Judge Says Injury Claims Linked to Generic Painkiller are Preempted

SAN JOSE, Calif. - Failure-to-warn claims filed against a manufacturer of a generic drug are preempted by federal law when the generic's labeling is identical to the listed drug's and contains warnings previously mandated by the FDA, a federal judge has ruled. Gaeta v. Perrigo Pharmaceuticals Co., et al., No. 05-4115 (N.D. Calif.).

In a June 13 award of summary judgment to generic ibuprofen maker Perrigo Pharmaceuticals Co., Judge James Ware ruled that the manufacturer would have challenged FDA authority had it included warning information on its label regarding the risk of liver injury associated with the product.

"Since …