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Michael Monheit
Michael Monheit
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In Zofran Lawsuit, Arkansas Mother Says Drug Caused Cleft Palate, Clubfeet


On September 14, 2015, an Arkansas mother filed suit against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran caused her child’s “numerous congenital defects.” In bringing her claim, she joins more than 60 other parents currently seeking damages from the international pharmaceutical giant. All claim that Glaxo has concealed mounting evidence of Zofran’s link to birth defects from the public.

While Plaintiff is a resident of Cabot, Arkansas, she has chosen to file her Zofran lawsuit in the US District Court for the Eastern District of Louisiana. Her claim was registered under the case number 2:15-cv-04399-SM-DEK and court documents have been made public on ZofranLegal.com.

Numerous Severe Birth Defects Allegedly Caused By Zofran

In her complaint, the mother tells a story that has now become tragically familiar. Experiencing severe morning sickness, she was prescribed Zofran, a powerful anti-nausea drug. Her son B.H. was born in 2007 and immediately diagnosed with “severe” birth defects.

The mother’s lawsuit is notable mainly for the extent of the harm allegedly caused by Zofran; she says B.H. was born with a cleft palate, bilateral clubfeet, respiratory distress syndrome and apnea.

  • Cleft palate, a hole in the roof of the mouth, has been named in at least 11 other Zofran lawsuits. The birth defect was linked to Zofran exposure by public health researchers at Boston University in 2012.
  • Clubfoot, in which a child’s foot is twisted abnormally at the ankle, has been mentioned considerably less, in only 1 other claim so far.
  • Respiratory distress syndrome, the result of insufficient lung development, is fairly common in premature babies. While the condition has not been named in any other Zofran lawsuits, it is a prevalent diagnosis among adverse event reports implicating the drug in fetal harm.

Now 8 years old, B.H. has already undergone two surgeries to address the conditions with which he was born, his mother says.

How Did Untested Drug Make Its Way Into Mothers’ Hands?

Zofran has been approved as a nausea treatment since 1991, but never for pregnant women suffering from morning sickness. Allegations that Glaxo promoted the drug for use during pregnancy, however, have been voiced for years. In fact, the accusation was first raised by no less a legal authority than the US Justice Department. In 2012, the federal government even filed a lawsuit against the company, saying it had unlawfully marketed Zofran directly to OB / GYNs.

While Glaxo continues to deny this, Zofran somehow became America’s leading pharmaceutical treatment for morning sickness. Millions of women have been prescribed the drug during pregnancy and some, like the mother from Arkansas, have delivered babies with birth defects.

Why Parents Believe Zofran Causes Birth Defects

But the wave of Zofran lawsuits would have never begun if not for three major scientific studies conducted between 2012 and 2014. Their shocking conclusions have troubled parents across the nation: Zofran may harm unborn children.

In 2012, researchers at Boston University found that babies who were exposed to Zofran in the first trimester were more than twice as likely to be born with cleft palate.

In 2013 and 2014, two huge European surveys, which reviewed prescription and birth records, found substantial evidence that Zofran increases the risk for congenital heart defects. Scientists have identified a specific subset of heart abnormalities, cardiac septal defects, for which the potential risk appears highest. Cardiac septal defects, commonly known as “holes in the heart,” are among the most common birth defects of the heart. Atrial septal defect, ventricular septal defect and atrioventricular septal defect are notable examples.

Can More Families File Zofran Lawsuits?


Over 60 lawsuits have already been filed, and a Multi-District Litigation (MDL) in Boston has been approved. In MDL 2657, the claims will proceed through pre-trial measures, like Discovery, in common. But this consolidation doesn’t restrict the rights of other families who may have been harmed by Zofran.

For a free legal consultation, contact the experienced Zofran lawyers at ZofranLegal.com. Just call 1-877-620-8411 to learn more about your legal options today.

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