STORY FROM: Drugs & Medical Devices

Learned Intermediary Doctrine Defeats Warning Claims in Enbrel Infection Case, 11th Cir. Affirms

TAMPA, Fla. - The learned intermediary doctrine bars failure-to-warn claims in an Enbrel infection case because the prescribing doctor had extensive knowledge of the drug's risks and testified that her decision to prescribe the drug would not have been altered by a different warning, a federal appellate court has affirmed.

In a Jan. 22 opinion, the 11th Circuit U.S. Court of Appeals further held that the direct "patient labeling requirement" in the FDA medication guidelines does not preempt Florida's learned intermediary doctrine.

In 2002, Rebecca Small began receiving two subcutaneous injections of Enbrel a week to treat her rheumatoid ...

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