This week, a Chicago federal court will empanel jurors to decide whether pharmaceutical maker GlaxoSmithKline should be made to pay the widow of a Chicago lawyer who committed suicide by jumping in front of a train after taking a generic version of Paxil, an antidepressant developed by GSK, because, the woman claims, the drug’s warning label, which was approved by federal regulators, did not contain enough information on suicide risk.
Jury selection was scheduled to begin March 14 in the trial pitting Wendy Dolin, wife of the deceased Stewart Dolin, against the United Kingdom-based GSK. The drugmaker’s U.S. operations are based in Philadelphia.
The trial, scheduled to potentially last as long as five weeks, is expected to be closely watched, testing the legal limits of liability that can be imposed on a name brand drugmaker for the alleged effects of a generic equivalent made by another company.
The case landed in the U.S. District Court for the Northern District of Illinois in Chicago in 2012, when Wendy Dolin introduced her complaint, alleging GSK should be held liable in the suicide death of her husband.
According to court documents, Stewart Dolin, an attorney and co-chair of the corporate and securities practice at Reed Smith LLP in Chicago, was prescribed paroxetine, a generic antidepressant equivalent to the name-brand Paxil drug, which had been developed by GSK.
Court documents said Dolin, after taking the drug one day in July 2010, took his own life by stepping in front of a CTA Blue Line train in The Loop. The court documents noted Dolin and his family were not facing financial pressure and his family life appeared normal or better.
GSK has said it is prepared to introduce evidence that Dolin was facing pressure at work, and was experiencing anxiety, as a result – feelings which led him to seek the help of a doctor, who prescribed the paroxetine as a treatment.
However, Dolin’s widow’s complaint alleges the warnings label on the drug, which lists certain dangerous sideffects, did not properly represent the adult suicide risk posed by the drug. The warning label on the generic paroxetine prescribed to Dolin, which had been manufactured by drugmaker Mylan, contained the same language as the label first developed and applied by GSK to Paxil.
Wendy Dolin’s lawsuit maintains the label misled Dolin’s doctor into prescribing the paroxetine, which he would not have done had the label contained complete information on the drug’s potential side-effects.
Dolin’s attorneys have maintained GSK was aware of the risks posed by the drug in elevating the risk of suicide in adults. The warning label, however, only noted an increased risk of suicidal thoughts and tendencies in Paxil and paroxetine users under the age of 24.
In court filings, GSK has noted those labels were reviewed and approved by the U.S. Food and Drug Administration. But further still, GSK maintained the FDA expressly refused a request by GSK to add language to the approved warning label, to include language expressly noting “there was a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine.”
According to GSK’s court filings, the FDA refused the request because the agency wished to keep language consistent on all similar antidepressants.
However, U.S. District Judge James Zagel refused on two separate occasions – once in February 2014 and again in February 2016 – to grant GSK’s request for summary judgment.
The judge, however, did dismiss Mylan from the action.
In 2014, Zagel indicated he could side with GSK on the question of product liability, saying it “hardly seems plausible” to require makers of a brand name drug to price their product sufficiently to account for potential judgments resulting from increased litigation risk as use of the generic version of the drug spreads after the pharmaceutical company’s patent protection expires.
But the judge said he believed Dolin should be allowed to pursue her claims of negligence in connection with the language on paroxetine’s warning label. Zagel said he believed, for the purposes of common law negligence, GSK “did indeed owe a duty of care” to the Dolins. The label developed by GSK for Paxil, the judge said, was the same as that affixed to the bottles containing the generic version, so “whether GSK is a ‘manufacturer’ in the context of this case and for purposes of the duty owed by manufacturers to design reasonably safe products is immaterial.”
GSK challenged these assertions in its 2015 motion for summary judgment, citing the apparent requirements of the FDA, which GSK said should trump Dolin’s claims under Illinois state law.
But Zagel brushed aside these assertions, as well, indicating in his February 2016 order that he did not believe GSK pressed hard enough to persuade the FDA to include the language pertaining to adult suicide risk. He pointed to language in the FDA’s response, in which, while apparently again refusing GSK’s request to boost the warning label, the regulators asked GSK to “please submit a formal meeting request” if GSK “would like to discuss this matter further.”
“GSK, however, never asked for a formal meeting, nor did it seek additional labeling regarding Paxil-specific data,” Zagel wrote. “Moreover, GSK never sent a separate supplement and declined the FDA’s invitation for a meeting to discuss the inclusion of … the adult warnings.”
The judge said he believed the question of “the adequacy of Paxil’s 2010 label” would be best decided by “expert testimony, and the underlying statistical evidence.”
“Reaching a decision before trial would be inappropriate,” Zagel wrote.
In a statement released March 13, GSK said it continued to disagree with the judge’s rulings on summary judgment.
The company has not publicly stated if it will appeal those rulings.
“Our focus is now on the trial and we feel confident going into opening statements after jury selection (Tuesday, March 14),” GSK’s legal team said in a prepared statement released by the company.
“We remain consistent in our stance that since GSK did not manufacture or market the generic paroxetine ingested by Mr. Dolin, it should not be held liable in this trial.”
GSK is represented in the action by attorneys with the firms of King & Spalding, of Atlanta, Ga.; Dentons US LLP, of Chicago; and Phillips Lytle LLP, of Buffalo, N.Y.
Dolin is represented by the Rapoport Law Offices, of Chicago, and the firm of Baum Hedlund Aristei & Goldman P.C., of Los Angeles.