You could be eligible to file a Zofran lawsuit if your baby was born with a serious birth defect that may be related to their mother’s use of the anti-nausea medication during pregnancy. While Zofran has never been approved to treat pregnant women, it is often prescribed off-label to relieve nausea and vomiting related to hyperemesis gravidarum, a condition experienced by some expectant mothers. A number of Zofran birth defect lawsuits are already pending in U.S. courts, and Bernstein Liebhard LLP is offering free, no-obligation case reviews to any family whose child was born with a congenital abnormality that might be related to Zofran, including:

  • Heart Defects, including atrial or ventricular septal defects
  • Musculoskeletal defects
  • Cleft Lip and/or cleft palate
  • Poor fetal growth
  • Kidney abnormalities
  • Musculoskeletal defects
  • Fetal death

To find out whether you have a valid Zofran claim, please contact our office today for more information about your possible legal options. A member of our staff will answer any questions you have, and fully explain the process for filing a Zofran lawsuit on behalf of your child.

What’s the Problem with Zofran?

Zofran has been available for over two decades, and is currently approved to alleviate nausea and vomiting associated with certain cancer treatments, or in patients who have just undergone surgery. While the medication was never approved to treat pregnant women, GlaxoSmithKline agreed in 2012 to pay $3 billion to settle claims with the U.S. Department of Justice over the tactics it used to market a number of medications, including Zofran. Among other things, the company was accused of promoting Zofran off-label to treat nausea and vomiting in pregnancy.

Unfortunately, evidence suggesting that Zofran poses a risk to unborn children is beginning to mount. In January 2012, research that drew from data on the National Birth Defects Prevention Study reported that women who where exposed to Zofran during their first trimester of pregnancy were 2.37 times more likely to have a baby with an oral cleft, such as a cleft lip or cleft palate. In 2013, another study involving  more than 900,000 pregnancies listed in a Danish health registry found that Zofran was associated with a 30% increased risk of birth defects overall, and a two-fold increased risk of heart abnormalities.

In 2014, an investigation published by the Toronto Star reported that at least 20 Canadian women treated with Zofran or generic equivalents during their pregnancy had given birth to children with serious complications, including oral clefts, kidney problems, musculoskeletal defects, and heart problems. The data reviewed by the Star, which came from the U.S. Food & Drug Administration’s adverse event database, also revealed a half dozen cases of fetal growth restriction, and one case were a baby was born with a mouth deformity, jaundice, heart murmur and two heart defects, including atrial septal defect. Two infant deaths were also noted.

A study published in December 2014 in Reproductive Toxicology found that pre-natal exposure to Zofran was associated with a two-fold risk of septal heart defects, including atrial septal defects and ventricular septal defects. An atrial septal defect occurs when a hole develops between the right and left upper chambers of the heart. Ventricle septal defects involve a hole between the heart’s lower chambers.

Possible Compensation for Victims of Zofran Birth Defects

If your baby was born with a birth defect that may be related to Zofran, you and your child could be entitled to compensation from GlaxoSmithKline. If you are interested in filing a Zofran birth defect lawsuit, please call our office as soon as possible to learn more about your legal rights. Free, no-obligation case reviews can also be obtained by calling 1-877-779-1414.

Published February 24, 2015 by