Also known as: failure to warn claims · failure-to-warn claim · failure-to-warn claims · failure to warn · duty to warn claim
Written by attorneys · grounded in primary & secondary sources — see below
A products-liability claim alleging that a manufacturer or seller breached its duty by failing to provide adequate warnings or instructions about foreseeable risks of the product. The claim requires proof that the warning was inadequate and that the inadequacy proximately caused the plaintiff's injury.
Farah Fox received a prescription for a medication from her physician. The manufacturer had sent detailed risk information to the physician about potential side effects. When Farah later suffered an adverse reaction, she sued the manufacturer for failure to warn. The court held the manufacturer not liable because the physician's independent judgment broke the causal chain.
Faith Fitzgerald took a prescription drug prescribed by her doctor after the manufacturer supplied risk data to the medical community. She developed a serious complication and sued the manufacturer directly for failure to warn. The court ruled that the manufacturer satisfied its duty by warning the physician rather than the patient.
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Fumiko Fujimoto smoked cigarettes for decades and later developed lung cancer. She sued the tobacco company alleging inadequate package warnings about health risks. The court examined whether the warnings given were sufficient to defeat the failure-to-warn claim.
Floyd Franklin received an injection of an antinausea drug by the IV-push method and suffered severe injury. He sued the brand-name manufacturer claiming the label failed to warn adequately about arterial risks. The court allowed the state failure-to-warn claim to proceed despite federal labeling approvals.
Francois Fortier took a generic drug and developed a movement disorder after prolonged use. He sued the generic manufacturer for failure to warn about the risk. The court held federal law preempted the claim because the manufacturer could not unilaterally change the label.
Forrest Falconer was exposed in utero to DES manufactured by multiple companies and later suffered injury. She brought a failure-to-warn claim but could not identify the specific manufacturer. The court permitted recovery under a market-share theory linking the warning defect to the producers.
Yes. When the manufacturer provides adequate warnings to the prescribing physician, the physician's independent judgment breaks the causal chain to the patient. Liability does not arise from a failure to warn the patient directly.
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Yes. Federal labeling requirements do not preempt state failure-to-warn claims when the manufacturer could have strengthened warnings through the FDA process.
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No. Federal law preempts failure-to-warn claims against generic manufacturers because they cannot unilaterally alter FDA-approved labels.
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A plaintiff's post-warning conduct may be considered in allocating comparative fault on the failure-to-warn claim.
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…invoked the District Court's diversity jurisdiction and asserted various state-law claims for relief, including (1) negligent failure to warn, (2) strict liability, (3) breach of express and implied warranty, (4) negligent infliction of emotional distress, (5) enhanced risk of disease, (6) medical monitoring, and (7) civil…