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
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
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