Lawsuits have been filed alleging cases of heart defects associated with Zofran in new born babies. Zofran is commonly prescribed to pregnant women with severe morning sickness. Although the FDA has not approved Zofran for this purpose, the drug is still being prescribed in a manner that the FDA describes as “off-label,” Zofran lawyers note.
If you or a loved one took Zofran while pregnant and delivered a baby with a birth defect, contact Attorney Group for more information. We offer free, no-obligation consultations and can inform you of your options. If you decide to pursue a claim, we can connect you with an affiliated Zofran lawsuit attorney.
Important: The time you have to pursue a claim is limited. Contact us for more information.
Types Of Heart Defects Associated With Zofran
Although heart defects in new born babies may occur as a result of non-Zofran use, for example, genetic causes or the baby’s mother’s use of alcohol during the pregnancy term, numerous types of heart defects have been linked to Zofran, including:
- Truncus Arteriosus (PTA): This heart defect occurs when a single blood vessel (truncus arteriosus) comes out of the right and left ventricles, instead of the normal two vessels (pulmonary artery and aorta), resulting in one arterial trunk coming from the heart and providing mixed blood to the coronary arteries, pulmonary arteries, and systemic circulation. Also referred to as PTA or Persistent Truncus Arteriosus and Common Arterial Trunk, subtypes of truncus arteriosus include Type I, Type II, and Type III. Up to 50 percent of these congenital defects are associated with DiGeorge Syndrome (a condition that causes heart defects, low calcium levels, and poor immune function) or 22q11.2 deletion which are genetic disorders and would disqualify the defect as Zofran related. The heart defect is also associated with a Large Ventral Septal Defect (VSD) or a Right Side Aortic Arch in about 30 percent of cases.
- Atrial Septal Defect (ASD): This defect occurs when there is a hole in the wall that separates the upper chambers of the heart. A hole in the heart is a normal part of development in the womb, but it should close before the baby is born. When it doesn’t close, the severity of the problem depends on the size of the hole and whether it closes on its own or not. This defect can lead to lower-than-normal oxygen levels in the arterial blood that supplies the brain, organs, and tissues. However, an ASD may not produce noticeable signs or symptoms, especially if the defect is small. Shunting is the net flow of blood through the defect, and is measured to determine how severe the defect is. Right to Left shunting indicates a more serious case of ASD and may cause pulmonary hypertension and Eisenmenger’s Syndrome and cyanosis. Atrial septal defect may also be associated with fetal alcohol syndrome (birth defects as a result of a mother’s use of alcohol during pregnancy), and genetic disorders like Down Syndrome (a genetic disorder caused when abnormal cell division results in extra genetic material from chromosome 21).
- Ventricular Septal Defect (VSD): A ventricular septal defect (VSD), a hole in the heart, is a common heart defect that is present at birth (congenital). The hole occurs in the wall that separates the heart’s lower chambers (septum) and allows blood to pass from the left to the right side of the heart. The oxygen-rich blood then gets pumped back to the lungs instead of out to the body, causing the heart to work harder. Although some ventricular septal defects may have a genetic link causing heart problems to occur more often in certain families, adverse side effects from taking Zofran have been linked to an increased risk of congenital heart defects including VSD.
- Tetralogy of Fallot (TOF): Tetralogy of Fallot (TOF) is a cardiac anomaly that refers to a combination of four related heart defects that commonly occur together. These are ventricular septal defect, overriding aorta, pulmonary stenosis, and right ventricular hypertrophy. TOFis the most common cause of blue baby syndrome and cyanosis in newborns. Children with TOF are more likely to have chromosome disorders, such as Down syndrome and DiGeorge syndrome.
- Hypoplastic Left Heart Syndrome (HLH): A heart defect that occurs when one or more parts of the left side of the heart do not fully develop. The mitral valve, left ventricle, aorta and/or the aortic valve may be very underdeveloped. This means that the left side of the heart cannot pump blood to the body very well, so the right side of the heart has to pump blood both to the lungs and to the rest of the body.
- Bicuspid Aortic Valve (BAV): The aortic valve conducts oxygen-rich blood from the left ventricle into the aorta, which carries it to the body tissues. Normally, this valve has three leaflets. Occasionally, people are born with an aortic valve that has only two leaflets. This is known as a bicuspid aortic valve. A bicuspid aortic valve may occur in isolation in an otherwise normal heart, or it may occur with other heart defects. Even though a BAV defect is a high heritable condition, it has been alleged in numerous lawsuits that BAV was caused by prenatal exposure to Zofran.
Other birth defects, including cleft palate and cleft lip with associated cleft palate, have also been linked to Zofran use by expectant mothers during the first trimester. Although never approved to treat morning sickness, plaintiffs in Zofran lawsuits claim that drug maker GlaxoSmithKline nevertheless promoted Zofran for this use and failed to adequately test the drug’s effect on developing babies.
Affected Families May Be Entitled to Compensation
Women who took Zofran while pregnant and delivered a baby with birth defects may be entitled to compensation on behalf of their child. Damages may include:
- Pain and suffering
- Medical expenses
- Mental anguish
- Disfigurement and scarring from a birth defect or medical treatment
If a child dies as a result of a birth defect, family members may be able to pursue wrongful death claims. These kinds of damages can include:
- Pain, suffering, and mental anguish resulting from the loss of a child
- Medical expenses attributable to the fatal birth defect
- Conscious pain and suffering of a loved one prior to death
Affected families are encouraged to speak with a Zofran lawsuit attorney to learn more about their rights and remedies.
Contact Us For More Information
If you or a loved one took Zofran and delivered a child with birth defects, contact Attorney Group for more information. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at [email protected].
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you may have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.
See our Frequently Asked Questions page for more information, and contact Attorney Group today.