Dangerous Drugs

Zofran lawsuit claims manufacturer knew that the drug could cause birth defects

August 12, 2022

Popular anti-nausea medication, Zofran, has been found to cause birth defects if mothers take the medication to help fight morning sickness. To make things worse, the makers of Zofran allegedly were aware of it and still actively recommended the drug be prescribed to pregnant women.

Known for being one of the most-prescribed pharmaceutical drugs for pregnant women dealing with morning sickness, Zofran (Ondansetron) has been used by millions of women across the US to help with the nausea and vomiting during the first trimester of pregnancy. While the drug become commonly used as a morning sickness medication, the drug was originally brought to market in 1991 to aid cancer patients with nausea and vomiting from chemotherapy or radiation treatments.

After the drug was approved by the FDA for cancer patients, doctors found that the drug was also helpful for women dealing with morning sickness – an “off label” use. While this is a fairly common practice for doctors, it can be very dangerous if there hasn’t been enough research on the side effects of off label uses. Despite minimal research on the effects of Zofran on pregnant women and the children, doctors continued to prescribe the drug due to its effectiveness in curbing morning sickness.

The first lawsuit is brought the makers of Zofran

In February of 2015, Cheri Flynn filed a lawsuit against Zofran on behalf of her two children who were born with serious birth defects. The Minnesota mother alleged that the birth defects (serious heart abnormalities) were caused by her taking Zofran and its negative affect on her babies’ ability to develop properly. Both daughters, born in 2004 and 2006, suffered major heart complications. The first had to undergo a surgery to repair a hole in her heart, while the other had a congenital heart defect.

During the court hearings, it was revealed that the manufacturer of Zofran, GlaxoSmithKline (GSK), was made aware that the drug presented an “unreasonable risk of harm” for developing babies as the drug passes through the placenta. Although they were made aware of this in 1992, GSK continued to allow doctors to prescribe the medication to expectant mothers. Over two decades after learning of the negative effects that Zofran may have on developing babies, GSK was still allowing doctors to prescribe the medication to pregnant women. Some Allegations brought against GSK state that they not only allowed it but actively promoted the drug to be prescribed to pregnant women.

Unbeknownst to her, Flynn’s case would kick off an assault of lawsuits against GSK for the effects its drug had on pregnant women and their developing children. By the close of 2015, almost 200 lawsuits had been filed against GSK. Due to the volume of cases they were combined into one Multi-District-Litigation (MDL) in the United States District Court of Massachusetts. This allows all the plaintiffs to share in each other’s resources instead of having to try each case in their own jurisdiction. The MDL has over 250 cases with 459 actions still pending. With 16 bellwether trials awaiting their day in court, it is unsure how long the MDL will be drawn out.

This isn't the first legal battle GSK has had to face

If the hundreds of lawsuits they face were not bad enough, this is not the first time GSK has had to face major legal issues. In 2012, the US Department of Justice brought a lawsuit against them with allegations of fraud and illegal promotion of several drugs, including Zofran. The settlement agreement that was reached by the two parties reveals that GSK promoted the sale and use of Zofran outside of the conditions the FDA had approved it.

Additionally, the settlement states that GSK promoted several other drugs outside of the parameters that the FDA had approved it for, including prescribing a depressionmedication to under-age children even though the drug was never approved for pediatric use. Along with pleading guilty to three counts of criminal information, GSK agreed to pay a total of $3 Billion to resolve the lawsuits. After the settlement had concluded as one of the largest health care fraud settlements in US history, then-deputy Attorney General James M. Cole called the settlement “unprecedented in both size and scope.”

This is much more than a single isolated incident involving GSK which shows that they are willing to put consumers' lives at risk for their profit. Unfortunately, GSK is one of many pharmaceutical companies that have repeatedly placed their company profits over the health and well-being of those they are supposedly trying to help. If you want to follow the case as it develops, Drug Watch does a great job of staying up to date with court finds and case updates.

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