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In Wake of Wyeth Pharma Decision, Congressional Democrats Introduce Bills to Nullify Supreme Court's Riegel Medical Device Preemption Ruling


On March 5, 2009, House Energy and Commerce Health Subcommittee Chairman Frank Pallone, Jr. (D-NJ) and House Energy and Commerce Chairman Henry Waxman (D-CA) introduced the Medical Device Safety Act of 2009 (H.R. 1346) ("MDSA"). If passed, the MDSA would authorize state product liability lawsuits for medical devices, effectively overturning the U.S. Supreme Court's 2008 decision in Riegel v. Medtronic.

In Riegel, the Supreme Court ruled that federal medical device law preempts state tort claims against manufacturers whose products are approved through the premarket approval process of the Food and Drug Administration ("FDA"). The Court determined that a preemption clause contained in Section 360k(a) of the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act explicitly bars the imposition of any state "requirements" that are "different from" or "in addition to" requirements established by the FDA.

The MDSA was referred to the House Energy and Commerce Committee and has sixty-five co-sponsors. Also on March 5, 2009, Senate Health, Education, Labor and Pensions Chairman Edward Kennedy (D-MA) introduced companion legislation in the Senate (S. 540). The Senate bill has seventeen co-sponsors and has been referred to the Senate Health, Education, Labor and Pensions Committee.

Introduction of the House and Senate legislation came just one day after the Supreme Court's ruling in Wyeth v. Levine, in which the Court ruled that federal law does not preempt a claim under state law alleging inadequate labeling of a pharmaceutical. In Wyeth, the plaintiff Diana Levine claimed she was injured by the inappropriate administration of Wyeth's prescription drug Phenergan. A Vermont jury concluded that the Phenergan label should have included stronger warnings against IV-push administration of the drug because of the known risk of intra-arterial injection and consequent development of gangrene. On appeal, Wyeth argued that Levine's suit was preempted because the FDA approved the Phenergan label. The Court held that federal law did not preempt Levine's claim because it was possible for Wyeth to comply with federal and state law.

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