As a corollary to our earlier article, "The 5 Ways to Prove Your Defective Products Claim," this article aims to expand upon one of those 5 categories, the defective products lawsuit that is based upon failure to warn cause of action. Generally speaking, the manufacturer of a product is duty-bound to apprise, or warn consumers about the hidden dangers that are associated with a consumer’s foreseeable use of its product -- even if the particular use is an unintended one, and even if the product is not otherwise defective. (Naturally, if the danger is present even where the use of the product is one contemplated by the manufacturer, then the plaintiff will also have a claim that the product was defectively designed.)

Since this particular type of claim is often litigated in the pharmaceutical context, I will provide a typical example. Pharmaceutical company P manufactures a drug which it has reason to know can cause the negative side effect of excessive bleeding in pregnant women, but fails to disclose it to consumers in its warnings. Woman W, who is pregnant, and is particularly concerned about vaginal bleeding due to her particular medical history, suffers hemorrhaging which requires corrective emergency surgery as a direct result of taking this drug. Had W known that P’s drug has this possible side effect, she would have used the comparable drug manufactured by C, which does not have this side effect.

In order to prevail on this theory, the plaintiff will have to prove that if adequate warnings had been provided, the injury would not have occurred. 

Importantly, and as a practical matter, this burden is often difficult to meet, because the defenses to this claim are typically quite formidable. In particular, defendants often rely on their apparent compliance with labeling requirements promulgated by the relevant overseeing body (such as the FDA) as proof that they acted properly. Therefore, even where they believe that they have a viable failure to warn claim, plaintiffs will almost always claim at least one more of the other 5 bases for bringing a defective products lawsuit.



Jonathan Cooper
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Non-Compete, Trade Secret and School Negligence Lawyer