The federal multidistrict litigation established last year for Zofran birth defects lawsuits continues to grow, with nearly 300 cases now pending in the U.S. District Court, District of Massachusetts.

Most recently, a Texas couple submitted a Short-Form Complaint on behalf of two children, including a daughter who died as a result of fatal heart birth defects. The parents claim that both children developed congenital abnormalities due to pre-natal Zofran exposure. While the case was initially filed last July in the U.S. District Court, District of Delaware, it was moved to the District of Massachusetts via a Conditional Transfer Order dated October 28, 2015.

According to their initial filing, the couple’s first child was born in July 2000, following a cesarean section that was necessitated by “severe physical malformations,” including a severely malformed aorta. The left side of the baby’s heart was also one-fifth the normal size.

The little girl would live her entire life in the NICU. Despite “multiple surgeries and medical treatments,” she died less than one month after her birth.

The couple had a second daughter two years later. According to the complaint, she was born with congenital kidney defects, and continues to suffer from “reflux, urinary and kidney maladies.”

During both pregnancies, the children’s mother took Zofran to relieve severe nausea and vomiting. The parents’ lawsuit blames the medication for the birth defects that plagued their children.

“GSK marketed Zofran “off label” as a safe and effective Morning Sickness treatment despite having knowledge that such representations were utterly unsupported and unproven and despite actual knowledge of the increased risk that  medication a pregnant woman takes can cross the placenta and affect her unborn child,” their complaint states.

Zofran and Birth Defects

Zofran is only approved to treat nausea related to surgery and certain cancer treatments. However, Zofran lawsuit plaintiffs claim that Glaxo has long marketed the medication as a safe and effective treatment for pregnancy-related nausea and vomiting, even though it has never been tested for this indication. Among other things, they point out that the company reached a $3 billion settlement with the U.S. Department of Justice in 2012 which, among other things, resolved claims that it had illegally marketed Zofran as a morning sickness remedy.

Plaintiffs also cite a number of studies that have linked Zofran to heart birth defects and other congenital abnormalities, including a 2014 Danish analysis of more than 900,000 pregnancies that indicated children may be two to four times more likely to suffer a septal cardiac defect following pre-natal exposure to the drug. Plaintiffs further claim that GlaxoSmithKline has received hundreds of reports linking Zofran to congenital abnormalities, but concealed this information and failed to provide proper warnings about this risk to patients and doctors.

Zofran Lawsuit Reviews

Bernstein Liebhard LLP offers free legal reviews to alleged victims of Zofran-related birth defects. To learn more about this litigation, please contact our office by calling 877-779-1414.

Published September 14, 2016 by