27 July 2015

Mother In Louisiana Claims Zofran Caused Atrial Septal Defect, Other Congenital Heart Defects

On June 26, 2015, a mother from Independence, Louisiana filed one of the latest lawsuits to claim that GlaxoSmithKline’s Zofran caused major birth defects. The mother has joined a growing litigation in which parents from across the country have alleged that prenatal exposure to Zofran, commonly prescribed as an “off label” morning sickness treatment, leads to increased birth defect risks.

Her complaint, filed in the US District Court of the Eastern District of Louisiana, was registered under case number 2:15-cv-02323. A copy of the court documents can be read by clicking the button below:

View Complaint: 2:15-cv-02323

This was the second new Zofran birth defect lawsuit to be filed on June 26. In the first, brought against GlaxoSmithKline in the US District Court for the District of New Jersey, a family claimed that prenatal exposure to Zofran had caused a child’s clubfoot.

Zofran Caused Congenital Heart Defects, Louisiana Parent Alleges

Plaintiff claims that she was prescribed Zofran as an “off label” morning sickness treatment beginning in the first trimester of her pregnancy, and continued taking the drug through her third trimester.

Company Promoted Zofran For Use During Pregnancy, Plaintiff Claims, Without Conducting Safety Tests

She notes that Zofran, a powerful anti-nausea medication, has never been approved for use during pregnancy. But like Plaintiffs before her, the mother accuses GlaxoSmithKline of promoting the drug as a “safe and effective” treatment for the nausea and vomiting that as many as 90% of women experience in the first trimester of pregnancy.

Citing a 2012 lawsuit in which the US Department of Justice charged the company for marketing several drugs, including Zofran, for unapproved uses, she alleges:

“at least as early as January 1998, despite available evidence showing that Zofran presented an unreasonable risk of harm to babies exposed to Zofran prenatally, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology (Ob/Gyn) healthcare practitioners […], among others, as a safe treatment alternative for morning sickness in pregnant women.”

Unlike the manufacturer of Diclegis, America’s only FDA-approved medication for the treatment of morning sickness, Plaintiff claims that GlaxoSmithKline “never conducted a single clinical trial” to determine Zofran’s safety during pregnancy before allegedly promoting the drug as a morning sickness treatment.

Atrial Septal Defect & Anomalous Pulmonary Venous Return: Were These Congenital Heart Defects Caused By Zofran?

The mother says that her son, named N.A. in the complaint, was born in 2006, and immediately diagnosed with “several severe congenital heart defects[,]” among them atrial septal defect and partial anomalous pulmonary venous return. She claims that these congenital abnormalities were caused by prenatal exposure to Zofran.

Atrial septal defect occurs when walls in the heart fail to form properly during early fetal development. Babies are born with an opening, or hole, in the barrier separating the heart’s two upper chambers, the atria. As a result, blood that has already collected oxygen in the lungs is allowed to mix with deoxygenated blood, reducing amounts of the vital nutrient ultimately available to the rest of the body. Over time, an atrial septal defect can cause pulmonary hypertension, high blood pressure in the lungs, and increases the risk of:

  • stroke
  • heart failure
  • arrhythmia – abnormal heart rhythms

In babies born with partial anomalous pulmonary venous return (PAPVR), several of the body’s pulmonary veins, which transport blood from the lungs to the heart, connect to the right atrium rather than the left. According to Medscape, PAPVR almost always occurs in conjunction with an atrial septal defect.

In court documents, the mother notes that her unborn child was exposed to Zofran “during the periods when his cardiac tissues were forming,” periods in which the development of his heart was most at risk of being altered by an environmental agent.

Now nine years old, N.A. has already undergone two surgeries to repair the congenital heart defects allegedly caused by Zofran, his mother writes in her complaint.

Studies Have Linked Zofran To Congenital Heart Defects, Atrial Septal Defect

Plaintiff cites two major studies that have established a potential association between Zofran and an increased risk for congenital heart defects, including the atrial septal defect with which N.A. was born.

In the “Andersen Study,” completed in 2013, a team of Danish researchers used every birth record filed in Denmark between 1997 and 2010 to investigate the link between Zofran’s active ingredient and birth defects. Women who took Zofran during the first trimester were found to be 2.1 times more likely to deliver babies with an atrial septal defect. These women were also between two and four times more likely to deliver children with other “cardiac septal defects,” including ventricular septal defect and atrioventricular septal defect.

In 2014, the “Danielsson Study” saw a team in Sweden review every Swedish birth record filed between 1998 and 2012. Women prescribed Zofran in the first trimester were at an increased risk of having babies with congenital heart defects, and specifically, a more than two-fold risk of delivering children with cardiac septal defects.

Prenatal Zofran exposure has also been associated with an increased risk for cleft palate.

In case 2:15-cv-02323, Plaintiff claims that GlaxoSmithKline has been concealing evidence of Zofran’s potential link to major birth defects for more than two decades. She says the company has received more than 200 reports of birth defects with suspected ties to the drug. Plaintiff claims that GlaxoSmithKline has failed to warn the public and health community of its product’s association with fetal harm.

Zofran Birth Defect Lawsuits

With Zofran claims mounting, the attorneys of Zofranlegal.com continue to offer free consultations to women who believe that Zofran caused their children to develop birth defects. Led by Monheit Law, our alliance of distinguished plaintiffs’ lawyers is dedicated to protecting the rights of parents and birth defect survivors nationwide.

To learn more about your legal options in a free case eligibility evaluation, call 1-877-620-8411 or fill out our contact form.