Chicago Judge Denies GSK’s Arguments
In 2014, a federal judge in Chicago denied most of defendant GlaxoSmithKline’s (GSK) motion for summary judgment in Wendy Dolin’s wrongful death lawsuit. The judge rejected GSK’s argument that the defendant’s common law negligence claim was, in essence, a product liability claim, and he supported the 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.
Fighting for Greater Accountability in the Pharmaceutical Industry
After our $3 million victory in her suit against GSK, Ms. Dolin 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.
At Baum Hedlund, we have the longest track-record handling SSRI (selective serotonin reuptake inhibitors) antidepressant litigation in the country, having successfully handled thousands of individual antidepressant-related injury and death cases involving suicide, withdrawal syndrome, and birth defects, since 1990. Our firm has testified before the FDA on several occasions and met with several members of Congress about the adverse reactions and risks concerning SSRI antidepressants. Our work has been acknowledged as helping prompt the FDA to require black box suicidality warnings on all antidepressant labels, and we also uncovered the SSRI cardio-birth defect connection, as well as pharmaceutical industry manipulation of the scientific literature through ghostwriting.
In addition to antidepressant litigation, our firm litigates personal injury, wrongful death and product liability cases and has a long track-record of success, winning numerous multi-million dollar jury awards and over $4 billion for our clients. In short, we become known for improving public safety by holding wrongdoers accountable when they act carelessly, resulting in harm to others.
Contact Baum Hedlund at (855) 948-5098 or submit our online form. We serve clients throughout Los Angeles, California, and the United States.
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
- 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
Court Transcripts from the Dolin Paxil Trial
- Day 1 A: 3/14/17 – Judge addresses jury
- Day 1 B: 3/14/17 – Plaintiff opening statement by David Rapoport
- Day 1 C: 3/14/17 – Plaintiff opening statement by David Rapoport resumed, Defense opening statement by Andy Bayman
- Day 2 A: 3/15/17 – Defense opening statement by Andy Bayman resumed, audio/video tape deposition of Pierre Garnier, John Davies and Geoffrey Dunbar, Dr. David Healy direct by Brent Wisner
- Day 2 B: 3/15/17 – Dr. David Healy direct by Brent Wisner resumed
- Day 2 C: 3/15/17 – Dr. David Healy direct by Brent Wisner resumed
- Day 3 A: 3/16/17 – Dr. David Healy direct by Brent Wisner resumed
- Day 3 B: 3/16/17 – Dr. David Healy direct by Brent Wisner resumed
- Day 3 C: 3/16/17 – Dr. David Healy direct by Brent Wisner resumed
- Day 4 A: 3/20/17 – Dr. David Healy cross by Andy Bayman
- Day 4 B: 3/20/17 – Dr. David Healy cross by Andy Bayman
- Day 4 C: 3/20/17 – Dr. David Healy cross by Andy Bayman, redirect by Brent Wisner
- Day 5 A: 3/21/17 – Deposition read of Dr. Martin Brecher, Dr. David Ross direct by Brent Wisner
- Day 5 B: 3/21/17 – Dr. David Ross direct by Brent Wisner resumed
- Day 5 C: 3/21/17 – Dr. David Ross direct by Brent Wisner resumed
- Day 6 A: 3/22/17 – Dr. David Ross direct by Brent Wisner resumed
- Day 6 B: 3/22/17 – Dr. David Ross cross by Andy Bayman
- Day 6 C: 3/22/17 – Dr. David Ross cross by Andy Bayman resumed
- Day 7 A: 3/23/17 – Dr. David Ross cross by Andy Bayman resumed
- Day 7 B: 3/23/17 – Dr. David Ross cross by Andy Bayman resumed
- Day 7 C: 3/23/17 – Dr. David Ross cross by Andy Bayman resumed, Dr. David Ross redirect by Brent Wisner
- Day 8 A: 3/27/17 – Dr. David Ross redirect by Brent Wisner resumed, Dr. David Ross further recross by Andy Bayman, Dr. Martin Sachman direct by David Rapoport, Dr. Martin Sachman cross by Todd Davis
- Day 8 B & C: 3/27/17 – Dr. Martin Sachman cross by Todd Davis resumed, Dr. Martin Sachman redirect by David Rapoport, Dr. Martin Sachman recross by Todd Davis
- Day 9 A: 3/28/17 – Audiotaped deposition of Jeffery Pecoraro, video deposition of Terry Schwartz, video deposition of Sydney Reed
- Day 9 B: 3/28/17 – Video deposition of Sydney Reed resumed, video deposition of Dr. Seoka Sahlstrom
- Day 10 A: 3/29/17 – Video deposition of Sydney Reed resumed, Dr. Joseph Glenmullen direct by David Rapoport
- Day 10 B: 3/29/17 – Dr. Joseph Glenmullen direct by David Rapoport resumed
- Day 11 A: 3/30/17 – Dr. Joseph Glenmullen cross by Todd Davis
- Day 11 B: 3/30/17 – Dr. Joseph Glenmullen cross by Todd Davis resumed, Dr. Joseph Glenmullen redirect by David Rapoport
- Day 12 A: 4/3/17 – Michael LoVallo direct by David Rapoport, Michael LoVallo cross by Andy Bayman
- Day 12 B: 4/3/17 – Michael LoVallo cross by Andy Bayman resumed, Michael LoVallo redirect by David Rapoport, Michael LoVallo recross by Andy Bayman, Wendy Dolin direct by David Rapoport, Wendy Dolin cross by Ursula Henninger
- Day 13 A: 4/4/17 – Wendy Dolin cross by Ursula Henninger resumed, Wendy Dolin redirect by David Rapoport, Robert Gibbons direct by Todd Davis
- Day 13 B: 4/4/17 – Robert Gibbons direct by Todd Davis resumed
- Day 14 A: 4/5/17 – Robert Gibbons direct by Todd Davis resumed, Robert Gibbons cross by Brent Wisner
- Day 14 B: 4/5/17 – Robert Gibbons cross by Brent Wisner resumed, Robert Gibbons redirect by Todd Davis, Robert Gibbons recross by Brent Wisner, Videotaped deposition of John Iino
- Day 15 A: 4/6/17 – Videotaped deposition of John Iino resumed, videotaped deposition of David DeNinno, Dr. John Kraus direct by Andy Bayman
- Day 15 B: 4/6/17 – Dr. John Kraus direct by Andy Bayman resumed
- Day 16 A: 4/10/17 – Dr. John Kraus direct by Andy Bayman resumed
- Day 16 B: 4/10/17 – Dr. John Kraus direct by Andy Bayman resumed; Dr. John Kraus cross by Brent Wisner
- Day 17 A: 4/11/17 – Dr. John Kraus cross by Brent Wisner resumed; Dr. John Kraus redirect by Andy Bayman; Dr. John Kraus – recross by Brent Wisner; Dr. John Kraus – further redirect by Andy Bayman; Laura Krueger deposition read by Todd Davis; video deposition of Edward Walsh played
- Day 17 B: 4/11/17 – Dr. Anthony Rothschild direct by Andy Bayman
- Day 18 A: 4/12/17 – Dr. Anthony Rothschild direct by Andy Bayman resumed
- Day 19 A: 4/13/17 – Dr. Anthony Rothschild direct by Andy Bayman resumed, Dr. Anthony Rothschild cross by David Rapoport, Dr. Anthony Rothschild redirect by Andy Bayman
- Day 19 B: 4/13/17 – Dr. Anthony Rothschild redirect by Andy Bayman resumed, Dr. David Healy rebuttal direct by Brent Wisner, Dr. David Healy rebuttal cross by Todd Davis
- Day 20: 4/17/17 – Final opening statement by David Rapoport, Closing arguments by Andy Bayman and Ursula Henninger, Closing argument rebuttal by David Rapoport
- Day 21: 4/18/17 – Charge to the jury – jury instructions
- Day 23: 4-20-2017 – Jury Verdict Read
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