BOSTON -- It's official. A panel of four scientists appointed by the judge who oversees all breast implant litigation in the Federal courts announced last week that the scientific evidence so far has failed to link breast implants with immune disorders.
That did not surprise scientists familiar with the issue. Implants sometimes leak or rupture, causing scarring in the breast, but there never was any credible evidence that silicone breast implants cause disease in the rest of the body. Yet over the past decade, litigation based on the possibility that breast implants cause immune disorders has dwarfed even asbestos lawsuits in the number of claimants and the amount awarded in damages.
Yes, there have been plenty of reports of women with breast implants who became ill. But it is necessary to figure out if the connection is coincidental. About a million American women have breast implants. A similar number of women in the general population are known to have some type of immune disorder, like rheumatoid arthritis or lupus. If we assume that there are 100 million adult women in the United States, then by coincidence alone about 10,000 of them will have both breast implants and an immune disorder.
To find out whether the claimed connection was more than coincidental, a score of epidemiologic studies compared women with breast implants to women without implants. Not one has shown that women with implants are more likely to get sick than other women.
So why the disconnect between science and the justice system? One problem is the way experts are used in courts. Product liability cases often involve disputes over matters of biological fact, like whether breast implants cause disease. Experts are hired by lawyers on both sides to present their opinions. But they are not required to cite scientific evidence -- a vague reference to their own "experience" or "unpublished research" will often do -- and they are virtually certain to try to buttress the claims of the lawyers who hired them, no matter how farfetched.
Juries rely heavily on expert testimony in these cases. Federal judges are supposed to screen out testimony that is not reliable and relevant before it is admitted into court. But judges are not trained to evaluate scientific testimony and tend to allow the airing of unsubstantiated opinions rather than risk excluding well-founded opinions.
That is why the appointment of a panel of scientists by Judge Sam C. Pointer Jr., who oversees breast implant cases in Federal courts, was so important. The four panelists were experts in fields related to silicone and immune disorders. Since they were hired by the court instead of by opposing lawyers, they had no stake in the outcome. Most important, they studied all the relevant published research and questioned expert witnesses chosen by both sides.
The implications of the report will reach beyond the breast implant controversy. Courts trying technical cases have become a hotbed of junk science, and the inconsistent and capricious jury verdicts that result often have more to do with the theatrical talents of the lawyers and expert witnesses than with the facts.
As class-action lawsuits become increasingly common, Judge Pointer's appointment of a dispassionate panel of experts to evaluate the strength of the scientific evidence is a model more courts should follow.
Marcia Angell, the executive editor of The New England Journal of Medicine, is the author of "Science on Trial," about breast implant cases.
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