We recently received a copy of Pfaff v. Merck & Co., No. 12-md-02331 (BMC), slip op. (E.D.N.Y. Sept. 9, 2022), and the decision has a number of useful – for our side – rulings concerning branded drug preemption post-Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).
Pfaff is a straggler from the In re Propecia (Finasteride) Products Liability Litigation MDL, most of which settled in 2019. The plaintiffs in Pfaff, who opted out of the settlement, had originally brought suit in California federal court back in 2015. Slip op. at p. 9. The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. Id. at pp. 8-9.
As with practically all post-Albrecht successful preemption cases, the drug had an extensive FDA regulatory history regarding the risk at issue (suicide) and related risks (chiefly depression and suicidal ideation). Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. §314.70(c)(6-7), and, as to this drug, the defendant itself filed a CBE supplement in 2011 and was allowed to add depression as an adverse reaction. Slip op. at p. 4. That submission prompted a significant internal FDA investigation that went beyond what the defendant had requested:
Rather than only relying on [defendant’s] reports, the [FDA’s pharmacovigilance division] also conducted its own research, which included analyzing all the reports of [relevant risk]-related events associated with [the drug] that were submitted to the FDA’s Adverse Event Reporting System (“AERS”) up until [that time]. The [division] also undertook a search of the medical literature [for the same time period] for case reports of [relevant risk]-related adverse events associated with [the drug].
Ultimately, the [pharmacovigilance division] concurred with [defendant’s] assessment to add depression to the Adverse Events . . . section of the label. Although [defendant] did not request any other changes, [that division], acting on its own accord, decided to also recommend adding “suicidal thoughts and behavior” to this same section.
Relying on [that division’s] report, [the FDA division with direct responsibility for this dermatologic drug] reached the same conclusion regarding the addition of the depression warning. But the [dermatology division] opposed adding the suicide warning.
Slip op. at pp. 4-5 (footnote and quotation marks omitted). This internal FDA decision was one of the reasons that preemption prevailed in Pfaff. The other was the FDA’s subsequent resolution of a P-side citizen petition:
[I]n 2017, the Post-Finasteride Syndrome Foundation (“PFS”) filed a citizen petition with the FDA. The group requested that the FDA either withdraw marketing approval . . . or order new labeling to strengthen or add warnings of “major depressive disorder and suicidal ideation.” The primary basis for the petition’s argument that suicidality should be added was the 2017 study. . . . [T]he FDA responded. Regarding the depression warning, the FDA determined that upgrading the warning to the W&P [warnings and precautions] section was “not justified”. . . . However, the FDA concluded that . . . [it would] requir[e] the addition of “suicidal ideation/behavior” to the AR section of the label.
Slip op. at pp. 7-8 (citation and footnotes omitted).
So, ten years after the plaintiffs’ decedent stopped using the drug, and based on a study published five years after that use stoppage, the FDA concluded the a label change was appropriate. Obviously, timing was key to the preemption holding in Pfaff.
But first, another thing Pfaff illustrates is the difference between federal and state law in the MDL context. As mentioned above, the suit originally arose in California. Thus, “[p]laintiffs’ claims all arise under California state law.” Id. at p. 10 (footnote omitted). However, since the MDL was situated in New York, the applicable federal preemption principles (where the Supreme Court has not spoken) were those articulated by the Second Circuit. “When determining questions of federal law, MDL transferee courts apply the law of the circuit in which it is located.” Id. (citations omitted). Both propositions are well recognized, but Pfaff ties them together in one neat package.
With that out of the way, Pfaff turned to Albrecht, the CBE regulation, that regulation’s “newly acquired information” requirement, and “clear evidence.”
The only avenue recognized in Albrecht for unilaterally changing an FDA-approved drug warning was “if the change complies with the CBE regulation.” Slip op. at p. 12 (citation and quotation marks omitted). However, “the CBE process will not be available where a drug manufacturer does not have newly acquired information on which to base a request for a change.” Id. “New” is key: “[T]he new analysis, and any new data, must reveal risks of a different type or of greater severity or frequency to constitute newly acquired information.” Id. at p. 13 (citations and quotation marks omitted). But even when newly acquired information is available, “clear evidence” that the FDA would not have approved the plaintiff’s preferred warning also leads to preemption. Id.
The plaintiffs in Pfaff advanced claims that implicated both prongs of post-Albrecht preemption analysis. First, their claim that “depression” should have been moved to the “warning” section failed because of the FDA’s resolution of the citizen petition. That petition, and everything in it, long post-dated the decedent’s drug use, which ended in 2012:
[P]laintiffs’ state law claims based on [defendant’s] failure to upgrade the depression warning to the W&P section are clearly preempted. This is because the FDA has explicitly declined to require such a warning in its letter response to the September 2017 citizen petition. There, the FDA unequivocally denied the petitioner’s “request to add major depressive disorder to the [W&P] section of labeling.”
Slip op. at pp. 13-14 (citation omitted). “No clearer evidence could be forthcoming that the FDA would not have approved the change in 2011 or anytime thereafter.” Id. at p. 14. Pfaff is yet another case confirming that FDA resolution of citizen petitions, no matter who submits them, is a proper post-Albrecht basis for “clear evidence” preemption.
Plaintiffs’ other claim in Pfaff was that there should have been a suicidality/suicidal ideation warning. Preemption was “less clear” (but still clear enough) because the FDA actually required such a warning – but ten years after the fact. Id. at p. 14. As mentioned above, however, when it responded to the defendant’s 2011 CBE supplement, the FDA took it upon itself to evaluate whether to add a suicidality warning even though the defendant’s supplement had been limited to “depression.” The FDA decided against it, but “did not also inform the [defendant].” Id. at p.15. “However, the FDA has since included documents in its response to the 2017 Citizen Petition, which make clear that, in retrospect, it would not have approved a suicidality warning in 2011.” Id. Thus, the defendant here “got lucky”:
The disapproval at issue occurred many years ago, and was merely illuminated by the citizen petition, rather than being resolved by it. When the FDA approved [defendant’s] supplemental CBE in 2011, [defendant] was not aware of the impossibility of adding a suicidality warning under federal law. Instead, it simply got lucky when it first uncovered these documents through [a Freedom of Information Act request], and then again when the FDA later decided to rely on them in its partial rejection of the citizen petition.
Slip op. at p. 16. Since the Supreme Court in Albrecht did not create any particular requirements for the transmission of an FDA disapproval, Pfaff found even an uncommunicated FDA disapproval preempted, since the FDA had plainly been acting “pursuant to [its] congressionally delegated authority” in considering the defendant’s CBE supplement. Id. at p. 15 (quoting Albrecht).
Pfaff found no basis for having “impossibility preemption to turn on a private party’s mental state regarding impossibility.” Id. at p. 16. All that matters is “whether, in fact, compliance with both state and federal regimes was legally impossible,” id., and the FDA’s resolution of the CBE supplement established that, even though the FDA did not tell anyone for several years.
Pfaff also rejected plaintiffs’ various attempts to jigger up “newly acquired information” where there wasn’t any. Most of the argument was simply wrong:
Plaintiffs’ argument is unsupported by the record. . . . [T]the FDA was fully informed of much of this information when it completed its CBE review. [Defendant] separately provided the FDA with adverse event reports relating to [its drug] and, further, the [the FDA] also unequivocally stated that it included this information its analysis, as well as all other adverse event reports related to [a similar drug].
Slip op. at pp. 16-17. Plaintiffs also threw “eight studies” against the wall. None of them stuck. “[O]nly two include human subjects, both of which the FDA knew about.” Id. at p. 17. A key take-away: animal studies don’t count as newly acquired information. Id. (citation omitted). Moreover, “none of these studies directly discussed or even mention suicidality.” Id.
Nor did 27 unanalyzed adverse events between the FDA’s resolution of the CBE supplement and the cessation of the decedent’s drug use qualify. Such raw data was not enough to demonstrate newly acquired information. Mere “adverse event[s], standing alone, do not mean that the drug caused [them].” Id. at p. 18 (citation and quotation marks omitted). That’s another useful take-away.
Last (and least) plaintiffs threw in another “seven studies.” Id. at pp. 18-19. Fail. First, “none of them even address suicidality.” Id. at p. 18. More importantly, “these studies were published after [the decedent] ceased taking [the drug].” Id. at p. 19. Thus, they didn’t even exist during the relevant time period. Without any newly acquired information, preemption barred the suicidality aspect of plaintiffs’ claim because the CBE exception was not available to permit any unilateral warning change. Id. at p. 19.
There you have it. A decision with the thoroughness typical of most post-Albrecht MDL decisions, and with numerous useful rulings on both the “clear evidence” and “newly acquired information” prongs of preemption under Albrecht. In retrospect, plaintiffs would have been better off taking the MDL settlement, but we’re glad they didn’t.