GlaxoSmithKline (GSK) paid $3 billion in 2012 to settle allegations of fraud and failure to report safety data. This is the largest health care fraud settlement in U.S. history and the largest settlement by a drug company ever.
Included in the fraud allegations against GlaxoSmithKline were its practices of marketing drugs for purposes other than what the FDA approved. For example, the cancer treatment and surgery drug, Zofran, was illegally marketed as an anti-nausea and anti-vomiting treatment acceptable for pregnant women suffering from morning sickness. The FDA only approved Zofran for post-operative nausea, but GSK is alleged to have paid kickbacks to doctors to encourage them to prescribe the drug to pregnant women.
Recent studies have begun to link the drug ondansetron, marketed by GlaxoSmithKline under the name Zofran, to severe fetal birth defects. Two lawsuits filed early in 2015 allege the drug manufacturer knew Zofran was unsafe for consumption by pregnant women, but failed to warn the public.
A 2011 study conducted at Harvard University, in association with the US Center for Disease Control, found that pregnant women who took Zofran during their first trimester of pregnancy were over twice as likely to deliver a newborn with cleft palate. Cleft palate is an opening or split along the roof of the mouth and can make breathing, feeding, and speech difficult. Cleft palate can require five or more surgeries to fully repair. Other studies have linked severe fetal heart defects to the use of Zofran by pregnant women.
The FDA Warns Pregnant Women About Dangers of Zofran
In November 2013, the FDA issued a warning not to use Zofran during pregnancy. The FDA came to this decision based on recent studies, including the study done at Harvard, which showed an association between the use of Zofran in early pregnancy and congenital cardiac malformations and oral clefts. Further, there are risks to pregnant women with electrolyte imbalance due to vomiting. More specifically, risks include Serotonin Syndrome that can cause symptoms such as confusion, agitation, autonomic instability, and neuromuscular changes. To find out more about birth defects associated with use of Zofran during pregnancy, read our Zofran Lawsuit page.
How to Make a Claim for Zofran Related Birth Defects?
If you took Zofran during your pregnancy, please call us to discuss the specifics of your potential claim. There are statutory regulations that limit the time you have to file a claim. Don’t delay in seeking a FREE CONSULTATION immediately. We are here to serve. Failing to act allows companies like GlaxoSmithKline a break for placing profits ahead their consumers’ well being.
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