WASHINGTON The U.S. Supreme Court handed a victory to Medtronic Inc (MDT.N) on Wednesday, 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 Food and Drug Administration.
The decision was the Supreme Court's first ruling on the legal effect of the FDA's approval of a medical device on liability lawsuits, Medtronic said.
The ruling could benefit other device makers, who have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court.
The Medtronic 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.
In a statement, Medtronic Chief Executive Bill Hawkins said the ruling was "a very important decision, which ensures that patients continue to have appropriate access to innovative, life-saving medical devices."
But Attorney Allison Zieve, who represented the family of the man who sued Medtronic, said the decision reduced the incentive for companies to make devices as safe as possible. Just the threat of a liability suit encourages manufacturers to improve product safety or remove a dangerous device from the market quickly, she said.
"By minimizing the incentive, the Supreme Court's decision poses a risk to the safety of medical devices," she said.
(Reporting by James Vicini, with additional reporting by Lisa Richwine; Editing by Dave Zimmerman and Braden Reddall)