With Zofran lawsuits being filed all around the country in both state and federal courts, another was added to the list of cases at the end of June. This new lawsuit, filed by the parents of a minor from Louisiana alleges that Zofran caused the child to be born with severe congenital heart defects. This lawsuit was brought by the parent and natural guardian of the boy, his mother.
What Happened In This Lawsuit?
Under case number 2:15-CV-02323, the boy is referred to as N.A. He was born in 2006 with an Atrial Septal Defect (ASD), a congenital heart defect. He was also diagnosed with partial anomalous pulmonary venous return. His mother was prescribed and ingested Zofran as a remedy for her morning sickness commencing in the first trimester. She took the drug continuously through her third trimester. The complaint outlined that N.A. has had two surgeries to repair his heart defects to date. Notable other facts included that there was no family history of birth defects and the family had two other births prior to N.A. that were completely healthy babies. The complaint makes the argument that had the parent known about the risks of in utero Zofran exposure, she would not have taken the drug and N.A. would never have had to suffer the defects.
What Does The Science Say About Zofran and ASD?
There have been several studies performed to date on the connection between Ondansetron (Zofran) and the relationship to birth defects. For a great summary of these studies, I encourage you to visit ZofranLegal.com. You will see a study of 900,000 births in Denmark, which was statistically significant in its conclusion that women who took Ondansetron during the first trimester had more than a doubling of the risk of giving birth to a child with a septal defect. Another study, referred to as the Danielsson study, confirmed this in concluding that mothers who took Zofran during pregnancy had a greater than two fold increased risk of delivering a child with a septal cardiac defect compared to mothers who did not take Zofran.
Notable Allegations In The Complaint
The pleadings outline and make some of the following allegations:
- Zofran was approved by the FDA for use in cancer patients who required chemo or radiotherapy
- the drug was marketed off-label as a safe and effective treatment for pregnancy related nausea
- Zofran became the number 1 most prescribed drug for morning sickness in the US in the 2000’s
- GSK knew that Zofran was unsafe for ingestion by expectant mothers and had received 200 reports of adverse events by 2000
- GSK settled a lawsuit with the US DOJ which contained allegations of off-label promotion of Zofran, among other drugs, and for giving kick-backs to doctors to prescribe the drugs
These allegations are very similar to some fifteen other lawsuits filed against GlaxoSmithKline in the Zofran litigation.
What To Do If You Took Zofran And Your Child Was Born With ASD?
There are a host of law firms out there at the moment that are accepting and filing Zofran lawsuits against GSK for allegedly causing child birth defects. Don’t delay in contacting an attorney. There are statute of limitations issues that may exist in your case. Speak with an experienced lawyer as soon as you can.