Created by FindLaw's team of legal writers and editors | Last reviewed December 03, 2018
An expectant mother wants nothing more than for her child to have a healthy start to life, so it came as a shock to many women when a popular morning-sickness drug became linked with birth defects, miscarriages, and other serious complications. The medication, marketed and sold by GlaxoSmithKline LLC (GSK) under the brand name Zofran, was originally approved for use in cancer patients undergoing chemotherapy and radiation therapy, as well as for certain surgeries. However, GSK began marketing the drug for an "off-label" use in pregnant women -- without approval from the Food and Drug Administration (FDA) -- to alleviate the nausea associated with morning sickness in the first trimester.
The company is now facing a growing number of Zofran lawsuits for failing to warn doctors and patients about the allegedly high potential for serious complications, including cleft palate and heart abnormalities. This article provides the basic facts about the drug and tips for how to pursue your legal options if you or a loved one has been injured by its off-label use.
Zofran and Morning Sickness: The Basics
Zofran is the brand-name for the drug ondansetron, which was first approved for use in 1990 mainly for nausea related to cancer treatments. Strativa Pharmaceuticals began selling a version of ondansetron called Zuplenz in 2010 that could be orally administered without water. Generic ondansetron entered the market in 2006 after the patent for Zofran expired and drugmaker Novartis acquired the rights to market Zofran in 2015.
The drug works by blocking the effects of serotonin, which is associated with nausea and vomiting. Soon after the drug's approval, GSK began marketing the medication for use in pregnant women to ease the nausea that is common in the first trimester of pregnancy, typically referred to as morning sickness.
While a few studies have shown a markedly increased risk of birth defects caused by the mother's use of Zofran during the first trimester, including one claiming it doubles the risk of a cleft palate, the overall body of research remains inconclusive. Another study published by the American Journal of Obstretrics and Gynecology in 2014 found that the use of ondansetron by expectant mothers was associated with an increased risk of club foot, cleft palate, and other birth defects in children.
What Zofran Lawsuits are Claiming
Both GSK and Novartis, which now sells the drug, have been named as defendants in lawsuits by more than 250 families, alleging a failure to warn about its potential risks to developing fetuses. Those claims were consolidated into a master complaint for multidistrict litigation in the U.S. District Court of Massachusetts on May 31, 2016. The complaint argues that the drugmakers should have taken into account the already-established role of serotonin in normal child development.
Injuries claimed by women who have taken Zofran include the following:
- Torsades de pointes: an abnormal heart rhythm that can lead to sudden cardiac death
- Serotonin syndrome: over-accumulation of serotonin in the body, which can cause mild to severe symptoms
- Various birth defects: including cleft lip cleft palate, club foot, skull deformities, and heart defects (such as holes in the heart)
Zofran lawsuits specifically claim that GSK and Novartis unlawfully marketed the drug for off-label use in pregnant women, concealed evidence pointing to possible birth defects, and failed to warn the public of these known risks.
Get Legal Assistance with Your Zofran Lawsuit Today
Discovering that your newborn child has a birth defect can be emotionally jarring for anyone, particularly if it may have been caused by a widely prescribed drug. If you took Zofran or other forms of ondansetron during the first trimester of your pregnancy and are concerned about birth defects or other complications, get immediate medical attention. It's also a good idea to discuss the possibility of filing a Zofran lawsuit with a skilled drug and medical device lawyer near you.
You Don’t Have To Solve This on Your Own – Get a Lawyer’s Help
Meeting with a lawyer can help you understand your options and how to best protect your rights. Visit our attorney directory to find a lawyer near you who can help.
Contact a qualified product liability attorney to make sure your rights are protected.