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.
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.