Rulings limit patients’ ability to sue device firms, drugmakers

American Medical News, May 8, 2008

Some physicians and consumer advocates worry that a recent U.S. Supreme Court ruling and a pending case could take away the legal aspect of patient safety when it comes to medical devices and pharmaceuticals. Justices ruled earlier this year that patients injured by certain medical devices approved by the Food and Drug Administration cannot sue the product's manufacturer. The court said federal regulations preempt state-based liability claims challenging the design or labeling of medical devices that clear the FDA's approval process.