Zofran is a medication designed to stop the body from producing chemicals that can cause vomiting and nausea. While many patients have benefitted from it, lawsuits are alleging that the drug is linked to birth defects such as heart malformations and cleft palate. Affected mothers may be eligible to file a New Jersey Zofran lawsuit if they took the drug during pregnancy and gave birth to a child with birth defects.
For more information, contact Attorney Group for New Jersey 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 New Jersey Zofran lawsuit attorney who can assist you throughout the legal process.
What Is Zofran?
Zofran is a medication manufactured by GlaxoSmithKline and is approved by the U.S. Food and Drug Administration (FDA) as a treatment for vomiting and anti-nausea in surgery, chemotherapy and radiation therapy patients. It can also prevent the normal complication of shaking in people who have had anesthesia. However, as of March 2015, the FDA has not been approved it for the treatment of morning sickness, although some doctors prescribe the drug “off label” for that purpose.
Doctors often prescribe medications that the FDA has approved for a different use. WebMD explains that this practice, known as off-label use, is legal because the FDA does not regulate how a drug is prescribed once it has been approved. After studies have identified conditions under which the medication is safe to use, doctors may pass it on to patients. Doctors do not have to provide the patient with information about the drug’s original intended use when writing an off-label prescription.
Most women are not surprised to experience some nausea and vomiting during the first trimester of their pregnancy. In some cases, the Mayo Clinic warns that this condition can last throughout the pregnancy. Some women may have symptoms so severe, it puts their health at risk. This is called hyperemesis gravidarum, and many doctors choose to prescribe medication to prevent dehydration, malnutrition, damage to the esophagus, and low birth weight.
Zofran and Pregnancy Research
According to obgynnews.com, some studies have indicated that Zofran may also be used to treat hyperemesis gravidarum without serious side effects. In spite of the fact that medical research involving this type of use was limited, Zofran has been prescribed to pregnant women for many years.
However, two studies involving on Zofran pregnancy use in Denmark provide an insight into the risks associated with taking Zofran while pregnant. There were nearly 2,000 pregnancies over eight years that researchers assessed in the first study. Researchers did not identify when in the pregnancy the drug was prescribed. The results indicated that there were no increased risk to the fetuses.
A similar study analyzed the results of nearly 900,000 pregnancies, and the time period analyzed in the second study was 13 years. These researchers found that heart defects were much more likely when the drug was taken during the first trimester.
Lawsuits Allege Other Risks
Many lawsuits have already been filed, alleging that birth defects were caused by Zofran taken during pregnancy. In one case, a plaintiff claims that drug maker, GlaxoSmithKline, had over 200 reports of birth defects that included severe malformations, heart defects and stillbirths. The plaintiff allegedly took the medication during her first trimester of pregnancy, and her daughter was born with an atrial septal defect, which is a hole between the upper chambers of the heart. The defect allows blood that has been oxygenated to mix with blood that has already circulated through the body.
In July 2012, the U.S. Justice Department reached a $3 billion settlement with GlaxoSmithKline to resolve allegations that the drug maker illegally marketed Zofran to pregnant women in order to increase the company’s profits. Additionally, these prescriptions were determined to be “off-label” since the medication was neither FDA-tested nor approved for use in pregnant women.
Zofran and Birth Defects
Lawsuits claim that Zofran can potentially cause birth defects, which include musculoskeletal irregularities, mouth disfigurements, jaundice, and heart defects. Specific birth defects allegedly linked to the use of Zofran during pregnancy, including:
- Heart murmur
- Cleft lip
- Atrial septal defect
- Heart defects
- Kidney defect
- Cleft palate
- Ventricular septal defect
- Fetal growth restriction
- Hole in the heart
- And more
Whereas many women have taken Zofran without incident, New Jersey Zofran lawsuit attorneys claim the manufacturer did not adequately disclose the risks of the drug to mothers who subsequently delivered children with birth defects.
How A New Jersey Zofran Lawsuit Can Help
Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
The parents of children who were born with birth defects linked to Zofran may be entitled to compensation for damages, including the child’s:
- Medical expenses
- Pain, suffering, and mental anguish
- Scarring or physical deformities caused by the birth defect or treatment
If a child died due to birth defects linked to Zofran, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of their child prior to death
- Pain, suffering, and mental anguish from the loss of a child
- Funeral expenses
Affected families are encouraged to seek the advice of a New Jersey Zofran lawsuit attorney to learn more about their rights and remedies.
Contact Us For More Information
For more information, contact Attorney Group for New Jersey. 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]oup.com.
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might 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 or file a lawsuit 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 for New Jersey today.