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    How far does the intermediary doctrine hold physicians accountable?


    David Goldberg, M.D., J.D
    Dr. Cosmetic has an enormously large dermatology practice. He sees both medical and cosmetic patients, and he injects thousands of patients with botulinum toxin injections. One of these patients, after seeing multiple television and magazine ads, came to Dr. Cosmetic and asked for the toxin by name.

    After treatment, the patient suffered an anaphylactic reaction to one of the toxin-associated proteins contained in the chosen botulinum toxin. She went into anaphylactic shock and suffered permanent renal damage. Such a terrible reaction has not been reported. Experts agree that such a reaction is certainly possible, but warning a patient of this reaction is not reasonable. The patient sued the drug manufacturer but not the physician.

    The manufacturer said responsibility lays with the physician because of the learned intermediary doctrine. What is the learned intermediary doctrine? Is Dr. Cosmetic liable?

    Learned intermediary doctrine

    Under traditional theories of products liability, a manufacturer is liable for injury caused because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of such information. Consumers have long accepted, however, that prescription pharmaceuticals come with inherent risks. But since the drugs are sold to consumers only at the recommendation of a physician, a different regime of products liability law is needed to govern tort actions when patients are injured by a medication.

    The learned intermediary doctrine arose to address the inadequacy of the standard products liability doctrine due to the special relationship between doctors and patients. As an expert in the medical field, a doctor assists patients in weighing the risks and benefits of a particular drug purchase, since the consumer on his or her own does not possess the requisite scientific knowledge to make an informed decision.

    Learned intermediary doctrine does not absolve a drug manufacturer of its duty to warn; rather, it replaces the consumer with the doctor in terms of who the manufacturer must warn. The drug company has a duty to warn the prescribing doctor, but not a duty to warn the end-consumer. Drug companies would find it impossible, or at the very least, difficult to properly provide a complex medical warning directly to the consumer in language that is easy to understand. Instead, the manufacturer must provide an adequate warning of risks to the prescribing doctor to fulfill its duty to warn.


    David J. Goldberg, M.D., J.D.
    Dr. Goldberg is Director of Skin Laser & Surgery Specialists of New York and New Jersey, Director of Mohs Surgery and laser research, ...

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