FDA Law Blog -- Last month, we reported on the U.S. Supreme Court’s 8-1 decision in Riegel v. Medtronic, in which the Court provided a definitive decision preempting state tort law claims for medical devices subject to an approved Premarket Approval Application. Immediately after the decision was issued, some members of Congress threatened to introduce legislation that would have the effect of overturning the Riegel decision. Representative Henry Waxman (D-CA) vowed that Congress will “pass legislation as quickly as possible to fix this nonsensical situation,” and House Energy and Commerce Health Subcommittee Chair Rep. Frank Pallone (D-NJ) stated that the Riegel decision “shows why it is more necessary than ever for Congress to step in and restore the protections that patients are entitled to if they are the victim of a life-altering accident caused by a medical device.”
