According to documents from the Judicial Panel on Multidistrict Litigation, as of October 15, 2015, there were 15 lawsuits consolidated in MDL-2657 (In Re: Zofran (Ondansetron) Products Liability Litigation) before US District Judge F. Dennis Saylor. Lawsuits are consolidated for pretrial proceedings when they have similar questions of fact, but the consolidation is not a comment on the merits of the individual lawsuits. Because the lawsuits were only consolidated in mid-October, there is still time for more lawsuits to be added to the multidistrict litigation.
Zofran is approved to treat nausea and vomiting linked to chemotherapy, radiation therapy and surgery. It is often prescribed off-label to pregnant women to treat morning sickness. Lawsuits allege, however, that the use of Zofran during pregnancy can result in babies born with major birth defects, including heart and kidney defects. Plaintiffs say they were not adequately warned about the risk of using Zofran while pregnant, and that GlaxoSmithKline, maker of Zofran, misled the public about the safety of the drug.
Although it is not illegal for doctors to prescribe medications off-label, it is illegal for drug companies to market drugs for off-label uses. In 2012, GlaxoSmithKline agreed to pay more than $1 billion to settle allegations that it illegally marketed medications - including Zofran - for off-label use.
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The lawsuit also alleges that GlaxoSmithKline marketed Zofran off-label “as an established safe and effective treatment for the very common side effect of a normal pregnancy - pregnancy related nausea and vomiting - otherwise known as ‘morning sickness.’” The drugmaker allegedly did so despite not having undertaken any studies to prove Zofran’s safety or effectiveness in pregnant women.
The lawsuit is Jody Huffmaster v. GlaxoSmithKline, case number 2:15-cv-04399-SM-DEK, in the US District Court, Eastern District of Louisiana.