An Alabama woman filed a Zofran lawsuit against GlaxoSmithKline, alleging the drug maker off-label marketed its anti-nausea drug Zofran as a morning sickness relief even though it knew Zofran was unsafe for use by pregnant women and could cause serious birth defects.

Plaintiff Heather R. was prescribed Zofran to alleviate morning sickness symptoms early in her first trimester of pregnancy and continued taking the drug into her third trimester. Her son, born in 2011, was subsequently diagnosed multiple congenital heart defects.

According to the Zofran lawsuit, Heather’s medical records state there is no genetic cause for her son’s condition as there is no family history of heart defects. The Zofran lawsuit further states that Heather has another son who was born healthy after a full-term pregnancy during which Heather did not take Zofran.

Heather claims that her son’s birth defects were caused by prenatal exposure to Zofran. She says that her son has been forced to undergo multiple surgeries to try and correct his numerous heart defects at only 14 months old. Had she known the truth about Zofran and the risk of birth defects and harm to her child, she says she would never have injested Zofran.

Heather is seeking compensatory and punitive damages, and equitable relief from the injuries to her son as a result of her prenatal exposure to Zofran.

What is Zofran?

GlaxoSmith Kline manufactures and distributes the anti-nausea drug Zofran (ondansetron). The prescription medication, which was FDA approved in 1991, was designed to help prevent vomiting and nausea associated with chemotherapy and radiation therapy, as well as the effects of anesthesia after surgery.

In recent years, controversy has arisen regarding “off-label” uses, such as treating morning sickness in pregnant women. Since Zofran was never tested or approved for this particular purpose, there is no hard data that shows ondansetron is safe for the developing the fetus.

The FDA classifies Zofran as a Pregnancy Risk Category B drug, which indicates there is no proven risk to the mother or fetus, with no data showing danger to animal test subjects.

Zofran During Pregnancy

An estimated 10 percent of pregnant women suffer from serious morning sickness and vomiting during their first trimester. The FDA has yet to approve a morning sickness drug in the United States, leaving physicians free to use their own discretion.

There is no legislation that prevents doctors from prescribing drugs for off-label uses, which in certain instances can actually help patients. On the other hand, unapproved prescriptions are handed out with no verifiable proof of the drug’s safety or efficacy.

Though GlaxoSmithKline never conducted clinical trials on Zofran to determine its long-term safety when used in pregnant women, it allegedly promoted the anti-nausea drug for morning sickness – an action that has become the topic of heated litigation.

Zofran Lawsuits

Pregnant women who were prescribed Zofran for morning sickness took the drug believing it to be safe for the developing fetus. According to birth defects lawsuits filed against GSK, however, these women were unknowingly putting their children at risk of life-changing Zofran side effects.

Over the coming months and years, as more families learn about the link between the anti-nausea drug and birth defects, it is expected that more Zofran lawsuits will be filed by parents across the country.

The Zofran Birth Defects Lawsuit is Case No. 2:15-cv-01053-VEH in the U.S. District Court for the Northern District of Alabama, Southern Division.