200 Zofran Lawsuits Included in MDL

Boston, MAThere are now 200 Zofran lawsuits sitting in MDL 2657, according to court documents, each one representing a woman who alleges her use of the anti-nausea drug caused her infant to be born with birth defects. Plaintiffs claim they were not properly warned about the risk of birth defects when they were prescribed Zofran off label to treat their morning sickness. Because litigation is still in the early stages, there is time for more lawsuits to be added to the MDL. Meanwhile, a class-action lawsuit has also been filed in Canada.

Earlier in 2015, Zofran lawsuits were consolidated into a multidistrict litigation (MDL-2657, In Re: Zofran Products Liability Litigation) before US District Judge F. Dennis Saylor for pretrial proceedings. As of December 15, 2015, 200 lawsuits were consolidated in the MDL, a significant increase from the 15 lawsuits initially consolidated. Lawsuits are consolidated when there are similar questions of fact, but consolidation is not a comment on the merits of the individual lawsuits.

Individually, however, those lawsuits allege women were prescribed Zofran off label to treat morning sickness, even though there were no studies done to prove Zofran was safe or effective in treating pregnant women. Zofran is approved to treat chemotherapy- and radiation-related nausea and vomiting, but not approved to treat morning sickness. It is not illegal for doctors to prescribe medications for unapproved uses, but it is illegal for drug companies to market their drugs off label.

Back in 2012, GlaxoSmithKline paid more than $1 billion to settle allegations it illegally marketed Zofran and other drugs for off-label use. A class-action lawsuit has also been filed in Canada by women who say their babies were born with birth defects after they took Zofran for morning sickness.

According to CTV News (12/7/15), around 12 women have joined the lawsuit, including Terra Mercer, who was given ondansetron (the generic name for Zofran) through an IV when her morning sickness was so bad she had blood in her vomit. Mercer’s daughter was later born with a cleft lip and cleft palate and will likely require multiple surgeries as she ages.

Women who have filed lawsuits against GlaxoSmithKline say they would not have taken the drug if they had known about the risk of birth defects or if they had known the drug was being prescribed off label.