Failure to Warn
A products claim that the manufacturer did not adequately disclose a known or knowable risk.
The dominant theory in pharmaceutical and device litigation, turning on what the manufacturer knew or should have known and when. It intersects directly with federal preemption, since a manufacturer that could not unilaterally have changed its labelling may argue the state-law claim is impossible to satisfy alongside federal requirements.
See also
- Design DefectA claim that the product's design itself was unreasonably dangerous.
- Preemption (Products)The defence that federal regulatory requirements displace state-law product claims.
- Learned Intermediary DoctrineThe rule that a manufacturer's duty to warn runs to the prescribing physician, not the patient.
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