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Michael Monheit
Michael Monheit
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In Zofran Lawsuit, Kentucky Parents Say Drug Caused Fatal Heart Defects


Almost 200 Zofran lawsuits have now been transferred to Boston. In their claims, Plaintiffs from across the country say GlaxoSmithKline’s anti-nausea drug causes birth defects. Sharing a core of common allegations, these lawsuits have been “consolidated,” in a legal mechanism known as Multi-District Litigation (MDL). As part of the Zofran MDL, the claims will proceed through a number of important pre-trial steps together.

But with the litigation now speeding up, it’s easy to forget about the families behind these claims. We’re going to highlight one of their stories here, and discuss how some families have chosen to begin rebuilding after tragedy.

Heart Defects, Allegedly Caused By Zofran, Claim 8 Day Old Child

On September 30, 2015, a couple from Somerset, Kentucky joined hundreds of other parents in filing their own Zofran lawsuit.

Their complaint was initially filed in the US District Court for the Eastern District of Kentucky under the case number 6:15-cv-00173-GFVT. It was transferred to the US District Court for Massachusetts on October 23, 2015 and is now logged as case 1:15-cv-13749.

America’s Leading Morning Sickness Treatment

In court documents, the family describes a scene common across the country: suffering from early-pregnancy morning sickness, a mother is prescribed Zofran.

Zofran is now the top-selling drug for morning sickness in the US. Since its approval in 1991, numerous other companies have begun making their own generic versions of the drug’s active ingredient, ondansetron. Several parents have filed lawsuits placing blame on both GlaxoSmithKline and one of these generic manufacturers, including the Kentucky family.

At the hospital, the mother’s prescription was changed from GlaxoSmithKline’s branded version to a generic, manufactured the couple claims by a subsidiary of Pfizer. At the time, Plaintiff claims she was never told that Zofran has been linked to major birth defects and, on her doctor’s orders, she began taking the drug. It was her child’s first trimester. This is the period during which a baby is just taking shape, when cells and organs undergo millions of changes at a furious pace.

Underdeveloped Heart Takes Newborn’s Life

The family’s child was born prematurely, at only 32 weeks, a 4.4 pound, 38 centimeter baby boy named B.E. in court documents.

Almost immediately, B.E. was diagnosed with a host of congenital heart defects. Of these abnormalities, hypoplastic right heart syndrome (HRHS) was particularly severe. Extraordinarily rare, HRHS is a condition in which the right side of a child’s heart is almost completely unformed.

Described as “vigorous” after birth in an autopsy report, the child would die of cardiac failure only 8 days after his birth.

His parents say they have suffered severe emotional distress in the three years following B.E.’s passing.

Heart Defects Make Up Majority Of Zofran Lawsuits

While the birth defects claimed in Zofran lawsuits range from clubfoot to cleft palate, most have been filed in relation to congenital heart defects.

Over the last 3 years, no less than 3 international teams of researchers have linked the drug to an increased risk for “hole in the heart” defects.

But Zofran’s packaging still makes no mention of these studies. Nor does it note the 2012 study performed at Harvard that found a more than two-fold increase in the risk of cleft palate associated with Zofran. Now, parents around the nation have begun to ask why.

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