Four families have now filed lawsuits against GlaxoSmithKline, alleging that the pharmaceutical giant’s anti-nausea drug Zofran caused their children’s debilitating birth defects. While Zofran is FDA approved to treat nausea and vomiting in patients undergoing cancer treatments and surgical anesthesia, it has never been approved for morning sickness. In their complaints, plaintiffs claim that GlaxoSmithKline not only failed to test Zofran’s effects on fetal development, but may in fact have known of the drug’s significant health risks and failed to warn the public.
Apr 08, 2015 /prREACH/ -- Multinational pharmaceutical conglomerate GlaxoSmithKline has manufactured the drug ondansetron since the early 1990s. Marketed under the brand name Zofran, it was eventually approved by the FDA as a treatment for nausea and vomiting in cancer patients. While Zofran’s approval was extended to treat certain patients undergoing surgical anesthesia, its effects in pregnant women have never been studied.
In 2012, the US Department of Justice brought multiple charges of healthcare fraud against GlaxoSmithKline. Among the government’s allegations was the claim that the company had unlawfully marketed Zofran to obstetricians and gynecologists as a “safe” treatment for morning sickness, without first seeking FDA approval. GlaxoSmithKline continues to deny these allegations, but ultimately settled the case for $3 billion.
Now that multiple epidemiological studies have established an association between ondansetron and birth defects, women across the nation have begun to come forward. As of March 2015, four plaintiffs have filed lawsuits against GlaxoSmithKline for birth defects they claim were caused by Zofran. For a summary of the studies, click here.
The First Lawsuit
On February 12, 2015, a mother from Minnesota, filed suit in the federal court for the Eastern District of Pennsylvania. Under case number 2:15-cv-00709PD, the plaintiff's complaint alleges that her two children, B.F. and T.F., were both born with cardiac septal defects, a congenital condition known commonly as “hole in the heart.”
The plaintiff’s claim states that she was prescribed Zofran in the first trimester of each pregnancy to treat severe morning sickness. She alleges that GlaxoSmithKline marketed Zofran as a safe and effective treatment for the nausea and vomiting that commonly accompanies early pregnancy, despite having never conducted clinical studies on pregnant women. Her complaint names GlaxoSmithKline’s conduct as “tantamount to using expectant mothers and their unborn children as human guinea pigs.”
The lawsuit goes on to allege that GlaxoSmithKline was well aware of Zofran’s possible dangers, but continued marketing the drug to OB / GYNs. Among the plainitff's claims:
GlaxoSmithKline performed studies on pregnant animals in the 1980s, and found evidence of Zofran’s toxicity, including intrauterine deaths and fetal malformation.
GlaxoSmithKline has received at least 200 reports of birth defects associated with Zofran in pregnant humans to date.
As a result of GlaxoSmithKline’s alleged fraudulent marketing, the family has suffered devastating, life-long consequences.
Due to their congenital heart defects, the plaintiff’s children have undergone multiple, invasive surgeries. Both suffer from growth and developmental delays. Along with compensatory damages for medical expenses and pain and suffering, the plaintiff seeks punitive damages in the case.
The Second Lawsuit
On February 16, 2015, another parent filed America’s second lawsuit alleging that GlaxoSmithKline’s fraudulent marketing placed a dangerous drug in the hands of unsuspecting expectant mothers. The complaint was filed in the federal court for the District of Massachusetts under case number 1:15-cv-10429.
In the complaint, the plaintiff claims that she was prescribed Zofran during the first trimester of pregnancy for symptoms of morning sickness. She states that she had no knowledge of Zofran’s potential dangers at the time. In 2000, the plaintiff’s daughter A.S. was born with “numerous congenital defects.” In all, the plaintiff names 9 birth defects suffered by her child:
- Atrial septal defect
- Right ventricular hypertension
- Aortic arch hypoplasia
- Facial dysmorphia
- Low set ears
- Hearing loss
- Sensitivity to light
- Inguinal hernia
- Webbed toes
In all other allegations, the plaintiff’s complaint closely follows that of the first filed lawsuit. She claims that GlaxoSmithKline was aware of Zofran’s harmful effects on fetal development, but continued unlawfully marketing the drug as a treatment for morning sickness. The plaintiff says that her daughter has been forced to suffer a total of thirteen invasive surgeries, lives with severe developmental delays and requires additional assistance at home and school.
Lawsuits Number 3 and 4
The two newest lawsuits were filed in the state of California with allegations similar to those outlined above. However, in these two cases, two new birth defects were introduced. Here, the plaintiffs alleged that Zofran caused bicuspid aortic stenosis (Case Number: CGC-15-544524 - Superior Court For The State Of California, County of San Francisco), and supraventricular tachycardia (Case Number: R615761042 - Superior Court For The State Of California, County of Alameda) - also known as SVT.
These recent lawsuits raise significant questions about GlaxoSmithKline’s corporate practices. If their allegations are true, women who were prescribed Zofran and delivered babies with birth defects may be entitled to compensation.
Families who would like to learn more about the possibility of filing a lawsuit against GlaxoSmithKline are urged to contact Monheit Law, a firm currently investigating claims of Zofran’s association with birth defects.