baby being checked up by the doctor
31 July 2015

Illinois Parents Claim Zofran Caused Tetralogy Of Fallot Heart Defects

On July 21, 2015, parents from Highland, Illinois filed the latest Zofran birth defect lawsuit, alleging that prenatal exposure to the anti-nausea drug caused their unborn son to develop a rare combination of congenital heart defects collectively known as Tetralogy of Fallot.

The family filed their claim, joining a dozen other Plaintiffs in the growing Zofran litigation, in the US District Court for the Southern District of Illinois. A copy of the court documents, logged as case number 3:15-cv-00787, can be found below:

View Complaint: 3:15-cv-00787

Zofran Caused Tetralogy of Fallot, A Combination Of Four Congenital Heart Defects, Plaintiffs Allege baby being checked up by the doctor

According to court documents, B.B.’s mother was first administered Zofran intravenously, and then prescribed tablets of the drug, early in her first trimester. Her son, delivered in 2006, was quickly diagnosed with a severe and complex congenital heart defect known as “Tetralogy of Fallot.” Now nine years old, B.B. has already undergone open-heart surgery and “multiple [additional] procedures,” his parents claim. His condition, marked by four separate congenital heart defects that often accompany one another, may be “permanent and / or […] fatal,” according to the Illinois family’s complaint.

Noting a series of epidemiological studies that have found an increased risk for congenital heart defects among babies exposed to Zofran in utero, Plaintiffs claim that their son’s congenital abnormalities were “a direct and proximate result” of his prenatal exposure to the drug.

What Is Tetralogy Of Fallot?

Tetralogy of Fallot (ToF), named for the French physician who was among the first to describe the condition, is not one cardiac birth defect, but four that often occur in combination:

  • Ventricular Septal Defect – a “hole in the heart,” or cardiac septal defect; a barrier separating the organ’s two lower chambers, the ventricles, fails to form properly, leaving an opening through which blood can flow.
  • Overriding Aorta – The aortic valve, which transports blood from the heart’s left ventricle to the aorta (and then out to the rest of the body) is abnormally large and appears connected to both the left and right ventricle.
  • Pulmonary Stenosis – “Stenosis,” an abnormal narrowing, of the pulmonary valve which controls blood flow from the right ventricle to the pulmonary artery. Pulmonary stenosis blocks blood flow from the heart to the lungs.
  • Right Ventricular Hypertrophy – forced to pump at high pressures, the right ventricle’s muscle walls thicken. Over time, this thickening makes the chamber rigid, forcing it to work even harder to pump adequate amounts of blood toward the lungs.

In combination, these four defects make it extremely difficult for the heart to provide cells and body tissues throughout the body with necessary amounts of oxygen. As a result, children born with ToF often present cyanosis, a blue tint to the skin and lips caused by inadequate oxygen supply. Many children experience “tet spells,” in which they become cyanotic suddenly and faint.

According to Plaintiffs, B.B.’s abnormalities “put[…] him at much greater risk of serious injury should he contract any type of infection.” The US Centers for Disease Control & Prevention expands on this fact, reporting that children born with Tetralogy of Fallot are also at a greater risk of suffering endocarditis, an infection in cardiac tissue.

The term “tetralogy,” denoting a condition with four parts, should not be confused with “teratology,” the study of birth defects and their causes. As a result, the field of teratology actually includes Tetralogy of Fallot as an object of research.

Plaintiffs write in their complaint that over time, “B.B. may present with long-term problems including arrhythmia, pulmonary regurgitation, and [require] re-operation.” Even adults who were born with Tetralogy of Fallot and had the defects surgically repaired require “lifelong regular follow-up with a cardiologist,” the American Heart Association reports.

Zofran Linked To Congenital Heart Defects In Multiple Studies

Plaintiffs cite three European studies, published between 2013 and 2014, that have found an association between prenatal exposure to Zofran and increased risks for congenital heart defects.

One of these papers, in which Danish researchers analyzed almost 900,000 prescription and birth records filed between 1997 and 2010, found that women prescribed Zofran’s active ingredient during the first trimester were 60% more likely to deliver babies with a congenital heart defect. Due to their extremely large sample size, the team was also able to identify specific abnormalities for which these babies were at an increased risk, including Atrial Septal Defect (ASD), a primary component of Tetralogy of Fallot. Women who ingested Zofran in early pregnancy were more than twice as likely to have babies with an ASD.

An abstract of the Danish study can be found on page 13 of this .PDF version of the peer-reviewed journal Pharmacoepidemiology & Therapeutic Risk Management.

A subsequent Swedish study would only support this link, finding women prescribed Zofran to be more than twice as likely to deliver children with “cardiac septal defects,” a category that includes ASD.

Zofran Birth Defect Lawsuits: Can Other Families File Claims?


Amid allegations that GlaxoSmithKline unlawfully promoted Zofran as an “off label” morning sickness (including charges leveled by the US Federal Government) and concealed evidence of the drug’s link to major birth defects, families continue to file new claims.

If these claims are true, any parent who was prescribed Zofran during early pregnancy and delivered a child with major birth defects may be entitled to file a lawsuit against GlaxoSmithKline. is sponsored by an alliance of experienced plaintiffs’ attorneys devoted to pursuing justice for parents and birth defect survivors nationwide. Led by Monheit Law, our experienced lawyers are providing free consultations to any family who believes that prenatal exposure to Zofran may have caused a child’s birth defects.

For more information and a case eligibility evaluation at no cost, call 1-877-620-8411 or fill out our contact form.

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