Zofran Lawsuit: A Comprehensive Guide (2024)

Andrii Daniels


Reviewed By Adam Ramirez, J.D.


Read in 5 mins

Pregnancy brings a variety of changes to a woman’s body. Some of these changes can be unpleasant and include nausea and vomiting. Before the Zofran lawsuit controversy, pregnant women across the United States relied on Zofran to get relief from these undesired symptoms of pregnancy.

The problem with using pharmaceuticals to get relief from morning sickness and other unwanted symptoms of pregnancy is that not all medications marketed to treat those symptoms are approved by the U.S. Food and Drug Administration (FDA) and not all of them are safe. Ondansetron, sold under the brand name “Zofran,” has been one of the most commonly prescribed medications to treat nausea and vomiting in pregnant women for decades.

However, what many pregnant women who take Zofran do not realize is that the use of this medication during pregnancy is considered an “off-label” use because the FDA never approved this drug for preventing morning sickness in pregnant women, not to mention that there have been studies linking the use of Zofran during pregnancy to an increased risk of birth defects.

Have you taken Zofran during pregnancy and your child was born with birth defects? You might want to discuss your legal options with a lawyer. ConsumerShield can connect you with the right legal experts to answer your questions and represent you in your Zofran lawsuit against the drug’s maker, GlaxoSmithKline. Get in touch today by filling out our ‘Contact Us’ form.

Zofran Lawsuit Updates

  1. Significant Ruling on Zofran Labeling
  2. Appeals Court Upholds Dismissal Decision

Free Zofran Lawsuit Case Review!

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What is the Zofran Lawsuit?

Since 2015, when the first Zofran lawsuit was filed over birth defect claims, the drug’s maker, GlaxoSmithKline (GSK), has been under fire for the promotion of the anti-nausea medication without the authorization required from the FDA. Plaintiffs in Zofran class action lawsuits claim that the drug’s warning label does not list the increased risk of birth defects to unborn children when the medication is taken during pregnancy.

History of Zofran

In 1991, Zofran was approved by the FDA to help treat nausea and vomiting in cancer patients after chemotherapy and radiotherapy. However, given the effectiveness of Zofran, many doctors started prescribing Zofran to pregnant women despite the fact that the medication was not approved by the FDA for that use.

After Zofran gained popularity and recognition among pregnant women, the drug’s maker, GlaxoSmithKline, started actively promoting the medication for morning sickness.

How Many Pregnant Women Were Exposed to Zofran?

The number of monthly prescriptions of Zofran to treat morning sickness in pregnant women skyrocketed from 50,000 in 2008 to 110,000 in 2013, even though there were already concerns regarding possible birth defects around that time. An article in the American Journal of Obstetrics and Gynecology in 2014 highlighted the studies that linked the use of Zofran during pregnancy to the increased risk of birth defects.

There are more than 6 million pregnancies a year in the United States, according to the Centers for Disease Control (CDC). A study published in the British Journal of Clinical Pharmacology indicates that 25% of pregnant women in the U.S. use ondansetron, the generic name of Zofran, to treat morning sickness. It thus can be estimated that about 1.5 million pregnant women in the U.S. could be exposed to Zofran every year.

What Birth Defects Are Caused by Zofran?

Since 2015, the use of Zofran during pregnancy has been linked to the following birth defects in Zofran class action lawsuits and individual lawsuits filed against GlaxoSmithKline:

  • Congenital heart defects
  • Cleft palate
  • Cleft lip
  • Neural tube defects
  • Musculoskeletal deformities
  • Ventricular Septal Defect (VSD)
  • Atrial Septal Defect (ASD)

If you took the anti-nausea medication while pregnant and your child was born with any of these or other birth defects, you might be entitled to financial compensation by joining forces with other plaintiffs in class action cases or filing an individual lawsuit.

FDA’s Stance And Advisory Warnings

The FDA has advised people to use Zofran during pregnancy cautiously. FDA has not yet approved the usage of Zofran for treating pregnancy-related morning sickness.

However, it yet admits that health experts may prescribe Zofran off-label only for severe conditions. Therefore, the FDA has given severe warnings concerning the impact of Zofran on the cardiac malformation of an infant.

Hence, these advisory warnings allow prescribers and pregnant women to take extra caution before deciding to take any Zofran pill.

Emerging Studies And Findings

Several studies and research have investigated the possible connection between the use of Zofran and its observed effects on the health of newly born during pregnancy. However, some studies found that the usage may lead to birth defects in the child, like orofacial clefts or cardiac malformation.

Whereas some studies do find the connection but not consistently, which changes the whole perspective of the findings. Therefore, it still needs further investigation to find out more about their connection and potential risks.

Cardiac Anomalies And Orofacial Clefts

The use of Zofran during pregnancy develops several birth defects in infants. However, orofacial clefts and cardiac malformation are the two most seen birth defects.

Several scientific studies have shown that the use of Zofran increases the chances of cleft palate or conventional heart anomalies in the newly born baby.

Therefore, it is necessary to observe these discoveries with a more critical point of view and consider other factors and potential causes of changes.

What Do Lawsuits Against GlaxoSmithKline Allege?

To date, GlaxoSmithKline has been named as the defendant in more than 600 lawsuits. Plaintiffs in Zofran lawsuits allege that GSK illegally and fraudulently promoted the drug as a way to treat morning sickness in pregnant women while having no FDA approval for that use.

What Are Zofran Class Action Lawsuits?

A class action lawsuit is a type of lawsuit that allows multiple plaintiffs – known as a “class” – to join forces and fight one defendant. If the plaintiffs win, the court will distribute the money paid by the defendant based on a set formula. In a typical Zofran class action lawsuit, mothers of children born with birth defects join forces against GlaxoSmithKline to recover compensation for the losses and damages incurred.

At ConsumerShield, we help women who had babies born with Zofran birth defects fight for the justice they deserve. We understand the pain and heartbreak a mother feels when her child is born with preventable birth defects because of a drug. Our team can review your situation and connect you with the right experts who can provide you with the legal guidance you need. Fill out our ‘Contact Us’ form to get started today.

Frequently Asked Questions

  • Orofacial clefts and cardiac anomalies are considered two alleged birth issues that especially occurred due to Zofran. Moreover, some scientific studies and researchers claim a possible link between the developing risk of infant birth defects and the usage of Zofran during pregnancy.

  • The Food and Drug Administrator has issued advisory communication and warning related to the use of Zofran during pregnancy. Moreover, FDA has found out that off-label prescription of Zofran to pregnant women may lead to concerning risks affecting the cardiac health of an infant.

  • If you have a firm belief that Zofran has affected the health of your child in any way, then approach a pharmaceutical litigation expert attorney. Consult with an expert attorney, as they can help you understand the legal proceedings and aid in filing a Zofran lawsuit if needed for compensation.

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