THE EVOLUTION OF BIOMATERIALS LIABILITY

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

Originally published May 1996

An Interview with James S. Benson

Senior Vice President for Technology and Regulatory Affairs, Health Industry Manufacturers Association (Washington, DC)

On March 11, James S. Benson visited the White House to encourage President Clinton to sign legislation that would protect the makers of biomaterials from liability. In those discussions, Benson was a representative of the medical device industry, but he brought to bear experience gained in a number of top-level positions at FDA and at the Health Industry Manufacturers Association. Benson has sought for years to put liability issues surrounding biomaterials into perspective. In this interview with MD&DI, Benson discusses the evolution of those issues over the last 20 years.

What is the central point at issue for biomaterials liability, and how did it develop?

One of the most important problems in the area of biomaterials is the issue of safety and what methods should be used for determining degrees of safety. No device is entirely risk-free for all patients at all times, so the relationship between risk and safety is important for both FDA and industry. And the agency's approach to these questions has changed dramatically over the years.

An example of that is the use of silicone in breast implants. Right after the 1976 amendments were passed, the classification of breast implants was on the agenda at FDA. But the issues back then were not toxicological; they involved the ethics of using breast implants and the mechanical aspects of these implants--their rupture rate and how long they would last.

Isn't silicone still considered relatively safe by the scientific community?

Not only by the scientific community but by many different industries. Silicone continues to be used ubiquitously in foods and many other products. But in the medical industry, class action suits have allowed junk science to determine the risk of using this material.

What do you mean by junk science?

When a doctor testifies that three out of four breast implant patients he has examined show signs of autoimmune disease, that implies that three out of four women with breast implants will develop this disease. But no matter how many such stories are told, the plural of anecdote is not data. Unfortunately, people sometimes get sick and encounter health problems. And it is human nature in those situations to look for something to blame other than aging or some naturally occurring disease process. So, a person who has something unique in his or her medical history may tend to blame that something else.

When that happens, there is an opportunity for class action suits. And then a lot of money is spent trying to produce evidence that can be convincing to a lay jury. That is the kind of situation we find ourselves in with biomaterials.

How has the fallout from breast implant litigation affected the biomaterials community in general?

The litigation itself, and the junk science that has played a part in proving the lawyers' cases, have raised questions about the use of all biomaterials. Just as significantly, these cases have led FDA to become more zealous in its regulatory approach to the point of seeking absolute risk determination.

There is now a movement to find out exactly what every biomaterial does. That is like counting stars. Can you ever be sure you have counted them all? When that approach is applied to biomaterials, the question becomes one of degree--how much testing is enough?

What is the greatest concern that has come from this evolving interest in the toxicity of biomaterials?

FDA's zeal for absolute risk determination, combined with junk science, has put us in a situation that is very dangerous. There has been a kind of indictment and conviction of silicone that has rubbed off on all biomaterials.

As a result, about 15 companies that supply raw materials of one type or another for the manufacture of medical devices have said that they will no longer do so because they can't risk the litigation. In short, over the last 20 years we have evolved from not worrying enough about toxicity to worrying too much.

James S. Benson was formerly deputy director (1982­1988) and director (1991­1992) of FDA's Center for Devices and Radiological Health, deputy FDA commissioner (1988­1990 and 1991), and acting FDA commissioner (1990).