In one of the latest lawsuits to emerge against the Zofran manufacturer GlaxoSmithKline (GSK), two parents claim that the anti-nausea drug caused their child to develop a soft cleft palate. The Mississippi couple filed the lawsuit on July 17, 2015, alleging their son, referred to as C.P.T. in court documents, was immediately diagnosed with the birth defect as a direct and proximate result of prenatal exposure to Zofran.
A soft cleft palate, otherwise known as a submucous cleft palate, occurs when there is an opening in the roof of the mouth. This type of cleft palate is caused when facial features forming during prenatal development don’t close properly. According to the Mayo Clinic, infants with this condition may experience difficulty with eating, swallowing and chronic ear infections.
The mother, Plaintiff Patricia D. Turnage, was prescribed Zofran at the beginning of her first trimester of pregnancy to alleviate and prevent symptoms of morning sickness. Turnage claims there is no history of birth defects in the child’s family, and she was not made aware of the potentially dangerous effects of Zofran until April 2015, three months following C.P.T.’s birth. Had she or her medical providers known about the risks associated with the anti-nausea drug, C.P.T. may not have been born with a soft cleft palate.
Link between Zofran and Cleft Palate
Though there have been only a handful of cases alleging the same orofacial clefts as experienced by C.P.T., a study led by Harvard in 2012 evaluated the risk of select birth defects as a result of taking Zofran. Researchers found a 2.37 times greater risk for developing cleft palate after prenatal exposure to Zonfran’s active ingredient, ondansetron.
What’s more, according to the Turnage family claim, GSK conducted animal studies in the 1980s that showed evidence of toxicity and birth defects. These studies also showed that ondansetron could travel through the placental barrier of pregnant mammals, thus exposing the fetus to the drug during its developmental stages. Despite these findings, GSK did not share this information with pregnant women or their physicians, and the company still marketed Zofran as an “off-label” anti-nausea drug for morning sickness.
Contacting an Attorney about Zofran
Birth defects, such as a cleft palate, are often a heavy emotional and financial burden on you and your family. If you took Zofran during your first trimester of pregnancy and your child was born with a birth defect you may be eligible for compensation from the manufacturer. Contact an attorney today to find out if you may qualify for a Zofran lawsuit.
Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.