Failure-To-Warn Claims Against Generic Dilantin Maker Preempted, Judge Rules

ATLANTA - A Georgia federal judge has ruled that failure-to-warn claims brought against the maker of generic Dilantin are preempted under PLIVA Inc. v. Mensing because, as a generic drug manufacturer, it could not have changed the label via the Changes Being Affected process. Moore v. Mylan Inc., No. 11-3037 (N.D. Ga.).

However, in the Jan. 5 order, Senior District Judge Marvin H. Shoob of the U.S. District Court for the Northern District of Georgia allowed failure-to-warn claims brought against the maker of Dilantin to the extent that they accuse it of failing to adequately warn doctors.

According to the …