Judge William Kuntz

Defendants make generic Phenytoin Sodium, an anti-epileptic. Plaintiffs’ removed lawsuit alleged the Phenytoin they took differed from reference listed drug Dilantin in terms of labelling and bioequivalence. They also claimed to have experienced severe cutaneous adverse reactions (SCAR events) resulting in, among other things, tissue loss, blistering and necrosis. Defendants allegedly failed to assure bioequivalence to Dilantin after changes in the manufacturing process. Discussing Wyeth v. Levine and Pliva v. Mensing—U.S. Supreme Court precedent concerning federal preemption over tort actions involving generic drugs—district court denied remand and dismissed plaintiffs’ lawsuit. It determined that plaintiffs’ state law claims of strict product liability, negligence, fraud, breach of implied warranties, negligence per se and wrongful death depended on their assertions that defendants failed to adequately warn of the risk of SCAR events, and failed to test for and maintain bioequivalence with Dilantin. Such claims are federally preempted. Further, the federal question at issue was a sufficiently substantial, necessary element of plaintiffs’ state-law claims to confer original jurisdiction on district court pursuant to 28 USC §1331.