Unapproved Usage of Zofran Linked to Birth Defects
If you took Zofran during your pregnancy, and your baby was born with defects, the drug makers could be to blame. While the anti-nausea medication has been prescribed (and proven to be successful) to those suffering from chemotherapy treatments, it was never meant to be given to women to assist with morning sickness due to pregnancy.
Due to the illegal marketing of Zofran, thousands of mothers and their babies have been irreparably harmed. The makers of Zofran have already made a multi-billion dollar payment to settle the largest healthcare fraud lawsuit in the history of the United States involving improper marketing practices for a number of its best-selling drugs, including Zofran. In exchange for making this $1 billion payment, GlaxoSmithKline was able to avoid criminal prosecution for its illegal marketing activities.
Zofran Birth Defects Lawsuits
Hundreds of parents have filed lawsuits against the manufacturers of Zofran, alleging that their babies suffered birth defects due to exposure to Zofran while their mothers were pregnant. Many thousands of additional children have likely been injured by Zofran, but not yet filed an individual lawsuit in the national consolidated multi-district (MDL) litigation proceedings, which are pending in federal court.
Taking the first steps to contacting an attorney about a birth defect injury claim may be difficult, but be assured that the drug and medical device lawyers at Searcy Denney can provide a voice to advocate for your family. Learn more about our dedicated team of lawyers and contact us today at (800) 780-8607. Our lawyers have filed individual lawsuits on behalf of the victims of Zofran, and have litigated thousands of other individual personal injury and wrongful death lawsuits on behalf of patients injured by defective drugs and medical implants.
Read on to learn more about Zofran, its troubling history and what you can do now.
About Zofran, The Anti-Nausea Medication
- The Issue: Zofran was never approved by the FDA to be used by pregnant women. Zofran was approved by the Food & Drug Administration for use in cancer patients suffering from nausea related to chemotherapy or radiation treatments in 1991. The medicine is made available in various doses as an injection, premixed injection, oral tablets, orally disintegrating tablets and an oral solution.
- Zofran Background: Zofran (ondansetron) is a medication used to help prevent nausea and vomiting caused by chemotherapy. Created by GlaxoSmithKline (GSK), the FDA approved the use of Zofran to assist cancer patients with nausea after treatments. Zofran is part of a class of anti-emetic drugs (which also includes Kytril, Anzemet and Aloxi) known as selective serotonin 5HT3 receptor antagonists. It is believed that Zofran and other medications in this same class block the effects of serotonin at the 5HT3 receptors, located along the vagal afferents in the gastrointestinal tract, and at similar receptors located in the area prostrema of the central nervous system, which is the structure in the brain that controls vomiting. And while the drug may benefit those suffering from side effects following surgery, post-op meds and other complications, it has been known to cause problems among pregnant women.
To learn more unique details, this video below by defective drug lawyer Calvin “Cal” Warriner, can tell you more.
The Problem with Zofran
Doctors prescribed Zofran to pregnant women to help treat nausea, vomiting and morning sickness during pregnancy. However, studies have linked the medication to birth defects. Specifically, it’s been found that when this anti-nausea drug is used during pregnancy (primarily during the first trimester), there is a 30 percent increased risk of:
- Birth Defects
- “Hole in the Heart” Defects
- ASD (Atrial Septal Defect)
- VSD (Ventral Septal Defect)
- Cleft Lip
- Cleft Palate
- Club Foot
How Does Zofran Affect Pregnant Mothers and Their Babies
These problems occur because Zofran has been known to cross the placenta. The drug passes from mother to fetus through the placenta quite rapidly, and in “large amounts.” Zofran also remains active in the fetus much longer than it does in the mother. While GlaxoSmithKline actively promoted the use of Zofran for the treatment of morning sickness, the drug manufacturer never conducted a single study confirming that the anti-nausea drug was safe for pregnant women or their unborn babies. In fact, pregnant women were often excluded from clinical trials that were completed to obtain government approval for the sale of Zofran. There were also studies conducted by others that confirmed that Zofran crossed the placental barrier, which should have led to a more rigorous study of the drug by GSK prior to marketing it to unsuspecting patients and doctors.
Misleading the Public and Concealing Evidence
Even though there was no safety data available, as early as 1998 and throughout the next decade, Zofran became one of the most-prescribed drugs for treating morning sickness in the United States. Patients and prescribing physicians were led to believe that Zofran was safe and effective for use during pregnancy, even though the drug manufacturer knew that it had failed to complete even the most basic testing of the drug.
Further, the manufacturers of Zofran concealed evidence from animal studies completed in the 1980s that showed that Zofran was toxic and caused the death of fetuses and malformations in the animals that were born alive. During this same time period, GlaxoSmithKline received several hundred adverse event reports of birth defects potentially associated with exposure to Zofran, but failed to properly investigate these serious safety alerts or provide adequate information to the public about the serious risks associated with ingestion of Zofran during pregnancy.
Zofran Lawsuit Infographic
GlaxoSmithKline, the makers of Zofran, knowingly allowed doctors to prescribe the anti-nausea drug to pregnant mothers. Unfortunately, the drug passes through the placenta quickly, and often in large amounts, which have been linked to birth defects. Below is an infographic that has been created to help visualize the defects to the limbs, head and heart. If you intend to share information about Zofran, this page can easily be shared on all social media platforms.
As the infographic shows, Zofran has been linked to a variety of birth defects, such as craniosynostosis (skull malformation), congenital heart defects, club foot and cleft lip. The FDA has since banned drug companies, including the makers of Zofran, from promoting drugs for off-label use.
Who is to Blame?
Court documents submitted by firm partner, Brenda Fulmer, show that GSK knew as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies, yet the drugmaker continued to market the drug to pregnant women.
These court documents on the Zofran lawsuit can be accessed by clicking here.
In 2006, Zofran lost its patent, and doctors then began prescribing generic versions of ondansetron to patients. These generic versions were manufactured by Novartis, and its subsidiary, Sandoz. Then, in 2010, Zuplenz was developed to capitalize on the void left by Zofran in the market.
The Largest Healthcare Fraud Settlement in US History
The U.S. Department of Justice (DOJ) filed criminal and civil claims against GSK in 2012, which resulted in the company pleading guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran. The drugmaker paid $3 billion as part of the legal settlement – the largest healthcare fraud settlement in U.S. history. The lawsuit claimed GSK not only promoted anti-nausea medicine to pregnant women without FDA approval (which is often referred to as “off label promotion”), but also paid kickbacks to doctors and healthcare providers.
Recalls and Safety Issues
In 2012, a recall was issued for 32-mg intravenous (IV) Zofran after a study linked it to heart rhythm disorders. It’s believed that Zofran may prolong the QT interval, which is how long it takes the heart muscles to recharge between beats.
Finally, in 2013, the FDA identified a potential safety issue linking Zofran with serotonin syndrome, which can be life-threatening for pregnant women and their fetuses.
Various symptoms of serotonin syndrome may occur, such as:
- Cognitive and Behavioral Changes
- Rapid Heartbeat
- Muscle Rigidity
- High Fever
- Loss of Consciousness
Pharmaceutical Companies Involved
In 2015, Galena Biopharma acquired licensing rights for Zuplenz, and launched it in the United States. Around this same time, Novartis acquired the rights to market Zofran from GSK.
Meanwhile, GSK is going back to court to defend more allegations regarding Zofran, and Novartis, Sandoz and Galena could ultimately face litigation, too. Specific claims against GSK include:
- The drugmaker had a duty to ensure its drug was safe before offering it to the public, and failed to determine safety risks before selling it.
- GSK failed to warn the public about dangerous side effects.
- The company advertised the anti-nausea drug as a safe treatment for morning sickness and hyperemesis gravidarum (nausea during pregnancy), even though it was not approved for this specific use.
- GSK misrepresented the animal studies of the drug, showing that it was safe. In reality, the results showed abnormal bone growth and signs of toxicity.
- The drugmaker failed to accurately evaluate data and safety information regarding the use of Zofran with pregnant women.
- The company produced a defective drug.
- GSK falsely and fraudulently claimed Zofran was safe for pregnant women.
Your Advocate in a Zofran Lawsuit
Are you considering a lawsuit against GlaxoSmithKline, or another drugmaker, due to the negative side effects of Zofran? If so, it’s important to understand you do not have to fight a billion dollar corporation accused of criminal allegations all alone. Major companies are powerful with extensive resources and many of the best lawyers on their staff.
Mothers and families around the country are taking action, and seeking legal advocates to help ensure this never happens to another child. Just in 2015, hundreds of families filed lawsuits across the country, stating the claims listed above. Our firm can and will advocate for you – learn more here on How We Help.
History of Zofran Lawsuits Filed
Just a handful of the lawsuits involving Zofran and GlaxoSmithKline include:
- February 2015
A woman in Massachusetts who took Zofran during her first trimester of pregnancy filed a lawsuit after she gave birth to a baby with three heart defects, facial deformities, webbed toes and a number of other birth defects.
- March 2015
After being exposed to Zofran during pregnancy, a Minnesota child was born with severe heart defects.
- April 2015
A boy was born with severe chromosomal birth defects after his mother used Zofran during pregnancy. As a result, the family filed a lawsuit against GSK in federal court in Alabama.
A mother in Texas filed a federal lawsuit, alleging that the anti-nausea drug caused her child to be born with heart defects, brain defects developmental delays and other congenital birth defects.
- May 2015
In California, a mother filed a lawsuit against GSK after she took Zofran during pregnancy, and her baby was born with a heart rhythm disorder known as supraventricular tachycardia (VT). This condition causes rapid breathing, shallow breathing and shortness of breath.
A mother in Arkansas gave birth to a baby with a cleft lip after taking Zofran during the first trimester of her pregnancy. She filed a lawsuit against the drugmaker for failing to warn about the risks associated with the drug when taken while pregnant.
- June 2015
Parents filed a lawsuit after their infant died of heart defects, alleging the tragic results happened due to the fact the mother took Zofran during her first trimester of pregnancy.
- July 2015
In New Jersey, the parents of a boy born with a clubfoot have filed a federal lawsuit, which claims Zofran is responsible for the severe orthopedic birth defect.
- April 2016
A lawsuit was filed on behalf of a North Florida girl who was exposed to Zofran in utero in 1998 and born with several cardiac birth defects, including an atrial septal defect, RV dilatation and bicuspid pulmonic valve.
Contact Our Attorneys Today
If you or someone you know was prescribed anti-nausea medication while pregnant, and their child has suffered from a birth defect, our lawyers can answer many of your questions, or offer a complete and confidential consultation. You may call (800) 780-8607 day or night, and everything that is discussed remains confidential. While we cannot undo the pain and suffering you’ve had to endure, we can determine if you qualify for compensation to help provide medical care and assistance. Our firm is committed to seeking justice for families throughout the United States whose lives have been affected by the unethical promotion and distribution of this medicine.
At Searcy Denney, we handle everything from phone calls to collecting medical records so that you can focus on what’s important: moving on with your life, and taking proper care of your child. Our goal is to make this process easy, quick, and hassle-free, as you have been through enough already. Contact us today for a free, no-obligation consultation. We look forward to hearing from you.