Also known as: strict liability failure to warn · failure to warn strict liability · failure to warn · warning defect
Written by attorneys · grounded in primary & secondary sources — see below
A theory of products liability holding a manufacturer responsible for harm caused by a product that is defective because it lacks adequate warnings of foreseeable dangers, even if the manufacturer was not negligent in its design or production process.
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Stella Shapiro received a prescription for a new medication from her doctor. The manufacturer had sent the physician a detailed letter describing the risk of severe liver damage. Stella later suffered liver failure and sued the manufacturer for failing to warn her directly. The court held the manufacturer not liable because the warning to the physician satisfied the duty.
Sarah Sullivan took a prescription antidepressant after her physician reviewed the manufacturer's risk information. The drug caused unexpected heart arrhythmia. Sarah sued the manufacturer claiming it should have warned patients directly. The court ruled the manufacturer fulfilled its obligation by warning the prescribing physician.
Sydney Santos developed a blood clot after using a prescription blood thinner. The manufacturer had known of the clotting risk at the time of distribution but provided no warning. Sydney sued under strict liability for failure to warn. The court applied comment k principles and imposed liability because the absence of a warning rendered the product defective.
Simon Stern, a therapist, learned that his patient planned to harm Simone Sanders. Simon did not warn Simone or authorities. After Simone was injured, she sued Simon for failure to warn. The court recognized a duty to warn the foreseeable victim even though the therapist had not acted negligently in other respects.
Scott Summers was injured by a medical device that allegedly lacked adequate warnings. He sued the manufacturer under state strict liability for failure to warn. The manufacturer argued federal regulations preempted the claim. The court examined whether the state warning requirement conflicted with federal device approval standards.
Simone Sanders developed cancer after exposure to a drug produced by multiple manufacturers. She could not identify which company made the product she took. Simone sued several manufacturers under a market-share theory for failure to warn of cancer risks. The court permitted recovery apportioned among the manufacturers based on their market shares.
The doctrine limits the manufacturer's duty to warning the prescribing physician rather than the patient directly. Liability does not arise if the warning to the physician is adequate. The physician's independent judgment breaks the causal chain to the patient.
Supporting sources
Under strict liability the reason for the missing warning is irrelevant. The manufacturer is liable even if it neither knew nor could have known of the danger at the time of sale. Negligence requires proof that the manufacturer knew or should have known of the risk.
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…