Medical device manufacturers in the U.S. can't be held liable for damages from patients injured by their devices if the products followed federal regulatory standards, according to a U.S. Supreme Court ruling this week.
In a February 20 decision, the court ruled in Riegel v. Medtronic that the Medical Device Amendments (MDA) of 1976 and the Federal Food, Drug, and Cosmetic Act (FFDCA) confer safety oversight authority for medical devices to the federal government rather than to states.
Charles Riegel brought suit in the state of New York against Medtronic when a catheter made by the company ruptured in his coronary artery during angioplasty, claiming that the device violated New York common law.
The Supreme Court, however, ruled that federal regulatory standards superseded state laws, and that a manufacturer is protected if its product has received U.S. Food and Drug Administration (FDA) approval. The court's decision not only supports a lower court ruling, but also blocks plaintiffs from bringing state product-liability lawsuits unless a company has breached FDA regulations.
Related Reading
U.S. justices weigh medical-device makers' liability, December 5, 2007
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