Ohio Child Suffers From Zofran Birth Defect His Mother ClaimsA young boy born in Ohio has undergone eight surgeries to correct a cleft lip and cleft palate which his mother alleges are due to the drug Zofran. GlaxoSmithKline has once again been named as the defendant in a lawsuit regarding their drug Zofran.
Ohio Zofran LawsuitThe lawsuit, which was filed in the United States District Court Northern District of Ohio Eastern Division under case number 5:15-cv-01411, is one of many that claim Zofran caused various birth defects. In this case, the complaint notes that the mother conceived her son in 2005. During her first trimester, she was prescribed Zofran to treat her morning sickness. On April 12th, 2006, her son was born and immediately diagnosed with a cleft lip and cleft palate.
Since his birth, the child has had to undergo eight surgeries, including four lip/palate repairs, a tonsillectomy, a pharyngoloplasty, an abbe flap surgery, and a bilateral alveolar bone graft. This amounts to almost one surgery for every year of his life. His doctors are projecting that his road to recovery will require more surgeries in the near future. The complaint states that “He has had difficulty eating, speaking, and sleeping throughout much of his young life. His birth defects have impaired his development and his enjoyment of a normal life at home and at school.”
The History of ZofranZofran is an anti-emetic drug used to treat nausea and vomiting. The drug did receive approval from the U.S. Food and Drug Administration, however only for treatment of chemotherapy, radiation, or anesthesia-related nausea and vomiting. The drug was not approved to treat morning sickness, and GSK did not perform any human studies to show that the drug was safe for expectant mothers and their unborn children.
Despite this, GSK decided to promote the use of Zofran to treat morning sickness “off-label”. In 1999, GSK received a letter from the FDA, stating that their “off-label” promotion failed to warn about potential side effects of taking the drug and did not comply with FDA standards.
GSK Settles in Lawsuit Filed By U.S. Justice DepartmentGSK ignored the FDA's warning and continued their marketing plan until the U.S. Department of Justice filed a lawsuit against them, claiming that their “off-label” promotions were unlawful. The lawsuit was settled in 2012, with GSK agreeing to pay fines of over three billion dollars.
In recent years, individual families have begun to file their own lawsuits against GSK, all alleging that the drug Zofran caused an unborn child’s birth defects. Defects noted include, transposition of the greater vessels, atrial septal defect, ventricular septal defect, cleft lip, cleft palate, kidney defects, and clubfoot.