Preemption: Ohio Pharmaceutical Litigation

A product liability action for inadequate warning is not preempted by federal labeling requirements where the action seeks to impose labeling requirements that are identical to those of the federal statute. However, such an action is preempted to the extent that it seeks to impose "more elaborate or different" labeling requirements.

A product liability action for inadequate warning is not preempted by federal labeling requirements where the action seeks to impose labeling requirements that are identical to those of the federal statute.  However, such an action is preempted to the extent that it seeks to impose “more elaborate or different” labeling requirements.(1)

1.Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090, 1098 (6th Cir. 1997), cert. denied, 522 U.S. 1075 (1998) (to be preempted, a state law requirement respecting a medical device must be different from or in addition to a relevant federal requirement and must relate to the safety or effectiveness of the medical device).