Zofran was approved by the FDA to help relieve nausea and vomiting in cancer patients who are undergoing chemotherapy treatment or after surgery. Zofran manufacturer GlaxoSmithKline decided to market the drug to pregnant women who suffered from morning sickness – without approval from the FDA. Pregnant women who took the drug have experienced dangerous complications, and have given birth to babies being born with serious birth defects and deformities caused by the drug.
In March 2013, the FDA identified a potential safety issue linking Zofran with serotonin syndrome, which can be life-threatening for a pregnant woman and her fetus. Symptoms include cognitive and behavioral changes (confusion, agitation), rapid heartbeat, diarrhea, shivering, muscle rigidity, seizures, high fever, and loss of consciousness.
Serious side effects of Zofran:
In 2012, GlaxoSmithKline pled guilty and agreed to pay $3 billion to settle civil and criminal fraud charges relating to its misleading and false promotion of Zofran.
The number of lawsuits against the drugmaker is growing, claiming the company knowingly marketed a drug to pregnant women with known risks and failed to warn about the side effects.
One of the first Zofran birth defect lawsuits was filed in February 2015. In October 2015, Zofran litigation was centralized in an MDL (multi-district litigation) in the District of Massachusetts.
If you or your child have suffered from injuries after taking Zofran, speak with a defective drug attorney at Kaiser Gornick LLP during a free consultation. We are one of the nation’s leading product liability litigation firms and have produced an impressive track record of recoveries totaling hundreds of millions of dollars for clients. Our experienced lawyers are nationally recognized advocates who have gone against pharmaceutical giants and large companies. We can stand up for you when you’ve been hurt by big businesses.