Last week Rheingold Giuffra Ruffo Plotkin & Hellman LLP filed a lawsuit against Glenmark and GlaxoSmithKline (GSK). The case, Plaintiff v. Glenmark Generics Inc., USA et al., 2:15-cv-07134 was filed in NJ District Court and assigned to Judge James B. Clark. GSK is the maker and distributor of Zofran, while Glenmark is a maker and distributor of a generic version of Zofran, known as ondansetron. The case alleges that the drug, used to treat morning sickness, caused a number of birth defects in Plaintiff, treatment of which necessitated open chest surgery.
The Plaintiff alleges that Zofran was approved by the Food and Drug Administration (hereinafter “FDA”) in 1991 to treat severe nausea in cancer patients undergoing chemotherapy and radiation treatments. To date, this remains the only FDA approved use for Zofran. It has never been approved for use in morning sickness.
Despite the fact that the FDA only approved Zofran for cancer patients, GlaxoSmithKline marketed Zofran to pregnant women suffering from morning sickness. There is also no warning of increased risks of birth defects within the product labeling for Zofran.
Studies and literature are proving greater links between Zofran and birth defects. Since at least the 1980s, when GSK received the results of the preclinical studies that it submitted in support of Zofran’s NDA 20-007, GSK has known of the risk that Zofran ingested during pregnancy in mammals crosses the placental barrier to expose the fetus to the drug. GSK began receiving reports of birth defects associated with the use of Zofran by pregnant women as early as 1992.
One hurdle in the litigation is that many potential litigants have ingested the generic version of Zofran, known as Ondansetron. However, at the time Ondansetron was first sold by Glenmark its warnings were inadequate and misleading. Part of the claim of mislabeling is that the pregnancy category selected was inadequate to warn pregnant women of a possible adverse risks to a fetus. Generic manufacturers knew or should have known of the birth defect risk, yet intended its biggest sales to be for morning sickness.
Rheingold Giuffra Ruffo Plotkin & Hellman LLP is a national firm located in New York City, handling personal injury cases including mass torts, a field which includes the Ondansetron and Zofran litigation. If you or someone you know has been injured by Zofran or Ondansetron contact our firm today.
