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Zofran, also known as Zuplenz or ondansetron, was approved in the early 1990s as a way to help cancer patients battle nausea and vomiting after chemotherapy and radiation therapy treatment. However, seeing an opening for a wider market, the drug’s manufacturer began marketing the medication as an off-label use for pregnant women. Yet, numerous cases of birth defects associated with Zofran continue to surface more and more.

If your baby developed birth defects and you were prescribed Zofran during pregnancy, you may have a valid Zofran lawsuit on your hands. It’s important, however, to understand what qualifies as a valid case and what you can expect during the lawsuit process.

Why a Lawsuit?

According to court documents, GlaxoSmithKline, the manufacturers of ondansetron, knew as early as the 1990s that the medication has the potential to cause birth defects, as the drug passes through the placenta once a pregnant patient takes it.

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Yet, even armed with the knowledge of the risks to pregnant women and their infants, GlaxoSmithKline didn’t warn the public of its dangers. In fact, the company has been accused of offering “kickbacks” to physicians who prescribe the medication to pregnant women.

In addition, GlaxoSmithKline not only marketed Zofran as a safe way to treat morning sickness, but the company also falsified animal studies on the drug, stating that it was safe despite the results showing that it can cause unusual bone growth and toxic illness.

Zofran is not currently approved by the United States Food and Drug Administration (FDA) to treat morning sickness, yet millions of women have been prescribed it.

Fraud Case Against GlaxoSmithKline

In 2012, the United States Department of Justice (DOJ) filed both a civil and criminal lawsuit against GlaxoSmithKline after uncovering one of the biggest medication frauds in the history of the nation.

According to court documents, the drug manufacturer promoted the use of its famous antidepressant medications, including Paxil, Wellbutrin, and Avandia as a safe and effective way to treat weight issues, sexual dysfunction, and other medical problems that the medications were not approved for.

No individual patients were involved in the lawsuit, but GlaxoSmithKline agreed to settle the case for $3 million after overwhelming evidence proved that the company used illegal practices to market their medications. Although the settlement has nothing to do with Zofran lawsuits, it does establish a proven pattern of GlaxoSmithKline falsely advertising their medications.

Current Lawsuits

In February, 2015, Tomisha LeClair of Norfolk County, Massachusetts, was the first plaintiff to file a Zofran lawsuit after her daughter was born in 2000 with several birth defects. LeClair was prescribed Zofran during her first trimester to help treat her nausea and vomiting.

Shortly after, a Texas mother also filed a lawsuit after her infant was diagnosed with a heart murmur, hydrocephalus, developmental delays, and hardened arteries. Similar to LeClair, the Texas plaintiff was prescribed Zofran for nausea and vomiting.

Two additional lawsuits followed, one in Alabama and another in Montana. Both plaintiffs were prescribed Zofran for nausea and vomiting during pregnancy and both plaintiffs’ babies were born with severe birth defects.

More lawsuits included two cases filed in California. As with the other plaintiffs, the mothers in the California cases were prescribed the medication for nausea and vomiting during the first trimester. Their infants were born with birth defects. One infant was born with a heart defect, while the other one was born with a life-threatening medical condition called bicuspid aortic stenosis, in which the heart’s aortic valves do not function normally.

Although lawsuits associated with Zofran birth defects are still relatively new, additional cases are expected to follow as more and more information concerning its risks to pregnant women continue to surface.

Do I Have a Zofran Lawsuit?

It’s hard to determine for sure if you have a lawsuit before speaking with an attorney, but if you took the medication while pregnant and your infant was born with birth defects, there is a good chance you qualify.

The most common birth defects associated with Zofran include:

  • Cleft lip
  • Cleft palate
  • Abdominal problems
  • Vision problems
  • Deformities of the skull
  • Club foot and webbed toes
  • Hearing loss
  • Mental issues
  • Light sensitivity

Factors that may disqualify you from a successful lawsuit include:

  • Lack of harm: Even though you may have taken Zofran while pregnant, there must be actual harm done to your baby.
  • Genetic Anomalies: It’s important to rule out any genetic issues before pursuing a lawsuit as it can hinder your ability to seek compensation if biological factors played into the birth defect.
  • Risky Behavior During Pregnancy: Drinking, smoking, and other associated risky behaviors during pregnancy may disqualify you from a successful lawsuit (this is a case by case basis, however, and you should consult an experienced attorney).
  • Knowledge of Risks: If you signed a disclaimer in which you knew about, and agreed to, taking the risks associated with Zofran while pregnant, it may be difficult to prove your case.

These factors are general circumstances that may affect the outcome of your lawsuit, but it’s important to speak with your attorney first as each case is different. For more information about how to find an experienced lawyer to help you with your lawsuit, refer to our article, Zofran Lawyer.

Important Steps To Remember When Filing a Lawsuit

There are a few critical steps that need to be done to ensure your best chances of success when filing a lawsuit for a Zofran case. First, make certain to keep records of all of your prenatal and postnatal medical documents, including information on your Zofran prescription. Next, find a reputable physician who is experienced in treating patients who’ve been prescribed risky drugs.

Finally, be certain to retain the legal services of an experienced and knowledgeable Zofran lawyer who specifically specializes in cases involving dangerous prescription drugs.


2:15-cv-00544-JEO, U.S. District Court, Northern District of Alabama

1:15-cv-00026-SPW-CSO in the United States District Court, District of Montana Billings Division