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Zofran Birth Defects Lawsuit

Did you take Zofran® or other morning sickness medication during pregnancy?
Was your baby born with a birth defect?

If so, let us help you explore your child’s potential Zofran lawsuit. There may be a link between taking Zofran® during pregnancy and serious birth defects. Our compassionate team of trial attorneys and staff are actively investigating Zofran’s link to birth defects and are accepting injury cases from across the country.

What is Zofran?

Zofran (ondansetron) is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It is in a class of medications called 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Zofran was not manufactured to prevent nausea or vomiting caused by factors other than cancer treatment or surgery. Yet, it is often prescribed as an “off label” treatment for women who suffer from morning sickness or other nausea and vomiting during pregnancy.

Zofran Blamed for Birth Defects

Studies indicate pregnant women who take Zofran while pregnant are at an increased risk of having babies with the following abnormalities:

  • Heart defects, including septal defects or holes in the heart
  • Craniofacial defects, including cleft palates
  • Kidney malformations

The Toronto Star, Canada’s largest daily newspaper, published an article detailing the risk of Zofran related to potential birth defects.

According to the Toronto Star analysis of 2012 records, at least 20 women who were treated with ondansetron during pregnancy “experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations.”

The article later states “four of the Canadian babies featured in the FDA side-effects report reviewed by the Star were born weighing as little as four-and-a-half pounds. In six cases, a suspected side-effect of ondanestron was listed as ‘fetal growth restriction.’”

When asked to comment by the Star on the side-effects research, manufacturer GlaxoSmithKline (GSK) said “the safety of ondansetron for use in human pregnancy has not been established …”

GSK Promoted Zofran for uses that were Not Approved as Safe and Effective by The Food And Drug Administration.

In later developments, GlaxoSmithKline, pleaded guilty and agreed to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the U.S. Department of Justice announced in 2012. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.

“At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.”

– James M. Cole, 2010 – 2015 U.S. Deputy Attorney General

As part of the 2012 settlement, GSK agreed to pay $2 billion in civil damages to federal and state health care programs, which is the largest civil recovery from a drug company in a single global resolution. This includes over $1 million in civil damages to resolve allegations relating to false claims arising from the off-label promotion and kickback allegations relating to nine drugs including Zofran.

“For a long time, our health care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid.”

– Bill Corr, Deputy Secretary of the Department of Health and Human Services (HHS), regarding the 2012 GSK settlement.

Do You Believe Your Child may have Unnecessarily Suffered because You took Zofran while Pregnant?

If so, our successful trial lawyers offer free consultations and will help you determine whether you can take legal action against the manufacturers of Zofran and ondansetron, including global health care giant GlaxoSmithKline. All consultations are completely confidential and will be conducted at no cost to you.

Contact an Experienced Pharmaceutical Litigation Lawyer

Call our firm at 254-761-3300 (Waco area) or 409-753-0000 (Beaumont area) to schedule a consultation and discuss your defective drug injury with our accomplished trial attorneys. Alternatively, you can fill out our online intake form and one of our experienced trial lawyers will contact you directly.


Contact the experienced litigation attorneys at Harrison Davis to schedule a free consultation and get the answers you need.

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