STORY FROM: Drugs & Medical Devices

Amiodarone Medication Guide, Off-Label Claims Not Preempted, Ill. Judge Rules

CHICAGO — Claims that a generic amiodarone manufacturer failed to provide a Medication Guide to distributors and negligently promoted the drug for off-label uses are not federally preempted because they allege violations of state law that parallel federal regulations, an Illinois federal judge has ruled.

In a March 29 order, Judge Edmond Chang of the U.S. District Court for the Northern District of Illinois further ruled there are questions of fact as to whether the claims were timely filed and barred by the learned intermediary doctrine.

However, the judge dismissed without prejudice the plaintiff’s fraudulent concealment claim, ruling that it ...

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