US Supreme Court Decides Groundbreaking Medical Device Case

A Landmark decision of the United States Supreme Court could nullify hundreds of cases against medical device manufacturers.

The case, Riegel v. Medtronic, was filed in New York federal court after the plaintiff developed a heart block due to application of the Medtronic Evergreen Balloon Catheter. Medtronic argued that it had obtained FDA approval for a Class III medical device pursuant to the Medical Device Amendments of 1976. When the trial Court dismissed the suit, the plaintiff appealed to the US Court of Appeals for the Second Circuit which affirmed the lower court's decision.

In an 8-1 decision, the US Supreme Court affirmed and held that state law tort claims against a device that has already obtained pre-market FDA approval are barred by the statute. This decision represents a major change in the law. Suits against all kinds of medical devices--from heart valves to breast implants--may have effectively been nullified with the stroke of a pen, according to a February 27, 2008 newsletter from the law firm of Weber Gallagher Simpson Stapleton Fires & Newby, LLP.