Claims that "non-drowsy" is false aren't preempted by FDCA

Calchi v. Topco Assoc., LLC, 2024 WL 4346420, No. 22-cv-747 (N.D. Ill. Sept. 30, 2024)

Is there any circuit style more distinctive than the Seventh Circuit style? (Cf.)

This is one of a number of lawsuits against purportedly non-drowsy cold meds that are allegedly in fact drowsiness-promoting because of an active ingredient called Dextromethorphan Hydrobromide, which studies allegedly confirm causes drowsiness. The court was snarky about the multiple lawsuits and their resemblances. Calchi herself sued a different manufacturer in the SDNY. “She might have a big fool-me-once, fool-me-twice problem (and an adequacy of class representation problem, too).”

TopCo argued FDA preemption. The FDA expressly considered the claim that “DXM caused drowsiness and determined that insufficient data existed to support such a finding.” So it doesn’t require a drowsiness warning. Thus, TopCo argued, Calchi’s claim would create separate requirements that are “not identical” to the federal requirements and are thus preempted.

Calchi responded that, regardless, TopCo cannot add false or misleading information to the label. Controlling Seventh Circuit precedent agreed with her (possibly to the court’s dismay). True, a state law that prohibits using the label “non-drowsy” for DXM seems “different from” the federal regulation, which doesn’t ban calling DXM “non-drowsy.” But Bell v. Publix Super Markets, Inc., 982 F.3d 468 (7th Cir. 2020), reasoned that, when the FDA standard of identity required only that the label call the item “Grated Parmesan Cheese,” and was silent about whether the products could be labeled as “100%” cheese, a deception claim wasn’t precluded. States may not “tack on further required disclosures” but they may prohibit advertisers “from voluntarily adding deceptive language to the federally permitted labels.” This was so because doing so doesn’t create any new requirement, given that the FDCA already provides that false or misleading labels constitute misbranding. This FDCA provision seems to distinguish consumer protection claims from attempts to add requirements orthogonal to the federal scheme. The court imagined a hypothetical where the federal government said things to park visitors like “don’t feed the bears” and “stay on the paths” and the state then wanted to add a “don’t swim in the rivers” rule. But here, the federal rule is similar to “don’t engage in dangerous behavior,” and the plaintiff is trying to establish that something is “dangerous.” If she’s right, then there’s no “difference” between the law and its application, just a level of specificity. The preemption question is whether states—whether through statutory torts or otherwise—can specify whether something is false or misleading if the FDA hasn’t opined on the issue.

Indeed, the court concluded, states can’t add to the list of required disclosures, but “if the federal government has not addressed a statement about D, then states can ban a statement about D if the states believe that D is false.” If the state law is directed to banning false and misleading statements, it “doesn’t add anything new, because federal law already prohibits false and misleading statements.” Thus, unless a monograph “protects a particular statement,” the preemption provision of the FDCA “does not expressly preempt state-law prohibitions on deceptive statements that sellers add voluntarily to their labels or advertising.”

Following the course of my thoughts exactly, the court suggested that “this issue boils down to an all-too-common, all-too-important question: who decides? … If the FDA looked at a statement, and took no position on whether it is false or misleading, can the states ban it?” But Bell made the question academic. (Thanks! I agree, it’s a super important question! Not much reasoning in the cases! FWIW, I incline towards the Bell position, because the FDA has way too much on its plate to go after whatever new language marketers think of next. But the ability of state legislatures to declare something to be false or misleading as a matter of law worries me. Does the First Amendment require advertisers to have an opportunity to disprove falsity/misleadingness of their commercial speech (outside the IP context?).)

Calchi alleged that TopCo shouldn’t have voluntarily placed a misleading “Non-Drowsy” label on its medicine. That’s not preempted.

A reasonable consumer could plausibly be materially deceived by “non-drowsy,” since there were plenty of obvious reasons to want to avoid drowsiness.

Calchi alleges that she bought a product, and would not have purchased the product without the misrepresentation. That’s enough to allege an injury. She also alleges that she paid more for the product than she otherwise would have paid. Based on this complaint, that theory is a bit shakier, but it is enough to get to the next stage of the case. She also alleged a pocketbook injury—she paid more than she otherwise would have—and that was enough at this stage, though the court expressed some skepticism about proof.