Photo of Stephen McConnell

We’ve pointed out several times recently (and will be pointing out in an ACI presentation today) that cases against over the counter (OTC) drugs are on the uptick. Why?  Here’s our theory: there are lots of OTC consumers, hence lots of potential plaintiffs, and there are no pesky learned intermediaries, which means that plaintiffs can state fraud theories that are weak, and maybe even a little weird. 

In Singo v. Ricola USA, Inc., 2024 WL 196709 (S.D.N.Y. Jan. 18, 2024), the plaintiff brought a purported class action, alleging that cough drops labeled as containing green tea with echinacea defrauded consumers because the only active ingredient was actually menthol. The plaintiff claimed that the label should have highlighted menthol, not green tea and echinacea, and that consumers were fooled into paying an inflated price. The plaintiff did not allege that the cough drops failed to work, though we are not suggesting that such an allegation would affect the preemption analysis. The plaintiff also did not deny that the cough drops tasted like green tea with echinacea. The complaint included causes of action under the consumer fraud statutes of New York and other states, as well as breach of warranty and violation of the Magnuson Moss Act. 

The defendant moved to dismiss the case because all the claims in the complaint were preempted by 21 U.S.C. section 379r(a) of the Food, Drug, and Cosmetic Act (FDCA), which stops states from imposing any requirement on OTC drugs that “is different from or in addition to, or that is otherwise not identical with” the FDA label.  That motion was granted.  

The Singo court reasoned that preemption is an affirmative defense, so the burden is on the defendant to make out the defense. At the same time, and more importantly, the court correctly held that there was no presumption against express preemption. The Singo court embraced the SCOTUS holding in Puerto Rico v. Franklin California Tax Free Tr., that there is no need for any presumption because the plain language of the statute “contains the best evidence of Congress’ preemptive intent.”  

Then the Singo court got down to business. The court took judicial notice of the full product label. Then it held that the claims were preempted by the FDCA. This case is particularly helpful to defense hacks because the court does not fall for the argument we’ve criticized that anything a plaintiff claims is “misleading” is automatically parallel to the general FDCA “false and misleading” provision.  

The cough drops were generally recognized as safe and effective (GRASE) per an FDA monograph. The plaintiff’s claim that the label misidentifies inactive ingredients as therapeutic goes beyond what the FDA’s monograph requires.  The product undisputedly complies with the monograph’s terms, since it includes the product’s established name and what it does. 

The plaintiff cannot attack a representation allowed by the relevant monograph as misleading.  That would undermine the FDA’s regulatory scheme, which provides specific rules and requirements for the proper labeling of OTC drugs.  As the Singo court observed, “[t]he core of Plaintiff’s claims then is that Defendant’s representations are false and misleading because of the placement of key words on the label.” That means that “any relief the Court would grant Plaintiff would require Defendant to place menthol on the front of the Product’s package.”   By seeking to force the active ingredient from the back to the front of the label, the plaintiff would be imposing an additional, non-identical requirement.  

By dismissing the complaint, the Singo case is music to our ears. It provides soothing relief. That relief is somewhat diminished because the court granted the plaintiff leave to amend.  Nevertheless, we predict that any future iteration of the complaint will continue to — well, do what people do when they have a cough drop in their mouths.