Also known as: inadequate instruction or warning · inadequate warnings · inadequate instructions · failure to warn · warning defect
Written by attorneys · grounded in primary & secondary sources — see below
A product is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe.
Island Manufacturing sold a prescription blood-pressure medication to physicians. The company provided the prescribing doctors with detailed risk information about potential liver damage. A patient later suffered liver failure after taking the drug. The patient sued the manufacturer directly for failure to warn. The court held that the manufacturer satisfied its duty because the warnings to the physician were adequate.
Interlink Communications produced a generic antidepressant. It supplied comprehensive risk data to doctors and pharmacists but did not send separate warnings directly to patients. A patient experienced severe side effects and sued the manufacturer for inadequate warnings. The court ruled that the manufacturer met its obligation by warning the learned intermediaries in the medical community.
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A therapist learned that a patient planned to harm a specific individual. The therapist did not issue any warning to the intended victim or authorities. The patient later attacked the victim. The victim sued the therapist for failure to warn. The court held that the therapist could be liable for not providing reasonable warnings that would have reduced the foreseeable risk of harm.
Ivy Investments manufactured a generic drug whose label matched the brand-name version. Patients suffered injuries and claimed the warnings were inadequate under state law. The manufacturer argued federal regulations prevented any label change. The court determined that the manufacturer could not prove impossibility of compliance and therefore faced potential liability for inadequate warnings.
Ironclad Industries sold a prescription medication. Patients alleged the drug was defective because of inadequate warnings about side effects. The manufacturer contended that strict liability for design defects should not apply to prescription drugs. The court agreed that consumer expectations tests are inappropriate for such drugs and focused instead on whether the warnings provided to physicians were reasonable.
Ingrid Innes received a prescription drug whose label complied with FDA requirements. She suffered serious injury and sued the manufacturer claiming the warnings remained inadequate under state products liability law. The manufacturer asserted that FDA approval preempted the state claim. The court held that compliance with federal labeling rules does not automatically shield the manufacturer from liability for defective warnings.
Instructions or warnings are inadequate when the foreseeable risks of harm could have been reduced or avoided by reasonable warnings that the seller failed to provide, rendering the product not reasonably safe.
No. Federal drug labeling requirements do not preempt state products liability law regarding defective warnings. A product may comply with FDA rules and still be considered defective under state tort law.
The doctrine provides that a prescription drug manufacturer satisfies its duty to warn by adequately warning the prescribing physician rather than the patient directly. Liability does not arise from a failure to warn the patient if the warnings to the physician were adequate.
…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…