When taken by pregnant women, the anti-nausea drug Zofran (ondansetron) has been linked to birth defects including cleft palate and congenital heart defects. If your child was born with one of these problems after you took Zofran during pregnancy, and you’re interested in filing a lawsuit against the manufacturers, our lawyers can help.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Update: Zofran Lawsuit Filed in Delaware
September 12, 2016 – A Texas couple who had one child who died from heart defects shortly after being born and another who developed severe kidney defects after the mother took Zofran in pregnancy have filed a products liability lawsuit against GSK. The complaint was originally filed in the U.S. District Court for the District of Delaware on July 24, 2015, and subsequently transferred to the Zofran MDL under case number 1:15-cv-13711-FDS.
What is Zofran?
Manufactured by GlaxoSmithKline (GSK), Zofran is approved to treat nausea and vomiting caused by chemotherapy, radiation therapy and certain kinds of surgery. The drug may also be prescribed “off-label” to pregnant women for morning sickness. Although off-label prescribing is legal and done at the doctor’s discretion, the use of Zofran during pregnancy has been linked to serious congenital birth defects.
Birth Defect Studies
In 2011, a study conducted by a grant from the Centers for Disease Control and Prevention (CDC) found that Zofran doubles the risk of birth defects, while a Danish study which included a cohort of more than 600,000 female Zofran users indicated there wasn’t an increased risk. However, the same day the results of the Danish study were presented, another group of doctors presented evidence that was the complete opposite, indicating that after following over 900,000 pregnant women who took Zofran, there was a 2-fold increased risk of heart defects (atrial septal defect) and cleft palate.
Zofran Birth Defects
Our lawyers are accepting potential lawsuits on behalf of families whose children were born with one or more of the following defects after the mother took Zofran during pregnancy:
- Heart defects
- Heart murmur (abnormal sound in the heart)
- Atrial septal defect (“hole in the heart”)
- Cleft lip
- Cleft palate
- Fetal growth restriction (poor growth in the womb)
- Kidney defects
- Musculoskeletal malformations
- Pregnancy complications
- Fetal death
- And more
Georgia Couple Alleges Daughter’s Cleft Palate from Zofran
April 28, 2016 – A couple from Norcross, Georgia, has filed a products liability lawsuit (PDF) against GSK alleging that Zofran caused their baby to be born with a cleft palate. The girl, referred to in court documents as “MCW”, has already been forced to undergo surgery to repair the cleft, participated in a sleep study and required 3 myringotomies, according to the lawsuit.
Zofran Birth Defect Allegations Similar to Thalidomide Claims a Generation Ago
February 29, 2016 – Concerns raised by plaintiffs in Zofran lawsuits echo those of parents a generation earlier, whose children were injured by the drug thalidomide. Like Zofran, thalidomide was hailed as a “wonder drug,” and prescribed off-label to pregnant women for morning sickness. Unfortunately, use of the drug for this purpose resulted in numerous adverse birth defects including blindness, phocomelia and cleft palate. The problems that thalidomide caused were so well known that plaintiffs in the Zofran litigation are wondering why any drugmaker would market a product that hadn’t been approved for use during pregnancy.
Judge Denies Motion to Dismiss Zofran Lawsuits
February 11, 2016 – The judge overseeing the Zofran multidistrict litigation (MDL 2657) in the District of Massachusetts has denied a request by GSK to dismiss the complaints (PDF), which argue that the drugmaker failed to warn about Zofran’s ability to cause birth defects. Judge Dennis F. Saylor, IV ruled that the litigation should proceed to the discovery phase, saying “The plaintiffs [should be given] some opportunity to develop the facts, whatever those facts may be.”
Lawsuits Consolidated in Massachusetts
October 13, 2015 – Federally-filed lawsuits filed alleging that Zofran caused birth defects in babies born to mothers who took the drug during pregnancy have been consolidated into a multidistrict litigation (MDL) in the District of Massachusetts. The litigation is: In Re Zofran Products Liability Litigation – MDL 2657. Click here to learn more.
Has There Been a Recall?
In 2012, the FDA issued a recall for the 32 mg intravenous dose of Zofran due to the “potential for cardiac risks” including QT interval prolongation and Torsades de Pointes, a potentially fatal abnormal heart rhythm. This was a limited recall and did not involve the oral version of the drug used for morning sickness; therefore, Zofran is still on the market and continues to be prescribed ‘off-label’ to pregnant woman around the country.
Do I Have a Zofran Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Case Evaluation: Again, if your baby was harmed by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.