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This post is from the non-Reed Smith side of the Blog.

Breaking new ground, a court has for the first time held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act expressly preempt product-liability claims implicating a Class II medical device brought to market through the “de novo” classification process. This is an important and long-overdue development.

As readers of the blog are painfully aware, courts have for years cited Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), for the proposition that the only claims expressly preempted by 21 U.S.C. § 360k(a) are those implicating Class III devices that received premarket approval under 21 U.S.C. § 360e, and that conversely claims implicating Class II devices or Class III devices that received 510(k) clearance rather than premarket approval are not preempted. As we have explained here and here, Lohr was outdated when decided and is inconsistent with the current statute. Nevertheless, for decades the overwhelming majority of lower courts have reflexively understood Lohr as conclusively foreclosing preemption in cases involving medical devices without premarket approval (or an investigational device exemption).

Fortunately, some courts have begun to rethink things.

For example, in Kelsey v. Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. Ct. 2019), which we discussed here, the court held that 21 U.S.C. § 360k(a), the MDA’s express-preemption provision, preempted design- and manufacturing-defect claims targeting device that was subject to “special controls” imposed by the FDA through the 510(k) clearance process under 21 U.S.C. § 360c(a)(1)(B).

In the case we report on today, Dickson v. Dexcom, Inc., 2024 WL 3417392 (W.D. La. July 15, 2024), the court held that § 360k(a) preempts claims challenging the safety and effectiveness of a Class II device whose sale was authorized by the FDA through the “de novo classification” process.

Congress first established the de novo classification process—codified at 21 U.S.C. § 360c(f)(2)(A)(iii)—as part of the Food and Drug Administration Modernization Act of 1997, and then amended the process when it enacted the Food and Drug Administration Safety and Innovation Act in 2012. For a device to be classified as a Class II device through the de novo classification process, its manufacturer must submit, among other things, the device’s draft labeling and “valid scientific evidence” demonstrating that any “special controls” imposed by the FDA pursuant to 21 U.S.C. § 360c(a)(1)(B) are adequate to provide a “reasonable assurance” of the device’s “safety and effectiveness.” 21 C.F.R. § 860.220.

Dickson involved an external glucose monitoring device. By regulation, all external glucose monitoring devices are subject to certain special controls. They require, among other things, that the device manufacturer submit “[r]obust clinical data demonstrating the accuracy of the device in the intended use population,” “[c]linical study results” meeting specified “performance requirements,” and proposed labeling that addresses certain enumerated topics. 21 C.F.R. § 862.1355.

As the Dickson court recognized, “the special controls established under 21 C.F.R. § 862.1355 are device-specific label and design requirements.” 2024 WL 3417392, at *5. This is significant because, according to the Supreme Court, 21 U.S.C. § 360k(a) preempts a state-law claim only when federal law has established “device-specific ‘requirements’” applicable to the device in question. Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008).

Having determined that the imposition of special controls through the de novo classification process establishes device-specific federal requirements, and therefore satisfies the first prong of Riegel’s preemption test, the Dickson court next considered whether the plaintiff’s claims were based on state-law requirements “different from, or in addition to” those federal requirements and thereby satisfied the second of the Riegel test.

The court had no trouble concluding that the plaintiff’s claims would in fact impose state-law requirements different from or in addition to the special controls imposed through the de novo classification process. As the court noted, the plaintiff did not allege that the “defendant failed to comply with the FDA regulations,” attacking instead “both the safety of the product’s design and the adequacy of its label notwithstanding the FDA’s approval.” 2024 WL 3417392, at *7. Under these circumstances, the plaintiff’s claims would necessarily “impose requirements ‘in addition to’ those made by the FDA” and were therefore expressly preempted by § 360k(a) as construed in Riegel. Id.

That should have been the end of the matter.

Unfortunately, the court then went astray and granted the plaintiff leave to amend her failure-to-warn claim based on a mistaken legal assumption.

The plaintiff argued that her failure-to-warn claim avoided preemption because the device’s label, although indisputably compliant with federal requirements, “could have been changed” to comply with purported state-law requirements “under the FDA’s Changes Being Effected (‘CBE’) regulations to reflect” what she characterized as “newly acquired information on the risk of harm.” Dickson, 2024 WL 3417392, at *7. Assuming “for the sake of argument that there might have been some way for [the manufacturer] to bring … post-approval information to the FDA’s attention that would have triggered a change in its labeling requirements,” the court allowed the plaintiff an opportunity to amend her complaint to adequately allege the existence of such “newly acquired information.” Id. at *8.

There are two major problems with that.

First, as the defendant noted and the plaintiff did not dispute, the medical-device “CBE regulation, 21 C.F.R. § 814.39(d)(2), is only applicable to manufacturers of Class III devices.” 2024 WL 3417392, at *8. Given that limitation, the Dickson defendant could not use the CBE regulation to change its label.

Second, even if contrary to fact § 814.39(d)(2) were applicable to Class II devices, it allows but does not require a manufacturer to provisionally change a device’s label under certain conditions. See 21 C.F.R. § 814.39(d)(1) (labeling change “may be placed in effect”) (emphasis added). But, “[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted” by 21 U.S.C. § 360k(a). McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005); cf. National Meat Ass’n v. Harris, 565 U.S. 452, 460 (2012) (if “a slaughterhouse may take one course of action” under federal law but “must take another” under state law, the state-law requirement is “different or additional” and is expressly preempted) (construing 21 U.S.C. § 678)).

If the plaintiff files an amended complaint, the defendant manufacturer will be allowed to file another motion to dismiss. Hopefully the court will correct its error on the second go. Despite its errant treatment of the medical-device CBE regulation, Dickson is an important decision inasmuch as it holds, Lohr notwithstanding, that claims targeting a Class II device that received de novo classification are subject to express preempted under 21 U.S.C. § 360k(a).