Women who use the anti-nausea drug Zofran during pregnancy may have an increased risk of having a baby with a cleft palate. This birth defect occurs when the roof of the mouth does not fuse together correctly in the womb, causing an opening in the upper mouth.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a cleft palate after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Ohio Mother Alleges Son’s Heart, Facial Defects From Zofran
July 6, 2016 – A woman from Sandusky, Ohio, has filed a lawsuit against GSK alleging that her son was born a cleft palate, atrial septal defect and ventricular septal defect after she took Zofran during pregnancy. The mother also claims her child has suffered “issues with vision and hearing,” likely as a result of her cleft palate. The complaint was filed June 24, 2016 under case number 1:16-cv-11281-FDS.
Zofran (generic: ondansetron) is approved to treat nausea and vomiting caused by chemotherapy, radiation therapy and certain types of surgery. The drug blocks neurotransmitters in the body that can trigger nausea and vomiting. Zofran was approved by the U.S. Food & Drug Administration (FDA) in 1991.
What’s the Problem?
Zofran is only approved to treat nausea and vomiting associated with cancer treatment and surgery; however, the drug is commonly prescribed in an “off-label” capacity (for which it was neither treated or approved) to pregnant women for morning sickness. Although it is legal for doctors to prescribe medications off-label, mothers who took Zofran in pregnancy have given birth to children with birth defects. In 2011, a study that examined data from the National Birth Defects Prevention Study (NBDPS) found that Zofran use during pregnancy doubles the risk that children will be born with a cleft palate.
What is a Cleft Palate?
A cleft palate is a split in the roof of the mouth that leaves a hole between the nose and mouth. This causes problems with feeding, hearing loss, dental problems and difficulties with speech. Fortunately, the defect is treatable, and most babies born with a cleft palate are able to recovery completely.
Cleft Palate Repair
Due to the large number of problems a cleft palate can create, a team of medical specialists are usually involved in the care of children with the defect. Members of a cleft palate treatment team may include a plastic surgeon, orthodontist, oral surgeon, speech therapist, nurse coordinator and/or social worker. The team works together to develop a plan suited to each patient’s specific needs. Treatment usually begins when the child is around 3 months old and often continues through adulthood.
Utah Couple Blames Zofran for Daughter’s Cleft Lip / Cleft Palate
February 19, 2016 – A Utah family whose daughter was born with a “wide right unilateral complete cleft lip and palate” filed a product liability lawsuit (PDF) today against GlaxoSmithKline (GSK) in the U.S. District Court for the District of Utah, Central Division. The complaint alleges that GSK “marketed and sold Zofran without adequate warning to healthcare providers and consumers that Zofran was causally associated with increased risks of birth defects.” On March 2, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a Conditional Transfer Order (PFD) to move the case to the multidistrict litigation (MDL) currently underway in Boston.
Arkansas Mother Claims Son’s Cleft Palate Caused by Zofran Exposure
December 23, 2015 – A woman from Arkansas has filed a lawsuit against GSK alleging that her use of Zofran for morning sickness during her first trimester of pregnancy caused her son to be born with multiple birth defects including cleft palate, clubfoot and respiratory distress syndrome (RDS). According to the complaint, the woman only used Zofran in one of her 3 pregnancies. Coincidentally, this was the only pregnancy where she delivered a child with birth defects. Click here to learn more.
Zofran Cleft Palate Lawsuit Filed in Minnesota
A lawsuit filed in Minnesota federal court on April 3 alleges that Zofran caused a baby girl to be born with a cleft palate after her took the drug for morning sickness during pregnancy. According to the complaint, the girl has undergone 10 surgeries since 1998 to repair her cleft palate. Click here to learn more.
Mississippi Family Claims Zofran Caused Daughter’s Soft Cleft Palate
A lawsuit was filed July 17 in U.S. District Court of the Southern District of Mississippi, Western Division, by a woman who claims her child was born with a “soft” cleft palate after she took Zofran for morning sickness during her first trimester of pregnancy.This form of the defect occurs when there is a split in the soft, muscular portion of the roof of the mouth, which can affect feeding, breathing, speech and language development. Click here to learn more.
California Mother Blames Zofran for Child’s Oral Cleft Defects
Lawsuit filed September 1 in the Central District of California by a woman who alleges GSK failed to warn about the risk of birth defects with Zofran. According to the complaint, the mother used Zofran during her 1st and 2nd trimesters of pregnancy, and subsequently had a daughter with congenital oral defects including cleft lip and cleft palate. Plaintiff claims she has no family history of neural tube defects, and that her daughter’s problems are the direct result of exposure to Zofran in utero.
Florida Couple Holds GSK Responsible for Injuries Son’s Injuries
November 6 – A man and wife from Florida have filed a lawsuit against GSK alleging that the mother’s use of Zofran during pregnancy caused their son to be born with a bilateral cleft lip and cleft palate. According to the complaint, the boy has undergone numerous surgeries and treatment from specialists in 3 states, yet continues to have problems eating and speaking, and suffers from development delays and a significantly diminished quality of life. Click here to learn more.
Additional Resources and Information
- Cleft Lip and Cleft Palate Surgery – American Society of Plastic Surgeons
- Cleft Palate: Frequently Asked Questions – University of Iowa Children’s Hospital
- Cleft Palate Foundation
Do I Have a Zofran Cleft Palate Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting new cleft palate cases in all 50 states.