A growing trend in medical device litigation is the claim that defendant manufacturers are responsible 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 may avoid federal preemption if the jurisdiction is required to do so by state law, regardless of federal requirements. The growth of this claim has been evident over the past 18 months, as both the US Courts of Appeals for the First and Second Circuits submitted certified questions to the Massachusetts and Connecticut Supreme Courts, respectively, asking whether the fact A manufacturer’s failure to report adverse events to a regulator, such as the FDA, constituted a cause of action under the respective state law. Watch plourde v. Sorin Group USA, 23 F.4th 29, 37 (1st Cir. 2022) (case settled before Massachusetts Supreme Court proceedings); Glover vs. Bausch & Lomb, 6 F.4th 229, 241 (2d Cir. 2021), certified question answered, 275 A.3d 168 (Conn. 2022) (finding there was a cause of action in Connecticut for failure to report adverse events to FDA).

Whether such a duty exists in the Commonwealth of Pennsylvania is an open question, and the Pennsylvania district courts have been divided on the issue. A review of the grounds for your decisions can give us an idea of ​​whether or not such a cause of action exists under Pennsylvania law.