Among the dozens of Zofran lawsuits filed during the summer of 2015, several claims have stood out. While the majority of complaints seek compensation in relation to congenital heart defects, a few, filed in Louisiana, Arkansas and Montana, say the anti-nausea drug caused cleft palate.
On July 17, 2015, a family from Mississippi became the latest parents to allege that early exposure to Zofran led to their child’s cleft palate. Filing suit in the US District Court for the Southern District of Mississippi, Plaintiffs seek compensation for medical expenses and pain and suffering from GlaxoSmithKline, the corporation behind Zofran.
Their complaint, registered as case number 5:15-cv-00070-DCB-MTP, can be viewed by clicking the button below:
Soft Cleft Palate Caused By “Off Label” Morning Sickness Drug, Parents Claim
In court documents, the mother writes of being prescribed Zofran during the first trimester of a recent pregnancy. The drug, approved to treat certain forms of severe nausea, has never been approved for use during pregnancy.
In fact, Plaintiffs say GlaxoSmithKline never even investigated Zofran’s possible effects on fetal development, before allegedly promoting the drug as a morning sickness treatment. Echoing allegations first made by the US Justice Department, the parents claim GSK marketed Zofran directly to obstetricians and gynecologists as a “safe and effective” treatment during pregnancy.
The parents from Mississippi say their son C.P.T. was born in January 2015 and soon diagnosed with a soft cleft palate. The family claims this abnormality was caused by C.P.T.’s exposure to Zofran prior to birth.
What Is A “Soft” Cleft Palate?
Cleft palate, one of the developed world’s most common birth defects, is a split or opening in the roof of a child’s mouth. This “cleft” is the result of mouth tissues failing to fuse properly during early development. After birth, it can lead to difficulties feeding, breathing and speaking.
But “soft” cleft palate is a less familiar term. Medical professionals often divide the roof of the mouth into two basic parts, the hard and soft palate.
The hard palate lies directly behind your teeth; it’s bone and, as the name suggests, hard. The bone is itself covered by a thin layer of tissue, which is soft, flexible and extends back toward the throat. At a certain point, the bone ends and the roof of the mouth becomes all soft tissue. This is the soft palate, and if the claims of C.P.T.’s family are true, he was born with a split or opening there.
How Has Cleft Palate Been Linked To Zofran?
The link between Zofran and heart defects is supported by two major European studies, both of which reviewed millions of birth records and found an increased risk of cardiac septal defects among babies exposed to Zofran.
But an earlier study, one conducted by researchers at Harvard and Boston University, identified an association between Zofran and cleft palate. Reviewing interviews with over 10,000 women, the team found that women who were prescribed Zofran during the first trimester were 2.37 times more likely to have children with a cleft palate.
Spurred by these results, along with allegations that Zofran’s manufacturer failed to report significant safety data to the US Food & Drug Administration, mothers who took Zofran during pregnancy and delivered children with orofacial clefts are filing lawsuits.