Zofran Lawyers Monheit Law Reports Ohio Parents Claim Zofran Caused Fatal Heart Defect

June 15, 2015 – – Zofran Laywers Monheit Law reports on June 10, 2015, a family from Ohio filed the most recent lawsuit against GlaxoSmithKline, manufacturer of the anti-nausea drug Zofran, report experienced birth defect attorneys at Monheit Law. This ongoing litigation, in which parents have claimed that Zofran, a common “off-label” treatment for morning sickness, caused their children to develop major birth defects, has now grown to at least 10 lawsuits.

This new complaint was filed in the US District Court for the Northern District of Ohio, Western Division, under case number 3:15-cv-1166. In court documents, which can be read here, a couple from Toledo alleges that their daughter was born with a severe congenital heart defect after being exposed to Zofran in utero. This abnormality would prove fatal, they claim, as their child passed away only three days after delivery.

The mother says that she was prescribed Zofran to relieve the symptoms of nausea and vomiting common during the first trimester. She states that her pregnancy was “unremarkable until nine days before delivery when the baby’s heart rate began to decelerate,” or slow abnormally. Her daughter was born on March 17, 2006, she claims, and quickly diagnosed with a “right ventrical heart defect.” After only three days, the child went into cardiac arrest and physicians were unable to revive her, plaintiff says. The child was pronounced dead on March 20, 2006.

Like previous plaintiffs, and the US federal government before them, this family alleges that GlaxoSmithKline promoted Zofran, a drug that is not approved for use during pregnancy, as a “safe and effective” morning sickness treatment. As these parents have noted, GlaxoSmithKline has never studied the effects of Zofran on pregnant women in clinical trials, a type of study that would be necessary for FDA approval of its use during pregnancy.

In 2012, the US Department of Justice charged GlaxoSmithKline for promoting Zofran to physicians as a remedy for morning sickness, in violation of federal law. While GlaxoSmithKline denies this allegation, every plaintiff in the Zofran litigation has maintained the accusation. But claimants go further, accusing the company of promoting Zofran for this “off-label” use even in the face of mounting evidence that the drug increases the risks for birth defects. Plaintiffs say that GlaxoSmithKline has concealed evidence indicating Zofran’s role in fetal harm from the US Food & Drug Administration, doctors and the public.

Plaintiffs note a series of recent epidemiological studies that have found an association between prenatal exposure to Zofran and significantly increased rates of birth defects, including heart defects like the one parents in this new case say proved fatal for their daughter. Claimants have also pointed to a wave of birth defect reports that they say GlaxoSmithKline has been receiving since at least 1992. Claimants allege that the company failed to report a significant amount of these reports to the FDA.

But the family from Ohio is notable for discussing the “Einarson study,” a study that other lawsuits have not mentioned. Completed in 2004, and funded by a grant from GlaxoSmithKline, this study compared the birth outcomes of 176 pregnant women who had taken Zofran to the birth outcomes of 176 women who had not. Plaintiffs write that “the study showed twice the rate of ‘Major malformation’ (3.5% as opposed to 1.8%)” among babies who were exposed to Zofran in utero. And while the article’s authors could not consider this increase “statistically significant” due to their study’s small sample size, plaintiffs claim that it was a “danger sign,” one that should have been investigated further. Plaintiffs accuse GlaxoSmithKline of failing to “commission a larger study,” and thus ignoring early evidence of Zofran’s potential link to major birth defects.

If these allegations are true, any parent who was prescribed Zofran during the first trimester and then delivered a child with birth defects may be able to bring a claim against GlaxoSmithKline. Led by attorney Michael Monheit, Esq., Monheit Law has gathered an alliance of experienced plaintiffs’ attorneys to investigate potential Zofran birth defect claims. The lawyers have been providing free consultations to parents and birth defect survivors who believe that prenatal exposure to Zofran may have caused them harm. For more information on the ongoing Zofran litigation and case eligibility, call 1-877-620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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