A drug created for cancer patients suffering from nausea, but prescribed frequently to pregnant women suffering from morning sickness, has become the target of a number of lawsuits nationwide. Ondansetron, known under the brand name Zofran, is manufactured by GlaxoSmithKline (GSK), and has been blamed by many families for the tragic birth defects suffered by their children after their mothers had used Zofran during pregnancy.
Zofran became a popular and successful treatment for the nausea that results from undergoing chemotherapy, and received approval from the Food and Drug Administration (FDA) for use among those patients. Due to its success, many doctors began to prescribe the drug to their patients who suffered from severe pregnancy-related nausea. This is what’s known as an “off-label” use of a drug, where a doctor prescribes a drug to treat a condition for which the drug did not receive FDA approval. This practice is not against the law for doctors, though it is against the law for drug companies to promote off-label prescriptions in any way. Unfortunately, a number of families began to report that their babies were born with serious birth defects after using Zofran during their first trimester, including defects in the formation of the cardiac septum separating the heart’s ventricles; cleft palates or lips; and malformed kidneys. In a peer-reviewed study whose results were published in the journal Reproductive Toxicology, scientists found that use of Zofran during pregnancy resulted in a statistically significant increase in chances that the baby would be born with a malformed heart.
Numerous lawsuits have been filed across the country, claiming that GSK was aware as early as 1992 that Zofran presented an “unreasonable risk of harm” to pregnant women taking the drug. Additionally, in 2012, the US Justice Department brought charges against the drug manufacturer, claiming that it promoted a number of drugs for off-label use, including Zofran, going so far as to bribe physicians to prescribe the drug for this off-label use. GSK settled those claims for $3 billion.
If you or someone you know in Kentucky has experienced the birth of a child with a tragic defect, and you believe that Zofran was to blame, explore your options to take legal action. Contact the experienced Lexington medical malpractice attorneys at Stephen M. O’Brien, PLLC, for a consultation on your claim, at 859-317-2056.