Summary Of Zofran Birth Defects Litigation Guide
Multi-national pharmaceutical conglomerate GlaxoSmithKline manufactures an anti-nauseau drug, ondansetron hydrochloride, under the brand name Zofran. During the 1980s, the company tested Zofran’s effects in pregnant rodents and rabbits. According to claims made in two recently-filed lawsuits, these tests revealed evidence of Zofran’s toxicity in animals, including intrauterine deaths and fetal malformation.
By 1991, the US Food & Drug Administration had approved Zofran for the treatment of extreme nausea in patients undergoing chemotherapy, radiation therapy and surgical anesthesia. The FDA has never approved Zofran for use as a morning sickness treatment, and has never stated that the drug is safe for morning sickness in pregnant women. For its part, the drug manufacturer has never performed any clinical trials to determine Zofran’s effects on pregnant women or fetal development. Despite its widespread usage for morning sickness, the company has not sought FDA approval for the drug’s use as a treatment for morning sickness.
But according to allegations made by the federal government, GlaxoSmithKline began marketing Zofran as a safe treatment for morning sickness in the early 1990s. In a case brought by the US Department of Justice, federal prosecutors claimed that GlaxoSmithKline marketed Zofran directly to obstetricians and gynecologists, and even paid kickbacks to physicians who prescribed the drug to pregnant women. While the company continues to deny these allegations, GlaxoSmithKline settled the case for a record-breaking $3 billion. It remains the largest settlement for alleged health care fraud in US history.
Several new lawsuits claim that GlaxoSmithKline received notifications of birth defects associated with Zofran as early as 1990. To date, the company has allegedly received as many as 200 such reports. Meanwhile, several significant epidemiological studies have begun to establish Zofran’s association with severe birth defects, including cleft palate and congenital heart defects. GlaxoSmithKline has offered no warnings that the drug is unsafe for pregnant women, and has not requested the FDA to do so on its behalf.
Monheit Law, with an alliance of prominent law firms, has begun to investigate claims of birth defects caused by Zofran. Families interested in learning more about possible litigation are urged to call (877) 620-8411 for additional information.