The Innovation versus Litigation Debate

April 30, 2009
12:00 pm

Last year, the Supreme Court, in its decision on Riegel v. Medtronic, essentially said that approval of a medical device by the U.S. Food and Drug Administration pre-empts liability cases in state courts against that device. There are rumblings on Capitol Hill concerning possible action to overturn the Riegel decision and create greater liability exposure for manufacturers.

Thus, the Riegel case becomes the latest platform from which to debate where to draw the line on acceptable litigation so that it doesn’t impede or undermine healthcare innovation.

This month, the Advanced Medical Technology Association (AdvaMed) held a press briefing on the issue. AdvaMed president and CEO Steve Ubl made the point that increasing the uncertainty over whether a medical device could face expensive state lawsuits, regardless of having successfully undergoing the FDA approval process, will have a chilling effect on innovation.

Syndicated columnist Michael Kinsley, no raving conservative by anybody’s standard, did an interesting piece on this topic on March 13. Writing about a different Supreme Court case, involving the FDA approval process and subsequent litigation on pharmaceutical products, Kinsley wrote,

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement.

Kinsley’s point is worth our attention. We need to protect patients and consumers (which is, after all, the FDA’s purpose), but we also want to ensure the continuing development of lifesaving and life-enhancing drugs and devices. We need to think long and hard about the point at which litigation stops serving as a necessary protection for consumers and starts causing real harm to current and future patients.

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