Supreme Court Upholds Preemption Claim Under Medical Device Amendments

The Supreme Court made it harder for consumers to sue manufacturers of federally-approved medical devices when it ruled in Riegel v. Medtronic that many state common law claims are preempted by federal law.  Riegel was injured when a balloon catheter burst during a medical procedure.  He sued claiming that the device was defectively designed and that the manufacturer failed to warn of this risk.  Medtronic argued that the Food & Drug Administration's approval of this device, and its inability to change either the design or warnings without the agency's approval, put it in an untenable position if it was also subject to state-law-based product defect claims.  The federal district court ruled that these claims were preempted by section 360K of the Medical Device Amendments to the federal Food, Drug & Cosmetics Act, a result upheld on appeal by U.S. Court of Appeals for the Second Circuit.  The Supreme Court accepted the case for review and heard argument on it in early December 2007.  See Pete Yost's article for The Associated Press.

JDP