In Stamps v. Collagen Corp., 984 F.2d 1416, 1422 (5th Cir. 1993), the 5th Circuit found that that state product liability claims against a medical device manufacturer were preempted the Medical Device Amendents of 1976. In reviewing Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the Supreme Court found that medical devices that underwent 510K review by the FDA, which is only a cursory review to determined if the device is equivalent to a device on the market prior to 1976, were not entitled to federal preemption of state tort law claims. Subsequent to Lohr, other circuits have found that devices subject to the much more rigorous requirements of PMA (pre-market approval) review were entitled to preemption. (See Brief - Federal courts split over whether PMA approval triggers federal preemption under the MDA - Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000)).
In this case, the 5th Circuit reviews its decision in Stamps in light of Lohr and subsequent cases in other circuits. It reaffirms Stamps in cases which involve PMA approval, distinguishing Lohr because the FDA did not do a comprehensive review of the device in Lohr and did not provide detailed guidance to the manufacturer on the design and manufacture of the device. In the instant case, the pacemaker was subject to detailed FDA review and the manufacturer was given specific guidance on design and manufacture. The court found that state tort claims alleging improper design, warning, and manufacture would constitute additional state requirements in conflict with federal regulation and thus were preempted. The court noted that plaintiffs were not able to produce evidence that the manufacturer deviated from the FDA requirements or that the manufacturer deceived the FDA during the review, either of which would have put the MDA preemption into question. The court provides an excellent review of MDA jurisprudence at this point in time.
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