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Anti-preemption bill resurfaces

This article was originally published in The Gray Sheet

Executive Summary

Congressional Democrats reintroduced legislation March 5 to reverse last year's U.S. Supreme Court Riegel v. Medtronic decision, which bars, in most cases, state personal injury suits involving PMA-approved devices. The move by Reps. Frank Pallone, Jr., D-NJ, and Henry A. Waxman, D-Calif., and Sens. Edward Kennedy, D-Mass., and Patrick Leahy, D-Vt., immediately followed the high-profile March 4 Wyeth v. Levine Supreme Court decision striking down federal pre-emption of lawsuits against drug makers for failing to properly warn the public of product risks. The Medical Device Safety Act of 2009 would revise language in the 1976 Medical Device Amendments that the high court says expressly pre-empts suits against PMA-approved devices. There is no such language in FDA drug oversight statutes, so the Wyeth decision does not create precedent for device suits. Still, says Waxman, in Wyeth, "the Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices." The legislation was introduced for the first time last year, but it is more likely to be signed by a President Obama than a President Bush ("1The Gray Sheet" March 24, 2008, p. 19)

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