A mother in Mississippi has filed a lawsuit against GlaxoSmithKline, claiming her son was born with a cleft palate because of the drug Zofran.
Sep 25, 2015 /prREACH/ -- A new lawsuit has been filed in the United States District Court For the Southern District of Mississippi Western Division under case number 5:15-cv-00070-DCB-MTP against GlaxoSmithKline, the manufacturers of Zofran.
The complaint alleges that a child, born in January of 2015, suffers from a cleft palate because his mother took Zofran during her pregnancy. The complaint states, “Despite the fact that the FDA did not approve Zofran for treatment of ‘morning sickness’ (nausea and vomiting related) in pregnant women, Defendant GSK marketed Zofran “off label” as a safe and effective treatment for morning sickness.”
The mother has noted that her first child was born without birth defects and that she did not take Zofran during that pregnancy. She further stated that had she “known the truth about Zofran’s unreasonable risk harm, long concealed by GSK, she never would have taken Zofran, and her child would have never been injured as described herein.”
According to the Centers for Disease Control and Prevention, a cleft palate occurs when the roof of the mouth fails to join together completely leaving a gap. In some children, both the front and back of the palate are open, and in others only part of the palate is open. If the defect is not corrected, these children often have trouble feeding and speaking clearly, as well as general dentistry issues. The only way to repair the defect is surgically and the first of potentially many surgeries often happens within the first few months of the baby’s life.
Zofran was approved by the U.S. Food and Drug Administration. but not for the treatment of morning sickness. The drug was only approved to treat nausea and vomiting in patients who are being treated with chemotherapy and radiation, or for nausea after anesthesia. GSK nonetheless moved forward with marketing which lead the medical community and the public to believe that the drug was safe for use during pregnancy.
On March 9th, 1999, the FDA’s Division of Drug Marketing, Advertising, and Communications informed GSK that the FDA had become aware of the promotional materials for Zofran and had deemed that the materials violated the Federal Food and Drug and Cosmetic Act. In a letter to GSK, the FDA wrote that the material “promotes Zofran in a manner that is false or misleading because it lacks fair balance.” Several years later, the U.S. Department of Justice filed its own lawsuit against GSK regarding the “off-label” promotion of numerous drugs, including Zofran. In 2012, GSK agreed to a settlement prior to going to trial.
After its “off-label” promotion, the company allegedly began to receive reports from medical professionals who had prescribed their drug to pregnant patients. These reports detailed cases in which a pregnant mother was given Zofran and later her child was diagnosed with a birth defect. Named birth defects include atrial septal defect (ASD), ventricular septal defect (VSD), cleft lip, cleft palate, and kidney defects.