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Paxil Lawsuit Alleges GSK Claims On Birth Defects Were Fraudulent

August 14, 2008

http://www.wvrecord.com/news/214204-parkersburg-family-files-paxil-lawsuit 

Parkersburg family files Paxil lawsuit

8/14/2008 10:45 AM
By Audrey Holsclaw -Kanawha Bureau

PARKERSBURG — A Wood County family has filed a federal lawsuit against GlaxoSmithKline over its drug Paxil after their son was born with birth defects.

Gerald and Paula McGee of Parkersburg filed the lawsuit in U.S. District Court on Aug. 11.

During the pregnancy, Paula McGee found herself depressed. Her physician prescribed Paxil, a GlaxoSmithKline drug and member of selective serotonin reuptake inhibitors (SSRIs) class of drugs.

When their son Cameron was born, he suffered from developmental delays, patent foramen ovale, right ventricular hypertrophy and heart murmurs, court paper say.

The McGees say Paula’s ingestion of Paxil during her pregnancy is responsible for Cameron’s conditions.

In the lawsuit, the McGees claim GlaxoSmithKline knew Paxil was associated with significant increased birth defects in babies whose mothers took it during pregnancy. The studies on animals also showed that Paxil increased serotonin, causing profound effects on the prenatal cardiac development, the lawsuit claims.

The lawsuit says GlaxoSmithKline went so far as to suggest that Paxil was safer than other SSRIs such as Prozac and Zoloft.

Filed by Teresa Toriseva of the Wheeling firm of Wexler Toriseva Wallace, the suit argues that this safety claim was untrue.

In 2005, Paxil’s label was revised to include a warning stating, “A recent retrospective epidemiological study of 3,581 pregnant women exposed to Paxil or other antidepressants during the 1st trimester suggested an increased risk of overall major congenital malformations and cardiovascular malformations … compared to other antidepressants.” Paxil has been shown to breach the placenta, which would have obvious and important implications for a developing fetus. 

The McGees allege that GlaxoSmithKline’s design, research, testing, advertising, promotion, and manufacturing of Paxil makes it strictly liable in tort for the bodily injuries and damages. Because of Paxil’s unsafe side effects related to pregnancy, they believe GlaxoSmithKline was negligent by not informing consumers and breached its warranty.

The suit states GlaxoSmithKline is responsible for the family’s suffering and Cameron’s birth defects as Paxil’s risks exceeded its benefits. The McGees are seeking a trial by jury to award “all damages allowable by law … to adequately compensate the Plaintiffs and punish the Defendant.”

The McGees are seeking damages for permanent bodily injuries, past and future medical bills, tremendous pain, suffering, loss of enjoyment of life, mental anguish, annoyance, inconvenience, pre- and post-judgment interest and litigation costs.

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