Studies have linked the use of the anti-nausea drug Zofran by women during pregnancy to birth defects, including heart defects, cleft lip, cleft palate, and other conditions. Originally introduced as a nausea and vomiting medication for people who have undergone surgery or are in cancer treatment, Zofran is now often prescribed “off-label” to pregnant women to treat morning sickness, a treatment that has not been approved by the U.S. Food and Drug Administration (FDA). Lawsuits claim that the drug maker GlaxoSmithKline neglected to disclose risks of birth defects for pregnant women who used the drug. A Pennsylvania Zofran lawsuit may be an option for families who have been affected by complications associated with Zofran.
If you took Zofran during pregnancy and your child has birth defects, contact Attorney Group for Pennsylvania for more information about the options available to you. At no out-of-pocket cost to you, we can help answer your questions in a confidential, no obligation consultation. If you have a case, we can connect you with an affiliated Zofran lawsuit attorney in Pennsylvania or another state who can assist you throughout the legal process.
What Is Zofran?
Zofran, the trade name for Ondansetron, is a medication produced by GlaxoSmithKline and is FDA approved 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 treatment of morning sickness, although many doctors prescribe the drug “off label” for that purpose.
Risks Of Zofran
There have been multiple studies in the past five years that suggest Zofran is not safe for fetuses and can cause moderate to severe birth defects if taken in the first trimester. For example, according to one study, the drug raises the risk of cleft palate, an oral malformation that WebMD defines as a hole in the soft palate, which is located on the roof of the mouth. Heart defects have also been identified as an increased risk by more than one study.
It is alleged that the most prevalent types of birth defects that Zofran can potentially cause include musculoskeletal irregularities, mouth disfigurements, jaundice, and heart defects. Specific birth defects have been 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, Pennsylvania Zofran lawsuit attorneys claim that the manufacturer did not adequately disclose the risks of the drug to mothers who subsequently delivered children with birth defects.
Pennsylvania Zofran Lawsuit – Other Risks
Many lawsuits have already been filed, alleging that birth defects were caused by Zofran taken during early pregnancy. In one case, a plaintiff claims that the company, 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. Because of the number of lawsuits already filed, litigation is being consolidated and centralized to a single venue so that all documentation and evidence can be combined in a single trial.
The Attorney Group for Pennsylvania can connect you with an experienced Zofran lawsuit attorney who can help you throughout the legal process.
Affected Families May Be Entitled to Compensation
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 Pennsylvania. 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 Pennsylvania today.