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22 September 2015

New Zofran Birth Defects Lawsuit: Illinois Mother Says Drug Caused Severely Undeveloped Heart

On July 16, 2015, a single mother from Illinois became one among more than 40 Plaintiffs to claim the anti-nausea drug Zofran caused severe birth defects.

The mother, who lives in Sandoval, a small town several hours west of Indianapolis, filed her claim in the US District Court for the Southern District of Illinois. Registered under case number 3:15-cv-00769, a copy of the court documents can be viewed below:

View Complaint: 3:15-cv-00769

Zofran Caused Malformed Heart, Illinois Parent Claims baby girl

The mother claims she was prescribed Zofran during a 2011 pregnancy, and gave birth to her son T.H. in 2012. Like every Plaintiff who has filed suit against GlaxoSmithKline, she says her exposure to the drug began during the first trimester.

Millions of women have been prescribed Zofran during pregnancy since the drug’s approval in 1991. But Zofran was never approved to treat morning sickness. Instead, the drug’s indications have always been restricted to nausea and vomiting in chemotherapy, radiotherapy and surgical patients. These are the uses for which the FDA has found Zofran both safe and effective.

In this new complaint, Plaintiff writes that immediately after his birth T.H. was diagnosed with a debilitating heart abnormality: hypoplastic right heart syndrome (HRHS).

What Is Hypoplastic Right Heart Syndrome?

HRHS occurs when the right side of a baby’s heart is severely underdeveloped. In some cases, the entire side may be almost completely undeveloped, with small malformed valves and pumping chambers unable to deliver blood to the lungs.

Most critically, the child’s pulmonary valve, a small “spigot” that controls blood flow to the lungs, is entirely absent.

Hypoplastic right heart syndrome is always a medical emergency requiring immediate intervention.

Son Faced Heart Transplant, Mother Says

While no cure for hypoplastic right heart syndrome exists, physicians often perform a series of open-heart procedures to improve blood flow. For severe cases, a pediatric heart transplant may be the only option.

T.H.’s mother says he underwent a transplant procedure soon after birth. She claims his undeveloped organ was removed and replaced with a donor heart.

The vast majority of Zofran birth defects claims have been filed in relation to heart defects. But the new Illinois complaint is believed to be one of only three Zofran lawsuits to name a “hypoplastic” condition. The term refers to an organ’s underdevelopment.

Zofran Birth Defects Lawsuits: What Do Families Allege?

Until recently, the popular “off label” morning sickness treatment’s possible effects on developing babies were entirely unknown. Then, in 2012, a Harvard study found a link between Zofran and cleft palate, a birth defect in the roof of the mouth. More research followed, including two European studies that found an association between the drug and congenital heart defects.

These results spurred a wave of litigation. Current lawsuits have focused on charges filed against GlaxoSmithKline in 2012 by the US Justice Department. In a landmark case of alleged health care fraud, the Federal Government said the company had unlawfully promoted Zofran to pregnancy physicians as a “safe and effective” morning sickness drug.

At the same time, Plaintiffs claim GlaxoSmithKline concealed mounting evidence of Zofran’s link to birth defect risks from the FDA, public and physicians nationwide.

Can Other Parents File Zofran Lawsuits?


Any parent who was prescribed Zofran during the first trimester and gave birth to a child with birth defects may be entitled to pursue compensation. is sponsored by a multi-state alliance of trial attorneys devoted to seeking justice for families and birth defect survivors. Contact our experienced lawyers for a free consultation today. You’ll learn more about your legal options and find the answers you need.

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