Medtronic has won a case that went to the U.S. Supreme Court over whether patients could sue manufacturers of PMA-approved devices in state courts. The high court ruled 8-1 that because FDA has already made a determination about the safety and effectiveness of the product, state lawsuits are barred when they would impose different requirements.

February 20, 2008

1 Min Read
Medtronic Wins Supreme Court Case

The ruling, which pertained to a patient named Charles Riegel who was injured by a Medtronic catheter, was released this morning, reports the Associated Press. The lone dissenter, Justice Ruth Bader Ginsburg, said that Congress never envisioned "a radical curtailment of state common-law lawsuits" when it granted FDA ultimate authority to determine the safety and effectiveness of PMA products. 510(k) products are subject to suits in state courts because they have not been evaluated as rigorously.This is a victory not only for Medtronic, but for FDA and the device industry as a whole. A loss would have meant that state courts could have made their own determinations as to what constituted safety and effectiveness. This would have undermined FDA's authority, exposed device companies to increased liability, and potentially thrown the whole medical device regulatory system into chaos. Remember, patients can still sue if the product violated FDA regulations. This is not the stripping-of-legal-rights scenario that some will make it out to be. 

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