A growing trend in medical device litigation is the claim that defendant manufacturers are liable for failing to report adverse events to the Food and Drug Administration (FDA). Unlike a standard failure-to-warn claim, a failure-to-report claim can avoid federal preemption if the jurisdiction has a state-law duty to do so, independent of federal requirements. The growth of this claim has been evident over the past 18 months, as both the U.S. Court of Appeals for the First and Second Circuits submitted certified questions to the Massachusetts and Connecticut Supreme Courts, respectively, asking if a manufacturer’s failure to report adverse events to a regulator, such as the FDA, constituted a cause of action under the respective state’s law. See Plourde v. Sorin Group USA, 23 F.4th 29, 37 (1st Cir. 2022) (case settled prior to Massachusetts Supreme Ct. proceedings); Glover v. Bausch & Lomb, 6 F.4th 229, 241 (2d Cir. 2021), certified question answered, 275 A.3d 168 (Conn. 2022) (finding that there was a Connecticut cause of action for failure to report adverse events to the FDA).
Whether such a duty exists in the commonwealth of Pennsylvania is an open question, and Pennsylvania district courts have split on the issue. A review of the rationales for their decisions can give us a window into whether or not such a cause of action exists under Pennsylvania law.