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

Under English law, a manufacturer is generally required to provide adequateinformation to the ultimate user of its products, including details of any latentdangers known to be inherent therein. This article examines the provision ofwarning information in relation to pharmaceutical products, and argues that thegeneral law applies to non-prescription drugs only. It postulates that themanufacturer of a prescription drug is required to convey warning informationto an intermediary, namely the physician, rather than to the patient. Theoperation of this 'learned intermediary rule' and its relationship to the principleof 'informed consent' to treatment is considered. It is suggested that theapproach of the English courts to informed consent may leave an injured patientunable to attain redress, even where a doctor has failed to act as learnedintermediary.The English position is compared to the situation in the United States ofAmerica, where it is generally accepted that the learned intermediary rule appliesto prescription drugs. In recent years, some American courts have developedexceptions to this rule, principally in the context of the provision of oralcontraceptives and vaccines. An attempt is made to account for this, and todetermine whether the English courts are likely to adopt similar exceptions