Off-Label Promotion Claims in Amiodarone Case Preempted, S.C. Federal Judge Rules

FLORENCE, S.C. — Claims based upon a generic drug maker’s alleged off-label promotion of amiodarone are preempted because the manufacturer could not have changed the warnings and could not have disseminated additional warnings regarding off-label use without violating federal law, a South Carolina federal judge has ruled.

On Sept. 29, Judge R. Bryan Harwell of the U.S. District Court for the District of South Carolina further found the learned intermediary doctrine bars the claims because the plaintiff failed to show that his doctor would have changed his prescribing decisions had he been presented with a different warning.

Hubert E. Bean …