Zofran Ventricular Septal Defect Lawsuit Filed by Parents of 11 Year Old

The parents of an 11-year-old girl claim that side effects of Zotran prescribed during the mother’s pregnancy caused the child to develop a severe heart malformation, known as a ventricular septal defect, which has required corrective surgery and will impact the child for the rest of her life.

The complaint (PDF) was filed in the U.S. District Court of the District of Massachusetts on Tuesday, by Janet Seper and Charles Beckenstein, on behalf of their daughter, who is identified only as Z.B. in the lawsuit because she remains a minor.

Seper indicates that she was prescribed the anti-nausea drug Zofran during the first trimester of her pregnancy, to help control pregnancy-related nausea, more commonly known as morning sickness. Two days after Z. B. was born, the child began showing signs of a heart problem and was diagnosed as having a ventricular septal defect (VSD), which was allegedly caused by exposure to Zofran during 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 severe heart defects or oral cleft defects, such as cleft palate or cleft lip, alleging that GlaxoSmithKline illegally marketed the drug for pregnant women and failed to adequately warn about the risk of birth defects.

A ventricular septal defect involves a hole in the wall of the heart that separates the two lower chambers. This causes blood to travel from the left ventricle chamber of the heart to the right, making the heart pump harder as extra blood goes into the lung arteries. The heart defect from Zofran can cause a child to breathe harder and faster than normal, stunt growth, and cause trouble with feeding and eventually cause permanent damage to the lungs. It also causes heart murmurs and pulmonary hypertension.

The lawsuit filed earlier this week by Seper and Beckenstein indicates that Z.B. had no prior family history of VSD, and alleges that GlaxoSmithGline failed to adequately

“Z.B. has undergone corrective surgery for her VSD,” the lawsuit notes. “Her birth defects put her at risk of future corrective surgery and impair her ability to develop fully and enjoy her childhood and life thereafter.”

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 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 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 emerged 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.

Seper and Beckenstein’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.