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Tetralogy Of Fallot Heart Defects Caused By Zofran, Says Parents

Last month, parents from Highland, Illinois filed a Zofran lawsuit against the makers of the medication, GlaxoKlineSmith. The lawsuit was filed after their unborn infant was diagnosed with a severe heart defect prior to birth.

According to court documents, filed at the United States District Court for the Southern District of Illinois, the plaintiffs’ baby, a boy, was diagnosed with a condition known as Tetralogy of Fallot, a serious birth defect that’s marked by four different heart defects.

The baby’s mother experienced severe nausea and vomiting. She was first given Zofran intravenously, but later switched to the pill form. She took the medication during her first trimester of pregnancy. In 2006, her infant son was born with a series of serious birth defects, and according to court documents, spent numerous hours in open-heart surgery. He also had to go through various other procedures in attempt to save his life.

The plaintiffs’ son is now a 9-year-old, and lives with the risk of developing life-threatening conditions, including:

  • Heart tissue infections
  • Pulmonary valve regurgitation
  • Arrhythmia

About Tetralogy of Fallot

Tetralogy of Fallot consists of four different types of the following heart defects, each of which are serious on their own, but when combined, can become life-threatening:

  • Ventricular Septal Defect (VSD): A hole in the heart’s chambers
  • Pulmonary Stenosis: The heart’s right ventricle valve, as well as the artery, are too narrow, causing major complications
  • Overriding Aorta: An aortic valve is too large, causing it to appear to arise out of both sides of the ventricles
  • Right Ventricular Hypertrophy: The chamber muscles thicken, causing the heart to work overtime, pumping excessive blood and adding additional pressure

Almost all instances of Tetralogy of Fallot are considered dire, emergency medical situations. Even after a patient goes through surgery and other invasive procedures, they typically will require lifelong medical care with a cardiologist.

Zofran and Tetralogy of Fallot

The plaintiffs in the Zofran lawsuit provided three separate studies performed on birth defects and Zofran. The studies indicate that pregnant women who take Zofran during pregnancy are  60% more likely to have infants with heart defects, especially cardiac septal defects.

In turn, the family is holding GlaxoSmithKline responsible for their child’s serious health issues, and alleges that the drug manufacturer concealed information regarding the heightened risks of birth defects associated with Zofran.

The U.S. Food and Drug Administration (FDA) has only approved Zofran for use by cancer patients undergoing chemotherapy, surgery, and other treatment options that bring on side effects such as nausea and vomiting. Yet, for many years now, GlaxoSmithKline has been marketing the drug as off-label use for morning sickness, even offering kickbacks to physicians who prescribe Zofran to pregnant women.

More Zofran Lawsuits Expected

Although there are already dozens of Zofran lawsuits filed by parents who had babies born with birth defects, these numbers are expected to grow as more and more people become aware of GlaxoSmithKline and how they promoted a medication that’s reportedly unsafe to take while pregnant.

If you or anyone you know were prescribed Zofran while pregnant and have babies with birth defects, you have the legal right to file suit against the responsible party. If you are taking Zofran while pregnant and your physician diagnosed your unborn infant with any malformation or defect, contact an experienced Zofran attorney as soon as possible.