Zofran Litigation and Settlement News

The skilled drug injury lawyers at Stern Law are currently litigating cases involving use of the prescription drug Zofran. If you took prescription Zofran while pregnant, and your child was born with a congenital defect, contact us today to see if you might be eligible to file a claim against the manufacturer.

Zofran (ondansetron) is a 5-HT3 receptor antagonist. It is a powerful anti-nausea medication manufactured by GlaxoSmithKline (GSK). The U.S. Food and Drug Administration (FDA) approved Zofran in 1991 for the narrow purpose of preventing and treating nausea and vomiting associated with chemotherapy and radiation treatment in cancer patients, as well as for general postoperative nausea.

In the early 2000s, however, Zofran became a widely prescribed remedy for nausea and vomiting in pregnant women, commonly referred to as morning sickness. Morning sickness is not an approved use for the drug, and pregnant women using Zofran are at risk for birth defects, including:

  • Club foot
  • Cleft palate
  • Cleft lip
  • Heart defects
  • Skull deformities

Stern Law and firms across the country have filed hundreds of lawsuits alleging GSK never sought approval for Zofran as treatment for morning sickness but knew about and facilitated this off-label use among healthcare providers. While doing so, it failed to conduct appropriate testing or issue warnings about the potential link between Zofran and serious birth defects. Importantly, in 2012, GSK pleaded guilty to criminal charges filed by the U.S. Department of Justice related to promotion of unapproved uses of its drugs. Around this same time, GSK agreed to civil settlements with the federal government for illegal marketing of various drugs, including Zofran.

Investigation is ongoing, and individual Zofran cases have been consolidated into a Multidistrict Litigation (MDL) in the District of Massachusetts federal court. Settlement negotiations have not yet taken place, but the parties are exchanging discovery and preparing for potential initial trials, called “bellwether” trials. If you believe you have a Zofran claim, you need competent legal representation to make sure your case is included in any potential settlements.

Contact Stern Law, PLLC

At Stern Law, we are dedicated to helping our clients and their families in the face of traumatic injuries. If you took Zofran while pregnant, and your child has a birth defect, contact Stern Law, PLLC, at (844) 808-7529, to schedule a free consultation with one of our experienced drug product attorneys.

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