A mother has claimed that her son required a heart transplant because the drug Zofran caused a severe birth defect while he was still in the womb.
Dec 18, 2015 /prREACH/ -- A mother has filed a lawsuit on behalf of her young son against the drug manufacturer, GlaxoSmithKline. Her complaint, filed in the United States District Court Southern District of Illinois under case number 3:15-cv-00769, alleges that her child’s heart defect was caused by the drug Zofran.
The mother was prescribed the drug to treat her morning sickness during her first trimester. She gave birth to her son in 2012. Shortly after his birth, doctors diagnosed him with right hypoplastic heart syndrome. This condition is caused by malformations of the chambers, valves, and vessels in the right side of the heart. This leads to a lack of oxygen in the blood and many children are diagnosed after parents notice that their skin has a blueish tint to it.
His condition was so severe that he need to undergo a heart transplant. His mother has alleged that his quality of life has been diminished and that if she had known about the risks associated with the drug, she would never have taken it.
Zofran was approved by the U.S. Food and Drug Administration, but only for patients who are experiencing nausea and vomiting after chemotherapy, radiation, and anesthesia. The drug was never approved for use by expectant mothers.
Despite the lack of approval, GSK marketed the drug as a safe and effective treatment for morning sickness, a condition commonly experienced during pregnancy. Thousands of doctors prescribed the drug off-label to their patients.
The U.S. Department of Justice pursued a lawsuit against the company, alleging that they had unlawfully promoted several of their drugs off-label, including Zofran. While GSK never admitted to any wrongdoing, they did agree to a settlement in which they paid $3 billion in fines.
This complaint is just one of many, each one alleging that Zofran caused birth defects in an unborn child. Many parents also claim that GSK failed to actually determine if the drug was safe for the expectant mother and unborn child because they never conducted testing, pre-clinical trials, or clinical trials. Commonly noted birth defects include cleft lip, cleft palate, atrial septal defect, ventricular septal defect, respiratory distress syndrome, and kidney defects.
Parents are seeking compensation for medical expenses, pain and suffering, emotional distress, and punitive damages