As defense attorneys who represent drug and device companies, we generally cheer when a state-law claim is held preempted by the FDCA. We are, however, not sure whether to cheer the decision we discuss today, Thogus Products Co. v. Bleep, LLC, 2023 WL 5607458 (N.D. Ohio 2023).
Thogus involved a contract dispute between a device manufacturer and one of its suppliers. The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations.
The question before the Thogus court was whether 21 U.S.C. § 337(a) bars enforcement of a private contract that requires compliance with the FDCA.
As a reminder, § 337(a) states that all actions to enforce the FDCA “shall be by and in the name of the United States.” This means that “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” with the statute and its implementing regulations and that private plaintiffs may not assert claims that “exist sole by virtue of the FDCA.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 353 (2001).
The Thogus court concluded that § 337(a) preempted the device manufacturer’s contract claim because it was, according to the court, “entirely dependent on the FDCA.” 2023 WL 5607458, at *10.
Maybe. Maybe not.
On the one hand, it is certainly true that a contract that imports standards from a federal medical-device regulation could not exist absent the FDCA, which authorizes the issuance of such regulations. In some sense then, the contract claim at issue in Thogus is akin to a negligence-per-se claim based on the violation of a state statute that adopts the FDCA as the state’s own. There should be no doubt that such claims are impliedly preempted by § 337(a) as construed in Buckman. Indeed, courts have repeatedly held that a negligence-per-se claim based on an alleged violation of the FDCA or its implementing regulations is preempted because, “despite its nominal state-law moniker,” such a claim “is in reality a claim for violations of … FDA regulations.” In re Trader Joe’s Tuna Litigation, 2017 WL 2408117, at *4 (C.D. Cal. 2017) (cleaned up); see also, e.g., Grant v. Corin Group PLC, 2016 WL 4447523, at *4 (S.D. Cal. 2016); Anderson v. Medtronic, Inc., 2015 WL 2115342, at *9 (S.D. Cal. 2015). Seen from this perspective, Thogus seems right.
But there is another way to look at it. A contract claim is arguably distinguishable from a negligence-per-se claim based on a state statute that adopts the FDCA as the state’s own. Under the Supremacy Clause (U.S. Const. art. VI, cl. 2), which is the constitutional basis for preemption, federal law trumps state law. A statute is plainly state law subject to preemption. Although backed by state law, be it common law or the UCC, a contract is not itself state law. It is merely a private agreement. It is not self-evident that § 337(a) bars the enforcement of private agreements.
Contracts and state law have been distinguished in a related context. Some courts have held that 21 U.S.C. § 360k(a), which expressly preempts any state-law medical-device requirement different from or in addition to the requirements imposed by the FDA, does not preempt express warranty claims because those claims are based on a device manufacturer’s voluntary commitments rather than requirements imposed by state law. In our view, the conclusion does not follow from the premise, because—as other courts have recognized (see, e.g., Thomas v. Alcon Labs., 116 F. Supp. 3d 1361 (N.D. Ga. 2013))—imposing liability on a breach-of-express-warranty theory in the absence of a federal regulatory violation is equivalent to state law requiring that a medical device be safer than is required by federal law, which is something that § 360k(a) indisputably precludes.
In Thogus, by contrast, the manufacturer’s contract claim would not have compelled the supplier to do anything other than that required by the FDA. Thus, enforcement of the supplier’s voluntary commitment to abide by the FDA’s CGMP regulations is at least arguably different from enforcing an express warranty in a way that would effectively supplant FDA regulations with heightened state-law standards.
So, no clear conclusions here as to the correctness of Thogus. Reactions are welcome.