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Zofran Birth Defects Lawsuits & Settlements

Does taking the nausea medication Zofran for morning sickness cause birth defects?

There are a lot of great things about pregnancy, but ask pregnant individuals what they disliked most and many will say morning sickness. Morning sickness describes the experience of nausea and vomiting that many pregnant individuals experience. These symptoms typically occur at the beginning of pregnancy (during the first trimester), but sometimes nausea can persist throughout the entire pregnancy.

In an effort to combat and overcome debilitating morning sickness, some pregnant individuals turn to anti-nausea prescription medication for help. One such pharmaceutical is Zofran.

Zofran is the brand name of the generic drug ondansetron. It ostensibly works by blocking the chemicals in the body that cause nausea and vomiting. Its intended purpose is to help ease the symptoms of chemotherapy, radiation and surgery. However, as we’ll discuss in this article, Zofran has increasingly been used for off-label purposes—particularly among pregnant individuals to treat morning sickness.

Unfortunately, there may be very serious and harmful side effects of taking Zofran while pregnant.

Is Zofran FDA approved?

"FDA approved" means the U.S. Food and Drug Administration has determined that the "benefits of the product outweigh the known risks for the intended use." The FDA defines intended use as "the objective of the persons legally responsible for the labeling of devices," meaning the drug manufacturer.

So what is Zofran’s intended use?

When the makers of Zofran asked for FDA approval, they had to identify its intended use.

The FDA’s approval of Zofran states the "Indications and Usage" as follows:

ZOFRAN is a 5-HT3 receptor antagonist indicated for the prevention of:

nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2.

nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

postoperative nausea and/or vomiting. (1)

Notably, this list of FDA-approved uses does NOT include treatment of nausea in pregnancies.

By the same token, pregnancy usage is not among the FDA list of contraindications.

However, the FDA includes a "Pregnancy Risk Summary" under "Use In Specific Populations." In summary, it says that "epidemiological studies on the association between ondansetron (Zofran) use and major birth defects" are inconsistent and inconclusive.

By comparison, Australia and the United Kingdom unequivocally discourage Zofran as morning sickness treatment because of the risk of birth defects.

Increased off-label prescriptions despite risks

Despite the lack of FDA approval of Zofran for treating morning sickness, doctors and other medical professionals are increasingly prescribing “off-label” Zofran for that purpose—despite the fact that off-label prescribing is illegal.

What’s more, it may be quite dangerous. Some of the birth defects linked to a mother's use of Zofran during pregnancy include congenital heart defects, including atrial and ventricular septal defects, kidney obstruction, and cleft palate.

A study in 2012 showed that using Zofran during the first trimester more than doubled the chance of cleft palate. Other studies have linked Zofran to various birth defects, especially when used during the first trimester.

Zofran birth defect lawsuits

GlaxoSmithKline (GSK), the manufacturer of Zofran, has been sued in more than 600 cases alleging fraudulent marketing of Zofran, misrepresenting studies, claiming that Zofran is safe for pregnant women and even bribing doctors to prescribe Zofran.

Lawsuits against GSK started in 2015. Court documents showed that Zofran knew that it is metabolized through the human placenta. Nevertheless, doctors continued to prescribe and GSK continued to sell the drug to expectant mothers.

In 2015, more than 150 cases against GSK were consolidated, with plaintiff approval, by a federal court in Massachusetts. That number has since climbed to more than 600 cases. No cases have been set for trial yet, and there are no reported settlements.

Notably, the private lawsuits that began in 2015 are not the only legal action the company has faced for Zofran.

In 2013, the federal government sued GSK for medical fraud. GSK agreed to pay a fine of $3 billion.

Since the first lawsuit in 2015, GSK sold Zofran to Novartis which is now named as the defendant. The lawsuits have not been settled and are still in the discovery stage.

As for new cases, there may be a problem with the statute of limitations. However, it might be argued that the statute is tolled (deferred) by the defendant's fraud or concealment.

The challenges of Zofran litigation

Large pharmaceutical companies like GSK and Novartis have seemingly bottomless resources at their disposal they can use to wear down weary plaintiffs tired of costly litigation. Complex lawsuits against such major corporations can take years and cost thousands of dollars.

The good news is that most reputable personal injury attorneys will take these cases on a contingency, meaning there is no upfront fee for the plaintiff. Instead, the attorney will take a percentage of the final verdict or settlement.

Unfortunately, since pending cases take a long time to resolve, there are not yet any significant precedents for settlement in Zofran birth defect cases. However, GSK's settlement with the federal government might signal a trend.

What should you do?

If your baby suffers from any of the following conditions and you took Zofran during your pregnancy, there might be a linkage:

  • Heart rhythm problems
  • Heart murmur
  • Ventricular septal defect (known as "hole in heart")
  • Atrial septal defect
  • Cleft palate
  • Cleft lip

Consult with an experienced Tennessee pharmaceutical liability attorney at Gilreath & Associates to explore your legal options.


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