Baby girl with his dad
08 October 2015

Zofran And Heart Defects: Lawsuit Says Child Underwent Surgery At 8 Months

As many as 60 families have now joined the Zofran litigation, and all signs suggest that the number of lawsuits will only grow. Parents across the nation claim GlaxoSmithKline’s anti-nausea drug causes birth defects. They say the company failed to notify patients of the drug’s potential danger.

A family in Alabama recently raised their voices, saying their daughter’s heart defects were caused by prenatal exposure to Zofran. But the parents’ lawsuit, filed on September 9, 2015, is notable for also naming a generic manufacturer as Defendant.

Residents of Elba, a city less than two hours south of Montgomery, the parents filed their claim in the US District Court for the Northern District of Alabama, Southern Division. A copy of the court documents can be found below. Their complaint was logged as case number 2:15-cv-01552-TMP.

View Complaint: 2:15-cv-01552-TMP

Alabama Parents Claim Zofran Caused Daughter’s Heart Defect Baby girl with his dad

Just like dozens of other families, the Alabama parents say their unborn daughter C.L. was exposed to Zofran during early pregnancy. The mother claims to have been prescribed the drug, a common “off label” morning sickness treatment, in the first trimester. She took it, as directed, well into her second trimester.

Plaintiffs’ daughter was born on January 24, 2013. According to records maintained by the child’s treating physician, C.L. was born with several congenital anomalies. Immediately after birth, a fetal echocardiogram found evidence of a congenital heart defect. The parents do not provide any more detail on their daughter’s alleged abnormalities.

But they claim C.L. underwent a surgical procedure within the first 8 months of her life. Physicians are generally wary of operating on a child so young, suggesting that the girl’s heart defect was particularly severe.

Filing A Lawsuit Against Generic Drug Companies

While the vast majority of Plaintiffs have brought their claims solely against GlaxoSmithKline, the Alabama family has filed their lawsuit against Glaxo and Dr. Reddy’s Laboratories.

Based in Hyderabad, India, Dr. Reddy’s manufactures a wealth of generic drugs, including a version of Zofran’s active ingredient ondansetron. The company’s US headquarters are in Princeton, New Jersey.

In most states, victims are severely restricted from suing generic drug companies. Brand name manufacturers control the text of warning labels, and generic companies are actually barred from altering their own warning labels until a brand does so first. This makes it exceedingly difficult to claim that a generic drug company failed to warn patients of any risks.

GlaxoSmithKline’s patent on Zofran expired in 2006, allowing a horde of smaller companies to produce and market their own versions of ondansetron. But as Plaintiffs argue, the company was “responsible for the adequacy of the label and warnings for all forms of ondansetron – whether brand name or generic” until the expiration of its patent.

Where Can Generic Zofran Lawsuits Be Filed?

Before October of 2015, four states recognized a legal theory known as “innovator liability.” Under this doctrine, injured people can sue a brand for failure to warn, even though their injuries may have been caused by a generic equivalent.

Throughout their claim, the parents write that C.L. was exposed to the “generic bioequivalent of Zofran.”

California, Illinois and Vermont continue to recognize innovator liability. Alabama used to, but a recent bill signed by Governor Robert Bentley ended that only one month after Plaintiffs’ filed their Zofran and heart defects lawsuit.

To learn more about filing a birth defect claim involving generic ondansetron, click here.

Is There A Link Between Zofran And Heart Defects?


An early study associated Zofran with an increased risk for cleft palate, but the majority of scientific evidence has supported a link between the drug and congenital heart defects.

At least three major studies have produced data suggesting that prenatal exposure to Zofran increases a child’s risk for developing heart defects. Researchers in Sweden and Denmark have identified a specific association between the unapproved morning sickness drug and “hole in the heart defects,” like atrial and ventricular septal defects.

Follow the link to find more information on the science behind lawsuits alleging a link between Zofran and heart defects.

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