Also known as: warning defect · warnings defects · warning defects · defective warning · defective warnings · failure to warn · inadequate warning
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 harm associated with the product's use or consumption. The defect exists if the warnings would not alert a reasonable user to the nature and extent of the danger or if the manufacturer knew or should have known of the risk yet provided no warning.
Wren Wright's physician prescribed a medication after receiving detailed risk information from the manufacturer. Wren later suffered a side effect listed in those materials. Because the manufacturer had warned the physician, the causal chain to Wren was broken and no warnings defect claim succeeded.
Wesley Wong received a prescription drug whose risks the manufacturer had fully disclosed to his doctor. Wesley sued the manufacturer directly for failure to warn him. The court held the manufacturer satisfied its duty by warning the physician, so no warnings defect liability arose.
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Whitney White underwent implantation of a medical device after her physician reviewed the manufacturer's warnings. She later claimed the warnings were inadequate. Generalized evidence of device risks did not show the physician would have altered the decision, defeating the warnings defect claim.
Wilma Wright took a prescription drug whose manufacturer knew of a serious side effect but provided no warning to the physician. The drug caused her injury. The absence of any warning created a warnings defect claim against the manufacturer.
Wilma Wright took a prescription drug whose manufacturer knew of a serious side effect but provided no warning. The drug caused her injury. The court applied strict liability principles to the warnings defect claim rather than limiting recovery to negligence.
Winston Ward smoked cigarettes whose manufacturer had complied with federal labeling rules. He sued under state law alleging inadequate warnings. Federal requirements preempted the state warnings defect claim.
A manufacturer must warn of possible adverse reactions only if it knew or should have known of the risk. Most jurisdictions treat allergic reactions as a failure-to-warn issue rather than finding the product defective for ordinary users.
Yes. Under Florida law the Eleventh Circuit held that a medical device manufacturer's duty to warn runs to the prescribing physician, not the patient, and causation requires proof that a better warning would have changed the physician's decision.
The plaintiff must show that the warning given to the physician was inadequate or misleading and that an adequate warning would have altered the physician's prescribing decision. Generalized awareness of risks is insufficient.
…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…