Claims Against Generic Hormone Drug Makers Preempted, Wis. Federal Judge Rules

MADISON, Wis. — A Wisconsin federal judge has dismissed claims brought against the makers of generic hormone drugs, finding they all sound in either failure to warn or defective design and are therefore preempted by the Food, Drug and Cosmetic Act.

In a July 11 order, Judge James D. Peterson of the U.S. District Court for the Western District of Wisconsin explained that the FDCA prevents generic drug makers from unilaterally altering their warning labels or the design of their products.

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