What is the “learned intermediary doctrine”?

The “learned intermediary doctrine” is a legal concept in the state of Virginia that deals with product liability, which holds that a manufacturer or seller of a product cannot be held responsible for injuries caused by the product if a knowledgeable healthcare provider has been between the manufacturer and the consumer. In other words, the manufacturer does not owe a duty to the consumer for warnings about a prescription drug; instead the duty is to the healthcare provider who prescribes the drug. This doctrine was first applied in Virginia in 1987 in the case of Grayson v. Lynchburg Foundry Co. In Virginia, the courts apply a three-part test when determining if the learned intermediary doctrine applies. First, there must be a prescription product or device that is intended to be administered by a healthcare provider. Second, the manufacturer must provide accurate and adequate warnings to the healthcare provider. Finally, the healthcare provider must be considered “learned”, meaning that they have enough knowledge and experience to make a proper evaluation of the warning. If these three criteria are met, the manufacturer will not be liable to the user of the prescription product or device. The learned intermediary doctrine protects the manufacturers of pharmaceuticals and medical devices from product liability suits. By placing the duty of warning on the healthcare provider, manufacturers are able to avoid costly and time consuming lawsuits. Additionally, by relying on healthcare professionals, manufacturers can ensure that the user of the product is getting accurate and up-to-date information regarding risks and proper usage.

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What is the “learned intermediary doctrine”?

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