U.S. Supreme Court Rules 8 to 1 in Favor of Medtronic in Riegel v. Medtronic

The decision affirmed the dismissal of the lawsuit brought by Charles Riegel, who was injured after a Medtronic balloon catheter burst during an angioplasty procedure in 1994.

Makers of medical devices are protected against liability for personal injuries provided the FDA has approved the device before it is marketed.

The Court ruled in favor of a 1976 law barring state-law claims challenging safety or effectiveness of devices that have won pre-market approval from the FDA.

The decision was seen as a victory for the Bush administration, which has fought for years to broaden the FDA’s authority over state regulation. The administration argued that there would be a serious undermining of the FDA’s authority if state-based juries could second-guess the agency.

Supreme Court Justice Antonin Scalia wrote that it would be difficult for a jury to properly assess the costs and benefits of a device, saying, “The patients who reaped those benefits are not represented in court. [The FDA may] approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”

Medtronic CEO Bill Hawkins said in a statement, “This is a very important decision, which ensures that patients continue to have appropriate access to innovative, life-saving medical devices. The decision recognizes the rights and interests of the vast majority of patients who benefit from a medical device.”

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