STORY FROM: Drugs & Medical Devices

Claims of Off-Label Promotion, Failure to Provide Medication Guide Dismissed in N.C. Cordarone Case

RALEIGH, N.C. — Claims accusing the makers of Cordarone and its generic equivalent of promoting the drugs for off-label use and of failing to provide a medication guide to consumers are preempted by federal law because they conflict with the Food, Drug and Cosmetic Act.

In a July 20 order, Judge Louise Flanagan of the U.S. District Court for the Eastern District of North Carolina explained that because the claims exist solely by virtue of the FDCA, and because such regulations do not have a parallel in state law, they are preempted and must be dismissed with prejudice.

In 2006, ...

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