Spilled pills
24 September 2015

New Zofran Cleft Palate Lawsuit Claims Child Underwent 8 Surgeries

In a new Zofran lawsuit, a mother from Ohio claims her son’s cleft palate and lip were caused by prenatal exposure to Zofran. She joins more than 40 other parents who have filed suit against the anti-nausea drug’s manufacturer, GlaxoSmithKline.

Plaintiff’s son C.L., now 9, has been forced to undergo 8 invasive surgical procedures during his short life, the mother claims.

The lawsuit was filed in the US District Court for the Northern District of Ohio, Eastern Division on July 16, 2015. The family live in Uniontown, a small village 20 minutes from downtown Akron, Ohio. A copy of the complaint, registered as case number 5:15-cv-01411, can be viewed below:

View Complaint: 5:15-cv-01411

Mother Claims Cleft Palate & Lip Caused By Zofran  Spilled pills

In court documents, the mother writes that she was prescribed Zofran as an “off label” morning sickness treatment. Her son, conceived in 2005, was exposed to the drug during the first trimester. This, she notes, is exactly when his oral tissues would have developed during gestation.

C.L. was born on April 12, 2006. Quoting his pediatrician’s notes, the mother writes that he was “unexpectedly diagnosed with bilateral cleft lip and complete cleft palate.”

In cases of bilateral cleft lip, a child’s upper lip is split by two gaps, one on either side of their nose. A complete cleft palate occurs when both bone and muscle layers of the roof of the mouth are split.

Numerous Traumatic Surgeries Required To Repair Oral Defects, Mother Says

This recent Zofran cleft palate lawsuit goes into excruciating detail to describe C.L.’s alleged treatments.

Even before his first surgery, C.L.’s orofacial clefts caused him severe pain, his mother claims. Before he had lived 3 months, the boy was outfitted with a prosthetic device, to cover the cleft in his palate. But the prostheses trapped bacteria close to the roof of his mouth, and C.L. soon developed a yeast infection: thrush.

Lip Repair & Ear Problems

On July 19, 2006, the mother writes, C.L. “submitted” to his first surgery, a lip repair. Surgeons attempted to reposition muscles and skin, creating a smooth upper lip.

Tubes were implanted in the child’s ears, to allow fluids to drain properly. Children with a cleft palate often suffer chronic ear infections, because they lack the muscles that would close the ear canal off from nasal passages.

Closing A Cleft Palate

C.L.’s second surgery came less than 4 months later, a procedure intended to cover the clefts at the front of his palate and restore some of the organ’s muscle function.

The following months were filled with congestion and ear drainage, the mother writes. During the child’s third procedure, a bilateral cleft palate repair in June of 2007, new tubes were inserted to help his middle ear drain.

His fourth surgery was an attempt to minimize the scarring on his upper lip, left by the initial repair. Plaintiff says multiple lesions in C.L.’s nose were also removed as he lay under anesthesia.

Confronting Speech Difficulties

Throughout 2008, C.L. required regular ear draining, the mother claims. That summer, he visited a speech pathologist for the first time. Noting that the boy was having significant difficulty feeding and speaking, the doctor recommended a tonsillectomy. The surgery, to remove C.L.’s tonsils was performed several months later.

But his swallowing problems continued, as did the almost continual drainage of his ears. In 2010, C.L. again went into surgery, his sixth in four years. In a procedure called pharyngoplasty, surgeons rearranged tissues from his palate and the back of his throat, with the goal of closing off a gap that allowed air to escape through his nose while talking.

Many children with cleft palate develop a condition called velopharyngeal insufficiency, which makes their voices nasal and their speech unclear.

One month after the pharyngoplasty, C.L. was diagnosed with sleep apnea, Plaintiff says. Over the next two years, Plaintiff’s child suffered continual nose, ear and hearing difficulties.

Returning To The Cleft Lip & Addressing Teeth

In 2012, C.L.’s surgeons addressed his upper lip again, performing an Abbe flap surgery. Transferring muscles and skin tissue from his lower lip, the doctors attempted to fill in the remaining gaps in his upper lip.

One year later, the boy would undergo his most recent procedure, a bilateral alveolar bone graft. In children with both cleft lip and cleft palate, the two openings often meet just behind the gum-line, leaving an indentation there, too. According to the Children’s Hospital of Pittsburgh, most children have a small portion of bone taken from their hip bone. The bone is then shaped to serve as a patch near the gum, allowing for healthier tooth development.

More Cleft Lip & Palate Repairs In The Future

C.L. and his mother were recently told that he will soon require another procedure on his palate, along with specialized tooth removals and a new set of ear drainage tubes.

Is There An Association Between Zofran & Cleft Palate?


In 2012, a team of public health researchers at Harvard & Boston University found that women exposed to Zofran during early pregnancy were 2.37 times more likely to deliver children with cleft palate.

At least 11 claims have been filed against GlaxoSmithKline in relation to cleft palate or cleft lip. But surpisingly, this new lawsuit is the first claim to explicitly reference that Zofran cleft palate study.

Plaintiff draws another link, noting that palate development relies fundamentally on serotonin, a neurotransmitter. The chemical, believed to trigger the impulse to vomit, is precisely what Zofran blocks to prevent nausea.

Like the dozens of other families to file Zofran lawsuits, the Ohio mothers says GlaxoSmithKline failed to notify the public and health professionals of the drug’s link to birth defects. If she had known of the association, she says that she would have opted for a different morning sickness treatment, like Diclegis. Diclegis is the only drug to be FDA approved for pregnancy-related nausea in 30 years.

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