Newest Zofran Birth Defects Lawsuit Filed In Mississippi
A Mississippi mother has alleged that her child was born with a cleft palate because she took Zofran while pregnant.
GlaxoSmithKlinehas been named as the defendant in the lawsuit, which was filed on July 17th, 2015.
Zofran, an anti-emetic approved by the FDA for treating nausea in chemotherapy and radiation patients, as well as patients experiencing nausea after being under anesthesia, has also been marketed for some time “off-label” by GSK for the treatment of morning sickness.
In the newest lawsuit, filed in The United States District Court for the Southern District of Mississippi Northern Division under case number 5:15-cv-00070-DCB-MTP, the claim notes that for “GSK to market Zofran lawfully for the treatment of morning sickness in pregnant women, it must first adequately test the drug (including performing appropriate clinical studies) and formally submit to the FDA evidence demonstrating that the drug is safe and effective for treatment of morning sickness.”
GSK never undertook this project prior to marketing the drug to both the medical community and the public as a treatment for morning sickness. On March 9th, 1999, GSK received a letter from the FDA which indicated that the company needed to “immediately cease distribution of this and other similar promotional materials for Zofran that contain the same or similar claims without balancing the risk information.” Several years later, the Department of Justice filed its own lawsuit against GSK regarding their “off-label” promotion of Zofran as well as several other drugs. GSK agreed to a settlement in 2012 and paid three billion dollars in fines.
During this time, GSK allegedly began receiving reports of birth defects associated with the use of Zofran during pregnancy, over 200 cases. Reported birth defects include cleft palate, cleft lip, atrial septal defect (ASD), ventricular septal defect (VSD), and kidney malformations.
Zofran Allegedly Causes Cleft Palate In Infant
The Mississippi lawsuit alleges that an infant child was born with a cleft palate because his mother took Zofran during her pregnancy. The child was born in January of 2015 and was immediately diagnosed with a soft cleft palate. Due to this defect, he will have to undergo surgical procedures in attempts to correct the cleft palate and ongoing medical care.
His mother notes that she did not take Zofran during her previous pregnancy and that her first child was born without birth defects. She states in the complaint that had she “known of the increased risk of birth defects, her child would not have been born with congenital malformations.”