If you took the drug Zofran during your pregnancy and your child was born with a birth defect, you may have suspected a link between the two. Your fears are not unfounded—many other mothers have faced the same tragic circumstance.
For years, Zofran has been marketed as a way to treat the symptoms of morning sickness, a use that was never FDA approved. Zofran was originally developed as a chemotherapy drug, and its use for morning sickness is considered “off-label.” The makers of Zofran, GlaxoSmithKline LLC, mounted a marketing campaign to get doctors to prescribe the drug for additional uses, hoping to maximize profit.
Pregnant mothers presented GlaxoSmithKline with a lucrative target. Some 70 to 80 percent of pregnant women suffer from nausea and vomiting at some point in their pregnancy, technically called hyperemesis gravidarum. The folk remedy of ginger ale and crackers doesn’t work for many women. The American Pregnancy Association estimates that for 60,000 women a year the condition is so serious the mother requires hospitalization and intravenous fluids to keep her hydrated.
Seeing an opportunity, GlaxoSmithKline encouraged doctors to prescribe Zofran to pregnant mothers for nausea and morning sickness. That decision has had disastrous consequences. Studies have found that pregnant women taking Zofran face double the rate of some birth defects. Countless babies have been put at risk unnecessarily.
This is not the first time GlaxoSmithKline has taken chances with Zofran and other drugs. In 1999, the FDA warned the company to change misleading promotional materials that did not mention Zofran’s side effects. And in 2012 GlaxoSmithKline pleaded guilty to three criminal charges involving misbranding its drugs and failing to report safety data. The company paid $3 billion in fines and for associated civil lawsuits.
Our attorneys at John Foy & Associates are outraged by this pharmaceutical company’s blatant disregard for mothers and their children. If you want to discuss your legal options, please call us at 404-400-4000 for a free and private consultation. Someone will answer the phone 24 hours a day, every day of the year.
What is Zofran and why would it be prescribed during a pregnancy?
Zofran was originally developed as an anti-nausea and anti-vomiting drug to help patients who are being treated with chemotherapy. You can see how such a drug would have great value to these patients, but they are not expected to get pregnant. The drug trials did not include the effects this would have on a fetus in utero.
Zofran has been used in hospitals and at home to treat nausea in pregnant women. There was no FDA-approved prescription for what is benignly called “morning sickness.”
What is “off-label” and why would a physician prescribe something that was not originally meant for pregnancy?
Off-label means that a medication is prescribed for something other than what the FDA approved it for. A physician is allowed to prescribe medications at his or her discretion, and some reports state that one out of five prescriptions are off-label. At times these off-label uses are for people outside the age or sex group for which the drug has been tested.
Physicians are busy people and often rely on what a drug manufacturer representative recommends. Nausea during pregnancy is very difficult on the mother and doctors may think they are helping out with this medicine.
I took Zofran during pregnancy and my child was born with a birth defect? Do I have a case against the manufacturer?
Yes. If you took Zofran during pregnancy and your child was born with a birth defect, you have two choices–either joining a class action lawsuit or a filing a separate personal injury claim against the manufacturer. Both suits have their advantages. A class action lawsuit is designed to represent the largest number of victims to fight a large entity. A personal injury lawsuit is what it sounds like—your sole claim alone against the manufacturer.
Either way, John Foy & Associates can represent you. Our attorneys can consult with you and decide which is the wiser claim for your situation. And we can represent you and your child throughout the process.
Give us a call at 404-400-4000 to discuss your options.
My child was born with a birth defect, and my doctor gave me something for morning sickness. What should I do?
If your child was born with a birth defect and you are unsure what your doctor prescribed you have the right to request a list of any medications you were prescribed. You can also call your pharmacist and ask for that list. If you are unsure what to do or are too uncomfortable asking, please call John Foy & Associates at 404-400-4000. We’ll help you out even if you don’t want to proceed with a claim.
Then we urge you to find legal representation to seek compensation to pay for any medical costs.
How do you prove that my child’s birth defect was from a defective drug? I mentioned it to my doctor and he said it could be from anything
You don’t need to prove anything. You need legal help with your claim. In a court, we don’t need to prove that your child’s birth defect was from a defective drug. We just have to prove that you were taking a drug that you should have not been prescribed and that your child was born with a birth defect. And we have access to unbiased medical experts who can provide a candid and educated opinion for your case.
Why would my doctor prescribe Zofran for morning sickness if he knew it could lead to a birth defect?
Pregnancy nausea can be quite serious and your physician may have felt justified in prescribing this drug to relieve your symptoms. It is difficult watching someone struggle helplessly and not be able offer help. It may have seemed like a calculated risk. Our claim would be against the manufacturer, not your physician.
Are my child and I separate plaintiffs in a Zofran Birth Defect Lawsuit?
You and your child would be separate plaintiffs in a Zofran Birth Defect case. If there is a settlement for your child, it may be set up as a legal trust so that your child’s interest are protected as he or she receives medical treatment.
What is a class action case and why can’t I just sue the manufacturer by myself?
A class action case is designed to allow a large number of people, “a class”, to fight one entity. The judge usually will assign a major law firm to represent the people and one or two clients are chosen as the representative plaintiff. Any settlement is distributed among all the plaintiffs using a formula set up by the court.
You can join a class action lawsuit by yourself, but we urge you to hire a local attorney who can represent your needs and stay abreast of the case.
If you want to sue a manufacturer by yourself we urge you to hire an experienced law firm that knows how to go up against a cadre of well-paid attorneys.
There is no charge for you for either kind of case. In a class action case the judge awards attorney fees. In a personal injury claim, the attorney fees are paid out of the settlement. If there is no settlement, there is no fee.
How can John Foy & Associates help me with a Zofran Birth Defect Lawsuit?
John Foy & Associates has built its business over the last 20 years helping people who have been injured by someone else’s negligence. What is more negligent than a pharmaceutical company preying on the sick and helpless?
We are one of Atlanta’s most established and well-respected law firms and we are that way because we operate in an ethical and respectful manner towards our clients. We are not afraid to go up against any size firm.
You’ve already been through a stressful pregnancy and now you have to be extraordinary to help your child. Let us help you. Give us a call at 404-400-4000 and find out how we can help.