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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Zofran Lawsuit: Mississippi Parents Say Drug Caused Cleft Palate


Among a trove of court documents obtained by attorneys at Monheit Law are several new Zofran lawsuits alleging the anti-nausea drug caused forms of cleft palate.

One of these recent claims was filed by a family in Mississippi who say exposure to Zofran during the first trimester caused their daughter C.P.T.’s soft “cleft palate.”

Family In Mississippi Claims Zofran Caused Soft Cleft Palate

The family brought their claim on July 17, 2015, the same day a spate of other Zofran lawsuits against GlaxoSmithKline were filed, in the US District Court for the Southern District of Mississippi, Western Division. They are believed to be the first parents to file suit in a Mississippi Federal Court.

A copy of their complaint, filed under case number 5:15-cv-00070-DCB-MTP, can be viewed at Zofran.Monheit.com.

Mother Says First Trimester Exposure Led To Birth Defect

Plaintiff claims she began taking Zofran early in the first trimester.

The drug is frequently prescribed as an “off label” treatment for morning sickness, although its safety and efficacy for that indication have never been established, and recent research has found an association between the drug and birth defects.

GlaxoSmithKline was charged by the Justice Department in 2012 for marketing Zofran as a morning sickness remedy to obstetricians and gynecologists.

The family’s child was born in January 2015 and soon diagnosed with a soft cleft palate. In this form of the condition, the soft, muscular portion of the roof of the mouth is split, or “cleft.” It can affect feeding, breathing, speech and the very process of language development.

Parents say their family has no history of any birth defects, let alone cleft palate, and that a previous child was born healthy and without congenital abnormalities.

Has Zofran Been Linked To Cleft Palate?


While at least two major studies have more recently linked the GlaxoSmithKline product to increased heart defect risks, an earlier paper, published by researchers at Harvard and Boston University, found a 2.37 times increase in the risk for cleft palate after prenatal exposure to Zofran’s active ingredient.

In the study, funded by the US Centers for Disease Control, public health researchers reviewed birth records compiled by Boston University’s Slone Epidemiology Center, whose National Birth Defects Prevention Study has tracked birth defect incidence across 8 states for almost 20 years. Using prescription records and midwife interviews, the researchers identified which women had been prescribed Zofran, and which hadn’t. Then they determined the likelihood that a woman being prescribed Zofran would deliver a child with birth defects.

Notably, the study didn’t look at any women who had delivered children with congenital heart defects, which have been associated with Zofran in multiple other papers.

But a statistically significant increase in the risk of cleft palate was identified: women prescribed Zofran were 2.37 times more likely to have babies with the condition.

Other Families May Be Entitled To Compensation

While at least 34 families have now filed Zofran lawsuits in Federal Courts, that number pales in comparison to the amount of women who have been exposed to the drug during pregnancy. Since the drug’s release in 1991, “off label” Zofran prescriptions have soared to over 1 million every year.

Many more parents may be eligible to file a claim against GlaxoSmithKline. If you were prescribed Zofran and gave birth to a child with birth defects, contact Monheit Law today. Our experienced attorneys have joined an alliance of trial lawyers to investigate your potential claim.

Call 1-877-620-8411 for a free consultation. If we can help, Monheit Law’s legal services are offered on a contingency-fee basis, so you pay nothing until we secure compensation in your case.

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