Judge Refuses GlaxoSmithKline Motion for New Paxil Suicide Trial

Chicago, Illinois — A federal judge has entered judgment against GlaxoSmithKline (“GSK”) affirming the April 20, 2017 jury verdict in favor of Wendy Dolin who alleged her husband’s 2010 suicide was the result of side effects he suffered while taking generic Paxil (paroxetine).

Following the jury’s $3,000,000 verdict in Dolin’s favor (rendered after a lengthy five-week trial), GSK moved the court to set aside the jury’s verdict because, according to GSK, “a reasonable jury would not have a legally sufficient basis to find for [Wendy Dolin]” or, in the alternative, the verdict was against the clear weight of the evidence and was unfair to GSK.

Judge Hart: $3 Million Verdict Against GSK Stands

Judge William T. Hart rejected all of GSK’s arguments for a new Paxil suicide trial.

Specifically, Judge Hart found that:

  • There was sufficient evidence presented during trial for the jury to conclude Mr. Dolin’s physician was not aware of the suicide risk;
  • There was sufficient evidence for the jury to conclude the Paxil label did not adequately warn of a suicide risk;
  • GSK did not present clear evidence the FDA would not have allowed the company to add a suicide warning to the Paxil label;
  • Dolin’s ingestion of the generic form of Paxil does not mean GSK cannot be held liable;
  • The testimony of Plaintiff’s expert witnesses was reliable;
  • Dolin’s experts’ testimony, to the degree that testimony may have gone beyond the four corners of the expert reports, did not prejudice GSK;
  • There was sufficient evidence for the jury to conclude there is a causal link between Mr. Dolin’s ingestion of paroxetine, his side effects and consequent suicide;
  • The court’s rejection of some of GSK’s jury instructions was not error; and
  • The court’s exclusion of certain evidence was not prejudicial.

In his ruling, Judge Hart noted:

The testimony of all of the medical experts who testified reveals that it is recognized in the medical community that some patients treated with SSRIs may be more likely to attempt or commit suicide. An SSRI may activate patients with suicidal ideations or induce symptoms of emotional volatility leading them to attempt or commit suicide in order to escape intolerable feelings.” Order, p. 6.

“Mr. Dolin’s attending physician … testified that … the label did not warn that the drug could induce suicidal behavior in adults over 24, rather that it stated the risk of suicide did not extend beyond age 24 and that he relied on those representations” and “had the label warned of the risk of adult suicidal behavior in persons over the age of 24, he would not have prescribed the drug for Mr. Dolin …” Order, p. 10.

Judge Hart further stated “[n]otwithstanding a vigorous cross-examination relating to the medical community’s knowledge of adult suicide risks, the jury was entitled to accept [Mr. Dolin’s attending physician’s] testimony that he relied on the statement that the risk of adult suicide did not extend beyond the age of 24 …” Order, pp. 10-11.

“The jury heard evidence of an analysis of placebo-controlled Paxil data, conducted by GSK, showing depressed patients of all ages given Paxil, as opposed to placebo, were 6.7 times more likely to engage in suicidal behavior and that the results were statistically significant.” Order, p. 11.

“The jury was also shown an analysis done by the FDA which showed a statistically significant 2.76 times increased risk for Paxil as opposed to placebo, across all psychiatric conductions among patients over 24.” Order, p. 12.

“In addition … the jury saw analyses done on uncontrolled Paxil data in the 1980s (using GSK’s and FDA’s methodology at that time), which showed an 8.9-fold increase suicidality risk versus placebo.” Order, p. 12.

Judge Hart noted that, in GSK’s analysis of clinical trials prior to Paxil’s approval, GSK “misattributed” certain suicide attempts which effectively hid a suicide “odds ratio for Paxil compared to placebo of 7.8.” Order, pp. 12-13.

Judge Hart also observed that, although GSK’s statistics expert (Dr. Robert Gibbons) discounted all of these past studies, “[a] difficulty with [Dr. Gibbon’s] opinion is that data he rejected were used by GSK in submissions to the medical community and to the FDA.” Order, p. 14.

In sum, Judge Hart ruled that the “adequacy of warnings is a question of fact for the jury in prescription drug cases unless the warning is plain, clear and unambiguous and the issue of label adequacy can be resolved as a matter of law. [Legal citation omitted.] This is not such a case. The jury was entitled to decide [ ] whether or not the label warnings were adequate. There was sufficient evidence for the jury to conclude that the label was inadequate and misleading.” Order, p. 14.

There is … no basis to set aside a jury’s finding that Mr. Dolin’s death was caused by the ingestion of paroxetine.” Order, p. 17.

GSK Lost Preemption Battle Prior to Dolin Paxil Suicide Trial

In rejecting GSK’s brand immunity/federal preemption argument, Judge Hart pointed out that, “in this case, GSK’s history of misconduct with this drug by failing to warn and providing false information to consumers and the FDA are factors which militate against providing label immunity based solely on the fact that a generic product was substituted for the prescription of Paxil because Illinois law permitted a druggist to substitute a possible lower cost identical product.”

By | 2017-09-15T16:16:20+00:00 September 14th, 2017|Blog, Paxil News, Pharma News, Press Releases, Michael L. Baum, R. Brent Wisner|