A mother from Ohio is suing to hold GlaxoSmithKline accountable for her child’s birth defects, alleging they were caused by the company’s drug Zofran.

The mother says her son was born with a cleft lip and palate after she took Zofran during pregnancy as a treatment for morning sickness, the birth defects lawsuit says.

Since his birth in 2006, he has had to undergo eight surgeries to correct the condition, including an abbe flap surgery, bilateral alveolar bone graft, pharyngoplasty, tonsillectomy, and four separate lip and palate repairs.

The mother says in her Zofran birth defects lawsuit that he is expected to need more surgeries in the future. She also says his birth defects have made eating, sleeping and speaking difficult, and he has not been able to enjoy a normal life.

This Zofran Birth Defects Lawsuit is Case No. 5:15-CV-01411 in the U.S. District Court for the Northern District of Ohio.

Zofran and Birth Defects

Zofran, also known by its generic name ondansetron, is a drug made and sold by GlaxoSmithKline to treat certain types of severe nausea. The FDA has approved Zofran as a treatment for the nausea and vomiting associated with chemotherapy, radiation therapy, or surgery. It has not been FDA-approved to treat nausea associated with any other cause.

Yet Zofran has been increasingly prescribed to treat morning sickness, the nausea and vomiting associated with the early stages of pregnancy.

According to one research study published in the American Journal of Obstetrics and Gynecology in December 2014, prescriptions of ondansetron as a treatment for morning sickness increased from 50,000 in 2008 to 110,000 in 2013.

The study also notes that another drug, the combination of doxylamine and pyroxidine, has been approved specifically for treatment of morning sickness, and that given the existence of that alternative, there is no reason to expose women and children to the uncertain risks associated with ondansetron.

Prescribing a drug for a use other than that approved by the FDA is known as “off-label” use. It’s permissible for doctors to prescribe any medication for whatever use they deem suitable on a case-by-case basis. Pharmaceutical manufacturers, however, are legally barred from promoting a drug for any off-label use.

That sort of promotion is just what GSK has been accused of by plaintiffs in Zofran lawsuits as well as by the Justice Department.

In 2012, the DOJ announced a settlement that put to rest an enormous investigation of GSK’s marketing practices involving several drugs.

In part, the settlement addressed allegations that GSK had actively promoted Zofran for use as a treatment for morning sickness. The DOJ also accused GSK of paying kickbacks to physicians for prescribing Zofran and other drugs.

This settlement also resolved four federal whistleblower lawsuits over the same alleged off-label promotion. These claims were brought under the federal False Claims Act, which lets citizens sue on behalf of the United States in cases where the defendant has allegedly defrauded the U.S. government.

GSK’s total financial penalty in the settlement added up to $3 billion. Aside from guilty pleas related to drugs other than Zofran, the settlement did not include any determination of liability on GSK’s part.