After 16 years of litigation and more than a dozen major scientific studies, the longstanding controversy over the safety of breast implants reached a milestone of sorts Wednesday, when Dow Corning Corp. agreed to pay $3.2 billion to settle the claims of tens of thousands of women who said they had become ill from their implants.
The tentative agreement did not end the conflict over implants; more chapters may be written in the months ahead as panels of judicially appointed scientists review what the science inspired by the lawsuits has wrought. But the long-running battle has illuminated the issues and forces at work when scientific controversies land in the courts or legal ones wind up in the laboratory.
Indeed, experts say the litigation is providing a laboratory for judges to decide how to deal with scientific controversy and questions of what evidence to admit in court.
Women suing the makers of implants have charged that their implants gave them a variety of illnesses, including well-established diseases like arthritis, cancer, lupus and multiple sclerosis, as well as what their attorneys have called "atypical diseases" with symptoms including fatigue and muscle pain.
The implant makers, buttressed by statements from several medical associations and the governments of Britain, Germany and Australia, insist that science has not found a link between the devices and disease, despite years of looking. The settlement, Dow Corning said, was a business decision. The company has approximately 19,000 cases pending that could go to court, said Douglas Schoettinger, a company lawyer, and each case would cost about $1 million to win.
The trouble began on Aug. 1, 1982, when Maria Stern of Boise, Idaho, sued Dow Corning. Ms. Stern said that she had become seriously ill after her implants leaked silicone throughout her body. She won a seven-figure settlement.
At that time, there was virtually no scientific evidence that silicone implants did -- or did not -- cause disease.
A wave of lawsuits followed. In 1992, Dr. David Kessler, who was then commissioner of the Food and Drug Administration, imposed a moratorium on the sale of silicone breast implants while scientific studies were conducted. A class-action suit was filed, drawing in tens of thousands of women. On May 15, 1995, faced with 177,000 breast implant claimants, Dow Corning filed for Chapter 11 bankruptcy.
By the mid-1990s, however, several large studies were failing to find a link between implants and the illnesses ascribed to them. In 1996, the American College of Rheumatology issued a statement saying the evidence was "compelling" that implants did not cause systemic disease. That same year, the Council on Scientific Affairs of the American Medical Association wrote that "to date, there is no conclusive or compelling evidence that relates silicone breast implants to human autoimmune disease." In 1997, the American Academy of Neurology wrote that "existing research shows no link between silicone breast implants and neurological disorders."
Dr. Marcia Angell, executive editor of The New England Journal of Medicine and author of a book on breast implants ("Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case," Norton, 1997), said in an interview that there are now about 15 well-designed epidemiological studies of implants and various diseases. "Not one has found diseases are more common in women with implants, which leaves us with the high likelihood that systemic diseases are coincidental," she said.
Kessler, who is now dean of Yale University's medical school, said in an interview that the science shows that "there were problems with these devices -- they broke, they leaked at a higher rate than anyone reported." But, he added, although the devices cause "local complications" like scarring and hardening of tissue, "there's no evidence that they cause systemic disease."
Those who say that the implants cause disease cite evidence of a different sort. Fenton Communications, a public relations company hired by lawyers for many of the plaintiffs to communicate the risks of implants, lists studies in which doctors cite their own experience seeing women who have had implants and subsequently contracted various diseases. It also lists studies concluding that silicone can provoke immune responses and that implants can rupture and spill silicone throughout the body.
Frederick Ellis, a Boston lawyer who represents women with implants, said that the latest studies show that silicone can cause illnesses in animals and that silicone degrades in the body into silica, a hard, glassy mineral, which can provoke autoimmune responses. Nonetheless, he said, "the science is still developing."
Ellis explained that lawyers had little choice but to jump into the litigation before a scientific consensus had time to form. The problem, he said, is the statute of limitations. The law in most states says that plaintiffs have three years to file a suit after "they reasonably should have known" that implants caused disease, Ellis explained. In California, he added, they have only one year.
"Plaintiffs are in a bind," he said. "A bunch of tort-reform advocates say, 'Wait until the science is really there."' But, Ellis added, "that's not the standard that applies in law."
Bert Black, a Dallas lawyer who is an expert on product liability involving scientific questions but who has no connection to the implant litigation, said there are other factors that push lawsuits forward in advance of science. One, he said, is that "if you wait until the scientific evidence comes in, some other lawyer is likely to corner the market."
"Here you'll be with all this evidence," he said, "but someone else has all the clients."
Then there is what Black calls the "plaintiffs' lawyers asbestos syndrome," referring to the multibillion-dollar asbestos litigation of some years ago that made some lawyers in the product liability field both rich and legendary. Those lawyers got into the litigation early -- long before the science was there to show that exposure to asbestos could cause serious lung disease. Then the science came along and proved them right, Black said, and "every young lawyer said, 'I've got to find the next asbestos."'
As the implant litigation reveals, one of the thorniest questions for the courts once lawsuits are filed is what sort of scientific evidence should be admitted, and who should decide.
A recent Supreme Court decision involving lawsuits charging that the morning-sickness drug Bendectin caused birth defects addressed this question. The court concluded that judges are supposed to control what sort of scientific evidence is allowed and to screen out ill-founded or speculative scientific theories.
But, said Edward Sherman, the dean of Tulane University's law school, who has no connection with the implant litigation, "Cases have shown how difficult it is to determine who is a legitimate expert witness, what is within the range of acceptable range of scientific knowledge and what is outside." He added: "I'd like to think that there are some certainties that science can give us, but in a lot of product liability cases it's very elusive to tie it down."
Nonetheless, several courts and scientific panels are attempting to do just that.
In Oregon, implants made women ill. But he said he would defer the effective date of his decision until an expert panel appointed by Sam C. Pointer Jr., a U.S. district judge in Alabama, issued its report on the science.
Pointer, who is coordinating all the breast implant cases in federal courts, including Dow Corning's, convened a panel of three disinterested scientists to advise him on the evidence tying implants to disease. Their report is expected in September.
In the meantime, the Institute of Medicine of the National Academy of Sciences has also appointed a panel of scientists to assess the implant evidence. Their report is expected in about a year. Daniel Quinn, a spokesman for the institute, said it has asked these scientists not to comment until then. And the British government, which issued a report in 1994, is scheduled to release another one on Tuesday summarizing the most recent evidence.
Dow Corning says it remains interested in what it calls a causation trial, in which a jury would decide whether scientific evidence supports the notion that implants cause disease. If the jury were to decide that the science did not support it, the company would not have to compensate women who said their implants made them ill.
Schoettinger, the Dow Corning lawyer, said he cannot say whether such a request is part of the proposed new settlement, since the details of that agreement must remain secret until it is approved by the plaintiffs.
But, Schoettinger said, the company is also pursuing another avenue. It has filed motions before a bankruptcy judge in Michigan and also before Pointer in Alabama asking that all the implant claims be dismissed. "This takes it a step further and says the science is so clear that a causation trial isn't necessary," he said. He added that these judges are waiting for the report by Pointer's panel before they decide what to do.
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