The Clash Of Medical Evidence

Huge amounts of money were changing hands and $4.25 billion more was promised? And whose hands were they? Many of those who welcomed the FDA ban believed that the law was not in front of the evidence, but that the evidence had been largely suppressed by rapacious implant manufacturers interested only in their profits and by the plastic surgeons who made a very good living implanting the devices. However, not even this conspiratorial theory does justice to the real complexity of the story. As suspected, the story is full of greed, but this greed is hardly limited to implant manufacturers and plastic surgeons. Plaintiffs' attorneys, doctors, researchers, and even implant recipients themselves are exploiting the lucrative opportunities. Four billion dollars is a lot of money, and there is even more to be had.

The breast implant story shows us some of the worst in human nature

How does the public decide whether silicone breast implants or any other product is harmful? How do researchers and doctors decide, as compared with judges and juries?

A tort is a wrongful act or injury for which damages are sought in a civil (as opposed to criminal) court. Americans increasingly turn to the courts to remedy a whole variety of complaints, and the number of tort cases -- particularly product liability and malpractice cases -- is growing accordingly. The breast implant case illustrates in the extreme the influence of the tort system. Even before the ban, there had been a steady trickle of lawsuits alleging that breast implants caused connective tissue or autoimmune disease. Successful lawsuits bred more lawsuits, which in turn bred publicity. Not surprisingly, as more women with implants and their doctors became aware of the possible risks, there were more reports of disease caused by implants. As the chairman of one of the FDA panels said, "The lawyers were ahead of the doctors, and the public was ahead of the FDA."11

After the ban, the plaintiffs' bar moved quickly, and many thousands of lawsuits were filed within a matter of months. The result has been an immense transfer of money from the breast implant manufacturers to plaintiffs and their lawyers. There has been little attention to the fact that the money originates from consumers who purchase the manufacturers' other products. Nor has there been much attention to other consequences of the lawsuits, although they are likely to be far-reaching. In particular, manufacturers of other medical devices and the suppliers of their raw materials are threatening to pull out of the market because of the legal liabilities. What accounts for the torrent of successful litigation, with all its ripple effects, in the absence of solid scientific evidence about the risks of breast implants? Several peculiarities of the American tort system, which I will discuss in later chapters, bear on this question. Tort reform is now a contentious political issue, and the breast implant controversy throws the debate into sharp relief. It well exemplifies the tension between the pressure to curb the excesses of the tort system and the need to maintain reasonable access to the courts to seek redress for injury.

Which came first -- the media spin or public opinion?

As in all media-intensive stories, it is impossible to say because public opinion and media reports are so closely intertwined. What can be said is that the tone of the coverage almost certainly reflects a predisposition of the public to see it that way. The public is easily swept up in medical alarms, particularly when there is an element of wrongdoing involved. The power of the media and public opinion is immense, and that is by and large appropriate in a democracy. But not all endeavors are meant to be ruled by public opinion.


Justice, for example, should not be, nor should science.