GlaxoSmithKline is asking that Zofran birth defects lawsuits be consolidated into an MDL, and is proposing that the cases be transferred to the federal court in the Eastern District of Pennsylvania.

At least 33 cases are pending in 20 different federal district courts. These Zofran birth defect lawsuits have been brought by families on behalf of children who were born with heart defects, cleft palate, cleft lip, or other congenital birth defects.

The lawsuits allege that these side effects were caused by using Zofran (ondansetron) during pregnancy.

The U.S. Food and Drug Administration has approved Zofran as an anti-nausea drug for cancer and surgery patients. Off-label, however, Zofran is commonly prescribed for pregnant women to combat morning sickness. A substantial portion of the drug’s annual sales in the last 10 years has come from morning sickness treatment.

Many plaintiffs involved in Zofran birth defect lawsuits support GlaxoSmithKline’s request to establish a multidistrict litigation. However, none of the plaintiffs support locating the MDL in the Eastern District of Pennsylvania, a district they argue would give GlaxoSmithKline a “home court” advantage.

Instead, plaintiffs have proposed locating the MDL in Alabama, California, Louisiana, Ohio, among other jurisdictions.

Zofran is a popular anti-nausea drug often used to deal with morning sickness, even though it does not have FDA approval for that use.

However, in a growing number of lawsuits, plaintiffs allege that GlaxoSmithKline, the manufacturer, either knew, or should have known for years about the potential Zofran had to increase the risk of birth defects.

Several studies have been conducted that highlight potential Zofran birth defect risks. These risks, plaintiffs claim, were not adequately disclosed on the warning label.

Researchers in Hong Kong found in 2006 that, when taken by pregnant women for morning sickness, a significant amount of Zofran crosses the placenta from mother to child.

A 2011 study concluded that the children of women who used Zofran for morning sickness may be 2.37 times more likely to be born with a cleft palate. This condition leaves children not only with a severe facial deformity, but may cause problems with speech and feeding.

Other studies have connected Zofran to potential heart defect risks. A study published in 2013 looked at more than 900,000 pregnancies in the Danish Medical Birth Registry, and found that children exposed to Zofran may be two to four times more likely to suffer a septal defect than children not exposed to Zofran.

Septal defects involve holes in the heart. A 2014 study found there is a statistically significant increased risk for certain heart defects after Zofran use during early stages 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.”

Plaintiffs involved in Zofran lawsuits allege the drug maker withheld information and warnings.

Lawsuits are being pursued on behalf of children born with birth defects, alleging that GlaxoSmithKline willfully disregarded both evidence of potential risk and the health and safety of these children.

If a multidistrict litigation is established, centralized cases in front of one judge would reduce duplicative discovery and avoid conflicting rulings.

If you or someone you know has used Zofran as an anti-nausea drug during pregnancy, and subsequently gave birth to a child with birth defects, you may be able to file a Zofran lawsuit against GlaxoSmithKline.