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    Zofran Lawsuit Claims Boy Required Eight Surgeries Due To Drug

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    A young boy in Ohio suffers from a cleft lip and cleft palate, which his mother alleges were caused by her ingestion of Zofran during her pregnancy.

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    A mother in Ohio has filed the newest of the Zofran birth defects lawsuits. The complaint was filed in the United States District Court Northern District of Ohio Eastern Division under claim number 5:15-cv-01411.

    The child was born on April 12th, 2006. At the time of his delivery, he was diagnosed with a severe cleft lip and cleft palate. Since his birth, he has undergone a total of eight surgeries in attempts to correct his birth defects, including four lip/palate repairs, a tonsillectomy, a pharyngoloplasty, an abbe flap surgery, and a bilateral alveolar bone graft. Doctors estimate that he will require several more surgical procedures in the near future.

    His mother alleges that his cleft lip and cleft palate were a direct result of her ingestion of the drug Zofran during her first trimester. She notes that she gave birth to two older children, neither of which have a birth defect, and that she did not take Zofran during those two pregnancies. She claims that her child has suffered immensely due to his exposure to the drug and 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.”

    Zofran is an anti-nausea medication which was never approved by the U.S. Food and Drug Administration to treat morning sickness. It was approved by the FDA to treat patients experiencing nausea and vomiting while undergoing chemotherapy and radiation, or patients who are nauseous after anesthesia.

    GlaxoSmithKline, the company that manufactures Zofran, proceeded to market Zofran “off-label” to the medical community and the public as safe for expectant mothers and their unborn children. After beginning their marketing campaign in the 90’s, GSK allegedly received more than 200 reports of children who were born with birth defects after their mothers were prescribed the drug. However, these reports did not deter their promotions.

    Nearly 50 lawsuits have been filed in recent years against GSK, all alleging that birth defects such as atrial septal defect, ventricular septal defect, cleft lip, cleft palate, kidney defects, and clubfoot, were caused by the drug.

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