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Commentary: Breast Implant Cases: Let The Science Testify

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It's a legal nightmare. Years after the implant controversy began, U.S. courts are still clogged with tens of thousands of lawsuits from women alleging that the devices made them sick. Yet no one has conclusively proved that the silicone sacs cause disease. So isn't it tempting to put the science on trial? Let a jury decide whether the claims have medical merit--or are the result of a legal system run amok.

That's essentially what the major implant maker, Dow Corning Corp., proposed on Dec. 2 as part of its bankruptcy-settlement plan. The idea: Have impartial, court-appointed experts lay out the scientific evidence in front of a jury of regular citizens picked by the court.

HARD LOOK. The proposal is an excellent idea, though putting it in place will be a tough sell. The hundreds of thousands of women (and their lawyers) claiming injury are already fighting the Dow gambit. But Dow's proposal is part of an encouraging trend: bringing more impartial science into the courtroom.

That surely would be bad news for the plaintiffs. In recent years, epidemiologists from institutions such as the Mayo Clinic & Foundation and Harvard University--who studied thousands of women with implants--failed to find a link between the devices and maladies such as scleroderma, joint pain, chronic fatigue, and arthritis. That's strong enough evidence for most juries to render a "not guilty" verdict. "This question has been answered to a degree that would satisfy almost any objective observer," argues Dr. John S. Sergent, chief medical officer at Vanderbilt University School of Medicine, who has testified as an expert before a congressional panel. While some doctors say implants have caused disease in their patients, scientists don't consider anecdotal reports to be scientific evidence. They say the big studies have settled the question.

That means that Dow assumes it will win the "science trial" it is proposing. That would save the company a lot of money. Under the proposed settlement, Dow will spend $600 million compensating women for problems such as ruptured implants or injury to the breast. An additional $1.4 billion set aside for a host of diseases claimed to be caused by silicone wouldn't be disbursed if the claims are dismissed as invalid.

That's why plaintiff lawyers, who depend on wrenching tales of a victim's suffering to sway juries, can't accept Dow's plan. The proposed trial wouldn't give individual doctors an opportunity to testify. That means the jury would be unlikely to hear about a patient who got significantly better after her implants were removed. Such true-life stories are enough to cause even the most objective jury to wonder whether the evidence is as clear-cut as scientists say. While epidemiological studies can show that the risk posed by implants is small, they can never prove that no one was hurt.

CRACKDOWN. As some legal experts say it will simply take more time for the science to catch up to the litigation, some judges are taking matters into their own hands. In Birmingham, Ala., U.S. District Judge Sam C. Pointer Jr. took the unusual step of asking an impartial scientific panel to review all the evidence in an upcoming case. His tactic could embolden other judges to crack down on anecdotal, unscientific evidence. Already, an Oregon judge has barred plaintiffs' experts who can't produce strong scientific evidence from testifying. "I'm very happy to see judges acknowledging that the adversarial process has not worked well," says Dr. Marcia Angell, executive editor of New England Journal of Medicine.

The plaintiffs' bar won't take these developments lying down. Trial lawyers learned the hard way back in 1985, when things went terribly wrong from their perspective. Drugmaker Marion Merrell Dow Inc. used a "science trial" similar to that proposed by Dow to end hundreds of lawsuits alleging that the antinausea drug Bendectin caused birth defects. The lesson of the case, where emotional tales of individual woe were not presented, is that "lawyers have great difficulty winning if you delete the sympathy factor," admits New York trial lawyer Paul D. Rheingold.

Having courts try to pick impartial experts isn't without pitfalls, of course. Few scientists are truly impartial, and very little science is totally certain. But developments such as Judge Pointer's panel and Dow's proposal are on the right track.By John Carey

The Epic Hack

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