This week the U.S. Supreme Court ruled 8 to 1 in favor of Medtronic in a court case, Riegel v. Medtronic, which essentially says that patients injured by FDA-approved devices can't collect damages if manufacturers complied with government standards.

Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after its catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law.

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. The Court said the 1976 federal law that requires FDA clearance for certain products would be disrupted by negligence suits under state law, just as it would be impaired by varying state regulations.

Congress' concern for those injured by FDA-approved devices was outweighed by its "solicitude for those who would suffer without new medical devices if juries were allowed to apply the (injury) law of 50 states to all innovations," says Justice Antonin Scalia in the majority opinion.

“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.”