Zoloft (ondansetron) is an anti-nausea drug made by GlaxoSmithKline. It was first approved by the FDA for use as a post-operative nausea treatment. It has also been approved for chemotherapy and radiation treatment patients with cancer. It was also used as an off-label prescription for the treatment of morning sickness in pregnant women. Off-label prescriptions are when a physician prescribes a pharmaceutical for a medical condition other than what the medication was approved for by the FDA. While this is completely permissible for doctors to do, pharmaceutical companies are expressly forbidden by law to engage in any sales and marketing activities aimed at inducing doctors to promote and prescribe pharmaceuticals for off-label uses.
GlaxoSmithKline settled one of the most significant corporate conduct lawsuits of all time in July 2012, when it agreed to plead guilty for three criminal indictments and pay criminal and civil fines, including allegations of off-label marketing and payment of kickbacks for Zofran. As part of the settlement agreement, GlaxoSmithKline agreed to pay a total of $3 billion in fines, $1 billion in criminal and an additional $2 billion to the federal government in civil fines.
Recent major birth defects lawsuits have used off-label prescription marketing of pharmaceuticals to pregnant women prior to significant clinical studies have been used to demonstrate failure to warn in a number of recent birth defects lawsuits in recent years.
Reports of children born with birth defects after the mother was prescribed Zofran during pregnancy appear to be much greater than in other pharmaceutical birth defects cases. This may be due to an increased awareness in parents of recent birth defects lawsuits allegedly caused by antidepressants, such as Celexa, Lexapro, Wellbutrin and Zoloft.