Tetralogy Of Fallot: Can My Family File A Zofran Lawsuit?

Parents across the country have been shocked to learn that America’s leading morning sickness drug, Zofran, may increase the risk for birth defects. Some have already taken action. In fact, dozens of families have filed lawsuits against the drug’s manufacturer, Britain-based drug giant GlaxoSmithKline.

Meanwhile, teams of researchers around the world continue to investigate Zofran’s potential effects on fetal development. So far, their results have been troubling. Reviewing millions of birth records, and scouring prescription databases, multiple independent groups have found evidence that the drug’s ingestion is associated with congenital heart abnormalities.

Has Tetralogy Of Fallot Been Linked To Zofran?

Not specifically, but several studies have found an association between the drug and congenital heart defects.

In 2013, a team from Denmark’s Copenhagen University revealed evidence linking prenatal exposure to Zofran and 60% increase in the risk for heart defects. The researchers analyzed every birth record filed in Denmark between 1997 and 2010, a total of 903,207 pregnancies.


In 2014, Swedish researchers came to a similar conclusion, based on their analysis of more than 1 million birth and prescription records filed between 1998 and 2012. Women who took Zofran during the first trimester were 62% more likely to deliver babies with heart defects.

Notably, both of these studies singled out a specific type of heart defect for which the risk seemed to be highest: cardiac septal defects. As their colloquial name, “hole in the heart” defects, implies, cardiac septal defects involve abnormal perforations in heart tissue. Generally, these holes allow blood to flow between heart chambers that aren’t allowed to communicate in healthy hearts.

Atrial septal defect, atrioventricular septal defect and ventricular septal defect, a primary component of tetralogy of Fallot (ToF), are all classified as “hole in the heart,” or cardiac septal defects.


Tetralogy of Fallot is a condition classically marked by four heart abnormalities that come together:

  • Ventricular septal defect – a hole in the wall between the heart’s two lower chambers.
  • Overriding aorta – the heart’s primary artery, which brings oxygen-rich blood to the body, is shifted to the right and sits directly over the ventricular septal defect
  • Pulmonary valve stenosis – the valve that controls blood flow from the heart to the lungs is abnormally narrow
  • Right ventricular hypertrophy – forced to work harder than normal, heart tissue can become thick and inflexible.



In the Swedish study, published as “Use of ondansetron during pregnancy and congenital malformations in the infant” by the journal Reproductive Toxicology, the authors found a 2.05 times increase in the risk for cardiac septal defects after Zofran exposure. The Danish study was more specific. In their report “Ondansetron use in early pregnancy and the risk of congenital malformations,” the researchers concluded that women exposed to Zofran were:


times more likely to deliver children with an atrial septal defect


times more likely to deliver children with a ventricular septal defect


times more likely to deliver children with an atrioventricular septal defect

With these results published years ago, many pregnant women have begun to wonder why they’re only learning of Zofran’s link to birth defects now. In their lawsuits, Plaintiffs say they would have never taken the risk, opting to leave their morning sickness untreated rather than place their unborn children in harm’s way.

Have Any Lawsuits Involved Tetralogy Of Fallot Yet?

Yes, at least one Zofran lawsuit has been filed in relation to a child born with tetralogy of Fallot. In their complaint, a family from Illinois says their son B.B. has been forced to undergo “an open heart surgery and multiple procedures” to repair his ToF heart defects.

According to KidsHealth (a publication of Nemours, a network of child-centered hospitals in New Jersey, Florida, Delaware and Pennsylvania), around 10% of children who are born with heart abnormalities are born with some form of tetralogy.

Further research is expected in the coming months. For now, the implications of ongoing studies are unknown, but if these imminent papers do link Zofran to an increased risk for tetralogy of Fallot, many other families are expected to file suit.

My Child Was Born With Tetralogy Of Fallot. What Can I Do?

If you were prescribed Zofran during the first trimester of your pregnancy, you may be eligible to file a lawsuit of your own. In a wave of civil claims, parents have accused GlaxoSmithKline of intentionally deceiving pregnant women, and their doctors, into believing that the drug was safe for them to take.

At the time, you probably had no idea that Zofran has been associated with an increased risk for heart defects. It’s unlikely your doctors mentioned the possibility at all. Plaintiffs say that lack of information was by design, a way for GlaxoSmithKline to get rich off families who are now paying the price.

Statistics on the true costs of tetralogy of Fallot are sparse. In 2013, health economists at University College London estimated the lifetime costs for treating a patient with ToF. In US dollars, their total came to $100,444, but note that healthcare costs in America are far higher than those in Britain, or any other industrialized nation.

Even before the studies we mentioned were published, families claim the company began receiving reports of birth defects linked to Zofran exposure. In fact, they say the first reports surfaced as early as 1992, only one year after the drug received its first approval as a nausea treatment for chemotherapy patients. Patients, however, the parents who would be affected by the drug’s potential risks most, were never informed, Plaintiffs say.

That’s why so many families have chosen to file Zofran lawsuits. Because they were never given the choice to weigh the drug’s benefits and risks for themselves. In their own words,

GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.

Looking Forward: Is My Child Still At Risk?

You already know full well the challenges of caring for a child born with heart defects. Maybe your journey began with the results of a fetal echocardiogram or ultrasound, the first clue that, for you, parenting would be different. Maybe it was only once your baby was born that you, and a pediatric cardiologist, had any idea something was threatening your child’s health.

Tetralogy of Fallot is the most common “cyanotic” heart defect. Because a baby’s blood can’t get enough oxygen, their skin, nails and lips turn blue. That’s why early pediatric surgeons called ToF the “blue baby syndrome.”

But those early signs quickly turned into a frenzy of activity. Babies with tetralogy of Fallot require surgery. It’s one of the only heart defects for which invasive procedures are indicated universally. Without treatment, often within one year of birth, these children are left at an increased risk of heart infections. Lacking the vital oxygen they need for growth and development, babies with untreated ToF almost always experience life-threatening complications later in life.

For most children, an initial open-heart surgery is only the beginning. While surgeons may be able to patch a baby’s ventricular septal defect and remove the obstruction blocking their pulmonary artery, many procedures necessitate follow-up surgeries as a child develops. Three, four and even five procedures are not uncommon. And routine checkups with a pediatric cardiologist are a must.

It’s a largely unspoken, and tragic, truth that many families are forced into bankruptcy, just to keep their children alive. Meanwhile, many kids will have to restrict their activities.

How Much Will Filing A Zofran Lawsuit Cost?


The last thing we want is for your pursuit for justice to become another burden. That’s why our experienced lawyers work on a contingency-fee basis: you owe nothing until we win a court award or settlement in your favor.

You can learn more about your legal options in a free consultation. ZofranLegal.com is sponsored by an alliance of dedicated attorneys, all devoted to protecting the rights of parents and birth defect survivors. Together, we bring over 100 years of combined legal experience. Many of our lawyers have focused their careers on complex pharmaceutical cases, and taken on big drug companies before. Now we’re prepared to fight for your rights.

Just fill out our contact form or call 1-877-620-8411 for more information.

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