Supreme Court Ruling Goes in Favor of Medical Device Makers

The U.S. Supreme Court on Wednesday ruled that patients who are injured by federally approved medical devices can't claim for damages if the medical-device manufacturers complied with government standards.

The ruling was a landmark victory for Medtronic Inc., the world's leading medical technology company that was sued by the widow of a man injured by a heart catheter manufactured by it. The device had been approved for sale by the Food and Drug Administration.

Charles Riegel, a New York man whose Evergreen Balloon Catheter manufactured by Medtronic burst during a 1996 angioplasty, filed a lawsuit against Fridley, Minnesota-based Medtronic. Riegel, who survived after emergency bypass surgery, accused Medtronic of negligence in the design, manufacture and labeling of the device. After his death in 2004, his wife Donna took over the suit.

The man was injured when a doctor inflated a balloon catheter during an artery-clearing procedure. But, Medtronic has stated the doctor used the device contrary to labeling instructions and in a patient for whom it was not recommended.

Voting 8-1 in Riegel v Medtronic, the justices barred the suit, saying the patient was not entitled to state law remedies because FDA already had approved the catheter. They also ruled that patients cannot sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

Writing for the majority, Justice Antonin Scalia said Medtronic could not be sued over the catheter’s design flaws as the FDA spends an average of 1,200 hours reviewing each device application and grants approval only if it finds the device reasonably safe and effective.

The decision applies to the riskiest devices, like spinal cord stimulators, pacemakers, drug-coated stents, artificial heart valves, and prosthetic hips and knees, which require FDA’s pre-market approval process, the most rigorous of the agency's testing procedures. The pre-market approval process is specified by the Medical Device Amendments of 1976.

"The decision recognizes the rights and interests of the vast majority of patients who benefit from a medical device," said Bill Hawkins, chief executive officer of Medtronic.

Justice Ruth Bader Ginsburg, who cast the sole vote against the ruling, said the 1976 law was not intended to baffle negligence suits. "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.

Meanwhile, Attorney Allison Zieve, who represented the family of the complainant, said the decision minimized the fear for medical-device manufacturers to make devices as safe as possible. Merely liability suit threat can motivate the companies to improve product safety or pull a health-hazardous 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.