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At least 34 lawsuits now claim the anti-nausea drug Zofran directly caused an unborn child to develop major birth defects. Many of the complaints, however, have been difficult to obtain, and their exact allegations remain unknown.

Parents From Texas Say Daughter’s Cleft Palate Caused By Zofran

But one of these recent lawsuits has now surfaced. Filed by parents currently living in Texas, the complaint has been made public by Monheit Law, a personal injury firm based in Pennsylvania and lead sponsor of the website

The claim was filed against Zofran’s manufacturer, multinational pharmaceutical giant GlaxoSmithKline, on July 23, 2015. It was logged as case number 5:15-cv-02090-EEF-KLH.

Former residents of Louisiana, the family has chosen to file its complaint in the US District Court for the Western District of Louisiana, where their daughter E.M. was born.

At least two other Zofran lawsuits have been brought in Louisiana, with the majority filed in Massachusetts, Alabama and Ohio.

In the court documents released by Monheit Law, a mother claims she was prescribed Zofran in late-1997, during the first trimester of a pregnancy that would result in E.M.’s birth on July 28, 1998. First trimester exposure, during a period in which fetal tissues and organs are coming to assume their full form, has been mentioned in the majority of Zofran birth defect lawsuits.

“Soon after birth,” Plaintiffs write, their daughter was diagnosed with a “secondary” cleft palate.

What Is A “Secondary Cleft Palate”?


While cleft palate, a split or opening in the roof of the mouth, is a commonly known congenital defect, the distinction between “primary” and “secondary” palates may be unfamiliar.

The primary palate lies directly behind the front teeth, and comes significantly lower than the secondary palate, a long shelf of hard bone that extends back toward the throat and separates the oral cavity from the nasal cavity. Forming after the primary palate, the secondary palate begins to develop during the sixth week of gestation, around when E.M.’s mother began to take Zofran.

Child Braved Three Surgeries Before Turning Five, Parents Claim

If the claims of E.M.’s parents are true, her secondary palate failed to form properly, leaving a hole or “cleft” that allows air, food and liquids to pass directly from her mouth into her nasal passages.

The family says E.M. underwent three surgeries before the age of five, and required years of “intensive speech therapy” as a result of her cleft palate.

Harvard Study Finds Babies Exposed To Zofran More Than Twice As Likely To Be Born With Cleft Palate

Led by managing partner Michael Monheit, Esquire, Monheit Law has followed the Zofran lawsuits closely. Monheit says at least two other complaints allege Zofran caused a form of cleft palate or lip.

He notes a 2012 study, spearheaded by researchers at Harvard and Boston University, that found a marked increase in the risk for cleft palate after exposure to Zofran.

The team reviewed interviews with more than 10,000 mothers to identify which parents had been prescribed Zofran as an “off label” morning sickness treatment. Correlating these self-reported exposures to birth records, the researchers found that first trimester exposure to Zofran was associated with a 2.37 times increase in the rate of cleft palate. They ascribed statistical significance to their findings.

How Did Zofran Become America’s Leading Morning Sickness Drug?

Monheit says Zofran first came to prominence as a morning sickness treatment more than two decades ago. Immediately after the drug’s initial approval for chemotherapy patients in 1991, public health officials noted a sharp spike in the number of Zofran prescriptions written to pregnant women.

“Now, Zofran is a first-line treatment for more severe cases of pregnancy-related nausea,” Monheit says. “But its effects on unborn children have never been adequately investigated by Glaxo, and the company has never sought its approval as a morning sickness drug.”   

GlaxoSmithKline has been accused of promoting Zofran, a drug approved only to treat severe nausea and vomiting in cancer and surgical patients, as a morning sickness treatment. Such so-called “off label” promotion, generally directed toward health care professionals, is illegal under federal law.

The allegation was initially leveled by the US Department of Justice, the country’s primary criminal enforcement agency, in a 2012 lawsuit that saw GlaxoSmithKline charged with multiple counts of fraudulent marketing.

Can Other Families File Zofran Lawsuits?


If you were prescribed Zofran during the first trimester and delivered a child with cleft palate or congenital heart defects, you may be eligible to file a lawsuit.

Michael Monheit has joined with an alliance of experienced trial lawyers to investigate these, and similar, allegations.

He is currently providing free consultations to parents and birth defect survivors who believe that Zofran may have contributed to a child’s congenital abnormalities. For more information on Zofran lawsuits and case eligibility, call 1-877-620-8411.  

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