If we advertised our blog as being non-drowsy, would that be false advertising?  We hope not.  

In Amara v. Publix Supermarkets, Inc., 2022 WL 3357575(M. D. Fla. August 15, 2022), the plaintiff claimed that a cough syrup was falsely advertised as non-drowsy.  According to the plaintiff, the cough syrup contained an ingredient called DXM that, contrary to the label, could make people sleepy.  (Call it a doze response.) The plaintiff said he would not have bought the medicine, or would have paid less for it, if he knew the narcoleptic truth.  He filed a putative class action based on various state consumer fraud laws, breach of contract, breach of warranty, etc., as well as the federal Magnuson Moss Warranty Act (MMWA).  He wanted his money back and he wanted an injunction. The defendant moved to dismiss the case because the plaintiff lacked standing , because the claims were preempted by the federal Food Drug and Cosmetic Act (FDCA) and because the claim of non-drowsiness was not deceptive. 

The Amara court held that the plaintiff had alleged an economic injury of overpayment, but had not alleged  “any future harm to himself that is real and immediate and/or certainly impending.”  He offered “only a speculative and conjectural statement that he intends to purchase the Product at some future date.”  Thus, the defendant’s motion on lack of standing was granted with respect to injunctive relief.  

But the plaintiff had alleged an economic injury of overpayment, so he had standing as far as that goes.  Did that mean that such claim could proceed? No, a defense victory rode in on a stallion called preemption.  For the plaintiff, that stallion must have seemed more like a nightmare.  

Congress expressly preempted certain claims with respect to over-the-counter (“OTC”) drugs. With limited exceptions, “no State or political subdivision of a State may establish or continue in effect any requirement…that is different from or in addition to, or that is otherwise not identical with, a requirement” for OTC drugs in the FDCA.  21 U.S.C. § 379r(a).  The FDA issued a final monograph for cough medicines that sets forth the specific disclosures that manufacturers must make on labels for products that contain DXM. That monograph mandates warnings about drowsiness for cough medicines containing  another ingredient, but does not require a disclosure of drowsiness as a side effect for products that contain DXM. 

The plaintiff attempted to sidestep this problem by arguing that because the defendant voluntarily added the affirmative misrepresentation of “non -drowsy” to the cough syrup labeling, requiring it to remove that statement would impose no additional disclosure requirements.  That is, the plaintiff said he was not seeking to add a drowsiness warning to the medicine; rather, he merely sought removal of the term “non-drowsy,” which he claimed was false and misleading. 

That is certainly clever. Most sophistry is.  The plaintiff invited the court to hold the defendant liable for labeling the product as “non-drowsy” when such labeling complied with the FDA’s Monograph.  The court declined that invitation.  According to the court,  “[i]f successful, this litigation would do exactly what Congress, in passing section 379r of the FDCA, sought to forbid:  using state law causes of action to boots trap labeling requirements that are ‘not identical with’ federal regulation.”  Accordingly, the court held that all of the plaintiff’s state-law claims were preempted by the FDCA because they sought to impose a labeling requirement that is “different from or in addition to, or that is otherwise not identical with, a requirement” for OTC drugs in the applicable regulations.

What about the plaintiff’s solitary federal claim under the MMWA?  Federal preemption does not bar federal claims.  But “a breach of warranty claim under the MMWA is dependent upon a viable underlying state breach of warranty claim.”  Because the underlying state-law warranty claims were dismissed, the MMWA claim would be dismissed as well. Additionally – and this is a lesson not to sleep on technicalities — the complaint failed to meet the requirement under the MMWA that the amount in controversy for any individual claim exceeds $25, since the plaintiff claims he purchased the product for approximately $4.99.

Here’s a delicious nightcap: because federal preemption cannot be cured by amendment, the court granted dismissal of the entire case with prejudice.

That’s Amara.  It’s a preemption wake-up call.