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Michael Monheit
Michael Monheit
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New Zofran Lawsuit: Illinois Mother Says Heart Defect Caused By Anti-Nausea Drug


With GlaxoSmithKline and more than 30 plaintiffs at odds over where to consolidate Zofran birth defect lawsuits, new families continue to step forward.

Mother From Illinois Claims Zofran Caused Ventricular Septal Defect

The latest Zofran lawsuit was filed on August 13, 2015. In her complaint, a mother from Salem, Illinois claims that fetal exposure to GlaxoSmithKline’s potent nausea medication, approved only for chemotherapy, radiotherapy and surgical patients, caused her son S.F. to develop a congenital heart defect.

Her lawsuit, filed in the US District Court of the Southern District of Illinois, was registered under case number 3:15-cv-00902. A copy of the complaint can be viewed here.

Michael Monheit, Esquire, managing partner at Monheit Law and lead sponsor of ZofranLegal.com, says this new complaint brings the total number of Zofran claims to at least 34. Monheit has joined with an alliance of experienced plaintiffs’ attorneys to investigate potential lawsuits against GlaxoSmithKline, a company charged in 2012 by the US Federal Government for promoting Zofran as a “safe and effective” morning sickness treatment, despite having never received FDA approval for that purpose.

Major Studies Link Zofran To Cardiac Septal Heart Defects

In fact, according to Monheit, GlaxoSmithKline has never even studied Zofran’s potential effects in pregnant women – or those it may pose to their unborn children. But now that millions of women have ingested the drug’s active ingredient (ondansetron) during early pregnancy, a number of research teams have been able to study Zofran’s possible link to major birth defects.

In her recent complaint, the mother from Illinois notes two of these studies in support of her allegations that Zofran caused her son’s congenital heart defect.

In “the Andersen Study,” Danish researchers analyzed more than 900,000 birth records filed between 1997 and 2010. The team found that women prescribed Zofran during the first trimester were anywhere between 2 and 4 times more likely to deliver children with “cardiac septal defects,” a category of cardiac abnormalities involving holes in the heart.

In “the Danielsson Study,” a team in Sweden reviewed every Swedish birth record filed between 1998 and 2012, a total of 1,501,434 infants. Babies exposed to Zofran’s active ingredient prenatally were found to be more than twice as likely to be born with cardiac septal defects.

Did Exposure To Zofran During First Trimester Cause A Child’s Heart Defect?

Plaintiff claims that she was prescribed Zofran as an “off label” morning sickness treatment early in her first trimester. As many current plaintiffs have noted, the anti-nausea drug is most often prescribed in the period during which fetal organs and body tissues are undergoing their most crucial transformations.

According to her complaint, Plaintiff gave birth to a son, named S.F. in court documents, in February of 2009. He was diagnosed with a ventricular septal defect, a hole in the wall separating the heart’s two primary pumping chambers, five months later his mother alleges.

In 2013’s “Andersen Study,” the Danish researchers identified a 2.3 time increase in the risk for ventricular septal defect among babies exposed to Zofran during the first trimester.

S.F.’s alleged abnormality leaves him “unable to participate fully in life,” the mother writes. Her son cannot “run or play” as other children can, she claims, and he “exhibits emotional difficulties […] not demonstrated by his two older siblings,” neither of whom were exposed to Zofran during development, the complaint notes.

With severe developmental delays, the mother from Illinois says, S.F. continues to wear a diaper at night, despite the fact that he is now six and a half.

Zofran Birth Defect Lawsuits: More Families May Be Eligible

Like so many parents before her, this newest plaintiff accuses GlaxoSmithKline of promoting a drug with the potential to cause major birth defects as a safe medicine for pregnant women.

If her claims, echoed by at least 33 other parents, are true, numerous American families may be eligible to file claims of their own against GlaxoSmithKline.

Along with the attorneys of ZofranLegal.com, Michael Monheit offers a free consultation to any parent who believes that prenatal exposure to Zofran may have caused a child’s major birth defect. To learn more in a case eligibility evaluation, call 1-877-620-8411. There’s no charge and no obligation, just the answers you need.

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