3rd Cir. Refuses to Reinstate Heart Medication Labeling Case Against Teva

  • Opinion

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 …


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