When women suffer from severe nausea during pregnancy, some turn to medication for relief. One such option, Zofran, has recently been the target of lawsuits, alleging that the drug is linked to birth defects such as heart malformations and cleft palate. Affected families may be eligible to file a South Carolina Zofran lawsuit and seek compensation for their damages.
For more information, contact Attorney Group for South Carolina 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 is a type of drug called serotonin 5-HT3 receptor antagonists. This class of medication works by limiting serotonin’s ability to function in the brain and other organs. The release of serotonin can cause nausea and vomiting. The drug’s manufacturer, GlaxoSmithKline, developed the drug for use in cancer patients undergoing chemotherapy or patients who have undergone a recent surgery.
Why Is Zofran Prescribed to Pregnant Women?
While it is unclear exactly why morning sickness occurs, the American Pregnancy Association estimates that nearly 50 percent of expecting mothers will experience the condition at some point during pregnancy. Typically, nausea can be controlled by changes in diet and avoiding triggers, such as certain smells or foods. However, when pregnant women experience excessive vomiting and are unable to gain weight, concerns over the growing fetus’ safety arise. In such cases, a doctor may choose to prescribe Zofran off-label, meaning for a use other than those approved by the U.S. Food and Drug Administration (FDA).
Zofran Side Effects
RxList lists the common side effects of Zofran as fever, headache, diarrhea, dizziness, blurred vision and drowsiness, among others. In 2011, the FDA issued a safety announcement in which it reported an increased risk in the potential for developing abnormal heart beats in patients taking Zofran. GlaxoSmithKline was asked to perform a study on the report, as well as to change labeling to include a warning of the risk to patients taking the drug as directed.
Zofran and Birth Defects
In 2013, a study performed by scientists in Denmark found that there was twice the risk of fetuses developing heart defects when the mother took Zofran in early pregnancy. The researchers studied over 900,000 births and identified 1,368 women who were prescribed Zofran. Of those who took Zofran during the first trimester, 4.7 percent of them gave birth to babies with congenital malformations, compared with only 3.5 percent of those mothers who did not take the drug.
An article published in the American Journal for Obstetrics and Gynecology in 2014 by Dr. Gideon Koren, cited the Danish study and raised concerns over the safety of both mother and child when Zofran is prescribed. Dr. Koren noted that one in four pregnant women are exposed to Zofran, and that in addition to congenital birth defects, the drug could also be linked to cleft palates.
Zofran Lawsuits Filed
GlaxoSmithKline is the defendant in nearly 200 Zofran lawsuits as of 2015, most of which have been consolidated into a multidistrict litigation. One such complaint filed in October 2015 alleges that the mother’s baby suffered multiple birth defects, including teratologic clubfoot deformity, caused by the use of Zofran. The lawsuit claims that GlaxoSmithKline knew of and concealed the risks related to the drug’s use in pregnancy.
Since the FDA has labeled Zofran as a Category B drug, some OB/GYNs continue to prescribe it despite the increasing reports of birth defects, since neither the FDA nor the manufacturer has told them not to.
Whereas many women have taken Zofran without incident, South Carolina Zofran lawsuit attorneys allege that the manufacturer did not adequately disclose the risks of the drug to mothers who subsequently delivered children with birth defects.
How a South 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 Zofran lawsuit attorney to learn more about their rights and remedies.
Contact Us For More Information
For more information, contact Attorney Group for South 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 South Carolina today.