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Michael Monheit
Michael Monheit
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In Zofran Lawsuit, Parents Say Drug Caused 3 Heart Defects


While most Zofran lawsuits may be on their way to Boston in coming weeks, that development hasn’t slowed the stream of new claims against GlaxoSmithKline. Over 60 families have now filed suit, alleging the company’s anti-nausea drug Zofran causes birth defects. Recent complaints continue to surface, including a claim filed by parents from Alabama.

In court documents obtained by the experienced Zofran lawyers at Monheit Law, a couple says the off-label morning sickness treatment caused their unborn child to develop multiple “hole in the heart” birth defects.

The parents filed their claim on September 18, 2015 in the US District Court for the Northern District of Alabama, Southern Division. It was logged under case number 2:15-cv-01638-RDP.

 Alabama Child Born With 3 Holes In The Heart, Parents Claim

Plaintiff says she suffered from pregnancy-related nausea early in a 2011 pregnancy. Like hundreds of thousands of women each year, she was prescribed Zofran, a drug never approved for use during pregnancy. She claims the drug was first administered through an IV during the first 8 weeks of her pregnancy, and then prescribed in pill form for another month.

While the family is now aware of Zofran’s link to major birth defects, described in at least four large-scale studies, they accuse GlaxoSmithKline of hiding that knowledge from patients and the medical community. The mother writes: “had GSK marketed Zofran in a truthful and non-misleading manner, [she] would never have taken Zofran.”

With Large Atrial Septal Defect, Newborn Confined To Hospital For Two Months

The family’s son, named W.T.T. in the complaint, showed signs of a problem immediately upon his delivery. According to his parents, W.T.T. was born “cyanotic,” with a blue tint to the skin and lips. The condition, almost always associated with a congenital heart defect, occurs when adequate amounts of oxygen fail to reach the skin.

Fearing complications, the family’s medical team transferred W.T.T. to a “larger medical facility for treatment and observation,” according to court documents. He was kept there, his parents claim, for two months. But first, W.T.T. would be diagnosed with “significant heart defects, specifically, three separate holes in his heart.” The largest of these holes, an atrial septal defect, lay between the organ’s two upper chambers.

W.T.T. Underwent Surgery At 4 Years Old

In 2015, doctors decided that W.T.T. had grown enough to withstand the stresses of an invasive procedure. That year he underwent a surgical procedure to repair his severe atrial septal defect, which was around 0.6 inches by 0.7 inches in size.

This is the first Zofran lawsuit to specify the exact severity of a “hole in the heart” defect, but far from the first to claim damages related to one. In fact, at least 40 of the currently-filed claims involve heart defects.

Why Did The Family Sue GlaxoSmithKline?

Echoing the US Justice Department, Plaintiffs accuse GlaxoSmithKline of promoting Zofran as a morning sickness treatment. The drug is approved to treat severe nausea in cancer patients, but its effects in pregnant women were never even studied. But that lack of safety data hasn’t stopped Zofran from becoming a leading treatment for pregnancy-related nausea.

In Plaintiffs’ own words:

“Zofran would never have become the most prescribed morning sickness drug in the United States, and Plaintiff […] would never have taken it, if GSK had not misleadingly marketed the drug as a safe and efficacious treatment for morning sickness.”

In fact, Plaintiffs claim the company knew full well that Zofran was unsafe for pregnant women to take. The family cite a steady flow of adverse event reports, submitted to the FDA by health care professionals, patients, generic drug manufacturers and GlaxoSmithKline itself, implicating Zofran as a potential cause of birth defects. Parents say the reports began surfacing as early as 1992, and have continued unabated since then.

But most notably, the family references a series of European studies designed to investigate Zofran’s effect on fetal development. In three major papers, published by scientists from Sweden and Denmark, the drug has been linked to an increased risk for heart defects, the parents contend. These studies even singled out “cardiac septal defects” (the medical term for “hole in the heart”) as a particular risk.

In the face of this “mounting evidence,” Plaintiffs claim GlaxoSmithKline has remained conspicuously silent. Noting that the drug’s warning label makes no mention of the studies or birth defect reports, they say the company has failed in its ethical and legal obligation to warn the public of Zofran’s potential association to birth defects.

Zofran MDL: What Happens Now That Lawsuits Have Been Consolidated?

These damning allegations were first raised in February 2015. Since then, major developments have altered the course of the Zofran litigation, which now includes more than 60 individual personal injury lawsuits. For one, the claims have been “consolidated,” and will be brought together in Boston, Massachusetts through a legal mechanism known as “Multi-District Litigation” or MDL.

In MDL 2657, crucial pre-trial steps, including discovery, will be conducted in common. Discovery is the main evidence-gathering stage of a lawsuit, when both sides of a dispute are allowed to exchange information, depose witnesses and interview medical experts. A single Federal Judge will preside over all the claims, making binding rulings that apply collectively if necessary.

These dramatic changes have no effect on the rights of other families. Eligible parents are free to investigate their legal options and file Zofran lawsuits of their own. For information on case eligibility, contact the dedicated Zofran team at Monheit Law for a free consultation. Call 1-877-620-8411 to learn more.

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