Also known as: warning defect · defective warning · defective warnings · failure to warn · inadequate warning · warning defectiveness
Written by attorneys · grounded in primary & secondary sources — see below
A category of product defect arising when a product poses hazards that reasonable warnings or instructions would have avoided. Liability attaches if the omission of such warnings renders the product not reasonably safe for foreseeable users and uses.
Watershed Pharmaceuticals supplied its antidepressant to Dr. Wells with a detailed package insert describing the risk of suicidal ideation in young adults. Dr. Wells reviewed the insert, discussed the risk with patient Willow West, and prescribed the drug anyway. When West later attempted suicide, her warning-defect claim against the manufacturer failed because the physician's independent judgment broke the causal chain.
Westmont Healthcare distributed a new anticoagulant accompanied by extensive risk information sent directly to physicians. Whitney White received the drug from her doctor but suffered a severe bleed. White's warning-defect suit against the manufacturer was dismissed because the company satisfied its duty by warning the learned intermediary rather than the patient.
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Warwick Electronics manufactured a cardiac stent and provided its warning label to implanting cardiologists. Warren Wu received the stent and later suffered thrombosis. Wu could not prevail on a warning-defect claim because he offered only general evidence that physicians knew of clotting risks. He failed to show that a different warning would have altered his doctor's prescribing choice.
Summit Equipment sold an ATV whose manual contained no warning against off-road operation. Owner Owen Ortiz rolled the vehicle on a trail and suffered injury. Ortiz prevailed on the warning-defect claim because the missing instruction rendered the product unsafe for a foreseeable use even though the design itself was sound.
Wrightway Engineering sold a utility vehicle whose owner's manual omitted any instruction against off-road use. Driver Warren Woods rolled the vehicle on rough terrain and sued for both design and warning defects. The warning claim proceeded independently because the absence of instructions rendered the product unsafe even if the design itself was not defective.
A pacemaker manufacturer complied with all FDA labeling rules yet provided no warning of a known lead-fracture risk. Patient Whitney White suffered injury when the lead fractured. White's state-law warning-defect claim was not preempted because federal requirements did not displace the separate state duty to warn of product dangers.
The doctrine provides that a drug manufacturer's duty to warn runs to the prescribing physician rather than the patient. Adequate warnings to the physician satisfy the duty and break the causal chain to the patient unless the warnings were inadequate or misleading.
The plaintiff must show that an adequate warning to the physician would have altered the prescribing decision. Generalized evidence that physicians were aware of risks is insufficient.
Warning defects arise from hazards that reasonable instructions or warnings would avoid. They are independent of manufacturing or design defects. A product may be free of those defects yet still defective for lack of warnings.
No. Federal drug labeling rules do not preempt state products-liability claims for inadequate warnings. A product may meet FDA standards and still be defective under state tort law.
…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…