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Zofran Caused Tetralogy Of Fallot Heart Defects, Illinois Family Alleges


In the latest Zofran birth defect lawsuit, parents from Highland, Illinois claim that exposure to the anti-nausea drug during early pregnancy caused their unborn child to develop Tetralogy of Fallot, a life-threatening combination of four congenital heart defects.

The family’s complaint, brought against Zofran’s manufacturer, GlaxoSmithKline, was filed on July 21, 2015 in the US District Court for the Southern District of Illinois. A copy of the court documents, registered under case number 3:15-cv-00787, can be read at ZofranLegal.com.

In filing their claim, the Illinois parents join at least 12 other families to allege that Zofran, which is commonly prescribed “off label” as a morning sickness treatment, causes major birth defects. The majority of lawsuits have been filed in relation to congenital heart defects, although several claims involve orofacial abnormalities like cleft palate and cleft lip.

Tetralogy Of Fallot Caused By Prenatal Exposure To Zofran, Parents In Illinois Claim In New Zofran Heart Defects Lawsuit

Suffering from nausea and vomiting, the mother claims she was prescribed Zofran, first intravenously and then in tablet form, early in the first trimester of pregnancy. According to court documents, her son B.B. was born in 2006 and immediately diagnosed with a critical and complex combination of congenital heart defects, collectively known as “Tetralogy of Fallot.” Now nine years old, B.B. suffers from a condition that may lead to “permanent and / or fatal” complications, his parents write.

The family says that B.B. has already been forced to undergo open-heart surgery, along with additional procedures. Due to his cardiac abnormalities, the child lives at an increased risk of endocarditis, a serious infection of heart tissue, arrhythmia, pulmonary valve regurgitation and may require further surgical interventions, according to his parents.

Citing a series of studies in which researchers have linked Zofran, a drug never approved for use during pregnancy, to increased risks for congenital heart defects, B.B.’s parents claim that his congenital abnormalities were caused by his exposure to the drug in utero.

Tetralogy Of Fallot: Were Four Congenital Heart Defects Caused By Zofran?

According to the US Centers for Disease Control & Prevention, approximately 1 in every 2,518 US babies will be born every year with Tetralogy of Fallot. The exceedingly rare condition is not one, but four congenital heart defects that often accompany one another:

  • Ventricular Septal Defect (VSD), a hole in the barrier that normally separates the heart’s two lower chambers, or ventricles. Ventricular septal defects act as a “shunt,” allowing blood to circumvent the lungs and flow directly back to the rest of the body. As a result, the body’s cells and tissues are “starved” of vital oxygen.
  • Overriding Aorta, an aortic valve that is abnormally enlarged and appears to rise from both the left and right ventricles, rather than the right chamber alone.

According to the Society of Thoracic Surgeons, the aortic valve controls blood flow between the left ventricle and the aorta in healthy human hearts. But in children born with Tetralogy of Fallot, an enlarged aortic valve allows blood from both sides of the heart to reach the aorta, the body’s largest artery which transports blood out towards the body. Both oxygenated and deoxygenated blood is thus pumped towards the brain, limbs and internal organs, depriving the body of significant amounts of vital nutrients.

  • Pulmonary Stenosis, in which a valve between the heart’s right ventricle and an artery that leads to the lungs is abnormally narrow. This narrowing, or “stenosis,” literally blocks blood from reaching its source of oxygen.
  • Right Ventricular Hypertrophy, a thickening of the chamber’s muscular walls. Forced to pump blood at excessive pressures, and strained by the effort of contraction, the right ventricle becomes rigid, inflexible and must work even harder to pump adequate amounts of blood toward the lungs.
Tetralogy of Fallot diagram

In this CDC diagram, we see how the four defects of Tetralogy of Fallot allow blood from both sides of the heart to flow through the aorta and out to the body.

With a heart that is unable to adequately supply the body with a sufficient supply of oxygen, children born with Tetralogy of Fallot often present symptoms of cyanosis: a bluish tint to their skin and lips. “Tet spells” occur in many children; they become cyanotic and faint, a fact that lent Tetralogy of Fallot its colloquial name: Blue Baby Syndrome.

Tetralogy of Fallot is in most cases a medical emergency. Even after repair, universally an invasive surgical procedure, adults will require “lifelong regular followup with a cardiologist,” according to the American Heart Association.

According to their complaint, the family has been advised by their doctors of a serious risk presented by B.B.’s ventricular septal defect: the improperly-formed cardiac tissue can “detach and block his arteries,” requiring emergency surgery “within the hour” to avoid a premature death.

Studies Find Zofran Increases Risk Of Congenital Heart Defects

Plaintiffs reference three major epidemiological studies, conducted in Europe between 2013 and 2014, that have linked prenatal exposure to Zofran to an increased risk for congenital heart defects.

In one of these studies, researchers in Denmark reviewed nearly 900,000 birth records logged between 1997 and 2010. Analyzing these records beside prescription logs, the team found that women who had been prescribed Zofran’s active ingredient were 60% more likely to have children with heart defects. Their analysis also revealed increased risks for “cardiac septal defects,” or “hole in the heart” defects, like the Ventricular Septal Defect with which B.B. was allegedly born. Women prescribed Zofran during the first trimester were more than twice as likely to deliver babies with a VSD.

Another study, conducted by Swedish researchers in 2014, concluded with a similar result. Out of a staggering 1.5 million pregnancies, women prescribed Zofran during early pregnancy were at more than a two-fold increased risk of delivering children with cardiac septal defects. The majority of these abnormalities were Ventricular Septal Defects.

Recent research has also identified an association between Zofran exposure and cleft palate. To learn more about the findings, click here.

Can Families Still File Zofran Birth Defect Lawsuits?


GlaxoSmithKline faces a number of serious allegations. Along with the US Department of Justice, Plaintiffs claim the company unlawfully promoted Zofran as an “off label” morning sickness treatment. Now, more than a dozen families say GSK has been concealing evidence of the drug’s potential link to birth defects for more than two decades.

If these allegations are true, any woman who delivered a child with major birth defects after being prescribed Zofran during early pregnancy may be entitled to file a claim.

Michael Monheit, Esq., managing partner of Monheit Law, has joined with an alliance of plaintiffs’ attorneys to investigate potential Zofran claims. The experienced lawyers provide free consultations to parents and birth defect survivors interested in learning more about the ongoing litigation and their own case eligibility. For more information, call 1-877-620-8411.

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