GlaxoSmithKline is facing a new Zofran birth defects lawsuit, from a mother who alleges the anti nausea drug caused her son to be born with numerous complications.

The mother was prescribed Zofran early during her pregnancy, for the off label purpose of being an effective morning sickness medication.

Plaintiff Karla C. is suing GlaxoSmithKline, for allegedly causing her son to be born with Zofran-induced birth defects. Her minor son A.R., was born in 2015 with multiple congenital heart defects and needed medical assistance soon after his birth.

Upon his birth, the child had to have his appendix removed due to being born with a severe hernia. Among the cardiac conditions her son was born with, he suffered an atrial septal defect with right ventricular hypertension and aortic arch hypoplasia.

Since his birth, A.R. has had to undergo numerous surgeries and treatments for his condition.

The child will most likely need further medical treatment to address these issues.  Karla alleges his birth defects were due to Zofran side effects. According to Karla’s Zofran birth defects lawsuit, A.R. had no genetic disposition for any of these cardiac abnormalities and has a sibling born without such birth defects.

Karla points out in her lawsuit that A.R.’s sibling, who was not born with birth defects, was not exposed to Zofran, as she did not take it as a morning sickness medication during that pregnancy.

Overview of Zofran Birth Defects

Zofran (Ondansetron) is an anti nausea medication manufactured by GlaxoSmithKline. It was approved by the FDA to treat chemotherapy or radiation patients. This drug works by blocking the 5-HT3 serotonin receptors in the stomach and throat, which essentially blocks the signal for vomiting and nausea.

Since this drug works directly with the brain signals, it is considered highly effective for chemotherapy patients. However soon after its approval date, a number of physicians began marketing the drug as a morning sickness medication to pregnant mothers.

While it is not illegal for a doctor to prescribe a drug for off-label purposes, it is is illegal for a manufacturing company to advertise it for such. GlaxoSmithKline allegedly did just that, claiming Zofran was a safe and effective morning sickness medication.

GlaxoSmithKline allegedly made these statements knowing there was no preclinical testing for pregnant mothers using Zofran, which means it was not known what Zofran side effects could occur with this patient group.

Karla and numerous other parents who had used Zofran as a morning sickness medication are filing legal action against GlaxoSmithKline for the birth defects their children were born with.

Karla claims that she never would have taken the drug if she knew the risks of Zofran birth defects, and that her life is permanently altered because of the company’s deceptive marketing.

The Zofran Morning Sickness Medication Lawsuit is Case No. 1:16-cv-21747-MGC, in the U.S. District Court of Southern Florida.