Review of Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case

David E. Bernstein*

For over a decade, manufacturers of silicone breast implants have battled lawsuits claiming that the implants cause breast cancer, medically-defined immune system diseases, and, most recently, "atypical auto-immune disease." The plaintiffs in these cases have the legal burden of proof, but have never had any credible scientific evidence supporting their claims. Nevertheless, the implant manufacturers have been forced to pay millions of dollars in verdicts and settlements, and have offered to pay billions more to settle the litigation. Dow Corning, the leading implant manufacturer, has been driven into bankruptcy. A few dozen plaintiffs' attorneys, along with some of their clients, have become rich (or, in some attorneys' cases, richer).

In Science on Trial, Marcia Angell, executive editor of the New England Journal of Medicine, does an admirable job of explaining how a product that has never been proven to cause anything worse than local complications became the subject of multi-billion dollar litigation. Angell explains that silicone breast implants were first marketed by Dow Corning in 1963. The implants proved reasonably popular and successful, and by the 1970's, Dow Corning had several competitors in the implant market. According to Angell, the implants had one major flaw: Manufacturers had never done adequate testing to prove that they were safe. When silicone implants were invented, medical devices did not come under FDA jurisdiction, and were therefore essentially unregulated. With the passage of the Medical Device Amendment to the Food, Drug and Cosmetic Act in 1976, Congress gave the FDA power to regulate medical devices. The MDA "grandfathered" existing devices, such as breast implants. In other words, the MDA allowed such devices to remain on the market until the FDA got around to classifying and regulating them, even if their safety was unproven.

The Reagan Administration was generally hostile to regulation, and the FDA did not classify breast implants until the Spring of 1988. With the end of the administration at hand, consumer activist Dr. Sidney Wolfe of the Naderite Public Citizen Health Research Group saw an opportunity to demonstrate the folly of lax regulation. In November 1988, Wolfe released leaked internal documents from Dow Corning and the FDA that showed the company's scientists had implanted a blob of silicone gel under the skin of 200 rats. Between one-fifth and one-quarter of the rats, depending on the sex and the type of gel, developed a form of cancer called fibrosarcoma. Wolfe argued that this study showed that silicone-filled implants, which could leak or rupture, were dangerous and should be banned. The attendant media publicity sent many women into something of a panic and helped create the first major wave of breast implant lawsuits. (Cooler scientific heads noted that any type of implant will cause cancer in a large percentage of specially-bred laboratory rats.)

Angell explains that implants mostly stayed out of the headlines for the next two years, until a December 1990 episode of NBC's Face to Face with Connie Chung precipitated widespread alarm about the safety of breast implants. Chung called silicone gel "an ooze of slimy gelatin that could be poisoning women." She interviewed several women who blamed implants for causing their autoimmune diseases, but never questioned whether any scientific evidence supported the presumed link. As Kathy McNamara-Meis reports in a recent issue of Forbes MediaCritic, Chung failed to mention that the two doctors she cited to support a link had never published studies on silicone breast implants in a major medical journal, or that both sources were paid medical experts for plaintiffs' lawyers involved in implant litigation. Chung's coverage set the tone for media coverage of breast implants for the next five years.

The implant manufacturers' troubles were compounded by Dr. David Kessler, who was sworn in as the new FDA chairman in April 1991. As Angell points out, Kessler saw his mission as reinvigorating the FDA. Within months, the agency had taken on some of the largest and best-known companies in the United States, often over trivial offenses. In a remarkably candid speech Kessler gave in December 1992 (and not mentioned in Science on Trial), he admitted that his goal was to win public support for his pro-regulation agenda: "I came to a regulatory agency that, in an era of deregulation, had fallen on hard times. . . . We needed to get things done, we needed to get things done quickly. We needed to send out a message that, ultimately, it was in no one's interest to deregulate a public health regulatory agency." Given Kessler's goal, he shared with Sidney Wolfe an interest in creating public doubt about the safety of breast implants.

Angell reports that one of Kessler's first official acts was to notify implant manufacturers that they had 90 days to file documents proving implants' safety. When these documents proved to be inadequate, Kessler scheduled a meeting of the FDA General & Plastic Surgery Devices Panel for November 1991 to advise him. After hearing testimony from implant opponents and proponents, the panel unanimously recommended implants remain available while manufacturers obtain more data on product safety. Angell suggests that Kessler was expected to follow the panel's recommendation. Media sources, however, have reported that Kessler was prepared to blithely ignore his experts' recommendations, and limit availability of implants to patients who needed them for reconstructive purposes. Kessler's obvious dilemma was how to ignore the panel's recommendation without seeming heavy-handed.

By this time, media attention to the alleged hazards of implants had sparked dozens of lawsuits alleging that breast implants cause cancer and/or immune system damage. Wolfe, meanwhile, coordinated his continued attacks on implants with

plaintiffs' attorneys. In December 1991, a San Francisco jury awarded Marianne Hopkins $7.5 million for connective tissue disease allegedly caused by her Dow Corning implants. The scientific evidence presented by Hopkins' attorney consisted of testimony by scientists with dubious credentials speculating on the possible link between implants and immune system disease. Hopkins' attorney therefore focused on internal Dow Corning documents that made the company look extremely irresponsible. The documents showed that Dow Corning officials, although aware that silicone was leaking out of their implants, had no long-term safety data regarding the implants. The documents did not, however, contain any new scientific evidence that Dow Corning had not provided to the FDA.

Within weeks of the trial, the documents found their way into Kessler's hands, even though they were under court seal. Kessler now had the cover he needed for his decision to ban the implants. Instead of turning over the documents to his scientific advisors, on January 6, 1992, Kessler called a press conference in which he announced a 45-day moratorium on sale and use of silicone-gel implants. (The moratorium was later made indefinite, with an exception for mastectomy reconstruction cases.) Kessler did not say the implants were unsafe, but that there was insufficient data on their safety.

Not surprisingly, this distinction was lost on the public. As a result of the moratorium and the attendant publicity, the dozens of lawsuits filed against implant manufacturers turned into hundreds. Over the next few months, media stories detailing the alleged dangers of breast implants were omnipresent, feeding the litigation frenzy. Reasonable scientific voices that questioned the hysteria over implants, including Angell's in the New England Journal of Medicine, were drowned out. By late 1992, conclusive scientific evidence showed that implants did not cause cancer. No valid studies had shown that implants could be linked to immune system disease. But it soon became apparent that the lack of scientific evidence supporting plaintiffs' claims was not going to save the manufacturers from the tort system. In December 1992, a Houston jury awarded $25 million to a woman who had a ruptured implant, but did not have any recognized disease. As Angell notes, the plaintiff's lawyer concentrated on his client's concern that she might eventually get immune system disease or breast cancer from the silicone that leaked into her body, in order to subtly shift the burden of proof to the manufacturer to prove that the implants were safe. He also tried to shift the jury's focus from his client, suggesting that the jury should punish the defendant on behalf of the other women with implants.

After the extravagant $25 million verdict, the litigation dam burst. Faced with thousands of lawsuits, the leading implant manufacturers agreed to contribute more than $4 billion to settle the implant litigation. This settlement eventually collapsed when 400,000 women came forward to claim their share of the money. Dow Corning later declared bankruptcy, while the other manufacturers continued to try to settle the litigation.

Meanwhile, new studies came out refuting any significant link between implants and cancer or auto-immune disease. The current epidemiological evidence strongly suggests that if implants cause disease at all, they do so very rarely. The litigation, however, has taken on a life of its own. As the title of the book suggests, Angell believes that science has been on trial throughout the breast implant fiasco. Science lost out to the political agendas of Sidney Wolfe and David Kessler. Science lost out in the tort process, where juries awarded millions of dollars to breast implant recipients based on sympathy for the plaintiffs, distaste for the defendants, and the patina of science provided by the "educated guesses" of a few marginal expert witnesses who believed that implants cause disease. Science lost out to the profit motive, first when manufacturers negligently failed to invest resources in adequate biological studies, and then when contingency fee attorneys exploited the resulting uncertainty. And science especially lost out in the media, where reporters preferred sensational tales alleging implant dangers to a calm accounting of the scientific evidence. In the second-to-last chapter of her book, Angell makes a lengthy plea in favor of science and the scientific process. A self-described feminist and liberal Democrat, she is troubled by the anti-science bias she perceives among many humanists, multiculturalists, environmentalists, ecologists, feminists, and proponents of alternative medicine. (Oddly, she fails to mention the anti-scientific influence of fundamentalist religious groups.) More generally, most Americans are appallingly ignorant of basic scientific concepts. As Angell points out, if the public was more knowledgeable about and favorably inclined toward science and the scientific process, the breast implant controversy would have unfolded in a far more sensible way.

Unfortunately, the same Americans who uncritically watch Connie Chung also serve on juries and are responsible for deciding complex scientific issues, including the purported relationship between breast implants and disease. Angell makes some sensible suggestions for limiting the ability of these jurors to do harm. First, she suggests abolishing or limiting contingency fees. As Angell points out, the typical contingency fee of 33 to 40% of a plaintiff's recovery allows plaintiffs' attorneys to mass-produce lawsuits of very little merit with little risk to themselves. If they find only one credulous jury out of every ten, they can still do very well. Angell also suggests that jury trials be abolished in tort cases. As a non-attorney, Angell can be forgiven for failing to recognize that the federal constitution and most state constitutions protect the right to a civil jury trial. Jury discretion can, however, still be limited by placing the issue of the amount of damages in the hands of judges. Doing so would secure the advantages of written explanation, precedent, visibility, experience, and greater ease of appeal.

Finally, Angell argues that scientific standards in the courtroom must be raised. She notes that "[i]f it were not for the nearly total lack of scientific standards in the breast implant cases, even a badly flawed legal system could not have worked such mischief." Despite the lack of valid scientific evidence supporting plaintiffs' claims, no court excluded their experts' testimony until 1996, years after the litigation began. In the one case to go to appeal on the issue of the validity of plaintiffs' scientific evidence, the Hopkins case, Judge Proctor

Hug of the Ninth Circuit Court of Appeals wrote what Angell demonstrates to be an ill-reasoned opinion upholding the admission of the evidence.

Angell suggests that judges can prevent the misuse of scientific evidence by appointing neutral scientific experts to advise the court and the jury. Judges have traditionally been reluctant to appoint such experts, but that may be changing. Since Science on Trial went to press, Judge Sam Pointer, who is in charge of all federal breast implant cases, has decided to appoint a panel of neutral scientific experts to advise him on the state of the scientific evidence regarding risk from silicone breast implants. Judge Robert Jones of Oregon, meanwhile, relied on the advice of such a panel in excluding plaintiff's expert evidence in December.

Science on Trial should serve as a call to members of the mainstream scientific community to join the battle against scientific dissembling in the media and in the legal and political arenas. Many scientists bemoan the misuse of science in the tort system in private but fail to speak up in public for fear that it will distract them from their work. For the greater good of science, however, it behooves such individuals to follow Marcia Angell's example, and turn their outrage into constructive criticism of how our legal system, and society in general, deal with scientific issues.

*Professor David Bernstein is an Assistant Professor, George Mason University School of Law; Adjunct Fellow, Center for Civil Justice Studies.


2001 The Federalist Society