Informed Intermediary Law and Legal Definition

Informed intermediary means a person who is in the chain of distribution from the manufacturer to the consumer and who knows the risks of the product. The manufacturer’s duty to caution against a drug’s side effects is fulfilled by giving adequate warning through an informed intermediary and not directly to the consumer. For example, the physician acts as an informed intermediary between the manufacturer and the patient. It is also called as learned intermediary.

In Bukowski v. CooperVision, Inc., 185 A.D.2d 31 (N.Y. App. Div. 1993), the court observed that “The informed or learned intermediary doctrine requires a manufacturer to warn of all potential dangers of which it knows or should know are associated with its product and, further, to take such steps as reasonably necessary to bring that knowledge to the attention of the medical community. The manufacturer discharges its duty in this regard by providing adequate warnings to the prescribing physician, who then acts as an informed intermediary between the manufacturer and the patient, assessing the risks and benefits of the drug and advising the patient of its possible risks and side effects. The informed intermediary doctrine has been extended to apply to certain medical devices. Implicit in the application of the doctrine is the existence of a medical professional with the knowledge and expertise to assimilate technical information and, further, the corresponding need for that professional to assess the risks and benefits posed by the drug or device in light of the particular patient's medical history and treatment needs.”