Stern Law Discusses Zofran Studies
Stern Law’s drug product attorneys are currently handling Zofran cases. If you took prescription Zofran while pregnant, and your child was born with a congenital defect, contact us today to see if you might have a claim for damages.
Zofran (ondansetron) is a 5-HT3 receptor antagonist. It is a potent anti-nausea medication manufactured by GlaxoSmithKline (GSK) that was approved in 1991 for distribution. The U.S. Food and Drug Administration (FDA) approved Zofran for the narrowly tailored use of preventing and treating nausea and vomiting associated with chemotherapy and radiation treatment in cancer patients.
Despite its specific intended use, Zofran became a widely prescribed remedy for morning sickness in pregnant women. In our Zofran cases, Stern Law is alleging GSK participated in this widespread off-label use by marketing Zofran to patients and healthcare providers as a safe “wonder drug” for common nausea and vomiting during pregnancy. It did so without conducting a single clinical trial to establish the safety and efficacy of Zofran use in pregnant women.
In fact, Zofran lawsuits allege GSK excluded pregnant women from its earlier clinical trials, so it had absolutely no evidence with which to support its off-label marketing. GSK’s animal testing and adverse event reports signaled Zofran toxicity to fetuses, but the manufacturer persisted in its endeavors to make Zofran the top-prescribed anti-nausea drug for expecting mothers.
GSK has already been the subject of an investigation and criminal charges by the United States Department of Justice for promotion of unapproved drug uses. In addition, Stern Law and law firms nationwide have filed hundreds of lawsuits against GSK alleging that it marketed and sold Zofran in an unreasonably dangerous conditions and exposed women and their children to congenital defects without providing a warning. Because of the volume of claimants, these Zofran cases have been centralized in one court in the District of Massachusetts in what is known as a Multidistrict Litigation (MDL). This court will oversee all pretrial matters and preside over the first Zofran trials.
Contact Stern Law, PLLC
Stern Law’s compassionate attorneys recognize that an injury to your child is the worst kind of injury your family can experience. We are dedicated to helping you achieve the justice you deserve. 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 accomplished drug product lawyers.