March 1, 2018 – Chicago, Illinois — The widow of a Chicago lawyer who took his own life while taking a generic version of Paxil (paroxetine), a GlaxoSmithKline (GSK) antidepressant, told a federal appeals court that a jury’s verdict holding GSK liable for her husband’s suicide should stand.
In the brief, filed on February 21, Wendy Dolin asserts that a $3 million jury verdict against GSK for her husband Stewart Dolin’s suicide was proper. Dolin, a 57-year-old attorney at the Chicago law firm of Reed Smith, was taking paroxetine when he took his own life.
“[GSK’s] appeal [of the jury’s verdict] is nothing more than a continued strategy by GSK to disavow its responsibility, enshrined in both Illinois and federal law, to do right by consumers and warn of serious risks associated with paroxetine.” — Excerpt from the Plaintiff’s Brief
The Brief’s Introduction states:
“For nearly thirty years, GlaxoSmithKline, LLC (“GSK”) has known the psychotropic drug paroxetine (Paxil) can increase the risk of suicidal behavior in adults. The drug primarily does this by causing a phenomenon called akathisia, a rare but dangerous reaction that causes extreme internal anguish and often outer signs of restlessness—it has been described in the medical literature as “a state worse than death[.]” People experiencing akathisia can be driven mad, causing them to commit suicide in violent and unexpected ways. The consequences of this side effect litter the case law: a catholic priest who killed himself; a man who “slashed his wrists with sheet metal, then drilled a chisel bit into his head[.]”; a man who killed his wife, daughter, and granddaughter before taking his own life; a 23-year-old college student who ingested cyanide; and, here, a successful attorney—debt-free and financially secure—with a strong 30-year marriage to his high school sweetheart, who impulsively left work, mid-day, and jumped in front of an L train.” The referenced cases are: Tucker v. SmithKline Beecham Corp., 701 F. Supp. 2d 1040, 1042 (S.D. Ind. 2010); Forst v. SmithKline Beecham Corp., 602 F. Supp. 2d 960, 963 (E.D. Wis. 2009); Estates of Tobin by Tobin v. Smithkline Beecham Pharm., 164 F. Supp. 2d, 1278, 1280 (D. Wyo. 2001) (this matter went to trial and the jury returned a verdict against GSK); Mason v. SmithKline Beecham Corp., 596 F.3d 387, 390 (7th Cir. 2010).
Stewart Dolin was debt-free, financially secure, and happily married to his high school sweetheart when he abruptly left work early in the afternoon of July 15, 2010, and jumped in front of an L train. His death sent shockwaves through the Chicago legal community and devastated his family and friends.
Two years after Stewart’s death, Wendy Dolin filed suit against GSK alleging GSK failed to warn consumers and the medical community about the increased risk of suicide among adults over the age of 24. The lawsuit also named generic manufacturer, Mylan.
In 2014, U.S. District Judge James Zagel, who oversaw the Dolin case before trial, dismissed Mylan from the lawsuit but held that GSK is responsible for labels that warn its customers about Paxil’s risks. GSK attempted to appeal the ruling to the 7th Circuit but Judge Zagel refused, allowing the case to proceed.
Generic Paxil Suicide Brand Name Drug Makers Are Responsible for Generic Drug Labels
During the trial, Dolin’s attorneys alleged that, despite GSK’s awareness of the suicide risk among adults of all ages, even before the drug was ever approved by the U.S. Food and Drug Administration (FDA). GSK never warned the medical community of the risk.
According to the Paxil suicide lawsuit, original data for paroxetine showed a nine-fold increased risk of suicidal behavior, but GSK incorrectly presented the data to the FDA and never issued a warning on the Paxil label. Internally, the drugmaker acknowledged the incorrect suicide data but continued to mislead the FDA, the medical community, and the public.
In 2003, the FDA learned that GSK was using the term “emotional lability” to code certain adverse events and almost all of these events related to suicidality. This prompted the FDA to investigate suicide for all selective serotonin reuptake inhibitors (SSRIs).
According to the lawsuit, “[w]hile GSK’s incomplete adult suicidality data was being reviewed by the FDA, GSK conducted its own analysis of the data and concluded that paroxetine was associated with a statistically-significant 6.7-fold increased risk of suicidal behavior in depressed adults of all ages.
After hearing arguments for five weeks, an Illinois jury agreed with Dolin that GSK was negligent for crafting and controlling the paroxetine label and that the paroxetine label proximately caused Mr. Dolin to be prescribed the paroxetine that led to his death.
GSK Brings Paxil Lawsuit Appeal Before Seventh Circuit
GSK has appealed the jury’s verdict to the U.S. Court of Appeals for the Seventh Circuit. GSK argued in its opening brief that federal and state courts have rejected the idea of “innovator liability,” which has become a favorite phrase of the pharmaceutical industry.
According to GSK, the district court held the company liable “for injuries allegedly resulting from Dolin’s ingestion of a drug manufactured and marketed by someone else[.]” Dolin’s attorneys, on the other hand, say GSK’s “innovator liability” claim erroneously attempts to reframe label liability into products liability.
According to the plaintiff’s brief:
“…that is like pushing someone in front of a bus and claiming it’s the bus manufacturer’s fault. While it is true this case involves the paroxetine compound, GSK’s liability turns on its negligence related to the creation and control of the paroxetine label, not the pills. The district court made this point abundantly clear.”
GSK also asserted in its brief that federal law preempts Dolin’s claims because the company attempted to add a suicide warning only to be rejected by the U.S. Food and Drug Administration (FDA). GSK told the appellate court that it added a suicidality warning to the paroxetine label and asked the FDA on four occasions if it could keep it, but the FDA ultimately rejected the warning.
The plaintiff’s brief disputes this claim:
“On the merits, GSK cannot prove the FDA would have rejected a warning because GSK never actually attempted to put proper warnings in the paroxetine label. GSK refers to the language it inserted in 2006, but as explained during the trial, those warnings were insufficient. And, without having attempted to insert the warnings required to satisfy Illinois law, GSK cannot then show that the FDA would have rejected those warnings. Moreover, even if the 2006 warnings were enough, that GSK specifically inserted adult suicide language into the label without objection from the FDA and then, in 2007, the FDA specifically invited GSK to discuss keeping that language in the label, undermines any suggestion that the FDA would have rejected a label change. On this record, GSK falls short of meeting the clear evidence standard.”
The case is Wendy B. Dolin v. GlaxoSmithKline LLC, case number 17-3030 in the Seventh Circuit Court of Appeals.