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Shezad Malik MD JD
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California Zofran Heart Birth Defect Lawsuit

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Katherine and Matthew Murray from California has filed a Zofran personal injury and product liability lawsuit after their child was born with a hole in the heart from Zofran used during the first trimester of pregnancy.

Zofran Birth Defect AttorneyAccording to the Murrays, GlaxoSmithKline Zofran’s manufacturer, failed to adequately warn about the congenital heart defects risks linked with the anti-nausea drug for treatment of morning sickness.

The Murrays filed their claim recently in the U.S. District for the Northern District of California.

What is Zofran?

Zofran (ondansetron) is a drug approved for treatment of nausea and vomiting associated with chemotherapy and surgery.

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.

Plaintiffs Murray Lawsuit Allegations

According to Mrs Murray, she was prescribed Zofran during the first trimester of her pregnancy. Murray claims that use of Zofran caused her child to develop severe heart problems, including an atrial septal defect, known as a hole in the heart.

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 maternal intake.

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) Pending

A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) for all Zofran lawsuits filed throughout the federal court system to be consolidated and centralized before one judge for pretrial proceedings.

There are close to 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.