Also known as:failure to warn defect · failure-to-warn defects · warning defect · failure to warn
Written by attorneys · grounded in primary & secondary sources — see below
A product defect arising when a manufacturer fails to provide adequate warnings or instructions about foreseeable risks of using the product. The absence of such warnings renders the product unreasonably dangerous even if it is properly designed and manufactured. Liability follows when the omitted warning would have allowed a reasonable user to avoid or mitigate the harm.
Sources & Authorities
How it applies
Common Examples
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Prescription Drug Warning to Physician
A pharmaceutical company distributed a new antidepressant after sending the prescribing physician a detailed letter describing rare but serious cardiac risks. The physician reviewed the letter, weighed the risks against the patient's history, and prescribed the drug anyway. When the patient later suffered a heart attack, the company avoided liability because its warning to the physician was complete and the physician's independent judgment broke the causal chain.
Manufacturer Duty Runs to Physician
A drug maker supplied an antibiotic with a package insert that fully disclosed seizure risks to the medical community. The prescribing doctor received the insert, discussed it with the patient, and issued the prescription. After the patient experienced a seizure, the manufacturer escaped failure-to-warn liability because its duty extended only to the learned intermediary physician rather than directly to the patient.
Select any source to read its text and confirm it supports the definition.
Cases
Study Supplements
Therapist Duty to Warn Potential Victim
A university therapist learned that a patient planned to kill a specific woman but took no steps to warn her. After the patient carried out the threat, the woman's parents sued the therapist for failure to warn. The claim proceeded because the therapist's omission of a warning about a foreseeable risk of serious harm constituted a defect in the professional service provided.
Tarasoff v. Regents of the University of California551 P.2d 334, 342 (Cal. 1976)
Attorney Failure to Warn on Plea Consequences
Defense counsel advised a noncitizen client to accept a guilty plea without disclosing that it would trigger automatic deportation. The client later faced removal proceedings and claimed the omitted warning rendered the representation defective. The court allowed the claim because the attorney failed to alert the client to a known and severe collateral risk of the plea.
Padilla v. Kentucky130 S. Ct. 1473, 1485 (2010)
Medical Device Labeling Adequacy
A pacemaker manufacturer sold its device with labeling that omitted known risks of battery failure. A patient suffered injury when the battery failed without warning. The patient's failure-to-warn claim survived because the labeling did not adequately inform physicians or patients of the specific hazard that materialized.
Medtronic, Inc. v. Lohr518 U.S. 470, 485 (1996)
Asbestos Product Risk Disclosure
An insulation company sold asbestos products without any warning labels about the danger of lung disease from inhalation. Workers who later developed asbestosis sued, alleging the complete absence of warnings made the product defective. The court permitted the claim because the manufacturer had failed to inform users of a known, serious risk that could have been avoided with proper instructions.
Beshada v. Johns-Mansville Products Corp.447 A.2d 539, 546-547 (N.J. 1982)
Common questions
Frequently Asked
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Does the learned intermediary doctrine shield a drug manufacturer from failure-to-warn liability?+
Yes when the manufacturer provides an adequate warning to the prescribing physician. The physician's independent medical judgment then breaks the causal chain to the patient unless the warning to the physician was inadequate or misleading.
Supporting sources
What must a plaintiff show to establish a failure-to-warn defect?+
The plaintiff must show that the manufacturer failed to warn of a foreseeable risk that rendered the product unreasonably dangerous and that an adequate warning would have allowed the user to avoid or mitigate the harm.
Supporting sources
Does failure to warn apply only to prescription drugs?+
No. The doctrine also covers other products such as cigarettes and industrial chemicals whenever the manufacturer omits warnings about risks that would let a consumer make an informed choice.
Supporting sources
130 S. Ct. 1473 (2010)Criminal Procedure
…and what warnings must be given.[^maj-2] Moreover, legislation could provide consequences for the misadvice, nonadvice, or failure to warn, other than nullification of a criminal conviction after the witnesses and evidence needed for retrial have disappeared. Federal immigration law might provide, for example, that the…