History was made in Chicago yesterday when, in a landmark court case, a jury decided that GlaxoSmithKline (GSK) failed to warn Stewart Dolin (top) of the risk of suicidal ideation which came with their SSRI antidepressant Paroxetine, marketed as Paxil in the USA and Seroxat in the UK. The company, therefore, was found liable for Stewart’s suicide.
Stewart consulted his doctor, Dr Sachman, about some temporary work-based anxiety, and was prescribed a generic version of Paroxetine. After 6 days on the drug, Stewart walked from his Chicago office to a nearby railway station, where he stepped in front of a train.
The case was brought by Stewart’s widow Wendy (right) who filed her complaint 5 years ago, maintaining that her husband would still be alive if it weren’t for the Paroxetine prescription he began taking days before his death.
That evening, Mrs A and I had the privilege of sitting down to dinner with Wendy, along with four other courageous women who had lost loved ones to an SSRI-induced death, and who had also spoken at the conference earlier in the day..
As well as Wendy, Mathy Downing and Kim Witczak had travelled from other parts of the USA, while Stephanie McGill Lynch and Leonie Fennell flew from Ireland. It is significant that Kim (left) has been at Wendy’s side throughout the case, while Leonie and Stephanie travelled all the way from Ireland to Chicago to support Wendy during the first week of the month-long trial.
The conduct of GSK’s lawyers, both before and throughout the trial, smacked of desperation. Before the trial even began, the team from King & Spalding had tried various moves to delay the trial and frustrate Wendy’s team. They subpoena-ed records of calls and texts from her mobile phone as well as calls from her home phone and her late husband’s company phone. The lawyers also asked Wendy about her love life, and showed Stewart’s private medical notes to her children.
They then started on key witness Dr David Healy (left). First of all, they claimed at a pre-trial hearing that the world’s foremost psychopharmacologist was not a credible witness. They based this on a number of selective quotes from his website, which turned out to have taken from the comments submitted by readers. Then they referred to a “fitness to practice” referral instigated by an ex-colleague in North Wales. In fact, the General Medical Council (GMC) had studied the claim and decided that the “report was unfounded and that Dr Healy did not engage in any conduct putting his fitness to practice medicine into question.”
GSK’s opening argument maintained that “Paxil does not cause suicide”, but testimony heard during the first week of the case showed conclusively that, not only is that premise fallacious, but that, for many years before Stewart’s death, GSK were well aware that they were peddling a lie but kept the truth from the public.
Their back-up argument was that, even if Paxil did cause Stewart’s death, GSK were not responsible as Stewart had been prescribed a generic version of the drug. This argument was rejected as, by law, any generic brand must use exactly the same chemical compound and the same product information labelling as the original.
When David Healy presented his testimony, he was able to show how GSK had falsified clinical trial results, how they had covered up the suicides of those taking the drug, and how, by claiming that the drug did not cause suicide, they persuaded doctors to prescribe it.
For the next few weeks, witnesses appeared to testify for and against GSK, to let the court know either what they knew about Paxil, or what they knew about Stewart.
One of GSK’s final witnesses was Anthony Rothschild (right), a self-appointed unqualified expert in psychological autopsies, which involves collecting information from medical records and other relevant documentation, as well as interviews of relatives, friends and healthcare personnel, to decide upon the motivation for suicide. On this occasion, Dr Rothschild failed to interview Stewart’s doctor, or any member of his family. His verdict was that Stewart Dolin’s state of mind caused his death and that Paxil had nothing to do with it. Dr Rothschild further claimed that there is no relationship between SSRIs, akathisia, and suicide. He went on to state that, even if there was such a relationship, Stewart Dolin was not suffering from akathisia.
It was said that GSK paid Dr Rothschild $165000 (about £129000) for his testimony, a sum which would have been seen to have been wasted as soon as Dr Healy returned to the stand to rebut his claims.
After David’s rebuttal, a defeated Todd Davis (left) from King & Spalding asked the judge to strike David’s testimony. Judge Hart’s reply was: “The motion to strike is denied.”
After the closing arguments the jury withdrew, to return three days later with the verdict. GSK was ordered to pay $3 million (approx £2.35m) to Wendy, who said after the award was announced: “This for me has not just been about the money. This has always been about awareness to a health issue, and the public has to be aware of this. None of us here are anti-drug, that’s not the issue, but we are patient advocates and we hope that people will start asking better questions.”
Wendy was represented by law firm Baum Hedland, whose attorney, Brent Wisner (right), said: “We feel justice has been served, and are hopeful this verdict will result in a labelling 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.”
Co-attorney Michael Baum (left) added: “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.”
Since Stewart’s death, Wendy has devoted much of her life to raising awareness about akathisia, a state of restlessness or anxiety that sometimes occurs as a side effect of antidepressants, and which has been described as so horrible that death can be seen as a welcome alternative. She has started a non-profit organisation, MISSD, the Medication-Induced Suicide Prevention and Education Foundation in memory of Stewart Dolin.
“I think Stewart would be very proud of his family,” said Wendy, “and how we’ve all stood together and made a difference, that we didn’t allow this injustice.”
Yesterday’s verdict has vindicated not only Wendy, but Mathy, Kim, Stephanie, Leonie and a countless number of people across the world who know that their loved ones died, not because of any internal flaw or external pressure, but because they were driven to their death by a toxic drug that was more likely to harm them than help them.
Update: September 17 2017
Shortly after the verdict in April, King & Spalding, lawyers for GSK, announced that they would be appealing the jury’s decision. In their application for a re-trial, GSK continued to maintain that there is no causal link between their SSRI Paroxetine (Paxil/Seroxat/Aropax) and suicide. Instead, they appeared to blame just about everyone and everything apart from their drug for Stewart’s death.
- Stewart’s doctor, for not warning him of the suicide risk.
- The FDA, for not adding a suicide warning for adults to the label.
- Stewart, who must have had an underlying illness.
- The company who made the generic version of the drug prescribed to Stewart.
- Expert witnesses, whose evidence was unreliable.
- The judge, for not directing the jury properly.
- The jury, for delivering the wrong verdict.
Yesterday, author and activist Bob Fiddaman, who was present throughout the original trial, revealed that all the spurious reasons put forward by GSK as to why there should be a re-trial had been comprehensively rebuffed by the judge responsible for assessing the validity of the appeal.
In his statement, Judge William T. Hart gave reasons why he had turned down every one of GSK’s claims:
- On the Paxil label, GSK did not adequately warn of an increased risk of suicide for adults taking the drug; Stewart’s doctor was therefore not aware of the suicide risk.
- Likewise, GSK did not make the FDA aware of the risk of suicide for adults.
- The fact that Stewart took the generic form of Paxil does not mean that GSK cannot be held liable.
- Testimony by expert witnesses was reliable.
- There were no errors in instructions given to the jury.
But the most damning judgement was: “There is a causal link between Mr. Dolin’s ingestion of Paroxetine, his side effects, and consequent suicide.”
The last statement may well impact on any future judgements involving similar SSRIs made by Lundbeck, Lilly and Pfizer, amongst others.
Hopefully, GSK will now leave Wendy and her family alone.
Wendy Beats Goliath by Leonie Fennell
Wendy Dolin Takes on GlaxoSmithKline and Wins – For Now at Least by Jim Gottstein
Lawsuit over a Suicide Points to a Risk of Antidepressants by Roni Carin Rabin (NY Times)
Dolin vs GSK – the Verdict by Bob Fiddaman
Interview with Wendy Dolin by Bob Fiddaman
Update (September 2018)
On August 22nd 2018, the Seventh Circuit Court of Appeals overturned the verdict claiming, “GSK had presented sufficient evidence time and again through the proceedings – before, during and after trial – to demonstrate it had no control of the drug labeling at the center of the case.” Therefore, they said, the lawsuit should have been dismissed.
This latest judgement is not about the propensity of Paroxetine to induce suicide, which is not in doubt. Nor is it about the obfuscation and suppression of evidence by GSK, who were well aware that their product induced suicide. The judgement concerned merely who was responsible for the label that warned patients that the generic version of Paroxetine induced suicide.