Did the Zofran you took during pregnancy cause your baby’s birth defect?
You owe it to yourself—and your child—to find out.
Zofran Lawsuit: The anti-nausea drug Zofran was never FDA-approved for morning sickness.
In fact, it causes serious birth defects. But drug manufacturer GlaxoSmithKline illegally promoted its use for pregnant women with nausea. They told doctors it was safe and paid them to prescribe it. Babies whose mothers took Zofran have been born with serious birth defects such as cleft palate, cleft lip, clubfoot, and heart defects such as atrial and ventricular septal defect (“hole in the heart”).
The U.S. Department of Justice successfully sued manufacturer GlaskoSmithKline for fraudulently promoting Zofran for pregnancy-related nausea and vomiting.
The court found GlaskoSmithKline had misled doctors about the safety of taking Zofran during pregnancy and paid them to prescribe it to their patients. In June 2012, the court ordered the company to pay a $3 billion settlement—the largest health care fraud settlement in history. Now, parents and families of babies with birth defects whose mothers took Zofran during pregnancy are seeking justice.
What is Zofran?
Zofran (generic: ondansedron) is an anti-nausea drug approved by the U.S. Food and Drug Administration in 1991 for use by cancer patients undergoing chemotherapy and radiation and post-surgery patients. It was never FDA-approved to treat morning sickness in pregnancy. In fact, the FDA labeled it a Pregnancy Category B drug—meaning there was not enough information to prove the drug was safe to take during pregnancy.
Did GlaxoSmithKline know this drug causes birth defects?
Yes. In the 1980s, Glaxo’s own research on animals showed “clinical signs of toxicity, premature births, intrauterine fetal deaths, and impairment of ossification [bone growth]” as well as heart defects and developmental delays, according to court documents.
Glaxo knew Zofran crossed the placental barrier at a high enough percentage to cause birth defects in animals. In the years that followed Zofran’s 1991 approval, Glaxo received reports of birth defects thought to be associated with Zofran. Published scientific studies also documented these effects.
Why didn’t the FDA protect me?
The FDA labeled Zofran a Pregnancy Category B drug—meaning there was not enough information to prove it was safe to take during pregnancy.
Because Glaxo couldn’t prove it was safe, it was illegal to promote its use for pregnant women.
In 2012, the U.S. Department of Justice sued Glaxo for fraud because it illegally promoted this drug for use in pregnant women. It won a settlement of $3 billion—the largest drug fraud settlement ever.
Do I have a case?
If you took Zofran during your first trimester of pregnancy and your baby died OR was born with birth defects, you may have a case against Zofran manufacturer GlaxoSmithKline. If you took Zofran before 2007, please contact us for a free consultation. We will individually review your case. If you meet case criteria, we will pursue your case as an individual lawsuit—not a class action. Please call 1-800-882-2525 for your free consultation.
Will I pay my legal costs up front?
No. Your case review is free. We will review your individual situation. If we determine that you have a case, you pay nothing unless we win your individual lawsuit. If your case meets our criteria, we will pursue it as an individual lawsuit—not a class action. Please call 1-800-882-2525
How long will a lawsuit take?
Depositions could last two to three years, so it’s important to act now to begin the legal process. Please call 1-800-882-2525. Cases against GlaxoSmithKline and Zofran have just started to be filed. Get started right away so you receive compensation as soon as possible.
What makes the Miller Firm the best choice to represent me and my child against GlaxoSmithKline?
When you select the Miller Firm to handle your individual lawsuit, you are not just hiring attorneys with decades of experience going up against big pharmaceutical companies. Our staff also includes doctors and nurses who understand and can help document every aspect of your case. Our staff knows the law. It knows the medical science. And it knows the effects of Zofran: Not just the physical effects – the cleft lip and palate, the heart deformities, the clubfoot. Not just the financial ones—medical expenses, lost work time. But the emotional ones—the fear, the worry, the guilt.
We want you to know this was not your fault.
GlaxoSmithKline lied to your doctor. All you wanted was help with morning sickness and a healthy pregnancy. Now, you want justice.
Please call 1-800-882-2525 for your free consultation. We want justice too.
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What are the risks of taking Zofran during pregnancy?
Each case may be different. Some babies have one defect. Others have more. Congenital birth defects that can be caused by Zofran include:
- Major Heart Defects
- Hole in the Heart (atrial or ventricular septal defect)
- Heart murmur
- Heart valve malfunction
- Cleft Lip or Palate
- Gastro-Intestinal Defects
- Kidney Problems
- Limb or Skeletal Defects
- Lung Defects
- Spina Bifida
What is the evidence?
Many studies have confirmed that Zofran causes birth defects in humans. A December 2014 research review in the American Journal of Obstetrics and Gynecology cited many scientific studies documenting many significant risks of taking Zolfran during pregnancy. Some notable findings:
A 2012 study of 900,000 Danish women revealed taking Zofran resulted in a twofold increased risk of cardiac deformities and an overall 30 percent increased risk of major congenital malformations.
A 2011 joint study by the Slone Epidemiology Center and the Centers for Disease Control and Prevention found Zofran caused a twofold increase in the risk of cleft palate.