During pregnancy, many women experience health issues alongside the excited anticipation of having a child. When complications place the mother and fetus at risk, doctors may prescribe medications to counter the symptoms. Choosing a drug that treats the illness without harming the patient can be problematic. One such option, Zofran, has recently been the target of lawsuits, alleging the drug is allegedly linked to birth defects such as heart malformations and cleft palate. Affected mothers may consider filing an Ohio Zofran lawsuit if they took the drug during pregnancy and gave birth to a child with birth defects.
monkeybusinessimages/iStock/ThinkstockFor more information, contact Attorney Group for Ohio. 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 Ohio or another state who can assist you throughout the legal process.
What Is Zofran?
One medication that a doctor may offer to treat morning sickness is Zofran. This drug was originally approved to treat nausea for cancer patients who are undergoing radiation therapy, surgery and chemotherapy. It prevents nausea and vomiting by blocking serotonin, which is a natural chemical in the body that is often a trigger.
The U.S. Food and Drug Administration (FDA) places Zofran in pregnancy category B, which indicates that it was administered to laboratory animals and caused no adverse side effects. However, the only indication it is appropriate for humans is the lack of concrete evidence of birth defects based on its limited use. There have not been adequate clinical trials to verify its safety for pregnant women and fetuses.
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.
Across the United States families are filing lawsuits against GlaxoSmithKline alleging that exposure to the drug while in utero may cause babies to develop clubfoot, cleft lip and palate, tetralogy of fallot, atrial septal defect and other complications. In some cases, the defects have proven fatal, and parents have lost their new babies. In others, the infants have had to endure multiple corrective surgeries.
Other 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, Ohio 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.
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.
How Can An Ohio Zofran Lawsuit 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 an Ohio Zofran lawsuit attorney to learn more about their rights and remedies.
Contact Us For More Information
For more information, contact Attorney Group for Ohio. 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 Ohio today.