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.  Continue Reading SDNY Dismisses Sunscreen Case Based on Preemption