As of now more than 280 Zofran lawsuits are pending in the U.S. District Court; District of Massachusetts alleging Zofran medication during Pregnancy to treat morning sickness can lead to newborns having cleft palate, cardiac malformations and kidney malfunctions. The lawsuit claims that GlaxoSmithKline knew that its representations of the drug were false because its effects have never even been studied for morning sickness in expectant mothers or their developing babies.
Zofran was approved in 1991 by the U.S. Food and Drug Administration to treat nausea and vomiting in chemotherapy, radiation and surgery patients. The medication has never been approved for the treatment of morning sickness in pregnant women. The drug has been prescribed to pregnant women suffering from morning sickness by the physicians without FDA approval, which is considered as “off-label. As a result birth defect rates due to Zofran have been increased.
A recent Zofran lawsuit was filed on behalf of a mother from Utah who gave birth to a girl child suffered from hip birth defect. She claims that GlaxoSmithKline’s anti-nausea drug caused her child to develop bilateral hip dysplasia, is an abnormal formation of the hip socket can eventually cause crippling lameness and painful arthritis of the joints. This problem may affect one or both hip joints. According to the lawsuit the mother was prescribed Zofran, generic name ondansetron in her first trimester of pregnancy to treat morning sickness. The fetal development in the initial stage of pregnancy is very delicate. For years Ondansetron, the most widely used drug to treat the most common complication of pregnancy, was never approved in by FDA to use in pregnancy.
The lawsuit filed as a Short Form complaint on August 15, 2016, is registered as document 333 in the Zofran Multi-District Litigation. The lawsuit clearly outlines the devastating effects that Zofran allegedly have on pregnant women and their children. As per the court documents plaintiffs’ daughter referred as A.C.D. was born in 2011. In the year 2014, three years after her birth unwillingly she went through hip surgery to correct the abnormal formation of the hip socket. As per A.C.D. mother, before reaching three years of age A.C.D. failed to meet several developmental milestones as compare to the other children of her age and due to her congenital condition she was unhealthy to develop physically and mentally.
In 2012, the U.S. Justice Department announced that GlaxoSmithKline had crossed the line. It is illegal for physician to prescribe an off label medication for unapproved uses. Plaintiffs from all over the nation filling lawsuit against Zofran allege that GlaxoSmithKline’s failure to adequately warn about the potential Zofran side effects on unborn babies. Drug labels do not include warnings about the risk of Zofran birth defects, the manufacturers are responsible for ignoring, manufacturing, selling and marketing a drug without disclosing its risks.