Paxil Judge Won't Lift Litigation Stay for GSK in Birth Defect Litigation

Tetralogy of fallot, which is a combination of several congenital heart defects.
Tetralogy of fallot is a combination of several congenital heart defects.

Philadelphia County Court of Common Pleas Judge Arnold New denied GlaxoSmithKline‘s motions on July 12 to lift a stay on litigation over birth defects allegedly caused by the antidepressant Paxil, according to Law360.

The court entered the stay on April 21 over the mass tort litigation until an appeal is decided in the initial case, Rader et al. v. SmithKlineBeecham Corp. et al.

Braden Rader was born with tetralogy of fallot, a combination of several congenital heart defects, allegedly caused by his mother’s use of Paxil during her 2003 pregnancy.

GSK argued unsuccessfully that the stay should be lifted because the other Paxil cases (see below) have dispositive issues that are unconnected to the Rader decision, according to Law360. It also argued that the stay does not advance a timely resolution of the litigation.

Case Status Court Term & No. Case Name
Active Case 0702-03220 In Re: Paxil Pregnancy Cases
Stayed By Order Of Court 1008-01144 Moore, Deceased Etal Vs Smithkline Beecham Corpor
Stayed By Order Of Court 1106-00402 Nieman Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1106-00489 Powell Etal Vs Smithkline Beecham Corporation Etal
Stayed By Order Of Court 1109-03678 Kenney Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03686 Staley Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03694 Cammarota Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03727 Guddeck Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03758 Cintao Etal Vs Smithkline Beecham Corporation

$3 billion in criminal fines over Paxil

In 2012 GSK pleaded guilty and agreed to to pay $3 billion in fines for introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement with the Department of Justice, GSK must pay

  • A total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.
  • The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
  • 2 billion to resolve its civil liabilities with the federal government under the False Claims Act. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.

For further reading, check out Top 5 Mass Tort Cases for Plaintiff Lawyers Right Now


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