The Justice Department has ordered GlaxoSmithKline (GSK) to pay $3 billion settlement to resolve allegations of illegally marketing several drugs, including Zofran in pregnant women.
Zofran Settlement Information
The U.S. Department of Justice and GSK agreed to a record-setting $3 billion settlement for illegal promotion of Zofran and several other drugs in July 2012. In a announcement, the agency stated:
“It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”
“Off-Label” in Pregnant Women
Zofran is a medication that is approved by the FDA for the treatment of nausea in chemotherapy patients. It has never been evaluated in clinical trials for safety or effectiveness in pregnant women with morning sickness.
Federal law prohibits pharmaceutical companies from marketing their medications for any purpose that is not expressly approved by the FDA. However, doctors are allowed to prescribe medications “off-label” for unapproved purposes.
Zofran is also Pregnancy Category B, which means no one knows if it causes birth defects in humans, but animal studies have shown no evidence of fetal harm.
According to the Prescribing Information for Zofran:
“Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”
Zofran Lawsuit Settlements
The $3 billion Zofran settlement does not provide any payments to pregnant women who had a baby with a birth defect after taking Zofran. It does, however, add evidence to legal claims from pregnant women who accuse GSK of negligence for promoting Zofran without adequate warnings about the risk of birth defects. In the future, it is possible that women seeking settlements will file their claims into a class action or other consolidated litigation.
If you decide to file a lawsuit, you could receive compensation for your child’s injury, including:
- Pain and suffering
- Medical expenses
- Decreased quality of life
- Lost income
- And more