STORY FROM: Drugs & Medical Devices

Fraudulent ‘Off-Label’ Promotion Claim Against Sandoz Survives Preemption in S.C. Amniodarone Case

FLORENCE, S.C. — A South Carolina federal judge has allowed plaintiffs in an amiodarone action to amend their claim accusing Sandoz Inc. of fraudulently promoting the drug for “off-label” uses, ruling that while the claim is not preempted by federal law, it does not state facts sufficient to establish causation in light of the learned intermediary doctrine.

In a March 31 order, Judge R. Bryan Harwell of the U.S. District Court for the District of South Carolina dismissed with prejudice plaintiff’s claims of failure to warn, design defect, and negligent “off-label” promotion, ruling they are preempted pursuant to Mensing, Bartlett ...

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