Zofran Lawsuits Being Filed Across The Country
Zofran, known also by its generic name ondansetron, is a powerful anti-nausea drug produced by GlaxoSmithKline, the world’s seventh largest pharmaceutical manufacturer.
Developed in the late 1980s, Zofran was eventually approved by the US Food & Drug Administration for the treatment of severe nausea and vomiting caused by cancer treatments, like chemotherapy and radiation therapy, and later for post-surgical nausea. To date, these are the only conditions for which Zofran is approved.
Thirty years ago, America’s only approved medication for “morning sickness,” the extremely common nausea and vomiting experienced during early pregnancy, was removed from the market. Until Zofran’s release in 1991, the health community had no way to treat it. And with about 6.7 million pregnancies every year, and around 80% to 90% of all pregnant women experiencing morning sickness at some point, major pharmaceutical companies were looking at a huge, untapped market.
Despite the fact that the FDA had never approved ondansetron for morning sickness, physicians began prescribing expectant mothers Zofran to relieve their symptoms. This practice, known as “off-label” prescription, is not regulated by the FDA.
March 5, 2015: California’s second lawsuit against GSK was filed by the mother of a child who was born with bicuspid aorta stenosis. The plaintiff alleges that taking Zofran for hypermesis gravidarium caused this congenital defect. To view the complaint summary, click here.
March 4, 2015: California mother files a lawsuit alleging that her child’s heart defect, supraventricular tachycardia, was caused by Zofran, which she took for morning sickness early in her pregnancy. For a summary click here.
March 1, 2015: Allegations that Zofran was the cause of 9 birth defects have been made in the first filed Zofran lawsuit complaints. These defects include atrial septal defect and hearing loss. For a full listing of the 9 defects, click here.
February 16, 2015: Massachusetts parent files lawsuit against GSK alleging that Zofran was the cause of numerous heart defects and facial malformations. The parent took Zofran during the first trimester of her pregnancy. For more details, click here.
February 12, 2015: Minnesota Mother of two, files lawsuit alleging Zofran caused serious congenital heart defects in both of her newborn children. This lawsuit was filed in federal court and you can read more about the claim here.
GlaxoSmithKline & Zofran: Was There Health Care Fraud?
In a case brought by the US Department of Justice (DOJ), federal prosecutors alleged that GlaxoSmithKline began promoting Zofran to physicians and pregnant women as a safe, effective treatment for nausea and vomiting of pregnancy (NVP).
While physicians are free to prescribe any medication they believe medically necessary, it is not permissible for pharmaceutical companies to market their drugs for “off-label” purposes.
In both criminal and civil cases, the DOJ alleged that GSK had unlawfully promoted certain prescription drugs, including Zofran, for “off-label, non-covered uses and [paid] kickbacks to physicians to prescribe those drugs.”
While GlaxoSmithKline never admitted to any deceit, the company agreed to pay $3 billion to settle the case. It was, and remains, the largest settlement for a case alleging health care fraud in the United States.
But it now appears that this alleged fraud may have been only part of the problem.
GSK Denies Zofran’s Risks For Pregnant Women & Their Babies
Morning sickness is experienced most commonly during the first trimester of pregnancy, when an embryo’s development is most critical and the risk of birth defects is highest. If a drug can adversely affect fetal development, it will do the most damage at this stage.
In order to seek FDA approval for the treatment of morning sickness, GlaxoSmithKline was required by law to test Zofran’s effects on pregnant women and their unborn babies. But GSK has only ever conducted studies on rabbits and rats. According to the FDA, “animal reproductive studies are not always predictive of human response.”
In other words, even if the clinical tests had proven ondansetron safe in animals, they would still have said nothing about its safety in humans.
But according to the first Zofran birth defect lawsuits, these animal reproduction studies actually revealed signs of toxicity: the pregnant animals showed abnormal behavior and their offspring suffered serious forms of developmental retardation.
Is it possible that GlaxoSmithKline ignored this evidence of danger, and failed to disclose it properly to the FDA? Did the company instead conduct prohibited promotion of Zofran directly to pregnant women’s OB/Gyns?
Do Birth Defects Happen After Using Zofran?
Now, a growing body of research has begun to indicate a troubling association with Zofran. Several major studies have associated pregnant women prescribed ondansetron with the birth of babies with birth defects.
Researchers from Harvard’s School of Public Health and the US Centers for Disease Control & Prevention found more than a two-fold risk of cleft palate in babies born to women who had taken ondansetron during early pregnancy.
Congenital Heart Defects
In 2013, two teams of Danish researchers reviewed a vast database of birth records, which included all births in Denmark. The first team looked at over 600,000 births between 2004 and 2011; 1,970 of those women had been exposed to ondansetron. The study found no evidence of major birth defects, but it contained a fatal flaw.
Half of the pregnant women under investigation had been prescribed Zofran after 10 weeks of pregnancy, after their embryos were more fully developed and the risk of a birth defect had dropped significantly.
Widening the search, the second team looked at more than 900,000 births between 1997 and 2010. In this sample group, 1,368 women redeemed prescriptions for ondansetron during their first trimester. The researchers “found an increase in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription of ondansetron in the first trimester of pregnancy.” Researchers using Swedish and Australian birth records have only confirmed these risks.
To learn more about the possible risks Zofran can present to unborn babies, click here.
Risks Of Arrhythmia
While the dangers that Zofran presents to developing babies have received the most attention, ondansetron can also cause severe complications in adults, both cancer patients and pregnant women, who take it.
In 2011, the FDA announced that it was investigating reports of “abnormal changes in the electrical activity of the heart” in patients taking Zofran. The agency instructed GlaxoSmithKline to perform a study that would determine ondansetron’s effects on heart activity.
GSK finished its study, which examined a 32 mg intravenous dose of Zofran, in 2012. Of the study, the FDA said that “preliminary results suggest that […] ondansetron may affect the electrical activity of the heart[,] which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.”
GlaxoSmithKline quickly pulled the 32 mg dose off the market, and altered Zofran’s warning label to alert physicians of the increased risks. Gideon Koren, an influential researcher who founded Toronto’s premier pregnancy risk counseling center, has found that the FDA’s new recommendations are not being followed by many doctors.
And the risk of abnormal heart beats may not be limited to pregnant women. Emergency room doctors working in Pennsylvania’s Lehigh Valley treated two pediatric patients, a 10 year old boy and an 86-day-old infant, with ondansetron after they were diagnosed with gastroenteritis. While ondansetron is “commonly used” off-label to reduce the nausea and vomiting caused by this condition, both children died from tachycardia, a dangerously fast heart beat.
Serotonin syndrome is a potentially fatal condition caused by elevated levels of serotonin, a neurotransmitter naturally-produced by the body. Serotonin is essential to triggering the sensation of nausea, and Zofran works by blocking the receptors that are themselves triggered by serotonin. In effect, Zofran allows serotonin to remain in a patient’s body at full strength, rather than doing its job and then being broken down.
In conjunction with other drugs that promote serotonin production, like many antidepressants, Zofran can significantly increase the risk for serotonin syndrome. In September of 2014, the FDA ordered GlaxoSmithKline to revise the drug’s warning label and notify physicians of this risk.
Can I File A Zofran Birth Defect Lawsuit?
Yes. If you took Zofran during your pregnancy and gave birth to a child with birth defects, you may be entitled to fair and adequate compensation.
According to allegations made by the US federal government, GlaxoSmithKline, one of the world’s largest companies, intentionally misled both patients and doctors in the name of sheer profit. If true, it is possible that thousands of families have been forced to endure the financial and emotional burdens that a child’s birth defect can inflict.
GSK should be held accountable for any and all failures to adequately warn the public, and families deserve the support they need.
The personal injury attorneys at Monheit Law can help. With over 25 years of proven trial experience, our firm focuses on cases involving defective and dangerous health care products.
We are now offering free consultations to families who believe that they have been harmed by GlaxoSmithKline and its corporate practices. If your baby suffered a birth defect after you took Zofran, call 866-761-1385 or complete our contact form to learn more about your legal options.