In an 8-1 decision, the United States Supreme Court has held that the preemption clause of the Medical Device Amendments, 21 U.S.C.S. § 360k(a) [“MDA”], bars state common-law tort claims that challenge the safety and effectiveness of a manufacturer’s heart catheter because that device had received pre-market approval from the FDA.

The case, Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008), involved a New York man who was injured in 1996 when a doctor inflated a balloon catheter during an artery-clearing procedure.  Medtronic said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended.  The patient’s widow sued Medtronic in a New York district court, alleging strict liability and negligence in design, testing, marketing, and labeling, among other claims.  The court dismissed the lawsuit, finding the plaintiff’s state law claims were preempted.  A U.S. appeals court agreed that the lawsuit was pre-empted by federal law, and the Supreme Court has now upheld that decision.

In the opinion, the high court outlines the “rigorous” review and approval process for Class III medical devices.  Noting that the MDA expressly pre-empts only state requirements “different from, or in addition to, any requirement applicable . . . to the device” under federal law (§ 360(a)(1)), the decision, authored by Justice Scalia, opines that New York’s common law duties in negligence, strict liability, and implied warranty impose such “requirements” under the ordinary meaning of that term.

This decision is being touted by legal commentators as “significant” in making it harder for consumers to sue manufacturers of federally approved medical devices.  However, they have cautioned that other cases involving drugs and drug-labeling are still pending before the high court.  In the lone dissent to Riegel, Justice Ruth Bader Ginsburg wrote that Congress never intended “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”