Learned Intermediary Doctrine Bars ‘Off-Label’ Marketing Claim in Amiodarone Case, S.C. Federal Judge Rules

FLORENCE, N.Y. — A South Carolina federal judge has dismissed with prejudice a lawsuit accusing Sandoz Inc. of fraudulently promoting amiodarone for “off-label” uses, finding the plaintiffs failed to allege facts sufficient to establish causation in light of the learned intermediary doctrine.

In a March 23 order, Judge R. Bryan Harwell of the U.S. District Court for the District of South Carolina further held that federal law preempts the fraudulent off-label marketing claim because Sandoz could not have changed the warnings regarding off-label use without violating federal law.

“The basis for Plaintiff’s ‘off-label’ marketing claim is that Sandoz, by …