Numerous Zofran lawsuits filed by mothers who took the anti-nausea medication while pregnant allege that the drug causes severe birth defects in developing fetuses. Several studies suggest that a link exists between Zofran use and an increased risk of birth defects, especially when taken to treat morning sickness during the first trimester of pregnancy.

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.”

Recent Zofran lawsuits against manufacturer GlaxoSmithKline include one filed by a family from San Francisco, who claim that Zofran caused their child to be born with heart abnormalities, and one filed by a family from Massachusetts, who allege the drug was responsible for their child being born with nine different birth defects.

Doctors may prescribe Zofran to pregnant women who are suffering from extreme morning sickness, despite the fact that the FDA never approved Zofran to treat morning sickness. Zofran was approved in the early 1990s to treat nausea in chemotherapy and radiation patients, but was never tested on pregnant women.

Overview of Zofran Birth Defects Allegations

GlaxoSmithKline did not conduct pre-clinical studies on Zofran to confirm whether or not the drug was safe for pregnant women, since the company did not create Zofran as a morning sickness treatment. Likewise, GSK never requested approval from the FDA for this purpose. Despite a lack of testing or approval, GSK allegedly marketed Zofran off label to treat pregnancy-related nausea and vomiting because of the drug’s popularity among newly pregnant women.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Despite the large payout, the company is still facing legal scrutiny from families who claim their children will live with the permanent consequences of alleged Zofran birth defects. These families are pursuing Zofran lawsuits to seek compensation for their children’s medical care, general physical care, and other punitive damages.