Did you or a loved one take Zofran during pregnancy, ultimately giving birth to a child with birth defects? If so, you could qualify for compensation from the drug’s manufacturer, GlaxoSmithKline or “GSK.”
Zofran is a prescription anti-nausea drug that was approved in 1991 by the U.S. Food and Drug Administration (FDA) for use in cancer patients who were undergoing chemotherapy. But like many prescription drugs, Zofran was also used “off-label,” meaning doctors prescribed it to treat nausea and vomiting in circumstances other than those that were investigated and approved by the FDA.
One of the most common off-label uses for Zofran was in pregnant women experiencing morning sickness and nausea. Zofran is a Pregnancy Category B drug, which means there have not been any authoritative and reliable studies performed to examine its impact in pregnant women. But shortly after Zofran started to be used off-label, reports of a higher incidence of birth defects started to surface, leading to further studies which have revealed an apparent link between birth defects and taking Zofran while pregnant.
Based in Orlando, Florida, lawyers with the Law Office of Hogan & Hogan, P.A. are here to help families to seek out the compensation you deserve for your child’s pain and suffering, birth defect-related medical expenses and other losses. Our goal is to pursue your case in a strategic manner, while keeping you, our client, informed and involved throughout the process.
If you took Zofran, especially during the first or second trimester of pregnancy, we encourage you to contact the Law Office of Hogan & Hogan, P.A. to arrange a no-cost consultation session to discuss your case. You must act quickly, though, because the law limits the time you have to file a Zofran lawsuit. Call 407-422-2188.
Common Questions About Zofran, Birth Defects, Pregnancy and Lawsuits
Attorneys with the Law Office of Hogan & Hogan, P.A. receive lots of questions from mothers who were prescribed Zofran during their pregnancy and ultimately gave birth to a child who suffers from a deformity. A congenital deformity can have lifelong effects on the child and their family members, so as experienced Zofran attorneys, it is our goal to help secure compensation for the past, present and future expenses.
Our legal team, which includes a number of top Florida attorneys, has gathered information to address some of the most common questions we receive concerning Zofran and birth defect lawsuits.
What Kind of Birth Defects Are Caused by Zofran?
The type of birth defects caused by Zofran can vary depending upon when the mother took the medication. Different organs and body systems form at different times during the pregnancy, so the timing of when the mother took Zofran during pregnancy impacts the nature of any birth defects that arise.
Studies have found the following:
- Cardiac defects are more likely in women who took Zofran in weeks 1-10 of pregnancy;
- Cleft palate is more likely in women who took Zofran in weeks 8-12 of pregnancy;
- Kidney defects are more likely in women who took Zofran in weeks 1-12 of pregnancy;
- Neural tube defects are more likely in women who took Zofran in weeks 1-8 of pregnancy; and
- Craniosynostosis is more likely in women who took Zofran in weeks 1-24 of pregnancy.
The most common Zofran side effects are:
- cleft lip and cleft palate;
- heart defects, including septal defects;
- kidney defects;
- musculoskeletal anomalies, including club foot;
- fetal growth restriction; and
- premature birth.
Women who take Zofran are also more likely to experience the death of the fetus.
What is the Overall Risk of Birth Defects in Women Who Took Zofran for Morning Sickness?
The risk of birth defects is believed to be approximately 30% higher in women who took Zofran during pregnancy. Multiple studies found that these babies have twice the risk of having a heart defect and more than twice the risk of having a cleft palate when compared to children born to mothers that did not take this anti-nausea drug.
In all, studies show that about 1 in 20 babies born to a mother who took this drug while pregnant will have some sort of birth defect. The typical risk of having a baby with a birth defect is about 1 in 35.
Why Does Zofran Cause Birth Defects in Pregnant Women?
It’s believed that Zofran is capable of passing into the placenta, and it remains active in the baby for a longer period of time than it is active in the mother. This medication was designed to work in a way similar to an SSRI drug, inhibiting the activity of serotonin. This impacts the manner in which the child develops.
What Claims Have Been Made Against GlaxoSmithKline?
Numerous parents have already filed lawsuits against GlaxoSmithKline and in 2012, the drug maker was also found guilty of federal charges that the company illegally and inappropriately promoted drugs — including Zofran.
There have been many allegations made against GlaxoSmithKline, including that the company failed to properly warn women about the risks of Zofran. It has been alleged that the company failed to fulfill its duty to ensure the drug’s safety prior to releasing it to the public.
In fact, some lawsuits have accused GlaxoSmithKline of marketing the drug for the treatment of morning sickness and a similar condition called hyperemesis gravidarium — off-label uses that have not been approved by the FDA.
The drugmaker allegedly “misrepresented” the results of animal studies, implying that the drug was safe. In reality, the study revealed serious issues. The drug was associated with toxicity and an increase in the prevalence of abnormal musculoskeletal development.
Drugmakers such as Novartis, which makes the generic version ondansetron, and Galena Biopharma, which makes a similar drug called Zuplenz, could also be subject to litigation.
How Much Will It Cost to Hire a Florida Lawyer to Handle My Zofran Lawsuit?
At the Law Office of Hogan & Hogan, P.A., our legal team usually accepts Zofran lawsuits on a contingency basis, so our fee is collected once our attorneys successfully secure a settlement or jury verdict for the client.
Trust Our Experienced Florida Attorneys to Handle Your Zofran Lawsuit
At the Law Office of Hogan & Hogan, P.A., we understand how devastating a birth defect can be for both the child and their family members. A birth defect can impact the quality of life, while also resulting in a lifetime of pain, suffering, and struggles. And this says nothing of the financial toll.
At the Law Office of Hogan & Hogan, P.A., we believe in a “clients first” approach to each and every case, so it is our goal to form a collaborative relationship with the client, answering your questions and keeping you involved and informed throughout the legal process. This is just one of the many things that sets our Orlando law firm apart from all others.
In addition to handling cases related to dangerous drugs, birth defects and the failure of defective medical devices, we also handle medical malpractice cases, wrongful death claims and personal injury lawsuits. Our goal is to help you find justice.
If you or a loved one gave birth to a child with birth defects caused by Zofran during pregnancy, the attorneys with the Law Office of Hogan & Hogan, P.A. are ready to discuss your case. But you must call as soon as possible since the law limits the amount of time you have to file a claim.
Contact the Law Office of Hogan & Hogan, P.A.’s elite team of Central Florida lawyers for a confidential, no-cost consultation session by calling 407-422-2188.