Today’s post looks at Rayes v. Novartis Pharms. Corp., No. EDCV21201JGBKKX, 2021 WL 2410677 (C.D. Cal. June 11, 2021), which contains an interesting discussion of an aspect of drug product preemption.  The Supreme Court discussed in Wyeth and later clarified in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1679 (2019), that the Changes Being Effected (CBE) regulation that allowed a manufacturer under limited circumstances to change a drug label (such as adding warning language), before getting FDA approval, is only triggered when there is “newly acquired evidence” that warrants that CBE step.

Defendant makes a drug—Beovu—that treats an eye disorder (Macular Degeneration).  After the drug was approved in 2019 (the third in its class to receive FDA approval),  there were scattered reports of side effects including retinal vasculitis and retinal vascular occlusion.   On June 9, 2020, Defendant revised the U.S. product label for Beovu to include a new warning regarding the risk of retinal vasculitis and/or retinal vascular occlusion. Plaintiff alleged that Defendant knew of Beovu’s risks before June 2020, and that peer-reviewed medical literature supported a relationship between administration of Beovu and retinal vasculitis and retinal vascular occlusion injuries. Plaintiff alleged he experienced the side effect and that Defendant failed to provide consumers and the medical community adequate data and warnings about the risks. 2021 WL 2410677, at *1–3.  Defendant filed a motion to dismiss on preemption grounds.
The court recognized that in order to bring a failure-to-warn claim that is not preempted by the FDCA, a plaintiff must plead a labeling deficiency that the defendant could have corrected using the “changes being effected” (“CBE”) regulation. Mahnke v. Bayer Corp., 2020 WL 2048622, at *3 (C.D. Cal. Mar. 10, 2020).  (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A)). Newly acquired information is defined as: “[D]ata, analyses, or other information not previously submitted to the [FDA] 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.” McGrath v. Bayer HealthCare Pharms. Inc., 393 F. Supp. 3d 161, 167 (E.D.N.Y. 2019). But, the court noted, the label had to have been inadequate when plaintiff used the drug, after its approval but before the label was changed and before he was injured.  This left a narrow window, and thus the complaint was full of allegations of newly acquired information that did not help his case.  Newly acquired information that postdates the injury cannot establish liability because it is not considered known or reasonably knowable under the circumstances.
The “only genuinely new information” that the plaintiff alleged were a handful of adverse event reports. The court easily concluded that this was not the kind of information which would have reasonably enabled Defendant to unilaterally change its labeling under the applicable regulations.

Claims arising out of Novartis‘ alleged misrepresentation to the FDA were preempted under Buckman.   Private causes of action based on allegations that a sponsor of an FDA-approved product misrepresented information submitted to the FDA are preempted by the FDCA.  Such claims do not rely on traditional state tort law. Accordingly, to the extent Plaintiff’s claims relied on a theory that Defendant misrepresented the safety of Beovu to the FDA, such claims were dismissed also.