About two weeks after a Chicago federal judge turned down its request for a new trial, pharmaceutical maker GlaxoSmithKline has formally appealed the judicial decisions the company has contended led to a jury improperly awarding $3 million to the widow of a Chicago lawyer who committed suicide by stepping in front of a train in Chicago’s Loop after taking a generic version of Paxil, an antidepressant developed by GSK.
On Sept. 26, GSK filed a notice of appeal in Chicago federal court, indicating it was asking the U.S. Seventh Circuit Court of Appeals to review several decisions from two federal judges on the way to a trial and verdict the company has contended, under federal law and legal precedent, should not have happened.
On Sept. 15, U.S. District Judge William Hart had refused GSK’s motion for a new trial, saying he continued to reject GSK’s contentions the drugmaker had been unfairly hampered in court from mounting its defense to the accusations leveled by plaintiff Wendy Dolin that the company should have disclosed more information on bottles of Paxil or its generic equivalents about the risk of suicide arising from taking the anti-depressant.
The case centers on the suicide of Stewart Dolin, a 57-year-old former attorney with the firm of Reed Smith LLP in Chicago, who took his own life by stepping in front of a Chicago Transit Authority train on a platform in the Loop in July 2010.
Dolin’s widow, Wendy, then filed suit against GSK, alleging the drug company was liable for her husband’s death, saying his mind was clouded by taking paroxetine, a generic equivalent of GSK’s Paxil. While paroxetine was manufactured by another company, Mylan, Dolin’s complaint asserted GSK, as the innovator of the drug, should be held liable for failing to warn doctors, including Stewart Dolin’s physician, of the suicide risk among adults taking Paxil and its generic equivalent.
The lawsuit has been closely watched by many, as it tested the legal limits of liability that can be imposed on the makers of a name brand drug for the alleged effects of a generic equivalent made by another company.
In this case, while the warning label only included language expressly noting “a statistically significant increase in the frequency of suicidal behavior in patients treated with paroxetine,” GSK contended that language was set by the federal Food and Drug Administration, and was left that way even after GSK attempted to persuade the regulatory agency to alter it to further address concerns over suicide risk.
GSK also argued, under legal precedent, it cannot be held liable for the decision of a patient who took a drug it did not make.
However, U.S. District Judge James Zagel refused on two separate occasions, in 2014 and again in 2016, to grant GSK’s requests for summary judgment on those grounds.
Concerning the assertions concerning FDA oversight, Zagel and Hart both noted they did not believe GSK had pressed the matter enough, never agreeing to “the FDA’s invitation for a meeting to discuss the inclusion of … adult warnings” concerning suicide risk.
In its appeal notice, GSK indicated it intended to appeal all of those decisions.
Further, the company indicated it was appealing Hart’s decision to refuse its request for a new trial or for a judgment to undo the verdict.
In those denied motions, GSK had asserted the judges’ decisions had tilted the courtroom in favor of Dolin, as the judges, they said, “did not allow for the fair presentation of evidence” and “gave Plaintiff free rein to violate basic rules of trial, while precluding GSK from responding and unreasonably restricting the presentation of its case.”
Specifically, GSK said Hart’s decisions during the trial prevented it from presenting evidence and expert witnesses to combat the plaintiffs’ claims that paroxetine use was marked by a tendency toward violent suicides, or to pursue a line of defense asserting pressures at work had contributed to Stewart Dolin’s suicide.
Judge Hart rejected those assertions on Sept. 15, saying he did not believe the jury would have reached a different conclusion even if GSK had been allowed to present more evidence and testimony – particularly so regarding suicide rates and Dolin’s potential work stressors.
He again rejected GSK’s contentions in another order issued Sept. 26, prompting GSK’s formal appeal.
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.