Arkansas Mother Moves Forward With Complaint Against GlaxoSmithKlineA mother from Arkansas has alleged that her son suffers from multiple birth defects because she took Zofran during her pregnancy. In the latest lawsuit against drug manufacturer GlaxoSmithKline (GSK), a mother is alleging that the drug Zofran caused her child’s cleft palate, clubfeet, and respiratory distress syndrome.
The Birth DefectsThe child in question was born in 2007. Since birth, he has been diagnosed with numerous congenital defects which have resulted in the need for two surgeries. His mother alleges that there is no known genetic cause for any of his conditions and that they were caused by Zofran. She took the drug, an anti-nausea medication, during her pregnancy to ease her morning sickness.
The plaintiff has also noted that she has two other children, both of whom were born without birth defects. During those pregnancies she did not take Zofran.
The Allegations Against GlaxoSmithKlineThis lawsuit is just one of many filed against GSK. In each case, parents allege that Zofran caused a birth defect in an unborn child. Birth defects include clubfoot, cleft lip, cleft palate, atrial septal defect (ASD), ventral septal defect (VSD), transposition of the greater vessels (TGV), and kidney defects.
Zofran: A HistoryZofran was first approved by the U.S. Food and Drug Administration in 1991. The approval indicated that the drug was to be administered to patients suffering from nausea and vomiting after being under anesthesia, or treated with chemotherapy and radiation. The FDA did not approve the drug as a treatment for morning sickness in expectant mothers.
Nonetheless, GSK began to market the drug “off-label” to pregnant women and their doctors as safe for both the mother and the unborn child. In the 2000’s, it became the most popular anti-nausea medication prescribed by OB/Gyns.
Since first beginning their marketing campaign, GSK has allegedly received more than 200 medical reports indicating that children being born to mothers who took the drug suffered from birth defects. The company came under fire when the U.S. Department of Justice filed a lawsuit which alleged that the “off-label” promotion of several of their drugs, including Zofran, was unlawful.