On June 10, a Ohio couple filed a Zofran birth defects lawsuit against GlaxoSmithKline, claiming the pharmaceutical company’s anti-nausea drug caused their daughter to be born with a heart defect, which eventually led to her death.

This is just one of at least 10 Zofran lawsuits brought against GSK, claiming the pharmaceutical company concealed evidence of Zofran birth defect risks from patients and the medical community.

In 1991, Zofran gained FDA approval as a treatment for vomiting and nausea that many patients experience after undergoing chemotherapy and surgery. Over time, doctors also became aware of Zofran’s ability to alleviate morning sickness symptoms if women took Zofran while pregnant. However, soon after it was also discovered that this treatment may increase their risk of giving birth to a child with birth defects.

Details of New Zofran Birth Defects Lawsuit

The plaintiff mother claims that after experiencing nausea and vomiting from pregnancy morning sickness, her physician prescribed the her Zofran as an “off label” (or non-FDA approved) treatment for morning sickness. She took the anti-nausea medication as prescribed and noted that her pregnancy proceeded normally until about few days before delivery.

According to her Zofran lawsuit, her unborn child’s “heart rate began to decelerate.” When the plaintiff’s daughter was born on March 17, 2006, the child was immediately diagnosed with a heart defect in the right ventricle, which required monitoring and care in the ICU. The child eventually went into cardiac arrest and caused her heart to stop beating, at which point doctors were unable to revive her. The child died on March 20, just three days after her birth, the Zofran birth defects lawsuit says.

Off Label Promotion of Zofran

The plaintiff couple filed this Zofran birth defects lawsuit alleging that their daughter’s death was a direct “result of […] defects and injuries caused by Zofran.” They further allege that GSK illegally promoted Zofran as a safe and effective morning sickness treatment absent of FDA approval.

And these off-label promotions seemed to have worked, as more and more pregnant women now use Zofran for morning sickness; however, this also allegedly led to an increase in birth defects. This birth defects lawsuit claims:

“[By 2000,] dozens of physician reports began to show a high rate of teratogenicity [the potential to adversely affect fetal development], with Zofran use being associated with congenital heart defects, kidney malformations, and cleft palate and other facial defects. Furthermore, data were showing intrauterine deaths, still births, deaths shortly after births, and serious congenital defects in children who survived.”

Like most Zofran birth defects lawsuits, this complaint seeks compensatory and punitive damages from GSK that will give the family some financial compensation for the pain and suffering they experienced, as well as the medical bills associated with the child’s resulting birth defects, and in this case will also most likely cover funeral costs.

This Zofran Birth Defects Lawsuit is Case No. 3:15-cv-1166, in the U.S. District Court for the Northern District of Ohio, Western Division.