A birth defect lawsuit has been filed by a Maine parent who claims her child was born with a heart defect after being exposed to Zofran in utero.

Plaintiff Melissa D. accused Zofran manufacturer GlaxoSmithKline of fraudulent misrepresentation, alleging that the maker assured expectant mothers and the healthcare community that Zofran was safe to use for morning sickness relief without testing it to determine whether this was true.

The Zofran lawsuit claims that when Melissa was pregnant with her third child (referred to in the lawsuit as E.D.) she suffered from morning sickness and was prescribed Zofran as an anti-nausea medication. Melissa claims that because Zofran lacked birth defect warnings, she did not have any reason to suspect it could potentially have an adverse effect on her unborn child.

Melissa states that she took the morning sickness drug throughout her pregnancy.

Two days after E.D. was born physicians diagnosed him with a ventricular septal defect, which is a hole in the heart wall separating the two lower chambers of the heart. Melissa claims that there is no family medical history to suggest her son’s condition was caused by genetics. In fact, her lawsuit notes her two other children were born completely healthy after pregnancies during which she did not take Zofran for nausea.

Melissa’s Zofran birth defect lawsuit claims that mothers-to-be, along with health care providers, had no reason to suspect the drug could cause defects because GSK “masked” side effects through unbalanced promotion of Zofran targeting pregnant women.

Melissa alleges that as a result of GSK’s acts and omissions, E.D. “was caused to suffer serious and dangerous side effects including but not limited to, severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, diminished enjoyment of life, and financial expenses for hospitalization and medical care.”

According to the birth defect lawsuit, had Melissa know of Zofran’s birth defect risk she never would have taken Zofran while pregnant.

Zofran “Morning Sickness” Drug

About six million U.S. women become pregnant each year, and up to 85 percent of those women experience pregnancy-related nausea (commonly known as morning sickness). The Zofran lawsuit alleges that “the absence of a prescription medication that was approved by the FDA for pregnancy-related nausea presented an extremely lucrative business opportunity for GSK to expand its sales of Zofran.”

The U.S. Food and Drug Administration approved Zofran to treat severe nausea in cancer patients undergoing chemotherapy. However, according to the Zofran lawsuit, it didn’t take long before GlaxoSmithKline began promoting the drug “off-label” to treat nausea related to morning sickness.

Plaintiff Melissa states that “GSK seized that opportunity, but the effect of its conduct was tantamount to experimenting with the lives of unsuspecting mothers-to-be and their babies in the United States.”

By 1999, the FDA ordered Zofran’s manufacturer to immediately stop promoting Zofran off-label. The Zofran lawsuit claims that GSK allegedly disregarded this mandate, and continued to widely circulate information that over-emphasized Zofran as a “pregnancy category B,” which created a false impression of its safety.

Zofran Birth Defects Lawsuit

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.

Multiple lawsuits have been filed by parents who claim Zofran caused various complications including cleft lip, cleft palate, kidney defects, congenital heart defect, respiratory defects, musculoskeletal defects, intrauterine death, stillbirth, and spontaneous abortions.

Melissa’s Zofran Birth Defect Lawsuit is Case No. 1:15-cv-13735-FDS in the U.S. District Court for the Northern District of California, San Francisco Division.