Also known as:fail to warn · fails to warn · failing to warn · failed to warn · duty to warn · inadequate warning
Written by attorneys · grounded in primary & secondary sources — see below
An omission by a party subject to a duty to inform of reasonable instructions or warnings about foreseeable risks of harm. The omission gives rise to liability when the harm could have been reduced or avoided by adequate warnings.
Sources & Authorities
How it applies
Common Examples
6
Prescription Drug Warning to Physician
Fabian Flynn received a prescription for a new medication from his doctor. The manufacturer had sent the physician a detailed letter describing the risk of severe liver damage in patients with a particular blood marker. Flynn developed liver failure after taking the drug. Because the manufacturer had adequately warned the physician, the learned intermediary doctrine prevented Flynn from recovering on a failure to warn claim against the manufacturer.
Manufacturer Duty Runs to Physician
Forrest Falconer was prescribed a blood pressure medication by his cardiologist. The manufacturer provided the physician with complete risk information about potential kidney complications but did not warn patients directly. Falconer suffered kidney damage. The court held that the manufacturer satisfied its duty by warning the physician rather than the patient.
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Cases
Casebooks
Hornbooks
Course Outlines
Study Supplements
Causation Requirement for Device Warning
Farah Fox received an implanted medical device after her surgeon reviewed the manufacturer's warnings to physicians. Fox later suffered complications and claimed the warnings were inadequate. She could not show that a different warning would have changed the surgeon's decision to implant the device. The court granted summary judgment because generalized awareness of risks did not establish causation.
Therapist Duty to Warn Potential Victim
Felicity French's therapist learned during sessions that a patient planned to harm French. The therapist did not warn French or take other steps to protect her. French was later attacked. The failure to warn the identifiable victim gave rise to liability for the therapist.
Tarasoff v. Regents of the University of California551 P.2d 334, 342 (Cal. 1976)
State Failure to Warn Claim Not Preempted
Fiona Foster received an injection of a prescription drug by the IV-push method and suffered severe injury. She sued the manufacturer alleging inadequate warnings about that method of administration. The manufacturer argued federal drug labeling rules barred the claim. The court held that state failure to warn claims could proceed because FDA approval sets a floor rather than a ceiling for warnings.
Wyeth v. Levine555 U.S. 555 (2009)
Warning Defect Distinct from Design
Fatou Fall was injured when her new SUV rolled over during an ordinary turn. She claimed the vehicle was defective because the manufacturer failed to warn that the SUV had a higher rollover risk than ordinary passenger cars. The court treated the failure to warn claim separately from any design defect theory and allowed the warning claim to proceed on its own.
Denny v. Ford Motor Co.87 N.Y.2d 248, 639 N.Y.S.2d 250, 662 N.E.2d 730, 736 (1995)
Common questions
Frequently Asked
5
What must a plaintiff prove to establish a failure to warn claim?+
The plaintiff must show a foreseeable risk of harm inherent in the product or its use, that the supplier knew or should have known of the risk when marketing the product, and that the absence of a warning rendered the product unreasonably dangerous.
Does the learned intermediary doctrine apply outside prescription drugs?+
The doctrine has been extended to medical devices under Florida law, but it remains limited to situations where a physician acts as the learned intermediary between the manufacturer and the patient.
How does a plaintiff prove causation in a failure to warn case involving a learned intermediary?+
The plaintiff must show that an adequate warning to the physician would have altered the physician's prescribing decision. Generalized evidence that the physician knew of risks is insufficient.
Can a manufacturer cure a design or manufacturing defect with a warning?+
No. A warning cannot cure a product that is already defective because of a manufacturing or design flaw.
When is there no duty to warn about a product risk?+
There is no duty to warn of risks that are obvious to the ordinary user or generally known, such as the addictive qualities of alcohol.
551 P.2d 334, 342 (Cal. 1976)Torts
…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…