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Practice Tip: Pleading Medical Device Complaints

By Larry Goldhirsch
July 26, 2011

The heightened pleading requirements of Bell Atlantic Corp. v. Twombly, 550 US 544 (2007), require that practitioners who plan to file a complaint in a medical device case be even more cautious than usual. Otherwise, they may be subject to a dismissal on the pleadings. To begin with, a product liability case for the failure of a medical device is unlike other product cases. For Class III Medical Devices ' those that are most critical to human health and subject to extensive federal pre-market approval regulations ' a mere failure of the product is insufficient to bring an action. When “ordinary” products fail, the plaintiff can sue under state causes of action in negligence, strict liability in tort or breach of warranty; however, when a Class III device fails, such actions are expressly preempted by the Medical Device Act. 21 U.S.C. 360k(a).

State-Based Causes of Action

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