We’ve identified a number of instances just lately (and will likely be mentioning in an ACI presentation at present) that instances in opposition to over-the-counter (OTC) medication are on the uptick. Why?  Right here’s our idea: there are many OTC shoppers, therefore a lot of potential plaintiffs, and there aren’t any pesky discovered intermediaries, which signifies that plaintiffs can state fraud theories which might be weak, and possibly even a bit bizarre. 

In Singo v. Ricola USA, Inc., 2024 WL 196709 (S.D.N.Y. Jan. 18, 2024), the plaintiff introduced a purported class motion, alleging that cough drops labeled as containing inexperienced tea with echinacea defrauded shoppers as a result of the one lively ingredient was truly menthol. The plaintiff claimed that the label ought to have highlighted menthol, not inexperienced tea and echinacea, and that buyers had been fooled into paying an inflated value. The plaintiff didn’t allege that the cough drops did not work, although we’re not suggesting that such an allegation would have an effect on the preemption evaluation. The plaintiff additionally didn’t deny that the cough drops tasted like inexperienced tea with echinacea. The grievance included causes of motion below the patron fraud statutes of New York and different states, in addition to breach of guarantee and violation of the Magnuson Moss Act. 

The defendant moved to dismiss the case as a result of all of the claims within the grievance had been preempted by 21 U.S.C. part 379r(a) of the Meals, Drug, and Beauty Act (FDCA), which stops states from imposing any requirement on OTC medication that “is completely different from or along with, or that’s in any other case not similar with” the FDA label.  That movement was granted.  

The Singo court docket reasoned that preemption is an affirmative protection, so the burden is on the defendant to make out the protection. On the similar time, and extra importantly, the court docket appropriately held that there was no presumption in opposition to specific preemption. The Singo court docket embraced the SCOTUS holding in Puerto Rico v. Franklin California Tax Free Tr., that there is no such thing as a want for any presumption as a result of the plain language of the statute “accommodates the very best proof of Congress’ preemptive intent.”  

Then the Singo court docket obtained all the way down to enterprise. The court docket took judicial discover of the complete product label. Then it held that the claims had been preempted by the FDCA. This case is especially useful to protection hacks as a result of the court docket doesn’t fall for the argument we’ve criticized that something a plaintiff claims is “deceptive” is mechanically parallel to the overall FDCA “false and deceptive” provision.  

The cough drops had been typically acknowledged as protected and efficient (GRASE) per an FDA monograph. The plaintiff’s declare that the label misidentifies inactive substances as therapeutic goes past what the FDA’s monograph requires.  The product undisputedly complies with the monograph’s phrases, because it contains the product’s established title and what it does. 

The plaintiff can’t assault a illustration allowed by the related monograph as deceptive.  That will undermine the FDA’s regulatory scheme, which supplies particular guidelines and necessities for the correct labeling of OTC medication.  Because the Singo court docket noticed, “[t]he core of Plaintiff’s claims then is that Defendant’s representations are false and deceptive due to the position of key phrases on the label.” That signifies that “any aid the Court docket would grant Plaintiff would require Defendant to position menthol on the entrance of the Product’s package deal.”   By looking for to power the lively ingredient from the again to the entrance of the label, the plaintiff can be imposing a further, non-identical requirement.  

By dismissing the grievance, the Singo case is music to our ears. It supplies soothing aid. That aid is considerably diminished as a result of the court docket granted the plaintiff go away to amend.  However, we predict that any future iteration of the grievance will proceed to — nicely, do what individuals do after they have a cough drop of their mouths.