Why Judges Must Fight Bad Science : Big settlement in silicone implant cases reveals problem
The latest study to find no link between silicone breast implants and a variety of connective-tissue disorders underscores the conflict between scientific research, which is experimental and often ambiguous in nature, and the legal system, which allows for little ambiguity in reaching judgments. The study comes just a month after the Dow Corning Corp. filed for bankruptcy to protect itself against a riptide of legal claims from women who believe implants caused scleroderma, lupus, rheumatoid arthritis and other grave illnesses. And it comes 15 months after Dow Corning and other manufacturers agreed to set up a $4.2-billion fund to pay claims--claims for which there is scant scientific basis.
The companies were forced to act because tort lawyers have managed to use anecdotal evidence from undeniably ill patients and their doctors to persuade juries that there is a causative link. With more than 1 million women having received implants since 1962, the companies faced daunting monetary damages.
FEEDING FRENZY: The new study, from Harvard and the Brigham and Women’s Hospital in Boston, monitored 87,501 American women, all nurses. It found that those who had had breast implants were actually slightly less likely than others to have any of the suspect diseases or even symptoms of other autoimmune maladies thought to be related to leaking silicone implants. The Boston study had certain flaws, but it seconded numerous other studies, including one by the prestigious Mayo Clinic in Minnesota.
That said, the claims of plaintiffs’ lawyers and doctors that many of the women have rare immune diseases not detectable by conventional means should not be rejected out of hand. It is also worth noting that the implants were marketed before there were federal rules governing their safety and despite the fact that makers knew then they could leak and inflame nearby tissue.
But something is amiss here. Three years ago, the Food and Drug Administration banned cosmetic use of silicone implants, without conclusive proof they were harmful. Major makers of silicone and other polymers, including Du Pont, have pulled out of the market, causing an increase of as much as 15 times in the prices of silicone for catheters, heart valves and other crucial medical devices.
The $4.2-billion settlement approved by U.S. District Judge Samuel C. Pointer Jr. of Alabama has predictably begun to fall apart, because some avaricious lawyers, like bees swarming over a honey pot, have been recruiting plaintiffs to feed on awards of $105,000 to $1.4 million promised each claimant.
BARRIER TO JUNK SCIENCE: The lessons here are both complex and compelling. Silicone is not the only such case. Judges and juries have often overlooked rational evidence to award damages against the makers of Bendectin, a morning-sickness drug accused of causing birth defects. We are not arguing that tort law should be crippled to protect major corporations or polluters. The right to sue for damages should be preserved when the scientific evidence that a manufacturer has marketed a dangerous product is unequivocal, as in the case of tobacco.
Given the financial incentives, one cannot expect restraint from the tort bar. It is incumbent, therefore, on judges to take a more active role as gatekeepers to keep dubious science and dubious experts out of the courts. Many scientific and legal organizations are coming to their aid. And the Supreme Court, in the 1993 case of Daubert vs. Merrell Dow Pharmaceuticals, involving Bendectin, gave judges greater authority to control what scientific evidence could be introduced, at least in federal courts. That rule should be extended to the courts of California and other states before we encounter more legal imbroglios like the silicone implants.
