A complex U.S. Supreme Court drug-labeling decision that was issued this week gave both sides partial victories and has touched off a furious last-minute dispute in a similar drug case involving the suicide of a Reed Smith partner that the justices are set to consider Thursday.
Supplemental briefs in Dolin v. GlaxoSmithKline were filed on Wednesday, with the drug company telling the court that part of the May 20 decision in Merck Sharp & Dohme Corp. v. Albrecht was “irrelevant.” The plaintiff’s lawyer countered with a brief asserting that GlaxoSmithKline was “mistaken” and that the Dolin case should be granted review or sent back to an appeals court for review in light of the justices’ Merck decision.
At its closed conference on Thursday, the high court is scheduled to consider whether to grant certiorari in the Dolin case, along with dozens of other pending petitions.
Lisa Blatt, partner at Williams & Connolly, filed the supplemental brief for GlaxoSmithKline, while Bijan Esfandiari of the Los Angeles plaintiffs firm Baum, Hedlund, Aristei & Goldman wrote the supplemental brief on behalf of Wendy Dolin, widow of former Reed Smith partner Stewart Dolin.
In 2017, a Chicago federal jury awarded $3 million to the widow after finding that GlaxoSmithKline was liable for the 2010 suicide of Stewart Dolin, who was taking a generic version of the pharmaceutical company’s antidepressant drug Paxil.
But in August 2018 the U.S. Court of Appeals for the Seventh Circuit overturned the damage award, ruling that the Dolin case should have been dismissed before trial because the drug company was prevented in 2007 by the U.S. Food and Drug Administration from adding suicide as a warning on the label for Paxil.
Because of the FDA’s refusal, the Seventh Circuit ruled that federal law preempted Dolin’s Illinois law claim that the company should have warned of the risk.
That finding, based on the Supreme Court’s 2009 decision in Wyeth v. Levine, parallels the issue in Monday’s Merck case.
In its Merck decision, the Supreme Court ruled that the question of FDA label disapproval should be decided by judges, not juries, and sent the case back to the Third Circuit, which Merck had asked for. Merck said in a statement it was “pleased with the Supreme Court’s decision to confirm Merck’s position that the question of preemption should be decided by a Judge, thereby reversing the decision of the Third Circuit.”
But the Merck decision also established a higher standard for determining whether there is “clear evidence” that the FDA would not have approved a labeling change. The new standard was viewed as beneficial for plaintiffs because it would make it more difficult for drug companies to prove that they were forced by the FDA not to change their drug labels.
David Frederick, partner at Kellogg, Hansen, Todd, Figel & Frederick, who represented the plaintiffs In the Merck case, said in a statement on Monday, “This opinion protects access to justice for injured patients … The opinion makes clear that preemption can be established only by a formal FDA action prohibiting the manufacturer from changing its warning label to add any adequate warning under state law.”
In the Dolin case, Blatt asserted that the Seventh Circuit’s ruling used “precisely the analysis” established by the Merck decision this week, and so the GlaxoSmithKline case does not need to be reviewed by the justices or remanded.
But Esfandiari, arguing for Dolin, said the GlaxoSmithKline brief was mistaken, and that in fact, “GSK has not met [the Merck case’s] demanding defense that it fully informed the FDA” about the suicide issue related to Paxil.