In the ever-extending period of working from home and social distancing, we have spent some time watching various exemplars of the "superhero" genre and noted that the uber kitschy afterschool and weekend morning staple of our youth is not being recreated. (If Stevie Mac is from the Pleistocene, then our youth was in the Pliocene with the other hairy hominids.) There was something reassuringly silly and innocent about those shows, whether rendered in clunky animation or clunkier acting and costumes. Nowadays, shows are generally more complicated, layered, and darker. Back then, candy in the shape of cigarettes or gum shredded up like chewing tobacco seemed innocent. Now, electronic nicotine delivery systems ("ENDS"), also known as e-cigarettes and vaping products, are sold in a range of flavors perhaps designed to appeal to young taste buds.
It appears that the plaintiff in Yimam v. Mylé Vape, Inc., No. 2019 CA 008050, 2020 D.C. Super. LEXIS 7 (D.C. Super. June 11, 2020), was on something of a crusade with a test case against a vaping product manufacturer. Maybe he was just out to make some money, but his purchase of the products was clearly to set up the ability to sue. Why do we say that? Well, he bought defendant's "iced watermelon" and "pound cake" flavored products on November 26, 2019, to "test and evaluate" them and brought his consumer protection case within the next five weeks. We certainly have railed against untimely suits before, but this seems really fast and somewhat suspicious given the regulatory status of the products. The purchase of the products and initiation of the suit just happened to be within a seven and a half month gap when the products were being sold without an arguably required FDA authorization. The short version of this is that FDA had extended the time for certain ENDS products to file necessary premarket tobacco applications until August 2022, but a court struck that down in May 2019; while that decision was on appeal, FDA issued a the replacement guidance in January 2020 that extended the application deadline to May 2020. Id. at **2-4. Got it? So, it does not look like coincidence that the purchase and subsequent complaint occurred before the murky regulatory window closed. Arguably, consumer protection statutes are really meant to protect consumers and not test case purchasers, but that is not where the court took it. Instead, preemption, both express preemption under the Family Smoking Prevention and Tobacco Control Act of 2009 (mercifully, "TCA") and good old Buckman implied preemption, was the focus of the court's analysis. That is why we are discussing it, cartoonish lead-in notwithstanding.
Plaintiff teed up claims for deceptive trade practice under DC's expansive consumer protection act, unjust enrichment, and implied warranty. The gist of plaintiff's claims was that the products' packaging did not include any statement about FDA authorizations, submissions, or requirements, falsely implying to a purchaser (even one who did not intend to vape) that the products were legally on the market. On its face, the DC act might have covered this allegation given that it did not require that any consumer was misled or damaged by any misrepresentation or omission. It prohibited misrepresentations as to "approval" and material facts, failure to state material facts, and sales inconsistent with federal requirements. Id. at *5. The court considered these and their possible intersection with preemption in turn.
Rather than allege that there was an affirmative misrepresentation about approval status, plaintiff contended that "the very act of marketing the products, standing alone, constituted an implicit representation that the products had received premarket FDA approval." Id. at **7-8. As a matter of DC law and statutory interpretation, that allegation could not satisfy the requirement of a misrepresentation: "This would untether the term 'misrepresentation' from its ordinary definition . . . ." Id. at *8. This determination meant that the court did not address preemption yet, although we can certainly see how such a claim, if permitted, would have implicated both express and implied preemption.
The next theory that plaintiff offered—that the absence of FDA approval as a material fact that should have been disclosed—clearly did. "The claim that the defendant violated the CPPA [DC act] by failing to disclose on its packaging that its products lacked FDA approval is expressly preempted." Id.at *10. Like other express preemption provisions in the FDCA, the TCA's preempted state (and DC counts as a state for these purposes) requirements to the extent they were "different from, or in addition to," federal requirements. The federal labeling requirements for these products "do not impose an affirmative duty to advise consumers about the status of any marketing authorization order from the FDA." Id. at 11. That meant express preemption, sending our mind to how similar consumer fraud claims would fare with Class III and Class II medical devices. It was brought back when the court went ahead and analyzed implied preemption.
Starting with food and device cases recognizing that FDA's sole right to enforce violations of the FDCA means that state law (DC still counts) claims predicated on purported violations "intrude[] upon the FDA's exclusive province" and are impliedly preempted, the court quickly got to Buckman. Id. at **12-13 (citations omitted). Cutting through some of the usual smoke about what claims are not impliedly preempted, the court rightly framed the dispositive question as "whether the FDCA violation at issue is 'a critical element' of the state law claim" and whether the "claim would not exist in the absence of the FDCA." Id. at *14 (citations omitted again). When it comes to disclosing the lack of FDA approval, this is not a hard call:
[T]he resolution of this claim would necessarily require a determination that FDA premarket approval was required and not obtained in a circumstance in which the FDA has yet to conclude that such a violation occurred.
Id. at **14-15 (citations still omitted). That means implied preemption (Bam!) on top of express preemption (Pow!).
After that deep draw, it was quick work to conclude that plaintiff's remaining argument under the DC act—selling these ENDS without approval was inconsistent with federal requirements—would be impliedly preempted. Id. at **15-16. The violation of the FDCA would not only be a critical element of the claim, it would be the only element. (Plaintiff also attempted to argue that the DC act allowed an unenumerated claim for an unfair trade practice based on selling the ENDS without FDA approval, which also impliedly preempted even if it had been supported by DC law and properly pleaded. Id. at *17.)
Plaintiff also tried to get his claims for unjust enrichment and implied warranty left through the Buckman gauntlet. We cannot recall seeing an analysis like this for unjust enrichment, which is often asserted but rarely lasts long in product liability cases. The gist of the claim is that it is, well, unjust for the defendant to keep the payment for the ENDS because they were being sold in violation of the FDCA. Wham, with the TCA implied preemption out of nowhere. Id. at *20. (Really, out of the same place as all the other implied preemption.) The implied warranty claim was also based on the ENDS not being fit to sell because they were not approved by FDA, so—what is left? Blam!—implied preemption again. Id. at **21-22.
One last nugget (or easter egg, were this buried in the end credits) is that it looks like this dismissal did not come with leave for the plaintiff to amend. Because preemption knocked out every claim he asserted, there would be no point in letting plaintiff amend to try to come up with non-preempted ways to assert liability for selling products that were apparently purchased to launch a lawsuit.
Originally published by Reed Smith, July 2020
This article is presented for informational purposes only and is not intended to constitute legal advice.
