Design Defect, Implied Warranty Claims Preempted in Generic Reglan Case, Ark. Federal Judge Rules on Remand

LITTLE ROCK, Ark. — Claims of design defect and breach of implied warranty claims brought against the makers of generic Reglan are preempted because they would require the drug makers to redesign the composition of their products, which is prohibited by the Food, Drug and Cosmetic Act, an Arkansas federal judge has ruled.

On Feb. 28, Judge J. Leon Holmes of the U.S. District Court for the Eastern District of Arkansas found it is immaterial whether a state follows the risk-utility approach or the consumer-expectations approach in assessing the reasonableness of the danger of a drug.

Joyce Fullington sued Pfizer, …