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Zofran Caused Child’s Cleft Palate and 4 Surgeries, Says Ohio Mother

GlaxoSmithKline (GSK), the makers of the popular anti-nausea medication, Zofran, continue to face a string of lawsuits after women who took the drug during pregnancy are having babies with birth defects. In one of the latest Zofran lawsuits, an Ohio mother claims that her child cleft palate was a direct resulting of her taking Zofran while pregnant.

According to court documents filed at the United States District Court for the Northern District of Ohio, Eastern Division, an Ohio mother gave birth to a baby boy who was born with a severe case of cleft palate. The plaintiff was prescribed Zofran in 2005, after battling with extreme nausea and vomiting. Zofran, however, is only approved for use by people undergoing chemotherapy, surgery, and other cancer treatments that can cause nausea and vomiting. The medication has never been approved for morning sickness use, yet its been prescribed to numerous women as off label-use.

Consequently, the plaintiffs claims that her baby’s cleft palate issues are a direct result of taking Zofran while pregnant. She was never warned of the adverse affects of the medication and was never told it had the potential to cause birth defects. Immediately after the baby was born in 2006, physicians diagnosed the cleft palate, as well as cleft lip after they noticed a split in the baby’s upper lip.

Per the plaintiff, who has two older children, there is no family of history of cleft lip or cleft palate. The two older children were born healthy, without birth defects. The plaintiff did not take Zofran during her two previous pregnancies.

Cleft Palate and Cleft Lip Operations and Treatment

It’s important to note that while cleft lip and cleft palate may seem mild when compared to other birth defects, such as life-threatening heart abnormalities, the baby boy has endured numerous invasive surgeries in an attempt to repair his upper lip and the roof of his mouth.

Even after many surgeries, however, the child will still have undergo more invasive surgical treatments that may last well into his teen years. In addition to the surgeries for cleft lip and cleft palate repair, the boy also underwent a tonsillectomy surgery, in order to improve his speech. When a child has a cleft palate, air can escape through his/her nose, resulting in Velopharyngeal insufficiency (VPI). Tonsillectomy helps to repair VPI, a condition that makes speech difficult.

The boy’s cleft palate and cleft lip surgeries currently include a pharyngoplasty, an Abbe flap surgery, and a bilateral alveolar bone graft. Additional surgeries to correct the boy’s ear draining were performed, and according to the plaintiff, her son has dealt with considerable pain.

Although the plaintiff is filing for damages against GSK,  the exact amount of compensation she is seeking has not been specified yet.

If You Took Zofran While Pregnant

Did your baby develop birth defects after you took Zofran during pregnancy? If so, you may be entitled to considerable compensation for pain, suffering, medical expenses, rehabilitation costs, and more. Keep in mind that you have the legal right to file a Zofran lawsuit against the responsible party. Right now, GSK is facing a number of lawsuits for failing to disclose the risks of birth defects associated with taking Zofran.


U.S. District Court for the Northern District of Ohio, Eastern Division, case number 5:15-cv-01411