Zofran Lawsuit What is, Definition, Meaning

What is the Zofran Lawsuit? (2024)

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Andrii Daniels


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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 1983, the only FDA-approved medication to treat nausea and vomiting during pregnancy – Bendectin – was discontinued and withdrawn from the market. This left millions of pregnant women in the United States suffering from morning sickness with no approved medications to get symptom relief.

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 even though the promotion of drugs for off-label use is against the law.

How Many Pregnant Women Were Exposed to Zofran?

An article published in the American Journal of Obstetrics and Gynecology in 2014 showed that 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. The article also highlighted the studies that linked the use of Zofran during pregnancy to the increased risk of birth defects.

According to the Centers for Disease Control (CDC), there are more than 6 million pregnancies a year in the United States. 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. Provided that these numbers are correct, it can be estimated that about 1.5 million pregnant women in the U.S. could be exposed to Zofran every year.

What Are the Birth Defects 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.

What Do Lawsuits Against GlaxoSmithKline Allege?

To date, GlaxoSmithKline has been named as the defendant in more than 600 actions pursued in federal court. 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

  • The primary usage of Zofran is to give relief from post-surgery, post-radiation, post-chemotherapy vomiting, and nausea. It serves as an anti-nausea medicine that targets the receptors of serotonin in the gastrointestinal tract and brain, then blocks them.

  • Yes, various alternatives especially cure pregnancy-related morning sicknesses like vomiting and nausea. For a better approach, consult your physician expert for personalized prescriptions. Moreover, it is crucial to openly discuss beforehand any type of related benefits and risks before choosing any medicine during pregnancy.

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