Parents from Illinois have filed a Zofran birth defect lawsuit, alleging that prenatal exposure to the anti-nausea drug caused their son to develop a rare combination of congenital heart defects collectively known as Tetralogy of Fallot.

The family filed their Zoran birth defect lawsuit, joining a dozen other laintiffs in the growing Zofran litigation, in the U.S. District Court for the Southern District of Illinois.

Plaintiff Jamie B. was first administered Zofran intravenously, and then prescribed tablets of the morning sickness drug, early in her first trimester, according to her lawsuit. Her son, delivered in 2006, was quickly diagnosed with the severe and complex congenital heart defect.

Now 9 years old, the child has already undergone open-heart surgery and “multiple [additional] procedures,” his parents say. His condition, marked by four different congenital heart defects that often accompany one another, may be “permanent and / or […] fatal,” according to the Zofran birth defect lawsuit.

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

Jamie and Brad B. further allege that over time, “B.B. may present with long-term problems including arrhythmia, pulmonary regurgitation, and [require] re-operation.”

Noting a series of medical research studies that have found an increased risk for congenital heart defects among babies exposed to Zofran in utero, Jamie and Brad claim their son’s congenital birth defects were result of his prenatal exposure to the anti-nausea 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 – an abnormal narrowing of the pulmonary valve which controls blood flow from the right ventricle to the pulmonary artery, blocking 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 heart defects make it extremely difficult for the heart to provide the necessary amount of oxygen to cells. 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.

Zofran Birth Defect Lawsuits

Amid allegations that GlaxoSmithKline unlawfully promoted Zofran as an “off label” morning sickness drug and concealed evidence of the drug’s link to major birth defects, families continue to file Zofran lawsuits.

Any mother prescribed Zofran during pregnancy who delivered a child with birth defects may be entitled to file a Zofran birth defects lawsuit against GlaxoSmithKline.

The Zofran Birth Defects Lawsuit is Case No. 3:15-cv-00787 in the U.S. District Court for the Southern District of Illinois.