Failure-To-Warn Claims Against Generic Dilantin Maker Preempted, N.Y. Federal Judge Rules

NEW YORK – Failure-to-warn claims brought against Sun Pharmaceuticals Industries Ltd. (NSE:SUNPHARMA) as to its generic Dilantin are preempted, a New York federal judge ruled, explaining a specific FDA directive is needed before a generic drug maker may update its labeling.

In a Nov. 9 order, Judge William F. Kuntz II of the U.S. District Court for the Eastern District of New York also dismissed plaintiffs’ claims that Sun failed to test its antiepileptic drug for bioequivalence, finding they were inadequately pleaded.

In January, 28 individuals filed an amended complaint against Sun Pharmaceutical Industries Inc. in the Kings County (N.Y.) …