U.S. High Court Bars Some State Suits over Medical Devices

February 20, 2008

The Supreme Court handed a victory to Medtronic Inc., ruling that patients cannot sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

By an 8-1 vote, the court ruled a 1976 law creating federal safety oversight for medical devices bars state-law claims challenging safety or effectiveness of devices that have won premarket approval from the U.S. Food and Drug Administration.

The case involved a New York man who was injured in 1996 when a doctor inflated a balloon catheter during an artery-clearing procedure.

Medtronic has said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended. The company no longer makes that specific catheter.

A federal trial court in Albany, New York, dismissed the lawsuit, finding the patient was not entitled to state law remedies because of the FDA’s prior approval of the device.

A U.S. appeals court agreed that the lawsuit was pre-empted by federal law, and the Supreme Court upheld that decision.

Justice Antonin Scalia wrote for the court majority that state law claims are pre-empted when the FDA gives premarket approval. which imposes specific requirements for a particular medical device.

Justice Ruth Bader Ginsburg was the lone dissenter.

“Congress, in my view, did not intend (for the 1976 law) to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices,” she wrote.

(Additional reporting by Lisa Richwine) (Reporting by James Vicini, Editing by Dave Zimmerman)

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