Supreme Court Decision Limits Product-Liability Cases
BY LAUREN UZDIENSKI, FEBRUARY 20, 2008
In an 8-1 decision, the Supreme Court ruled in favor of Medtronic in the Reigel v. Medtronic case. As we reported in June, Charles Reigel sued Medtronic after a balloon catheter failed during his angioplasty. Medtronic argued successfully in several lower courts that FDA approval (that is, approval from a federal entity) pre-empted action against a company in state courts. Today, the Supreme Court affirmed the finding of lower courts that Medtronic cannot be sued over the faulty product. The decision is important for the device industry, since it largely restricts the number of product-liability cases that can go before the courts.
The decision also bolsters the authority of the FDA. Though recently plagued by accusations that the agency was failing to adequately protect consumers, the outcome today affirms the Court's confidence in the FDA approval process.
