Paxil Verdict: Jury Awards $2.5M for Paxil-related
Injuries in First Paxil Birth Defect Trial
Court Transcripts | Media Coverage

A jury has rendered a favorable verdict for the family who sued GlaxoSmithKline, P.L.C. (GSK) in the first of a series of Paxil birth defect trials, alleging that for years GSK failed to warn consumers about Paxil’s potential risks of birth defects and hid those risks to boost profits.

The Paxil trial began on September 14, 2009 in Philadelphia’s Common Pleas Court. After almost a month of trial, on October 13, 2009, the jury found Glaxo failed to properly warn doctors and pregnant users of Paxil’s risk and concluded that GSK must pay $2.5M to the family of Lyam Kilker, whose mother took Paxil during her pregnancy with Lyam.

First Paxil Birth Defect Trial Underway in Philadelphia Against World’s Second Biggest Drug-maker, GlaxoSmithKline

The case, Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, is the first of three early trials that will set the stage for about 600 similar lawsuits accusing GSK of ignoring evidence that Paxil may have caused heart defects and other injuries suffered by infants born to women taking the antidepressant. Plaintiffs allege that GSK did not warn about the risks of Paxil until forced to add a warning label, when the FDA on December 8, 2005 sent out a “Dear Doctor letter” to physicians suggesting Paxil might contribute to heart defects in infants when taken in the first trimester of pregnancy. Lyam Kilker is one such child born with severe heart malformations that developed while his mother was taking Paxil.

Lyam Kilker and his mother, Michelle David, are represented by Houston, Texas attorneys Sean Patrick Tracey and Shawn P. Fox of Tracey Law Firm, Clayton A. Clark and Scott A. Love of Clark, Dean, Burnett, Adam D. Peavy of Bailey, Perrin, Bailey, and Philadelphia attorney, Jamie L. Sheller of Sheller, P.C.

Ms. David claims that taking Paxil during her pregnancy caused life threatening heart problems suffered by her now three year-old son. She said she would never have taken Paxil while pregnant if she knew that Paxil posed a risk of birth defects.

Lyam was born with two holes in his heart and underwent multiple open-heart surgeries within six months of his birth. He will eventually need another surgery.


In the Court of Common Pleas, First Judicial District of Pennsylvania, Civil Trial Division

LYAM KILKER, a Minor,  by MICHELLE M. DAVID, as Next Friend and Individually
VS.
SMITHKLINE BEECHAM CORPORATION d/b/a GLAXOSMITHKLINE


Plaintiff's Experts

  • David Healy, M.D. FRCPsych, Neuropyschopharmacologist, Professor of Psychiatry, Cardiff University, University Hospital Wales North Wales Department of Psychological Medicine
  • Suzanne Parisian, M.D., former FDA employee
  • Shira Kramer, Ph.D., Epidemiologist
  • Ra-id Abdulla, M.D., Pediatric Cardiologist, Professor of Pediatrics,
    Rush University, Chicago
  • Valerie Parisi, RN, Lifecare Planner

Defendant's Experts

  • Anthony Sciali, M.D., OB/GYN, Reproductive Toxicologist, George Washington University
  • Stephen Hobbiger, BSC, Vice President of Neuroscience, Global Clinical Safety & Pharmaco Vigilance
  • H. Scott Baldwin, M.D., Pediatric Cardiologist, Children's Hospital at Vanderbilt
  • Judith Jones, M.D., Ph.D., FDA expert, Clinical Pharmacologist, Pharmacoepidemiologist
  • Patrick Wier, Ph.D, GlaxoSmithKline Pharmaceuticals vice-president of nonclinical safety
    assessment worldwide
  • Gary Shaw, Ph.D., Epidemiologist

Court Transcripts

9/15/09 AM:  Opening Statements

Plaintiff's Evidence

Defendant's Evidence

10/08/09 AM:  Closing Arguments
10/08/09 PM:  Closing Arguments (continued); Jury's Instructions

10/13/09 AM:  The Verdict


Media Coverage