Zofran (ondansetron) has been around since 1991 in one form or another. It was initially developed by GlaxoSmithKline (GSK) as an anti-nausea drug intended for patients undergoing chemotherapy, radiation, and surgery.
Because it worked well for these patients, some doctors prescribed Zofran® off-label for expectant mothers suffering from a serious form of morning sickness called hyperemesis gravidarum (HG). It probably came as a welcome relief. Women with HG experience nausea and vomiting so severe that they can not keep any food down, and it can sometimes last throughout the entire pregnancy. This can lead to malnutrition, dehydration, low birth weight for the baby, and a host of additional miseries.
Zofran®, however, was not intended or tested for off-label use for pregnant mothers. Unfortunately, some studies have linked Zofran® use during the first trimester of pregnancy with birth defects such as heart and kidney malformations. In 2012, documents in a court case between the U.S. Department of Justice and GSK alleged that GSK promoted the off-label use, and even gave doctors kickbacks to prescribe Zofran® for morning sickness.
Multidistrict litigation is ongoing. If you or someone you know took Zofran early in a pregnancy and subsequently gave birth to a child with a birth defect, please contact our office at 402 505-3555 as soon as possible. A statute of limitations may limit the amount of time you have to file the claim.