Also known as: failure to warn theory · failure-to-warn · failure to warn · failure to warn doctrine
Written by attorneys · grounded in primary & secondary sources — see below
A theory of strict products liability under which a manufacturer is held responsible for harm caused by its product when it fails to provide adequate warnings about risks that were known or knowable at the time of distribution. The theory requires that the absence of a warning rendered the product unsafe for its users. Knowability of the risk is a component of liability because a warning cannot be given for dangers that could not have been discovered through available scientific knowledge.
Fatou Fall's doctor prescribed a medication manufactured by Ferrum Metals. The company had sent the physician detailed risk information about potential side effects. Fatou suffered the side effect but could not recover from the manufacturer because the physician's independent judgment broke the chain of causation.
Francesca Fowler took a prescription drug made by Freeman Engineering. The manufacturer had supplied complete warnings to the medical community about known dangers. Francesca could not prevail on a direct failure-to-warn claim against the company because the physician served as the learned intermediary.
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Francois Fortier, a therapist, learned that his patient planned to harm Fabian Flynn. The therapist failed to warn Flynn or authorities. Flynn was injured and recovered against the therapist under a failure-to-warn theory for not disclosing the foreseeable danger.
Francisco Frost received an injection of a drug made by Fidelity Trust. State law allowed a claim that the label failed to warn adequately about an administration method. The claim proceeded because federal labeling rules did not preempt the state failure-to-warn theory.
Farid Farahani took a generic drug produced by Fusion Power. Federal law required the generic label to match the brand-name label exactly. Farid's state failure-to-warn claim was barred because the manufacturer could not unilaterally change the warning.
A smoker sued a cigarette manufacturer alleging inadequate warnings about health risks. The court examined whether the failure-to-warn theory survived preemption and comparative fault rules. The claim turned on the adequacy of the warnings provided on the packages.
Yes. 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 prevent liability for failure to warn the patient directly.
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Yes. Knowability of the risk is a required component. Evidence that the risk was neither known nor knowable at the time of manufacture is admissible because a manufacturer cannot warn of an unknowable danger.
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It depends on the type of drug. Brand-name drug claims are not preempted, but generic drug claims are preempted when the manufacturer cannot unilaterally alter the label to add stronger warnings.
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…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…