U.S. District Judge F. Dennis Saylor IV said, “No!” to GlaxoSmithKline PLC’s latest move in the MDL the Big Pharma giant is in over its anti-nausea drug, Zofran. The plaintiffs claim that the “off-label” use of the drug for morning sickness caused birth defects. The GSK motion to dismiss in Zofran MDL denied.
Another Zofran lawsuit has been filed against GlaxoSmithKline alleging that the drug causes birth defects. G.K., a male child, was born without one kidney. He is also missing the connective tissues that would make a kidney transplant possible. Other birth defects include a deferens that is not fully functional, a defect that may limit G.K.’s sexual function as an adult and make it impossible for him to father a child.
The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”
Pre-settlement funding helps financially vulnerable parties who have suffered damages effectively enforce their rights and get the compensation they deserve and desperately need.
How sure are you that all the medications in your medicine cabinet are child-proof? This is an important thing to consider if you have children at home. It’s also important to keep tabs on recalls related to child safety, such as the recent one issued by Novartis and Sandoz over “several blister packaged prescription medications…due to the products failing to meet child-resistant closure requirements as per the Poison Prevention Packaging Act.”