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Parents in Ohio claim that a heart defect, allegedly caused by the anti-nausea drug Zofran, led to the death of their newborn daughter in the most recent lawsuit filed against GlaxoSmithKline. This newest complaint, filed on June 10, 2015, comes amid a storm of allegations accusing the company of concealing evidence of Zofran’s potential risks from the public and health community. It is at least the tenth lawsuit brought in the ongoing Zofran litigation.

The family filed their lawsuit in the US District Court for the Northern District of Ohio, Western Division. Their complaint was registered under case number 3:15-cv-1166, and a copy of the court documents can be found at

Zofran Caused Heart Defect That Proved Fatal To Newborn, Ohio Parents Allege

After presenting to her physician with pregnancy-related symptoms of nausea and vomiting, plaintiff says that she was prescribed Zofran as an “off-label” morning sickness treatment. She took Zofran as prescribed, and writes that her pregnancy proceeded “unremarkabl[y]” until several days before the delivery date, when her unborn child’s “heart rate began to decelerate,” or slow down abnormally.

Her daughter was born on March 17, 2006, plaintiff says, and immediately diagnosed with a “right ventrical heart defect.” The child was confined to the Intensive Care Unit (ICU) for monitoring until she “crashed,” going into cardiac arrest. Her heart had stopped beating, and physicians were unable to revive her.

Plaintiff’s daughter died on March 20, 2006, only three days after her birth, according to court documents.

Plaintiffs allege that their daughter’s untimely death was the “result of […] defects and injuries caused by Zofran.”

Plaintiffs Claim GlaxoSmithKline “Ignored Danger Signs,” Promoted Zofran Unlawfully For Use During Pregnancy

Like other claimants, plaintiffs allege that GlaxoSmithKline unlawfully promoted Zofran as a “safe and effective” treatment for pregnancy-related nausea, without the FDA’s approval, and cite a 2012 lawsuit in which the US Department of Justice charged GlaxoSmithKline for doing precisely that. The company eventually entered a settlement agreement to resolve the federal government’s allegations, including charges of promoting Zofran for “off-label” use during pregnancy.

And while GlaxoSmithKline continues to deny the government’s allegations relating to Zofran, plaintiffs insist that the company promoted its drug as a safe medication for pregnant women to take.

According to the complaint, “as GlaxoSmithKline’s promotion efforts paid off, more pregnant women used Zofran and this led to an increasing number of adverse events.” They claim that by 2000,

“dozens of physician reports began to show a high rate of teratogenicity [the potential to adversely affect fetal development], with Zofran use being associated with congenital heart defects, kidney malformations, and cleft palate and other facial defects. Furthermore, data were showing intrauterine deaths, still births, deaths shortly after births, and serious congenital defects in children who survived.”

The complaint’s attention then turns to two studies conducted to investigate Zofran’s potential adverse effects on fetal development. The studies, conducted in 2004 and 2011, were both completed before GlaxoSmithKline entered its settlement agreement with the federal government in July of 2012.

Plaintiffs’ claim that these studies revealed evidence of Zofran’s association with increased birth defect risks, but say that GlaxoSmithKline “ignored [these] danger signs.” The company failed to commission further studies, and simply continued its alleged program of off-label promotion, they write.

The “Einarson Study”: Plaintiffs Claim Early Evidence Of Zofran’s Potential Risks Was “Ignored”

The first study, which plaintiffs refer to as “the Einarson study,” was completed in 2004. Researchers compared the birth outcomes of 176 pregnant women who had been prescribed Zofran against the birth outcomes of two other groups: 176 women who had taken other anti-nausea drugs and 176 women who had not taken any drugs for nausea.

As plaintiffs write, “the study showed twice the rate of ‘Major malformation’ (3.5% as opposed to 1.8%)” among children exposed to Zofran prenatally.

While the study reported six cases of major malformation among babies exposed to Zofran, its authors note that “after the study was completed, a physician phoned to inform us […] that a patient of his, who was in our study and gave birth to a normal child, had a second child also exposed to [Zofran’s active ingredient], born with a mild hydronephrosis.”

In their complaint, the family says that the Einarson study’s authors “could not call [the doubling in major malformations] statistically significant because of the small sample size of only 176.” Even so, plaintiffs consider the study’s results a “danger sign[…],” one that they claim was ignored by GlaxoSmithKline. They say that the company did not “commission a larger study” to further investigate the Einarson study’s results.

It is notable that the Einarson study was funded through a grant from GlaxoSmithKline.

The “Anderka Study”: Researchers At Harvard Find Increase In Cleft Palate Risks

In the second study, named the “Anderka study” in court documents, researchers from Harvard and Boston Universities investigated the potential of Zofran’s active ingredient to adversely affect fetal development. They found that women who were prescribed Zofran were 2.37 times more likely to deliver babies with a cleft palate, and wrote in their conclusion that several anti-nausea medications, including Zofran’s active ingredient, “warrant further investigation.”

Plaintiffs accuse GlaxoSmithKline of failing to pursue that “further investigation.” They say that “GlaxoSmithKline owed […] all consumers a duty of reasonable care in how it designed Zofran, warned of Zofran’s dangers, and promoted, marketed, detailed, and sold Zofran.” According to these parents, the company failed to investigate early warning signs allegedly demonstrated by the Einarson and Anderka studies in further research, and thus breached that duty of care.

As the family writes in their complaint, after the Anderka study’s publication, “additional studies have shown more clearly what [plaintiffs claim] early data evidenced: a link between Zofran and birth defects, particularly […] heart defects.” They refer to one such study, conducted in 2014 by a team of Swedish researchers. Reviewing hundreds of thousands of birth records, the team found that prenatal exposure to Zofran was associated with more than a 60% increase in the rate of congenital heart defects, and a two-fold increase for a specific category of heart defects: cardiac septal defects.

At least two other major studies have investigated Zofran’s association with birth defects. Both articles present data indicating an increased risk of congenital heart defects, and plaintiffs claim that their daughter’s death was caused by one such birth defect.

Plaintiffs say that GlaxoSmithKline has ignored this mounting evidence of the drug’s link to major birth defects. In fact, they allege that “GlaxoSmithKline maintains its position that it is unaware of any link and continues to refuse to update the Zofran label.”

Other Families May Be Able To File Zofran Birth Defect Lawsuits

If the allegations made in this, and at least 9 other claims, prove true, women who were prescribed Zofran during the first trimester of pregnancy and delivered children with major birth defects may be eligible to bring their own claims against GlaxoSmithKline.

Led by attorney Michael Monheit, Esq., Monheit Law has joined together with an alliance of plaintiffs’ lawyers to investigate potential claims. The lawyers are currently offering free consultations to any parent or birth defect survivor who believes that prenatal exposure to Zofran may have caused them harm. To learn more about case eligibility, call 1-877-620-8411.

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