Trial Court Dismissal of Zofran Birth Defect Lawsuits Upheld on Appeal Before First Circuit

The 2021 decision to dismiss all Zofran birth defect lawsuits was upheld, after the appeals court affirmed the FDA would not have let GlaxoSmithKline change the label warnings even if it had wanted to do so.

A federal appeals court has upheld a 2021 decision which resulted in the dismissal of several hundred Zofran birth defect lawsuits, finding that the drug maker GlaxoSmithKline can not be held liable for failing to warn about side effects of the anti-nausea drug that is commonly used during pregnancy.

Zofran (ondansetron) is a prescription medication introduced in 1991 for treatment of nausea and vomiting associated with chemotherapy or following surgery. However, it has also been widely prescribed off-label for morning sickness in pregnant women, and more than 400 families filed product liability lawsuits against GlaxoSmithKline alleging that exposure to the medication caused children to develop birth defects and congenital malformations, including cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other life-long health problems.

Given common questions of fact and law raised in the claims, lawsuits filed throughout the federal court system were centralized before U.S. District Judge Dennis Saylor in the District of Massachusetts, who presided over coordinated discovery and pretrial proceedings in the cases for several years.

In June 2021, Judge Saylor issued an order dismissing all Zofran lawsuits, after determining the state-law based failure to warn claims were preempted by federal law, since the FDA had ample opportunity to change Zofran’s warning label, and refused to do so.

Plaintiffs appealed the decision to the U.S. Court of Appeals for the First Circuit, which issued an opinion (PDF) on January 9, upholding the dismissal of the cases.

“The district court granted summary judgment in favor of GSK, finding that federal law preempted plaintiffs’ state law claims because there was clear evidence that the Food and Drug Administration (FDA) would have rejected the warning that plaintiffs allege is required under state law,” the opinion states. “We affirm the district court’s grant of summary judgment.”

Plaintiffs had argued that GlaxoSmithKline knew about Japanese studies conducted as early as 1991, which linked Zofran to an increased risk of birth defects, but the drug makers allegedly withheld the information from the FDA until 2019. However, the appeals court determined that the studies did not constitute new risk information that would have allowed GlaxoSmithKline to change the label without the FDA’s approval.

The court pointed out that even after the agency became aware of the Japanese studies, it still approved a label in 2021 that indicated the animal data revealed no significant risks to developing human offspring.

Plaintiffs have not yet indicated whether they will appeal the decision to the U.S. Supreme Court.