Zofran Lawsuit Claims Tennessee Girl Died At 11 Weeks Of Heart Defects

The legal community has watched as a steady stream of lawsuits claim GlaxoSmithKline’s anti-nausea drug Zofran causes birth defects. In September 2015, almost every day saw a new filing in Federal Courts spanning the country. At least 56 claims have now been filed, but few tell a story as tragic as the one recounted in a Zofran lawsuit brought on September 4.

In the lawsuit, a mother says her daughter N.R. was born with her heart on the right side of her body, rather than the left as normal. The child, Plaintiff claims, was exposed to Zofran throughout the first trimester of pregnancy. Upon delivery, N.R. was restricted to the Neonatal Intensive Care Unit, hooked continuously to life-support machines. Plaintiff says her daughter died at 11 weeks old, just before a heart transplant procedure was scheduled.

The complaint was filed in the US District Court for the State of Tennessee, Middle District, Nashville. Herself a resident of Gallatin, a small city one hour northeast of Nashville, the mother’s claim was logged as case number 3:15-cv-00958. Monheit Law has made the court documents public on its website ZofranLegal.com.

Zofran has never been approved for use during pregnancy. Nonetheless, the drug quickly rose to prominence in the mid-1990s, eventually becoming America’s leading pharmaceutical morning sickness treatment.

Like dozens of other Plaintiffs, the Tennessee mother says her daughter’s exposure to Zofran was a direct result of a fraudulent marketing campaign run by the drug’s manufacturer. She cites a 2012 Justice Department lawsuit, in which the Federal Government charged Glaxo for unlawfully marketing Zofran to OB / GYNs. The company’s marketing materials portrayed Zofran as an established “safe and effective” morning sickness drug, the government claimed. Zofran’s safety and efficacy during pregnancy have never been established, and GlaxoSmithKline has never attempted to investigate the drug’s effect on fetal development.

In court documents, Plaintiff writes that she was initially prescribed Zofran during early pregnancy, a period during which fetal cardiac tissues are just beginning to form. Suffering from severe nausea, quite possibly hyperemesis gravidarum, the mother says she was hospitalized on “several occasions” and given Zofran intravenously.

Her daughter, named N.R. in the complaint, was born on June 23, 2014. But a fetal echocardiogram soon revealed evidence of multiple congenital heart defects. Plaintiff lists three severe abnormalities: an atrioventricular septal defect, heterotaxy syndrome and aortic insufficiency.

Atrioventricular septal defect (AVSD), a large hole at the heart’s center, usually requires immediate surgical intervention. The hole prevents fully-oxygenated blood from reaching the body’s vital organs and tissues. Heterotaxy syndrome occurs when the heart rotates away from its normal position during early development. Rather than remaining seated on the chest’s left side, the organ migrates toward the right. Heterotaxy syndrome is also known as Isomerism. Aortic insufficiency is closely associated with heterotaxy syndrome. In this condition, the aortic valve, which controls the flow of oxygen-rich blood toward the rest of the body, can’t close properly.

After being diagnosed, N.R. was removed to the NICU and placed on life-support. She would need a heart transplant, her mother claims, but with her development severely impaired, the child died on September 8, 2014. She lived to the age of 11 weeks.

Heart defects have been linked to Zofran exposure by several major studies, and the majority of Zofran lawsuits have been filed in relation to such abnormalities. In the “Pasternak study,” Danish researchers reviewed every birth record filed in Denmark between 1997 and 2010. Women prescribed Zofran were found to be almost five times more likely to have children with atrioventricular septal defects, the same anomaly from which N.R. allegedly suffered.

According to the experienced attorneys at Monheit Law, many other families may be eligible to file Zofran lawsuits of their own. Any parent who was prescribed Zofran and then delivered a child with birth defects may be entitled to significant compensation. Monheit Law is now offering free consultations to any family or birth defect survivor interested in learning more. Call 1-877-620-8411 for more information on legal options.