State Law Claims Against Generic HRT Drug Makers Preempted, 7th Cir. Affirms

MADISON, Wis. — Various state law claims asserted against the makers of generic hormone replacement therapy drugs are preempted by the Food, Drug and Cosmetic Act because they all sound in either failure to warn or defective design, a federal appeals court has affirmed.

In an Oct. 18 opinion, the 7th Circuit U.S. Court of Appeals explained that the FDCA prevents generic drug makers from unilaterally altering their warning labels or the design of their products and, as such, the plaintiffs’ claims are preempted.

For more than 10 years, Kathleen Wagner took brand name and generic HRT drugs as prescribed …