HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, February 20, 2009

Suing Medical Device Manufacturers . . . .

Last year, in Riegel v. Medtronic, the United States Supreme Court barred patients from suing in tort makers of medical devices if the Food and Drug Administration had approved them. Now several lawmakers consider legislation to overturn that ruling.  The New York Times reports,

But now, some members of Congress want to give potential plaintiffs . . . a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.  A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.  The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

“Consumers face the worse of all possible worlds,” said David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog. “The F.D.A. 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.” . . .

Mr. Pallone says he also expects the House Energy and Commerce Committee to hold hearings this session to question whether the F.D.A. process for approving devices is adequate. “The F.D.A. has limited resources and can’t assess all the risks that a device poses once it gets on the market,” he said.

Medical device producers and some conservative legal groups have lined up to oppose the legislation, which is supported by plaintiffs’ lawyers. Last year, at a Congressional hearing, the Advanced Medical Technology Association, a device industry trade group, said that the F.D.A. was the appropriate body to set nationwide safety standards and that allowing juries to second-guess such decisions would stifle product innovation.  “We are clearly very troubled by this legislation,” Christopher White, the trade group’s general counsel said in an interview. “Our concern is that it would undermine the F.D.A. process.”

The Supreme Court, in a case argued last fall, is now weighing whether to give the same type of legal protections to drug manufacturers. In that case, like the one decided in February 2008, the Bush administration supported pre-empting many product liability suits against F.D.A.-approved products . . . .

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