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 Alexis A. 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, which was filed June 6 in the U.S. District Court, Eastern District of Louisiana, Zofran is only drug approved to treat severe nausea associated with chemotherapy cancer treatments and surgery. But Alexis 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.

Alexis claims that her son was born in 2006 with severe lung and heart defects 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.

In January 2012, research that looked at data from the National Birth Defects Prevention Study found that Zofran use during the first trimester of pregnancy was associated with a 2.37-fold increase in the incidence of cleft lip and cleft palate.

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

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.”

Zofran Lawsuits

Alexis’ lawsuit is one of at least a dozen Zofran birth defects lawsuits filed this year. The rapid growth of the Zofran birth defects litigation recently prompted GSK to ask the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed claims in a single U.S. District Court.

The company contends that a multidistrict litigation would reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges, and better serve the convenience of the parties, witnesses and the courts.

In a Motion filed with the JPML on July 6, GSK proposed that the proceeding be established in the U.S. District Court, Eastern District of Pennsylvania, where its U.S. operations are headquartered.

The Zofran Birth Defects Lawsuit is Case No. 2:15-cv-ILRL-MBN in the U.S. District Court for the Eastern District of Louisiana.