An unexpected bit of good news as we go into November. Bexis will be presenting at the Reed Smith annual client CLE program on big-deal pending cases.  In preparation, he took a look at the SCOTUSBlog page for Merck Sharp & Dohme Corp. v. Albrecht, No 17-290 (that’s the Supreme Court name for In re Fosamax in the Third Circuit).  There’s a new entry from last Friday: “Justice Alito is no longer recused in this case.”  See also, from the Supreme Court’s official docket:

Oct 26 2018 Justice Alito is no longer recused in this case.

That’s good news for our side, because as we mentioned at the time certiorari was accepted:

We do note one unfortunate aspect of the order granting review: “Justice Alito took no part in the consideration or decision of this petition.” Since Justice Alito has historically supported preemption – he wrote the dissent in Wyeth v. Levine, 555 U.S. 555 (2009) – that means we’re short a vote.

Not any more. Our understanding, based on something we heard several years ago, is that Justice Alito at one time held stock in Merck. Evidently not any longer. While we’re not counting our chickens in Albrecht before they’ve hatched, we’re not playing a man short any longer, either. So we like our side’s chances in Albrecht even better now.

For more of our Albrecht/Fosamax coverage see here, here, here, and here.

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”).

Continue Reading Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment − a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016). Brazil is the second major branded (innovator) drug preemption win in an Invokana case in little over a month.

Yes, we brought you the first one, too, right here (discussing Fleming v. Janssen Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2016 WL 3180299 (W.D. Tenn. May 6, 2016)).

In Brazil the plaintiff brought the usual defect claims (manufacturing, design, warning) under Georgia law. The defendants moved to dismiss.

In the most significant part of the Brazil opinion, the defendants successfully asserted preemption. First and foremost, we direct our readers’ attention to the last holding in Brazil, because it has potentially the widest impact. The court held that, under the preemption rationale in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), no warning claims could be asserted against anybody other than the then-current holder of a drug’s New Drug Application (“NDA”). Why? Because nobody else had the ability to change that drug’s warnings.

Defendants argue that Plaintiff’s claims against Janssen Ortho, which are premised on a failure to warn, are preempted because Janssen Ortho is not the NDA applicant and thus cannot seek to change [the drug’s] label. [A different entity] holds the NDA for [the drug]. The Court agrees. When a company does not have the NDA, it has no more power to change the label of a drug than a generic manufacturer. A distributor, even of a brand name drug, has no power to change labeling. That power lies with the applicant who filed the [NDA]. Because Janssen Ortho could not independently do under federal law what state law requires of it,’ the state law claims brought against it are preempted.”

Brazil, 2016 WL 3180299, at *11 (citation and quotation marks omitted) (emphasis added).

Continue Reading Something Went Right In Brazil