Judge Says FDA Regs Prevented Label Change, Finds Claims Preempted

MINNEAPOLIS - Failure-to-warn claims asserted against manufacturers of generic drugs are preempted by federal law because the warning labels that give rise to the claims cannot be unilaterally altered to include safety information that doesn't appear on the brand name product, a federal judge has ruled. Mensing v. Wyeth Inc., et al., No. 07-3919 (D. Minn.).

Judge Donovan W. Frank of the U.S. District Court for the District of Minnesota issued the finding in a June 17 ruling dismissing a case filed by a plaintiff who suffered a movement disorder after ingesting generic Reglan.

Gladys Mensing's contention that manufacturers …