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Michael Monheit
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Plaintiff Alleges Exposure To Zofran Caused Congenital Heart Defects In Two Pregnancies


Gavel represents Zofran birth defect lawsuitOn February 12, 2015, a woman from Minnesota filed suit against GlaxoSmithKline (GSK) in the United States District Court of the Eastern District of Pennsylvania. Her complaint, filed under case number 2:15-cv-00709, was the first in an ongoing litigation surrounding the company’s anti-nausea drug Zofran. To date, seven other claims have been brought against GlaxoSmithKline.

In this article, we’ll outline the allegations made in this first Zofran birth defect lawsuit.

Mother Claims Zofran Caused Her Two Childrens’ Congenital Heart Defects

In 2004, plaintiff was prescribed Zofran to alleviate the symptoms of nausea and vomiting that commonly accompany early pregnancy.

Her complaint notes that Zofran was never approved for use in pregnant women. Zofran’s active ingredient, ondansetron, has only been FDA approved for the treatment of severe nausea and vomiting in three circumstances:

  • patients undergoing chemotherapy as a cancer treatment
  • patients undergoing radiotherapy, another cancer treatment
  • patients undergoing surgical anesthesia

Plaintiff Says GSK Unlawfully Marketed Zofran As Safe Treatment For Morning Sickness

Despite the fact that Zofran’s manufacturer has never conducted clinical trials to test the drug’s safety or efficacy during pregnancy, plaintiff alleges that GlaxoSmithKline “marketed Zofran ‘off-label’ as a safe and effective treatment” for morning sickness.

Under US law, pharmaceutical manufacturers are not allowed to promote drugs for any uses that have not been FDA approved. Indeed, plaintiff references a series of federal charges filed against GlaxoSmithKline in 2012, many of which involved “off-label” promotion. In her complaint, claimant notes that:

“at or around the same time, GSK also entered civil settlements with United States that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically.”

While GlaxoSmithKline has always denied that it promoted Zofran as a safe and effective treatment for morning sickness, plaintiff alleges that the company did, conduct she calls “tantamount to using expectant mothers and their unborn children as human guinea pigs.”

Two Children Born With Congenital Heart Defects, Developmental Delays

Plaintiff’s child, B.F., was born in 2004 “with a congenital heart defect.” According to the complaint, the child’s birth defect “prevented her from thriving physically and developmentally. As a result of her condition, B.T.’s growth metrics were below the fifth percentile compared with other children her age.” B.T. was finally forced to endure surgery, a procedure that repaired what the complaint refers to as a “hole in her heart.”

Plaintiff became pregnant again in 2006, and was prescribed Zofran to treat her morning sickness for the second time. Her second child, T.F., was born the same year, and diagnosed with a congenital heart defect. The complaint states that T.F. “was unable to breathe adequately [after birth] and required 24-hour monitoring with an electronic alarm that would alert her parents and caregivers that her oxygen levels were dangerously low.” Like B.F. before her, T.F. suffered from growth and development delays.

You can find more information on congenital heart defects here.

Was GlaxoSmithKline Aware Of Zofran’s Potential Risks During Pregnancy?

Plaintiff alleges that because GlaxoSmithKline “had never once undertaken a single study on the effects of [Zofran] on a pregnant mother or her growing child in utero,” the company had no evidence to support claims that it was safe for pregnant women to take.

Not only that, she claims that “GSK knew that Zofran was unsafe for ingestion by expectant mothers.”

Animal Studies Revealed Evidence Of Zofran’s “Toxicity”

First, she describes a series of studies conducted on pregnant rabbits and rats during the 1980s. These tests were intended to study Zofran’s potential “teratological” effects. In other words, they were meant to demonstrate whether or not exposure to Zofran could cause any abnormalities in fetal development.

One study proved that Zofran’s active ingredient could pass through the placental barrier, traveling from a pregnant animal’s blood to that of its unborn offspring. This result was independently confirmed in human subjects by researchers in Hong Kong in 2006.

According to plaintiff, the other animal studies “revealed clinical signs of toxicity,” including:

  • “premature births,
  • intrauterine fetal deaths, and
  • impairment of ossification (incomplete bone growth)”

Notably, the rate of intrauterine deaths observed increased as the dosage of ondansetron administered increased.

But rather than report these results as potential signs of ondansetron’s risk during fetal development, plaintiff states that GlaxoSmithKline told the FDA that its animal studies “show[ed] no harm to the fetus.”

Plaintiff notes that animal studies are never assumed to predict similar results in human subjects. In other words, even if these studies did not show harm to animal fetuses, GlaxoSmithKline could not have used that fact to support claims that Zofran was safe in pregnant humans.

GlaxoSmithKline Received Reports Of Birth Defects Associated With Zofran As Early As 1992

After reviewing the results of GSK’s animal studies, plaintiff states that “at least as early as 1992, [the company] began receiving reports of birth defects associated with the use of Zofran by pregnant women.”

She claims that GlaxoSmithKline has received over 200 such reports to date, and that many involve birth defects like:

  • congenital heart defects,
  • orofacial anomalies (including cleft palate and cleft lip),
  • musculoskeletal anomalies and
  • kidney malformations.

Plaintiff notes that under federal law pharmaceutical companies are “free to add or strengthen – without prior approval from the FDA – a contraindication, warning, precaution, or adverse reaction” to a drug’s labeling.

In light of the birth defect reports, she claims that GlaxoSmithKline had an “obligation” to strengthen Zofran’s warning label with information on these severe adverse events. But Zofran’s label has borne the same statements in regard to pregnancy since 1993.

Multiple Studies Find Increase In Birth Defects After Exposure To Zofran’s Active Ingredient

Plaintiff references three separate studies conducted to investigate ondansetron’s potential association with congenital birth defects.

1. “The Pasternak Study”

Performed using Danish birth records filed between 2004 and 2011, the Pasternak study identified all the pregnant women who had redeemed prescriptions for ondansetron in Denmark over that 8 year period. Comparing these Zofran-exposed pregnancies to unexposed ones, the researchers reported in their supplemental materials that women who took ondansetron were:

  • 41% more likely to have a baby with ventricular septal defect (VSD),
  • 22% more likely to have babies with any cardiac septal defect and
  • “greater than four-times more likely to have offspring with atrioventricular septal defect” (AVSD).

VSD and AVSD are two of the most common congenital heart defects. Both involve incomplete formation of cardiac tissue and are often referred to as “holes in the heart.” The complaint describes the defect with which B.F. was born in the same words.

2. “The Andersen Study”

The Anderson study was conducted immediately after the Pasternak study, and also investigated Danish birth records. Only this time, researchers expanded their data set to include all pregnancies in Denmark from 1997 to 2010.

Notably, the Anderson study eliminated from consideration pregnant women who had taken ondansetron after the first trimester. By the end of the first trimester, fetal organs are almost completely developed. The risk of developing a birth defect drops considerably afterwards. The Pasternak study’s methodology failed to account for this fact, and plaintiff claims that “this characteristic of the [Pasternak] study led to an under-reporting of the actual risk of prenatal Zofran exposure.”

The Andersen study found that “mothers who ingested Zofran during their first-trimester of pregnancy were more likely than mothers who did not to have a child with a congenital heart defect, and had a two- to four-fold greater risk of having a baby with a septal cardiac defect.”

The term “septal cardiac defect” refers to VSDs, AVSDs and other “hole in the heart” birth defects.

3. “The Danielsson Study”

Using birth records from Sweden, a team of Swedish researchers investigated more than 1.5 million births from 1998 to 2012. Much like the Andersen study, the Danielsson study concluded that ondansetron exposure was linked to a significant increase in congenital heart defects (CHD).

The risk of delivering a baby with any CHD was found to be 62% higher for mothers prescribed Zofran during the first trimester, and more than 200% greater in regard to cardiac septal defects.

Plaintiff does not mention two similar studies, most likely because the Pasternak, Andersen and Danielsson studies support an association between ondansetron and congenital heart defects specifically. To find information on this additional research, which has found an association between Zofran’s active ingredient, cleft palate and kidney malformations, click here.

Can Other Families File Zofran Birth Defect Claims?

In summary, the plaintiff in America’s first Zofran birth defect lawsuit alleges that:

  • GlaxoSmithKline unlawfully promoted Zofran to doctors as a “safe and effective” treatment for morning sickness
  • On the contrary, GlaxoSmithKline knew as early as 1992 that Zofran was associated with an increased risk of birth defects
  • GlaxoSmithKline under-reported these risks to the FDA, and failed to warn the public, doctors and pregnant women

Whether or not these allegations are true is a matter that will be decided in this, and at least six other, cases that have now been filed against GlaxoSmithKline. But if they are, any mother who was prescribed Zofran as a morning sickness treatment during the first trimester and then delivered a child with birth defects may be eligible to bring a claim for compensation against the pharmaceutical manufacturer.

If you would to like learn more about the on-going Zofran litigation, contact Monheit Law for a free consultation. We have joined together with a multi-state coalition of plaintiffs’ attorneys to investigate Zofran birth defect claims. We’re here to review your case eligibility 24 / 7, 7 days a week. Click this link to speak with an experienced lawyer today.

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