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Zofran lawsuit — GSK requests split of generic, branded cases

Attorneys for the pharmaceutical company asked the court to request all plaintiffs to file whether they suffered an injury allegedly caused by the branded version of Zofran, or one of the many generic ondansetron medications. A mandatory “product identification” should be used by the court as an instrument to speed the proceedings by separating all appropriate Zofran lawsuits from those thought irrelevant. Today the number of total lawsuits filed across the United States rose to over 200, and the U.S. Judicial Panel on Multidistrict Litigation is consolidating all of them in a product liability litigation MDL number 2657 in the District of Massachusetts overseen by Honourable Judge F. Dennis Saylor IV.

Originally intended as an antiemetic drug to prevent nausea and vomiting during surgery and cancer chemotherapy, ondansetron has been aggressively marketed to pregnant women as an off-label treatment for morning sickness. However, neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) ever approved this medication for this use. No studies or clinical trials were ever performed to adequately test this drug’s safety or effectiveness in pregnant women. Many women who took Zofran during the first trimester of pregnancy later suffered from serious side effects, the most dangerous of which was the risk for a fetal malformation. A study published in 2006 demonstrated that ondansetron may cross the maternal placenta, exposing the baby to its effects. Zofran birth defects include serious heart and kidney malformations such as atrial and ventricular septal defect and hydronephrosis, as well as hypospadias, cleft palate and neural tube defects. In 2012, the U.S. Department of Justice forced GSK to pay a $3 billion fine to resolve fraud allegations and negligence in reporting safety data of several drugs including Zofran.

Since the various generic ondansetron versions hit the market, however, branded Zofran sales were reduced by up to 90 percent during the last 10 years. GSK claims not to be responsible for the damage caused to the pregnant women who took one of the 30 generic ondansetron medications available. The pharmaceutical company asked the court to split branded drugs lawsuits from generic ones to “promote efficiency” by removing all the cases which may be deemed legally irrelevant. However, due to the “innovator liability,” the original manufacturer is held responsible for all the damage caused by subsequent drugs. Only GSK can, in fact, change the drug’s warning labels, so generic companies cannot warn the public (or, in this case, pregnant women) about additional risks associated with the use of this medication.

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