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27 August 2015

Alabama Mother Claims Zofran Caused Hypoplastic Left Heart Syndrome, Kidney Birth Defects

As the Judicial Panel on Multidistrict Litigation (JPML) prepares to consider consolidating Zofran birth defect lawsuits, new complaints continue to surface.

In a recent lawsuit, filed on July 23, 2015, a mother from Birmingham, Alabama says the popular anti-nausea drug caused her unborn child to develop a congenital heart defect and kidney defect. She joins at least 34 other US parents who have leveled a number of serious allegations against the drug’s manufacturer, GlaxoSmithKline.

A copy of the mother’s complaint, filed under case number 2:15-cv-01233-JEO in the US District Court for the Northern District of Alabama, Southern Division, can be viewed below:

View Complaint:2:15-cv-01233-JEO

Parent In Alabama Claims Son Born With Congenital Heart & Kidney Defects After Prenatal Zofran Exposure baby feet

According to court documents, Plaintiff was prescribed Zofran during the first trimester, and continued taking the drug to alleviate her symptoms of morning sickness throughout the pregnancy.

In 2014, her son Z.P. was born.

But the alleged effects of Zofran exposure had already become apparent during the second trimester. The mother claims that her son was prenatally diagnosed via ultrasound with a severe congenital heart defect: Hypoplastic Left Heart Syndrome. An echocardiogram after Z.P.’s birth would confirm this diagnosis, Plaintiff writes.

Z.P. also suffers from an unspecified kidney defect, according to his mother.

In her complaint, she says that Z.P.’s treating physicians have not been able to identify a genetic cause for the child’s congenital defects. The family, Plaintiff claims, has no history of the conditions from which her child allegedly suffers. Z.P. has a six-year-old sister, who was born “healthy and with no defect,” the mother writes.

Plaintiff notes that her ingestion of Zofran, and thus Z.P.’s prenatal exposure to the drug, occurred “during the periods when [his heart and kidney] tissues [were] forming and susceptible to developmental insult from environmental exposure.”

What Is Hypoplastic Left Heart Syndrome?

Hypoplastic Left Heart Syndrome (HLHS) is a rare congenital abnormality of the heart. According to the Centers for Disease Control, around 1 out of every 4,344 US babies are born with HLHS annually.

“Hypoplasia” simply refers to an organ or tissue’s failure to develop completely prior to birth.

In babies born with HLHS, the heart’s left side didn’t form properly, leaving the organ’s left ventricle and atrium, along with the valves and vessels that allow for adequate blood flow, severely underdeveloped.

Far too small to properly pump oxygen-rich blood out to the body, the heart’s left side is forced to rely on several small openings, including the patent ductus arteriosus, labeled PDA in the diagram to the right.

In healthy hearts, the PDA remains open only before birth, and quickly closes after delivery as a baby begins to depend on its own lungs for oxygen.

But for children with HLHS, these tiny openings that link the heart’s right and left sides remain necessary after birth. Rather than flowing down into the abnormally-small left ventricle, oxygenated blood in the left atrium is pushed directly over to the right side through the open PDA. From here, the organ’s right side is burdened with pumping all blood out, whether it’s going to the lungs or to the body.

If the PDA closes, which it usually does even in children with Hypoplastic Left Heart Syndrome, it becomes extremely difficult for the heart to supply any oxygen-rich blood to the body.

Can Hypoplastic Left Heart Syndrome Be Cured?


A series of open-heart surgeries is almost always required to treat HLHS. But note that even these extensive invasive procedures are palliative, not curative; they are designed to help blood flow bypass the underdeveloped heart chambers entirely, but cannot cure HLHS.

Cincinnati Children’s Hospital reports that some health centers in America consider pediatric heart transplantation as the “primary treatment” for HLHS.

Zofran Lawsuits In Alabama, Illinois, Vermont & California

The mother’s lawsuit is notable for mentioning generic equivalents of Zofran. In her complaint, she says that she was prescribed “Zofran and/or its generic bioequivalent.”

Currently only four states in America recognize the legal theory of “innovator liability.” Alabama is one of them, along with Vermont, Illinois and California, although Alabama’s Governor recently signed a bill into law that will end the theory’s recognition in October of 2015.

Under “innovator liability,” a brand name drug manufacturer, like GlaxoSmithKline, can be held liable for injuries allegedly caused by a generic company’s drug. Generic equivalents are required to be identical to their brand name predecessors in every way, including labeling. In fact, generic companies are not allowed to alter their own warning labels until the brand name product’s label is altered first.

Thus if a brand name company fails to adequately warn the public of a safety risk, the generic company will necessarily fail to warn patients, too. But this creates a major problem: if generic manufacturers are bound to the actions of an innovator company, how can they be held liable for failing to warn the public?

“Innovator liability” seeks to address this problem, by holding brand name companies accountable for their failure to warn, no matter which company actually manufactured the generic equivalent in question.

Why Are Families Filing Zofran Birth Defect Lawsuits?

In their lawsuits, Plaintiffs accuse GlaxoSmithKline of promoting Zofran “off label,” for the unapproved indication of nausea and vomiting during pregnancy.

Parents claim the company actively avoided studying the drug’s effects on developing children in order to fraudulently market Zofran to health care professionals as a “safe and effective” morning sickness treatment.

This was the opinion of the US Federal Government, which filed a battery of civil and criminal charges against GlaxoSmithKline in 2012. One of the Department of Justice’s specific allegations was that the company had been promoting Zofran as a morning sickness treatment without approval.

Now that a number of large studies have associated prenatal exposure to Zofran with an increased risk for cleft palate and congenital heart defects, parents across the country say GlaxoSmithKline failed to warn health care professionals and patients of the drug’s potential risks.

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