A Colorado Zofran lawsuit may be an option for women who took the medication during pregnancy form morning sickness and gave birth to babies with birth defects. Plaintiffs claim Zofran manufacturer GlaxoSmithKline promoted the drug as an anti-nausea medication for use in pregnant women, despite the lack of approval by the U.S. Food and Drug Administration (FDA) for that use. The use of Zofran during pregnancy, particularly during the first trimester, has been linked to birth defects, including heart malformations, cleft lip or cleft palate. Affected patients and their families may be able to seek compensation with the help of a Colorado Zofran lawsuit attorney.
If you took Zofran during pregnancy and your child was born with birth defects, contact Attorney Group for Colorado to learn more about your options. At no out-of-pocket cost to you, we can answer your questions. If you have a case, we can connect you with an affiliated attorney who can help you throughout the legal process.
What is Zofran
Zofran, or ondansetron, is a medication approved by the FDA to prevent vomiting and nausea in patients undergoing surgery, radiation therapy, and cancer chemotherapy. It is included in a class of drugs known as 5-HT3 receptor agonists and, according to its manufacturer, works by blocking serotonin, a natural substance in the body known to cause vomiting and nausea. While Zofran has been FDA-approved for use in certain patients, it has not been approved for use in pregnant women.
Use of Zofran During Pregnancy May Cause Birth Defects
Women in their first trimester of pregnancy commonly experience nausea and vomiting, a condition also known as as “morning sickness.” Despite the lack of studies establishing Zofran as a safe and effective method of treating morning sickness in pregnant women, the drug was allegedly promoted to treat sickness in these patients. Lawsuits allege GlaxoSmithKline promoted this “off-label” use while neglecting to warn that Zofran use during pregnancy may lead to birth defects.
A study in a medical journal highlighted the risk of women taking Zofran during pregnancy. Another study conducted in 2013 analyzed more than 900,000 pregnant women between 1997 and 2010, finding that pregnant women taking Zofran were two times more likely to deliver a baby with heart defects and had a 30% overall greater risk of birth defects. In cases of cleft lip, cleft palate and heart defects, reconstructive surgery is required, and in some instances, babies with mouth or palate malformations may find it difficult to eat or swallow.
According to plaintiffs, GlaxoSmithKline knew or should have known that Zofran presented a risk to newborns. Lawsuits allege the manufacturer placed desire for profits ahead of consumer safety by promoting the off-label use of Zofran for morning sickness while failing to warn about the risk of birth defects.
The U.S. Justice Department reportedly reached a settlement in July 2012 with GlaxoSmithKline to resolve allegations that the drug maker illegally promoted the “off-label” use of Zofran and other drugs. According to the Department of Justice, the total $3 billion settlement amount was the largest for healthcare fraud allegations in the history of U.S. pharmaceutical settlements.
How A Colorado Abilify 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 and damages that may result.
When patients suffer from severe side effects from a dangerous or defective drug, they may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Economic Losses
- Medical and other treatment expenses
- Pain, suffering, and mental anguish
- Loss of income or ability to work
Patients who have suffered loss as a result of taking Zofran are encouraged to speak with a Colorado Zofran lawsuit attorney to learn more about their rights and remedies.
For more information, contact Attorney Group for Colorado. 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.