We've blogged before about the substantive (preemption) and procedural (removal) aspects of the Eliquis MDL – both of which the defense seemed to be winning. However, we cautioned in our 2018 "Best Of" post that these favorable decisions "still face[d] an appeal."
No longer. The appeal has been decided, and the plaintiff's losing streak continues. The Second Circuit just unanimously delivered a big win for our side. See Gibbons v. Bristol-Myers Squibb Co., ___ F.3d ___, 2019 WL 1339013 (2d Cir. March 26, 2019). The appeals court addressed both the substantive and procedural issues and both results were great for us, and yet another disaster for the other side.
Claims Impliedly Preempted
Defendants prevailed substantively on implied preemption. "The FDA's premarket approval of a new drug application includes the approval of the exact text in the proposed label." Gibbons, 2019 WL 1339013, at *5 (quoting Wyeth v. Levine, 555 U.S. 555, 568 (2009)). The regulatory exception to FDA pre-approval of label changes that prevented preemption in Levine, "the 'changes being effected' ('CBE') regulation, set forth at 21 C.F.R. § 314.70(c)(6)(iii)," id., did not apply, and thus did not prevent preemption.
A manufacturer's possession of "newly acquired information" is a prerequisite to the applicability of the CBE regulation. Id. at *6. Such evidence can be "either new data or new analyses of previously submitted data." Id. (citing 21 C.F.R. §314.3(b)). Plaintiffs didn't plead that any existed in their complaints.
Critically, Gibbons recognized the general applicability of what we call the " independence principle" to all prescription drugs, even though it was first articulated in the generic drug preemption context:
[T]he Courts of Appeals have synthesized the requirements [of Levine/Mensing/Bartlett] to properly plead and then prove a state law failure-to-warn claim based on post-drug-release information. Thus, to state a claim for failure-to-warn that is not preempted by the FDCA, a plaintiff must plead a labeling deficiency that Defendants could have corrected using the CBE regulation. If the plaintiff meets that standard, the burden shifts to the party asserting a preemption defense to demonstrate that there is clear evidence that the FDA would not have approved a change to the prescription drug's label.
Id. (analyzing In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268, 283 (3d Cir. 2017), cert. granted, 138 S. Ct. 2705 (2018); Dolin v. GlaxoSmithKline LLC, 901 F.3d 803, 812 (7th Cir. 2018); and In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015)).
As the district court had discussed at length, the Eliquis MDL "[p]laintiffs' claims here fail at the first step." Gibbons, 2019 WL 1339013, at *6. Their complaints "consist of conclusory and vague allegations and do not plausibly allege the existence of newly acquired information." Id. (citation and quotation marks omitted). The plaintiffs' complaints:
Provide[d] no basis upon which the court could conclude that the bleeding events covered by the alleged "reports" and "studies" presented a different type of risk than those the company had discussed with the FDA, or were more severe or more frequent than bleeding events that the government already knew about.
Id. Basically, Gibbons is the TwIqbal decision to end all TwIqbal decisions, at least in the preemption context. The prerequisites for an unpreempted claim, such as "newly acquired evidence," must meet federal pleading standards.
Finally plaintiffs could not prevent preemption by making their complaints less specific – a trick they pulled in the district court by deleting references and exhibits in amended complaints. If the first complaints failed, the second, even vaguer, complaints did as well. "[T]he other complaints now before this court [] did not provide enough information about the existence of newly-acquired information to meet the Rule 8 threshold." Id. at *7. "Plaintiffs' complaints simply do not contain sufficient factual information to state a claim." Id.
Thus the Eliquis plaintiffs are out of court in an MDL that never got past the pleading stage. If anyone wonders why we consider preemption our side's most powerful defense, Gibbons is Exhibit A.
Removal Before Service Allowed
Before reaching preemption, the Gibbons court had to dispose of a procedural issue that implicated jurisdiction. That issue is one of our favorites – removal before service, a/k/a " snap" or " wrinkle" removal, depending on who is writing the blog post. Many of the plaintiffs in the Eliquis MDL ended up in federal court because the defendants removed these diverse cases to federal court before the plaintiffs got around to serving the in-state ("forum") defendant. This was done pursuant to the language of the removal statute, which recognizes the so-called "forum defendant rule" only as to parties "properly joined and served as defendants." 28 U.S.C. §1441(b)(2). Utilizing electronic docket monitoring techniques, the defendants were able to remove cases more quickly than the plaintiffs could serve them. Gibbons, 2019 WL 1339013, at *2.
The express terms of the statute thus allow removal before service. "Plaintiffs do not even attempt to argue that the text of §1441(b)(2) supports their position." Id. at *4. Plaintiffs, of course, claimed that allowing this sort of removal to defeat the forum-defendant rule was an "absurd" result. Id. The Second Circuit disagreed. First, the standard for "absurdity" is quite high – as it should be since by definition this argument seeks to ignore the plain language of a statute:
[A] statute is not "absurd" merely because it produces results that a court or litigant finds anomalous or perhaps unwise. To the contrary, courts should look beyond a statute's text . . . only where the result of applying the plain language would be, in a genuine sense, absurd, i.e., where it is quite impossible that Congress could have intended the result and where the alleged absurdity is so clear as to be obvious to most anyone.
Id. (citation and quotation marks omitted). Second, under this standard removal before service was hardly "absurd."
[T]he language of the statute cannot be simply brushed aside. Allowing a defendant that has not been served to remove a lawsuit to federal court does not contravene Congress's intent to combat fraudulent joinder. In fact, Congress may well have adopted the "properly joined and served" requirement . . . to both limit gamesmanship and provide a bright-line rule keyed on service.
Id. (citing Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., 902 F.3d 147, 153 (3d Cir. 2018)).
Nor did "state by-state variation" in service procedures (some build in delay, others don't) justify disregarding what Congress enacted:
[S]tate-by-state variation is not uncommon in federal litigation, including in the removal context, and it does not follow from the existence of variation that we must look beyond the plain text of Section 1441(b)(2).
Id. at *5 (citation omitted). The Gibbons court therefore concluded that removal before service "is neither absurd nor fundamentally unfair." Id.
Gibbons means that we're now 2-0 against the "absurd result" argument in appellate cases involving removal before service.
Editorial comment:
Eliquis is one of a group of drugs called " novel oral anticoagulants" ("NOACs"). Another one is Xarelto, which has also been targeted by plaintiffs' lawyers because – no big surprise – the "anti" in "anticoagulant" means they all have an inherent risk of uncontrolled bleeding. So, why is the Xarelto litigation settling for $775 million while the Eliquis plaintiffs are going home empty-handed? Basically it comes down to the MDL judge. Abusive discovery involving plaintiffs with meritless claims is the main expense driver in MDLs. Having a judge who is willing to consider FDCA-based preemption arguments on their merits – and on the pleadings − versus a judge that will never grant a preemption argument, is a difference literally worth hundreds of millions of dollars.
This article is presented for informational purposes only and is not intended to constitute legal advice.