Late last year we awarded our #10 spot on our Worst of 2020 post to In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2020 WL 7418006 (D.N.J. Dec. 18, 2020) (“VLI”). At that point the decision was brand new, and we promised a more in-depth analysis. Here it is.
VLI fits neatly into our ongoing critique of MDL practice, where all too often the law – particularly pertaining to preemption – is distorted to become a settlement tool. Since thorough briefing is another aspect of MDL practice (one with which we have no gripe), it’s hard to understand how VLI could possibly otherwise describe the then-11-year-old Wyeth v. Levine, 555 U.S. 555 (2009), decision as “the latest, single-most, on-point Supreme Court case for preemption of the FDCA in a pharmaceutical context.” 2020 WL 7418006, at *7. It’s not, by a long shot.
The Supreme Court has issued three newer prescription drug implied preemption decisions: Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019); Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013); and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and VLI cites none of them. These omissions are particularly troubling, as Albrecht in particular spent several pages revising the mess that was the Levine decision. See 139 S. Ct. at 1676-78 (beginning with “[w]e begin by describing” Levine). We can’t think of the last time we’ve seen the Supreme Court expend the kind of ink it did in Albrecht going through a prior precedent (Levine) almost line by line. Thus, contrary to VLI, Levine is certainly not the “latest,” nor after Albrecht is it particularly “on point.”
From this poor foundation flows an equally questionable preemption rationale. The claims at issue were “negligence per se, strict liability-defective design, breach of express warranty, fraud misstatement and negligent misstatement and state consumer-protection laws.” 2020 WL 7418006, at *7. VLI lets all of them skate by. VLI did so precisely by failing to apply more recent United States Supreme Court precedent.
To reach this result, VLI relies upon what it describes as “the traditional presumption against preemption of state law.” Id. at *9. That’s interesting, because this language quoted verbatim from a prior unpublished decision of the same court: Tigert v. Ranbaxy Pharmaceuticals, Inc., 2012 WL 6595806 (D.N.J. Dec. 18, 2012). We took a look at Tigert, as well, due to its common authorship. Sure enough, the presumption against preemption was all over Tigert – cited no fewer than six times. See 2012 WL 6595806, at *1 (“the presumption against preemption obtains in this case”); *3 (praising Desiano v. Warner Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2006), for “first f[inding] that the ‘presumption against preemption,’ . . . attached to the plaintiff’s claims because they fell within . . . ‘a sphere in which the presumption against preemption . . . stands at its strongest’”); *4 (criticizing Lofton v. McNiel [sic] Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012), for “[s]kirting the question of whether the presumption against preemption applied” and “overlook[ing] these critical differences when it failed to recognize the applicability of the presumption against preemption”); at *5 (the source of the “traditional presumption against preemption of state law” language quoted in VLI).
What has happened since Levine and Tigert?
The effective abolition of the presumption against preemption, that’s what.
First, in Mensing, an implied preemption case, four justices went on record in favor of abolishing the presumption against preemption altogether. See 564 U.S. at 621-23 (“courts should not strain to find ways to reconcile federal law with seemingly conflicting state law”).
Second, in Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016), the Court abolished the presumption against preemption in express preemption cases, holding that, when a statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.” See our post here.
Third, the Third Circuit in Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018), refused to follow P.R. v. Franklin unless the Court did so in a product liability preemption case. See our post here.
Fourth, in Albrecht, the Court did just that − its aforementioned multi-page restatement of Levine conspicuously omitted any reference to any “presumption” and instead retreated to the Court’s earlier language about merely an “assumption” that “historic police powers” should not be “superseded.” See our post here.
So the primary reason why we’re critical of VLI is that its failure to apply current United States Supreme Court preemption precedent resulted in a decision that was obsolete the day it was written.
But there’s more. VLI takes a “narrow” view of Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 2020 WL 7418006, at *9 (again quoting from the unpublished Tigert decision). Thus, it refused even to hold negligence per se claims preempted. Id. at *9-10. However, by its nature negligence per se takes “a legislative enactment or an administrative regulation which is adopted by the court as defining the standard of conduct of a reasonable man.” Ries v. National Railroad Passenger Corp., 960 F.2d 1156, 1158 (3d Cir. 1992) (quoting Restatement (Second) of Torts §288B(1) (1965)). In an FDCA-based negligence per se claim, it is thus hard to view the FDCA violation as anything other than the “critical element in [a plaintiff’s] case” so that the “duty” that negligence per se defines “exist[s] solely by virtue of the [MDA] . . . requirements.” Buckman, 531 U.S. at 353. Once again, the reason negligence per se survived in VLI is reliance on the obsolete presumption against preemption:
[T]he Supreme Court in Buckman “reached concerns of interference [with the FDA’s regime] only after first finding that . . . the traditional presumption against preemption of state law did not apply.” Thus, this Court ruled in Tigert that “the Supreme Court’s narrow ruling in Buckman is unstable ground on which to rest a finding of preemption.” . . . “Because of its important role in state regulation of matters of health and safety, common law liability cannot be easily displaced in our federal system.”
2020 WL 7418006, at *9 (citations omitted).
Thus VLI ruled, contrary to Third Circuit precedent, that Buckman does not preempt FDCA-based negligence per se. In one of Bexis’ Bone Screw cases, the Third Circuit held (pre-Buckman):
[Plaintiffs’] interpretation of per se liability would allow private plaintiffs to recover for violations of a federal statute that creates no private cause of action and, in fact, expressly...
