The Lawletter Vol 37 No 3
The U.S. District Court for the Western District of Pennsylvania recently decided a case involving issues of preemption under the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"). See Gross v. Stryker Corp., Civ. No. 11-1229, 2012 WL 876719 (W.D. Pa. Mar. 14, 2012). The case is important because it explains clearly both the grounds upon which a manufacturer may defend on the basis of MDA preemption and the basis upon which a plaintiff may circumvent the preemptive effect of the statute in bringing state tort claims.
In Gross, the plaintiff had received an implantation of an artificial hip prosthesis manufactured by the defendant. The plaintiff alleged that the device was defective and that the defect had caused him to suffer a serious infection at the operation site, with attendant pain and the necessity of a corrective procedure. The plaintiff sued under state law theories of strict liability, negligence, and breach of express and implied warranties.
The defendant argued that the plaintiff's state law claims were preempted by the MDA. The MDA contains an express preemptive section, which provides that no State may establish any requirement for a medical device that is different from or in addition to any requirement imposed under the FDCA and that relates to the safety or effectiveness of the device. See 21 U.S.C. § 360k(a). The court agreed that the plaintiff's claims were preempted by the MDA.
Initially, the court noted that for a state cause of action to be preempted by the MDA, the medical device at issue must have been subject to specific federal requirements related to its safety and effectiveness and the plaintiff's claim must be premised on state law that imposes different requirements. The court noted that, generally, state common-law claims contesting the safety and effectiveness of a device that received approval under the premarket approval process ("PMA") conducted by the Food and Drug Administration ("FDA"), such as the hip prosthesis at issue in the case at hand, are subject to express preemption. This is because questions regarding a device's safety and effectiveness are requirements addressed in the PMA.
The court concluded that the plaintiff's state breach-of-implied-warranty claim imposed a requirement different from or in addition to the federal requirements and, therefore, was preempted by the MDA in light of the fact that Pennsylvania's "below commercial standards" requirement was not the same as the standards imposed by the FDA. The court similarly concluded that the plaintiff's negligence claim ran afoul of the preemptive reach of the MDA, given that the plaintiff alleged that the defendant had been negligent in placing the device into the stream of commerce when it contained unsafe manufacturing residuals or bacteria.
The court observed, however, that the MDA does not preclude all state law claims against the manufacturer of a medical device. According to the court, a plaintiff may premise a state claim on an allegation that the manufacturer violated FDA regulations, since the duties asserted by such a claim would parallel, rather than add to, the federal requirements. In order to state such a claim, a plaintiff may not merely recite that the defendant violated FDA regulations but must set forth facts showing action or inaction in the defendant's efforts to take part in the PMA or to implement its results. In the case under consideration, the plaintiff failed to state such a claim because he did not allege which precise duty the defendant had violated. Although the complaint averred that the defendant had breached FDA duties pursuant to current good-manufacturing-practice requirements, the court noted that these do not constitute a formal performance standard for a specific device, with which the manufacturer must comply.