What is the Zofran Lawsuit?
In 2012, GlaxoSmithKline (GSK), the pharmaceutical company that manufactures Zofran, agreed to pay $3 billion to settle claims with the U.S. Department of Justice for a variety of civil and criminal allegations. As part of the settlement, GSK agreed to resolve its civil liability for promoting several drugs, including Zofran, for off-label use. Even though GSK paid settlements of $3 Billion, this has not released the company from liability for damages or injuries that may have occurred as a result of Zofran use.
What is Zofran and what is it used for?
Zofran is the brand name for the generic medication, odansetron hydrochloride, manufactured by the UK pharmaceutical giant, GlaxoSmithKline (GSK), who has operations in 115 countries and estimated annual revenue of $35 Billion.Available as an oral tablet, oral solution, oral disintegrating tablet and as an intravenous injectable, Zofran was FDA approved to treat or prevent nausea and vomiting in patients receiving cancer treatment (chemotherapy and/or radiation therapy) and in surgery or for post-operative related nausea care.
A 5-HT3 receptor antagonist, Zofran works by blocking serotonin levels in the brain that would otherwise activate a nauseous or vomitous response in patients. An effective anti-nausea medication when used as directed, Zofran began to be used in what is called “off-label” treatment for morning sickness. While physicians are allowed to and often do use certain medications for “off-label” treatments at their professional discretion, usually when they feel the benefits outweigh the risks to their patients (and in this case, the developing fetus of their patient), drug manufacturers are forbidden by law to promote or market medications for these types of uses.
According to the American Journal of Obstetrics & Gynecology (AJOG), “about 1 million pregnant American women are exposed to ondansetron (Zofran) out of 4 million pregnancies a year.” Some recent reports show that using Zofran increases the risk of having a child with birth defects by as much as 30%. A significant percentage considering such a large number of pregnancies exposed each year.
In fact, a 2011 study found that ondansetron (Zofran) can actually double the chance of a child being born with cleft palate.
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Potential birth defects caused by Zofran may include:
- Congenital heart defects
- Cleft palate
- Kidney malformation
- Musculoskeletal defects
- Club foot
- Craniosynostosis (a condition characterized by an abnormally shaped skull that can lead to mental impairment and vision problems)
- Fetal growth restriction
- Spontaneous abortion
- Fetal death
When you hire an attorney from Meshbesher & Spence, you will not pay any attorney fees until you receive compensation. In the event that you do not recover compensation for your injuries, you owe us nothing. This kind of pay structure is called a “contingent fee agreement”.
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The attorneys of Meshbesher & Spence have been representing families in crisis for over 50 years. Ron Meshbesher established his Minneapolis legal practice in 1961 with a skilled staff dedicated to preserving and defending the welfare of individuals and families. Our highly skilled litigators specialize in personal injury, class action, and civil litigation. The experienced lawyers at Meshbesher & Spence will help you seek compensation for your injuries.
Zofran – You’re not alone
Nausea or vomiting during pregnancy (NVP), commonly referred to as morning sickness, occurs in 80% of pregnancies. In its most serious form, NVP can lead to hyperemesis gravidarum, a condition characterized by extreme nausea and vomiting that can cause malnutrition, placing the lives of the mother and fetus at risk. NVP often requires hospitalization.
With this in mind, it’s not surprising to find that approximately 10-15% of pregnant women use medications to treat morning sickness. In fact, according to a recent article in the American Journal of Obstetrics & Gynecology (AJOG), “about 1 million pregnant American women are exposed to ondansetron out of 4 million pregnancies a year.” Some recent reports show that using Zofran increase the risk of having a child with birth defects by 30%. That’s a high risk in a large number of pregnancies.
Zofran and birth defects
Because morning sickness most often occurs during the first trimester, the pregnant mother is taking Zofran at the infant’s most critical and fragile stage of development. Birth defects commonly linked to Zofran include the following:
Heart problems such as septal defects (holes in the heart)
Craniosynostosis: a condition characterized by an abnormally shaped skull that sometimes may not leave enough space for the brain, leading to mental impairment and vision problems
Why is GSK negligent?
Treatment of anti-nausea associated with surgery and chemotherapy are the only uses for Zofran, and its generic counterpart, that have been approved by the U.S. Food and Drug Administration (FDA). Yet GSK has been promoting Zofran (as well as other drugs) for off-label uses such as morning sickness for a long time. In 2012, GSK readily admitting their culpability, agreeing to pay $3-billion to settle claims with the U.S. Department of Justice regarding the drug.
An approved solution for morning sickness
According to AJOG, pregnant women now have a viable alternative to taking non-tested drugs for morning sickness. In 2013, the FDA approved using a combination of doxylamine and pyridoxine to treat nausea and vomiting in pregnant women. “Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety,” the article stated.
Have you or a loved one suffered from birth defects that may have been caused by Zofran? If so, call one of our experienced pharmaceutical drug attorneys at 1-888-728-9866 for a free consultation. Or, fill out this simple form http://www.meshbesher.com/practice-areas/zofran-birth-defects (on the right side of the screen) and one of our attorneys will contact you to gather more information.
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