Liability for pharmaceutical products: a critique of the 'learned intermediary' rule

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    Abstract

    Under English law, a manufacturer is generally required to provide adequate
    information to the ultimate user of its products, including details of any latent
    dangers known to be inherent therein. This article examines the provision of
    warning information in relation to pharmaceutical products, and argues that the
    general law applies to non-prescription drugs only. It postulates that the
    manufacturer of a prescription drug is required to convey warning information
    to an intermediary, namely the physician, rather than to the patient. The
    operation of this 'learned intermediary rule' and its relationship to the principle
    of 'informed consent' to treatment is considered. It is suggested that the
    approach of the English courts to informed consent may leave an injured patient
    unable to attain redress, even where a doctor has failed to act as learned
    intermediary.
    The English position is compared to the situation in the United States of
    America, where it is generally accepted that the learned intermediary rule applies
    to prescription drugs. In recent years, some American courts have developed
    exceptions to this rule, principally in the context of the provision of oral
    contraceptives and vaccines. An attempt is made to account for this, and to
    determine whether the English courts are likely to adopt similar exceptions.
    Original languageEnglish
    Pages (from-to)59-82
    JournalOxford Journal of Legal Studies
    Volume12
    Issue number1
    DOIs
    Publication statusPublished - 1992

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