We have now reported on a couple of of those “non-drowsy” cough syrup circumstances. The courts are break up. Some have put the circumstances to mattress (right here and right here), however a couple of have given us nightmares (right here). Newport v. CVS Pharmacy, Inc., 2024 U.S. Dist. LEXIS 211026 (E.D. Mo. Nov. 20, 2024), sadly falls within the latter class.
The allegations in Newport seem like practically an identical to the opposite circumstances. A typical cough suppressant discovered in lots of over-the-counter cough medicines is dextromethorphan hydrobromide (DXM). CVS sells its personal model of such a cough medication. The label on the cough medication says “non-drowsy.” Plaintiff alleges she relied on that assertion in deciding on the drugs, that she paid a “premium worth,” and she or he in truth turned drowsy after taking it. She filed a putative class motion alleging breach of guarantee, breach of implied contract, unjust enrichment, and violations of varied state shopper safety legal guidelines. Defendants moved to dismiss all claims on a number of grounds. Of chief curiosity to us is the courtroom’s ruling on preemption.
The FDCA has an specific preemption clause for OTC medicine – necessities which might be “totally different from or along with” or “not in any other case an identical with” the FDCA are preempted. Product legal responsibility claims have an exception, however this isn’t a merchandise case. Our first clue that this choice was headed within the unsuitable course was the courtroom’s resurrection of the presumption in opposition to preemption in an specific preemption case, regardless of circuit courtroom selections (together with the 8th Circuit) holding that such a presumption now not exists. Id. at *6.
Due to the specific preemption clause, this case ought to be targeted on the federal laws governing OTC medicines that are present in monographs promulgated by the FDA. The monograph for chilly and cough OTC medicines requires sure merchandise on this class to hold a warning that the drug could trigger drowsiness. DXM isn’t certainly one of them. So, plaintiff’s case invitations the courtroom to carry the defendant responsible for labeling the product as “non-drowsy” when such labeling complied with the FDA’s monograph. Why then isn’t it preempted?
Certainly, each the courtroom and plaintiff agreed that if plaintiff was in search of so as to add a drowsiness warning to the drugs; moderately than merely in search of removing of the time period “non-drowsy,” which she claimed was false and deceptive—her declare can be preempted. Id. at *8-9. We don’t see the distinction. Claims of omission and claims of misrepresentation are two sides of the identical coin. It doesn’t matter what you name it, the declare is premised on requiring one thing on the label that’s “along with” what federal regulation requires, making it preempted.
The courtroom and plaintiff are appropriate that the FDA monograph doesn’t explicitly handle the time period “non-drowsy,” however that’s too slim a spotlight. It ignores for example that the FDA’s professional panel thought of scientific literature and knowledge and concluded that DXM didn’t require a drowsiness warning. Id. at *9. Info that’s accessible within the monograph’s regulatory historical past however which the courtroom refused to think about as a result of it lacks “power of regulation.” Id. at *12. It’s undisputed that the FDA did look at whether or not sure merchandise needed to carry a “could trigger drowsiness” warning and explicitly decided that DXM didn’t require it. Subsequently, the difficulty of drowsiness for DXM merchandise was explicitly determined by the FDA.
The ruling in Newport permits plaintiff to contradict the FDA’s conclusion that there was an absence of scientific proof that this product causes drowsiness; exactly what Congress sought to stop by enacting the specific preemption clause.