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A wave of lawsuits have been filed against the international pharmaceutical giant GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran causes major birth defects.

Mothers across the country say that after being prescribed the “off label” morning sickness treatment, they gave birth to children with congenital heart defects and cleft palate.

At least 45 claims have been filed so far, but with more than 1 million women prescribed Zofran during pregnancy every year, other parents are expected to step forward in the coming months.

Ohio Mother Says Cleft Palate Caused By Zofran, Son Endured 8 Surgeries

Zofran birth defects lawsuit cleft palate
A cleft lip and palate following surgical repair.

One of the most recent lawsuits was filed on July 16, 2015, by a mother living in Uniontown, Ohio, a tiny village 20 minutes south of Akron. After taking Zofran during the first trimester, she says the drug caused her unborn son to develop a cleft lip and cleft palate. The mother’s child C.L., now 9 years old, has already undergone 8 surgeries, she claims.

Her complaint was filed in the US District Court for the Northern District of Ohio, Eastern Division. It was logged as case number 5:15-cv-01411, and joins dozens of other Zofran birth defects lawsuits filed in Federal Courts across the country.

This is believed to be at least the 11th lawsuit to claim Zofran caused orofacial clefts, a group of birth defects that involve splits or openings in a child’s mouth.

The court documents, made public by the trial attorneys at Monheit Law, can be viewed at

Zofran Birth Defects: Did Unapproved Morning Sickness Drug Cause Cleft Palate & Lip?

C.L. was conceived in 2005. The mother claims she was prescribed Zofran early in her first trimester, as an “off label” treatment for the nausea and vomiting that a majority of pregnant women experience.

Zofran was never approved for any use during pregnancy. But every Plaintiff to join the growing Zofran litigation has claimed GlaxoSmithKline promoted the drug as a “safe and effective” morning sickness treatment. In fact, the Justice Department made an identical allegation in 2012.

Born on April 12, 2006, C.L. was immediately diagnosed with a cleft palate, a split in the roof of his mouth, and a cleft lip, an opening in his upper lip.

Plaintiff says her family has no history of orofacial cleft defects, and her two other children were born without congenital abnormalities after pregnancies in which she did not take Zofran.

C.L. Forced To Brave 8 Invasive Procedures, Mother Alleges

While C.L.’s alleged hardships may sound extreme, extensive treatments are far from uncommon for children with orofacial clefts. Most children born with a cleft palate will require more than one surgical procedure, and many need a series of such surgeries over the course of adolescence, reaching even into the teen years.

To date, young C.L. has allegedly undergone 4 lip and palate repair procedures, in which doctors have attempted to reconstruct his mouth’s musculature and “patch” the clefts with surrounding tissues.

Associated Conditions Require Their Own Treatment

A tonsillectomy was also necessary, his mother says. Removing a child’s tonsils can improve the clarity of a child’s speech. A cleft in the palate allows air to escape through a child’s nose while they’re talking, leading to a disorder known as velopharyngeal insufficiency.

Pharyngoplasty was performed, Plaintiff says, another attempt to allow C.L. to speak clearly. By rearranging soft palate tissues, along with those from the back of the throat, surgeons attempted to close off the gap causing the boy’s velopharyngeal insufficiency.

To attend to his cleft lip, Plaintiff claims her son underwent an Abbe flap surgery, in which skin and muscles from his lower lip were transferred to correct the cleft in his upper lip. Abbe flap is commonly used to treat bilateral clefts, when the lip is split twice, once on each side of a child’s nose.

A bilateral alveolar bone graft was also performed, the mother writes. Most cleft lips will extend inside the mouth, affecting the gums. Bone grafts are frequently used to fill the depressions that result, providing a flatter surface and promoting healthy tooth development. The procedure can also repair gaps that extend up to separate the bottom of a child’s nostrils.

Still more surgeries, Plaintiff says, were required to address C.L.’s ear drainage problems, which are ongoing and continue to cause their son considerable pain. She says that her son’s doctors anticipate more procedures in the future.

Has Zofran Been Linked To Cleft Palate?


In a 2012 study, researchers at Harvard University, in association with the US Centers for Disease Control, found that women exposed to Zofran during early pregnancy were more than twice as likely to deliver children with cleft palate.

Perhaps surprisingly, the Ohio mother’s complaint is the first Zofran birth defects lawsuit to mention this study explicitly.

Are Other Families Eligible For Compensation?

Any parent who was prescribed Zofran as a morning sickness treatment and delivered a child with major birth defects may be able to file a lawsuit.

The experienced lawyers at Monheit Law have joined together with a coalition of plaintiffs’ attorneys to investigate potential claims. If you believe Zofran may have caused your child’s birth defects, contact their managing partner, Michael Monheit, Esq., today at 1-877-620-8411. Your consultation is free, and comes at no obligation.

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