A Zofran lawsuit may be an option for mothers who took the drug to treat morning sickness while pregnant and delivered a child with birth defects. Studies have allegedly linked the use of the anti-nausea drug Zofran by women during pregnancy to birth defects, including Zofran heart defects, cleft lip, cleft palate, and other conditions. Affected families may be elgible to seek compensation for damages with the help of a bad drug attorney.
For more information, contact Attorney Group today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
What is Zofran?
Zofran, or Ondansetron, is made by GlaxoSmithKline and is approved by the U.S. Food and Drug Administration (FDA) as a treatment for anti-nausea and vomiting in surgery and chemotherapy patients. As of January 2017, it has not been approved by the FDA to treat morning sickness. Numerous lawsuits have been filed alleging that the drug maker failed to disclose the risks of birth defects to women who were prescribed the drug. Affected families may be eligible to file a Zofran lawsuit and seek compensation for damages.
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How Does Zofran Work?
Zofran is a 5-HT3 receptor antagonist that works by blocking the neurotransmitter serotonin. According to the Annals of Palliative Medicine, approximately 80% of the body’s serotonin is located in the GI tract, and it induces nausea and vomiting by acting on the gut and brain stem’s 5-HT3 receptors. Zofran inhibits serotonin from making this interaction, suppressing nausea and vomiting.
Zofran and Pregnancy
As of February 2017, the FDA has not approved the use of Zofran for morning sickness. Although off-label prescriptions are a common practice, pharmaceutical companies are not allowed to promote off-label uses not indicated by the FDA.
Zofran lawsuits note that several epidemiological studies have examined the association between prenatal exposure to Zofran and the risk of congenital heart defects in babies.
One study examined over 900,000 pregnant women between 1997 and 2010 and found a twofold-increased risk of heart defects, in addition to a 30 percent overall increased risk of birth defects in women who took Zofran.
Another study, published in January 2012 in Birth Defects Research reported a 2.4-fold increased risk of cleft palate linked to Zofran use during pregnancy. The data for the study was gathered from approximately 9,000 pregnant women who took part in the National Birth Defects Prevention Study.
Other studies, in Sweden and Denmark specifically, show that the use of Zofran during pregnancy significantly increases the risk of cardiovascular defects. In addition to studies showing risks of dangerous side effects in pregnant women, families have recently filed lawsuits with a number of allegations against GlaxoSmithKline, including that the drug maker promoted Zofran off-label as a “safe” treatment for morning sickness, that their children’s’ birth defects were caused by exposure to Zofran, and that the drug maker failed to disclose Zofran pregnancy risks to the public despite receiving over 200 reports of birth defects from women who had taken the drug while pregnant.
Evidence to support such claims includes allegations by the U.S. Department of Justice in 2012 that the drug maker’s promotion of Zofran as a treatment for morning sickness was unlawful. It was also alleged that GlaxoSmithKline had never conducted any clinical trials that showed that the use of Zofran during pregnancy was safe.
The following birth defects have been linked to the use of Zofran during pregnancy:
- Heart defects
- Heart murmur
- Atrial septal defect
- Ventricular septal defect
- Cleft lip
- Cleft palate
- Kidney defects
- Fetal growth restriction
Zofran Birth Defects
Infants identified in studies were born weighing as little as five pounds or less, even though they were full-term. Zofran was also linked to fetal growth restriction in six babies who were studied. A 2006 report from the FDA, which investigated deaths of children under age 16 who used Zofran noted that known adverse reactions in children included cardiac arrhythmias, bradycardia, palpitations and syncope.
Lawsuits also allege that the following birth defects have been associated with use of Zofran during pregnancy:
- Heart defects
- Cleft lip
- Cleft palate
Drugs taken during pregnancy can cross the placenta to reach the fetus, the same path taken by oxygen and nutrients. The drugs’ direct interaction with the fetus can cause abnormal development, resulting in birth defects, or even death. The placenta may also be affected by the drugs, causing the baby to be underdeveloped at birth due to constriction of the placenta’s blood vessels.
The fetus can also be indirectly injured by drugs. They may cause the muscles of the mother’s uterus to forcefully contract, reducing the fetus’ blood supply or causing preterm labor.
Zofran Heart Defects
Congenital heart defects linked to Zofran use during pregnancy include the following:
- Atrial Septal Defect (ASD): A defect also known as a “hole in the heart,” an ASD allows the passing of blood between the heart’s atria (two upper chambers). A large ASD can cause low oxygen levels in the bloodstream, damage to the lungs, and other life-threatening complications.
- Ventricular Septal Defect (VSD): A VSD is a “hole” between the heart’s two ventricles (lower chambers), and is much less common than ASD. In some cases, a baby is born with both the ASD and VSD.
- Heart Murmur: A heart murmur is an abnormal sound heard by a doctor when listening to a baby’s heart through a stethoscope. Many heart murmurs are harmless, but different heart defects make different sounds.
Zofran Cleft Palate and Cleft Lip
Possible birth defects from Zofran use during pregnancy include cleft palate and cleft lip. A cleft palate is a birth defect in which a baby has a split in the roof of the mouth (the hard palate). In severe cases, the defect also includes the soft palate, or the back of the throat.
A cleft lip is a congenital birth defect in which the tissue that normally forms the baby’s upper lip does not grow together, causing a split. It normally occurs during the 7th week of pregnancy. Zofran lawyers note that reconstructive surgery is often required to fix a cleft lip within the first few years of life. Babies born with a cleft lip or cleft palate are also at risk of malnutrition if they have difficulty swallowing and/or eating.
Other Zofran Side Effects
Other potential serious side effects allegedly linked to Zofran include serotonin syndrome and QT interval prolongation. Serotonin syndrome typically occurs in people who take medications that affect the body’s serotonin levels. Symptoms of serotonin syndrome include confusion, agitation, restlessness, dilated pupils, and rapid heart rate. In some cases, more serious symptoms such as high fever, seizures, and irregular heartbeat can be life threatening.
Have There Been Zofran Settlements?
A rise in the number of familes filing a Zofran lawsuit claiming that use of the drug during pregnancy caused birth defects may prompt other affected families to wonder if any Zofran settlements have been reached. Although GlaxoSmithKline did reach a $3 billion settlement with the federal government in 2012 for off-label promotion of drugs, including Zofran as a treatment for morning sickness, no known Zofran settlements have been reached with individual claimants as of June 2015.
GlaxoSmithKline’s 2012 settlement with the federal government, which was the largest of its kind in U.S. history, does not bar family members of children born with birth defects from bringing individual claims against the drug maker.
Has There Been A Zofran Recall?
There has not been a Zofran recall issued for dosages used to treat morning sickness. However, after it was linked with a heart arrhythmia known as torsades de pointes, a Zofran recall was issued for the 32 mg single-dose intravenous version of the drug in 2012. A drug safety communication was released by the FDA the same year, warning physicians of the risk of arrhythmia linked to the 32 mg IV Zofran.
Is There A Zofran Class Action Lawsuit?
As of February 2017, there have been no Zofran class action lawsuits filed. A person must individually file a Zofran lawsuit, as the case is not expected to be a class action. It is anticipated that individually filed Zofran claims will be consolidated for pre-trial proceeding in multi-district litigation (MDL). An MDL often occurs when a defendant or defendants have caused a similar harm to different people in different ways. In these cases, pursuing individual claims separately is often inefficient, and the respective damages to the plaintiffs are unique to the point of a class action not being appropriate. Exclusive to federal courts, MDLs transfer a number of individual cases to a single court for consolidated pre-trial proceedings.
In contrast to an MDL, a class action lawsuit involves representative plaintiffs filing a complaint alleging the actions of the defendant or defendants harmed them and other members of the class. Members of the class often seek similar compensation, but can choose to opt-out of the settlement and pursue their own individual claims. Class action settlements are approved by the court overseeing the cases.
- January 2016A federal judge denied GlaxoSmithKline’s motion to dismiss Zofran lawsuits, allowing affected families to seek discovery from the drug maker regarding its knowledge of the risks of Zofran birth defects and other matters.
- May 2015Arkansas couple files a Zofran lawsuit claiming that the drug maker wrongfully marketed Zofran for morning sickness off-label and concealed the risk of birth defects.
- February 2015Massachusetts woman filed a Zofran lawsuit claiming use of Zofran while pregnant caused her child’s heart defects and other conditions.
- June 2014The Toronto Star published the results of an investigation into the use of Zofran by pregnant women. The drug is not approved to treat pregnant women in Canada, yet the drug was reportedly promoted for what is known as an off-label use. The Star reviewed reports from the FDA regarding Zofran and birth defects and found that at least 20 Canadian women treated with the drug had experienced side effects. Two infants died and there were multiple incidents of heart and kidney defects in newborns.
- July 2012Zofran manufacturer GlaxoSmithKline was ordered to pay $3 billion by the United States Justice Department for off-label promotion of drugs, including Zofran to pregnant women suffering from morning sickness.
How a Zofran Lawsuit Can Help
Women who took Zofran during pregnancy, particularly during the first trimester, and delivered a child with birth defects, including cleft lip, cleft palate, and heart defects, may be able to pursue claims for compensation for medical expenses they incurred on behalf of their children, as well as other damages sustained by the child. Compensation can be based on a number of factors, including:
- The permanency of the child’s injury
- Past and future medical expenses
- Scarring and disfigurement resulting from the injury or medical treatment
- Past and future pain and suffering resulting from the injury
The families of children who have died as a result of their birth defects may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.