Manufacturers of medical devices suffered a major setback recently when a federal appellate court held that "premarket approval" of medical devices by the Food and Drug Administration ("FDA") has no preemptive effect on product liability claims brought under state law. As a result of the court's holding, manufacturers of medical devices may face continuing exposure to product liability suits, even when there has been full compliance with the FDA requirements during the "rigorous" premarket approval process.
In Goodlin v. Medtronic, Inc., No. 97-5801, 1999 U.S. App. LEXIS 2507 (11th Cir. Feb. 18, 1999), the plaintiff was a pacemaker recipient who underwent open-heart surgery after the manufacturer issued a warning about the risk of a defect in the lead to the pacemaker. The plaintiff underwent open-heart surgery to replace the lead, but surgery revealed no signs of a defect. Thereafter, plaintiff asserted claims against the manufacturer for negligent design and strict product liability. The district court concluded that the FDA had found the pacemaker to be safe and effective during the premarket approval process. As a result, the court found that the plaintiff's claims were preempted, and entered judgment for the manufacturer.
The United States Court of Appeals for the Eleventh Circuit reversed. The appellate court recognized that Section 360k(a) of the Federal Food, Drug and Cosmetic Act contains an express provision that federal law will preempt conflicting requirements of state law. Citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 501 (1996), the court noted that the plaintiff's claims would not be preempted unless the premarket approval process imposes a "specific federal requirement" on a "particular device."
The court recognized that during the often "rigorous" premarket approval process, the FDA demands the "submission of detailed information regarding the safety and effectiveness of the device under review." Goodlin, id. at 5-6. The court also conceded that after FDA approval, a manufacturer may not alter its labeling, product design, or manufacturing process in any way. Nevertheless, the court of appeals determined that the FDA's premarket approval process imposes no "specific federal requirement" because the process does not impose "any ascertainable substantive prerequisite for approval." Goodlin, id. at 29.
The court also determined that the premarket approval process does not apply to a "particular device." Instead, the court observed that "[t]he federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements." Goodlin, id. at 33.
Finding that the premarket approval process imposes "no specific federal requirement," on a "particular device," the Eleventh Circuit expressly rejected the Seventh Circuit's resolution of the same issue in Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), cert. denied, __ U.S. __, 118 S. Ct. 1300 (1998). As a result, there now exists a split of authority among the circuits, and Supreme Court resolution appears necessary.
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