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Preemption: Congress moving on medical device legislation

The House Energy and Commerce Committee, Subcommittee on Health, has a hearing scheduled Tuesday, May 12th, on H. R. 1346, the Medical Device Safety Act. This is the bill that would end federal preemption for FDA-approved medical devices, allowing (encouraging, inviting, definitely producing) more product liability suits in state courts. The bill (and its Senate companion, S. 560) come in response to the U.S. Supreme Court's ruling in Riegel v. Medtronic. (Opinion.)

Wyeth v. Levine was the wedge ruling, energizing the political and PR campaign to undermine preemption. The May issue of "Trial," the AAJ's magazine, has several articles devoted to the topic. As the AAJ summarizes in this recent news release, "FDA 'Internal Meeting' on Devices Shows Patient Safety at Risk": "AAJ has been working in a large coalition of consumer and patient safety groups to enact the Medical Device Safety Act (MDSA), legislation that would restore the rights of medical device patients to seek justice in state courts when they have been harmed by unsafe medical devices."

The goal for the lawyers and consumer and patient safety groups is to replace a federal regulatory regime with 50 different and changeable state regimes, determined by litigation and jury awards. Damaged as a result would be consumer and patient safety.

No witnesses listed yet for the hearing: May 12, Subcommittee on Health, hearing on H.R. 1346, Medical Device Safety Act of 2009, 2 p.m., 2123 Rayburn

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.