In September of 2005 Faith Gibson of Canada gave birth to Meah, a beautiful baby girl. Meah was born with a hole in her heart, which required surgery and a seven-month hospital stay. Faith believed at the time that her daughter’s condition was just an unfortunate happenstance, but last year after reading an article about birth defects associated with the prescription antidepressant Paxil she started to speculate that the Paxil she took during her pregnancy could have been responsible for Meah’s terrible birth defect. In December of 2005, the same month Meah was born, the FDA issued a warning for an elevated risk of cardiovascular birth defects associated for the children of women taking Paxil during pregnancy. Faith is now launching a lawsuit against GlaxoSmithKline, the makers of Paxil, alleging that the company failed to provide adequate safety information regarding the risks of taking Paxil during pregnancy.
Gibson’s lawsuit alleges that GSK “knew or ought to have known . . . that there was a significant risk of serious adverse cardiovascular complication for newborns from pregnant mothers ingesting Paxil” and that the hole in Meah’s heart was caused or contributed to by the use of Paxil.
The 2005 FDA warning came in response to a major U.S. study that found the occurrence of major birth defects, particularly cardiovascular defects, associated with the children of mothers taking Paxil during their first trimester to be twice that of women not taking the drug. A later study out of Sweden reaffirmed these findings.
Gibson’s lawyer, David Rosenberg, said part of what the suit will clarify is what GSK knew about the dangers of the drug and when.
GlaxoSmithKline has not issued a public statement regarding the lawsuit.