Zofran Heart Birth Defect Cases Heading to Massachusetts

Recently, earlier in October after hearing arguments, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated and centralized all federal Zofran lawsuits before U.S. District Judge Dennis Saylor, in the District of Massachusetts, for coordinated discovery and pretrial proceedings.

What is Zofran?

Zofran (ondansetron) is a drug approved for treatment of nausea and vomiting associated with chemotherapy and surgery. Zofran is manufactured by pharma powerhouse, GlaxoSmithKline.

But it has been prescribed increasingly “off-label” to treat morning sickness and hyperemesis gravidarum among pregnant women. In other words, prescribed by doctors for other uses, other than those medical indications approved by the FDA.

Many Zofran birth defect lawsuits, share similar allegations that the popular anti-nausea medication was illegally marketed for use among pregnant women, even though the manufacturers failed to notify the FDA that it was safe or effective for pregnant women and fetuses.

Zofran Crosses The Placenta

In 2006, Hong Kong medical researchers found that Zofran crosses the placenta in large amounts when taken by pregnant women.

According to the these findings, they recommended that the “developmental significance of this drug exposure requires further investigation.”

Zofran Linked to Cleft Lip and Cleft Palate

In 2011, a study demonstrated that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use.

Cleft lip and cleft palate can lead to severe facial deformity, which can occur when development of the unborn child is affected during the first trimester.

Zofran Linked to Heart Birth Defects

An August 2013 study involving the Danish Medical Birth Registry found that children may be two to four times more likely to suffer a septal defect, or holes in the heart, after Zofran use by the mother.

Zofran use during the first trimester linked to:

• 30% Increased Risk of Congenital Malformations;
• 1.6 Times Risk of Heart Defects with Zofran;
• 2.1 Times Risk of Atrial Septal Defects or ASD;
• 2.3 Times Risk of Ventricular Septal Defects or VSD; and
• 4.8 Times Risk of Atrioventricular Septal Defect or AVSD.

In 2014, a study published by the medical journal Reproductive Toxicology found that there is an increased risk for heart defects with Zofran use early in pregnancy.

Mothers prescribed Zofran had a 62% increased risk of having a baby develop a heart defect, with a 2 fold increased risk of a septal cardiac defect, or holes in the heart.

Zofran Lawsuit Federal Multidistrict (MDL) Massachusetts

There are over 50 lawsuits filed nationwide that share similar allegations of children injured with heart defects, cleft palate, cleft lip or other congenital malformations as a result of Zofran off label use during pregnancy.

MDL centralization and coordination is common in mass tort pharmaceutical litigation, where there are a large group of plaintiffs that claim similar allegations of injury. Here in one court, before one judge the litigation process is streamlined, discovery is fast tracked and trials are set rapidly. Early multiple trials can set the stage for a global settlement.

In a transfer order released on October 13, the U.S. JPML noted that the litigation will be assigned to Judge Saylor who is presiding over four Zfran personal injury birth defect cases, and the first Zofran complaint filed in the federal court system.