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.
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.
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).
Those familiar with his legend know that Hall of famer Casey Stengel managed the New York Yankees in their mid-century heyday and, for a short time at their inception, the New York Mets. But he also is remembered as one of baseball’s great characters.
One story about Stengel was told by the great broadcaster Curt Gowdy. He was having a beer with Stengel at a bar in Cleveland. Stengel received his beer and quickly downed it in one long gulp, leading Gowdy to ask why he drank it so fast. Stengel said he drank beer that way ever since “the accident.”
In a much-anticipated ruling on the appeal of a $3 million verdict against GlaxoSmithKline (GSK) in a wrongful death case involving the Paxil generic, paroxetine, the U.S. Court of Appeals for the Seventh Circuit reversed on Wednesday and held that the plaintiff’s claims were preempted under Wyeth v. Levine, 555 U.S. 555 (2009). Dolin v. GlaxoSmithKline LLC, No. 17-3030, slip op. at 25 (7th Cir. August 22, 2018). The appellate court’s decision was also notable in that the court ruled on the preemption issues without addressing whether Illinois law would permit a claim of “innovator liability” against brand manufacturer GSK when the plaintiff had only taken generic paroxetine manufactured by a different company. Id.