Judge Finds Breast-Implant Health Evidence Beyond Pale

Heeding advice from an outside scientific panel, a federal judge in Oregon this week ruled that evidence linking silicone breast implants to immune disorders in 70 women was too weak to be presented to a jury. If an appeals court agrees, the decision could strike a blow to implant lawsuits nationwide and encourage the broader use of such expert panels in cases where the scientific evidence is in dispute.

U.S. District Judge Robert E. Jones based his opinion on a 4-day hearing in which four independent scientists* heard lawyers and expert witnesses discuss evidence favoring the women's claims of autoimmune and other illnesses made in a lawsuit against the makers of their implants, Baxter Healthcare Corp. and Bristol-Myers Squibb Co. The judge agreed with the companies' request to exclude from the trial "any expert testimony concerning a general causal link between silicone-gel breast implants" and illness. He added, "I am mindful that this opinion goes farther in evaluating and in eliminating plaintiffs' claims than any other opinion in breast-implant litigation pending in this country."

Indeed, the decision could affect the tens of thousands of other pending implant cases, legal experts say. "It's certainly, I'm sure, going to have some impact on settlement discussions," says Margaret Berger of Brooklyn Law School. But until the decision has been appealed, she says, "it's very hard to determine what kind of legal effect it's going to have."

Another reason for withholding judgment is that a U.S. district judge in Alabama has just appointed a similar panel to examine the scientific case against implants in a class settlement that could amount to $3 billion. That panel will work a bit differently, rendering a report that will serve as evidence during a trial. Oregon Judge Jones said he will not implement his decision until after he has seen the Alabama panel's conclusions, which could take a year.

The case is also important, Berger says, "because scientific panels have not been used to much of an extent before." Jones wrote that he turned to a panel of experts in accordance with a 1993 Supreme Court decision calling on judges to be "gatekeepers" and screen out faulty science.

* Merwyn R. Greenlick, epidemiologist, Oregon Health Sciences University
Robert F. Wilkens, rheumatologist, Seattle practitioner
Mary Stenzel-Poore, immunotoxicologist, Oregon Health Sciences University
Ronald McClard, polymer chemist, Reed College