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In Latest Zofran Birth Defect Lawsuit, Mother Claims Drug Caused Heart & Kidney Defects


With the number of filed Zofran birth defect lawsuits grown to at least 34, court documents continue to surface.

In the latest complaint to emerge, a mother from Birmingham, Alabama claims prenatal exposure to the anti-nausea drug caused her son’s rare congenital heart defect and kidney defects.

Registered as case number 2:15-cv-01233-JEO, the mother’s claim was filed in the US District Court for the Northern District of Alabama, Southern Division. A copy of the court documents can be found at ZofranLegal.com.

Alabama Mother Says Zofran Caused Hypoplastic Left Heart Syndrome & Kidney Birth Defects

Like millions of American women, the Alabama mother claims she was prescribed Zofran as an “off label” morning sickness treatment, and notes that the drug has never been approved for use during pregnancy. Not only that, she says GlaxoSmithKline, Zofran’s manufacturer, intentionally avoided studying the drug’s effects on fetal development.

According to her complaint, Plaintiff began taking Zofran during her first trimester and continued taking the drug as prescribed throughout pregnancy.

But in her own words, the drug’s alleged risks would become apparent before the birth of her son Z.P. In a routine ultrasound examination, her unborn child was diagnosed with Hypoplastic Left Heart Syndrome (HLHS), a rare and severe congenital heart defect that almost always requires a battery of surgical interventions to treat.

The mother claims that Zofran, a drug linked to increased heart defect risks by several major studies, caused her child’s potentially-fatal condition, along with an unspecified kidney defect.

Congenital Heart Defects: Hypoplastic Left Heart Syndrome

Plaintiff notes that her unborn son was exposed to Zofran “during the periods when [his heart and kidney] tissues [were] forming and susceptible to developmental insult from environmental exposure.”

She notes a number of large-scale epidemiological studies that have found a marked increase in the rate of congenital heart defects among babies exposed to Zofran during the first trimester.

But what is Hypoplastic Left Heart Syndrome?

A form of hypoplasia, in which an organ or tissue fails to form completely, HLHS occurs when the heart’s left side develops improperly.

How Does HLHS Affect Blood Flow?

Hypoplastic Left Heart Syndrome

A diagram of Hypoplastic Left Heart Syndrome from the CDC. In healthy human hearts, the left ventricle (LV) would occupy the entire pink region in the picture’s bottom right.

Rather than growing into a large, vital chamber for pumping oxygen-rich blood toward the body, the organ’s left ventricle remains so small that it fails to function at all. The left atrium, which holds blood after its journey to the lungs, is dangerously small, too, and the surrounding valves and blood vessels can all be dangerously underdeveloped.

HLHS forces the heart’s right side to take on most of the blood-pumping burden. Faced by a non-functional left ventricle, oxygen-rich blood must reroute through a series of small openings between the right and left side to enter the heart’s right atrium. From here, both oxygenated and deoxygenated bloods are pumped out together, rather than remaining separated. The body is often starved for oxygen as a result.

Can Hypoplastic Left Heart Syndrome Be Treated?

Yes, but never cured.

Surgeons rely on a series of open-heart surgeries to help the blood’s flow bypass the heart’s underdeveloped left side completely. These are not curative procedures, but palliative ones, and most children born with HLHS will continue to have life-long complications.

In some severe cases, children will have to undergo pediatric heart transplants, a dangerous procedure in any circumstance that can become tragic for newborn patients.

According to Cincinnati Children’s Hospital, HLHS is “uniformly fatal” without treatment, “often within the first hours or days of life.”

Can Other Parents File Zofran Birth Defect Lawsuits?

Current estimates place “off label” Zofran prescriptions for morning sickness around 1 million annually.

Any mother who was prescribed Zofran during the first trimester and then delivered a child with major birth defects may be eligible to file a claim against GlaxoSmithKline.

Michael Monheit, Esquire, managing partner at Monheit Law and lead sponsor of ZofranLegal.com, has joined an alliance of experienced plaintiffs’ attorneys to investigate potential Zofran lawsuits. Together, this coalition of distinguished trial lawyers is offering free consultations to families and birth defect survivors interested in learning about their own case eligibility. For more information, call 1-877-620-8411.


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