Also known as: warning defects · defective warning · defective warnings · failure to warn · inadequate warning
Written by attorneys · grounded in primary & secondary sources — see below
A product defect that arises when a manufacturer fails to provide adequate warnings or instructions about foreseeable hidden dangers associated with the product's use. The defect renders the product unreasonably dangerous because users lack information needed to avoid or mitigate the risks. Liability turns on whether the warning was sufficient in content, placement, and method of communication to alert the expected users.
Whitney White's physician prescribed a medication after receiving the manufacturer's detailed risk disclosure. Whitney later suffered a side effect listed in the materials given to the doctor. The manufacturer avoids liability because the warning to the learned intermediary satisfied the duty and the physician's independent judgment broke any causal link to the patient.
Winston West's doctor reviewed the package insert and medical literature supplied by the drug maker before prescribing. Winston developed a known complication. The manufacturer met its obligation by warning physicians rather than patients directly, so no warning defect claim succeeds.
Select any source to read its text and confirm it supports the definition.
Willa Whitman's surgeon implanted a medical device after receiving only generalized risk information. Willa suffered harm that a more specific warning would have prevented the surgeon from proceeding. The manufacturer faces liability because the inadequate warning to the physician altered the prescribing decision.
Wyatt Wilson's therapist learned of a specific threat to Wallace Webb. The therapist took no steps to warn Wallace. The failure to provide an adequate warning of the foreseeable danger supports a claim that the warning obligation was breached.
Whitney Washington received a prescription drug whose risks were not fully disclosed to her physician. The manufacturer had not supplied information that would have changed the doctor's decision. The resulting harm supports a warning defect claim under the applicable standard for prescription products.
Wallace Webb used a medical device that complied with federal labeling rules yet lacked warnings required by state law. The manufacturer faces a warning defect suit because federal requirements do not preempt the state claim.
A warning defect concerns the absence or inadequacy of information about hidden risks, while a design defect concerns the product's configuration itself. Courts evaluate warning adequacy under a negligence-like reasonableness standard focused on whether the information supplied would alert expected users.
Supporting sources
Yes. The doctrine holds that a manufacturer's duty to warn runs to the prescribing physician rather than the patient. Adequate disclosure to the physician satisfies the duty and prevents liability for failure to warn the patient directly.
The plaintiff must show that the warning given to the physician was inadequate and that a proper warning would have changed the physician's prescribing decision. Generalized awareness of risks is insufficient to establish causation.
No. Federal drug labeling rules do not preempt state products liability claims for inadequate warnings. A product may satisfy FDA standards yet 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…