Ondansetron, a powerful anti-nausea drug, is manufactured by GlaxoSmithKline under the brand name Zofran.
Since at least the mid-1990s, Zofran has been America’s top-selling drug for “morning sickness,” the nausea and vomiting commonly experienced during the first trimester of pregnancy.
But the FDA has never approved the drug for that purpose.
New Zofran Lawsuits Seek Damages For These 9 Birth Defects
Several studies have now begun to establish a link between Zofran and serious birth defects. Thus far, researchers have tentatively identified an association between ondansetron prescribed during the first trimester and two major forms of birth defect:
- Cleft Palate
- Congenital Heart Defects
Two newly filed lawsuits go further.
In Dockets 1:15-cv-10429 and 2:15-cv-00709PD, mothers respectively from Massachusetts and Minnesota claim that their children were born with multiple, debilitating birth defects after they took Zofran for morning sickness.
In this article, we’ll review the defects named in both lawsuits and then conclude by discussing GlaxoSmithKline’s potential liability for congenital disorders that may be caused by Zofran.
Congenital Heart Defects
Two large-scale studies, one using Danish birth records and the other birth records from Sweden, have found evidence that women who take ondansetron are more likely to deliver children with heart defects.
In Denmark, women prescribed ondansetron during their first trimester were 4.8 times more likely to have babies with atrioventricular septal defects, a rare congenital disorder that involves holes in the heart. The Swedish team found that babies exposed to ondansetron during early pregnancy were 1.62 times as likely to develop a cardiac septum defect.
You can find more information on their research here.
1. Atrial Septal Defect
The two upper chambers of the human heart, or “atria,” are normally separated by a wall called the septum. When this wall is complete, blood pressure on both sides can be properly maintained.
But in a congenital disorder known as atrial septal defect, the septum that usually closes off each atrium fails to form a complete barrier. With the wall incomplete, blood is allowed to flow back and forth, rather than where it needs to go. This puts an undue strain on arteries, veins and the heart itself, forcing the organ to work harder than usual.
In Docket 1:15-cv-10429, the plaintiff alleges that her daughter was born with an atrial septal defect. She claims that her child’s birth defects were caused by Zofran. Docket 2:15-cv-00709PD’s plaintiff makes similar allegations in her own complaint. The plaintiff in that case claims that her two daughters were both born with congenital heart defects.
2. Aortic Arch Hypoplasia
The aorta is quite possibly the most important artery in the human body. Bringing oxygen-rich blood from the heart, your aorta nourishes almost every other part of your body. It runs throughout your brain, along both arms, down the torso and through your legs.
Where the aorta connects to the heart, it sweeps up and over, directly in front of your windpipe. This sweep is called the aortic arch and, needless to say, it is essential.
But when this arch does not form fully, it can become blocked, diminishing or fully interrupting the flow of blood. This congenital condition, called aortic arch hypoplasia, always requires immediate surgery. And due to the heart’s extreme delicacy, treatment is almost universally difficult.
According to Rady Childrens Hospital in San Diego, surgery for aortic arch hypoplasia “must often be performed by heart surgeons specifically trained and experienced to operate on small, newborn babies and infants.” The operation is open heart and necessitates the use of a cardiopulmonary bypass, an external machine that temporarily “breathes” and “pumps blood” for the patient.
Unfortunately, these surgeries can “multiply.” Rady reports that patients sometimes “return […] with some recurrent blockage near the repair site.” In their experience, this complication is “relatively common.”
Aortic arch hypoplasia is often accompanied by a ventricular septal defect, a problem that the Danish researchers found was 4.8 times more prevalent in babies born to women who had taken ondansetron.
The plaintiff in Docket 1:15-cv-10429 claims that her daughter was born with aortic arch hypoplasia.
3. Ventricular Hypertension
Possibly as a result of her other heart defects, the daughter of Docket 1:15-cv-10429’s plaintiff suffers from ventricular hypertension, a form of high blood pressure that strains arteries in the lungs.
Also known as Eisenmenger complex, many atrial septal defects force too much blood to flow through the lungs. This condition is often associated with ventricular hypertension. Unfortunately, hypertension requires numerous additional treatments beyond the open heart surgeries that can fix an atrial septal defect. In some cases, the condition never goes away.
Cleft Palate & Orofacial Defects
Early in 2012, researchers at Harvard and Boston University, working in tandem with the US Centers for Disease Control, found that women prescribed ondansetron were 2.37 times more likely to deliver a child with cleft palate.
4. Facial Dysmorphia
Although the plaintiff in Docket 1:15-cv-10429 does not detail the “facial dysmorphia” suffered by her daughter, it is possible that her child was born with a cleft palate.
During early fetal development, the palate (roof of the mouth) is formed from two distinct patches of tissue that gradually come together and fuse. When these tissues are insufficient, and cannot close completely, babies can be born with large splits, or “clefts,” that separate the roof of the mouth.
Feeding and breathing are difficult for children with cleft palates. The condition can require as many as five surgeries to repair. In any case, a team of dedicated specialists will be needed.
5. Hearing Loss
Hearing loss is often associated with orofacial defects like cleft palate. Because the mouth is closely connected to the sinuses, an abnormal opening can cause frequent ear infections, as fluids build up in the middle ear.
Untreated ear infections are a common cause of permanent damage to the body structures that make hearing possible.
In Docket 1:15-cv-10429, plaintiff alleges that Zofran caused her child’s permanent hearing loss.
Other Birth Defects Possibly Caused By Zofran
In Docket 1:15-cv-10429, the plaintiff names four other birth defects in her lawsuit against GlaxoSmithKline. While there is currently no medical evidence supporting an association between Zofran and these additional defects, her allegations strongly suggest that the health community should begin investigating Zofran’s potential dangers immediately.
6. Webbed Toes
Feet actually begin as a solid mass of soft tissues; during early development, they have not yet separated into toes. Syndactyly, a condition commonly known as “webbed toes,” occurs when two or more toes remain fused.
While syndactyly does not impair the foot’s function in any significant way, children with webbed toes often fear negative reactions from their peers. Any form of prolonged anxiety or social pressure can result in debilitating psychological conditions.
7. Sensitivity To Light
Unlike most “phobias,” photophobia, an intense sensitivity to light, is not the product of fear but a true physical condition.
The disorder is characterized by severe pain in the presence of light.
8. Inguinal Hernia
Inguinal hernia is a condition in which contents of the abdominal cavity, like the stomach and intestines, protrude further than they should. While these hernias are rarely painful at birth, organs that push forward can eventually lead to severe complications, including gangrene and death.
9. Low Set Ears
When a child is born with ears that are attached to the head at a point significantly lower than normal, their condition is called “low-set ears.”
Low-set ears are associated with several congenital disorders, including:
- Down’s syndrome,
- Turner syndrome,
- Cri du chat syndrome and
- Patau syndrome
Is GlaxoSmithKline Liable For Birth Defects?
Again, the drug produced by GlaxoSmithKline as Zofran is approved to treat nausea and vomiting only in certain patients:
- people receiving cancer treatments, like chemotherapy and irradiation therapy, and
- people suffering from nausea after surgical anesthesia.
But somehow, ondansetron has swept another, extremely lucrative market: pregnant women seeking relief for morning sickness.
This fact comes despite the reality that Zofran was never approved by the FDA for use in pregnancy. GlaxoSmithKline has never even tested the drug’s effects during pregnancy, and has yet to demonstrate its safety for developing babies.
As to Zofran’s astounding rise in popularity, the US Department of Justice (DOJ) has a theory. In 2012, the DOJ accused GlaxoSmithKline of marketing Zofran directly to obstetricians and gynecologists as a “safe” treatment for morning sickness.
GlaxoSmithKline has not admitted any liability, but the company did settle the federal government’s charges (which included multiple allegations of fraudulent marketing) for $3 billion.
If these claims are true, women who delivered babies with birth defects after taking Zofran may deserve substantial compensation.