The mother of a 15-year-old born with numerous congenital defects, including heart defects, filed a Zofran lawsuit against pharmaceutical giant GlaxoSmithKline (GSK), alleging that its anti-nausea drug caused her child’s medical issues.

Tomisha L. of Boston began taking Zofran, prescribed by her doctor, early in her first trimester of pregnancy to alleviate the symptoms of morning sickness. When her child was born in 2000, it was discovered that the baby suffered from a host of issues including an atrial septal defect, right ventricular hypertension and aortic arch hypoplasia. There were subsequent diagnoses of facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia and webbed toes.

During the first five years of her life, the baby required 13 surgeries. She is developmentally delayed.

There is no history of birth defects in the child’s family and the mother underwent genetic testing which failed to detect a genetic anomaly. The mother gave birth to the girl’s healthy older brother following a pregnancy in which she had not been treated with Zofran, according to the Zofran lawsuit.

Had the mother known the truth about Zofran’s unreasonable risk of harm “long concealed by GSK,” she would never have taken Zofran, and her child would never had been injured as described herein, she alleges in the Zofran lawsuit.

In 1991, the U.S. Food and Drug Administration (FDA) approved Zofran, a highly potent anti-nausea medication, for use in cancer patients undergoing chemotherapy or radiation therapy. GSK began marketing Zofran for “off label” use as a safe and effective treatment for the very common side effect of normal pregnancy-related nausea and vomiting known as morning sickness.

“GSK did this despite having knowledge that such representations were utterly false, as GSK had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child in utero,” according to the Zofran product liability lawsuit.

By 1992, “mounting evidence” began coming into GSK of reports of birth defects associated with Zofran. To date, the company has received more than 200 reports of birth defects, yet never disclosed the information to pregnant women or their doctors, Tomisha alleges.

Large-scale epidemiological studies have also shown an elevated risk of developing birth defects such as those suffered by Tomisha’s daughter.

The Zofran lawsuit states that GSK never conducted a single clinical trial before marketing Zofran to pregnant women and accuses the drug maker of opting not to do so “because they would have hampered its marketing of Zofran and decreased profits by linking the drug to serious birth defects.”

GSK’s conduct, the lawsuit continues, “was tantamount to using expectant mothers and their unborn children as human guinea pigs.”

The serious birth defects caused by Zofran are permanent and lasting in nature, according to the Zofran lawsuit. The girl also endured physical pain and mental anguish, including diminished enjoyment of life, and will require lifelong medical treatment, monitoring and/or medications.