STORY FROM: Drugs & Medical Devices

Pa. Federal Judge Refuses to Create New ‘FDA Exception’ to Learned Intermediary Doctrine

PHILADELPHIA — A Pennsylvania federal judge has refused to create a new “FDA exception” to the learned intermediary doctrine in an amiodarone wrongful death action, ruling that “it would break new ground and significantly expand liability” under commonwealth law.

In a May 26 order, Judge Eduardo C. Robreno of the U.S. District Court for the Eastern District of Pennsylvania further held that even if adopted, the exception would be inapplicable in the instant case because it was not foreseeable that the drug would be dispensed without a physician’s considered prescription.

Joanne Polt was prescribed amiodarone “off-label” to treat atrial ...

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