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Glaxo Faces More Paxil Birth Defect Lawsuits

Dec 11, 2009 | Parker Waichman LLP

GlaxoSmithKline has been hit with three more Paxil birth defect lawsuits, this time in Texas.

Paxil is one of a class of drugs known as selective serotonin reuptake inhibitors (SSRI). On two occasions in 2005, the Food & Drug Administration (FDA) requested that the labeling of Paxil be changed to include warnings on three studies that found an increase risk of birth defects. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). That same year, the FDA also classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

As we reported previously, Glaxo lost the first Paxil birth defect lawsuit to go to trial in October.  A Philadelphia, PA jury ordered the drug maker to pay $2.5 million to the family of a 3-year-old boy, who was born with heart defects. The jury found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating the child’s mother about Paxil's birth defect risk. It also concluded the antidepressant was a “factual cause” of the child’s heart defects.

While the  plaintiffs in the Pennsylvania Paxil lawsuit  were not awarded punitive damages because the jury did not find Glaxo’s handling of the drug to be “outrageous," the jury award was more than double the $1.2 million they had originally sought.

The Texas Paxil lawsuits were filed just this week on behalf of three women who allege that Paxil (paroxetine) caused cardiac birth defects in their children, said the SouthEast Texas Record.

The lawsuits allege that the women gave birth to babies—between April 2002 and July 2005—born with multiple injuries. "The injuries suffered were direct results of the plaintiffs' ingestion of Paxil during their pregnancies in manners and dosages recommended and prescribed by their doctors," said the suit, quoted the SouthEast Texas Record.

The Paxil lawsuits, which were filed in Galveston County 405th District Court, seek compensatory damages for pain and suffering, mental and emotional anguish, and losses of society and consortium.

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