Millions of women endure unbearable morning sickness during the course of their pregnancy. Severe morning sickness can lead to a painful and uncomfortable pregnancy. So when your doctor offers medicine to alleviate the condition, you trust your doctor won’t prescribe you anything that could cause life-threatening birth defects in your unborn child. However, this exact scenario has led to hundreds of families filing Zofran lawsuits against the manufacturer of the drug. If you took Zofran during your pregnancy and your child was born with a birth defect, contact a Zofran birth defects lawyer from The Carlson Law Firm.
The Carlson Law Firm has more than 40 years representing clients of dangerous drugs. We know that from the moment you find out you’re pregnant, you begin taking your health seriously. You want to have a healthy pregnancy and begin making healthy life choices, if you haven’t already, to ensure you have a healthy baby. Our team of compassionate attorneys will fight tirelessly on your behalf to get the compensation your family deserves. Contact The Carlson Law Firm to speak with a Zofran birth defects lawyer. We will help you get the justice you deserve.
What is Zofran?
Ondansetron, marketed as Zofran, is used to prevent nausea and vomiting. The drug blocks the actions of serotonin in the body that can trigger nausea and vomiting. The drug received approval from the U.S. Food and Drug Administration (FDA) in 1991. It was designed to prevent nausea and vomiting in cancer patients receive chemotherapy, radiation therapy, and surgery. The drug was never and is still not approved to treat morning sickness. However, this does not stop physicians across the country from treating nausea and vomiting of pregnancy with the drug.
By 2009, Zofran became America’s most popular medicine for morning sickness treatment—overtaking its nearest competitor promethazine. In 2013, two times as many pregnant women had a Zofran prescription over promethazine. According to an article from a December 2014 American Journal of Obstetrics and Gynecology,
Hundreds of families have filed Zofran lawsuits against GlaxoSmithKline, claiming the company’s anti-nausea drug causes birth defects. Despite never receiving approval for use during pregnancy, Zofran is currently the top-selling morning sickness drug in the US. More than 1 million women receive prescriptions for the drug every year. For many, this occurs in their first trimester, when developing fetuses are most susceptible to harm.
Is it safe to take Zofran while pregnant?
The FDA strongly warns against Zofran use in pregnancy. Prescribing Zofran during pregnancy is what is considered an off-label use. Doctors sometimes prescribe medication to treat conditions in patients that haven’t been tested. Initially, Zofran (Ondansetron) was approved by the FDA in 1991 for the treatment of nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Zofran works by blocking serotonin and increasing gastric emptying. Generic versions, labeled Ondansetron, have been available since 2006.
At no point was Zofran submitted to the FDA – let alone approved by the FDA – for use by pregnant women to control morning sickness. The FDA classified Zofran as Pregnancy Category B, meaning it is untested for safety. No human studies were done to prove it is safe for pregnant women, making use of Zofran during pregnancy “off-label.” No Zofran dosage is approved as safe for pregnancy.
Does Zofran Cause Birth Defects?
Some medical journals published articles presenting evidence that suggests a link between the use of Zofran by pregnant women and birth defects. Although the issue is still being debated and studied, the consensus among medical professionals is that Zofran should not be considered as a treatment for morning sickness unless all other treatments have failed. Experts established that Zofran can be transferred to the fetus through the placenta up to twelve weeks after conception.
Possible birth defects include, but aren’t limited to:
- Heart defect
- Atrial Septal Defect (ASD)
- Ventricular Septal Defect (VSD)
- Atrioventricular Septal Defect (AVSD)
- Heart murmur
- Cleft lip
- Cleft palate
- Kidney defects
- Fetal growth restrictions
All of these birth defects will require a lifetime of medical care for children and families. In fact, health care costs will be much higher compared to children born without these defects. Experts are still studying the effects of Zofran on unborn children. In June 2012, The Justice Department announced a $3 billion settlement with the makers of Zofran for illegal promotion of many of their drugs.
First Trimester Fetal Development
The first trimester of pregnancy is the most critical for organ formation. Organ formation occurs in a process called organogenesis. Between weeks four and 10, development of the embryo’s stem cells quickly differentiate. The genetic information contained in each nucleus becomes specialized in both form and function. For example, after six weeks of transformation, the cells will have been arranged themselves into the organs that sustain life.
How does Zofran Lead to Birth Defects?
Zofran works by blocking the actions of chemicals in the body that trigger nausea and vomiting. Unfortunately, the period in which organogenesis occurs aligns with when pregnant women are likely to experience morning sickness. This interference with other chemicals in the body is thought to lead to interruptions in developing embryos.
Because the early stages of organogenesis involve the formation of vital organs, it is an extremely delicate and important process. Even among cells without anomalies, chemical or toxic interference in the development stages can interrupt cellular differentiation, multiplication, and alignment. If organ development is in any way inhibited or altered, these abnormalities result in birth defects.
Zofran Septal Defects – ASD, VSD and AVSD
Researchers, using data from the Denmark Medical Birth Registry, found that for all women who gave birth from 1997 to 2010 (a total of 903,207 births in the study period), 1,368 women took Zofran during their first trimester.
Of those women using Zofran during their first trimester of pregnancy, 61 (4.7%) gave birth to children with congenital malformations. Specifically, the study found that there was a 160 percent increase in heart defects in infants born to women who took Zofran during pregnancy compared to those who did not.
The dangers of Zofran during pregnancy are even more pronounced with regard to the increased risk for septal birth defects. The study found that children born to women taking Zofran during their first trimester were 210% more likely to have Atrial Septal Defects (ASD), 230% more likely to have Ventricular Septal Defects (VSD), and 480% more likely to have Atrioventricular Septal Defects (AVSD).
Zofran’s Heart Birth Defects
Morning sickness typically begins around the sixth week of pregnancy and continues through the 12th week. Despite what the name implies, pregnancy nausea and vomiting can happen any time day or night. In more severe cases, such as hyperemesis gravidarum, this can translate to pregnant women feeling sick for weeks on end in the early stages of their pregnancies. While doctors prescribed the drug off-label with the intent to help their patients, it has in fact done significant harm to unborn children.
What is a Ventricular Septal Defect (VSD)?
Of the many birth defects, ventricular septal defects (VSD) are one of the most serious. This is a condition when an infant has a hole in the heart. The hole is in the wall that allows blood to flow from the left side of the heart to the right side in its lower two chambers. The hole causes the blood to pump back into the lungs instead of the body as it should. Smaller holes may not be very harmful, while larger ventricular septal defects require surgery. If your child is not eating well, gets fatigued abnormally quickly or has a fast breath, contact your doctor immediately.
What is an Atrial Septal Defect (ASD)?
An atrial septal defect (ASD) is a hole in the wall between the heart’s two upper chambers. A small ASD may close on its own during infancy or childhood. However, a large ASD allows oxygenated blood to flow from the left upper chamber into the right upper chamber of the heart. This mixes deoxygenated blood with oxygenated which is then pumped into the lungs. This may lead to overfilled lungs and an overworked heart. Eventually, this will weaken and enlarge the right side of the heart.
What is Atrioventricular Septal Defect (AVSD)?
There are two forms of atrioventricular septal defect (AVSD), complete or incomplete. Both types of AVSD require surgery.
Complete: There is a large hole in the center of the heart that lets blood flow between all four chambers. However, instead of two separate valves, there is one common atrioventricular valve in the center of the heart. This often has flaps that do not close tightly or are not properly formed.
Incomplete: In incomplete AVSD, most of the defects present in AVSD are present. An infant with this condition will have a heart murmur and a range of symptoms including breathing problems, weak pulse, poor feeding and swelling of the belly or legs.
What Are Other Birth Defects Associated with Zofran?
Zofran is also associated with cleft palate and cleft lip. Cleft issues are the fourth most common type of birth defect. Also, boys are nearly twice as likely to develop these issues when compared to infant girls. Issues that can arise from orofacial cleft include eating or nutrition issues, hearing problems, infections, issues with speech and dental issues.
A cleft lip, on the other hand, occurs when a relatively narrow portion of skin tissue fails to form in the upper lip. This cleft or gap extends from the upper lip beyond the base of the nose. Some cases involve issues of the upper jaw and upper gums. Cleft lips affect 1 in 700 babies.
In both cleft palates and cleft lips, some medical issues can arise. Eating and nutrition issues may arise when a child is trying to feed. During breastfeeding or formula feeding allows food to pass through the cleft which may cause difficulty for the child to get the right amount of nutrition.
A surgeon can typically repair a child’s cleft lip in one surgery. The surgery is usually performed after the child is three months.
A cleft palate specifically refers to the roof of the mouth. In these cases, the skin tissue fails to fuse and results in a split of the roof of the mouth. Cleft palates can be hard or soft. A soft cleft palate involved the skin at the back of the roof of the mouth. A hard cleft palate is when the separation occurs in the front of the roof of the mouth where there tend to be more bones.
Cleft palates typically require much more treatment than a cleft lip. Treatment extends over the course of 18-21 years and includes several surgeries.
If you took Zofran and your child developed a cleft palate in utero, contact our firm. We have a Zofran Birth Defects Attorney who can assist with your case.
Why are People Filing Zofran Lawsuits?
Court documents show that GlaxoSmithKline knew that its product was linked to increased harm to unborn babies as early as 1992. As noted, Zofran was never intended for use during pregnancy. However, that did not stop it from becoming a top-selling morning sickness drug in the U.S. throughout the 1990s. By 1999, the FDA became concerned that GlaxoSmithKline was marketing the drug in a false or misleading manner. The organization issued a warning letter in March 1999. The letter forbid the company from distributing its promotional materials because of a failure to note risks associated with Zofran.
In 2003, two former employees of GlaxoSmithKline alleged the company promoted the off-label use of Zofran for morning sickness. GlaxoSmithKline agreed to pay the government $3 billion after the Justice Department took the company to court for fraud in 2011. This remains the largest settlement for alleged health care fraud in U.S. history.
Children with mothers who took the drug to abate morning sickness and nausea risk being born with a cleft palate, kidney malformation, and heart defects. These are health conditions that no parent wants to hear. These conditions were avoidable if the company had been upfront about the drug’s use.
What is the Basis of Private Zofran Lawsuits Against GlaxoSmithKline?
Families are suing GlaxoSmithKline over allegations that its marketing of the drug targeted pregnant women without FDA approval. Also, the lawsuits claim that the company paid doctors to prescribe it and failed to provide warnings about the risks. Because of its negligence in reporting the risks, GlaxoSmithKline is now at the center of nearly 600 lawsuits in federal courts.
Another drug manufacturer, Novartis, is also named in lawsuits filed after March 23 because of its purchase of GlaxoSmithKline’s oncology division.
A Minnesota mother filed the first lawsuit against GlaxoSmithKline in February 2015. She filed her Zofran lawsuit on behalf of her two daughters born with congenital heart defects. More families quickly followed suit. Lawsuits came pouring in from New Jersey, Texas, Alabama, Ohio, Montana, Louisiana, Arkansas, and Massachusetts.
Common Zofran Lawsuit Claims against GlaxoSmithKline
Despite knowing that the drug passes through the human placenta during pregnancy, GlaxoSmithKline continued to promote the drug to doctors and pregnant women for morning sickness. Claims against the company include:
- A legal obligation to ensure Zofran was safe before releasing and promoting it
- Failure to warn the public and medical communities about the risk of Zofran side effects
- Marketing Zofran as a safe treatment for off-label treatments, such as morning sickness and hyperemesis gravidarum
- Misrepresenting animal studies claiming Zofran was safe
- Failure to analyze all data and safety information about Zofran use by pregnant women
- Falsely and fraudulently claiming Zofran was safe for pregnant women
- Manufacturing a defective drug
If you are the parent of a loved one who has suffered life-threatening injuries as the result of Zofran use, contact The Carlson Law Firm today. We have a team of attorneys who can assist you in getting the compensation you deserve. Contact a Zofran Birth Defects Lawyer from The Carlson Law Firm to schedule a free case evaluation today.
Why Contact A Zofran Birth Defects Lawyer At The Carlson Law Firm
If you or someone you know has a child with birth defects after taking Zofran while pregnant or experienced any of the dangerous side effects, contact a personal injury attorney immediately. The Carlson Law Firm has the resources to stand against a defective drug company and can help receive compensation for your losses. Contact The Carlson Law Firm for a free consultation to see if you have a case.