Montgomery County, Pennsylvania

HomePennsylvaniaMontgomery County

Email Michael Monheit Michael Monheit on LinkedIn Michael Monheit on Twitter Michael Monheit on Facebook Michael Monheit on Avvo
Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

Zofran Lawsuit Claims Drug Caused Cleft Lip


More than 45 Zofran lawsuits have been filed in Federal Courts across the nation. Dozens of US families have raised their voices, claiming GlaxoSmithKline’s anti-nausea drug causes major birth defects.

As Possible MDL Approaches, Missouri Parents Say Zofran Caused Cleft Lip

Now, the legal community waits expectantly for a decision from the Judicial Panel on Multi-district Litigation (JPML), a federal body that may very well determine the course of Zofran-related claims present and future.

For now, the future of the Zofran litigation remains unclear, even as new lawsuits continue to surface.

Did Zofran Cause Missouri Boy’s Cleft Lip?

One of these recent claims was filed by a couple who say the popular “off label” morning sickness treatment caused their unborn son E.V. to develop a cleft lip.

The Zofran lawsuit was originally filed on August 27, 2015 in the Philadelphia County Court of Common Pleas. It was then removed to the US District Court for the Eastern District of Pennsylvania on September 1, 2015. The family’s complaint was registered under case number 2:15-cv-04912, and has been made public on ZofranLegal.com.

The family formerly lived in Illinois and are now residents of Missouri.

Son Forced To Brave Two Surgeries, But Scars Remain, Plaintiffs Claim

In court documents, the mother claims she was prescribed Zofran during the first trimester of pregnancy. Her son, E.V., was born in 2006 with a cleft lip, “a birth defect in which the upper lip does not form properly, leaving an opening on one side of the mouth and extending into his nostril.”

During infancy, E.V. underwent surgery to close the cleft in his lip and, while successful, the procedure left his mouth with visible scarring. Over the next six years, the boy endured “emotional trauma and teasing from his classmates,” the parents write. A second surgery performed in 2012 attempted to correct the appearance of his lip, but the family says significant scarring remains visible “from his upper lip into his nose.” According to the complaint, the cartilage under E.V.’s nose is still “malformed” and asymmetrical.

GlaxoSmithKline Marketed A Dangerous Product Unlawfully, Zofran Lawsuit Alleges

The parents frame their claim as a product liability lawsuit, alleging that Zofran:

  • is defective in design
  • was inadequately tested
  • is dangerous to human health
  • was improperly marketed
  • lacked proper warnings

Like the US Justice Department, the family claims GlaxoSmithKline unlawfully promoted Zofran for use during pregnancy, an indication for which it has never been approved. They allege the company marketed Zofran to OB / GYNs as a “safe and effective” morning sickness treatment, despite having never studied the drug’s effects on unborn children.

They then note a series of large epidemiological studies that have found an association between Zofran and birth defects. One of these studies, published in 2012 by researchers at Harvard University, concluded that women who took Zofran in the first trimester were 2.37 times more likely to have children with cleft palate, a birth defect often associated with cleft lip.

Plaintiffs also claim GlaxoSmithKline has received numerous reports of birth defects with suspected ties to Zofran. But their complaint contains one of the most succinct overviews of the allegations provided so far. The family writes:

“In light of these studies and reports, Defendant did nothing. In defiance of its legal and ethical duties Defendant continued to promote Zofran off-label for morning sickness without warning the medical community or the public at large of birth defects linked to Zofran.”

Are Zofran Lawsuits Headed Toward Consolidation?

The JPML has the authority to determine whether or not existing lawsuits are similar enough to warrant consolidation. If so, claims filed in Federal Court would be transferred to a single court for “coordinated” pretrial proceedings. Experts and witnesses would testify once, in common, and a single federal judge would be able to pass down rulings that hold for each lawsuit.

In many Multi-district Litigations, or MDLs, the judge will also select a number of test cases, so called “bellwether trials,” to be heard before a jury first. The results of these trials often provide valuable information for both sides in a dispute, including whether or not settlements are a more feasible option than seeing every lawsuit to trial.

Time Remains For More Zofran Lawsuits

With the JPML’s decision fast approaching, more families may be eligible to file a Zofran lawsuit. If you or a loved one were prescribed Zofran in the first trimester and then delivered a child with birth defects, contact the attorneys at Monheit Law today.

Led by Michael Monheit, Esq., Monheit Law has joined with a multi-state alliance of trial lawyers devoted to protecting the rights of families across the nation. The attorneys currently offer a free consultation to any parent or birth defect survivor interested in learning more about their legal options.

Call 1-877-620-8411 to find more information on your case eligibility.

Leave a Comment

Have an opinion? Please leave a comment using the box below.

For information on acceptable commenting practices, please visit Lifehacker's guide to weblog comments. Comments containing spam or profanity will be filtered or deleted.