A Reversal of Medtronic v. Riegel? A Legislative Update on Liability Against Medical Device Companies


On March 5, 2009, both the House and the Senate proposed legislation amending the Federal Food, Drug, and Cosmetic Act to reverse the 2008 Supreme Court decision in Medtronic v. Riegel H.R. 1346; S. 540. The law, if passed, would permit plaintiffs to bring state law liability suits against medical device companies with respect to devices approved by the federal Food and Drug Administration ("the FDA") under the premarket approval ("PMA") process, a longer, more complicated evaluation process undertaken by the FDA in approving a device.

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