One of the newest Zofran lawsuits has been filed in the United States District Court of the District of Massachusetts under case number 1:15-cv-13002-FDS.
In this case, the plaintiff, who is the mother of a young daughter, alleges that her child’s birth defect is secondary to the mother taking Zofran during her pregnancy to alleviate the morning sickness she was experiencing.
The child named in the lawsuit was born in 2008. At the time of her delivery she was immediately taken for additional diagnostic testing because the doctor was concerned about her color. Within hours, she was diagnosed with Transposition of the Greater Vessels (TGV) and pulmonary stenosis.
Transposition of the Greater Vessels is particularly dangerous because in this condition the blood goes to the lungs, receives oxygen, returns to the heart, and then goes back into the lungs. The circulating blood never reaches the rest of the body which means the body is deprived of oxygen. The child in this case had to undergo a life-saving procedure within the first 5 days of her life called an Arterial Switch. She has also had a balloon atrial septostomy in an attempt to correct her pulmonary stenosis, however, this procedure failed.
The complaint alleges that “Every day, the plaintiffs live in fear of what could happen to their daughter and the effect her condition has and will continue to have on her daily activities.”
Zofran’s FDA Approval
The mother was prescribed Zofran, an anti-emetic manufactured by GlaxoSmithKline, during her first trimester. Zofran was approved by the FDA for the treatment of nausea. However, the drug was only approved for patients that were being treated for post anesthesia nausea or nausea associated with chemotherapy and radiation. The drug was not approved by the FDA for pregnant women. The lawsuit alleges that “GSK knew that Zofran was unsafe for ingestion by expectant mothers.”
This new lawsuit is one of many, each alleging that Zofran caused an unborn child’s birth defects. The birth defects named in recent lawsuits include atrial septal defect, ventricular septal defect, cleft lip, cleft palate, and clubfoot.