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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