Zofran is a drug manufactured by GlaxoSmithKline (GSK) to prevent nausea and vomiting in patients that have recently undergone surgery, radiation, or chemotherapy. Since it was approved by the FDA in 1991, the drug has been used for the aforementioned purposes, but Zofran has also been used off-label to help treat morning sickness in pregnant women.
Though Zofran has never been approved by the FDA for this use, doctors can use drugs in ways not approved by the FDA (called an off-label use). In fact, it is estimated that over 1 million pregnant women are prescribed or treated with Zofran every year. The issue that GSK is facing now is not the fact that the drug is used on pregnant women off-label, but that GSK promoted Zofran for such a use, which is illegal.
This problem comes on the heels of studies that have shown that pregnant women taking Zofran during their first trimester can cause the baby to be born with serious complications or birth defects. Unfortunately, sometimes the complications are so serious that the baby dies. A Danish study conducted on pregnant women taking Zofran concluded that there is an overall 30% increase in the risk of major congenital malformations when a person takes Zofran during pregnancy.
In 2012, GSK was facing serious criminal and civil charges brought by the U.S. Department of Justice (DOJ). The DOJ was alleging that GSK marketed Zofran as a treatment option for morning sickness, that GSK unlawfully promoted Zofran as a potential treatment for morning sickness, and that GSK paid kickbacks to physicians who prescribed Zofran for such off-label uses. Ultimately, GSK settled the cases against it for $3B, making it the largest healthcare fraud settlement in U.S. history.
As a result of GSK marketing Zofran toward pregnant women, almost 300 lawsuits have been filed against the company. The plaintiffs are alleging that GSK failed to warn them of the dangerous defects their babies could be born with and that GSK made misrepresentations about Zofran’s safety and effectiveness. The pending lawsuits against GSK have been transferred to a multidistrict litigation (MDL) in Massachusetts under Judge F. Dennis Saylor IV.
The first Zofran trials to be heard will be the bellwether trials, which will allow parties to test their arguments with a goal of resolving the entire litigation. At this time, there is no date for when the first bellwether trial will be heard, and the next status conference for the MDL will be in April of 2016.