Photo of Andrew Tauber

The decision we report on today, Frye v. Novartis Pharms. Corp., 2022 WL 4305656 (E.D. Ark. 2022), leaves us shaking our heads. The court denied the defendant’s motion to dismiss, which was based on preemption and other grounds. In the course of denying the motion, the court misconstrued the law at least once and possibly twice.

Frye involves a biologic designed to treat Neovascular Age-Related Macular Degeneration. Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. See 42 U.S.C. § 262(a). To apply, the manufacturer must submit the label that it proposes using. See 21 C.F.R. § 601.2(a). Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” 21 C.F.R. § 601.2(d).

Once approved, a biologics label generally may not be changed without prior FDA approval. But under certain circumstances, a biologics manufacturer, like a branded-drug manufacturer, may provisionally change a label without prior FDA approval using the Changes Being Effected (CBE) provision found at 21 C.F.R. § 601.12(f)(2). But a label may not be changed under that provision unless the manufacturer possesses “newly acquired information,” which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

21 C.F.R. § 601.12(f)(6).

Plaintiff received the biologic just months after it had been licensed by the FDA. Alleging that the biologic caused her to suffer retinal vascular occlusion, the Frye plaintiff asserted failure-to-warn and other related claims. The biologic’s FDA-sanctioned label described reports of retinal vascular occlusion in patients who received the biologic and identified retinal vascular occlusion as an adverse event observed during clinical trials. Nonetheless, the plaintiff alleged that the label did not adequately warn of the risk.

Relying on allegations that by the time she received the biologic the defendant knew of a reanalysis of the clinical-trial data showing a higher rate of retinal vascular occlusion and was aware of eleven adverse-event reports involving retinal vascular occlusion, the plaintiff argued that the CBE regulation allowed—and state-law required—the defendant to change its label.

The defendant moved to dismiss on, among other grounds, preemption. The defendant argued that the plaintiff’s claims were preempted because, on the facts alleged in the complaint, federal law prohibited it from changing the label as purportedly required by state law. In particular, the defendant argued that the plaintiff alleged no facts plausibly suggesting the existence of “newly acquired information” that would have allowed the defendant to provisionally change the label without prior FDA authorization. Even if the data reanalysis and adverse-event reports were new information in a colloquial sense, the defendant argued, they did not meet the regulatory definition of “newly acquired information” because they did not “reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.” 21 C.F.R. § 601.12(f)(6)

The court denied the defendant’s motion because it was, it said, “unable to conclude that, as a matter of law,” the adverse event reports and data reanalysis did “not constitute newly acquired information of events or analyses revealing risks different in type or of greater severity than previously reported to the FDA.” 2022 WL 4305656, at *8. It’s not clear how best to interpret this rationale. If it is simply a statement about the adequacy of the plaintiff’s complaint, then it is nothing more than a perhaps overly generous application of the federal pleading standards that will have no bearing on summary judgment. But if the court means that the issue of preemption cannot be decided “as a matter of law,” that would be legal error given the Supreme Court’s declaration that the “question of pre-emption is one for a judge to decide, not a jury.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (2019).

Whether or not the Frye court properly understands Albrecht, it flatly misconstrued Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Although its analysis is hard to follow, the court seems to find Buckman “inapplicab[le]” because it “concerned a medical device” and Congress enacted “an express preemption provision for medical devices.”  2022 WL 4305656, at *5, *7. From this the court concluded that “impossibility preemption” was the only form of preemption possibly relevant to the plaintiff’s claims. Not so.

Yes, Buckman involved a medical device, and yes, Congress has enacted an express preemption provision applicable to medical devices. But none of that is relevant. Buckman was an implied preemption case, not an express preemption case, that turned on 21 U.S.C. § 337(a), which applies to all products regulated under the FDCA, not 21 U.S.C. § 360k(a), which applies only to medical devices Moreover, although it does not explicitly use the term, Buckman involved obstacle preemption, not impossibility preemption. In other words, it did not depend on the defendant’s inability to simultaneously comply with state and federal law but rather on the fact that applying state law would frustrate Congress’s goal of having the FDA balance competing objectives when deciding how to enforce the FDCA.

Regardless of its underpinnings, Buckman clearly proscribes as preempted state-law fraud-on-the-FDA claims. One would think this holding relevant in Frye given the plaintiff’s allegation that the defendant withheld information regarding the risk of retinal vascular occlusion from the FDA during the licensing process. But the Frye court found otherwise. Although it acknowledged the plaintiff’s allegation that the defendant knowingly failed to present accurate information to the FDA, the court effectively ignored it, saying that, “in context,” the allegation is meant to “illustrate[]” the defendant’s “state of mind” rather than assert “any claim of fraud on the FDA.” 2022 WL 4305656, at *7.

Whether or not denial of the defendant’s motion to dismiss was proper, Frye’s analysis leaves a lot to be desired.