A group of families have taken legal action against the makers of Zofran after the company didn’t provide enough warning that their product can cause birth defects. According to the accusers, the company that manufactures the drug, GlaxoSmithKline (GSK), did not warn consumers about the risks despite being aware of them early on.
After outside studies showed that the popular anti-nausea medication caused cardiovascular and cleft-palate birth defects, GSK added a warning on the product. Early labels, however, did not include this information. Some believe that the company intentionally withheld the information from its customers.
Additionally, the drug was never approved by the U.S. Food and Drug Administration for treating pregnant mothers. Initially, the medication was only approved for patients suffering from the nausea caused by cancer treatments such as chemotherapy. According to the lawsuit, GSK still marketed the drug to pregnant women, even though the FDA had never approved it for this purpose.
Is GSK to Blame for the Resulting Birth Defects?
Because of their failure to provide proper warning, women have given birth to children with one or more of the following birth defects:
- Mental problems
- Cleft palates
- Heart issues
- Stomach issues
- Hearing problems
- Skull deformities
The company is now facing federal charges for illegal marketing and fraud, and the court has ordered that they pay damages of $3 billion to the families they harmed. Hopefully, these penalties will serve as a reminder to businesses that this kind of behavior will not be tolerated.