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Medtronic Statement Regarding U.S. Supreme Court’s Favorable Decision in Riegel v. Medtronic, Inc.


The U.S. Supreme Court ruled 8 to 1 today in favor of Medtronic (NYSE:MDT) in Riegel v. Medtronic, Inc. The decision reaffirms that the U.S. Food and Drug Administration (FDA) pre-market approval process for medical devices, which expertly balances the patient benefits and risks, appropriately preempts state tort lawsuits involving devices approved through that process.

The Court ruled that Congress has granted the 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,” said 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.”


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