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Supreme Court rules in favor of device makers

Pharma Compliance Alert, February 27, 2008

The Supreme Court handed down some good news for medical device makers last 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 pre-marketing review, according to a New York Times article.

The ruling could bode well for the pharmaceutical industry. The Court heard arguments Monday in a case filed by citizens who allege they were harmed by Warner-Lambert's withdrawn diabetes drug Rezulin. The dispute hinges on whether state or federal law takes precedence. A ruling is expected by the end of June.

The medical device case decided last week, Riegel v. Medtronic, concerned only medical devices that had gone through the pre-market 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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