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Illinois Couple Blames Zofran for Child’s Tetralogy of Fallot

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On July 21, 2015, an Illinois couple filed a new Zofran birth defects lawsuit on behalf of their young son. They claim that the mother’s intake of Zofran during pregnancy caused the baby to suffer a congenital heart defect.

The couple blames manufacturer GlaxoSmithKline (GSK) for failing to provide adequate warnings about Zofran’s potential to cause birth defects. They filed the case in the U.S. District Court for the Southern District of Illinois, and are seeking in excess of $75,000 in damages.

Zofran Linked to Tetralogy of Fallot

According to the complaint, the mother took Zofran to prevent symptoms of morning sickness during her pregnancy. Though Zofran was never FDA-approved for such treatment, GSK advertised it to doctors as an effective off-label solution for morning sickness.

The couple’s son was born in 2006. Doctors diagnosed him with a congenital heart defect called “Tetralogy of Fallot.” This is a actually a combination of four defects in the heart:

1. A hole in the septum between the heart’s two lower chambers (ventricular septal defect)
2. Narrowing of the valve and the passage that goes from the right ventricle to the pulmonary (lung) artery
3. Overly thickened muscle of the right ventricle
4. Improperly developed aorta, which is the main artery carrying blood from the heart to the body—in this defect, it is located between the left and right ventricles (lower chambers of the heart) instead of being attached only to the left ventricle

Because of this defect, the couple’s child has already had to undergo open-heart surgery and multiple other medical procedures. It is expected that he will have to undergo additional surgeries, and that he will be at greater risk of injury caused by infection.

The mother claims that she was not aware that Zofran could cause birth defects, and that had she not been misled by GSK’s marketing materials, she would have never taken it during pregnancy. It was only recently that she learned that the drug was linked to an increased risk of birth defects.

GSK Pled Guilty to Criminal Charges Partially Concerning Zofran

It was back in 2006, the same year this couple’s child was born, that scientists discovered in a human study that Zofran was able to cross the placental barrier. Later studies linked the drug with a number of various birth defects, including cleft lip and palate, heart defects, and musculoskeletal anomalies.

In 2012, the company pled guilty to criminal charges lodged by the Department of Justice (DOJ) for the “off-label” promotion of drugs for uses never approved by the FDA. The civil settlement agreement between GSK and the DOJ stated that the company “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA,” and that it disseminated false representations about the safety and efficacy of the drug.

Indeed, Zofran was originally approved for the treatment of nausea and vomiting in chemotherapy patients and patients recovering from surgery. The drug was never studied in pregnant women.