Zofran Pregnancy Issues and Lawsuits

An expectant mother wants nothing more than for her child to have a healthy start to life. They may enter pregnancy expecting at least a little morning sickness, but would never take an anti-nausea drug if they knew it could harm their baby.

GlaxoSmithKline LLC (GSK) first asked the U.S. Food and Drug Administration (FDA) to approve Zofran to treat nausea in cancer patients. Years later, GSK marketed the drug to pregnant women but didn’t get FDA approval. They promised women that Zofran would help reduce morning sickness in the first trimester.

Some women who took Zofran gave birth to babies with birth defects. Hundreds of women hired lawyers to file Zofran lawsuits. The plaintiffs argued that the drug manufacturer didn’t warn providers about the risks. These birth injuries included cleft palate and heart abnormalities.

This article explains the use, risks, and side effects of Zofran. You’ll also find an update on the status of the Zofran lawsuit, which ended in January 2023, when the United States Court of Appeals for the First Circuit affirmed the MDL judge’s ruling dismissing all Zofran lawsuits.

Drug manufacturers have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you or your baby has been harmed by Zofran or another medication, you have legal options. Contact a product liability attorney near you to share your story and learn if you have a valid claim.

Zofran and Morning Sickness: The Basics

Zofran is the brand name for the drug ondansetron. Zofran works by blocking the effects of serotonin, which is associated with nausea and vomiting.

More than 80% of all women suffer morning sickness, nausea, or vomiting at some point early in their pregnancy. GSK decided to market Zofran for the off-label use of alleviating morning sickness.

What they didn’t do was warn the public about the potential side effects of taking the drug while pregnant. Some mothers claimed that their use of Zofran during the first trimester of pregnancy resulted in birth defects.

Some studies have shown an increased risk of congenital health issues in babies born to women who used Zofran as an anti-nausea drug during their first trimester. For example, there is evidence that shows the use of Zofran (ondansetron) by expectant mothers increases the risk of:

• Club foot
• Cleft palate
• Heart defects

Other studies have reported no definitive link between congenital health issues and the use of Zofran during the early months of pregnancy.

Plaintiffs’ Claims in Zofran Lawsuits

GSK isn’t the only company manufacturing and selling ondansetron. Once the patent expired, other drugmakers could profit off the medication.

Hundreds of plaintiffs sued GSK in federal court. Their claims alleged that the defendants failed to warn about the drug’s potential risks to developing fetuses.

The courts consolidated these claims into a master complaint for multidistrict litigation (MDL) in the U.S. District Court of Massachusetts before Judge F. Dennis Saylor, IV in 2015. The complaint argued that the drugmakers should have considered the already-established role of serotonin in normal child development.

Zofran injury lawsuits claimed that drug manufacturers:

• Unfairly marketed the drug for off-label use in pregnant women
• Concealed evidence pointing to possible congenital health issues
• Failed to warn the public of these known risks

Status of Zofran Litigation

In 2021, when the Zofran trial commenced, the district court dismissed all 425 claims. The court indicated that federal law preempted any state law claims raised by the plaintiffs.

In January 2023, attorneys for the plaintiffs filed a motion with the United States Court of Appeals for the First Circuit asking that the court revive the cases. The court rejected their request, stating that federal law still preempted the plaintiffs’ claims. The court also found that the Japanese research on the effects of Zofran in their animal studies was not new information. It was a complete victory for the defense, dismissing all plaintiffs’ claims. This ruling effectively ended every Zofran lawsuit in the United States.

Does Zofran Pose a Danger for Pregnant Women and Their Newborns?​

As mentioned above, plaintiffs in the Zofran lawsuits argued that the defendants knew that the drug caused congenital health issues in newborns but chose to hide that fact. The problem is that the evidence of whether the medication does cause these problems is inconclusive.

In 2023, the U.S. Centers for Disease Control and Prevention (CDC) published a study that found that pregnant women who took Zofran had no greater risk of having a child with congenital health issues than women who didn’t take the drug.

Other studies have reached similar conclusions. The CDC, along with other experts, confirmed that further research is needed to determine whether the prescription drug ondansetron is safe to use if you are pregnant.

Did GSK Perform Research on Zofran Before Marketing It To Expectant Mothers?​

One fact that plaintiffs’ attorneys pointed to was that GSK did not perform any studies or research on the effects of Zofran on pregnant women or the fetus before marketing it for this off-label use.

The Courts found that studies done before the FDA approved Zofran did not show a specific link between congenital health issues and the medication. Even when a recent Japanese study found that the drug caused birth problems in animal fetuses, the FDA still didn’t require a unique warning label.

Did Zofran Affect the Health of Your Baby? Use? Consult an Attorney

If you believe Zofran has caused a medical issue for your unborn child, you should seek appropriate medical treatment. You may also want to consult with an experienced attorney. They can advise you about the viability of any claim against the drug manufacturers for your damages given the outcome of the Zofran MDL.

FindLaw’s directory of personal injury attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug litigation.