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Each New York State law claim plaintiffs plead depends on allegations that defendant failed to adequately warn of the risk of SCAR events and to test for and maintain bioequivalence of Dilantin. Plaintiffs' failure to warn claims are preempted by federal

April 11, 2013
Bowdrie v. Sun Pharmaceutical Industries Ltd., 12-CV-853, NYLJ 1202578792711, at *1 (EDNY, Decided 11/9/12)

The defendant pharmaceutical companies make generic Phenytoin Sodium; the brand name of the designer drug is Dilantin. Dilantin and the generic Phenytoin are anti-epileptic drugs used to slow down impulses in the brain that cause seizures. The plaintiffs' removed lawsuit alleged the Phenytoin they took differed from reference listed drug Dilantin in terms of labeling and bioequivalence. They also claimed to have experienced severe cutaneous adverse reactions (SCAR events) resulting in, among other things, tissue loss, blistering and necrosis. The 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—the district court denied remand and dismissed the plaintiffs' lawsuit. It determined that the 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 the 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 the plaintiffs' state-law claims to confer original jurisdiction on the district court pursuant to 28 USC §1331.

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