Zofran Side Effects Caused Baby to be Born With Cleft Larynx, Lawsuit Alleges

A recently filed lawsuit alleges that side effects of Zofran used during pregnancy to combat morning sickness caused an Oregon woman’s son to suffer congenital malformations, including a cleft larynx and palate. 

The complaint (PDF) was filed by Karen Harrison in the U.S. District Court for the District of Massachusetts on January 14, alleging that GlaxoSmithKline failed to adequately warn women or the medical community that the anti-nausea drug may cause children to develop severe birth defects.

Harrison indicates that she began taking Zofran during the first trimester of pregnancy with her son, identified only as O.H. in the lawsuit. The medication was prescribed to alleviate pregnancy-related morning sickness. However, Zofran side effects allegedly impacted the development of the child, causing a cleft palate and laryngeal cleft.

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The cleft birth defects from Zofran resulted in a gap between the oesophagus and trachea, allowing fluid and food to get into the newborn’s airway. Laryngeal clefts can cause serious problems with feeding such as coughing, cyanosis, and stunted weight gain. It can also lead to pulmonary infections.

Harrison indicates that the family has no prior history of similar birth defects.

The Zofran cleft lawsuit not only seeks compensatory damages for the child and punitive damages designed to punish GlaxoSmithKline for withholding information from women and the medical community, but also asks the court to force the drug maker to update the Zofran pregnancy warnings.

Zofran Birth Defect Risks

The case joins a growing number of Zofran lawsuits filed by parents throughout the U.S. over the past year, each raising similar allegations that GlaxoSmithKline illegally marketed Zofran to expecting mothers as a morning sickness treatment, while failing to warn them that the drug could increase the risk of birth defects when taken during pregnancy.

In July 2012, the company agreed to pay the federal government $3 billion to resolve criminal and civil claims filed by the Department of Justice for its illegal off-label marketing of Zofran and a number of other drugs.

The Zofran birth defect litigation has rapidly grown over the past year, 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.

Harrison’s 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 more than 200 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, it is expected that 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.


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