Not long ago, in our “Post-Albrecht Preemption Pummels Pradaxa Plaintiffs” post we discussed several recent favorable preemption decisions in product liability litigation involving that drug: Ridings v. Maurice, ___ F. Supp.3d ___, 2020 WL 1264178 (Mag. W.D. Mo. March 16, 2020), Adkins v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 WL 1704646 (Conn. Super. March 13, 2020), Ridings v. Maurice, 2019 WL 8223599 (W.D. Mo. Oct. 20, 2019), and Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 5068452 (Conn. Super. Sept. 11, 2019).
Those were all favorable cases, but they were all by trial-level courts, and thus subject to the vagaries of the appellate process. How about a similar decision from the other end of the appellate process? Thus, we present Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., ___ A.3d ___, slip op., 2020 WL 2121063 (Conn. May 4, 2020).
Boone was an appeal from a trial that produced a defense verdict. The opinion addresses several rather case/product-specific issues before it gets to the preemption topic that is near and dear to our blogging hearts. Thus, we’ll pass over pages *2-11 of the Connecticut Supreme Court’s opinion (which resolve disputes over spoliation and rebuttal evidence).
Boone unanimously affirmed the trial court’s grant of a preemption summary judgment motion against “a design defect claim related to the defendants’ failure to develop and market a reversal agent.” 2020 WL 2121063, at *12. This claim ran afoul of what we call the “Mensing independence principle” – “The relevant inquiry, [Mensing] held, was whether the defendants ‘‘could independently do under federal law what state law requires. . . .” Id. at *14 (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 620 (2011)) (emphasis supplied by Boone).
The preempted claim, which really isn’t a “design defect” since it doesn’t involve any aspect of the actual product’s design, see id. at *12 n.32, was that the defendant should not have sold the drug at all until it had also developed and obtained FDA approval for a different drug. As the Boone court recognized, id. at *14, this claim was also preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). Moreover, footnote 32 is itself interesting, since usually courts steer away from deciding constitutional issues when they can avoid them. But in Boone, “[b]ecause we conclude that the trial court properly granted the defendants’ motion for summary judgment on federal preemption grounds,” the court did not address whether a claim was stated under Connecticut state law. Preemption was evidently an easy call in Boone.
Boone recognized that, despite a purported presumption against preemption, the logic of Mensing and Bartlett “compels” preemption. Plaintiff was using state law to hold one drug’s FDA approval hostage to the agency also approving a second drug. That theory self-evidently depended on the FDA acting to approve the second drug – which required preemption. “[I]t is enough to hold that when a party cannot satisfy its state duties without the [f]ederal [g]overnment’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for [preemption] purposes.’’ Boone, 2020 WL 2121063, at *14 n.34 (quoting Mensing, 564 U.S. at 623-24) (emphasis added by Boone).
In order to cure the design defect alleged by the plaintiff, the defendants would have had to bring [the second drug] to market before the [alleged injury occurred]. Because there is no dispute that [the second drug] was not approved by the FDA until [later], the defendants could not have satisfied their alleged state law duty to the decedent without marketing an unapproved drug in violation of federal law.
Id. at *15.
Plaintiff unsuccessfully argued “that the test for preemption set forth in Mensing and Bartlett is inapplicable to present case because those cases do not involve brand-name drugs.” Id. No dice. While the “different levels of control” that branded and generic manufacturers exercised over their labels “informed the [supreme] court’s analysis . . ., the nature of the underlying test remained consistent: whether the defendant ‘‘could independently do under federal law what state law requires.” Id. (once again quoting and emphasizing Mensing independence principle). Boone agreed with the holding in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), that, ‘‘contrary to [the plaintiff’s] contention that the impossibility preemption in Mensing and Bartlett is limited to generic drugs, we view Levine, Mensing, and Bartlett as together stating the same test for impossibility preemption.’ Boone, 2020 WL 2121063, at *15 (quoting Yates, 808 F.3d at 296-97).
Along the way, Boone rejected the plaintiff’s argument (which readers will recognize from our previous Pradaxa preemption pummels plaintiffs post) that Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), somehow confined the preemption inquiry in branded drug cases to the so-called “clear evidence” test. Boone made clear that “clear evidence” was only a piece of the implied preemption puzzle:
The plaintiff in the present case asserts that a recent United States Supreme Court case explaining that particular standard, [Albrecht], stands for the broad proposition that impossibility preemption ‘‘only applies when a defendant can affirmatively show that it attempted to get the FDA to allow the safer alternative proposed by the plaintiff and the FDA affirmatively and officially rejected it.’’ (Footnote omitted.) We disagree. The clear evidence standard in [Levine] applies only when a defendant seeks to prove that compliance with a state law obligation remains impossible notwithstanding its ability to act unilaterally under federal law.
2020 WL 2121063, at *13 n.33 (emphasis original). The clear evidence test applies when drug manufacturers “could have satisfied their state law obligation to provide a label with an adequate warning by unilaterally making label amendments.” Id. (citing FDA CBE regulation). Because the plaintiff’s preempted theory was not something that could be addressed by a CBE label change, “Albrecht is inapposite.” Id.
The plaintiff’s last-ditch, state-of-the-art argument against preemption in Boone also failed. Whether or not it was “technologically feasible” to seek FDA approval of the second drug, doing so still required the FDA to act to grant approval. That pesky Mensing independence principle sank the plaintiff once again.
Although such practical considerations may sometimes limit the options available to a manufacturer; that fact is inapposite to the question of whether marketing [the second drug] would have required the FDA’s ‘‘special permission and assistance.” For similar reasons, we are also unpersuaded that the FDA’s subsequent approval of [the second drug] is dispositive. The possibility that the FDA would have looked favorably on an earlier application does nothing to alter the fact that, at the time of the decedent’s death, the defendants were prevented from unilaterally marketing [the second drug] under federal law.
Boone, 2020 WL 2121063, at *15 (quoting Mensing, other citations omitted). Boone agreed with earlier decisions (including Maurice) that had held similar claims preempted. Id. at *15 n.38 (reaching “same conclusion” as Ridings v. Maurice, 2019 WL 4888910, at *6 (W.D. Mo. Aug. 12, 2019), and Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 849081, at *13 (M.D. Ga. Jan. 2, 2018), and giving the “but see” to In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1395312, at *3 (E.D. La. April 13, 2017)). We agree that the Xarelto decision is wrongly decided.
Unless the plaintiff wants to appeal Boone to the United States Supreme Court – go ahead make our day, after Bartlett we can imagine what the Court would do with this theory – this is the end of the appellate line. Further, given the Connecticut Supreme Court’s reasoning in Boone, we’re cautiously optimistic that it will uphold the later Connecticut state decisions in Roberto and Adkins, which are wending their way through the appellate process. While the arguments aren’t all identical, at least two of those plaintiffs’ major contentions (generics are different and Albrecht) bit the dust in Boone.
Finally, we are gratified to see implied impossibility preemption applied to “you should have made a different/additional drug” claims. The same preemption rationale that Boone adopted should also be fatal to the claims we discussed here, that the drug that reduced AIDS from a death sentence to a treatable chronic condition was “defective” because the defendant didn’t make a “better” drug sooner. Any defect claim predicated on the possible FDA approval of a different drug necessarily depends on action by the FDA, and is thus preempted under the Mensing independence principle.