We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. When we say long-held, we mean it, because we had a few of the first cases where this theory was put
Delaware Court Grants Summary Judgment After Excluding Causation Expert Whose Opinion Was Not Stated In Terms of “Medical Probability.”
In today’s case, Chapman v. AstraZeneca, a Delaware state court granted summary judgment to the defendant pharmaceutical manufacturer after excluding the plaintiff’s causation expert under Delaware Rule of Evidence 702 because the expert’s opinion was not “stated in terms of medical probability.”
The plaintiff claimed that the defendant’s proton pump inhibitor, a class of…
Failure-to-Warn Claim Targeting Branded Drug Held Preempted: Litigation-Driven Expert Analysis Is Not “Newly Acquired Information” for Purposes of the “Changes Being Effected” Regulation
Under Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. § 314.70(c)(6)(iii)(A). Because the…
Exclusion of Expert Causation Evidence Sounds Familiar
After eschewing our blogging duties during a very long trial—followed by short deliberations and a verdict for the good guys—we are back at it. Normally, a significant criterion in how we select a case for a post is the length of the decision—the shorter, the better for our normally busy work lives. After trial, there…
Major Questions Remain in Wake of Trump Drug Pricing Executive Orders
This post is a little different. Several of my colleagues – Reed Smith attorneys Robert J. Hill, Joseph W. Metro, Kevin M. Madagan, Andrew Y. Lu, Sung W. Park, Janine R. Tougas – wrote a client alert on the four recent executive orders that concerned pharmaceutical pricing. We had…
The Demise of Drug Design Litigation: Death by Federal Preemption
That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase). Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts: Products Liability, has…
Fosamax in U.S. Supreme Court – Justice Alito Un-Recuses
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 …
Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More
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
Something Went Right In Brazil
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).…