A Zofran birth defects lawsuit alleges a mother’s use of the drug during pregnancy caused her son to be born with serious birth defects.

The lawsuit says GlaxoSmithKline, illegally marketed Zofran as a morning sickness treatment, a use for which it was not approved by the Food and Drug Administration.

The lawsuit was filed by Jody H. on  behalf of her son. Jody says she began taking Zofran early in her first trimester of pregnancy and continued using the drug through her pregnancy in 2007.

Her son was born with numerous congenital defects including a cleft palate, clubfeet, respiratory distress syndrome, and apnea. Since his birth the boy has undergone two surgeries.

The Zofran lawsuit also alleges that B.H. has no known genetic cause or family predisposition for his conditions. His mother reported that she had previous given birth two health children.

Jodi says that had she been aware of the risks of taking Zofran while pregnant she never would have used the medication to treat her nausea.

Zofran is a popular anti-nausea medication that entered the market in as a treatment for nausea for patients undergoing surgery or chemotherapy. The medication has not been FDA-approved to treat morning sickness in women who are pregnant.

It is illegal for pharmaceutical manufacturers to promote medications for non-FDA approved (off label) uses. However it is not illegal for doctors and other prescribing medical professionals to suggest or prescribe medications for off-label uses.

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.

Civil lawsuits have alleged that GlaxoSmithKline knew as early as 1992 that prenatal exposure to Zofran could cause severe birth defects. Claims against GSK generally include negligence, strict products liability, fraud, and failure to warn.

Awards and settlements from successful Zofran lawsuits help victims pay the past and future medical bills of the children affected by the medication. Successful plaintiffs can also receive compensation for the pain and suffering endured due to the side effects of the medication.

Lawsuits like these help hold pharmaceutical companies accountable for the actions and to their consumers.

This Zofran birth defects lawsuit Case No. 2:15-cv-04399-SM-DEK,  filed in the United States District Court in the Eastern District of Louisiana.