In preparing a motion to dismiss in a branded pharmaceutical drug case alleging failure to warn, defense counsel should review the complaint and consider an implied “impossibility” preemption argument that has been gaining momentum in various federal courts since 2015. Specifically, this defense is based on a manufacturer’s inability to change the drug’s labeling without FDA approval in the absence of “newly acquired information.”
After the FDA approves a drug, the Changes Being Effected (CBE) regulation permits a manufacturer to add or strengthen a warning label based on “newly acquired information” without first obtaining FDA approval of such a change. “Newly acquired information” is defined by the regulation as:
data, analyses, or other information not previously submitted to the Agency, 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) (emphasis added).
Three U.S. Supreme Court decisions have outlined the test for impossibility preemption in pharmaceutical drug cases. In Wyeth v. Levine, the Court explained that the impossibility variety of conflict preemption does not exist where a federal regulatory provision expressly allows a manufacturer to unilaterally do what state law allegedly would require.555 U.S. 555, 572-73 (2009). In PLIVA v. Mensing, the Court clarified that “[t]he question for ‘impossibility’ is whether a private party could independently do under federal law what state law requires of it,” defining independently to mean unilaterally, “without the Federal Government’s special permission and assistance.” 564 U.S. 604, 620-24 (2009). “The Court thus limited Levine to situations in which the drug manufacturer can, ‘of its own volition . . . strengthen its label in compliance with its state tort duty.’” Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281, 295 (6th Cir. 2015). Finally, in Mutual Pharmaceutical Co., Inc. v. Bartlett, the Court confirmed the core holding of Mensing that, when a party cannot satisfy its alleged state law duties before obtaining FDA approval, those state law claims are preempted. 133 S. Ct. 2466, 2471 (2013).
Under this framework, if a complaint alleges that the manufacturer should have provided a different warning label after FDA approval of the drug, such allegations may be preempted where “the information upon which the [complaint] relies to plausibly plead these claims, does not, upon examination, demonstrate that any newly acquired information exists to support a label change pursuant to CBE regulations.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 673 (S.D.N.Y. 2017) (Utts II). This argument equally applies to post-approval information that does not suggest a greater severity or frequency of the risks alleged by the plaintiff than previously included in submissions to the FDA, or to reports that pre-date the drug’s FDA approval, if such reports were previously submitted to the FDA and therefore, by definition, not “newly acquired.”
The first post-Bartlett case to recognize the “newly acquired information” argument was the First Circuit Court in its Marcus v. Forest Pharmaceuticals opinion in 2015, followed by orders coming out of the Eliquis multi-district ligation in the Southern District of New York. (See In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 36 (1st Cir. 2015); Utts I, 226 F. Supp. 3d at 178; Utts II, 251 F. Supp. 3d at 673.)
In the past year, the “newly acquired information” argument has become well-grounded in the law and supported by substantial precedent. (See Bell v. Boehringer Ingelheim Pharm., Inc., No. CV 17-1153, 2018 WL 2447788, at *6 (W.D. Pa. May 31, 2018); McGee v. Boehringer Ingelheim Pharm., Inc., No. 4:16-CV-2082-KOB, 2018 WL 1399237, at *4 (N.D. Ala. Mar. 20, 2018). Both plaintiff’s and defense’s counsel should consider how this now well-established preemption defense will impact their cases, particularly at the pleadings stage.
Lauren Treadaway is an associate at Sidley Austin LLP in New York, New York.