The Trials of Silicone

PERSONAL-INJURY LAWYERS may have survived, though just barely, the drubbing they got when they hauled McDonald's into court for selling a woman a cup of coffee that scalded her and won a $640,000 jury verdict. But they are going to need all the good PR their contingency fees can buy if they want to survive the breast-implant controversy. Although the scientific evidence on the safety of silicone implants (mostly breast, but also jaw, limb and others) is completely unsettled, patients claiming they became grievously ill after receiving implants have won 18 verdicts since 1984 for up to $25 million, and an undisclosed number of out-of-court settlements. Implant manufacturers, in an attempt to put the lawsuits behind them, in 1994 offered to pay out $4.25 billion--the largest class-action settlement ever. Since there was still no good evidence that silicone caused systemic disease, critics called this court-sanctioned robbery.

Things went downhill from there. The class-action settlement fell apart last year. Once again facing more than 19,000 lawsuits, Dow Corning Corp., which sold about half of all implants, filed for bankruptcy-court protection. But far from settling anything, the legal maneuvers keep setting off new furors. Last week Dow Corning filed a new reorganization plan with the U.S. Bankruptcy Court in Michigan, with a controversial proviso: no patient claiming that an implant gave her a serious disease would collect unless a "science trial" found that implants can indeed cause systemic disease.

A science trial would seem exactly the cure for the "breast-implant fiasco," as Columbia University law professor David Bernstein called it. Because courts allowed "junk science" into evidence, argues Dr. Marcia Angell in her recent book "Science on Trial," one woman won millions of dollars from Dow Corning even though her own rheumatologist testified that her symptoms of connective-tissue disease began before she received implants (other doctors disagreed). Many lawsuits have avoided altogether the issue of what caused a disease. They charged instead that the manufacturers hid research documents, played down the failure rate of breast implants (at least 5 percent, and possibly 70) and told doctors that implants would last a lifetime before quietly amending that to 10 years. What could be more welcome, then, than asking a jury to decide, based on the testimony only of researchers deemed credible by the court, whether silicone can cause debilitating, systemic disease? And to decide it once and for all? As Barbara Houser, a Houston attorney for Dow Corning, asks, "Why does it make sense to have this issue tried 8,000 times?"

The Dow Corning proposal reflects a touching faith that science will figure out what a preponderance of evidence implies. But research on silicone implants is anything but definitive:

About 1 percent of American women have breast implants. And 1 percent have connective-tissue disease. So, by chance alone, among 100 million adult women, 10,000 will have both. Do the thousands of implant recipients with diseases have them because of their implants or because of other factors? Two epidemiological studies seem to exonerate silicone. In 1994 researchers at the Mayo Clinic reported a study of 749 Minnesota women who had received implants. They were no more likely to develop 12 connective-tissue diseases than 1,498 women without implants. A study by Harvard Medical School researchers, published last year, analyzed the medical histories of 87,501 nurses. Of the 876 with implants, there was no detectably higher incidence of classic connective-tissue disease. But neither study was conclusive. As Angell concedes, "The [Mayo Clinic] study sample was not large enough to rule out with reasonable certainty as much as a threefold increased risk" of disease. Still, that would raise the risk of developing connective-tissue disease for a woman with implants from 1 percent to only 3 percent. Similarly, the nurses' study could not rule out a doubling of risk, to 2 percent.

Last February another Harvard study found a "small but statistically significant increased risk" of autoimmune disorders in 10,830 women with silicone implants. Implants seemed to raise the risk of disease 24 percent. But this is hardly the smoking gun the plaintiffs have been looking for. The researchers relied on women's own reports of disease and did not check their claims against medical records. On the other hand, the study looked only for classic, well-defined disorders. As FDA commissioner David Kessler and colleagues argue in a recent paper, "no study has specifically addressed atypical connective tissue disease."

A 1994 survey of animal, cell-culture and immunology experiments by the British government found them "disappointingly poor." Consider the claim by a Memphis, Tenn., lab that it could detect in blood samples an immune response to leaked silicone. Last March Dr. V. Leroy Young of Washington University School of Medicine reported sending the lab 12 blood samples that he said came from implant patients; in fact, they were from women without implants. All 12 came back as testing positive for a reaction to silicone. Saying he is "not proud of this deception," Young argues that the test for a silicone reaction is "either meaningless or too sensitive to be clinically useful."

Recent court decisions based on science have favored the manufacturers. In Oregon, a federal district court held hearings this summer at which only "reputable" science was introduced. Judge Robert Jones concluded that there were "no scientifically valid studies" supporting the plaintiffs' position that "could be submitted to the jury." And in October two district-court judges in New York ruled, after a weeklong hearing, that the "evidence of both defendants' and plaintiffs' experts supports the conclusion that the silicone implants . . . do not cause classical recognized diseases."

This string of legal setbacks, lawyers for implant patients insist, is not why they oppose Dow Corning's offer of a science trial. They object that the deck seems to be stacked in the company's favor. If the jury in the science trial decided in favor of the patients--agreeing that silicone implants can made recipients grievously sick--Dow Corning could still contest whether a specific woman's illness was caused by her implants. Says Elizabeth Cabraser, a San Francisco lawyer representing implant patients, "It would be heads Dow Corning wins, tails the women lose." Also, lawyers for the women suspect that "Dow Corning is trying to get something through before the science destroys them," says Philadelphia attorney Stephen Scheller. One study that Dow Corning funded at the University of Michigan, and which is still in the pipeline, looked at 206 people with autoimmune disorders. It finds that those with silicone implants had triple the risk of contracting the disorders of people without implants.

The idea of a science trial of silicone is based on the science trial of Bendectin, an anti-morning-sickness drug. The manufacturer faced lawsuits claiming that Bendectin caused birth defects. In 1985 a trial judge allowed science testimony only by recognized experts, and only about reputable, published studies. The jury decided in favor of the company. And in a landmark 1993 ruling, the U.S. Supreme Court agreed that trial courts could and should serve as gatekeepers for scientific evidence, barring fringe science. In a trial held under the Bendectin guidelines, says Houser, "we think we would prevail."

If the jury in a science trial exonerated silicone implants, the looming liability that sent Dow Corning into bankruptcy would be lifted. The company, which reports $250 billion in sales and $247 million in profits this year, could emerge as robust as ever. But the plaintiffs' attorneys have no intention of letting Dow Corning off the hook. They are negotiating an alternative plan. First they want Dow Corning to make available more than the $600 million it has earmarked for women with localized problems from implants, such as hardening of tissue or infections due to leakage or rupture of the implant. That amount, says Sybil Goldrich, cofounder of an implant-information clearinghouse, would not cover the surgical costs of removing them from an estimated 300,000 patients with Dow Corning implants. Patients' attorneys are also likely to propose 30 or so trials--not just one--to decide whether Dow Corning's implants made women ill. The results would be used to guide the bankruptcy court on how much of Dow Corning's assets should be made available to patients. Fiasco or not, the breast-implant controversy will plague both science and the courts a while longer.

As many as 2 million women have had breast implants; several thousand have sued manufacturers alleging harm from the silicone. A brief history of the controversy:

Early 1940s: Dow Corning begins producingsilicones

1962: First silicone-breast-implant procedure performed

1975: Mammary Task Force formed at Dow Coring to give implant's a softer, more natural consistency

1976: Breast implants come under FDA purview

1977: First Successful lawsuit: jury awards $170,000 to woman whose implants ruptured

1982: Australian physician reports first cases of implant-related connective-tissue disease

Nov. 1984: Woman wins first case alleging implant-related autoimmune disease

June 1988: FDA requires manufacturers to prove safety of implants

April 1991: FDA gives manufacturers 90 days to submit safety data; only four comply; evidence deemed insufficient

April 1992: FDA bans silicone implants, saying manufacturers failed to prove them safe

December 1992: Jury awards Texas woman $25 million, largest judgement to date

April 1994: Dow Corning and other manufacturers offer a $4.25 billion settlement

May 1995: Dow Corning files for bankruptcy

Sept. 1995: Federal judge pronounces settlement dead

Oct. 1995: Jury awards $14.1 million in first suit against parent company, Dow Chemical

Nov. 1995: Manufacturers, not including Dow Corning, approve a new settlement that would pay up to $250,000 per claim

Dec. 1996: Dow Corning makes its new sesttlement offer contingent on a "science trial"