The U.S. Supreme Court has ruled 8 to 1 in favor of Medtronic in Riegel v. Medtronic, Inc., after the company was sued by a patient when a Medtronic device malfunctioned during a medical procedure.

The Supreme Court’s intention was to decide whether federal regulatory approval of medical devices should protect manufacturers from product-liability lawsuits in state courts.

According to Medtronic, the decision reaffirms that the FDA pre-market approval process for medical devices appropriately preempts state tort lawsuits involving devices approved through that process. 

The Supreme Court ruled that Congress has granted FDA the exclusive authority to assess the proper balance in its pre-market review of the device. The decision of the Court is the first ever to rule on the legal effect of FDA pre-market device approval on tort lawsuits.

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