More than 260 families who allege the popular anti-nausea medication Zofran caused birth defects are taking one more step forward in holding the manufacturers responsible.

On May 31st, plaintiffs’ lawyers in the Zofran litigation filed a Master Long Form Complaint that summarizes the plaintiffs’ shared allegations against the defendants. The next step is for each plaintiff to file a Short Form Complaint that includes personal details for each lawsuit.

A federal court in Boston has approved the Short Form Complaint created by the plaintiffs’ lawyers and the defendants. Each of the 260 families will be able to share their unique situation and suffering caused by Zofran’s side effects. Filing these individual Short Form Complaints helps move the litigation forward.

Zofran Side Effects

Zofran became popular as an off-label treatment for morning sickness in pregnant women; however, studies have now found a link between Zofran taken during the first trimester and birth defects. Plaintiffs in the class action lawsuit claim the drug caused cleft palates, club feet, skull deformities, and congenital heart defects.

When Zofran was approved by the FDA in the early 1990s, it was for treating nausea in cancer patients and patients who had undergone surgery. Although it was never approved specifically to treat morning sickness in pregnant women, Zofran’s manufacturer, GlaxoSmithKline (GSK), saw a huge opportunity in off-label uses of the drug.

GSK illegally marketed Zofran to pregnant women for the treatment of morning sickness and in GSK pled guilty to charges of illegally marketing several of their medications, including Zofran. The company was ordered to pay a massive $3 billion fine to the U.S. Department of Justice.

As the class action lawsuit moves forward, it is anticipated more lawsuits will follow. Although it will be some time before any Zofran lawsuits go to trial, plaintiffs can at least formalize their complaints against GSK.