An Illinois child was born with Hypoplastic Right Heart Syndrome After His Mother Took ZofranA mother has claimed that her son needed a heart transplant due to a defect caused by the drug Zofran.
By Laurence Banville
The Heart DefectThe mother, in this case, was prescribed Zofran during her first trimester to treat her morning sickness. Her pregnancy progressed normally and she gave birth to her child in 2012. Shortly after his birth, he was diagnosed with hypoplastic right heart syndrome.
Hypoplastic right heart syndrome is when the vessels, valves, and chambers of the right side of the heart are malformed. This results in decreased blood flow to the lungs. Many babies are diagnosed after the parents notice a bluish tint to the fingernails, lips, or other areas of the body due to the decreased amounts of oxygen in the blood.
This child’s defect was so severe that he had to undergo a heart transplant.
GlaxoSmithKline’s CampaignGSK first earned approval for Zofran from the U.S. Food and Drug Administration in the early 90’s. The approval covered the use of the drug as an antiemetic for patients experiencing nausea and vomiting after anesthesia, radiation, and chemotherapy. The FDA did not approve the drug for the treatment for morning sickness.
GSK decided to market the drug as an effective treatment for morning sickness, safe for both the mother and unborn child. This campaign was hugely successful, and soon, Zofran became one of the most popular drugs prescribed by OB/Gyns. Thousands of women around the country took Zofran.
The Ongoing LitigationOver the last two years, parents have filed lawsuits against GSK, each one alleging that Zofran caused a birth defect in an unborn child. Each complaint alleges that GSK failed to conduct proper testing, pre-clinical, and clinical trials to determine if the drug was actually safe for expectant mothers and their unborn children. In some cases, the parents allege that the company went so far as to provide incentives for doctors so that they would prescribe the drug to their patients.
Cardiac defects like right hypoplastic heart syndrome are not the only defects noted in the ongoing litigation. Other defects include cleft lip, cleft palate, respiratory distress syndrome, clubfoot, and kidney defects.
Parents are seeking compensatory damages such as medical expenses, as well as punitive damages.
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