Law360, New York (August 1, 2017, 10:12 PM EDT) — GlaxoSmithKline pressed an Illinois federal court Monday to undo a $3 million verdict in favor of the widow of a Reed Smith LLP lawyer who committed suicide after taking generic Paxil, saying the prescribing doctor’s knowledge of the risks relieved the drugmaker of responsibility.
Wendy Dolin sued GSK in 2012, two years after her husband Stewart stepped in front of a train in downtown Chicago. Stewart Dolin had struggled with anxiety and depression off and on, and began taking paroxetine just a few days before his death. A jury this spring awarded $2 million for wrongful death and $1 million for pain and suffering in the days before he took his life.
Glaxo’s new brief elaborates on earlier arguments it has made in favor of a new trial, after Wendy Dolin urged against the move in recent weeks. The drugmaker said that the trial testimony of Stewart Dolin’s prescribing doctor revealed that he believed paroxetine could increase Dolin’s suicidality. Via the learned-intermediary doctrine, Glaxo said, that would mean it had washed its hands of the matter.
“Plaintiff fails to identify a single Illinois decision holding that a manufacturer can be held liable for failure to warn” in a suit like this, the company said.
The trial testimony of prescribing doctor Martin Sachman “shows that he was aware of the very risk that mattered to him when deciding to prescribe paroxetine for Mr. Dolin.”
GSK included an excerpt of his questioning where he was asked, “When you reinitiated paroxetine for Mr. Dolin in 2010, you went over with him the fact that he needed to be on the [lookout] for the signs and symptoms of agitation, increased restlessness or insomnia, panic attacks, worsening depression, or suicidal thoughts or behavior after he started the medication?”
Sachman replied, “Right.”
The company pushed back against Wendy Dolin’s claim that the risk Sachman was saying he was aware of was the obvious depression-related suicide risk, not a medication-related risk; Dolin “selectively cites” Sachman’s testimony to reach that conclusion, the drugmaker said, and didn’t try to push back against Sachman’s agreement that he didn’t realize that a 2006 label that warned him properly about what happened to Dolin was later changed before Dolin’s death.
GSK also said its hands were tied because drug regulators would not allow the company to use the specific warning language that it wanted. The label for the drug changed more than once between 2006 and 2010 as the U.S. Food and Drug Administration examined it.
And the company also took issue with a myriad of jury instructions that it says didn’t fully separate out different elements necessary for liability.
According to Wendy Dolin, the doctor testified that when he decided to prescribe the drug he relied on the 2010 Paxil label, which didn’t warn that Paxil could lead to suicidality in adults over 24. The doctor also testified that if GSK had warned of that risk, he wouldn’t have prescribed paroxetine to Dolin in 2010, Wendy Dolin said.
But Dolin says GSK never proposed her desired warning: A short statement that taking Paxil is associated with suicidality in adults over 24. “Since GSK never attempted to insert that simple warning anywhere into the Paxil label, GSK cannot meet its burden of providing ‘clear evidence’ that the FDA would have rejected such a labeling change, especially when the only FDA expert to testify at trial rejected that notion,” Dolin said.
Dolin argued the company had failed to alert drug regulators that research showed increased suicide risk in adults. With a short exception, the potential for suicide in adults was left off, and doctors were left uninformed, the suit said.
The FDA also invited GSK to discuss the inclusion of language specific to adult suicidality in the label at a formal meeting in 2007, but the company didn’t take the agency up on its offer, Dolin said.
Representatives for the parties were not immediately available for comment Tuesday.
The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.
–Additional reporting by Emily Field. Editing by Brian Baresch.