Democratic Lawmakers Plan To Reintroduce Legislation To Overturn Supreme Court Decision on Medical Device Liability

Democratic lawmakers this year plan to reintroduce legislation that effectively would overturn a 2008 Supreme Court decision under which FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts, the New York Times reports. House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) and Health Subcommittee Chair Frank Pallone (D-N.J.) plan to reintroduce the legislation in the near future. In addition, Democratic senators in the next few months plan to reintroduce a similar bill, which Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and Judiciary Committee Chair Patrick Leahy (D-Vt.) sponsored last year.

Since the Supreme Court issued the decision, judges nationwide have dismissed a number of product liability lawsuits filed by patients and their survivors against medical device companies. Supporters of the legislation believe that FDA approval of medical devices does not ensure their safety and that the decision leaves patients with no legal recourse when they experience injuries as a result of the products.

Pallone said, "Tort actions serve as a backstop to the FDA and provide another level of protection." In addition, Pallone said that he expects the Energy and Commerce Committee to hold hearings this year about the FDA approval process for medical devices. He said, "The FDA has limited resources and can't assess all the risks that a device poses once it gets on the market." Georgetown University Law Center professor David Vladeck said, "Consumers face the worse of all possible worlds," adding, "FDA has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can't sue companies for redress."

Medical device companies and conservative law groups oppose legislation that would overturn the Supreme Court decision. Christopher White, general counsel for the Advanced Medical Technology Association, said "We are clearly very troubled by this legislation. Our concern is that it would undermine the FDA process" (Meier, New York Times, 2/20).