Photo of Andrew Tauber

Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the FDCA requires generic versions of a drug to carry the same label as the branded version and thus prohibits generic manufacturers from unilaterally changing their labels even provisionally, failure-to-warn claims implicating generic drugs are preempted (so long as the generic manufacturer provided the drug’s FDA-approved warning label). Branded manufacturers, by contrast, may unilaterally change their labels under certain circumstances. To do so, the manufacturer must have “newly acquired information,” which is defined as “data, analyses, or other information not previously submitted to the [FDA], which may include (but is 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. § 314.3(b). Because federal law prohibits a pharmaceutical manufacturer from unilaterally changing its label absent “newly acquired information,” in the absence of such information it is impossible for a manufacturer to simultaneously comply with federal law and a putative state-law duty to change its label.

The issue in today’s case, R.S.B. ex rel. Hammar v. Merck & Co., 2022 WL 3927868 (E.D. Wis. 2022), was whether there was “newly acquired information” that would have allowed the branded drug manufacturer to use the CBE regulation to change its label to comply with a purported state-law duty to warn of a particular risk supposedly associated with its product. Concluding that there was no such information, and that federal law therefore prohibited a labeling change, the court held that the plaintiff’s failure-to-warn claim was preempted.

The plaintiffs argued that there were two pieces of newly acquired information that would have allowed the manufacturer to change its label—an expert’s reanalysis of previously known data and an academic article reporting on an adverse event associated with the drug. The Hammar court found neither constituted “newly acquired information” for purposes of 21 C.F.R. § 314.70.

According to the plaintiffs, their expert’s reanalysis of previously published data showed that the drug in question had a higher risk of neuropsychiatric side effects than originally reported to the FDA. The Hammar court rejected the reanalysis on two grounds. First, the court said that it could not rely on the expert’s purported opinion because the plaintiffs had failed to place her report in the record. Second, and more importantly, the court held that even if it did consider the expert’s reanalysis the reanalysis did “not constitute newly acquired information” because it was “litigation-driven and unsupported by any published research.” 2022 WL 3927868, at *4 (citing In re Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d 1007, 1024–25 (S.D. Cal. 2021), aff’d, 2022 WL 898595 (9th Cir. 2022)). As the court put it, “Plaintiffs are not entitled to create their own ‘newly acquired information’ through the use of experts.” Id. (quoting R.S.B. v. Merck & Co., Inc., 2021 WL 6128161, at *4 (E.D. Wis. 2021)).

Tacitly acknowledging that the manufacturer did not know of the reanalysis when its drug was ingested, the plaintiffs argued that the manufacturer “could have undertaken the same analysis” as the plaintiffs’ expert had and that, “had it done so, it would have had information that allowed it to invoke the CBE regulation.” 2022 WL 3927868, at *4. The court, however, rejected the plaintiffs’ “attempt to shift the burden” of locating new information onto the manufacturer, holding that the plaintiffs’ “burden-shifting argument upends the preemption framework laid out by the various Courts of Appeal and would allow litigants to circumvent it by merely alleging that a manufacturer should have created the newly acquired information.” Id. (internal quotation marks omitted). “Such an argument, said the court, “cannot stand.” Id. Indeed, the regulation’s text precludes such an argument inasmuch as it predicates use of the CBE regulation on information that is newly acquired, not on information that could be newly acquired.

The court also found no merit to the plaintiffs’ contention that the adverse event reported in the medical literature constituted “newly acquired information” that would have allowed use of the CBE provision. According to the court, “[a] single report, unaccompanied by any significant analysis, does not demonstrate the existence of a risk that is of a different type or greater severity or frequency, such that a manufacturer can invoke the CBE regulation. 2022 WL 3927868, at *4. To the contrary, “[c]ourts have … rejected the notion that analyses based on adverse event reports—much less the reports standing alone—can constitute ‘newly acquired information.’” Id. (quoting Gayle v. Pfizer Inc., 452 F. Supp. 3d 78, 88 (S.D.N.Y. 2020), aff’d, 847 F. App’x 79 (2d Cir. 2021)).

So, two take-aways for practitioners litigating failure-to-warn claims implicating a branded drug:  First, the mere fact that the manufacturer could have uncovered certain information does not mean that the manufacturer actually possessed “newly acquired information.” Second, anecdotal adverse-event reports do not constitute “newly acquired information” within the meaning of the CBE regulation.

Go forth and defend.