Failure to Warn

Failure to Warn

Failure to Warn

A failure to warn claim alleges the manufacturer knew or should have known of a risk and did not adequately communicate it through warnings or instructions. Adequacy concerns content, prominence, and whether the warning reached the appropriate audience.

There is generally no duty to warn of open and obvious dangers or of risks unknowable at the time of sale.

Alternative Names:

Warning Defect, Inadequate Warning

Why it Matters?

Warning claims are attractive to plaintiffs because they require no engineering critique and can be argued from the label alone. The strongest defenses are causation-based rather than adequacy-based: evidence that the user never read the warning, or in prescription cases that the physician was already aware of the risk, defeats the claim regardless of what the label said. The learned intermediary doctrine performs that function in pharmaceutical and device litigation.

Frequently Confused with

Related terms

Frequently asked questions

Is there a duty to warn of obvious dangers?

Is there a duty to warn of obvious dangers?

Generally no. Risks that are open and obvious to an ordinary user typically require no warning, though the analysis depends on the user population.

What is a heeding presumption?

What is a heeding presumption?

A rule in some states presuming a user would have followed an adequate warning, which shifts the causation burden to the manufacturer.