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Infant's Death Prompts Zofran Birth Defect Lawsuit

Kentucky case is first Zofran birth defect lawsuit involving post-birth exposure to the drug.

Parents from Kentucky have filed a Zofran birth defect lawsuit against Zofran manufacturer GlaxoSmithKline, alleging their infant's exposure to the anti-nausea drug both in-utero and after birth caused fatal congenital heart defects and, eventually, death. The case names 5 additional defendants: the parent's pediatrician and medical practice are listed, as well as two generic medication manufacturers, and a publisher of drug pamphlets on Zofran. The case is unique in that it involves a both mother who took Zofran during preganancy, and an infant who was prescribed the drug. Details explain that the plaintiff was allegedly prescribed GSK's Zofran in order to treat her morning sickness. She began taking the drug, and therefore exposing her baby to the drug during the first trimester. The first trimester is also a time when a fetus' heart does much of its developing. She notes that she was given a pamphlet to read which discussed Zofran and its potential benefits and risks. The pamphlet, authored by First Databank, never mentioned any potential risk of birth defects. Zofran was approved by the U.S. Food and Drug Administration for individuals suffering from bouts of nausea and vomiting associated with chemotherapy, radiation, and anesthesia. The drug was never approved for or tested for safety on pregnant women. After the approval, however, plaintiffs allege that manufacturer GSK marketed the drug "off-label" to expectant mothers and Ob/Gyns across the nation. Before the couple's daughter was born, an ultrasound came back showing that the infant had developed severe caudal regression. This is when the lower portion of the spine develops abnormally. The infant was born on January 15th of 2014, and was quickly diagnosed with 3 congenital defects: renal agenesis, (born with just one kidney), ventricular septal defect, (a hole located between the heart's chambers), and truncus arteriosus, (the infant was born with a common artery that connected to both of the heart's chambers). At just 7 weeks old, the baby girl required open-heart surgery. Initially, she developed a buildup of fluid around her heart, however, post-surgery, she seemed to be "progressing well" according to claims. Just one month later while at home, the infant began to vomit bile. After multiple calls to the pediatrician when the vomiting occurred again, the mother brought her daughter in to be seen. She stated that her baby seemed pale and lethargic, but also that the pediatrician did not seem concerned, indicating that the mother was simply being "panicky." The pediatrician went on to prescribe the infant Zofran, in an effort to stop the vomiting. The mother indicates that at this point she expressed concerns, because she had been told that her daughter shouldn't take "certain kinds of medications." The pediatrician reassured her that it was fine for the infant to be given Zofran, and the mother administered a single dose that evening. The following morning, according to complaints, the mother says that her daughter became increasingly lethargic. She was unable to reach the pediatrician and received no return call, so she called the family's pediatric cardiologist who instructed her to take the infant to the ER. As the woman was buckling her baby into the carseat to drive to the ER, however, the infant "stopped breathing and died." A later autopsy showed that the baby had died from cardiopulmonary arrest due to her congenital heart defects and that the Zofran may have "contributed to her death." Originally posted by Monheit Law on DigitalJournal.com. Zofran Birth Defect Lawsuit - Ball & Bonholtzer Trial Attorney - Los Angeles    

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