Monday, Dec. 30, 1996

RULING OUT "JUNK SCIENCE"

By J. MADELEINE NASH

Silicone breast implants have been blamed for virtually every ailment imaginable--muscle aches, joint pain, mysterious rashes, even serious autoimmune diseases like lupus and scleroderma. So it is little wonder that implant lawsuits have clogged the nation's courts and forced one manufacturer, Dow Corning, to seek pre-emptive bankruptcy. Yet many medical and legal experts have long suspected that the blame laid on implants is based on "junk science." Last week, in a bold opinion that surprised legal experts across the country, a federal district court judge in Portland, Oregon, endorsed that view. Expert testimony linking implants to "any systemic illness or syndrome or autoimmune disorder of any kind," Judge Robert E. Jones declared, was so lacking in scientific credibility that it didn't belong in the courtroom.

Although Jones is handling only 70 breast-implant cases, his opinion is expected to exert considerable influence on other judges who are grappling with similar suits brought by thousands of women. One reason: Jones took the unusual step of appointing four independent experts to assess the purported link between the rupture of silicone implants and specific physical complaints. These experts--an immunologist, an immunologist/toxicologist, a rheumatologist and a polymer chemist--arrived at the same conclusion reached by many others, including Dr. Marcia Angell, executive editor of the New England Journal of Medicine: localized problems, notably the painful hardening of breast tissue, can accompany implants, but as yet no compelling evidence links the leakage of silicone gel to more debilitating disease. "This is the beginning of the end of the breast-implant litigation and may well have wider ramifications," predicts David Bernstein, a law professor at Virginia's George Mason University.

The courts have long struggled with the problem of expert witnesses who champion theories not accepted--and sometimes hotly contested--by the majority of scientists in their field. Breast-implant suits, for example, have produced a brand-new affliction, "atypical connective-tissue disease," that has as yet no formal medical standing. Argues Dallas attorney Bert Black, who heads the American Bar Association's section on science and technology: "One should not force companies to pay out millions of dollars and drive useful products off the market on the basis of a disease that isn't even a hypothesis yet." But University of Iowa law professor Michael Green cautions, "It's only when you accumulate a fair amount of evidence that you can confidently conclude that there is no problem. The plaintiffs may be wrong about breast implants, but they were right about asbestos, and they were right about the Dalkon Shield."

Certainly Judge Jones can be applauded for attempting to apply rational standards to an area of testimony that too often has promoted confusion over clarity. He has heeded the Supreme Court's ruling, in Daubert v. Merrell Dow Pharmaceuticals, that judges should try to independently assess the scientific merits of expert testimony--and in so doing, he may hasten the resolution of a legal ordeal that has brought anxiety and psychological pain to many women.

--By J. Madeleine Nash