grave doubts as to whether that evidence was properly admissible because it trespassed on an area peculiarly and exclusively within the jury's province, namely the way in which they evaluated the relationship between one piece of evidence and another. The Bayes theorem might be an appropriate and useful tool for statisticians, but it was not appropriate for us in jury trials or as a means to assist the jury in its task.' So there we have it. To hell with rationality as we know it-their Lordships have pronounced."

Dr Angell's excellent book should be read by all who are concerned about both medical science and justice. Compulsory epidemiology courses for judges may be an unreasonable aim, but some training in critical appraisal of evidence would seem to be essential.

J A MUIR GRAY,
director of research and development,
Anglia and Oxford NHS Executive,
Oxford



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