We’ve noticed quite a few prescription drug preemption decisions lately involving “newly acquired information.” That’s because the Supreme Court doubled down in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), on the boundary of impossibility preemption being set by a defendant’s ability to utilize the FDA’s “changes being effected” regulation, 21 C.F.R. §314.70(c)(6)(iii)(A), to make certain label changes unilaterally. 139 S. Ct. at 1673. If a defendant can’t make a CBE change, then it has to get FDA pre-approval for that change, so a state-law claim for not based on not changing the label is preempted under the Mensing independence principle. You can find all these cases on our post-Levine prescription drug preemption cheat sheet.
While we question the wisdom of having something as important as preemption turn on the complexities of an FDA regulation not intended for that purpose, Albrecht is what it is. Thus, we’ve been parsing the CBE regulation closely, looking at the prerequisites for its application. Chief among them is a requirement that a manufacturer possess “newly acquired information” concerning a “clinically significant adverse reaction.” See 21 C.F.R. §201.57(c)(6)(i) (defining “newly acquired information” for purposes of CBE regulation as concerning an adverse reaction that is either “potentially fatal,” “serious even if infrequent,” or can “be prevented or mitigated through appropriate use of the drug”). These definitions give our side quite a bit to work with.
Albrecht was decided a little less than a year ago. Post-Albrecht precedent can’t tell us definitively what “newly acquired information” is, but we can identify with some confidence four things that are not enough.
First, because the information in question must be “new,” when “the undisputed evidence shows that the FDA was aware of the nature of the data it received from” the manufacturer, that data isn’t “new,” even when it is later regurgitated in another article. Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 815 (7th Cir. 2018) (blogged about here). In CBE-land, plagiarism cannot preclude preemption. “[A]ny claim that a drug label should be changed based solely on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.” In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Product Liability Litigation, 185 F. Supp.3d 761, 769 (D.S.C. 2016). “New” information must “reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA.” Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (quoting 21 C.F.R. §314.3(b)) (blogged about here).
Thus, the plaintiffs in Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (W.D. Mo. March 16, 2020) (blogged about here), could not avoid preemption where “[b]y and large, nearly all of the ‘newly acquired information’” they relied upon “still relies upon . . . and reflects information – for all intents and purposes – that was provided to the FDA at the time of the initial approval of [the drug] for the American market.” Id. at *15. Information that was in essence “previously submitted to the [FDA]” or that “contained the same figures as [defendant’s pre-approval] analysis, which [was] submitted to the FDA” doesn’t become shiny and new again simply because somebody discusses it again later on. Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452, *18 (Conn. Super. Sept. 11, 2019) (blogged about here). Accord Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 1890681, at *10 (Conn. Super. March 13, 2020) (reaching same conclusion as Roberto) (blogged about here).
Second, data cannot be “new” when that data did not exist until after a particular plaintiff’s use of the drug was over. “[N]ewly acquired information must have been available to [defendant] after the FDA approved the relevant label on . . ., but before Plaintiff last used [the product].” Mahnke v. Bayer Corp., 2020 WL 2048622, at *3 (C.D. Cal. March 10, 2020). “The Court will disregard the many articles cited in the Amended Complaint that were published after [plaintiff’s] last [use of the product]. These studies can have no bearing on her failure-to-warn claim.” Sabol v. Bayer Healthcare Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2020 WL 705170, at *12 n.13 (S.D.N.Y. Feb. 12, 2020) (blogged about here).
[T[he complaint does not cite any newly acquired information that arose after the FDA’s approval of [the product’s] revised label . . . and before Plaintiff was administered [the product. . . . Without factual allegations that [defendant] had new information in this time period such that it could have or should have amended the label pursuant to the CBE regulation, the complaint is barred as preempted.
Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019) (blogged about here).
In Ridings, the plaintiff used the drug at issue between early 2012 and mid-2013. 2020 WL 1264178, at *5, 11. “[S]tudies published after a plaintiff’s injury [are not] relevant to constitute newly acquired information.” Id. (quoting Roberto, 2019 WL 5068452, at *14). “Based on [that] reasoning,” Ridings determined that post-use materials could not “constitute even prima facie ‘newly acquired information’” and did not consider that material further. Id. at *16. Accord McGrath v. Bayer HealthCare Pharmaceuticals, Inc., 393 F. Supp.3d 161, 170 (E.D.N.Y. 2019) (“this study . . . was published after Plaintiff’s exposure to [the product] and thus cannot support a failure-to-warn claim based on what [defendant] knew or should have known”).
Third, “[c]linically significant” risks must be “‘potentially fatal’ or ‘serious,’ [or have] a ‘significant impact on therapeutic decision-making.’” Klein v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019) (quoting 71 Fed. Reg. 3922, 3946 (FDA Jan. 24, 2006)) (blogged about here). Thus, post-Albrecht case law also rejects inconclusive studies as “newly acquired information.”
[S]tudies concluding that it “remains unknown” whether a drug is linked to a particular adverse reaction or risk or that “further studies are required to address possible clinical consequences” do not constitute reasonable or well-grounded scientific evidence of “clinically significant adverse effects” under the CBE regulation.
Ridings, 2020 WL 1264178, at *15.
McGrath likewise held that “[r]eports and studies that . . . do not reach any conclusions regarding the adverse effects or risks” of a product cannot be “newly acquired information” that could support a going ahead with a CBE warning change. 393 F. Supp.3d at 169 (emphasis original). “[I]t helps precious little to mount scientific minutiae on top of technical jargon if that information ultimately does not plead a plausible causal association between [the product] and adverse effects.” Id. See Sabol, 2020 WL 705170, at *13 (“a tentative, at best, suggestion of a causal relationship” cannot “support the inference” of “a clinically significant adverse reaction that would require a manufacturer to change its label”); Adkins, 2020 WL 1704646, at *13 (article’s “rather tentative statement . . . and its conclusion that its proposal . . . ‘lends itself to further clinical trials’ do not establish newly acquired information”).In sum, the “new information” at issue must make out a “a reasonable, if not compelling, causal association” so that the risk at issue “become[s] apparent” as specified by Albrecht. McGrath, 393 F. Supp.3d at 170-71 (quoting Albrecht, 138 S. Ct. at 1677) (emphasis original).
Fourth, unanalyzed adverse event reports are sufficiently low on the hierarchy of scientific evidence that they “do not necessarily reflect a conclusion . . . that the drug caused or contributed to an adverse effect.” Gayle v. Pfizer Inc., ___ F. Supp.3d ___, 2020 WL 1685313, at *5 (S.D.N.Y. April 7, 2020) (quoting 21 C.F.R. §314.80(l)).
[A]dverse event reports do not constitute “newly acquired information.” In order to qualify as “newly acquired information,” the information must demonstrate “reasonable evidence of a causal association with a drug.” But “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” The reports describe instances where patients taking [the drug] were diagnosed with [a condition] but do not reach any conclusions regarding a causal association. Under a plain reading of the regulations, adverse event reports, without any analysis indicating causality, cannot constitute “newly acquired information.”
Id. (quoting Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011), other citations omitted). Raw AERs “miss the mark,” where plaintiffs “offer no analysis” and “merely proffer the adverse event reports by themselves.” Id. Voluntarily collected AERs are such weak evidence that “sheer numbers of case reports . . . reveal little about how frequently the events occur in the broader patient population.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 664 (S.D.N.Y. 2017) (blogged about here), aff’d, 919 F.3d 699 (2d Cir. 2019). Even “[r]eports and studies that discuss” adverse events are not “newly acquired information.” McGrath, 393 F. Supp.3d at 169.
We’ve said it before, and we’ll say it again – many (probably most) allegations of causation that we get from the other side are based on pseudoscientific garbage. With Albrecht mandating that courts, not juries, decide preemption questions, plaintiffs are no longer entitled to the benefit of the doubt, because courts now have to decide “material” factual disputes in the preemption context. A judge who “simply ask[s] himself or herself whether the relevant federal and state laws irreconcilably conflict,” 139 S. Ct. at 1679, is much more likely to see the garbage for what it is, and to do the right thing.