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Patora v. Vi-Jon, LLC, 2023 U.S. Dist. LEXIS 153421 (S.D.N.Y. Aug. 30, 2023), is a typical express preemption decision resulting in dismissal of a typical consumer protection-based purely economic loss class action against an over the counter (OTC) product.  The plaintiffs, suing on behalf of a putative class, alleged that they purchased an OTC laxative product that contained a bacterial contaminant.  The defendant had recalled the product. The plaintiffs asserted that they became ill as a result of the bacteria, but their claim was not for personal injury, it was for the money they paid for the laxative.  According to the plaintiffs, the laxative label was deficient because it did not list the bacteria as an ingredient, nor did it warn of the possibility of bacterial contamination.  The plaintiffs contended that they, naturally, would not have purchased the product if they knew of the bacterial contamination.  The product was worthless. The plaintiffs wanted their money back.  The complaint set forth causes of action for deceptive acts or practices and false advertising under New York General Business Law.

The defendant filed a motion under Fed. R. Civ. P. 12(b)(6) to dismiss the complaint because the claims were expressly preempted by the Food, Drug and Cosmetic Act, 21 U.S.C. section 301 et seq. (FDCA).  The FDCA contains an express preemption provision for state laws governing OTC drugs, including laxatives.  Under that express preemption provision, no state can enforce any OTC labeling requirement not “identical” to what the FDA requires.  In essence, the plaintiffs were attempting to turn what amounted to manufacturing defect allegations (if the bacteria was in the laxative, it got in by mistake) into a warning claim more amenable to class action status by claiming that a possible contaminant should have been listed as an “ingredient” in the OTC product’s labeling.  We’re tempted to call the claim clever, but it actually isn’t.  We’ve seen it before and it has failed before.  

The FDA promulgated regulations define a drug active “ingredient” as a substance “intended” to furnish pharmacological activity or other direct effect in the diagnosis, mitigation, treatment, or prevention of disease.  A contaminant does not come close to fitting the bill. An inactive ingredient is any other “component,” which, in turn, is “intended” for use in the manufacture of a drug product. Intention, then, is at the heart of the matter.  Some people say that divining anyone’s intention is impossible.  Perhaps you’ve heard something like that with respect to some recent indictments of rather famous figures.  But juries make determinations about intention every day.  Sometimes judges do, too,  Sometimes it is really easy.  That was the case in Patora.  No one suggested that the alleged bacteria was intended to be in the laxative.  Therefore, the bacteria is not an active or inactive ingredient, and federal law does not require that the bacteria appear on the ingredients list.  The plaintiffs’ insistence that the bacteria be listed as an ingredient is not only not “identical” to federal regulations, it is directly contrary to them.
Moreover, to the extent that the plaintiffs’ claim is more about absence of warning as opposed to absence of an ingredient listing, the claim still runs counter to federal law.  OTC products are required to contain warnings included in an applicable OTC monograph.  Not all OTC products are included in a monograph, but the laxative product in question was listed in a 2023 monograph.  That monograph set forth nine specific warnings.  The Patora court read the monograph and concluded that “neither the general OTC requirements for warning labels nor the 2023 monograph laxative-specific requirements for warning labels mandate a warning related to the potential inclusion of any bacteria” – let alone the specific one in this case.  

Since the FDCA does not mandate the disclosure that the plaintiffs were demanding, the plaintiffs’ claims were expressly preempted. The Patora court quoted another case saying that the plaintiffs’ claims are “exactly what the FDCA does not permit.”  Given the obvious express preemption of these contaminant-as-ingredient claims, and given the build-up of precedent on precisely this point, by now these claims by plaintiffs are utterly frivolous.