GlaxoSmithKline Must Face Paxil Birth Defect Lawsuits in Illinois State Court

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

Affirming a trial court ruling, an Illinois appeals court ruled that GlaxoSmithKline (GSK) will have to face a lawsuit in a Cook County, Illinois, court charging that its antidepressant drug Paxil causes birth defeats.

The First District Appellate Court denied an appeal by GSK, and upheld the ruling by Judge Larry G. Axelrood that the company’s “substantial-in-state contacts” gave state courts jurisdiction, including over complaints filed by out-of-state plaintiffs.

In this lawsuit, eight minor plaintiffs from six states, including Illinois, filed a products liability suit in the circuit court of Cook County against defendant GSK, a global pharmaceutical company based in the UK. The case is M.M., a Minor, by and Through Audrey Meyers, et. al. vs. Glaxosmithkline LLC (PDF), f/k/a Smithklinebeecham Corporation, d/b/a Smithklinebeecham; Wolters Kluwer Health, Inc.; Wolters Kluwer United States, Inc.; and Walgreens Company, 2016 IL App (1st) 151909, Case No. 1-15-1909, Fifth Division (August 26, 2016).

Catastrophic birth defects

The suit alleges that the minor plaintiffs suffered catastrophic birth defects as a result of their mothers’ ingestion of Paxil. Defendant GSK moved to dismiss the claims of the out-of-state plaintiffs, arguing that the court lacked both general and specific jurisdiction. However, the trial court found that Illinois had specific personal jurisdiction over defendant GSK based on:

  1. GSK’s substantial in-state contacts, namely its contracts with 17 Illinois physicians to run 18 to 21 clinical trials on Paxil in Illinois as part of a multi-center study and,
  2. The fact that plaintiffs’ claims arose from defendant GSK’s acts or omissions related to those trials.

The plaintiffs allege that there was a “significantly increased risk of congenital defects in babies whose mothers ingested” the drug. This  knowledge was “scientifically knowable through appropriate research and testing.” Plaintiffs allege that the FDA requires defendant GSK “to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and [Paxil].” Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession.

The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

Inadequately cautioned patients

Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession. The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

Meanwhile in the Philadelphia County Court of Common Pleas, Judge Arnold New denied GSK’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 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.

$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

Larry Bodine

Attorney Larry Bodine is Editor of Mass Tort Nexus, and the Editor of The National Trial Lawyers. He is the former Editor in Chief of Lawyers.com and the American Bar Association Journal. He is a cum laude graduate of both Seton Hall University Law School and Amherst College.

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