Zofran Tetralogy of Fallot Lawsuit Filed Over Heart Defect Suffered by Baby

GlaxoSmithKline faces a new Zofran birth defect lawsuit filed by an Illinois couple, which alleges that side effects of the anti-nausea drug used during pregnancy caused their child to suffer a severe congenital birth defect, known as Tetralogy of Fallot.

The complaint (PDF) was filed by Jamie and Brad Bircher in the U.S. District Court of the Southern District of Illinois on July 21, indicating that the drug maker has engaged in illegal promotion and failed to provide adequate Zofran warnings for pregnant women.

Jamie Bircher indicates that her doctor prescribed Zofran during pregnancy with her son in 2006, and that side effects of the medication caused her son to be born with Tetralogy of Fallot, resulting in what is known as “blue baby syndrome.”

Tetralogy of Fallot is a congenital heart defect that causes poorly oxygenated blood to flow into the body. The condition requires heart surgery and even after a successful correction, 90% of patients develop a leaking pulmonary valve in adulthood that worsens over time, usually resulting in the need for future surgical procedures.

“[The] birth defects impair [the Plainitffs’ son’s] ability to develop fully and enjoy life both at home and at school because he lives with a much higher risk of severe injuries from infections and a serious risk that the tissue lining the ventricular septal defect will detach and block his arteries, which could be fatal without emergency surgery within the hour,” the lawsuit states. “Plaintiffs have been advised by physicians that their son’s condition is likely permanent because it has not healed in the past six years.”

The Birchers indicate that there is no family history of congenital heart defects, and that there is a direct connection between use of Zofran and Tetralogy of Fallot diagnosed for their son.

Zofran (ondansetron) is a widely used prescription medication for treatment of nausea and vomiting. Although the FDA has only approved Zofran for use among cancer and surgery patients, it is commonly prescribed “off-label” to pregnant women for treatment of morning sickness or pregnancy-associated nausea and vomiting.

The Bircher family joins a growing number other families throughout the United States who are pursuing lawsuits against GlaxoSmithKline, alleging that warnings about the potential pregnancy side effects of Zofran were withheld from consumers and the medical community.

Plaintiffs allege that GlaxoSmithKline knew or should have known about the potential Zofran pregnancy safety risks, yet illegally marketed the drug for use among pregnant women. Lawsuits claim that children have been born with various heart defects from Zofran, including atrial septal defects (ASD), ventrical septal defects (VSD), Tetralogy of Fallot and other injuries.

Some complaints also allege that children were born with cleft lip or cleft palate from Zofran use during pregnancy, which involves gap or split in the roof of the mouth or lip.

Zofran Birth Defect Litigation Status

As a growing number of complaints continue to be filed in different U.S. District Courts nationwide, GlaxoSmithKline has asked that coordinated pretrial proceedings be established in the federal court system, known as an MDL or Multidistrict Litigation.

The drug maker filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) requesting that all cases be centralized before one judge for discovery and a series of early trial dates to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

The litigation has emerged following a number of studies in recent years that have raised questions about the safety of Zofran for pregnant women.

As Zofran birth defect lawyers continue to review and file cases on behalf of families throughout the U.S., it is ultimately expected that hundreds, if not thousands, of complaints will be brought against GlaxoSmithKline.

The Bircher lawsuit accuses the drug maker of negligence, breach of warranty, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation.