Bexis is updating (probably for the last time) the preemption chapter of his drug and device product liability treatise, so expect blogposts like this on preemption-related topics.
Briefly, preemption in the prescription drug context is limited to implied preemption because, unlike medical devices, the FDCA lacks any preemption language applicable to those products. The foundation for prescription drug preemption is what the Blog calls the “Mensing independence principle: “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.” PLIVA v. Mensing, 564 U.S. 604, 623-24 (2011).
Plaintiffs’ primary way around this principle is what the FDA calls its “changes being effected” (“CBE”) regulations – which are essentially the same for both drugs and biologics (and devices, but they benefit from express preemption, so the device regulation is rarely invoked). These regulations allow unilateral, that is, “independent,” changes to “strengthen” warnings if certain conditions are met. The chief condition is for the change to be based on “newly acquired information.” E.g., 21 C.F.R. §314.70(c)(6)(iii).
Every jot and tittle of this regulation (and other regulations that the CBE regulation references) have been litigated since the Supreme Court first went this route in Wyeth v. Levine, 555 U.S. 555 (2009). The aspect we’re considering today is who can create “newly acquired information.”
Plaintiffs, of course, would dearly love to be able to create newly acquired information themselves, using their own experts to gin up something “new” in every preemption case. But no, they can’t. Litigation usually (but see, medical monitoring) follows injury, and a CBE label change cannot be based on information that doesn’t yet exist. The In re Zofran (Ondansetron) Products Liability Litigation, 57 F.4th 327, 340 (1st Cir. 2023), decision roundly rejected ex post facto expert opinions when advanced as “newly acquired information.” First, as we mentioned recently, Zofran rejected expert opinions on preemption issues – preemption being a question of law – as “likely inadmissible.” Id. at 340. Second, a litigation-driven expert reinterpretation of earlier data could not be “newly acquired” within the meaning of the CBE regulation, because the defendant cannot submit something that didn’t exist:
[The] expert report was not prepared, and thus not available to or possessed by [the defendant], until [well after the plaintiff’s injury]. Thus, it cannot serve as newly acquired information that would have triggered an obligation by [defendant] to unilaterally amend [the drug’s] label prior to [that time].
Id. (the bracketed time happening to be 2018).
MDL plaintiffs had previously tried the same gambit in In re Incretin-Based Therapies Products Liability Litigation, 524 F. Supp.3d 1007 (S.D. Cal. 2021), aff’d, 2022 WL 898595 (9th Cir. March 28, 2022), having their expert conduct a “re-analysis of the slide images” underlying a published study and claiming that was newly acquired information. Id. at 1024. “The Court disagree[d].”
This expert report was generated in preparation for litigation and is not supported by published research. The Court therefore finds that one unpublished and litigation-driven animal study does not make a risk apparent or otherwise constitute reasonable evidence of association.
Id. at 1024-25 (citations and quotation marks omitted).
In reliance on both Zofran and Incretin, similar bought-and-paid-for expert testimony was excluded in Bueno v. Merck & Co., 746 F. Supp.3d 853 (S.D. Cal. 2024), and Parker v. Merck & Co., 2024 WL 3974764 (S.D. Cal. Aug. 27, 2024), two substantively identical opinions. Unable to find anything that could pass as newly acquired information, these plaintiffs turned to their experts to make something...
