Photo of Andrew Tauber

We defend drug and device manufacturers. Our cases involve drugs and devices. Not surprisingly, we tend to cite drug and device decisions. But there is no reason to ignore helpful decisions arising in other contexts. The case we report on today—Jimenez v. Holiday CVS, LLC, 2023 WL 4251176 (S.D. Fla. 2023)—is such a decision.

Applying Florida law, Jimenez dismissed a failure-to-warn claim involving cosmetics. Its grounds for doing so are applicable to drug and device cases.

The plaintiff was allegedly injured by applying the defendant manufacturer’s product after its expiration date. She asserted a failure-to-warn claim based on the defendant’s failure to warn of the risk of such injury.

The defendant moved to dismiss on three grounds, arguing that plaintiff’s claim failed because (1) she did not adequately plead that the warning the manufacturer had given was inadequate; (2) she did not allege that she had read the product’s purportedly inadequate warning label; and (3) her use of the product after its expiration date was not an intended use of the product.

The court accepted the first two grounds but not the third.

Plaintiff claimed that she was injured because the manufacturer “fail[ed] to adequately warn of the potential harm, risk, side effect, and/or allergic reaction that” the product allegedly “caused her.” 2023 WL 4251176 at *1. That allegation, the court held, did not sufficiently plead “the inadequacy of any warning” given by the manufacturer. Id. at *2. Citing two Eleventh Circuit decisions in support, the court explained that to state a failure-to-warn claim under Florida law a plaintiff must “plead the contents of the warning provided or how the information provided was inadequate.” Id. (citing Witt v. Stryker Corp., 648 F. App’x 867, 871 (11th Cir. 2016); Bailey v. Janssen Pharmaceutica, Inc, 288 F. App’x 597, 609 (11th Cir. 2008)). Because the plaintiff plead neither, the court found that her claim was “not supported by sufficient factual allegations.” Id.

Separately, the court held that the plaintiff had failed to adequately allege proximate causation. Again relying on an Eleventh Circuit decision, the court explained that, under Florida law, “where the person to whom the manufacturer owed a duty to warn … has not read the label, an inadequate warning cannot be the proximate cause of the plaintiff’s injuries.” 2023 WL 4251176 at *2 (quoting Leoncio v. Louisville Ladder, Inc., 601 F. App’x 932, 933 (11th Cir. 2015)). The court found the plaintiff’s allegations insufficient to support a failure-to-warn claim because her complaint “contain[ed] no allegations that Plaintiff read the label” on the product. Id. at *3.

Finally, although the court acknowledged that “Florida law instructs that strict liability is limited to injuries arising from the intended use of a product,” it rejected the manufacturer’s argument that use of a product after its expiration date is not an intended use, finding that the manufacturer had cited no authority in support of its argument.

Each aspect of the court’s decision has implications for drug and device cases under Florida law.

First, a rule requiring that a plaintiff plead how the warnings given a manufacturer are inadequate is a powerful gatekeeper whose logic applies to drugs and devices no less than cosmetics. Following what appears to be loose language from the Eleventh Circuit, the Jimenez court case the rule in terms of having to “plead the contents of the warning given or how the information provided was inadequate” (2023 WL 4251176 at *2 (emphasis added)), but the disjunctive seems mistaken. Even if a plaintiff pleads the content of whatever warning was given, that by itself does not allege facts sufficient to show that warning was inadequate. A plaintiff should be required to plead why a given warning was inadequate.

Second, so long as one recognizes that the relevant actor is not the patient but the patient’s doctor, the failure-to-read doctrine, under which there can be no proximate causation unless the label is read, applies with equal force in the drug and device context. If a doctor did not read—and thus did not rely—on a label, nothing that the label said or didn’t say could have affected the doctor’s treatment decision.

Finally, if there is authority for the proposition that use of a product after its expiration date is not an intended use of that product, it could be useful when defending cases involving over-the-counter drugs. Please let us know if you are aware of such authority.