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 North Carolina 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 North Carolina. At no out-of-pocket cost to you, we can help answer your questions in a confidential, no obligation consultation. If you choose to pursue a claim, we can connect you with an affiliated Zofran lawsuit attorney in North Carolina or another state 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.
Common Side Effects
When patients take a prescription medication, they may experience side effects that are either mild or serious in nature. According to WebMD, some of the common, but less serious side effects associated with taking Zofran include dizziness, lightheadedness, headaches, excessive tiredness or drowsiness and constipation.
Comparatively, some of the more serious side effects that can occur after taking Zofran include muscle spasms or stiffness, vision changes and stomach pain. Patients are encouraged to notify their doctor if they experience any of these serious side effects, or if some of the less serious side effects of taking this drug, like constipation, persist.
Lawsuits Allege Other Risks
Many studies have been published concerning Zofran safety and pregnancy. In one of these studies, according to the National Center for Biotechnology Information, researchers examined data from the National Birth Defects Prevention Study compared with randomly selected live births. Of the 5,859 women who were part of the control group, 67.1 percent said that they experienced nausea and vomiting during their first trimester of pregnancy, and 15.4 percent of the women said that they took at least one medication to treat these symptoms. After analyzing the data, the researchers reported that the risks associated with taking ondansetron (Generic Zofran) during pregnancy warranted further investigation.
While many women have filed lawsuits against Zofran’s manufacturer GlaxoSmithKline claiming that the medication causes birth defects, the drug manufacturer was also fined $3 billion in 2012 for alleged illicit drug marketing. In that case, the U.S. Department of Justice argued that the drug corporation was civilly liable for promoting certain of its drugs, including Zofran, for off-label use, in addition to other claims. The manufacturer settled the claims, and the fine it was required to pay was the largest ever paid by a company that produced prescription drugs at the time.
Although doctors are allowed to prescribe drugs for unapproved uses, consistent with the standard of care governing medical professionals, drug companies are prohibited by law from promoting drugs for uses unapproved by the FDA. Off-label use is nevertheless common, and it is estimated that one out of every five outpatient prescriptions written in the U.S. are issued for other purposes besides their approved one.
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, North Carolina 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 North Carolina 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 North Carolina Zofran lawsuit attorney to learn more about their rights and remedies.
Contact Us For More Information
For more information, contact Attorney Group for North Carolina. 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 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 North Carolina today.