A wrongful death lawsuit has been filed by a woman who blames the anti-nausea drug Zofran for causing her twin children to develop severe birth defects.
One of the twins died from severe heart defects, as well as other organ defects. The surviving twin was also diagnosed with heart defects and may require future surgeries and medical treatment.
The lawsuit was filed on June 8 by Holly L. Estapa and Martin W. Hauger on behalf of their minor children, In Re: Zofran (Ondansetron) Products Liability Litigation, Case No. 1:16-cv-11061.
As of June 7, there were 265 Zofran lawsuits pending in a centralized federal litigation in Massachusetts. Other lawsuits have been filed in state and federal courts around the nation. Experts say these cases will likely be transferred to Boston.
In another lawsuit filed in Idaho, lawyers accused drug-makers of “using expectant mothers and their unborn children as human guinea pigs.”
GlaxoSmithKline (GSK) marketed Zofran toward pregnant women with morning sickness, even though it was never tested for safety during pregnancy and was only FDA-approved for chemotherapy patients. In recent years, several studies have found higher rates of birth defects in babies exposed to Zofran in the womb.
One study from Denmark involving 900,000 pregnancies found a doubled risk of heart defects and a 30% increased risk of birth defects overall. In another study published in 2012, Zofran was linked to a 2.4-fold increased risk of cleft palate.