Also known as: warning-label liability · warning labels liability · failure to warn · inadequate warning · product warning liability
Written by attorneys · grounded in primary & secondary sources — see below
A doctrine in products liability under which a prescription drug or medical device manufacturer satisfies its duty to warn of risks by providing adequate information to the prescribing physician rather than directly to the patient.
Wanda Weaver's physician prescribed a branded drug after reviewing the manufacturer's detailed risk disclosure. When Wanda later suffered the disclosed side effect, she sued the manufacturer for failure to warn her directly. The court applied the learned intermediary doctrine and dismissed the claim because the warning to the physician was sufficient.
Warren Woods received a prescription drug after his physician reviewed the manufacturer's warning. After an adverse reaction, Warren sued the manufacturer. The court held that the manufacturer's duty to warn ran solely to the prescribing physician, satisfying its obligation without direct patient notice.
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Willow Walker sued a medical device manufacturer after suffering complications from an implanted device. She presented only general evidence that physicians knew of certain risks. The court granted summary judgment because she failed to show that a better warning to her physician would have altered the prescribing decision.
A psychiatrist learned that a patient on medication planned to harm another. The manufacturer had warned physicians of the risk. The court held the warning to the physician adequate under the learned intermediary rule, satisfying the manufacturer's obligation.
William Williams sued a prescription drug manufacturer alleging failure to warn after an adverse reaction. The court refused to require direct patient warnings because patients rely on physicians. It evaluated the warning under the learned intermediary standard.
Wendy Wu could not identify which manufacturer produced the drug that injured her. She sued several companies that had used identical warnings. The court examined whether the shared warning to physicians was adequate under learned intermediary principles.
Yes. The doctrine holds that the manufacturer's duty to warn runs to the prescribing physician rather than the patient. An adequate warning to the physician satisfies the duty and prevents liability for failure to warn the patient directly.
Supporting sources
The plaintiff must show that the warning given to the physician was inadequate or misleading and that an adequate warning would have changed the physician's prescribing decision. Generalized evidence that physicians knew of risks is insufficient to establish causation.
Physicians act as learned intermediaries who evaluate the risks and benefits of medications for individual patients. A manufacturer satisfies its duty by providing adequate warnings to the medical community rather than directly to patients.
Supporting sources
…without leave to amend. The Supreme Court held that plaintiffs could state a cause of action against the psychotherapists for failure to warn the victim of a danger of violence posed by the patient, but could not state a cause of action for failure to confine the patient. Majority opinion Opinion of Tobriner, J. On…