Pharmaceutical Litigation


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Zofran Birth Defect – Heart Defects

Many pregnant women suffer from morning sickness – nausea and vomiting that typically begins around the 6th week of pregnancy and continues through the 12th week. Contrary to what the name implies, nausea and vomiting can occur any time of the day or night, not just in the mornings.

Although its safety for use during pregnancy has never been established, many doctors have prescribed Zofran off-label (for a use not approved by the FDA) for morning sickness. Tragically, recent research indicates that use of Zofran during the first trimester of pregnancy – when morning sickness typically occurs – can lead to serious birth defects, including fetal heart defects.

If your baby was born with a heart defect after Zofran was used in early pregnancy, consult with a knowledgeable product liability lawyer as soon as possible. At Farah & Farah, we understand how painful it is to see your infant suffering as a result of another party’s negligence. Our dedicated legal team is ready to fight to hold responsible parties accountable and pursue the compensation you and your family deserve for your losses.

Types of Heart Defects Attributed to Zofran

A study on ondansetron (Zofran) use in early pregnancy and the risk of congenital malformations was conducted by Danish researchers and presented in August 2013. Researchers found that infants exposed to Zofran during the first trimester of pregnancy had the following increased risks of “hole-in-the-heart” defects involving cardiac tissue that did not develop properly in the womb:

  • Atrial Septal Defect (ASD) – 2.1 times: ASD is a hole in the wall between the heart’s two upper chambers. If the ASD is small, it may close on its own during infancy or childhood. A large ASD allows oxygenated blood to flow from the left upper chamber into the right upper chamber of the heart, mixing with deoxygenated blood which is pumped into the lungs. This can cause overfilled lungs and an overworked heart and eventually weaken and enlarge the right side of the heart.
  • Ventricular Septal Defect (VSD) – 2.3 times: This is a hole in the wall between the heart’s lower chambers that allows blood to pass from the left side of the heart to the right. This defect allows oxygen-rich (red) blood to pass through and mix with oxygen-poor (blue) blood, causing higher than normal pressure in the blood vessels of the lungs, which could lead to lung disease.
  • Atrioventricular Septal Defect (AVSD) – 4.8 times: AVSD can be complete or incomplete. With complete AVSD, there is a large hole in the center of the heart that lets blood flow between all four chambers. Instead of two separate valves, there is one common atrioventricular valve in the center of the heart, which often has flaps that do not close tightly or are not properly formed. With incomplete AVSD, some but not all of the defects in complete AVSD are present. An infant with this condition will have a heart murmur and a range of symptoms including breathing problems, weak pulse, poor feeding, and swelling of the belly or legs. Whether complete or incomplete, AVSD will require surgery.

Accountability for Birth Defects Caused By Dangerous Drugs

Patients, including expectant mothers, naturally rely on the advice of their physicians about which medications are safe to take and the best medical course to treat their conditions. Doctors, in turn, rely on the FDA to ensure that medications are safe before they are released on the market for use by the public.

Ultimately, the responsibility lies with drug manufactures to perform sufficient testing on their products to ensure safety before they begin promoting and marketing the drug. Unfortunately, profit sometimes comes first, and drugs are marketed and administered to patients with inadequate testing. This type of negligence can have tragic consequences, particularly when unborn babies are affected.

Several studies have shown that Zofran can cause serious birth defects when taken during the first trimester of pregnancy, and the drug has never been approved by FDA for use during pregnancy. The U.S. Department of Justice settled a lawsuit against Zofran manufacturer GlaxoSmithKline for several billion dollars in 2012. The case involved allegations of improper off-label promotions, as well as a doctor kickback program.

Our Zofran attorneys at Farah & Farah are committed to holding GlaxoSmithKline responsible for the harm this dangerous drug has caused to infants and their families. We are dedicated to tenaciously pursuing justice and full and fair compensation for our clients. If you were prescribed Zofran during pregnancy and your child was born with a heart defect as a result, contact us at (800) 533-3555 to learn about your legal options in a free case consultation.

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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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