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Michael Monheit
Michael Monheit
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New Jersey Family Claims Zofran Caused Clubfoot


On June 26, 2015, a family from Bergen County, New Jersey filed the newest lawsuit to allege that GlaxoSmithKline’s Zofran, a potent anti-nausea drug never approved for use during pregnancy, caused their unborn child to develop a major birth defect. In their complaint, parents claim that prenatal exposure to Zofran led to their son’s “clubfoot,” a condition known to the medical community as talipes equinovarus. Now three years old, the child has been forced to endure extensive treatments, his parents say.

Plaintiffs filed their lawsuit in the US District Court for the District of New Jersey. A copy of their complaint, logged as case number 2:15-cv-04536-JLL-JAD, can be found at ZofranLegal.com.

Son’s Clubfoot Birth Defect Allegedly Caused By Zofran, Plaintiffs Say

In filing their complaint, the New Jersey parents have become one among at least 15 other families to claim that GlaxoSmithKline unlawfully promoted its anti-nausea drug as a morning sickness treatment. Like Plaintiffs before them, the family says that the company has concealed mounting evidence of Zofran’s association with increased birth defect risks for more than two decades.

According to court documents, the mother became pregnant in late 2010, and was soon hospitalized with symptoms of dehydration and nausea. After being diagnosed with hyperemesis gravidarum, the most severe form of morning sickness, she was administered Zofran intravenously in the hospital, Plaintiff claims.

She then describes her prescription history in detail. Initially prescribed 4 milligram Zofran tablets taken every six hours, the mother claims that her dosage was increased to 8 milligrams when her nausea and vomiting extended beyond eight weeks of pregnancy. Plaintiff says that she was then put on a “Zofran Pump,” described as a device that delivers premixed injections through the patient’s stomach every four hours, for around four days. She was then prescribed a dissolvable 8 mg tablet of Zofran, taken every four hours, for the remainder of her pregnancy, court documents state.

Referred to as B.M. in the complaint, her son was born on September 24, 2011. Upon delivery, the child was diagnosed with “clubfoot,” or talipes equinovarus, a congenital condition in which one or both feet appear to be twisted inwards at the ankle, the family claims. This congenital abnormality, Plaintiffs allege, was caused by B.M.’s lengthy prenatal exposure to Zofran.

Plaintiffs Describe Son’s Extensive Treatments For Clubfoot Allegedly Caused By Zofran

The complaint also goes into substantial detail explaining the treatments intended to correct the birth defect with which B.M. was allegedly born.

Court documents begin by describing a process of manual manipulation, in which the child’s feet were bent and straightened by physicians, and plaster casts applied to “set” a more normal alignment in place. Plaintiffs claim that their son’s first casts were applied only nine days after his birth. The process, according to their complaint, was repeated every week for the first two months of his life.

Plaintiffs write that their son then underwent a tenotomy, a surgical procedure in which the Achilles tendons are cut and lengthened in order to gradually realign the feet. After what court documents refer to as “several weeks” in a new cast, B.M. was allegedly prescribed a “Mitchell shoe.” This device, commonly employed to treat clubfoot, uses a metal bar that, when attached to both shoes, holds a child’s feet at angles turned outward from the body. The boy’s parents claim that he wore the device for 23 hours, every day, for the next six months. The length of time B.M. spent in Mitchell shoes was gradually over six month periods, from 23 hours a day to 18 and then 12.

Clubfoot device treating Zofran birth defect

A sketch used in case 2:15-cv-04536-JLL-JAD to illustrate Mitchell Shoes and a “Ponseti abduction brace.”

Plaintiffs say that their son, now three years old, continues to wear the device at night, impairing his ability to sleep properly. The extensive treatments required to correct B.M.’s birth defect also impeded his ability to learn to walk; according to court documents, Plaintiffs’ child “was reduced to crawling with plaster casts and subsequent orthopedic devices fastened to his feet.” The shoes caused him to suffer from “pressure blisters and sores,” the parents write, and forced them to undergo “great hardships” finding a school prepared to accept him.

GlaxoSmithKline Concealed Evidence Of Zofran’s Alleged Birth Defect Risks, Plaintiffs Say

Plaintiffs’ allegations echoes those leveled against GlaxoSmithKline in at least 15 other Zofran birth defect lawsuits filed to date.

The parents begin by noting that Zofran has never been approved for use during pregnancy. In fact, GlaxoSmithKline has never even studied the drug’s effects in pregnant women, or those it may have on fetal development, they write.

But citing a 2012 lawsuit filed by the US Federal Government, Plaintiffs claim that the company began promoting Zofran as a “safe and effective” treatment alternative for morning sickness almost immediately after the drug’s approval in 1991. The Department of Justice’s case, in which the Government charged GlaxoSmithKline with promoting Zofran for “off label” use during pregnancy directly to obstetricians and gynecologists, was ultimately settled for $3 billion. GlaxoSmithKline continues to deny any wrongdoing in relation to Zofran.

But Plaintiffs in Zofran birth defect lawsuits have insisted on GlaxoSmithKline’s alleged “off label” promotion of Zofran, and gone further.

As in previous complaints, the New Jersey family claims that the company has received mounting evidence that Zofran has the potential to increase the risk of birth defects for more than two decades. Plaintiffs say that GlaxoSmithKline has concealed this alleged evidence, hiding unfavorable early trial data from the FDA and failing to warn patients and the public of the drug’s association to congenital abnormalities.

Studies Link Prenatal Zofran Exposure To Increased Heart Defect Risks

Plaintiffs cite three large epidemiological studies, conducted between 2013 and 2014, that all produced data suggesting a link between Zofran and major birth defects.

Reviewing hundreds of thousands of birth and prescription records, researchers in Denmark and Sweden found that women prescribed Zofran during the first trimester were between two and four times more likely to deliver babies with congenital heart defects.

In their complaint, the family says that GlaxoSmithKline has failed to inform the public of the risks identified by these studies, along with “more than 200″ reports of birth defects in which Zofran was a suspected cause.

Reviewing FDA Data, Monheit Law Finds Hundreds Of Adverse Event Reports Linking Zofran To Birth Anomalies

In a recent Freedom of Information Act (FOIA) request, Monheit Law requested every Adverse Event Report submitted to the FDA linking Zofran exposure to an unfavorable health outcome. In response, the firm received more than 8,600 individual reports, logged with the regulatory agency between January 1, 1991 and April 30, 2015.

After analyzing the data sent by the FDA, the attorneys have identified 475 reports of birth defects, congenital anomalies and other adverse fetal events so far. Reports of congenital heart defects are frequent, as are craniofacial defects like cleft palate, a condition that researchers at Harvard University found was more than twice as likely among babies exposed to Zofran in utero. 

The full results of Monheit Law’s Zofran FOIA request, along with an infographic highlighting the firm’s findings, can be found here.

Zofran Birth Defect Lawsuits: More Families May Be Eligible To File A Claim

Monheit Law has joined a multi-state coalition of experienced plaintiffs’ attorneys to investigate potential Zofran birth defect lawsuits. The lawyers sponsor ZofranLegal.com, a resource where families can find information about the ongoing Zofran litigation and studies that have linked Zofran to increased birth defect risks.

Any woman who was prescribed Zofran as an “off label” treatment for morning sickness and then delivered a baby with major birth defects may be eligible to bring a claim against GlaxoSmithKline.

Led by Michael Monheit, Esq., the attorneys at ZofranLegal.com are providing free consultations to families who believe that a child’s birth defects may have been caused by prenatal exposure to Zofran. For a case eligibility evaluation at no cost and no obligation, call 1-877-620-8411.

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