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Widow Blames Weak Warning Label on Generic Paxil for Husband’s Suicide


Justice has been served! $3 Million jury verdict against GSK in landmark generic Paxil suicide case

Stewart Dolin took six generic Paxil (paroxetine) tablets in the days before he took his own life in 2010. According to a lawsuit filed by his widow, the small number of prescription meds triggered Stewart’s suicide rather than treat his anxiety.

“If you ask anyone who knew him, he was laid back, high on life, so there was this unbelievable disconnect between how he lived his life: a beautiful man, a beautiful life. The tragedy and violence of his death … it was, it just didn’t make sense,” said Wendy Dolin of her late husband, during an interview with NBC News Chicago on May 28, 2014.

“I Googled ‘akathisia and Paxil’ and it was like, bone chilling … if this can happen to someone like Stewart, I don’t think anyone is immune,” Dolin said.

The lawsuit, now in federal court in Chicago, claims that the warning label on the bottle of generic Paxil that Stewart Dolin was taking did not include the risk of increased suicidality for adults over the age of 24. Furthermore, the lawsuit claims that GlaxoSmithKline (GSK), the manufacturer of Paxil, knew of the increased risk and suppressed this information from the public.

GSK Depositions Played at Dolin Paxil Suicide Trial

The trial of Dolin v. Smithkline Beecham Corp. (D/B/A GlaxoSmithKline-GSK) began on March 14, 2017 in Chicago, Illinois over the alleged paroxetine-induced wrongful death of Wendy Dolin’s late husband, Stewart Dolin. Mr. Dolin was a partner at the law firm Reed Smith.

On July 10, 2010, 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 GlaxoSmithKline (“GSK”). People use the term Paxil to refer to brand name Paxil and, sometimes, to generic paroxetine. Generic and name brand 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.

The following depositions have been taken from GSK executives relating to Paxil suicide cases. In the first video, former GSK CEO Jean-Pierre Garnier says in his testimony that GSK’s way of counting suicidal behavior events in GSK’s Paxil clinical trials was incorrect.

In the next deposition, GlaxoSmithKline biostatistician John Davies is questioned about GSK’s improperly counting suicidal behavior and its effect on calculating suicide risk rates during Paxil clinical trials.

Lastly, former GlaxoSmithKline executive Dr. Geoffrey Dunbar says in his testimony that he helped author the drafts of the Paxil suicide report that the U.S. Food and Drug Administration (FDA) asked for in 1991. The calculations in this report showed and suggested that instead of Paxil increasing the suicide risk by nearly 9 times, the drug decreased suicidal behavior. He admits in his deposition that his reports include improperly counted suicidal behavior events and that publications in which he participated writing had incorrectly conveyed Paxil reduced suicidal behavior.

Click the icon in the upper left corner for more deposition videos

The law prohibits generic drug manufacturers from changing drug labels produced by the brand name manufacturer. This puts consumers in a tough spot: if they claim to have suffered harm as a result of taking a generic drug, the warning they claim as being insufficient was not actually issued by the company that distributed the drug. This puts Wendy Dolin’s case in what her attorney, Brent Wisner calls the “donut hole of liability.”

Brent Wisner Paxil

R. Brent Wisner on NBC 5 News Chicago discussing a lawsuit claiming generic Paxil (paroxetine) tablets triggered Stewart Dolin’s suicide.

“That’s where you have the generic maker on one hand saying, ‘we don’t know about these risks. We can’t be held responsible for them … plus, we can’t change the label,'” says Wisner, an attorney at Baum Hedlund Aristei & Goldman. “The label as it existed was not sufficient. In fact, it says the risk of suicide does not extend beyond the age of 24. That’s in the Black Box, the first thing you read. And that is factually incorrect and misleading.”

Many cases against both a brand name drug manufacturer and a generic drug manufacturer are dismissed, according to NBC Chicago. But Wendy Dolin’s lawsuit could be a game-changer for prescription drug litigation. In February, her case against GSK was allowed to move forward. On February 28, 2014, Federal District Court Judge James B. Zagel rejected GSK’s efforts to dismiss the case. In his court order, Judge Zagel wrote: “it was entirely foreseeable that negligence on the part of GSK with respect to paroxetine’s design and warning label could result in injury to a consumer ingesting a subsequent generic version of the drug.”

At present, Wendy Dolin is narrowing her focus on raising awareness about akathisia, which is a side effect associated with selective serotonin reuptake inhibitors (SSRI) like Paxil. “I Googled ‘akathisia and Paxil’ and it was like, bone-chilling,” says Dolin. “What had not made any sense was like, ‘Oh my God. That’s what happened to Stewart.'”

Dolin says that if she and her husband had known about the warning signs and side effects, they could have taken action to stop the medicine. Her organization, MISSD, the Medicine-Induced Suicide Education Foundation in Memory of Stewart Dolin, is committed to sharing these side effects in order to educate the public about the dangers of SSRI’s. “If this can happen to someone like Stewart, I don’t think anyone is immune.”


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