The Supreme Court granted certiorari yesterday on a case testing whether plaintiffs can recover for personal injuries sustained by medical devices under state law. In the personal injury case, the plaintiffs were injured by when a ballon catheter ruptured during an angioplasty. The injured patient filed a lawsuit for violations of New York state product liability law including negligent design and breach of warranty.
Medtronic, the company that made the balloon catheter, was able to get the case dismissed under a preemption provision of the Medical Devices Amendments to the Food, Drug, and Cosmetics Act. Federal law preempts state law claims for medical devices that received pre-market approval by the FDA, such as Medtronic’s balloon catheter, where state law creates regulations that are more stringent than federal regulations.
Supporters of the plaintiffs argue that dismissing these types of state law claims would strip consumers of valuable state protections. This would make it more difficult for those injured by medical devices to seek recovery.
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