Generic Paxil Suicide – Judge Rules Widow’s Case Can Move Forward against GSK — (Baum Hedlund)

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Stewart Dolin had the perfect life. He was married to his high school sweetheart for 36 years. He was the father of two grown children with whom he had a very close and meaningful relationship. He was a senior partner of a large international law firm, managing hundreds of corporate lawyers. He enjoyed his work and derived satisfaction from cultivating relationships with his clients, as well as helping them achieve the results they desired. He enjoyed travel, skiing, dining, joking around with his family and friends and an occasional cigar. He was 57 years old, and high on life.

In the summer of 2010, Stewart developed some anxiety regarding work. He was prescribed Paxil (paroxetine), a selective serotonin reuptake inhibitor (“SSRI”). Stewart’s prescription was filled with a generic version of Paxil, manufactured by Mylan. Within days, Stewart’s anxiety became worse. He felt restless, had trouble sleeping, even asked his wife to listen to a meditation tape with him (hardly typical behavior). He kept saying, “I still feel so anxious.”

On July 15, 2010, (six days after beginning the medication), following a regular lunch with a business associate, Stewart left his office and walked to a nearby train platform. A registered nurse who was also on the platform later reported seeing Stewart pacing back and forth and looking very agitated. As a train approached, Stewart took his own life. This happy, funny, loving, wealthy, dedicated husband and father who loved life left no note and no logical reason why he would suddenly want to end it all. Neither Paxil nor the generic version listed suicidal behavior as a potential side effect for men of Stewart’s age.

We did not know it then, but Stewart was suffering from akathisia.


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Generic Paxil Suicide – Judge Rules Widow’s Case Can Move Forward against GSK

Baum Hedlund

March 4, 2014,

Chicago, Illinois – – A federal judge in Chicago denied most of defendant GlaxoSmithKline’s (GSK) motion for summary judgment in a wrongful death lawsuit filed by the family of a prominent Chicago attorney who committed suicide six days after he started taking a generic version of GSK’s antidepressant drug, Paxil (paroxetine).

Plaintiff Wendy B. Dolin, wife of the deceased, Stewart Dolin, (57-year-old former partner at Reed Smith in Chicago), charges that GSK negligently failed to warn her and her husband of what it knew to be a significant risk of suicide associated with its drug.  The Paxil warning label, which by law must be copied by generic manufacturers, states that the risk of suicidality does not extend past the age of 24, even though GSK’s clinical trials show that taking Paxil increases the risk of suicidality by nearly 700%.  The ruling by Judge James B. Zagel of the Northern District of Illinois, Eastern Division, permits Ms. Dolin to proceed with her action against GSK for negligence, products liability, and fraud, even though GSK is not the manufacturer of the specific generic version of Paxil that led to Mr. Dolin’s death. The lawsuit was filed on July 9, 2012.

A motion to dismiss filed by the second defendant named in the suit, Mylan, Inc., the manufacturer of the generic drug that Mr. Dolin took, was granted by Judge Zagel, based upon federal pre-emption. Federal law prohibits generic drug makers from making unilateral changes to a drug’s warning label and places responsibility for the label’s content squarely on the drug’s creator, GSK. GSK and Mylan are both based in Pennsylvania. Ms. Dolin is a resident of Cook County, Ill.

Mr. Dolin was initially prescribed Paxil by his family doctor for work-related anxiety and depression. His prescription was ultimately filled with a generic version of the drug—a requirement under Illinois law that unless a prescription expressly states brand name only, pharmacists are required to use cheaper generics. Six days after starting generic Paxil, Mr. Dolin left his office, walked to a nearby Chicago Transit Authority Blue Line station in downtown Chicago, and leapt to his death in front of a northbound train. Autopsy results confirmed the presence of paroxetine in Mr. Dolin’s blood. In her lawsuit, the plaintiff contends that GSK was aware that paroxetine increased the risk of suicidal behavior by 6.7 times and that GSK has been aware of this risk for over 20 years. Plaintiff alleges that GSK negligently concealed this risk both in bringing the drug to market and in its labeling.

The judge rejected GSK’s argument that the defendant’s common law negligence claim was, in essence, a product liability claim and he supported plaintiff’s assertion that GSK was negligent in connection with paroxetine’s design and drug labeling. In his ruling, 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.” The fact that GSK did not make the generic drug that Mr. Dolin took, said Judge Zagel, “does not lessen the likelihood that GSK’s allegedly tortious conduct would lead to the Plaintiff’s injury.”

Later in his ruling, the judge restated this point, writing, “The negligence here is extrinsic to the Paxil manufacturing process and, if true, could proximately cause injury to consumers of all versions of paroxetine, including the generic version that Mr. Dolin ingested.” Several other arguments by GSK that on their face appeared to be little more than efforts to confuse the issue were also found by the judge to be without merit.

“This is a significant victory for consumers,” stated R. Brent Wisner, one of Ms. Dolin’s lawyers, who argued the motion before Judge Zagel last year. “Until this ruling, consumers in Illinois, who happen to have their prescription filled with a generic, fell into a doughnut hole of liability.  Generic manufacturers point the finger at the brand name manufacturer, arguing that generics have no control over the label.  And brand name manufacturers point the finger at the generics, claiming they are not liable because they didn’t make that particular pill. Judge Zagel’s opinion, which joins a handful of courts around the country, takes a broader view of the duty a brand name manufacturer owes to consumers.  This ruling appropriately addresses the fact that brand manufacturers still control the labeling, which generic manufacturers must copy, and if a drug label is false or misleading, the drug manufacturer has the ability and responsibility to make it 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.”

In the original complaint, the plaintiff charges GSK with negligently and fraudulently misrepresenting the safety and efficacy of paroxetine, negligently and fraudulently manipulating clinical trial data to obscure the suicidal behavior risk associated with paroxetine, and negligently and fraudulently touting the drug’s safety and efficacy through ghostwritten journal articles and through its sales force and routine visits to physician’s offices, including the prescribing physician in this case.

Ms. Dolin has started a unique non-profit organization called MISSD (The Medication-Induced Suicide Education Foundation in Memory of Stewart Dolin) dedicated to honoring the memory of Stewart and other victims of akathisia by raising awareness. Her work in this area has led to a groundswell of support and awareness of the risks associated with SSRIs.