Parents of a girl born with birth defects filed a lawsuit against GlaxoSmithKline (GSK) alleging her health issues were caused by her mother’s use of its drug Zofran.

Plaintiffs Karla E. and Edward E. allege that Karla was prescribed the anti-nausea medicine Zofran to treat her morning sickness in 2004. According to the Zofran lawsuit, Karla and her doctor were unaware that Zofran use during pregnancy could cause birth defects.

Doctors told Karla soon after delivery that her daughter’s heart had not formed correctly. Maia was born with pulmonary atresia with diplastic tricuspid valve. The family had no history of birth defects.

Karla’s daughter spent her first 10 days in intensive care. Multiple surgeries followed. And Maia required heart monitoring and is projected to have more surgeries as she gets older.

The lawsuit says her heart defect was caused by GSK’s negligence and failure to warn of the risks of pregnant women using Zofran.

Zofran is a go-to treatment for cancer patients suffering from nausea caused by chemotherapy or radiation. However, it became common for doctors to prescribe the drug to pregnant women suffering from morning sickness, even though the FDA did not approve the drug for such use.

Doctors are allowed to prescribe drugs for purposes not approved by the FDA. but drug companies may not market the medications for any use other than what the FDA allows. GSK allegedly promoted use of Zofran by pregnant mothers.

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.

If you took Zofran during pregnancy and your baby was born with birth defects you may have a legal claim. Experienced attorneys are available to provide you with a free case review to assist you in understanding your options.

The Zofran Birth Defects Lawsuit is Case No:. 5-15-cv-04455-NC in the U.S. District Court for the Northern District of California.