A grieving mother from Tennessee recently filed a Zofran birth defects lawsuit against GlaxoSmithKline on behalf of her deceased daughter, who allegedly died as a result of exposure to Zofran during pregnancy.

Plaintiff Shalania R. filed the Zofran lawsuit alleging her daughter was born with extreme and numerous congenital birth defects as the result of prenatal exposure to the morning sickness drug. After birth, medical tests revealed that the child suffered from at least three life-threatening heart defects and would need a heart transplant in order to survive.

Sadly, Shalania’s daughter lived for 11 weeks in total, with the lawsuit claiming that her Zofran birth defects impaired her development and ultimately led to her early death.

According to the Zofran birth defects lawsuit, GlaxoSmithKline had never performed any studies on the potential effects of Zofran on pregnant women or their fetuses.

The Zofran birth defects lawsuit further alleges that not only did GlaxoSmithKline not perform Zofran pregnancy studies, but even had knowledge from their research in the 1980s showing birth defects in the offspring of animal test subjects. Later, studies showed that Zofran easily crosses the human placenta barrier, which exposes the fetuses of pregnant mothers taking Zofran to potential adverse effects.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

What is Zofran?

Zofran (ondansetron) is a powerful anti-nausea drug developed by GlaxoSmithKline meant to be used on patients suffering from severe nausea, such as the kind resulting from chemotherapy or radiation treatments. The U.S. Food and Drug Administration (FDA) approved Zofran for such cancer patients in 1991.

Despite the fact that Zofran was only approved for severe nausea, GlaxoSmithKline marked Zofran “off label” as a safe and effective treatment to deal with the morning sickness that comes along with pregnancy.

The medical community is largely unaware that Zofran could be unsafe during pregnancy, though a number of studies have detailed potential pregnancy risks when Zofran is used early on, as in the first trimester. A substantial portion of the drug’s annual sales in the last ten years has come from morning sickness treatment.

Zofran Lawsuits

Shalania claims that had she been made aware of the potentially fatal Zofran side effects, she would never have taken Zofran, and her daughter would have not been born with fatal birth defects. She further claims that GlaxoSmithKline deliberately concealed this information from the medical community, consumers, and herself in order to boost sales from marketing and selling Zofran as a morning sickness treatment.

Shalania is seeking compensatory and punitive damages totaling $4 million. She has demanded a jury trial for this case.

Many injured mothers have come forward, filing Zofran birth defects lawsuits on behalf of their children, alleging that ingesting Zofran during pregnancy directly caused their children harm.

If you or someone you know has used Zofran as an anti-nausea drug during pregnancy, and has subsequently given birth to a child with birth defects, you may be able to file a Zofran birth defects lawsuit against GlaxoSmithKline for failing to adequately warn of the potential risks associated with their product.

The Zofran Birth Defects Lawsuit is Case No. 3:15-cv-00958, in the U.S. District Court for the Middle District of Tennessee.