Zofran Birth Injury Lawsuit: What to Know

What Is Zofran?

First approved by the FDA in January 1991, Zofran (ondansetron) is a powerful anti-nausea drug typically prescribed for chemotherapy or radiation patients. Its patent was obtained by GlaxoSmithKline (GSK), a pharmaceutical company, which began expanding Zofran’s market and medical uses. 

The drug eventually became used to treat nausea and morning sickness in pregnant women. Additionally, studies have shown Zofran can potentially help with schizophrenia, dyskinesia, and Parkinson’s disease. With so many uses, it’s easy to see why Zofran was such a popular drug. Unfortunately, it’s also been shown to create an increased risk of birth defects, leading to hundreds of lawsuits.

Why Was Zofran Prescribed to Pregnant Women?

Despite its lack of FDA approval, Zofran (ondansetron) became increasingly popular among pregnant women in the late 1990s and early 2000s. This was due to the convincing marketing tactics of GlaxoSmithKline, the drug’s manufacturer. Because of Zofran’s impressive anti-nausea capabilities, physicians began prescribing it to pregnant women suffering from morning sickness, unaware of the potential risks.

It was incredibly tempting for physicians to prescribe Zofran, considering it was easy to use and effective. Unfortunately, this decision had severe side effects for babies, namely congenital malformations, and negative repercussions for hundreds of families across the country.

What Were the Complications Caused by These Prescriptions?

Taking Zofran during pregnancy has been linked to various birth defects, including cleft palate, heart defects, and other severe abnormalities and deformities in newborns. These complications can cause lifelong physical, psychological, and financial hardship for families. Most notably, these families have to pay for the expensive healthcare treatments needed for their children, including surgeries, therapies, and medications.

History of Zofran Claims

The first Zofran lawsuit was filed in February 2015. In Minnesota, Cheri Flynn claimed that her two daughters were born with severe congenital heart defects caused by Zofran when she took it during her pregnancy. Only four days later, another mother from Massachusetts filed a similar lawsuit. This mother, Tomisha Leclair, had a daughter with multiple congenital defects, including:

• Webbed toes
• Facial dysmorphia
• Low set ears
• Heart defects
• Light sensitivity
• Inguinal hernia

The daughter required over ten surgeries to manage several of these issues. Another case popped up in July 2015. Angela and Brian Kutzer’s son was born missing one kidney and only a partial vas deferens, impacting his ability to have children. Another case involved parents Charles Jank III and Ashley Davis. Their son, C.J., was born with a cleft lip and cleft palate. The mother, Ashley, took Zofran during her first trimester of pregnancy. Unfortunately, C.J. now lives with severe mental developmental problems and communication issues.

As you can see, the legal situation surrounding Zofran is complex and has been developing over the years. In fact, over 623 similar lawsuits have been filed. Unfortunately, most of these cases have been dismissed.

Where Do Zofran Claims Stand Now?

In 2022, a federal judge overseeing the Zofran multidistrict litigation (MDL) dismissed 425 lawsuits against GlaxoSmithKline. The ruling stated that the FDA would not have allowed a warning about pregnancy risks on the drug label, citing its earlier rejection of such warnings. This means the remaining mass tort birth defect claims filed by pregnant women who took Zofran are unlikely to be successful.

Questions Others Are Asking

Learn more about Zofran class action lawsuits from our frequently asked questions.

Did Zofran get recalled?

No, Zofran has not been recalled by the FDA. However, there is now a black box warning about taking the drug, and many parents have filed lawsuits against GlaxoSmithKline for birth injuries caused by the drug.

How does Zofran affect the brain?

Zofran blocks the effects of serotonin in the brain, which is a major contributor to nausea, vomiting, and other neurological effects. This can reduce or eliminate feelings of nausea and vomiting, but it also has the potential to cause birth defects in unborn babies.

Does Zofran have a black box warning?

Yes—in 2012, the FDA issued a black box warning on Zofran, citing the potential for an electrocardiogram to spot a prolonged QT interval when using this drug, which may lead to irregular and potentially fatal heart rhythms.