02 October 2015

Missouri Family’s Lawsuit Claims Zofran Caused Son’s Cleft Lip

On October 1, 2015, the Judicial Panel on Multi-District Litigation heard oral arguments on consolidating Zofran lawsuits. But the legal community is still waiting for the federal panel’s decision.

In the meantime, new claims against GlaxoSmithKline continue to surface.

New Zofran Lawsuit Seeks Damages For Boy’s Cleft Lip

One recent lawsuit was filed by a family from Missouri. They claim Glaxo’s potent anti-nausea drug caused their son E.V. to develop a cleft lip.

The parents, originally residents of Illinois, filed their lawsuit on August 27, 2015 in the Philadelphia County Court of Common Pleas. It was removed to the US District Court for the Eastern District of Pennsylvania five days later, on September 1, 2015.

A copy of the court documents, registered as case 2:15-cv-04912, can be viewed below:

View Complaint: 2:15-cv-04912

Child Faced 2 Surgeries By The Age Of Six, Parents Claim

The mother says she was prescribed Zofran in the first trimester, a time at which fetal tissues are just beginning to form. Developing fetuses are at most risk of suffering harm from “environmental” factors, like pharmaceutical drugs, during the first 10 weeks of pregnancy.

E.V., the family’s child, was born in 2006, and diagnosed immediately with a complete cleft lip. In cases of complete cleft lip, the lip fails to form properly during early development, resulting in a long split or opening running from a child’s upper lip into their nostril.

The boy underwent his first surgical procedure while still in infancy, the family writes. Surgeons successfully closed E.V.’s cleft lip, but the repair left “visible scarring.” In 2012, at the age of six, E.V. braved another surgery. While this procedure too was largely successful, the child continues to have visible scarring from his upper lip to his nose, according to the complaint.

The parents say their son has “endured emotional trauma” and been repeatedly harassed by his classmates for his physical appearance.

Why Are Parents Filing Zofran Lawsuits?

As in at least 45 other Zofran lawsuits, Plaintiffs claim:

  • GlaxoSmithKline unlawfully promoted Zofran as a morning sickness treatment, despite having never studied the drug’s effects on developing babies
  • GlaxoSmithKline has received mounting evidence of Zofran’s potential to increase the risk for major birth defects, including cleft palate
  • GlaxoSmithKline has failed to warn the public and health community of its product’s link to fetal harm

They note one of the first studies to investigate Zofran’s potential effects on unborn children, a 2012 study that found a 2.37 times increase in the risk for cleft palate among babies exposed to Zofran. Like cleft lip, cleft palate is an oral birth defect that occurs when facial tissues fail to fuse properly. It is often associated with cleft lip.

Can My Family Seek Justice?


Any parent who was prescribed Zofran during early pregnancy and delivered a child with birth defects may be eligible to file a claim.

Call today and our experienced attorneys will guide you through your legal options for free. Just call 1-877-620-8411.

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