Two women who were treated with Zofran to control nausea and vomiting during the first trimesters of their pregnancies have filed suit against GlaxoSmithKline. Both of the Zofran lawsuits allege that the pharmaceutical giant concealed the drug’s link with birth defects, while at the same time the company promoted its off-label use to treat pregnant women suffering from morning sickness.
The first Zofran complaint was filed February 12th by a woman who was treated with the medication 2004 and 2006 while she was expecting. She claims that the drug caused both of her children to be born with serious heart birth defects. Her case is pending in the U.S. District Court, Eastern District of Pennsylvania.
The second Zofran birth defect lawsuit was filed just four days later, in the U.S. District Court, District of Massachusetts. The mother who filed that lawsuit also received Zofran in the early stages of her pregnancy, and alleges that the drug caused her daughter to develop congenital heart problems and other abnormalities. Since the baby’s birth, she has had to endure 13 different surgeries, and continues to suffer from developmental delays and other issues.
Among other things, the lawsuits point out that Zofran has never been approved to treat nausea and vomiting in pregnancy. Yet in 2012, GlaxoSmithKline agreed to pay $3 billion to settle charges with the federal government involving the marketing of several drugs, including the anti-nausea medication. Among other things, the U.S. Department of Justice had accused the company of promoting Zofran as an off-label treatment for morning sickness.
The Zofran lawsuits also claim that GlaxoSmithKline withheld results from animal and other studies that indicated Zofran might harm a developing fetus. They also assert that by the early 2000’s, Glaxo had received numerous reports connecting the drug to congenital heart abnormalities and other birth defects.
“In many instances, GSK received multiple reports in the same month, the same week and even the same day,” the lawsuits state. “For example, on or about September 13, 2000, GSK received three separate reports involving Zofran use and adverse events. For two of those incidents, the impact on the baby was so severe that the baby died”