Zofran Malformations Caused Termination of Pregnancy, Lawsuit Alleges

According to allegations raised in recently filed product liability lawsuit, side effects of Zofran used during pregnancy caused an unborn baby to suffer malformations that were so severe the pregnancy had to be terminated.

The complaint (PDF) was filed by Alexis Ostrander in the U.S. District Court for the District of Massachusetts on July 25, alleging that GlaxoSmithKline failed to adequately warn women and the medical community about the risks associated with using the anti-nausea medication during pregnancy.

Ostrander indicates that she was prescribed Zofran to address symptoms of morning sickness she developed after she became pregnant in 2014, which is a common use of the medication, even though the drug maker never obtained FDA approval for treatment pregnancy-associated nausea and vomiting.

“In July 2014, Plaintiff learned, through diagnostic testing, that her unborn child had developed severe physical malformations, including severe and life-threatening abdominal defects,” the lawsuit states. “These malformations were the direct and proximate result of prenatal exposure to Zofran. As a result of these severe and life-threatening defects to her unborn child, Plaintiff terminated her pregnancy on or about August 13, 2014.”

The case joins a growing number of Zofran lawsuits filed in recent months, each involving similar allegations that the drug maker withheld information about the risk of malformations and congenital birth defects that may be caused by exposure to the medication during pregnancy.

Ostrander and other families allege that GlaxoSmithKline (GSK) knew or should have known that Zofran was dangerous for pregnant women, yet engaged in illegal marketing that encouraged doctors to prescribe the medication off-label, providing false and misleading information about the Zofran pregnancy risks.

“At least as early as 1992, GSK began receiving reports of birth defects associated with use of Zofran by pregnant women,” according to the complaint filed by Ostrander. “By 2000, GSK had recieved at least 32 reports of birth defects arising from Zofran treatment in pregnant women. These reports included congenital heart disease, dysmorphism, intrauterine death, stillbirth, kidney malfunction, congenital diaphragmatic anomaly, congenital musculoskeletal anomalies and orofacial anomalies, among others.”

Ostrander’s case will be consolidated with at least 270 other complaints pending in the federal court system, which are currently consolidated for pretrial proceedings as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Dennis Saylor in the District of Massachusetts for coordinated discovery and bellwether trials.

As Zofran birth defect lawyers continue to review and file complaints on behalf of families nationwide, it is widely expected that more than 1,000 cases may ultimately 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.