A Zofran user claims that the popular anti-nausea medication caused two of her children to be born with birth defects. The plaintiff, a Minnesota woman, filed a Zofran lawsuit against GlaxoSmithKline (GSK) for failing to warn against Zofran birth defects, including the heart defects her children allegedly developed as a direct result of Zofran use.

The plaintiff’s two children, both girls, were born with Zofran birth defects affecting their hearts. One daughter, born in 2004, was required to undergo heart surgery to repair the damage allegedly caused by the anti-nausea medication. The second child, born in 2006, was also born with a congenital heart defect and required 24/7 monitoring because she could not breathe properly and was connected to a monitoring system that let others know when her oxygen levels were low.

Both children allegedly experienced delays in their growth and development due to Zofran’s side effects.

Zofran Birth Defects

The popular anti-nausea medication has been used by many pregnant women to treat morning sickness. Despite the fact that the FDA has not approved the drug for use by pregnant women, GSK has been accused of marketing the drug for that population.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

While doctors are allowed to prescribe medications for off-label use, drug manufacturers are not allowed to market the drug for uses that the FDA has not approved. Zofran is only approved as a medication for severe cases of nausea, such as that experienced by patients undergoing chemotherapy, radiotherapy, and surgical anesthesia.

Zofran Lawsuit

The Zofran lawsuit alleges that GSK did not adequately study Zofran use in pregnant women. One animal study showed that Zofran could pass through the placental barrier, which is how the nausea medication would affect a fetus. Animal studies also showed that Zofran could cause premature births, fetal death, and incomplete bone growth.

These dangers were not included on the Zofran warning label, which gives no mention of Zofran birth defects such as congenital heart defects, cleft palate, cleft lip, kidney malfunctions, and others.

Zofran lawsuits may help parents receive compensation for the medical costs associated with raising a child with a Zofran birth defect, as well as the cost of education, compensation for pain and suffering, and loss of future earnings.