When is Enough Enough?

David E. Bernstein*

Even in these times of budget surpluses, there never seems to be quite enough money for research into breast cancer. AIDS, prostate cancer, and other modern plagues. So why do California Senator Barbara Boxer and Rep. Gene Green of Houston, Texas, want to force the National Institutes of Health to waste millions of dollars on unnecessary studies of the health effects of breasts implants?

The answer appears to be that they are acting at the behest of trial lawyers representing women with breast implants. These lawyers will lose billions of dollars in future legal fees if they fail to keep alive their claim that breast implants cause immune system disease. The problem the attorneys face is that overwhelming scientific evidence contradicts that claim. Studies conducted at Harvard University, the Mayo Clinic, Johns Hopkins, and similarly prestigious institutions have all found no connection between breast implants and immune system disease.

Recently, an Independent Review Group appointed by the British government concluded, after reviewing dozens of scientific studies, that there is no evidence that breast implants cause immune system disease. The Review Group concluded that no further epidemiological studies on this issue are justified. Case closed.

The Institute of Medicine and a scientific panel appointed by a federal judge are due to come out with their own reports this year. Everyone expects their conclusions will be similar to the British report.

Unfortunately, while the scientific controversy over the safety of implants is ending, the legal proceedings stagger on. Despite a recent global settlement by Dow Corning, hundreds of plaintiffs still have cases pending against other manufacturers. The Boxer/Green bill is simply the latest skirmish in the trial lawyers' efforts to keep the breast implant litigation alive. Ten years ago, when the litigation over breast implants began in earnest, most plaintiffs claimed that the implants caused breast cancer. Scientific studies soon convincingly rebutted this theory, and the cancer cases slowly disappeared. Trial lawyers then began filing lawsuits alleging that their clients contracted immune system diseases such as lupus and rheumatoid arthritis from breast implants. After some initial successes, a series of scientific studies were published rebutting that claim as well. Juries became increasingly skeptical of breast implant cases.

The trial lawyers, however, did not give up. They began to argue that breast implants cause "atypical" immune disorders, creating a variety of symptoms. The beauty of the atypical theory - from the trial lawyers' perspective - is that it bought them time while scientists struggled with the difficult task of figuring out how to study whether women with implants have purported disorders previously unknown to medicine.

Unfortunately for the trial lawyers, the atypical disease theory has not won any support in the scientific community, except for their own highly-paid expert witnesses. Indeed, the recently released British study concluded that "good evidence for the existence of atypical connective tissue disease or undefined conditions such as `silicone poisoning' is lacking." Despite the scientific consensus that there is no good evidence that implants cause any type of disease, and much evidence that they do not, many judges are still letting the trial lawyers bring their cases to trial. While most jurors are conscientious, they are not scientifically-trained, and are inclined to give the benefit of the doubt to an injured plaintiff. As long as trial lawyers can make it appear as though a scientific controversy remains, they have a chance to persuade juries to award damages to their clients.

Even if 80 percent of juries continue to find in favor of the implant manufacturers, the trial lawyers will still profit. After all, the average successful breast implant plaintiff has won several million dollars, and her lawyers take a third of that. The threat of these occasional victories has been enough to persuade the implant manufacturers to pay out billions of dollars in settlements. The only way to end the implant litigation once and for all is to allow the scientific controversy over implants to run its course. In the absence of political interference such as the Boxer/Green bill, it appears that implants will soon be exonerated from charges that they cause disease. Unfortunately, trial lawyers and the politicians who rely on them for support have a vested interest in keeping the breast implant controversy alive.

Of course, supports of the Boxer/Green bill claim to be advocating for women's health but this raises the question: How will spending taxpayer money to keep alive claims based on junk science promote women's health?

*David Bernstein is Professor of Evidence at George Mason Univesity School of Law and co-author of Phantom Risk: Scientific Inferences And The Law.


2001 The Federalist Society