Also known as: warning defect · instruction defect · failure to warn · inadequate warning · inadequate instructions
Written by attorneys · grounded in primary & secondary sources — see below
A type of product defect that exists when a manufacturer fails to equip a product with adequate warnings of hidden hazards or instructions for safe use that reasonably could have been provided.
Winston West received a prescription for a new medication from his physician. The manufacturer had sent the physician a detailed letter describing the drug's risk of liver damage. When Winston later suffered liver injury, his claim for warning defect failed because the physician's independent judgment broke the chain of causation to the manufacturer.
Wren Wallace underwent surgery involving an implanted device. The device maker had distributed updated risk information to the surgical community before the procedure. Wren's later suit alleging a warning defect was rejected because the duty to warn ran only to the physician who evaluated the risks for her specific case.
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Wanda Weaver was prescribed a medical device after her doctor reviewed the manufacturer's warnings. She later claimed the warnings were inadequate, but offered only evidence that physicians generally knew of similar risks. The court dismissed the warning defect claim because she could not show that a better warning would have changed her physician's prescribing decision.
Wesley Wong smoked cigarettes whose packages carried the warnings required by federal law. He sued the manufacturer for failure to warn of additional risks. The claim was barred because the manufacturer had satisfied its duty by warning the medical and regulatory community that in turn informed consumers through labeling.
Willow Walker took a prescription drug whose manufacturer had supplied the prescribing physician with all known risks. When Willow suffered an adverse reaction, her warning defect claim failed because the physician, acting as learned intermediary, had received adequate information to make an informed prescribing choice.
Wren Wright received a pacemaker whose manufacturer had warned her cardiologist of potential lead fractures. After a fracture occurred, Wren alleged a warning defect. The claim did not proceed because the manufacturer had fulfilled its obligation by warning the physician rather than the patient directly.
Yes. Under Florida law the Eleventh Circuit has held that a medical device manufacturer's duty to warn runs to the prescribing physician, not the patient, just as it does for prescription drugs.
A plaintiff must show that an inadequate warning to the physician would have altered the physician's prescribing decision. Generalized evidence that physicians were aware of risks is insufficient.
The doctrine shields the manufacturer when it has adequately warned the prescribing physician of the product's risks and the physician's independent medical judgment breaks the causal chain to the patient.
The manufacturer satisfies its duty by providing adequate warnings to the medical community, including prescribing physicians who evaluate risks and benefits for individual patients.
…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…