Also known as: failure to warn claim · failure-to-warn claims · failure-to-warn claim · duty to warn · inadequate warning
Written by attorneys · grounded in primary & secondary sources — see below
A products-liability claim asserting that a manufacturer failed to provide adequate warnings about the risks associated with its product. The claim requires proof that the warning was inadequate and that the inadequacy caused the plaintiff's harm.
Felipe Figueroa took a prescription medication prescribed by his physician and suffered a severe reaction not listed on the label. He sued the manufacturer alleging failure to warn. The court held the manufacturer owed its duty only to the physician, so the claim failed because the physician had received the warnings.
Fiona Foster received an implanted medical device from her surgeon and later experienced complications. She sued the device maker for failure to warn. The court required her to prove that a better warning to the surgeon would have changed the decision to implant the device, and her general evidence of risks did not suffice.
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Francois Fortier received an injection of a brand-name drug and suffered tissue damage. He sued the manufacturer claiming the label failed to warn adequately about the injection method. The claim proceeded because federal approval of the label did not preempt the state-law failure-to-warn action.
Farah Fox was harmed by a patient who had confided violent intentions to a therapist. She sued the therapist's employer for failure to warn her of the danger. The court recognized a duty to warn the foreseeable victim when the therapist knew of the specific threat.
Finn Fletcher took a generic drug and developed a movement disorder after prolonged use. He sued the generic manufacturer for failure to warn. The claim was preempted because federal law prevented the generic maker from unilaterally changing the label.
Forrest Falconer used an experimental prescription drug and suffered an adverse reaction. He sued the manufacturer for failure to warn of known risks. The court held that the manufacturer could avoid strict liability by providing proper warnings to physicians even when the drug carried medically recognizable risks.
The plaintiff must show that an adequate warning to the physician would have altered the prescribing decision. Generalized evidence that the physician knew of risks is insufficient.
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No. Federal law does not prevent a state jury from finding the label inadequate even after FDA approval, because Congress did not intend to eliminate state remedies for drug injuries.
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A therapist owes a duty to warn a foreseeable victim when the patient has communicated a serious threat of violence against a specific person and the therapist determines or should determine that the patient presents a danger.
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No. Federal regulations require generic labels to match the brand-name label exactly, so a generic maker cannot unilaterally strengthen warnings and failure-to-warn claims against generics are preempted.
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Yes. A device manufacturer's duty to warn runs to the prescribing physician rather than the patient, and the plaintiff must prove that a better warning would have changed the physician's decision.
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…of 1963. We shall conclude that plaintiffs' complaints state a cause of action against the psychotherapists for breach of the duty to warn Tatiana or her parents, but that they do not state a cause of action against the police for failure to warn or failure to confine. We further conclude that the police defendants are immune…