In Chasse v. Stryker Corp., et al., No. 12-11694-PBS (D. Mass. Mar. 20, 2013), plaintiffs filed a class action complaint against the manufacturers of a hip replacement system that they alleged had been negligently manufactured and distributed. Plaintiffs alleged that defendants’ violations of various federal regulatory requirements, including Current Good Manufacturing Practice (“CGMP”) requirements of the Quality System Regulation, 21 C.F.R. Part 820, promulgated under the Medical Device Amendments (“MDA”) to the Federal Food, Drug and Cosmetic Act (“FDCA”), constituted negligence under Massachusetts law. Defendants moved to dismiss the complaint on the ground that plaintiffs’ negligence claim was preempted by the MDA’s express preemption provision, 21 U.S.C. § 360k, which preempts any state law requirements that are “different from, or in addition to,” any requirements imposed by the FDCA.
The court first noted that the key question raised by the motion was whether the complaint pleaded a “parallel” claim that avoids preemption under the United States Supreme Court’s 2008 decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (see April 2008 Foley Hoag Product Liability Update). In Riegel, the Court held the MDA does not prevent a state from providing a damages remedy for claims premised on a violation of FDCA regulations because the state duties in such a case merely “parallel,” rather than add to or differ from, federal requirements. Defendants argued that CGMPs are not device-specific regulations and are therefore too general to constitute binding federal requirements that could form the basis for a “parallel” claim under state law.
In considering the motion, the court highlighted several federal trial and appellate court decisions that had addressed the same issue. The court acknowledged that some federal district courts, including the United States District Courts for the Western District of Pennsylvania and the Eastern District of New York, had reasoned that CGMPs are too general to serve as a basis for a parallel claim. The court found each of three circuit court decisions cited by defendants distinguishable, however, as none of them were specific to CGMPs and in each of those cases the holding rested in part on the determination that the plaintiff had failed to identify a specific regulatory violation that had allegedly caused his or her injury. In contrast, the Fifth and Seventh Circuit Courts of Appeals had addressed the precise issue involved here and held that CGMPs are “legally binding requirements” that can serve as the basis of a “parallel” claim, at least when their violation is alleged to have caused the plaintiff’s specific injury. Persuaded by the reasoning of these two appellate decisions, the court denied defendants’ motion.