We can sum up the claim in Telebrands Corp. v. Luminas Int’l LLC, like this—hey court, it’s not fair that I’m following the FDA’s rules and my competitors are not, so you should force them to do so to even the playing field. 2023 U.S. Dist. LEXIS 179285 (S.D. Cal. Jul. 12, 2023). To which the court appropriately said—you’ve come to the wrong place; FDA rules are the FDA’s to enforce. In other words, all your claims are impliedly preempted and so they are dismissed without leave to amend.
Plaintiff is an online seller of over-the-counter analgesic patches used for pain relief. Plaintiff has listed its patches on the FDA’s National Drug Code (“NDC”) database. Id. at *2. Doing so comes with obligations to comply with FDA’s labeling requirements for such OTC drugs, which Plaintiff alleges they do. Plaintiff alleges that at least two of its competitors (several others were voluntarily dismissed) sell their products misbranded because they don’t comply with FDA’s “branding, labeling, registration, and listing requirements.” Id. at *3.
Plaintiff brought claims under the unfair competition laws of California, Florida, Pennsylvania, Delaware, and Colorado. Each claim alleges that defendants’ failure to comply with FDA’s regulations is an unfair business practice and/or causes “consumer confusion.” Therefore, to rule on any of plaintiff’s claims, the court would have to determine whether the FDA requires the sellers of OTC pain patches to register their products on the NDC and comply with attendant regulations. That’s the FDA’s job, not the court’s.
The Food, Drug, and Cosmetic Act (“FDCA”) does not contain a private right of action. A provision that has been enforced and reinforced in the courts for at least the last 22 years when the Supreme Court decided Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). Telebrands sets out a nice history of the development of implied preemption law in the Ninth Circuit since Buckman. See Telebrands, at *8-11. In doing so, found that that precedent required dismissal here.
For instance, in Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. So, if defendants had been marketing their products as FDA-approved when they were not, that claim may not be preempted as it does not require litigation of an FDCA violation. A claim based on non-disclosure of registry status with the FDA, however, would require the court to adjudicate whether registry was required—an issue solely within the discretion of the FDA. Similarly, the court in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F4th 1040, 1049 (9th Cir. 2022), in reviewing claims brough by a competitor under unfair trade practices statutes, held that a state law claim is preempted where the “claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.”
Like in these other cases, the plaintiff in Telebrands was not alleging an affirmative misrepresentation that stood separate from any allegation of FDCA violations. Because “an FDCA violation is a critical element of each claim,” regardless of how styled, plaintiff’s claims are impliedly preempted. And because no additional factual allegations could change this “critical element,” the case was dismissed with prejudice.