A “failure to communicate” claim against the maker of generic Reglan was completely preempted by federal law regulating the pharmaceutical industry, the 11th U.S. Circuit Court of Appeals has ruled in affirming judgment.
Federal law does not preempt a product liability suit alleging that the maker of a generic form of Fosamax failed to update its warning label in conformity with revised brand-name warnings, the California Court of Appeal has ruled in affirming judgment.
The U.S. Supreme Court has agreed to decide whether federal law preempts state law design defect claims targeting generic pharmaceutical products.
Published: May 9, 2012
Tags: drug litigation, failure to warn, Federal Food Drug and Cosmetic Act, federal preemption, generic drug litigation, generic drugs, PLIVA v. Mensing, preemption, product liability, Wyeth v. Levine
Since last year, when generic drug makers won a victory on the issue of federal preemption before the U.S. Supreme Court, lower courts have been dismissing cases against generic drug makers left and right.
But last week a federal appeals court issued a ruling that gives plaintiffs a long-awaited opening in those suits.
Reglan lawsuits are rising; so is debate over preemption for failure-to-warn claims against makers of generic versions of the drug. The FDA and Solicitor General have been asked for opinions on generic preemption.