Off-Label Promotion Claims Against Generic Cordarone Maker Preempted, Ky. Federal Judge Rules

FRANKFORT, Ky. — Claims that a generic Cordarone maker prompted the drug for off-label use are preempted because federal law barred the defendant from altering any warnings, labeling, or the composition of the generic drug, a Kentucky federal judge has ruled.

In a Sept. 29 order, Judge Gregory Van Tatenhove of the US District Court for the eastern district of Kentucky also dismissed claims that the defendant drug maker failed to provide the plaintiff with a medication guide because it asserts violations of the federal regulatory scheme, which only the Food and Drug Administration can enforce.

Cathy Moore was prescribed …