The United States Judicial Panel on Multi-District Litigation (JPML) recently assembled to determine whether the cases known as In Re: Zofran (ondansetron) Products Liability Litigation should be given Multi-District Litigation (MDL) treatment, and if so, where the litigation should be consolidated. Granting MDL treatment consolidates all federal lawsuits filed across the United States into one centralized district. This consolidation streamlines the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

Plaintiffs in the Zofran litigation allege that GlaxoSmithKline (GSK), the manufacturer of Zofran, fraudulently misrepresented the safety of its anti-nausea drug for pregnant women to prescribing doctors, resulting in unsuspecting pregnant women ingesting the drug and unknowingly harming their unborn babies. The most common birth defects include cleft palate, spina bifida and heart defects. It is further alleged that GSK marketed Zofran to pregnant women without FDA approval, as the FDA only approved the drug to treat post-operative surgery patients and certain patients undergoing cancer treatments.

On October 13, 2015, the JMPL agreed with the parties that the cases should be consolidated for discovery purposes and ordered all federal cases to be transferred to the District of Massachusetts before US District Judge F. Dennis Saylor. There are currently about 60 cases before Judge Saylor, but with the establishment of MDL No. 2657, additional cases are expected to be filed shortly.

Anyone affected should seek legal counsel immediately.

Zofran (ondansetron), manufactured by GlaxoSmithKline (GSK), is a member of a class of drugs known as 5-HT3 receptor antagonists, which work by blocking the actions of serotonin. Zofran is commonly prescribed for use by pregnant women suffering from morning sickness. Studies show that Zofran use by pregnant women can lead to a heightened risk of severe birth defects, including heart development irregularities, cleft lip and cleft palate.

On July 6, 2015, GSK filed a motion with the Judicial Panel on Multidistrict Litigation requesting the court to consolidate all Zofran cases before one judge into a Multi-District Litigation (MDL). Granting MDL treatment consolidates all federal lawsuits filed across the United States into one centralized district. This consolidation streamlines the pretrial discovery process, allowing the parties to avoid duplicative discovery and inconsistent rulings from different judges.

GSK argues that the United States District Court for the Eastern District of Pennsylvania, located in Philadelphia, PA, is the most convenient venue for the MDL.

If you or your child has suffered any injury as a result of taking Zofran, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Zofran manufacturers.

Zofran (ondansetron), manufactured by GlaxoSmithKline (GSK), is a member of a class of drugs known as 5-HT3 receptor antagonists, which work by blocking the actions of serotonin. Zofran is commonly prescribed for use by pregnant women suffering from morning sickness. Studies show that Zofran use by pregnant women can lead to a heightened risk of severe birth defects, including heart development irregularities, cleft lip and cleft palate.

A recent study by researchers at Harvard and Boston University’s Slone Epidemiology Center show that women exposed to Zofran, or a generic form of ondansetron, were 2.37 times more likely to deliver a baby with a cleft palate. These findings follow a series of epidemiological studies that have found an increased risk of major birth defects associated with exposure to Zofran during early pregnancy. For example, Swedish researchers, analyzing birth records from 1998 through 2012, concluded that “mothers who took Zofran during early pregnancy had a 62% increased risk of having a baby with a cardiovascular defect.”

If you or your child has suffered any injury as a result of taking Zofran, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Zofran manufacturers.

Zofran (ondansetron), manufactured by GlaxoSmithKline (GSK), is a member of a class of drugs known as 5-HT3 receptor antagonists, which work by blocking the actions of serotonin. Zofran was approved by the Food and Drug Administration (FDA) in January 1991, to treat chemotherapy-related nausea, and the approval was later expanded to treat postoperative nausea and vomiting. Since then, it has been increasingly prescribed for off-label uses, such as use by pregnant women suffering from morning sickness. Studies show that Zofran use by pregnant women can lead to a heightened risk of severe birth defects, including heart development irregularities, cleft lip and cleft palate.

In 2012, GSK agreed to pay the United States Department of Justice $3 billion to settle numerous civil and criminal allegations, including the illegal marketing of Zofran. The company is now facing lawsuits filed on behalf of children born with heart defects or craniofacial birth defects because their mothers took Zofran during pregnancy.

If you or your child has suffered any injury as a result of taking Zofran, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Zofran manufacturers.

Zofran (ondansetron), manufactured by GlaxoSmithKline, is a member of a class of drugs known as 5-HT3 receptor antagonists, which work by blocking the actions of serotonin. Zofran was approved by the Food and Drug Administration (FDA) in January 1991, to treat chemotherapy-related nausea, and the approval was later expanded to treat postoperative nausea and vomiting.

According to recent allegations, it is believed that Zofran has also been marketed and prescribed for off-label uses, such as use by pregnant women suffering from morning sickness. According to a recent article published by the American Journal of Obstetrics & Gynecology, “Presently 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration.”

Studies show that Zofran use by pregnant women can lead to a heightened risk of severe birth defects, including heart development irregularities, cleft lip and cleft palate.

If you feel you have experienced any side-effects from taking Zofran, you can contact Stark & Stark and speak to one of the Mass Tort/Pharmaceutical Litigation attorneys, free of charge, who can help assess any claims that you might have against the Zofran manufacturers.