Zofran Caused Cleft Palate and Cleft Lip in Child After Anti-Nausea Drug Used During Pregnancy, Lawsuit Alleges

The mother and father of a nine year old boy allege that side effects of Zofran, which was prescribed during pregnancy to combat the symptoms of morning sickness, caused their child to be born with severe birth defects, including a cleft palate and cleft lip. 

The complaint (PDF) was filed by Ashley Davis and Charles Janke III on April 20, in the U.S. District Court for the Southern District of Indiana. The couple filed the lawsuit against GlaxoSmithKline on behalf of their child, a minor identified only as C.J.

According to allegations raised in the case, Davis was prescribed Zofran early in her pregnancy with C.J., to alleviate and prevent pregnancy-related nausea and vomiting, commonly referred to as morning sickness. Her son, C.J., was born in January 2007, with Zofran oral cleft defects, which involve a failure of the mouth and lip to merge and form properly during development. This can cause a number of serious health complications, including the need for corrective surgery, difficulty talking, eating an dan increased risk for infections.

Davis and Janke indicate that the oral cleft defects suffered by their son are a direct result of exposure to Zofran in utero, and that GlaxoSmithKline failed to warn them or their doctors that there was a risk of birth defects.

“As a result of these birth defects, C.J. is unable to participate fully in life and has required multiple surgeries and ongoing speech therapy,” the lawsuit states. “C.J. also exhibits physical malformations resulting from the clefts and subsequent surgeries. Additionally, C.J. has experienced developmental delays, including interference with speaking and dental development.”

The case joins a growing number of Zofran lawsuits filed by families throughout the U.S., each involving similar claims that children have suffered birth defects or malformations following exposure to the drug early in pregnancy.

Zofran Birth Defect Risks

Zofran (ondansetron) is a popular anti-nausea and vomiting medication that was introduced by GlaxoSmithKline in 1991. Although it has been widely marketed for use among pregnant women, the medication is only approved for treatment of nausea associated with chemotherapy or surgery.

In July 2012, GlaxoSmithKline agreed to pay the federal government $3 billion to resolve criminal and civil claims stemmig from the alleged illegal off-label marketing of a number of drugs, including use of Zofran among pregnant women. While approved medications can be prescribed “off-label” for any reason a doctor sees fit, drug makers are prohibited from promoting such uses until they have conducted adequate studies to establish it is safe and effective.

The Zofran birth defect litigation has rapidly emerged over the past two years, as more and more families learned about the link between the anti-nausea drug to their children’s congenital malformations, including heart problems, cleft lip, cleft palate and other congenital malformations.

The complaint will be transferred into a federal multidistrict litigation (MDL) established for all Zofran cases filed throughout the federal court system, which are currently centralized before U.S. District Judge Dennis Saylor in the District of Massachusetts.

There are currently several hundred similar complaints pending before Judge Saylor. However, as Zofran birth defect lawyers continue to review and file cases, it is ultimately expected that more than 1,000 cases may be included in the litigation.

As part of the coordinated proceedings, a small group of cases will be prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout a number of cases.

If GlaxoSmithKline fails to reach Zofran settlements to resolve birth defect cases following these early “bellwether” trials, each of the individual lawsuits included in the MDL may end up being remanded back to U.S. District Courts nationwide for separate trial dates.