Many Torts Later, the Case Against Implants Collapses

By Doug Bandow
Copyright 1998 Wall Street Journal
November 30, 1998


A week from today the Supreme Court is scheduled to hear oral arguments in Kumho Tire Co. v. Carmichael on the admission of expert testimony. This seemingly esoteric, technical issue carries great practical import, given the explosive spread of junk science in the courtroom.

Consider silicone breast implant litigation, one of the great legal deluges in history: More than 176,000 women have filed suit against Dow Corning alone, alleging that its implants caused a variety of maladies. The company was forced to file for bankruptcy protection in 1995. Now the curtain is about to fall on this long-running legal production: On Nov. 9 Dow Corning filed a $3.2 billion settlement proposal.

The company is yielding even as the scientific case against silicone implants finally, and completely, collapses. The proverbial Fat Lady is busy singing: Implants don't cause disease.

Silicone breast implants first came on to the market in the 1960s. Two decades later some women began blaming one medical condition or another on their implants. There was no evidence to back such claims. Rather, explains Dr. Marcia Angell, executive editor of the New England Journal of Medicine, and author of "Science on Trial," many women "developed symptoms that any woman over 25 could develop" and looked for a culprit. They found one in implants, and sued.

Bad publicity followed. David Kessler, then head of the Food and Drug Administration, ordered silicone implants off the market, as the trial bar and its allies furiously fanned the legal flames.

Yet the case against implants has weakened with every passing year. More than a score of peer-reviewed studies--by Harvard University, the Mayo Clinic, Johns Hopkins University and the University of Michigan, among many others--found no or only a negligible link between implants and various diseases.

This year has been particularly bad for the trial bar. On July 4 the European Committee on Quality Assurance and Medical Devices in Plastic Surgery reported that the evidence was "conclusive" that implants did not cause auto-immune or connective tissue diseases, and that "there is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease or a 'new silicone disease' exist."

Two weeks later the Independent Review Group, established by Britain's minister for health, came to a similar conclusion. It found "no histopathological or conclusive immunological evidence" and "no epidemiological evidence" of implant-caused diseases.

This scientific record is causing judges to be more skeptical about the "science" routinely introduced in breast implant cases. Late last year a Texas jury awarded four women $1.5 million in their suit against 3M Co. to compensate for alleged injuries caused by implants. The Houston Chronicle later interviewed jurors, who admitted being unconvinced that implants were to blame: "We agreed that there was no way to prove one way or another about the sickness," explained one. But they sympathized with the plaintiffs and decided to hand over some of 3M's money.

The state Court of Appeals proceeded to overturn the verdict. In a devastating 47-page opinion, Justice Donald Ross ruled in July that the trial court should have excluded the plaintiffs' so-called expert testimony. These witnesses, concluded Justice Ross, offered theories that were not widely accepted in the scientific community, had neither tested nor published their theories, and had not submitted them to peer review.

Similar is federal District Court Judge Robert Vining's opinion in a suit against McGhan Medical Corp. and 3M. In an opinion issued this month, Judge Vining concluded that one witness's proposed testimony "would not be scientifically reliable," while the arguments of another were "not based on good scientific methodology."

Finally, declared Judge Vining, the views of a third witness, the notorious Dr. Douglas Shanklin, "are not based on reliable methodology and, therefore, should be excluded." Dr. Shanklin of the University of Tennessee has turned implant litigation into a profitable industry--testing and "treating" women with implants, as well as testifying in lawsuits. According to Judge Vining, Dr. Shanklin's "opinions have not been subjected to peer review, are not generally accepted by the scientific community, and other studies have been unable to reproduce his theories."

Expected as early as today are the findings of an expert panel appointed by District Court Judge Sam Pointer, who is coordinating pending federal breast implant litigation. The betting is that this group, too, will conclude what every other major study has concluded: There is no serious evidence linking implants to disease.

Growing judicial scrutiny of expert testimony has been spurred by the Supreme Court's 1993 opinion in Daubert v. Merrell Dow Pharmaceuticals. In Daubert the court ruled that expert evidence must be both relevant and reliable to be admitted, which means judges must weigh its "scientific validity." In an attempt to aid judges in doing so, the National Judicial College will be offering a class next year on science in the courtroom. This month the college ran a short demonstration course, covering laboratory evidence, probability theory, mechanical engineering, toxic torts, social science, and other related issues.

Kumho Tire is likely to hasten this trend. Daubert involved scientific expert testimony; Kumho Tire covers non-scientific expert testimony. In the latter, a family sued over an accident caused by a tire blowout. At issue was the reliability of their expert, who testified that the tire was defective. The district court excluded his testimony for failing to meet Daubert's standards; the 11th Circuit Court of Appeals ruled that his testimony fell outside of Daubert, but that the trial court nevertheless had to assess relevance and reliability.

It has long been said that if you torture statistics long enough, they will confess to anything. So too is it with science in the courtroom. You can hire an expert to say almost anything. The result has been a rash of dubious mass torts--Bendectin, electromagnetic fields, multiple chemical sensitivity and silicone breast implants.

But now, after more than a decade, implant litigation is winding down as the case for liability dissolves. The Supreme Court should use its decision in Kumho Tire to continue pressing judges to act as scientific gatekeepers. Otherwise lawsuits become legal lotteries where causation and harm are irrelevant to judgment and damages.

By Doug Bandow, an attorney and senior fellow at the Cato Institute in Washington, D.C.

Comments on this posting?

Click here to post a public comment on the Trash Talk Bulletin Board.

Click here to send a private comment to the Junkman.


Material presented on this home page constitutes opinion of Steven J. Milloy.
Copyright © 1998 Steven J. Milloy. All rights reserved on original material. Material copyrighted by others is used either with permission or under a claim of "fair use." Site developed and hosted by WestLake Solutions, Inc.
 1