It’s the start of cold and flu season, so why not talk about cough syrup. Most cough medicines come in two versions – daytime and nighttime. The nighttime version typically contains an antihistamine which are known to cause drowsiness. Daytime versions often contain an expectorant (to thin and loosen mucus) and a cough suppressant. A common cough suppressant is dextromethorphan hydrobromide (DXM). That is the ingredient at issue in Goldstein v. Walmart, Inc., 2022 U.S. Dist LEXIS 196743 (S.D.N.Y. Oct. 28, 2022).
Walmart sells its own brand of OTC cough medicine containing DXM and the label says “Non-Drowsy.” Plaintiff alleges she relied on that statement in selecting the medicine and she became unexpectedly drowsy after taking it. She filed a putative class action alleging breach of express warranty, breach of the Magnuson-Moss Warranty Act, and violations of various state consumer protection laws. Defendants moved to dismiss all claims as preempted.
The federal regulations governing OTC medicines are found in monographs which are promulgated by the FDA and set the approved active ingredients for a class of drugs as well as any conditions under which they are considered safe and effective. Id. at *7-8. There is a monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic drugs. It requires certain products in this class to carry a warning that the drug may cause drowsiness. DXM is not one of them. Id. at *8.
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. The opinion does a thorough walk through of the relevant case law. Id. at *21-31. Plaintiff tried to squeeze her claims through a small gap in the preemption window: “preemption does not preclude a state-law claim if the state requirement is outside the scope of the relevant federal requirements.” Id. at *23. Courts within the Southern District of New York have approached the scope question and reached slightly different conclusions.
The most stringent test for scope was if a state law diverges from federal law at all it is preempted. Id. at *26. In that case, because the FDA had issued a monograph, the only action that would not be preempted is if the defendant put something on its label that the FDA affirmatively prohibited. A less strict standard was offered in a case involving bottled water. There plaintiff alleged the logo on the bottle misrepresented the source of the water. However, the FDA had stated that source information was not required to be disclosed. Because federal law is not silent on the subject of source, claims seeking to impose liability due to failure to disclose the source were preempted. Id. at *28.
Applying the analyses from those cases, the court in Goldstein concluded plaintiff’s claims did not fall outside the scope of federal requirements and were therefore preempted. The monograph addresses drowsiness identifies which products must contain a drowsiness warning. For products containing DXM, the FDA requires a warning not to take if taking certain other types of medications. But “t]he FDA tellingly did not require a warning on oral antitussives that contain DXM that they may cause drowsiness.” Id. at *32. The monograph also notes that the FDA considered scientific literature regarding “slight drowsiness” as a side effect of DXM but that it was unaware of any data supporting the need for a warning. So, “the FDA considered the Plaintiff’s claim that DXM caused drowsiness and determined that insufficient data existed to support such a finding.” Id. at *33. As such the claim is preempted under either the strict or more lenient scope test.
Plaintiff’s primary argument in opposition is that her claim should not be preempted because it is a misrepresentation claim rather than an omission claim. That because her claim can be remedied by removing the objectionable language, it is not preempted. But a misrepresentation claim suing over a non-drowsiness statement is just the flip side of an omission claim to add an affirmative drowsiness label. “Virtually every omission claim could be repackaged as a misrepresentation claim.” Id. No matter what you call it, the claim is premised on requiring something on the label that is different from what federal law requires, making it preempted.
Plaintiff is correct that the FDA did not explicitly address the term “non-drowsy” in the monograph, but that is too narrow a question. 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. Id. at *36. To allow plaintiff’s claim certainly would lead to “the patchwork of inconsistent packaging regulations that Congress sought to prevent.” Id. at *39.