The California mother and father of a child born with birth defects have filed a Zofran birth defects lawsuit against the drug’s manufacturer, GlaxoSmithKline. The child was born in 2009 with bicuspid aortic stenosis, a condition that limits the hearts effectiveness in controlling blood flow and could be fatal in some cases.
The lawsuit alleges that the birth defect developed after the mother was given Zofran during her first trimester to treat morning sickness. However, the drug has only been approved to treat nausea in post-surgery and cancer patients. Several studies have found a potential link between using Zofran while pregnant and giving birth to a child with birth defects.
GlaxoSmithKline has previously been in legal trouble for illegally promoting its drug for unapproved uses. In 2012, the company paid $3 billion to resolve allegations brought forth by the U.S. Department of Justice that it promoted several drugs to doctors for unapproved uses, including Zofran.