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 up.  Didn’t work.  The expert took a study that the defendant had published, and “recalculated” it.  Bueno, 746 F. Supp.3d at 877.  Predictably, the expert found the published analysis “flawed” and massaged the data to reach the desired contrary conclusion that the drug was actually “significantly associated” with the condition the plaintiff claimed to have.  Id.

Bueno found that approach not very bueno as a preemption dodge.

The Court rejects Plaintiff’s argument.  While “new analyses of previously submitted data” can constitute “newly acquired information” in certain circumstances, 21 C.F.R. § 314.3(b), new analyses do not comprise newly acquired information when conducted by an expert in preparation for litigation with the benefit of hindsight.

Id. at 878 (citation and quotation marks omitted); see Parker, 2024 WL 3974764, at *13 (identical analysis).

In re Gardasil Products Liability Litigation, 770 F. Supp.3d 893, 916 (W.D.N.C. 2025), likewise gave the back of the judicial hand to the plaintiffs’ attempt at self-help through creating after-the-fact “newly acquired information.”

[T]he governing regulations do not permit a plaintiff to present an expert report created for litigation – here well more than a decade after the plaintiff claims a warning should have been given – that in essence says that the manufacturer and the FDA got it wrong and then have that opinion be sufficient to avoid preemption.  Preemption must be judged on the information actually available to the manufacturer at the relevant time which was “not submitted” to the FDA.

Id. at 916 (citation omitted).

There are also some unreported decisions that reach the same result.  R.S.B. v. Merck & Co., 2022 WL 3927868, at *4 (E.D. Wis. Aug. 31, 2022 (plaintiffs’ expert’s “conclusions are litigation-driven and unsupported by any published research, and therefore do not constitute newly acquired information”); R.S.B. v. Merck & Co., 2021 WL 6128161 at *4 (E.D. Wis. Dec. 28, 2021):

But “new analyses of previously submitted data” does not mean an analysis conducted by an expert in preparation for litigation with the benefit of hindsight. . . .  In other words, Plaintiffs are not entitled to create their own “newly acquired information” through the use of experts; rather, they must point to the existence of newly acquired information that [defendant] possessed during the relevant time period.

(Emphasis original); In re Byetta Cases, 2021 WL 2462800, at *16 (Cal. Super. April 6, 2021) (reaching the same conclusion as Incretin, above, about the same litigation-driven slide reanalysis); Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, at *19 (Conn. Super. Sept. 11, 2019) (“the court is unaware of any authority for the proposition that expert testimony at trial, unsupported by any published research, can constitute newly acquired information”).

Having failed with do-it-yourself “newly acquired information,” plaintiffs also have a fallback position – that defendants had some sort of “testing” duty that obligated them to create newly acquired information that never existed at the time of the relevant submissions to the FDA.  That claim hasn’t received much judicial love either.  As one of our scorecards demonstrates, most states don’t recognize any independent testing duty in any circumstance.  Nor have newly acquired information-related arguments fared any better.  We’ll start with Bueno/Parker, which “additionally” addressed, and rejected, this argument.  “[A]sserting that a manufacturer could or should have done more studies − i.e., that a manufacturer should have created the ‘newly acquired information’ − is insufficient to avoid preemption under the CBE regulation.”  Bueno, 746 F. Supp.3d at 878 (citation and quotation marks omitted); see Parker, 2024 WL 3974764, at *13 (identical analysis).  Bueno/Parker quoted Holley v. Gilead Sciences, Inc., 2023 WL 6390598, at *8 (N.D. Cal. Sept. 28, 2023).

Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), aff’d, 847 F. App’x 79 (2d Cir. 2021), was emphatic in rejecting such an unprecedented extension of the already discredited duty to test to preemption:

Plaintiffs also argue that [defendant] could have analyzed the adverse event reports and that [its] alleged failure to do that amounts to “newly acquired evidence”. . . .  This argument is also unavailing.  To shift the burden to [defendant], Plaintiffs must demonstrate the existence of “newly acquired information.”  Plaintiffs’ attempt to shift the burden to [defendant] upends the framework [for considering such evidence].  Under Plaintiffs’ theory, any litigant could circumvent [preemption] by merely alleging that a manufacturer should have created the “newly acquired information.”

Id. at 88.  For additional precedent for rejecting any affirmative duty to test in the preemption context, see:  Dickson v. Dexcom, Inc., 2024 WL 4291511, at *4 (W.D. La. Sept. 25, 2024) (“Likewise, it is insufficient to assert that a manufacturer ‘could have or should have done more studies’ to create such ‘newly acquired information.’”); R.S.B., 2022 WL 3927868, at *4 (E.D. Wis. Aug. 31, 2022) (“Plaintiffs attempt to shift the burden to [defendant]by arguing that it could have undertaken the same analysis that [their expert] did, . . . [b]ut this burden-shifting argument ‘upends’ the preemption framework laid out by the various Courts of Appeal and would allow litigants to circumvent it”).

These decisions make good sense.  There’s a reason why the FDA’s CBE regulations exist – to provide an avenue to address different and emergent risks ASAP.  This purpose is not served by after-the-fact, litigation-inspired junk science, or by demanding “more studies” in the absence any known reason for conducting them.