Back in 2012, we published our “Distribute This!” post about In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012), lauding its ruling that, under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett,
You’ll find plenty of decisions from the amiodarone litigation discussed on the blog. Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing. But there are cases involving exposure to the branded product as well. And earlier this…
Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016). With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date. The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.
Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury. Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury). The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue. Id. at 699.
[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.
Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).
Many states have legislation on the books that insulates non- manufacturing intermediate sellers from strict liability. Here’s a bunch that we’re aware of. Ala. Code §§6-5-501, 6-5-521; Colo. Rev. Stat. §13-21-402(2); 18 Del. Code Ann. §7001; Ga. Code Ann. §51-1-11.1(b); Idaho Code §6-1407; Ill. Ann. Stat., Ch. 735 §5/2-621(a)-(c)(ignore the WL red unconstitutionality flag; the prior provision remains); Iowa Code §613.18; Kan. Stat. Ann. §60-3306; Ky. Rev. Stat. Ann. §411.340; La. Rev. Stat. Ann. §9:2800.52(5); Md. Code Ann. § 5-311; Minn. Stat. Ann. §544.41; Mo. Rev. Stat. §537.762; Miss. Code. Ann. § 11-1-63(h); Neb. Rev. Stat. §25-21, 181; N.C. Gen. Stat. §99B-2; N.D. Cent. Code §28-01.1-06.1; Ohio Rev. Code Ann. §2307.78; S.D. Comp. L. §20-9-9; Tenn. Code Ann. §29-28-106; Tex. Civ. Prac. & Rem. Code Ann. § 82.003; Wash. Rev. Code Ann. §7.72.040; Wis. Stat. Ann. §895.047(2). If we missed any, let us know and we’ll add them. Some of these are “innocent supplier” statutes, many with caveats about the manufacturer being subject to suit. Some are “sealed container” statutes. What they have in common is the imposition of limits on the liability of non-manufacturing distributors of products.
Have these statutes been applied to the distributors of prescription medical products? Yes, we’re happy to report, and that’s what this post is about.
Because it applied implied preemption, the decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) is powerful. We’ve previously mentioned how we think Mensing’s principles might be invoked in some claims against non-PMA medical devices, where express preemption is precluded by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).