Dolin v. GSK Paxil Trial Exhibits

Paxil Trial Exhibits

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

The trial of Dolin v. Smithkline Beecham Corp. (also known as GlaxoSmithKline or GSK) began in March of 2017 in Chicago, Illinois. Plaintiff Wendy Dolin filed the lawsuit against GSK in 2012 over the alleged paroxetine-induced wrongful death of her late husband, Stewart Dolin, who was a partner at the law firm Reed Smith.

Stewart Dolin began taking paroxetine in July of 2010. Paxil, the brand name version of generic paroxetine, was researched, developed, manufactured and marketed by GSK. Paxil and paroxetine are the same chemical compound and share the same product labeling. GSK created and was responsible for maintaining the accuracy of the Paxil label.

In the early afternoon on July 15, 2010, Stewart Dolin walked to a Chicago Transit Authority station shortly after a business lunch with a colleague. A woman at the station noticed that Mr. Dolin was pacing and appeared to be agitated as he looked in the direction of an approaching train that was not yet in sight. When the moving train appeared, the woman observed Mr. Dolin leap in front of the train, where he was struck. Ultimately, Mr. Dolin was pronounced dead from the injuries he suffered due to the collision and his contact with the electrified track after the collision.

Read court transcripts from the Dolin Paxil trial

Per the lawsuit allegations, GSK failed to adequately warn Mr. Dolin’s doctor about Paxil/paroxetine’s association with an increased risk of suicidal behavior in adults of all ages. The Court previously ruled that, although GSK did not manufacture the pills Mr. Dolin ingested, the company was responsible for the label and knew or should have known any failure to warn would result in harm to those taking generic versions of the drug.

Background Information

GSK’s knowledge of the association between Paxil and an increased risk of suicidal behavior in adults

Plaintiff’s Statement of Genuine Issues of Material Fact in Opposition to Defendant GSK’s Motion for Summary Judgment (Federal Preemption)

Robert Temple M.D. deposition (7-Dec-04)

Plaintiff Exhibits Shown During Closing Arguments

Should Have Happened

GSK Timeline Part 1

GSK Timeline Part 2

Stewart Dolin’s Deteriorating Condition while on Paroxetine

The following Dolin v. GSK Paxil trial exhibits have been admitted as evidence and are available to the public.

Documents labeled ‘PTX’ are Plaintiff exhibits, ‘DX’ are Defense exhibits and ‘JX’ are joint Plaintiff/Defense exhibits.

PTX 075: Integrated Summary of Safety (1989) – excerpt

PTX 129: Results for review about suicides in 1991 report by Davies (10-May-02)

PTX 034: Dunner Dunbar

PTX 100: Memo Brand re Metanalaysis Examining Suicidal Ideation (5-Jul-95)

PTX 017: Email from Burnham to Kumar regarding FDA request for the incidence of all deaths and suicides (18-Nov-99)

JX 4: 2006 GSK to healthcare professionals “Dear Doctor” letter re “Clinical Worsening and Suicide Risk”

PTX 012: Stone Jones excerpts

JX 1: 2010 Paxil label prescribing information with black box label showing no risk beyond age 24

Dolin exhibit 347

Plaintiff’s Exhibit 347: Each picture depicts a real person who committed suicide while taking Paxil in a GSK-clinical trial.  The red “Vs” mean their specific suicides were violent in nature.  There were multiple suicides using firearms, including a murder suicide by one patient.  There were also two deaths from people jumping in front of trains. 

When it comes to suicide attempts, GSK did not keep track of all the attempted suicides in their clinical trials because, according to their company witness, it would be too burdensome. 

PTX 003 – Martin Brecher M.D. deposition (3-Mar-03)

PTX 008: GSK Email to FDA from Arning re GSK Paroxetine Adult Suicidality Analysis MDD and non-MDD (5-Apr-06)

PTX 009: Apr 5 2006 GSK letter to FDA with briefing doc & proposed labeling

PTX 013: Paroxetine-Clinical Worsening And Suicide Risks In Adults revised by Dr. Kraus (10-Apr-06)

PTX 014: Teicher (1990)

PTX 016: GSK internal email dated 6252001_Redacted

PTX 026: SKB Memo from Brand to SK&F re Approved Clinicals – Papers for Field Consultant Use (25-Apr-95)

PTX 027: FDA email between Mosholder and Katz regarding Paxil and Pediatric Suicidality (3-Jun-03)

PTX 028: Paxil Summary Basis of Approval

PTX 030: Life Expectancy Charts (22-Sep-15)

PTX 048: 1992 Paxil Label

PTX 082: SKB letter from Donnelly to Leber (FDA) re paroxetine -Suicidal Ideation Behavior (10-May-91)

PTX 110: Email from Kohler to Kline (SKB) regarding FDA request for data on deaths (24-Jun-99)

PTX 114: Email Brand to Kumar re Incidence of death-suicide in Paroxetine (7-Dec-99)

PTX 115: SKB memo and record of FDA conversation with Seika re FDA request for deaths and suicides (8-Dec-99)

PTX 122: Results for review about suicide attempts in 1991 report by Davies (6-Feb-02)

PTX 124: Wheadon memo to reanalyze NDA data on Suicide Attempts with Paxil (10-Apr-02)

PTX 293: Paxil Label [PDR] (2002)

PTX 344: GSK Monthly Highlights for June 2007

DX 25: Letter from GSK dated December 16, 1999 General Correspondence: Response to FDA Request for Information

DX 101: Letter from GSK dated March 8, 2006 Re New Drug Application for Paxil

DX 123: Email dated May 2, 2007 from Renmeet Grewal at the FDA to Barbara Arning at GSK re Adult Suicidality Letter

DX 124: Email dated May 7, 2007 from Renmeet Grewal at the FDA to Barbara Arning at GSK re Paxil labeling

DX 127:  Email dated May 15, 2007 from Renmeet Grewal at the FDA to Barbara Arning at GSK re Paxil specific language labeling

DX 128: Email dated June 21, 2007 from Renmeet Grewal at the FDA about class labeling revisions for all drugs to treat major depressive disorder

DX 129: Email dated June 22, 2007 from Renmeet Grewal at the FDA re class labeling revisions

JX 2: 2008 Mylan Pharmaceuticals, Inc. paroxetine label prescribing information

JX 3: 2007 Paxil label prescribing information

JX5: Paxil Tablet and Oral Suspension Prescribing Information re Suicidality in Children and Adolescents

JX6: February 2005 Letter from GSK to Healthcare Professionals re Boxed Warning has been added to Paxil

JX7: May 2004 Letter from GSK to Healthcare Professionals re the FDA cautioning physicians to closely monitor people being treated with antidepressants

JX8: 2004 Paxil Tablet and Oral Suspension Description & Prescribing Information

JX13: Clinical Review: Relationship Between Antidepressant Drugs and Suicidality in Adults