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Supreme Court rules in favor of device makers

Device Regulation Alert: Safety, Compliance and Reimbursement News, February 25, 2008

The Supreme Court handed down some good news for medical device makers on Wednesday when it ruled 8-1 that medical device makers are immune from liability for personal injuries if their devices passed the FDA's most stringent premarketing review, according to a New York Times article.

The case before the court, Riegel v. Medtronic, concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices that are available today reached the market through a different process.

Judge Antonin Scalia, writing for the majority, said state suits are barred if they would impose requirements that are different from federal requirements. He added that jurors would not be able to weigh the dangers and benefits of devices as well as agency experts.

It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected. The decision does not affect lawsuits claiming a device was improperly made.

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