Design Defect, Off-Label Claims in Amiodarone Suit Not Preempted, Ohio Judge Rules

COLUMBUS, Ohio — State law claims of design defect and off-label promotion brought against Sandoz Inc. in connection with its generic antiarrhythmic drug are not preempted by the Federal Food and Cosmetic Act because they are not based on a failure-to-warn theory, an Ohio federal judge has ruled.

However, Judge James L. Graham of the U.S. District Court for the Southern District of Florida further ruled in the Jan. 25 order that plaintiff’s failure-to-warn claim is preempted because it falls within the ambit of PLIVA v. Mensing.

Frederick Arters sued Sandoz Inc. and Eon Labs Inc. in the Delaware County …