Families across the country, including many in Mississippi, are filing lawsuits against GlaxoSmithKline (GSK) for birth defects which they believe to have been caused by a drug manufactured by GSK. Several studies have now shown a link between use of Zofran early in a pregnancy and the occurrence of certain birth defects. For example, one study showed a link between Zofran use and the occurrence of fetal heart malformation, namely in the septum dividing the baby’s heart’s ventricles. Another study found a possible link between Zofran used to treat pregnancy-related nausea and the increased likelihood of craniofacial defects, including cleft lips, cleft palates, and malformed skulls. GSK denies that there are any links between the defects and Zofran use.
Zofran, also known by its generic name Ondansetron, was initially developed for use in treating nausea in cancer patients undergoing chemotherapy, and it was this purpose for which the FDA offered approval of the drug. When physicians saw how well the drug performed as a treatment for nausea, doctors began to prescribe it off-label to pregnant women who suffered from particularly severe nausea and morning sickness. “Off-label” indicates where a drug is prescribed for a use for which the FDA has not specifically approved it. While such prescriptions are not illegal, the companies manufacturing drugs which become popular for off-label uses are not legally permitted to promote the drugs for those off-label uses. The U.S. Department of Justice found cause to believe that GSK was promoting Zofran for use as an anti-nausea drug for pregnant women, and even that GSK was paying physicians to prescribe the drug to pregnant women, despite a growing number of claims that the drug was linked to birth defects. The Justice Department filed both civil and criminal claims against GSK based on these and other allegations, which GSK settled for $3 billion, all while denying that they had committed any wrongdoing.
Birth defects are tragic events in a young family’s life, and can lead to decades of struggles with health and enormous treatment and rehabilitation expenses. If you or someone you know gave birth to a child with birth defects after taking Zofran during early pregnancy, contact a skilled personal injury attorney to explore your legal options. Contact experienced Biloxi, Mississippi attorney Corban Gunn for a consultation on your possible birth defect lawsuit at 866-212-7533, or online.