The plaintiff in the case, Faith Gibson, filed a lawsuit against GlaxoSmithKline, alleging she was not adequately informed of the risk of birth defects linked to Paxil. Gibson's daughter, Meah, was born in 2005 with a hole in her heart. As an infant, she required surgery and months in hospital.
According to The Vancouver Sun (09/06/11), shortly after Meah's birth, the US Food and Drug Administration (FDA) issued a warning about the risk of heart birth defects in infants exposed to Paxil prior to birth. Gibson's lawsuit alleges that GlaxoSmithKline knew or should have known about the risk of cardiovascular defects and failed to either warn patients about the problem or to issue a recall.
GlaxoSmithKline countered by requesting the medical records of Gibson and her daughter from two years before Gibson began taking Paxil up to the present. According to the company, they needed that information to respond to the lawsuit, which is in the class-action certification stage.
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"I never would have taken [Paxil] had I been told [about the risks]," Gibson said in an interview with The Vancouver Province (03/06/08). Although the hole in Meah's heart was fixed, Meah is still vulnerable to infections and has a permanent scar on her chest.
In 2010, GlaxoSmithKline reportedly settled 200 lawsuits alleging Paxil was linked to cardiovascular birth defects. The drugmaker was also ordered to pay $2.5 million to the family of Lyam Kilker after a lawsuit was filed by the family alleging Paxil was responsible for his birth defects.