• Supreme Court Holds that State Tort Law is Expressly Preempted by Food, Drug and Cosmetic Act in Suits Involving FDA Approved Devices
  • March 11, 2008 | Author: Robert P. Charrow
  • Law Firms: Greenberg Traurig, LLP - Washington Office ; Greenberg Traurig, LLP - Chicago Office
  • On February 20, the Supreme Court of the United States in Riegel v. Medtronic, Inc., No. 06-179, held that state law tort suits challenging the design, manufacture or labeling of medical devices approved for marketing under the FDA's Premarket Approval (PMA) process are preempted by the Medical Device Amendments of 1976 (MDA). The Court's decision resolved a long-festering Circuit split pitting the 11th Circuit (holding no preemption) against six other Circuits (2nd, 3rd, 5th, 6th, 7th, and 8th) all holding, to varying degrees, that the MDA preempts state tort claims involving devices approved by FDA under its PMA authority.