Also known as:failure to warn defects · failure-to-warn defect · failure to warn defect · failure to warn · inadequate warning defect
Written by attorneys · grounded in primary & secondary sources — see below
A product defect that arises when a manufacturer or supplier fails to provide reasonable warnings or instructions about dangers that it knows or has reason to know exist in the product's intended use. Liability follows when the supplier has no reason to believe users will discover the danger on their own and the failure to warn proximately causes harm to a foreseeable user.
Sources & Authorities
How it applies
Common Examples
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Drug Manufacturer Warns Physician Only
Fernando Farrell's physician prescribed a new medication manufactured by Frontier Capital. Frontier had sent the physician detailed risk information about a rare cardiac side effect, but provided no direct warning to patients. When Fernando suffered the side effect, he sued Frontier for failure to warn. The court held Frontier satisfied its duty because the physician acted as a learned intermediary who evaluated the risks for Fernando.
Prescription Drug Warning to Medical Community
Faye Fuller received a prescription drug from her doctor after Franklin Foundry supplied the medication with warnings only to physicians. The company knew the drug carried a risk of severe liver damage but relied on doctors to assess individual patient suitability. When Faye developed liver damage, her suit against Franklin failed because the duty to warn ran to the prescribing physician rather than directly to the patient.
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Cases
Course Outlines
Supplier Warns of Known Machine Hazard
Francisco Frost lent a cutting press to Freeman Engineering knowing the emergency stop sometimes failed after repeated use. Frost gave no warning about the defect. Worker Fumiko Fujimoto was injured when the stop failed during normal operation. Frost faced liability for failure to warn because it knew of the danger and had no reason to believe users would discover it on their own.
Tarasoff v. Regents of the University of California551 P.2d 334, 342 (Cal. 1976)
Cigarette Manufacturer Inadequate Warning
Floyd Franklin smoked cigarettes made by Frostline Textiles for decades. The company knew of lung cancer risks but its warnings were limited and did not convey the full extent of the hazard. After Floyd developed lung cancer, his failure-to-warn claim proceeded because the warnings failed to adequately inform users of the known dangers.
Cipollone v. Liggett Group, Inc.893 F.2d 541 (3d Cir.1990), affirmed in part and reversed in part, 505 U.S. 504 (1992)
Medical Device Warning Preemption Issue
Felipe Figueroa received a pacemaker manufactured by Frontier Capital that later malfunctioned. Federal regulations governed the device's labeling. When Felipe sued for failure to warn, the court examined whether state failure-to-warn claims were preempted by federal requirements for the device.
Medtronic, Inc. v. Lohr518 U.S. 470, 485 (1996)
Asbestos Supplier Strict Warning Duty
Fumiko Fujimoto worked with insulation supplied by Franklin Foundry that contained asbestos. The supplier knew of the health risks but provided no warnings. After Fumiko developed asbestosis, the failure-to-warn claim succeeded because the supplier had a duty to warn of known dangers even without proof of a feasible alternative design.
Beshada v. Johns-Mansville Products Corp.447 A.2d 539, 546-547 (N.J. 1982)
Common questions
Frequently Asked
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What elements must a plaintiff prove for a negligent failure-to-warn claim against a supplier?+
A plaintiff must show the supplier knew or had reason to know the product was likely dangerous for its intended use, had no reason to believe users would realize the danger, failed to exercise reasonable care to warn foreseeable users, and the lack of warning caused the harm.
Does the learned intermediary doctrine shield a drug manufacturer from failure-to-warn liability?+
Yes when the manufacturer provides adequate warnings to the prescribing physician. The physician's independent judgment breaks the causal chain to the patient unless the warnings to the physician were inadequate or misleading.
How does a failure-to-warn defect differ from a manufacturing or design defect?+
A failure-to-warn defect focuses on missing or inadequate information about known risks rather than a flaw in production or the product's basic design. The three defect types are distinct and governed by different legal standards.
551 P.2d 334, 342 (Cal. 1976)Torts
…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…
TortsNegligence · The duty question, including failure to act, unforeseeable plaintiffs, and obligations to control the conduct of third partiesUBEFoundational