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Michael Monheit
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Texas Mother Claims Zofran Exposure Led To Birth Defects


On April 17, 2015, a mother from Texarkana, Texas filed the sixth lawsuit in a litigation surrounding GlaxoSmithKline’s potent anti-nausea medication Zofran. Along with six additional plaintiffs who have filed their own individual claims, she says that prenatal exposure to Zofran caused her child to develop major birth defects.

In Texas, A Mother Says Zofran Caused Her Daughter’s Congenital Heart Defects

In her complaint, filed in the United States District Court for the Eastern District of Texas, Texarkana Division under case number 5:15-34, this mother claims that she was prescribed Zofran during early pregnancy as an “off label” treatment for morning sickness.

Court documents note that Zofran has never been approved by the FDA for use during pregnancy, and that the drug’s manufacturer, GlaxoSmithKline, has never “carried out a single study on the effects of this powerful drug on a pregnant mother or her growing fetus.”

Pharmaceutical manufacturers are not allowed to promote drugs for unapproved uses in the US. But according to plaintiff, almost immediately after the drug’s initial approval in 1991, GlaxoSmithKline “launched a marketing scheme to promote Zofran to [obstetricians and gynecologists] as a safe treatment alternative for Morning Sickness.”

US Federal Government Claims GlaxoSmithKline Unlawfully Promoted Zofran As Morning Sickness Treatment

Citing a lawsuit filed against GlaxoSmithKline by the federal government in 2012, plaintiff alleges that the company unlawfully marketed Zofran as a “safe and effective” treatment for the nausea and vomiting of pregnancy.

In a landmark case of alleged health care fraud, the US Department of Justice claimed that GlaxoSmithKline had:

  • “promoted the sale and use of Zofran for a variety of conditions other than those for which it was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea),
  • made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran concerning [the drug’s use as a morning sickness treatment] and
  • offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”

Under the weight of these damning allegations, GlaxoSmithKline agreed to settle the government’s case for a record-breaking $3 billion.

But the company continues to maintain that it never promoted Zofran for use during pregnancy. Plaintiffs in at least seven Zofran birth defect lawsuits claim otherwise, insisting that GlaxoSmithKline’s alleged “off label” promotion of Zofran placed a drug with unknown, and potentially devastating, effects on fetal development directly into the hands of unsuspecting pregnant women.

Zofran Caused Child’s Congenital Heart Defects, Plaintiff Alleges

After being exposed to Zofran during the first trimester, plaintiff’s daughter “was born in 2014 with numerous congenital defects.” Court documents list a number of birth defects allegedly caused by Zofran exposure, including:

  • “heart murmur,
  • fluid on the brain,
  • thickened arteries and
  • multiple developmental delays.”

It should be noted that both “heart murmur” and “thickened arteries” are often symptoms of a congenital heart defect. Primarily diagnosed in relation to a class of heart defects known as “cardiac septal defects,” heart murmur is a characteristic sound produced by blood flowing over improperly formed cardiac walls. Arteries often become thick in response to the undue stress that a cardiac septal defect forces heart chambers to endure.

Studies Find Link Between Zofran & Increased Congenital Heart Defect Risks

In support of her claim that Zofran caused her daughter’s heart defects, plaintiff cites a number of epidemiological studies that have found an increased risk of congenital heart defects among babies exposed to Zofran during early development.

The mother refers to three studies, conducted in 2013 and 2014 by separate teams of researchers in Sweden and Denmark.

The first study, which reviewed the prescription and birth records from more than 600,000 Danish pregnancies, indicated in supplemental materials that women prescribed Zofran were:

  • 22% more likely to deliver babies with a cardiac septal defect
  • 41% more likely to deliver babies with a ventricular septal defect
  • Four times more likely to deliver babies with an atrioventricular septal defect

Subsequent research only strengthened Zofran’s association to an increased risk of congenital heart defects. A second Danish team expanded on the first, including more than 900,000 live births between 1997 and 2010. The researchers concluded that mothers prescribed Zofran during the first trimester, when birth defects are most likely to develop, were:

  • 60% more likely to deliver babies with a congenital heart defect
  • 2.1 times more likely to deliver babies with an atrial septal defect
  • 2.3 times more likely to deliver babies with a ventricular septal defect
  • 4.8 times more likely to deliver babies with an atrioventricular septal defect

Using similar methods, a group in Sweden found that pregnant women who took Zofran in early pregnancy were:

  • 62% more likely to deliver babies with a congenital heart defect
  • More than twice as likely to deliver babies with a cardiac septal defect

According to plaintiff, GlaxoSmithKline did not just ignore this mounting evidence of Zofran’s potential risks, the company has been actively concealing the link for years.

Plaintiff Alleges GlaxoSmithKline Knew Of Zofran’s Potential Risks, Failed To Warn Public

She refers first to a series of studies performed on pregnant animals in the mid-1980s. These trials were conducted by GlaxoSmithKline to determine whether or not Zofran posed any “teratogenic” risks in rats and rabbits. A “teratogen” is any chemical, substance or factor that causes malformations in a developing embryo. According to plaintiff, the studies revealed two significant findings:

  1. Zofran’s active ingredient is able to cross the placental barrier in pregnant mammals. In other words, Zofran can be transferred from maternal blood to the body tissues of her unborn offspring.
  2. Animals administered Zofran demonstrated “clinical signs of toxicity” including “premature births, intrauterine fetal deaths and […] incomplete bone growth.”

But in relaying its study results to the FDA, GlaxoSmithKline reported that Zofran had not been associated with any harm to the fetus, plaintiff claims.

Next, plaintiff claims that GlaxoSmithKline began receiving reports of birth defects with suspected ties to Zofran exposure, as early as 1992. Up to the present, the company has received more than 200 of these reports, she says, and the most commonly-reported abnormalities have been congenital heart defects.

Citing federal laws (21 C.F.R. § 201.57(e)) that require manufacturers “describe clinically significant adverse reactions” in a drug’s labeling, plaintiff claims that GlaxoSmithKline was legally obligated to include information on these birth defect reports. But as her complaint notes, Zofran’s warning label has listed the same pregnancy-related information since 1993, and makes no mention of either birth defect reports or the recent epidemiological studies that have associated Zofran to major birth defect risks.

Can My Family File A Zofran Birth Defect Lawsuit?

If the allegations leveled against GlaxoSmithKline in Zofran birth defect lawsuits are true, any parent who was prescribed Zofran as an “off label” morning sickness treatment during early pregnancy and then gave birth to a child with congenital abnormalities may be eligible to file a claim.

Monheit Law has gathered an alliance of experienced attorneys to investigate potential Zofran cases. Together, these lawyers are providing free consultations to families and birth defect survivors interested in learning more about the ongoing Zofran litigation and their own case eligibility. For more information, call 1-877-620-8411.

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