FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation.  21 U.S.C. §337(a).  That is the foundation on which prescription drug and device preemption is built. However, preemption is about the interplay between federal and state law requirements and where the latter must cede to the former.  When two federal statutes are at issue, the question is one of preclusion rather than preemption.  It’s a little bit po-tay-to versus po-tah-to, but the Supreme Court made sure to draw the distinction in POM Wonderful v. Coca-Cola Co., 134 S.Ct. 2228 (2014), and since we do not want to suggest that POM Wonderful had any effect on preemption, we restate the distinction here.

The other thing that distinguishes the case we are going to address today is it is not a products liability case, but rather a Lanham Act case – essentially marketing litigation between competitors.  That is what POM Wonderful was about as well, but in the food context rather than drugs and devices, and it found the FDCA was not preclusive.  Since POM Wonderful is not a SCOTUS decision we would rave about, we keep an eye on cases that examine the interplay between the FDCA and the Lanham Act just to make sure nothing creeps over to the products liability area we are focused on.  So far, so good.  While case specific holdings on the issue vary, the general principle is that if a Lanham Act claim challenges an FDA policy choice, meaning the court has to interpret or enforce FDA regulations, it is barred.  If it doesn’t, it’s not.  That does not stray too far from “no private enforcement” to keep us at night.

The most recent case to examine the intersection between the Lanham Act and the FDCA is Ciccio v. SmileDirectClub, LLC, 2022 U.S. Dist. LEXIS 49562 (M.D. Tenn. Mar. 21, 2022).  We gather from the opinion that the court has entertained numerous pleadings motions and discovery disputes that it did not rehash in this most recent decision, nor did it want to “belabor the details” of the case again.  But we think we got the gist.  Defendant sells plastic aligners for orthodontic use.  Orthodontists brought a Lanham Act claim against defendant alleging their misleading marketing deceived consumers into purchasing the aligners as an alternative to traditional orthodontic treatment which they allege the devices were not.  Id. at *3-4.  While plaintiffs’ claims survived earlier motions to dismiss, defendants brought this new motion to address the narrow issue of whether claims based on the allegation that defendant “improperly marketed itself as in compliance with federal regulations governing dental devices” were adequately pleaded.  Plaintiffs’ claim boils down to an allegation that defendant’s marketing misled consumers to believe the aligners were FDA approved when they were in fact not.

As a representation about FDA-approval status was not squarely addressed in POM Wonderful, defendants argued the claims in Ciccio “more seriously intrude on FDA’s prerogatives under the FDCA” such as to make the case more akin to Buckman than POM Wonderful.  Nothing would make us happier than a Lanham Act dismissal based on Buckman, but Ciccio is not that case.  Courts to have looked at the issue have gone both ways.  Ciccio at *19-20.  Here the court was persuaded that plaintiffs’ claims were not that defendant had “violated the FDCA or [ ] any general duty to disclose” whether a product is FDA-approved, but rather that their marketing was “misleading in a way that could have been, but was not, rectified by such a disclosure.”  Id. at *21.  If you can remedy the problem by disclosing, doesn’t that create a duty to disclose?  While that does make us wonder, we’ll leave that alone for now because we have an amendment to our Buckman statement above – Nothing would make us happier than a Lanham Act dismissal based on Buckman, but Ciccio is not that case – yet:

It may be that, once the facts of SmileDirect’s dealings with the FDA are established and in the record, the plaintiffs will be unable to state any theory of the case under the [Tennessee Consumer Protection Act] TCPA that would avoid Buckman-type preemption because any such claim would improperly call on this court to intrude on the FDA’s decisionmaking.

Id. at *29-30.  Yes, we know the court here was talking about plaintiff’s state law claim which is a matter of preemption as opposed to preclusion.  But the analysis should equally apply to the Lanham Act and preclusion. If the facts, in this case or another, ask the court to “improperly intrude” on FDA decision-making, such claims are preempted and/or precluded.  We retain our ability to rest easy that POM Wonderful and its progeny have left untouched the foundation of drug and device products liability preemption.