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Zofran (ondansetron) is commonly prescribed to pregnant women as a treatment for nausea and morning sickness. The drug, however, has not been approved by the U.S. Food and Drug Administration (FDA) for this use and can cause serious birth defects.
If you took Zofran while pregnant and your child was born with a birth defect, you may be entitled to compensation through a Zofran lawsuit. Our experienced class action lawyers can help you fight for compensation for medical bills, pain and suffering, and more. Schedule a free consultation today to learn more. We do not get paid unless you do.
Not Approved to Treat Morning Sickness
Zofran was originally developed to treat nausea and vomiting in post-surgical and cancer patients. However, the drug’s manufacturer, GlaxoSmithKline, also encouraged doctors to use the drug for pregnant women suffering from nausea and morning sickness. Many doctors may not have known Zofran was not approved for morning sickness.
Marketing a drug for a purpose for which it has not been approved is an illegal practice known as “off-label marketing.”
In 2012, the company plead guilty to federal charges of illegal marketing of several drugs and agreed to a $3 billion settlement with the U.S. Department of Justice. This settlement, however, does not compensate women who delivered children with birth defects after taking Zofran during pregnancy.
Women whose children were born with birth defects may be entitled to file a Zofran lawsuit against GlaxoSmithKline for its failure to warn about the dangerous side effects associated with its drug. Our attorneys can help you determine your legal options.
Birth Defects Linked to Zofran
Morning sickness usually occurs in the first trimester of pregnancy, which is when fetuses are most susceptible to developing birth defects from prescribed drugs.
A 2012 study of women taking Zofran, or its generic version ondansetron, for morning sickness found that children exposed to this drug were two times more likely to develop cleft palates than those not exposed to the medication.
In 2013, researchers analyzed medical records of more than 600,000 children exposed to Zofran during pregnancy and found an increased risk for a child to be born with a birth defect, specifically heart defects. However, another group of researchers looking at the same data found no increased risk.
A Toronto Star investigation in 2014 analyzed the medical records of Canadian women who submitted reports to the FDA’s Adverse Events Report Database and found 20 cases in which women taking Zofran delivered babies with birth defects. The investigation also uncovered two reports of infant deaths.
Some of the most common birth defects associated with this dangerous drug are:
- Heart defects
- Septal defects (holes in the heart)
- Heart murmur
- Cleft palate
- Cleft lip
- Skull deformities
- Club foot
- Kidney malformations
If you took Zofran during pregnancy and your child was born with any of these birth defects, or others not listed, you deserve justice. A Zofran lawsuit can help secure your future and provide you with the compensation you deserve.
Current Zofran Lawsuits
Despite evidence that links Zofran to causing birth defects, GlaxoSmithKline did not warn doctors or patients about these life-altering side effects. Because of this, hundreds of families have filed lawsuits against the drug’s manufacturer seeking compensation for the harm done to their children.
More than 300 of these cases have been consolidated into multidistrict litigation in the U.S. District Court for the District of Massachusetts, with many others expected to be filed.
Learn More About Filing a Zofran Lawsuit
Women who took Zofran while pregnant and gave birth to children with serious health problems or physical malformations should contact our experienced dangerous drug attorneys.
At Janet, Janet & Suggs, LLC, we have a strong record of recovering significant verdicts and settlements against large pharmaceutical companies. Our team has the knowledge and the resources to go up against these giant companies and have successfully represented thousands of clients in this area.
Your initial consultation with our firm is always free, and because we work on a contingency fee basis, we charge nothing unless you recover compensation.