Also known as: duty to warn third parties · duty to warn · third-party warning duty
Written by attorneys · grounded in primary & secondary sources — see below
A product liability rule under which manufacturers of prescription drugs and medical devices satisfy their duty to warn by providing adequate information to the prescribing physician rather than directly to the patient. The physician functions as a learned intermediary who assesses individual risks and benefits before prescribing.
Diamond Manufacturing produces a prescription medication and supplies detailed risk information to prescribing physicians. A patient later suffers an adverse reaction that the physician did not discuss with her. Because the manufacturer fulfilled its obligation by warning the physician, it faces no direct liability to the patient for failure to warn.
Dixon Foods distributes a medical device after providing risk data to the implanting surgeon. The patient claims the warning was inadequate and sues the manufacturer. The court requires proof that a better warning would have changed the surgeon's decision. General awareness of risks among physicians does not establish causation.
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Yes. The Eleventh Circuit applied Florida law to hold that a medical device manufacturer's duty to warn runs to the prescribing physician, not the patient, just as it does for drugs.
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The plaintiff must show that an adequate warning to the physician would have altered the prescribing decision. Generalized evidence that physicians knew of the risk is insufficient.
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Physicians evaluate the risks and benefits of medications or devices for each individual patient and are therefore the appropriate recipients of manufacturer warnings.
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