Cleft lip facial deformities—often accompanied by cleft palate— occur in one in 700 babies, according to WebMD. In most cases, the cause of cleft lip and cleft palate are unknown. But some individuals are now learning that they were born with cleft lip or cleft palate because of an anti-nausea drug, Zofran® their mother took during pregnancy.
Zofran® was approved by the U.S. Food and Drug Administration (FDA) in 1991 to treat nausea and vomiting caused by chemotherapy and radiation. It was also prescribed off-label to alleviate nausea in pregnant women suffering from morning sickness, but it was never approved for this use.
The anti-nausea drug was prescribed for morning sickness because GlaxoSmithKline (GSK) promoted Zofran off-label for this use. GSK’s actions were wrong and illegal. Zofran was not safe or approved for pregnant women. These unlawful actions resulted in women giving birth to children with Zofran birth defects, including cleft lip and cleft palate.
A 2012 Center for Birth Defects Research and Prevention study found a possible link between Zofran and birth defects. The study suggested that pregnant women who took Zofran during the first trimester had a twofold increased risk of having a child with cleft lip or cleft palate.
Babies born with cleft lip and cleft palate can be subject to a lifetime of medical treatment. WebMD advises that patients may be required to undergo multiple surgeries over the course of 18 years and may require visits to multiple specialists including:
- Plastic surgeons
- Oral surgeons
- Otolaryngologists (ear nose and throat doctor)
- Speech therapists and pathologists
Treating cleft lip and cleft palate can be expensive. Families should not have to pay because GSK failed to warn about the link between Zofran and birth defects.
Children born with cleft lip or cleft palate as a result of Zofran pregnancy use may be eligible to file a Zofran birth defects lawsuit to seek compensation for medical expenses.
Greg Spizer is a partner of Anapol Weiss and co-chairs the firm's Mass Tort Department. He concentrates his practice on pharmaceutical liability, professional malpractice, products liability and other civil and commercial litigation.