Zofran (commonly known as Ondansetron) is a popular anti-nausea drug for chemotherapy patients. However, doctors often prescribe the drug off-label to reduce “morning sickness” symptoms during pregnancy. Many women say it helps combat nausea, and doctors are willing to prescribe it. Despite the drug’s popularity, the U.S. Food and Drug Administration never approved Zofran for use during pregnancy. Recent evidence shows that Zofran can be dangerous for fetal development. In fact, many recent Zofran lawsuit filings allege that the drug can cause severe birth defects if used to treat nausea during pregnancy.
Pharmaceutical giant GlaxoSmithKline (GSK) promoted Zofran “off-label” for treating morning sickness during pregnancy. However, the company didn’t complete clinical safety tests prior to marketing Zofran for this purpose. Due to illegal marketing tactics GSK used while promoting the drug off-label, affected parents may seek justice and compensation through a Zofran lawsuit. Plaintiffs currently claim the drug caused their child to suffer debilitating birth defects, and they were unaware about potential risks.
If you or a loved one took Zofran during pregnancy and had a child with birth defects, you may qualify financial compensation. Read on for some answers to frequently asked Zofran lawsuit questions.
Here are the most frequently asked Zofran lawsuit questions:
Filing a Zofran Lawsuit
1: How many Zofran lawsuits are currently underway?
While the numbers continue to grow, there are currently over 230 lawsuits that have named GSK, filed from parents across the United States because of the use of Zofran during pregnancy. The lawsuits are being consolidated in the U.S. District Court of Massachusetts.
2: What are the main allegations made against GSK?
Most of the cases are filed by parents in behalf of their young children, sharing common allegations that fetal exposure to Zofran caused a range of birth defects in utero—some of them fatal.
3: What is the timeline to file a Zofran lawsuit case?
All civil cases have time limits for filing an eligible claim. States set their own time limits, otherwise known as the “statute of limitations,” and each one varies. An attorney can help you determine what the statute of limitation is for your state.
4: Do I have to pay an attorney to determine whether or not I have a case for my child’s birth defect case?
You should not have to pay for a consultation regarding your case. If you have to, it may be fraudulent. Our Zofran attorney’s will never charge you for a consultation regarding your case.
Settlements and Verdicts
5: Have any cases been settled between the plaintiffs and GSK so far?
Plaintiffs are awaiting the “discovery” period of the legal processes. This will give insight into the results of investigations surrounding the drug. To date, a federal judicial panel consolidated over 430 birth injury cases under Zofran MDL 2657.
6: How much can I expect from a settlement if I sue GSK for my child’s birth defect?
Since no individuals have yet won a settlement, this one’s hard to answer. Parents filed the first lawsuits in early 2015, and typically, complicated litigation such as this may take years. However, based on precedence from similar drugs as well as the extreme damages involved, legal experts believe GSK will pay substantially for putting profits before patient safety. In fact, GSK settled similar allegations from the U.S. Justice Department for $3 billion in 2011. However, the drug giant never accepted liability or admitted to committing healthcare fraud for promoting Zofran off-label to treat morning sickness.
7: What factors can influence a Zofran lawsuit settlement?
While all cases involve similar allegations, each Zofran lawsuit is unique. Only the jury or judge can decide what settlement amount constitutes “fair compensation” for your child’s birth injury. However, other key factors may play a role in potential settlement amounts, including:
- The effect the birth defect from Zofran has on the overall physical and mental health of the child.
- The extent of the Zofran birth defect or injury.
- The medical costs or treatment required because of the injury.
- Your child’s future mental as well as physical pain and suffering.
- Long-term injuries or defects that could affect the plaintiff’s future health, potential for employment or success, and quality of life.
Birth Defect Concerns
8: What common birth defects do women report after taking Zofran?
Birth defects range in severity, but often include cleft palates, cleft lips, clubfoot, heart defects, and craniosynostosis (a condition in which the skull is shaped abnormally, not leaving enough space for the brain; this often leads to vision problems, eating issues, and mental impairment). Other potential birth defects include musculoskeletal abnormalities, intrauterine growth restriction, heart murmurs, kidney malformations, jaundice, and death.
9: As a mother, should I have known that Zofran was unsafe to take during pregnancy?
No. The lack of testing from GSK and their promotion to OB-GYN’s specifically lead doctors to believe that Zofran was safe during pregnancy.
10: Can I file a lawsuit if my child was born with jaundice after I took Zofran?
Recent medical studies link Zofran to jaundice. Jaundice occurs in newborns when there is a high level of bilirubin present in the blood. Bilirubin is a yellow substance the body creates when replacing old red blood cells. The liver then works to break down the substance, removing it from the body in stool. An extremely high level of bilirubin can damage the brain, in a condition called kernicterus.
If your child was born with extreme jaundice after you took Zofran during pregnancy, you may have a case.
FDA Approvals and Safety
11: What FDA-approved drugs are safe to treat morning sickness during pregnancy?
The only FDA-approved morning sickness drug currently available is Diclegis®. However, physicians typically recommend dietary changes to alleviate nausea before prescribing it for morning sickness.
12: Do studies show any benefits or risks to pregnant women who take Zofran?
Yes. A 2014 Danish study published in the American Journal of Obstetrics and Gynecology clearly demonstrates Zofran’s dangers. The study involving 900,000 Danish women found a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent risk of major congenital malformations.”
The study also notes, “Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy.”
Check Your Eligibility for a Zofran Lawsuit Cash Settlement
Still have questions? An attorney can review your medical information and quickly determine if you may qualify for a cash settlement from the manufacturer. An attorney is the best way to secure the compensation and justice you deserve for your child’s injuries. To see in just minutes if you may qualify for financial compensation, get your free Zofran case review today. Once you’ve submitted your information, an experienced lawyer will call to discuss your Zofran lawsuit settlement options.
Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.