Zofran (commonly known as Ondansetron) is a popular anti-nausea drug often prescribed off-label to reduce symptoms of “morning sickness” during pregnancy. Many women have found it to be helpful to combat nausea, and many doctors are more than willing to write a prescription for it, despite the fact that it has not been approved for use during pregnancy. Recent evidence is showing that Zofran’s effects can be dangerous for the unborn child, causing severe birth defects when used during pregnancy.
Pharmaceutical giant GlaxoSmithKline, (GSK) has promoted Zofran as an “off-label” solution for pregnancy morning sickness, though it has not been tested or FDA-approved for this use. Because of the illegal marketing tactics GSK has undergone to promote Zofran, hundreds are now filing lawsuits, claiming that the drug caused their child to be born with debilitating birth defects.
If you or a loved one have taken Zofran during pregnancy and given birth to a child with birth defects, you may be entitled to financial compensation. Read on for some of the most commonly asked questions asked regarding the Zofran lawsuit.
Here are the most frequently asked Zofran lawsuit questions:
Filing a Lawsuit
1: How many Zofran lawsuits have been filed to date?
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?
As with all civil lawsuits, there are set deadlines for filing claims. These time limits are referred to as “statute of limitations.” They vary from state to state. 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, no cases have been settled, though they should begin to take place soon.
6: How much can I expect to receive from filing a lawsuit against GSK for my child’s birth defect?
Because no cases to date have been settled, it is difficult to predict the answer to this question. The first complaints were filed in early 2015, and typically complicated litigation such as this take several years. However, based on precedence from similar drugs as well as the extreme damages involved with this drug, it is predicted that GSK will pay substantially for putting their profits before the safety of unborn children.
7: What factors are considered as part of a Zofran lawsuit settlement?
The lawsuit will consider multiple factors. Although the lawsuits all involve similar allegations, each case is different. The amount awarded will be based on what the jury determines is fair compensation. However, the following are key factors that will likely be considered:
- 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.
- Future mental and physical pain that will likely be suffered in the future for the child.
- 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 are the most common birth defects reported?
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 have shown that Zofran is associated with 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. Contact a qualified Zofran attorney for more information.
FDA Approvals and Safety
11: Are there any FDA-approved drugs that are safe for pregnancy morning sickness?
Diclegis is currently the only drug approved by the FDA for morning sickness. However, it is recommended by physicians that changes in diet or other non-medicine treatments be tried first to alleviate nausea and morning sickness before taking it.
12: Have any studies been done to demonstrate the safety or danger of Zofran for pregnant women?
Yes. A Danish study conducted by Doctor Gideon Koren, MD was published in the December 2014 issue of American Journal of Obstetrics and Gynecology. The study involved 900,000 Danish women, and 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.”
Still have questions? Feel free to contact one of our qualified attorneys to determine whether or not you have a case. There are no obligations, and they will be able to help you get the justice you deserve for your child’s injuries. Get more answers to Zofran lawsuit questions and take a free Zofran case evaluation today to see if you may qualify for financial compensation.