Zofran, GlaxoSmithKline’s anti-nausea drug, is FDA approved for the treatment of extreme nausea caused by certain forms of cancer therapy and surgical anesthesia. But from 1991 to 2006, Zofran was also America’s first choice in treating the nausea and vomiting common during early pregnancy.
The US Department of Justice (DOJ) filed multiple civil and criminal charges against GlaxoSmithKline in 2012. The government’s allegations included the marketing by GSK of Zofran to pregnant women’s physicians for the treatment of morning sickness. Despite the fact that the drug’s active ingredient, ondansetron, had never been approved for use in pregnant women, and no tests had ever been conducted to investigate its effect on unborn babies, the DOJ claimed that GlaxoSmithKline had illegally marketed Zofran for this unapproved, “off-label” purpose.
GlaxoSmithKline ultimately settled both lawsuits for a total of $3 billion. But recent research has uncovered a troubling link between Zofran prescribed during the first trimester and the potential for severe birth defects. Now, a wave of personal injury lawsuits allege that GSK was well aware of ondansetron’s dangers, but did nothing to protect the public.
Birth Defects Linked To Zofran
In 2006, Chinese researchers discovered that ondansetron easily passes through the placental barrier during the first weeks of fetal gestation. The risk of developing a birth defect is highest during these crucial early stages, when face, brain, arms and legs are just coming into being. This is also the time at which morning sickness begins for most women, and when Zofran is most likely to be prescribed.
A team of researchers at Harvard University and Boston University’s Slone Epidemiology Center found that women who had taken ondansetron were 2.37 times more likely to deliver babies with cleft palates than women who had not. The “palate” is another word for the the roof of your mouth.
In normal fetal development, a baby’s body tissues begin growing from opposite sides of its face, meeting in the middle to eventually form the structure and facial features considered normal. These sides usually meet, and “fuse” together, around 6 to 11 weeks of pregnancy. If the tissues that will make up the palate don’t join properly in the center, a baby will be born with an opening, or “cleft,” along the roof of its mouth.
The US Centers for Disease Control estimates that about 2,650 babies are born with cleft palates every year. Other sources have put the incidence closer to one in 2,000 babies. Girls are twice as likely to be born with isolated cleft palates (without a cleft lip) as boys.
What Causes Cleft Palate?
While the precise physical mechanism that leads to a cleft palate is unknown, researchers agree that three factors are probably involved:
- Genetic traits passed from parents to child
- Exposure to toxins or dangerous medications
- Genetic syndromes
Unlike inherited genetic traits, syndromes are caused by new genetic mutations that occur during the copying process of a parent’s unique chromosomal DNA. Each syndrome is characterized by a variety of physical or chemical anomalies, and there are over 400 distinct genetic syndromes that include cleft lips or palates among their symptoms.
The American Academy of Otolaryngology notes that around 30% of babies born with cleft palates have a genetic syndrome as the cause. Apert, Miller, Nager and Pierre Robin Syndromes are a few examples.
Living With A Cleft Palate
Babies born with cleft palates often have trouble feeding, and may require external feeding devices, nutritionists and the assistance of speech therapists who specialize in swallowing problems.
Without a smooth, unbroken surface for air to pass over, breathing can also be difficult. After initial surgeries, children generally experience improved respiration, although oral appliances may be needed going forward.
Later in life, people with craniofacial anomalies may experience difficulty speaking clearly. Because an opening in the palate also affects the body’s upper airways, hearing impairment is common. Several structures in the ear can be inhibited by increased fluid levels, and ear infections are usually more frequent in children with cleft palates.
Developmentally, young children acquire normal language skills by hearing others speak and forming speech sounds themselves. Because these abilities may be impacted by a cleft palate, many affected children need speech therapists and pathologists to develop a good grasp on language.
Cleft palates may, or may not, affect the growth and alignment of teeth.
While society’s understanding of disabilities is changing for the better, children with cleft palates are often subjected to taunting, demeaning comments as they age. Social pressures can lead to long-term psychological trauma, and feelings of isolation are common as children realize that they look “different” from others.
Treating A Cleft Palate
Cleft palates are highly individual, and the proper treatment for a baby will depend on the cleft’s severity and other health issues.
Surgical procedures can successfully repair cleft palates in most cases, although a degree of scarring will likely be permanent. In most cases, multiple surgeries will be necessary, including one called palatoplasy that is performed between 9 and 12 months after birth. The goal of palatoplasy is to connect the palate’s muscles across the cleft, and then cover the opening by rearranging soft tissues.
As a child ages, and their facial structure changes, further procedures may be required to improve speech and guide tooth development.
Because clefts result in numerous symptoms, beyond simple structural anomalies, most families will need the help of a team of physicians and therapists.
Similar to a cleft palate, cleft lips occur during early fetal development when the tissues that would fuse together to create a smooth, continuous upper lip are insufficient. Children with cleft lips have a narrow gap that separates the lip and may or may not extend upwards into their nostril.
Unlike cleft palates, which usually appear split down the center of the roof’s mouth, lips can be split on either side of the nose, or both. Boys are twice as likely to be born with cleft lips as girls.
It’s important to note that no medical studies have yet linked Zofran to a higher risk of cleft lip. But around 50% of all children born with orofacial defects have both a cleft lip and palate, while only 20% involve the lip alone.
Treating A Cleft Lip
Surgery to repair a cleft lip is performed much earlier than that for a cleft palate, usually between 6 and 12 weeks after birth. One or two procedures are usually sufficient to restore a baby’s ability to feed, breath and speak normally.
Because cleft lips also entail a cleft in a baby’s gums, significant orthodontic work may be necessary to promote proper tooth development. Ongoing speech therapy is also common, as children born with orofacial anomalies have more difficulty forming sounds.
If a cleft lip extends to affect the nose, reconstructive surgery (called rhinoplasty) can close the gap and further surgeries may be able to “normalize” a child’s appearance.
How Much Does Treating A Cleft Lip Or Palate Cost?
According to the Consumer Guide to Dentistry, initial surgeries to repair a cleft lip or palate “run a minimum of $5,000.” Other estimates come in around $10,000. The need for multiple surgeries (many children receive five over the course of adolescence) can compound this cost significantly.
According to CleftLine.org, around 50% of babies born with orofacial clefts will require ongoing speech therapy, which can cost as much as $100 per hour. Orthodontists, nose and throat doctors and social workers may all be needed as well.
The Utah Department of Health estimated the lifetime cost of an orofacial cleft as $101,000.
Congenital Heart Defects
Multiple studies have demonstrated a link between Zofran and birth defects that involve the heart’s formation in fetal development. In particular, ondansetron seems to increase the incidence of “cardiac septum defects,” a range of congenital disorders often referred to as “hole in the heart” defects.
Swedish researchers who reviewed birth records between 1998 and 2012 found that women who had taken ondansetron were 1.62 times more likely to deliver babies with cardiac septum defects. Looking at Danish birth records from 2004 to 2011, another group of researchers found an even higher risk. According to their findings, “atrioventricular septal defects” (a synonym for cardiac septum defects) were 4.8 times more likely when pregnant women had been exposed to ondansetron and Zofran.
What Is An Atrioventricular Septal Defect?
The human heart is made of four chambers. The two on top are called atrium, and the two on bottom are called ventricles. During normal fetal development, a barrier forms to separate the atrium from one another, while another closes off the ventricles. These walls are called “atrioventricular septa”; a septum is simply a wall that divides a large cavity into smaller ones.
In healthy hearts, blood flows from the body and enters into the right atrium. The atrium contracts, pumping the blood down into the right ventricle. It then exits the heart altogether, eventually reaching the lungs where it picks up oxygen. This oxygen-rich blood then flows all the way around to enter the heart’s left atrium. It’s pumped down to the left ventricle, and then out to nourish the rest of your body with the oxygen it picked up in the lungs.
But when the barriers do not close completely, and a hole remains, blood can flow from left to right between the atria or ventricles, rather than down on its normal course.
When blood from the left atrium, which is already full of oxygen, is pushed over to the right atrium, it goes back to the lungs. But it doesn’t need to be there, because it’s already been filled with oxygen. As a result, the heart is forced to work harder than it should to deliver oxygen to the rest of the body. The same goes for an incomplete barrier between the ventricles.
Specific Heart Defects
Due to their larger study size, the Danish team was able to identify more specifically the congenital defects linked to Zofran.
They found that women who took ondansetron during early pregnancy were 2.1 times more likely to deliver babies with atrial septal defects, holes in the barrier separating each atrium.
But a condition known as an Inlet Ventricular Septal Defect was even more common, 2.3 times as likely in women who took Zofran. This defect involves a hole near the valve that allows blood to enter a ventricle.
Risks & Complications Of A Heart Defect
If an atrioventricular septal defect is relatively small, it may heal on its own during a baby’s infancy. In many cases, the effects are so minimal that the condition is never even diagnosed.
After birth, the main risk of a small hole in the heart is an infection called subacute bacterial endocarditis (SBE), caused by bacteria found in the blood. Generally, SBE occurs after medical procedures, and can be easily avoided using antibiotics.
But years of improper blood flow put a strain on the heart. Adults with small cardiac defects generally begin to present symptoms by the age of 30, although it may take decades after that for the problem to become clear. Heart murmurs, frequent infections in the lungs, fatigue and swelling legs are all possible signs of a cardiac defect that may only be apparent later in life.
Adolescents and adults with atrioventricular septal defects are at an increased risk for high blood pressure, arrhythmias (abnormal heart rhythms), stroke and heart failure. Pulmonary hypertension, in which arteries that transport blood to the lungs are stressed by high blood pressure, may cause permanent damage.
When defects are large, the symptoms may not appear until months after birth. This usually presents as congestive heart failure, a condition that will inhibit the child’s growth, enlarge the liver and cause abnormally high heart and respiration rates. Medications and surgical intervention may be necessary to avoid death.
Treating A Heart Defect
There are several drugs that can reduce the amount of work a baby’s heart needs to perform and strengthen its heartbeat. Sometimes, this treatment is enough. As the child grows stronger, the defect will close of its own accord.
When medications do not work, surgery is required. This is an open heart surgery, during which a patch will be placed over the hole. After recovery, new heart tissue will grow over the patch.
How Much Does Repairing A Heart Defect Cost?
The cost of surgical intervention for a cardiac defect varies widely depending on pre-existing conditions and the length of hospital stay.
Researchers from the Duke University Medical Center investigated the health care costs for 58 patients undergoing surgery for the repair of atrioventricular septal defects. Treatments for patients younger than 6 months cost as much as $48,252; while those for patients older than two maxed out at $15,819.
According to the Centers for Disease Control, medical costs for the average infant with a congenital heart defect came to $23,000 in 2005, although costs were higher for more severe defects. In 2014 dollars, that’s almost $28,000.
You May Be Asking Yourself, “Did GlaxoSmithKline Cause My Baby’s Birth Defect?”
Did you deliver a child with a birth defect after taking Zofran for morning sickness?
You may be eligible to file a lawsuit against Zofran’s manufacturer, GlaxoSmithKline. Recent lawsuits have claimed that GSK hid numerous signs of ondansetron’s devastating effect on fetal development from doctors and patients, all in the name of record profits. The US Department of Justice has already held the company accountable for marketing Zofran illegally, but individual families have yet to be compensated.
The experienced personal injury attorneys at Monheit Law can help. With decades of proven trial experience, our lawyers are dedicated to protecting the rights of ordinary people victimized by corporate greed.
Call 866-761-1385 today to schedule your free consultation. Speak with one of our attorneys today, learn more about your legal options and begin making decisions in your best interest. There’s no cost, and no obligation, just the answers you need.