3rd Cir. Refuses to Reinstate Heart Medication Labeling Case Against Teva
September 9, 2022
WILMINGTON, Del. — A federal appellate panel has upheld dismissal of a lawsuit accusing Teva Pharmaceuticals of failing to distribute medication guides with its generic Cordarone and failing to report adverse events concerning “off-label” uses to the FDA.
On Sept. 7, the 3rd Circuit U.S. found the claims were insufficiently pled pursuant to Federal Rules of Civil Procedure 8 and 9.
Plaintiffs are individuals who alleged injuries caused by the ingestion of Cordarone (amiodarone) for the “off-label” treatment of atrial fibrillation.
The FDA approved Cordarone only for use as a "drug of last resort" by patients suffering from life-threatening …