Learned Intermediary Doctrine Defeats Aldara Off-Label Use Action, Md. Federal Judge Rules

BALTIMORE — The learned intermediary doctrine defeats claims that the makers of Aldara failed to warn of the dangers of using the drug for off-label uses, a Maryland federal magistrate judge has ruled, explaining that drug makers are under no obligation to warn a patient of risks associated with such off-label use.

Because the plaintiff's doctor prescribed Aldara for an off-label use, defendants are not responsible for the alleged consequences of the plaintiff's use of that drug, Magistrate Judge Beth P. Gesner of the U.S. District Court for the District of Maryland ruled on April 16.

Brenda Louise Morris was …