Zofran birth defects lawsuits allege drug maker GlaxoSmithKline wrongfully promoted the drug for the unapproved treatment of morning sickness. Studies have reportedly linked the use of the drug during the first trimester of pregnancy with an increased risk of severe Zofran birth defects, including cleft lip, cleft palate, and heart defects. Affected families may be eligible to file a lawsuit and seek compensation with the help of a Zofran lawsuit attorney.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Zofran birth defects lawsuit attorney who can assist you throughout the legal process.
What is Zofran and How Does It Work?
The U.S. Food and Drug Administration (FDA) approved Zofran, or Ondansetron, to treat nausea and vomiting in chemotherapy and surgery patients in 1991. Zofran works by inhibiting the nausea-inducing neurotransmitter serotonin from interacting with HT3-receptors in the body. Morning sickness is common during the first trimester of pregnancy, and attorneys allege GlaxoSmithKline promoted Zofran for the “off-label,” or unapproved, use of treating morning sickness and failed to disclose risks for women who took Zofran during the first trimester.
Zofran Birth Defects
Studies have reportedly linked use of Zofran during pregnancy with an increased risk of birth defects, including cleft lip, cleft palate, and heart defects. An August 2013 study reported an almost two-fold increased risk of congenital heart defects with Zofran use during pregnancy, including atrial septal defects, ventricular defects, and heart murmurs. A 30 percent overall increased risk of birth defects was reported in women who took Zofran.
GlaxoSmithKline agreed to pay $3 billion in a settlement with U.S. Justice Department in 2012 for off-label promotion of drugs, including Zofran to pregnant women for morning sickness. At that time, the settlement reached was reportedly the largest settlement of its kind in U.S. history.
In addition to heart defects, cleft lip, and cleft palate, increased risks of kidney defects and fetal growth restriction have also been allegedly associated with the use of Zofran during pregnancy. When a pregnant woman takes Zofran, the drug can cross the placenta through the same path taken by oxygen and nutrients and interact with the fetus. This may cause the fetus to develop abnormally or be malnourished and underdeveloped at birth.
Have Questions About Zofran Birth Defects?
Women who took Zofran during pregnancy, particularly during the first trimester, and delivered a child with birth defects, including cleft lip, cleft palate, and heart defects, may be able to pursue claims for compensation for medical expenses they incurred on behalf of their children, as well as other damages sustained by the child. Compensation can be based on a number of factors, including:
- The permanency of the child’s injury
- Past and future medical expenses
- Scarring and disfigurement resulting from the injury or medical treatment
- Past and future pain and suffering resulting from the injury
The families of children who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
For more information, contact Attorney Group. After you contact us, an attorney will follow up to 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.