Zofran®  (ondansetron and ondansetron hydrochloride) was approved by the FDA in 1991 to treat nausea associated with chemotherapy and surgery.  Since that time, Zofran® has been widely used “off label” to treat nausea that comes with pregnancy.  Zofran® has never been approved by the FDA to treat nausea associated with pregnancy and Zofran® has never been proven safe for unborn children.  To the contrary, there is substantial scientific evidence to suggest that Zofran® can cause heart defects, cleft lip and cleft palate, and other birth defects.


The off label use of Zofran® to treat nausea in pregnant women didn’t happen accidentally.  GlaxoSmithKline paid about $3 billion to settle criminal charges arising out of the off label marketing of Zofran and other illegal marketing activities.   Make your own conclusions about this company after reading this.  Glaxo’s Settlement With The Government.   The Department of Justice called it the “Largest Health Care Fraud Settlement In U.S. History.”     Glaxo To Plead Guilty And Pay $3 Billion.


The federal court system has centralized the Zofran® litigation in the United States District Court for the District Of Massachusetts.  As of May, 2016, that court presided over more than 200 individual Zofran lawsuits.

The number of Zofran lawsuits jumped to 238 by March 2016. Two months later, 259 actions had been brought under the MDL.

As of September 2018, 623 total actions had been filed and 459 actions were still pending. The discovery phase of the proceedings began in 2016. As of October 2018, GSK and plaintiffs were selecting 16 cases (eight each) for the first bellwether trials. Due to Covid-19, the first bellwether trial may be pushed into 2021, and GSK has offered no settlements in pending cases.


We currently represent about 30 families from across the country in Zofran® cases.  If you took Zofran® or its generic, ondansetron during the first trimester of your pregnancy and your child was born with a birth defect, take the first step to protect your child’s rights by calling us for a free consultation from an experienced lawyer.  Our toll free number is (877) 704-7674.  These are serious cases and they deserve individual attention.  Our clients owe us nothing for the investigation or prosecution of their case unless we obtain a recovery for them.

This web site is designed for general information only. The information presented at this site should not be construed to be formal legal advice nor the formation of a lawyer/client relationship. The choice of a lawyer is an important decision and should not be based solely upon advertisements. Past results afford no guarantee of future results. Every case is different and must be judged on its own merits.  Attorneys David Summers and Aaron Johnson are licensed in Missouri and Kansas; however our attorneys have handled cases nationwide, including mass tort claims that are filed in federal courts.*  Always consult your doctor before making any change in medication.

* In order to represent clients in states where the attorneys are not licensed, they must be granted admission pro hac vice or associate with local counsel.