In Howard v. Zimmer, Inc., 2013 WL 1130759 (Okla. Mar. 19, 2013), the Oklahoma Supreme Court, answering a certified question from the U.S. Court of Appeals for the Tenth Circuit, found that violations of federal regulations can constitute negligence per se under Oklahoma law. Plaintiff claimed his knee implant failed because the manufacturer left an oily residue on the implant in violation of federal good manufacturing process (“GMP”) regulations. The Court allowed this state-law claim to proceed despite the provision of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 337(a), that all violations of the FDCA be enforced by the federal government.
The Oklahoma court distinguished between enforcing a federal regulation—which only FDA has authority to do—versus allowing a “parallel” state law claim for negligence per se to be grounded in a violation of a federal regulation. 2013 WL 1130759 at *7. The court observed that the U.S. Supreme Court recognized in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) that such “parallel claims” would not be preempted by federal law, and held that this is “precisely the situation presented here.” 2013 WL 1130759 at *6. A vigorous dissent criticized the breadth of the majority’s holding and questioned whether the GMP regulation at issue mandated only a process rather than a particular result and may not have been intended to benefit consumers.
The Oklahoma Court correctly noted that “[t]here is no unanimity in the courts which have addressed the issue of whether negligence per se claims should be allowed to proceed under the FDCA.” Id. State law plays a critical role in the breadth of the so-called “parallel claims” exception to medical device preemption under Riegel, making this an issue to watch.