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New York Times
(Reuters) – GlaxoSmithKline must pay $3 million to a woman who sued the drug company over the death of her husband, a lawyer who committed suicide after taking a generic version of the antidepressant Paxil, a U.S. jury said on Thursday.
The jury’s award followed a trial in federal court in Chicago in a lawsuit over the death of Stewart Dolin, a partner at Reed Smith LLP who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK’s Paxil.
The verdict by the nine-member jury in favor of Dolin’s wife, Wendy Dolin, was confirmed by GSK, which said in a statement it was disappointed and planned to appeal.
“GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable,” GSK said. “Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit.”
Brent Wisner, a lawyer for Wendy Dolin, said his client was “very pleased” with the verdict, adding that “justice has been served.”
Wendy Dolin filed the lawsuit in 2012 against London-based GSK and Mylan, which manufactured paroxetine hydrochloride, the generic version of Paxil her 57-year-old husband was taking before his suicide.
A federal judge dismissed Mylan from the lawsuit in 2014 but allowed Dolin to proceed against GSK because it controlled the drug’s design and label, which applied to both the brand-name and generic versions of the drug.
The label included a “black box” warning that paroxetine, like all SSRI-type antidepressants, can increase the risk of suicidal behavior by users under age 25.
At trial, Dolin’s lawyers had requested $39 million. They alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label.
In his opening statement on March 14, GSK attorney Andrew Bayman said the label was appropriate and its wording was mandated by the U.S. Food and Drug Administration.
The case is Dolin v. GlaxoSmithKline, U.S. District Court, Northern District of Illinois, No. 12-cv-6403.
(Reporting by Nate Raymond in Boston and Barbara Grzincic in Baltimore; Editing by Cynthia Osterman)
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$3M Jury Verdict Against GSK in Landmark Paxil Suicide Case — (Baum Hedlund Aristei Goldman)
April 20, 2017
Chicago, Illinois – A federal jury has sided with the widow of a deceased Chicago attorney in her generic Paxil suicide lawsuit against GlaxoSmithKline (GSK), ordering the pharmaceutical giant to pay $3 million.
The jury verdict resolves allegations in the trial of Dolin v. Smithkline Beecham Corp. (D/B/A GlaxoSmithKline-GSK) over the paroxetine-induced wrongful death of Wendy Dolin’s late husband, Stewart Dolin, who was a partner at the Chicago law firm Reed Smith when he took his own life in 2010.
“We are very pleased with the jury’s verdict and are grateful for their diligent service,” said Brent Wisner, co-lead trial counsel for Ms. Dolin in the Paxil suicide case. “We feel justice has been served, and are hopeful this verdict will result in a labeling change to warn that people of all ages are at risk. This should send a clear message to GSK and other drug manufacturers that hiding data and manipulating science will not be tolerated. Brand drug manufacturers have the ability and responsibility to make their drug labels accurate. If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand name or generic version of that drug, you have a duty to warn.”
On July 10, 2010, 57-year-old Stewart Dolin began taking the prescription antidepressant medication paroxetine. The brand name version of this medication is called Paxil, which was researched, developed, manufactured and marketed by GSK. Paroxetine and Paxil are the same chemical compound and both use the same product information labeling. GSK created and was responsible for maintaining the accuracy of the Paxil label.
In the early afternoon on July 15, 2010, Stewart Dolin died when he was struck by a CTA Blue-Line train in the subway station near Washington Street in Chicago. Just before this, a nurse at the subway station who did not know Mr. Dolin noticed him pacing back and forth while looking in the direction of an approaching train that was not yet in sight. When the moving train appeared, the nurse observed Mr. Dolin leap in front of the train, where he was struck. Mr. Dolin was pronounced dead from the injuries he suffered due to the collision and his contact with the electrified track after the collision.
The lawsuit alleged GSK failed to adequately warn Mr. Dolin’s doctor about Paxil/paroxetine’s association with an increased risk of suicidal behavior in adults of all ages. The Court previously ruled that, although GSK did not manufacture the pills Mr. Dolin ingested, the company was responsible for the label and knew or should have known any failure to warn would result in harm to those taking generic versions of the drug.
“Glaxo has known for two decades that Paxil can cause people of all ages to commit suicide.
The company not only hid the risk, but stuck its head in the sand and ignored countless suicides that occurred in its clinical trials,” said attorney Michael Baum, who also represented Ms. Dolin. He added that the drug’s Black Box warning – which states there is a suicide risk for children, adolescents and young adults, but the risk ends at age 24 – is “just wrong.”
During the five-week trial, GSK swore off its responsibility for ensuring the truthfulness of the label, arguing that, because the FDA never made GSK warn of a suicide risk, the company should be exonerated. According to Mr. Baum, this argument is “akin to a car speeding past a cop, the cop doesn’t stop the car, and the car crashes into another car and kills someone—the driver who killed someone cannot state it’s not his fault because the cop didn’t stop them.”
In the end, the jury disagreed with GSK’s arguments, finding that the drug maker cannot sluff off its responsibility for its labeling just because the FDA let the company get away with it.
Wendy Dolin was represented in her case by R. Brent Wisner and Michael Baum of Baum, Hedlund, Aristei & Goldman and David E. Rapoport and Matthew Sims of Rapoport Law Offices P.C.
For more information about the trial, visit Paxil Injuries or MISSD.co
Dolin v. GSK Trial Transcripts (Live link available at Baum Hedlund site)
Dolin v. GSK Trial Exhibits (Live link available at Baum Hedlund site)
To view complete case transcript click here
GlaxoSmithKline LLC v. James B. Zagel, No. 14-2051 (Chicago 7th Cir. 2014) — (United States Court of Appeals)
Decided June 4, 2014
Petition for writ of Mandamus
Defendent petitions for a writ of mandamus in this tort suit, which arises under the diversity jurisdiction. Petitioner developed paroxetine hydrochloride, an antidepressant which received the FDA’s approval and was marketed as Paxil. After patent protection ended, other manufacturers began to sell generic paroxetine hydrochloride. Stewart Dolin used one of these generic substitutes for Paxil, and later committed suicide, allegedly as a consequence of the drug. His estate asks for damages from petitioner, even though petitioner did not make the drug that Dolin took. (Mutual Pharmaceutical Co vs Bartlett 133S. Ct 2466 (2013) makes it difficult if not impossible to hold the generic manufacturer liable).
The district court denied petitioner’s motion for summary judgement, ruling that the inventor and initial marketer of a drug can be liable for harms caused by the sale of generic equivalents. The district judge then denied petitioner’s request to certify the decision for an interlocutory appeal under 28 U.S.C. 1292(b).
Petitioner asks us to issue a writ of mandamus to rectify a district court’s usurption, or grave misuse of power when an appeal when an appeal from final judgement would be an inadequate remedy. A district court does not abuse its power by taking one view, rather than another, of a debatable legal issue. The district court recognized that a majority of federal courts has ruled in favour of the pioneer manufacturer, but others have ruled just as the district court did. The Supreme Court has yet to resolve this conflict. While the issue escapes definitive resolution, taking one position rather than another cannot be a usurpation of power.
What is more, the question can be resolved on appeal from a final judgement, should the petitioner lose in the district court. Petitioner expresses concern that it will win on some other ground (perhaps a jury will decide that the drug’s warnings about suicide risk are adequate, that warning was unnecessary or that the drug did not cause Dolin’s death). The possibility that the “innovator liability” issue will not matter in the end would be a poor reason to engage in interlocutory review. Most cases potentially entail many subjects that turn out not to matter; the process of litigation winnows issues. That is a major benefit of the final-decision rule, not a reason to disregard it.
The petition for a writ of mandamus is denied.