Scientists Take New Role in Implants Case

Do silicone breast implants cause disease?

Experts have clashed in many courtrooms on the question, one of America’s toughest, most costly and most symbolic health controversies.

But the battle at a federal hearing here earlier this summer was different, even historic, because the scientists were in the jury box, not on the witness stand.

The four-member National Science Panel, the first of its kind, will report on the evidence later this year to U.S. District Judge Sam C. Pointer Jr., who is overseeing federal class-action suits against implant makers Bristol-Myers Squibb, 3M Corp. and Baxter International.

The panel is being closely watched as a possible new model for coping with complex and hotly disputed findings in personal injury, product liability and malpractice cases. “This is an innovative approach to presenting difficult scientific evidence in a federal court,” said Joe Cecil, a legal scholar with the Federal Judicial Center, a government research body that provided $400,000 for the science panel’s work and is studying the results.

The problem that the panel is tackling is at least as old as an 1858 U.S. Supreme Court lament that “opposite opinions of persons professing to be experts can be obtained in any amount.” Many scholars and scientists agree that juries are flummoxed by the scientific information they have to weigh and unduly swayed by a variety of distinctly unscientific emotions, including sympathy for plaintiffs, antipathy toward corporate defendants and personal like or dislike of hired-gun expert witnesses.

But silicone implant suits have crystallized the tension between science and law because the stakes are so high and the gap between experts’ opinions so wide.

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This judicial experiment, overseen by Pointer, addresses the inconsistency of jury verdicts on the implant question. A Texas jury in 1992 awarded one woman $25 million, but a California jury threw out a similar case in August largely because no sound evidence linked the plaintiff’s implants to her illness.

Proponents of the science panel approach see it as lending consistency and impartiality to the trial system. Enlisting neutral scientists to advise judges and lay juries on technical evidence is “the single most important reform we could have in our tort system,” said Dr. Marcia Angell, executive editor of the New England Journal of Medicine.

Her 1996 book, “Science on Trial,” sharply criticized implant suits, saying they are based on spurious evidence advanced by greedy plaintiffs’ lawyers and a handful of doctors prostituting themselves as expert witnesses. The panel, she said in an interview, is a “giant step forward.”

Essentially, the panel’s report will be presented as expert testimony in Pointer’s court and others handling implant lawsuits and settlements. (About 10,000 lawsuits against the largest implant maker, Dow Corning, are tied to the company’s bankruptcy proceeding in Michigan. The company made another, $2.4-billion settlement offer last week to the nearly half a million implant recipients who registered to reserve the right to sue.)

It will be “overwhelmingly important,” said Joseph Sanders, a University of Houston law professor and co-author of a 1997 textbook, “Modern Scientific Evidence.”

The panel report could also figure in a trial now underway in New Orleans--the first class-action suit against implant makers to get to a jury. It ruled in mid-August that Dow Chemical, as half owner of Dow Corning, can be held liable for injuries to implant recipients. Next the jury will consider whether the implants actually caused the plaintiffs’ illnesses, as they claim. The science panel’s conclusions “certainly could impact on the New Orleans trial,” said Kenneth Bass, an attorney representing Dow Chemical.

John McGoldrick, vice president and general counsel for Bristol-Myers Squibb, said the science panel will cut through the “junk science” proffered by the plaintiffs and “put the focus where we think it ought to be, on the true medicine and the real science.”

But plaintiffs also see an opportunity. “This allows us to put on our best attempt to prove” that implants cause systemic disease, said Michael Williams, an attorney in Portland, Ore. Even though the implant recipients would appear to have the most to lose from such a hearing--their claims could be gutted if the panel finds little scientific support for them--it was plaintiffs’ lawyers who requested it.

They hope to use the hearing to regain momentum that has been lost recently as juries and judges have ruled against plaintiffs and as impressive new studies have failed to strongly support a disease link. “In the court of public opinion, we’ve lost already,” Williams said. “If we even get a ‘maybe’ out of the panel, it’s an enormous defeat for the defense.”

Although both sides say they support the science panel, some lawyers and scholars have expressed concern about the approach. They worry that it may be too elitist, possibly wresting decision-making power from lay juries, and too conservative, making it harder for injured parties to get their day in court.

Expert panels may reduce junk science and thus “prevent mistaken verdicts against defendants,” said philosopher Carl Cranor, an associate dean at UC Riverside and author of the 1993 book “Regulating Toxic Substances.” “But it may also make mistakes in not compensating meritorious plaintiffs.”

Weighing the Arguments

In three days of lofty testimony and scorched-earth cross-examination before the four-member panel, nine researchers argued the plaintiffs’ case that silicone implants cause an atypical disease. And 11 argued for the defense, saying there was no reasonable proof that the implants brought on the women’s problems.

The panelists, who are barred from speaking with the news media, are Dr. Betty Diamond of Albert Einstein College of Medicine in New York, Dr. Barbara Hulka of the University of North Carolina, Dr. Peter Tugwell of the University of Ottawa and Nancy Kerkvliet of Oregon State University.

In spite of the hearing’s esoteric nature, the main point of argument was clear. Yes, the plaintiffs had amassed lots of evidence that they said supported their claim--but was the evidence scientific?

First came the plaintiffs’ experts. Dr. Lu-Jean Feng, a plastic surgeon at Case Western Reserve University in Cleveland, said she had removed silicone breast implants from 842 women between 1990 and 1996, and 62% of the implants had ruptured after seven years. Many of the women had swollen lymph glands, she said, and other symptoms such as fatigue and joint or muscle tenderness. And many reported feeling better after Feng removed the implants, suggesting to her that the implants caused the symptoms.

But the science panelists and then a defense attorney questioned whether Feng’s patients were typical of women with implants or whether her fame as an expert at implant removal attracted patients with ruptured implants--a complication that manufacturers acknowledge, though they say there is a much lower rate than Feng had observed.

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Other plaintiffs’ experts arguing for a link between implants and disease faced similar questions about possible “selection bias,” or mistakenly basing a general conclusion on a sample of patients who do not represent the whole group.

Perhaps the most important dispute over possible bias in implant studies concerned the 2,000 or so women treated by Dr. Stuart Silverman, a rheumatologist at the UCLA Medical Center, and Dr. Gary Solomon, a rheumatologist at the Hospital for Joint Diseases in New York. They argued that the women suffered from a unique disorder, which they called “systemic silicone-related disease,” whose symptoms included flu-like muscle pain, joint pain, skin rashes and fatigue. Symptoms generally appeared about six years after the implants were inserted, they said.

Again, science panelists and attorneys for the defendants raised questions about the sample, this time because plaintiffs’ lawyers had referred most of the women to the doctors. The defense suggested that the doctors were merely certifying the implant recipients as ill for the sake of litigation.

The doctors acknowledged that their clinical sample was marred by “referral bias,” as experts call it, but they countered that the large number of patients they saw overshadowed that source of potential error.

The other basic issue highlighted by Solomon’s and Silverman’s patients was whether the implants caused the women’s illness, as the doctors maintained, or just happened to be present in women who were sick with rheumatic, connective-tissue or other diseases.

Out of the million or so women to receive silicone breast implants before the Food and Drug Administration slapped a moratorium on selling them in 1992, thousands would be expected to develop fibromyalgia, a chronic rheumatic disease causing diffuse muscle soreness and fatigue, and thousands more chronic fatigue syndrome. Defense attorneys suggested that the doctors could not distinguish between women with those disorders and “systemic silicone-related disease.”

That point was dramatized by an expert for the defense, Dr. John Sergent, a rheumatologist at Vanderbilt University, who said he currently had nine female patients who met the diagnostic criteria for “systemic silicone-related disease”--even though none of them had breast implants. Instead, he said, they suffered from fibromyalgia or other rheumatic diseases. “There may be no difference between this putative new disease and fibromyalgia,” he said.

One plaintiffs’ expert that the defense did not aggressively cross-examine was Sander Greenland, a biostatistics expert at both UCLA and USC. Citing recent large epidemiological studies that have been represented as ruling out an association between silicone breast implants and disease, he said that it was a “fallacy” to say that those studies showed there was no risk to women.

Even the widely publicized studies, by the Mayo Clinic and Harvard Medical School, did not include enough people to pick up a small but perhaps significant increase in the risk of a rare rheumatic disease like scleroderma. To him, “the epidemiological data does not demonstrate an effect” of implants on disease risk, “nor does it demonstrate no effect.”

To many observers of the controversy, the difficulty boils down to an age-old conflict between science and the law, professions that apply strikingly different meanings to such basic concepts as “evidence” and “proof” in their pursuit of the truth.

In civil law cases, a jury accepts a claim that is backed by the “preponderance of the evidence”--a standard of proof that a scientist might scoff at. Whereas scientists struggle to unlock nature’s secrets at its own stately pace, plaintiffs don’t have the luxury of waiting until all the studies are in. As the saying goes, “justice delayed is justice denied.”

Heidi Li Feldman, currently a visiting professor at the Georgetown School of Law who has studied breast implant litigation, said “there’s a collision course between the scientific perspective and the all-or-nothing legal standard used in trials.” Judge Pointer’s panel is “an extremely interesting experiment” in solving the problem.

David Faigman, a professor at the Hastings School of Law and coauthor of “Modern Scientific Evidence,” said the science panel was a step toward the future: “What we’re seeing now is a transition from a basically scientifically illiterate legal system to what will be in 20 or 30 years a more sophisticated consumer of scientific method.”