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August 21, 2008

Medical Devices - Pleading to Avoid Preemption

An Illinois federal district court suggested two possible ways to get around a federal preemption ruling even as it dismissed a medical device product liability complaint on preemption grounds (Heisner v. Genzyme Corp., N.D. Ill., No. 08-C-593, 7/25/08), The court noted that the U.S. Supreme Court's ruled in Riegel v. Medtronic, 128 S.Ct. 999 (2008) that the preemption provision in the Medical Device Amendments to the Food, Drug and Cosmetic Act applicable to Class III medical devices that have satisfied the Food & Drug Adminstration's premarket approval process, precludes state common-law tort claims against device manufacturers if those claims would impose requirements that are "different from, or in addition to" federal requirements for the device.  But, the court said, the Riegel opinion specifically declined to address whether claims based on state requirements that are "parallel to" federal requirements are preempted.

The parallel exception applied when resolution of a plaintiff's state law claims would impose requirements that are "substantially identical" to the applicable federal requirements.  For example, a state-law-based claim for failure to comply with federal requirements (such as a manufacturing defect claim) would not, if successful, impose a requirement different from or in addition to a federal requirement.  The complaint in Heisner referred only to a "defect" in the device, making it impossible for the court to determine whether a failure to comply with federal requirements was alleged therefore allowing the claim to proceed.  If the claim was simply that the alleged defect was intrinsic to the device, then it would be preempted.  The court gave the plaintiff leave to amend to clarify the nature of the defect claim.

Similarly, the court gave Heisner leave to amend his complaint to state a claim that Genzyme had failed to comply with post-approval reporting requirements.  The complaint contained a "vague suggestion" that Genzyme may have violated these reporting requirements, but was insufficient to put Genzyme on notice of such a claim.


August 21, 2008 | Permalink


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