The duty requires monitoring product performance and updating warnings as new hazard information emerges. It applies most clearly in pharmaceutical and medical device contexts where postmarket surveillance is regulated.
It overlaps with the post-sale duty to warn.
Alternative Names:
Ongoing Duty to Warn, Continuous Warning Obligation
Why it Matters?
Adverse event data is the evidence that establishes when the duty arose, since a manufacturer that received reports of a hazard and did not update labeling faces a claim independent of the original warning's adequacy. Pharmaceutical labeling changes are also constrained by regulatory approval requirements, which is the basis for the impossibility preemption defense where a manufacturer could not unilaterally strengthen the warning.
Frequently Confused with
Related terms
Frequently asked questions
What establishes when the duty arose?
How does preemption interact?
