Another woman who was prescribed Zofran to alleviate morning sickness symptoms during pregnancy filed a lawsuit against GlaxoSmithKline (GSK) over birth defects allegedly caused by the anti-nausea drug.

Plaintiff Janay W. claims in the Zofran lawsuit that GSK promoted the drug for morning sickness relief, even though it had knowledge that Zofran caused serious birth defects as early as 1992.

According to the Zofran lawsuit, Zofran is only drug approved to treat severe nausea associated with chemotherapy cancer treatments and surgery. But Janay alleges that GSK promoted Zofran as a safe and effective treatment for morning sickness, even though the FDA had never approved it for this indication.

Janay’s son was born in 2015 with severe heart defects and club foot for which he had to undergo surgery at just two months; she claims that his problems were due to her use of Zofran during pregnancy.

She further asserts that she would have never used Zofran had she been aware of evidence linking the nausea medication to birth defects.

Zofran Use In Pregnancy

The FDA has placed Zofran in Pregnancy Category B, which means that there have been no well-controlled studies of its effects in pregnancy. In February 2013, research involving more than 600,000 Danish mothers, including nearly 2,000 who were treated with Zofran during pregnancy, found no risk of birth defects.

However, half of the women included in the study received the drug after their 10th week of gestation, which is beyond the time when most fetal malformations will occur.

Later that year, scientists using data from the same Danish health registry concluded that women who took Zofran during the first trimester of pregnancy were 30% more likely to have a baby with a major birth defect.

While the earlier research had only looked at data from 2004 through 2011, the authors of the second study used data from a 13-year period. The later study also drew from a larger pool of subjects, as it included nearly 900,000 women, of which some 1,248 received Zofran early in pregnancy.

Finally, a study published in December 2014 in Reproductive Toxicology found that prenatal exposure to Zofran was associated with double the risk of septal heart defects, including atrial septal defects and ventricular septal defects.

Zofran Lawsuits

Janay’s lawsuit is one of at least a dozen Zofran birth defects lawsuits filed this year. 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. 1:15-cv-ILRL-MBN in the U.S. District Court for the Southern District of Alabama.