The manufacturer of the anti-nausea drug Zofran is facing multiple lawsuits, and has a history of hiding safety information and misrepresenting the product. GlaxoSmithKline (GSK), a global health care company, pled guilty and paid more than $3 billion in 2012 to resolve safety and fraud allegations from the U.S. Department of Justice.
The GlaxoSmithKline settlement was, at the time, the largest of its kind in U.S. history. GSK pled guilty to misbranding several of its drugs as well as hiding safety information. Allegations also included promoting its anti-nausea drug Zofran for unapproved uses, particularly as a treatment for morning sickness in pregnant women.
Studies have since found that pregnant women who use Zofran are much more likely to give birth to a child with severe birth defects, including cleft lip/palate defects and heart defects. Multiple patients have filed Zofran lawsuits against GSK after using Zofran while pregnant and then giving birth to a child with birth defects.