Supreme Court Upholds Medical Device Amendment Preemption

Kelley Drye’s Litigation Practice Group has prepared a Client Advisory on the recent U.S. Supreme Court decision in Riegel v. Medtronic, in which the Supreme Court held that certain common law claims against medical device companies are pre-empted. The advisory reviews the key majority, concurring, and dissenting opinions of the Justices and offers some insight on the scope of the holding and its impact on medical device companies. It also includes a brief discussion of other pre-emption cases pending before the Court.

What this means for you

In the first of three recent cases accepted for review by the Supreme Court dealing with pre-emption of common law actions in cases involving FDA regulated products, the Supreme Court has upheld express pre-emption of the majority of claims involving a significant group of medical devices. In Riegel v. Medtronic, the Supreme Court held that most common law claims involving class III devices given premarket approval by the FDA are pre-empted.