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A growing trend in medical device litigation is the assertion that defendant manufacturers are liable for failing to report adverse events to the Food and Drug Administration (FDA). Unlike a standard no-warn requirement, a no-report requirement can avoid federal preemption if the jurisdiction has a state right to do so regardless of the federal requirements. The growth of this requirement has been evident over the past 18 months, as the US Court of Appeals for the First and Second Circuits presented certified questions to the Massachusetts and Connecticut Supreme Courts, respectively, asking whether adverse events had been underreported by the manufacturer. a regulatory agency such as the FDA has a cause of action under the applicable state law. See Plourde v. Sorin Group USA, 23 F.4th 29, 37 (1st Cir. 2022) (case settled prior to Massachusetts Supreme Court proceedings); Glover v. Bausch & Lomb, 6 F.4th 229, 241 (2d Cir. 2021), affirmed reply, 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 been divided on the issue. Reviewing the reasoning behind their decisions can give us a window into whether such a cause of action exists under Pennsylvania law.


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