Zofran or ondansetron is a potent anti-emetic drug approved by the United States Food and Drug Administration (FDA) for the treatment of severe nausea and vomiting associated with chemotherapy, radiation treatment and surgery. Although the FDA only approved Zofran for use in seriously ill patients, GlaxoSmithKline (GSK) has illegally marketed Zofran “off-label” as a safe and effective treatment for the very common side effect of pregnancy-related nausea or “morning sickness.” It is estimated that 75% of pregnant women will experience some degree of morning sickness. However it has been determined in many studies that there is also a high risk of Zofran contributing to birth defects
Dating back to the early 1990s, GSK began to receive mounting evidence of reports of Zofran-related congenital birth defects, including atrial septal defects, ventricular septal defects and cleft lip and palate. Undeterred by this data or the lack of FDA approval, GSK’s sales representatives specifically promoted Zofran to pregnant women as a morning sickness drug for over a decade.
An atrial septal defect or ASD is a hole between the upper chambers of the heart called the atria which allows blood to flow between the chambers. The defect allows oxygen-rich blood to flow directly from the left side of the heart to the right side of the heart, where it mixes with the oxygen-poor blood, or vice versa. This leads to below normal oxygen levels in the arterial blood which supplies the brain, organs, and tissues.
A ventricular septal defect or VSD is a hole between the left and right ventricles of the heart. A ventricular septal defect is usually symptomless at birth and does not manifest itself until a child is a few weeks old. A ventricular septal defect that is not surgically corrected or fails to close on its own can increase pulmonary resistance and lead to cyanosis.
A cleft palate is a split in the roof of the mouth. In extreme cases, the defect involves both the hard palate (roof of the mouth) and the soft palate (back of the throat). A cleft lip is a split or separation of the two side of the upper lip. Children born with a cleft palate or lip may experience significant functional limitations in feeding, hearing, and speech development. Surgery is often required to correct these defects. The goal of cleft lip surgery is to restore normal appearance and function to the upper lip. The surgical repair of a cleft lip is not performed until sometime after the infant reaches ten pounds in weight and is at least ten weeks of age. It is also important to initiate treatment to correct the cleft palate early in a child’s life, often between six and eighteen months of age.
Unlike other anti-nausea medications, GSK never conducted a single study on the possible side effects, including birth defects, of Zofran on pregnant women or children in utero. Additionally, GSK has never warned physicians or patients in the drug’s prescribing information or promotional materials that Zofran should not be used during pregnancy due to the risk of birth defects.
In 2012, GSK pled guilty to criminal charges lodged by the United States of America for the off-label promotion of its drugs for unapproved uses. At that same time, GSK entered into a $1 billion civil settlement with the Department of Justice for its illegal marketing of Zofran and other medications despite the link between Zofran and birth defects.
Three recent epidemiological studies have examined the association between prenatal exposure to Zofran and the risk of congenital heart defects in children born to mothers on the drug. All three studies found that a mother exposed to Zofran during pregnancy had a more than doubled risk of having a baby with a congenital heart defect or cleft lip or palate than a mother who did not ingest Zofran during pregnancy.
Zofran Litigation Update
The Zofran birth defect litigation is a new, emerging mass tort.
As of April 2015, only five Zofran lawsuits have been filed in courts around the U.S., including cases in Alabama, California, Massachusetts, Montana and Pennsylvania. Over time, additional claims will be court filed against GSK. We anticipate that a multi-district litigation (MDL) for Zofran lawsuits will be established in the future.
If you or a loved one used Zofran during pregnancy and gave birth to a child with a birth defect, you may be entitled to pursue a claim against the manufacturers for damages. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.