At ACI’s December session in New York we will be part of a panel discussion on product liability actions against over the counter (OTC) medicines. Such lawsuits are certainly not new, but some aspects of them are. For example, so called “independent” laboratories have played an outsized, perhaps inappropriate, role in driving such lawsuits. In addition, proof of use problems abound with OTC products. Without prescription records, can the mere say-so of a plaintiff carry the day on usage, or should there be corroboration in the form of bottles, photographs, receipts, loyalty program records, etc.? Scientific issues of medical causation can be very different with OTC drugs as compared with rX versions. There are usually different doses and durations. Warning causation can also take a very different shape in OTC world. The absence of a learned intermediary (though, to be sure, sometimes there is a learned intermediary advising the patient to take an OTC medicine – what to do about that?) makes it easier for patients to engage in misuse. At the same time, alleged injuries from OTC medicines can be every bit as profound as from prescription drugs. Think of all those terrible SJS/TEN cases.

And then there is the defense of preemption. As we’ve written about several times before (here, for example), there is pretty broad express preemption of non-product liability actions against OTC medicines. Now after all that wind-up, we come to today’s case, Truss v. Bayer Healthcare Pharmaceuticals Inc., et al., 2022 WL 16951538 (S.D.N.Y. Nov. 15, 2022), which is a defense favorable OTC drug preemption case involving a purported economic loss class action against a sunscreen manufacturer. The plaintiffs filed a putative class action claiming that the sunscreen manufacturers falsely marketed the sunscreen as being hypoallergenic and gentle for skin even though the sunscreen actually contained benzophenone, which they allege to be hazardous degradation product. (Yes, this is yet another case in which the plaintiff alleges harm from chemical breakdown/degradation substances in a product. Perhaps a new chapter in the plaintiff drug and device playbook is being written.) The plaintiffs asserted claims under California and New York consumer protection laws, as well as common law theories of unjust enrichment and breach of warranty. The defendant filed a motion to dismiss.

Because Truss is not a product liability case, the exception to OTC preemption did not apply. The plaintiffs were not seeking compensation for personal injuries; they simply wanted their money back after having used the product without incident The sunscreen products at issue were governed by a monograph. The FDA promulgates a monograph, which is “a detailed regulation … for each therapeutic class of OTC drug products,” after a notice and comment process. By following a monograph, manufacturers seeking to sell a new OTC drug in interstate commerce may qualify for an FDA determination that a medication is generally recognized as safe and effective (GRASE) while bypassing individualized review. Monographs set forth “the FDA-approved active ingredients for a given therapeutic class of OTC drugs and provide the conditions under which each ingredient is” GRASE.

The court granted the defendants/ motion to dismiss based on preemption of the plaintiffs’ informational claims because the FDCA’s OTC monograph for the sunscreen required disclosure of only active ingredients, not degradation products. Whether an ingredient is “active” or even just a “component” seems to turn on whether the manufacturer intended the ingredient to furnish pharmacological activity or have some effect on diagnosis, care, treatment, prevention, etc. In Truss, the plaintiffs did not allege that the defendants manufactured the sunscreen to contain benzophenone. The FDA did require disclosure of the active ingredient that allegedly degrades into benzophenone, but that’s as far as the requirement goes. Because the plaintiffs were demanding disclosure of the degradation product, they were seeking to impose a labeling requirement in addition to what the FDA required — and that is exactly what is preempted. The plaintiffs lawsuit “would lead precisely to the patchwork of inconsistent packaging regulations that Congress sought to prevent.”

The plaintiffs endeavored to sidestep this rather obvious preemption by focusing, not just on the absence of disclosure of degradation products, but also on the manufacturer’s affirmative representations that the sunscreen is “free” of a different, related degradation chemical. But the plaintiffs admitted that the degradation product disclaimed in the label is a different compound from the one the plaintiffs were complaining about. That mismatch doomed the claim.

The plaintiffs also seized on the sunscreen label’s statement that the product was “hypoallergenic and gentle.” In support of the plaintiff’s allegation that such statement was a lie, the plaintiffs relied on two studies. The court read those two studies and concluded that they did not demonstrate that potentially allergenic benzophenone was present in the sunscreen. Thus, the plaintiffs “fail plausibly to allege the Product’s labelling as ‘hypoallergenic’ is false or misleading.

The court dismissed the case. We’d say it’s time for fun in the sun, but the thermometer here in a bucolic tract outside Philly tells us to stay indoors. See you in NYC next month.