The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed here and here addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to clarify the standard arising from Wyeth v. Levine, 555 US 555 (2009) that a labeling claim against a manufacturer is preempted for “impossibility” if there is “clear evidence” that the FDA would have rejected a manufacturer’s proposed label change. Albrecht explained that impossibility preemption requires the “manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.” But Albrecht left unclear what the “clear evidence” showing entails and left open several important questions about how it is to be applied.
Category: Failure to Warn
Third Circuit Clarifies Next Steps in Fosamax Decision
On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+ lawsuits pending regarding the medication Fosamax in Merck Sharpe & Dohme v. Albrecht. As previously discussed on this blog in May 2019, the United States Supreme Court held that the issue of federal preemption is one to be decided by the court and not a jury, while somewhat clarifying the “clear evidence” standard governing the analysis.
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Worth the Wait? Some Semi-Mature Thoughts on Albrecht
For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical products liability lawyers have had the opportunity to acquire some Zen and enlightenment about the Supreme Court’s highly anticipated preemption decision in Merck Sharp & Dohme, Inc. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019). An initial description of the decision is here.
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District of Delaware Grants Motions for Summary Judgment in Three Risperdal Gynecomastia Cases
In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused gynecomastia (breast tissue growth) in men, the United States District Court for the District of Delaware granted motions for summary judgment for defendant Janssen Pharmaceuticals, Inc. The three opinions clarify that Delaware law would not impose innovator liability on a branded drug manufacturer when the plaintiff had used only a generic drug, and addressed “but-for” warnings causation and proximate cause in prescription drug products liability cases. [Disclosure: Drinker Biddle & Reath. LLP attorneys were co-counsel of record in these cases for Janssen.]
Labeling Preemption Questions are for the Court, not the Jury, Holds U.S. Supreme Court in Fosamax Decision That Clarifies the “Clear Evidence” Standard
A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held today.
The Court also clarified the “clear evidence” standard governing an impossibility preemption defense to failure-to-warn claims.
The Presumption of Regularity in Prescription Drug Cases
In products liability cases involving prescription medicines, defendants sometimes rely on a preemption defense that FDA would not have approved – or in some cases, already rejected – the warnings that plaintiffs argue were required by state law. Where the evidence shows FDA considered and rejected plaintiffs’ proposed warnings, plaintiffs often argue that the Agency would have approved their proposed warnings were it not for some technical issue. For example, that FDA rejected the warning because the manufacturer asked to put it in the wrong section of the label or FDA would have approved it had the manufacturer asked rather than some third party in a Citizen’s Petition. In rejecting such arguments courts often point, explicitly or implicitly, to the presumption of regularity, which “presumes” government agencies have “properly discharged their official duties” unless “clear evidence” shows otherwise. See United States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926); see also Nat’l Archives & Recs Admin. v. Favish, 541 U.S. 157, 174 (2004) (requiring “meaningful evidentiary showing” to rebut presumption of regularity).
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