Failure To Warn And The Learned Intermediary Doctrine
Failure to warn actions generally arise in products liability actions against pharmaceutical companies. Failure to warn is when a manufacturer or seller of a product fails to provide the consumer with adequate or sufficient warnings of the potential risk of injury known to result from the use of its product, and that failure results in an injury. In cases against pharmaceutical manufacturers, the failure to include adequate warnings in the labels of drugs and medical devices may render the product defective.
In most jurisdictions, a manufacturer’s duty to warn is triggered when the manufacturer knew or should have known of the risk of an injury. A breach of this duty results in liability of the manufacturer for injuries sustained by consumers of its product. In an action against a pharmaceutical manufacturer, the manufacturer has the duty to warn the prescribing physician, and not the patient, of all risks attendant to a pharmaceutical drug or medical device. This is known as the “learned intermediary doctrine.” The learned intermediary doctrine provides that a pharmaceutical manufacturer’s duty to warn has been fulfilled when it adequately warns the prescribing physicians - the learned intermediary – of the risks and dangers associated with its product. This doctrine is based on the principle that the prescribing physician is the one that interacts and communicates with the patient. Therefore, under the “heeding presumption”, which is followed in certain states, the fact finder is allowed to presume that the patient would have heeded to an adequate warning if one had been given by his or her physician and would have avoided injury. Accordingly, if the fact-finder finds that the pharmaceutical manufacturer adequately warned the prescribing doctor of the risks and dangers of its product, the manufacturer’s duty is discharged. The learned intermediary doctrine is one of the most important defenses used by manufacturers of medical devices and drugs as it shields them from liability.