We have reported on a few of these “non-drowsy” cough syrup cases. The courts are split. Some have put the cases to bed (here and here), but a few have given us nightmares (here). Newport v. CVS Pharmacy, Inc., 2024 U.S. Dist. LEXIS 211026 (E.D. Mo. Nov. 20, 2024), unfortunately falls in the latter category.
The allegations in Newport appear to be nearly identical to the other cases. A common cough suppressant found in many over-the-counter cough medicines is dextromethorphan hydrobromide (DXM). CVS sells its own brand of such a cough medicine. The label on the cough medicine says “non-drowsy.” Plaintiff alleges she relied on that statement in selecting the medicine, that she paid a “premium price,” and she in fact became drowsy after taking it. She filed a putative class action alleging breach of warranty, breach of implied contract, unjust enrichment, and violations of various state consumer protection laws. Defendants moved to dismiss all claims on several grounds. Of chief interest to us is the court’s ruling on preemption.
The FDCA has an express preemption clause for OTC drugs – requirements that are “different from or in addition to” or “not otherwise identical with” the FDCA are preempted. Product liability claims have an exception, but this is not a products case. Our first clue that this decision was headed in the wrong direction was the court’s resurrection of the presumption against preemption in an express preemption case, despite circuit court decisions (including the 8th Circuit) holding that such a presumption no longer exists. Id. at *6.
Because of the express preemption clause, this case should be focused on the federal regulations governing OTC medicines which are found in monographs promulgated by the FDA. The monograph for cold and cough OTC medicines requires certain products in this class to carry a warning that the drug may cause drowsiness. DXM is not one of them. So, plaintiff’s case invites the court to hold the defendant liable for labeling the product as “non-drowsy” when such labeling complied with the FDA’s monograph. Why then isn’t it preempted?
Indeed, both the court and plaintiff agreed that if plaintiff was seeking to add a drowsiness warning to the medicine; rather than merely seeking removal of the term “non-drowsy,” which she claimed was false and misleading—her claim would be preempted. Id. at *8-9. We don’t see the difference. Claims of omission and claims of misrepresentation are two sides of the same coin. No matter what you call it, the claim is premised on requiring something on the label that is “in addition to” what federal law requires, making it preempted.
The court and plaintiff are correct that the FDA monograph does not explicitly address the term “non-drowsy,” but that is too narrow a focus. It ignores for instance that the FDA’s expert panel considered scientific literature and data and concluded that DXM did not require a drowsiness warning. Id. at *9. Information that is available in the monograph’s regulatory history but which the court refused to consider because it lacks “force of law.” Id. at *12. It is undisputed that the FDA did examine whether certain products had to carry a “may cause drowsiness” warning and explicitly determined that DXM did not require it. Therefore, the issue of drowsiness for DXM products was explicitly decided by the FDA.
The ruling in Newport allows plaintiff to contradict the FDA’s conclusion that there was a lack of scientific evidence that this product causes drowsiness; precisely what Congress sought to prevent by enacting the express preemption clause.