Zofran Birth Defects

zofran birth defectsScores of Zofran birth defects lawsuits have been filed in U.S. courts on behalf of children who were born with heart malformations, cleft lip and cleft palate, kidney defects and other congenital abnormalities, allegedly due to their mother’s use of Zofran during the first trimester of pregnancy. These lawsuits site a number of recent studies that suggest pre-natal exposure to Zofran increases the risk for birth defects.

Zofran Birth Defects Investigation

The nationwide law firm of Bernstein Liebhard LLP is now investigating legal claims involving the potential for Zofran to cause birth defects. If you believe your baby was harmed by this medication, please contact our Firm today, at (888) 994-5118 to learn more about your legal options.

Zofran Litigation News

  • December 2015: The federal Zofran litigation convenes its first Status Conference on December 16th. A day later, it issues a series of orders including one that will allow plaintiffs to file cases directly in the District of Massachusetts. The Plaintiffs Steering Committee is also established. Read More
  • December 2015: Zofran cases involving birth defects continue to mount, with hundreds of claims pending in court around the country. A recent case filed in Alabama federal court blames Zofran for the atrial septal defect suffered by the plaintiffs’ son. The federal multidistrict underway in Massachusetts is scheduled to hold its next status conference on December 15th.  Read More
  • October 2015: The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established a centralized proceeding for all federally-filed Zofran birth defects lawsuits in the U.S. District Court, District of Massachusetts. An Order dated October 13th indicates that 12 Zofran cases were initially transferred to the new litigation. However, more than 40 additional cases currently pending in federal courts around the country are likely to be transferred there, as will any Zofran birth defects claims filed in federal courts in the future. Read More
  • September 2015: The JPML indicates that it will hear Oral Arguments regarding the creation of a new multidistrict litigation for all federally-filed Zofran lawsuits at its October 1st Hearing Session. While GlaxoSmithKline and plaintiffs both favor centralization of the Zofran birth defects docket, there is disagreement as to venue. Glaxo has asked the JPML to locate the proceeding in the U.S. District Court, Eastern District of Pennsylvania, which is central to its U.S. operations. However, plaintiffs have suggested a number of other federal courts for the litigation. Read More
  • February 2015: Zofran lawsuits have begun to mount in U.S. courts. One of the first was filed on February 12th in the U.S. District Court, Eastern District of Pennsylvania, by a woman who claims that Zofran was responsible for heart defects suffered by both of her children. Just four days later, a second Zofran heart defects case is filed in the U.S. District Court, District of Massachusetts, by a woman who alleges that pre-natal Zofran exposure caused her daughter to develop congenital heart problems and other abnormalities. Read More

Zofran and Birth Defects

Zofran is an anti-nausea medication marketed by GlaxoSmithKline that is currently approved to treat nausea and vomiting related to surgery and certain cancer treatments. The drug has never been approved by the U.S. Food & Drug Administration (FDA) to treat morning sickness, but a 2014 analysis that appeared in the American Journal of Obstetrics and Gynecology suggested that as many as one million U.S. women annually have been prescribed Zofran or a generic equivalent for this off-label indication.

The FDA has placed Zofran in Pregnancy Category B, which indicates that its impact on a developing pregnancy has not been well-studied. In recent years, however, some research has suggested that Zofran might be associated with an increased risk of birth defects if taken by an expectant mother during the first trimester of pregnancy.

  • 2006: A paper entitled Placental Transfer of Ondansetron During Early Human Pregnancy concludes that the active ingredient in Zofran readily crosses the placental barrier during the first trimester of pregnancy. The authors of the study examined 41 patients who were prescribed the drug before their pregnancies were terminated during the first trimester. Zofran was found in all 41 fetal samples.
  • November 2011: A study appearing in Birth Defects Research linked Zofran to a 2.4-fold increased risk of cleft palate.
  • January 2012: Research that looked at data from the National Birth Defects Prevention Study found that Zofran use during the first trimester of pregnancy was associated with a 2.37-fold increase in the incidence of oral clefts, such as cleft lip and cleft palate.
  • 2013: A study that drew data from 900,000 pregnancies included in a Danish health registry concluded that women who took Zofran during the first trimester were 30% more likely to have a baby with a major birth defect. The study also concluded that the drug was associated with a 2-fold increased risks of major cardiac malformations.
  • December 2014: Research appearing in Reproductive Toxicology found that pre-natal exposure to Zofran was associated with double the risk of septal heart defects, including atrial septal defects and ventricular septal defects.

Zofran Legal Help

Bernstein Liebhard LLP is now offering free, no-obligation legal reviews to alleged victims of Zofran birth defects, including:

To obtain the legal help you need, please contact our office at (888) 994-5118.

Last Modified: January 6, 2016

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