Today we report on Thornton v. Tyson Foods, Inc., — F.4th —-, 2022 WL 727628 (10th Cir. 2022)—a favorable express-preemption decision under the Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601–695, that is directly applicable to medical-device cases. Although decided under a different statute, Thornton makes clear that the FDCA bars state-law claims challenging labeling statements approved by the FDA through the premarket approval process—even if those statements are allegedly false and the relevant state prohibits “misbranding.”
The plaintiffs in Thornton sued several meat manufacturers, alleging that they falsely labeled their beef products as “Products of the USA” when those products were in fact made from cattle raised and sometimes even slaughtered abroad. According to the plaintiffs, the purportedly false labels violated New Mexico’s consumer-protection law.
The Tenth Circuit held that the plaintiffs’ claims were expressly preempted by 21 U.S.C. § 678, which—in language akin to that used in 21 U.S.C. § 360(k)(a) with respect to medical devices—prohibits states from imposing meat-labeling requirements that “are in addition to, or different than those” imposed by federal law.
Because the FMIA requires that the Department of Agriculture approve the labels affixed to meat products much as the FDCA requires that the FDA approve the labeling that accompanies medical devices with premarket approval, and because the FMIA and FDCA’s respective preemption provisions are indistinguishable in relevant part, what the Tenth Circuit concluded with respect to claims challenging meat labels applies equally to claims challenging device labels.
Under the FDCA, the manufacturer of a medical device that requires premarket approval must obtain FDA approval of the device’s labeling, and the FDA may approve proposed labeling only if it “is neither false nor misleading.” 21 U.S.C. § 360e(d)(1)(A). So too with respect to meat labeling under the FMIA, which bars the sale of meat products unless their labeling has been approved by the Department of Agriculture, which approves only those labels that it determines are “not false or misleading.” 21 U.S.C. § 607(d).
As already noted, the Thornton plaintiffs claimed that the defendant beef manufacturers violated New Mexico’s state consumer-protection law by falsely labeling their products “Products of the USA” despite being made from cattle raised and sometimes slaughtered abroad. The problem for plaintiffs was that the Department of Agriculture had approved those labels pursuant to a guidance document under which a product’s label “may bear the phrase ‘Product of the U.S.A.’ if the product is processed in the U.S.” Thornton, 2022 WL 727628, at *2 (cleaned up). Because the Department’s approval of a label under the FMIA is a determination that the label “is not false or misleading” (id. quoting Cohen v. ConAgra Brands, Inc., 16 F.4th 1283, 1288 (9th Cir. 2021)), any state-law claim that the label is misleading would necessarily rest on “a requirement different from” the federal requirements and is therefore expressly preempted by § 678’s prohibition of state-law meat-labeling requirements that “are in addition to, or different than those” imposed by federal law. Id. at *4.
Echoing an argument that we see in medical-device litigation, the Thornton plaintiffs insisted that their false labeling claims did not rest on a state-law requirement different from the federal requirements—and thus were not preempted—because New Mexico law, like federal law, prohibits misbranding and a meat product is misbranded under both New Mexico and federal law if its labeling is “false or misleading in any particular.” 21 U.S.C. § 601(n)(1). The Tenth Circuit rightly rejected the argument, explaining that because the Department of Agriculture “has already determined that defendants’ labels are not deceptive or misleading under federal law,” the “defendants’ products are,” as a matter of federal law, “not misbranded” and any state-law determination to the contrary is preempted. 2022 WL 727628, at *5.
This point needs to be emphasized whenever plaintiffs in a medical-device case argue that their claims escape preemption under 21 U.S.C. § 360k(a) because the device’s purported labeling defect renders the device misbranded. That argument—the argument that state-law claims do not impose requirements different from, or in addition to, the requirements imposed by federal law because both state and federal law prohibit misbranding—proceeds at too high a level of generality. Yes, both state and federal law prohibit misbranding, but if the FDA has approved a device’s labeling through the premarket approval process, that labeling cannot be challenged under state law, even if it might otherwise be deemed false or misleading.