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

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.