Few drugs have been marketed as recklessly as Zofran, and lawsuits around the country are taking on the drug’s manufacturer, GlaxoSmithKline, over its gross negligence. Also known by its trade name ondansetron, it is considered an essential medication by the World Health Organization and was initially approved for use by the FDA in 1991. With that kind of history, patients might assume that it’s among the safer drugs out there, and it is in some patients. Unfortunately, ondansetron has been marketed and prescribed heavily to a group of patients it was never intended for, and this has resulted in serious harm to many families.
WHAT IS THE REASON BEHIND ZOFRAN LAWSUITS?
Ondansetron is approved for use in patients recovering from surgery or chemotherapy, as it can greatly reduce nausea and vomiting in these people. Over the years, the drug has proven highly effective in these patients and remains a frontline option. However, perhaps noticing a potentially big market for its medication, GlaxoSmithKline pushed and paid doctors to recommend the medication to pregnant women dealing with morning sickness. Marketing materials concerning the drug were often targeted to pregnant women, a move that could be seen as exploiting the worry and stress that often comes with pregnancy.
The reason why the drug is under fire, though, is that it is linked to a spectrum of birth defects. Though placed in the FDA’s pregnancy category B (which suggests there is no danger to human fetuses), several recent studies have come to a much different conclusion. Chief among them is a 2014 study published in the American Journal of Obstetrics and Gynecology, which followed 900,000 Danish women. Researchers managing the study found double the risk of heart malformations in fetuses exposed to ondansetron during development. The study also noted a 30 percent overall increase in malformations when ondansetron was used during pregnancy. In addition to heart defects, researchers found cleft lip and palate defects, hearing and vision issues, physical deformities like webbed toes, poor skull development, and delayed mental development.
Perhaps most troubling is that released court documents have shown that GlaxoSmithKline may have been aware of the risks as far back as 1992. The company performed its own internal studies on animal fetuses and found many of the same birth defects that recent studies have shown. Internal company research also discovered a higher rate of intrauterine fetal death and confirmed that ondansetron can navigate to placental and fetal tissue.
Unsurprisingly, Zofran lawsuits have hit GlaxoSmithKline hard, and most claims assert that the company has exhibited extreme recklessness in its marketing initiatives. In fact, GlaxoSmithKline has pled guilty to fraud and illegal promotion of ondansetron, and will have to pay out more than $3 billion in fines and settlements. That is one of the largest judgments levied against a pharmaceutical company in history, but given the company’s deceptive marketing and willingness to harm the most vulnerable for profit, it is well deserved.