Multiple families have now filed legal claims against GlaxoSmithKline, in an ongoing litigation that involves the company’s anti-nausea drug Zofran. These parents allege that Zofran, which is commonly prescribed as an “off label” treatment for morning sickness, caused their children’s major birth defects.
Lawsuits Claim Zofran Causes Major Birth Defects
While their lawsuits all share a similar set of allegations, plaintiffs claim damages for a wide range of major birth defects allegedly caused by Zofran. In this article, we’ll present a general overview of the plaintiffs’ claims, and then turn to a discussion of the specific birth defects that have been named.
Plaintiffs Say GlaxoSmithKline Promoted Zofran As Morning Sickness Treatment
After noting that the FDA has never approved Zofran as a treatment for morning sickness, plaintiffs claim that GlaxoSmithKline unlawfully promoted the drug for use during pregnancy.
They cite a 2012 Department of Justice lawsuit, in which the federal government charged the company for “making false and / or unsubstantiated representations” of Zofran’s safety and efficacy in relation to “pregnancy-related nausea.”
In short, the government accused GSK of promoting Zofran to doctors as a safe morning sickness treatment, without ever conducting clinical trials involving pregnant women or seeking the drug’s approval for that use. While the company continues to deny that it presented Zofran as a safe treatment for morning sickness, GlaxoSmithKline did plead guilty to three criminal charges unrelated to Zofran. In order to resolve its civil and criminal liabilities, GSK entered a settlement agreement that totaled $3 billion.
Plaintiffs have reiterated the federal government’s allegation, and are insistent that the company promoted Zofran directly to health care professionals for use during pregnancy.
“Safe & Effective” Treatment For Morning Sickness Approved In 2013
Plaintiffs are also quick to note that since 2013, a drug called Diclegis has been FDA approved for the treatment of morning sickness. The drug was developed specifically for use during pregnancy, and its manufacturer has conducted extensive clinical trials to determine Diclegis’ safety and efficacy in pregnant women. Diclegis’ inability to alter fetal development has been demonstrated by at least 27 large-scale epidemiological studies.
Plaintiffs say that unlike the company behind Diclegis, GlaxoSmithKline “never conducted a single clinical trial before marketing Zofran to pregnant women.” In fact, according to many complaints, the company “chose not to study Zofran in pregnant women or seek FDA approval [because these studies] would have hampered its marketing of Zofran and decreased profits.”
Why is that important? As we’ll see, plaintiffs allege that GlaxoSmithKline hid significant safety information from medical professionals. They say that if doctors had been made aware of Zofran’s association with birth defects, that knowledge would have discouraged many physicians from prescribing a potentially harmful drug to pregnant women.
But according to plaintiffs, GlaxoSmithKline actively concealed that evidence of risk from doctors. As a result, they claim that physicians were unable to make fully-informed decisions in the best interests of their patients. Quite possibly, one of those decisions could have been to prescribe the FDA-approved treatment for morning sickness, Diclegis, rather than the “off label” choice of Zofran.
Plaintiffs Claim GlaxoSmithKline “Knew That Zofran Was Unsafe For Ingestion By Expectant Mothers”
Plaintiffs go on to say that GlaxoSmithKline has actually been aware of Zofran’s potential risks during early pregnancy for at least two decades.
Many of the complaints begin by referring to a series of preclinical trials that GlaxoSmithKline conducted in the 1980s. These studies, which involved pregnant rats and rabbits, were performed before Zofran’s initial approval as a treatment for severe nausea and vomiting in chemotherapy patients.
Preclinical Trials Reveal Zofran’s Ability To Cross Placental Barrier
Plaintiffs say that these studies revealed that Zofran’s active ingredient, ondansetron, is able to cross the placental barrier in pregnant mammals. Complaints refer to a 2006 study performed by researchers in Hong Kong that confirmed this result in human subjects. In other words, ondansetron can readily pass from a mother’s blood to the body of her unborn child. This is information that plaintiffs claim GlaxoSmithKline hid from patients and physicians.
Citing medical experts, many of the complaints note that harmful drugs primarily enter fetal tissue by crossing the placental barrier.
Did GlaxoSmithKline Falsely Report Results Of Animal Studies?
Plaintiffs allege that these preclinical animal trials also revealed evidence of fetal harm. They claim that researchers reported observing increased rates of intrauterine death and developmental retardation in offspring exposed to Zofran prior to delivery.
Parents say that these results demonstrated “clinical signs of toxicity,” but allege that GlaxoSmithKline reported the results to the FDA as “show[ing] no harm to the fetus.”
Plaintiffs Say GlaxoSmithKline Concealed Birth Defect Reports
According to plaintiffs, GlaxoSmithKline “began receiving reports of birth defects associated with the use of Zofran by pregnant women” as early as 1992.
To date, they say that the company has received more than 200 reports of this nature. Plaintiffs claim that GSK had an obligation to disclose these severe adverse events to the public, but failed to do so.
Major Epidemiological Studies Find Association Between Zofran & Increased Risks Of Birth Defects
After reviewing the results of GSK’s early animal studies, and noting the hundreds of birth defect reports that the company has allegedly received, plaintiffs turn to a series of studies that have attempted to investigate Zofran’s possible effects on fetal development.
Most of the complaints limit their discussion of this research to three studies, conducted between 2013 and 2014, that all found higher rates of congenital heart defects among babies exposed to Zofran’s active ingredient during early pregnancy. But two other studies have also found a link between Zofran and increased risks of cleft palate and kidney defects.
Did GlaxoSmithKline Fail To Warn The Public & Health Community?
Plaintiffs claim that these birth defect reports and epidemiological studies were significant warning signs, concrete evidence of Zofran’s association with increased risks of major birth defects. They say that GlaxoSmithKline was warned of the drug’s potential dangers, but failed to warn the public, pregnant women and their doctors.
Complaints focus on Zofran’s warning label. Plaintiffs claim that GlaxoSmithKline had both the ability and an obligation under federal law to include information of Zofran’s association with birth defects. But as many plaintiffs note, Zofran’s labeling in relation to pregnancy has remained the same since 1993.
We’ve investigated drug labeling revisions extensively in this in-depth article.
Seven Complaints, Numerous Birth Defects
Now that we’ve covered the allegations brought against GlaxoSmithKline, we’ll turn to a discussion of the individual complaints that have been filed against the company.
Mother From Minnesota Alleges Zofran Caused Congenital Heart Defects
- Case number: 2:15-cv-00709-PD
- Filed on February 12, 2015 in the United States District Court of the Eastern District of Pennsylvania
In the first Zofran birth defect lawsuit filed in America, a mother from Alexandria, Minnesota claims that after being prescribed Zofran for morning sickness during two pregnancies, both of her children were born with congenital heart defects.
She says that her daughters’ congenital abnormalities have “prevented [them] from thriving physically and developmentally.” In 2011, one of the plaintiff’s children was “forced to undergo surgery to repair the hole in her heart.”
While the complaint does not specify the precise nature of this birth defect, it is possible that plaintiff’s daughter suffers from a cardiac septal defect. In 2013, Danish researchers found that women who had been prescribed Zofran’s active ingredient were more than twice as likely to deliver children with atrial and ventricular septal defects, abnormalities that are commonly known as “hole in the heart” defects. A team in Sweden found a similarly increased risk for cardiac septal defects one year later.
Massachusetts Parent Claims Drug Caused 9 Birth Defects
- Case number: 1:15-cv-10429
- Filed on February 16, 2015 in the United States District Court of the District of Massachusetts
In this lawsuit, a mother from Boston claims that she was prescribed Zofran to alleviate the symptoms of morning sickness in 2000. Her daughter, born that year, was subsequently diagnosed with 9 birth defects:
- Atrial septal defect
- Right ventricular hypertension
- Aortic arch hypoplasia
- Facial dysmorphia
- Low set ears
- Hearing loss
- Sensitivity to light
- Inguinal hernia
- Webbed toes
The plaintiff claims that these birth defects were caused by prenatal exposure to Zofran. She says that her daughter has been forced to “undergo ten surgeries to try and correct her numerous congenital abnormalities” and that these “birth defects impair her [daughter’s] development and enjoyment of a normal life at home and at school due to substantial developmental delays.”
Mother In Oakland Files Third Zofran Lawsuit, For Supraventricular Tachycardia
- Case number: RG15761042
- Filed on March 4, 2015 in the Superior Court for the State of California, County of Alameda
In her complaint, a resident of Oakland, California claims that after being prescribed Zofran as a morning sickness treatment, her son was born with supraventricular tachycardia. This is a congenital heart defect, but unlike other CHDs that have been named in Zofran lawsuits, it involves the electrical activity of cardiac tissue rather than a structural abnormality.
The heart’s four chambers are controlled by electrical impulses that trigger contraction and dilation. In healthy hearts, the organ beats anywhere between 60 and 100 times per minute. But in patients with supraventricular tachycardia, these electrical impulses don’t work correctly, and can result in “episodes” in which the patient’s heart beats extremely fast. In some children, the heart can even beat up to 300 times per minute. Rapid breathing and shortness of breath are common symptoms, and ones specifically named in plaintiff’s complaint.
San Francisco Parents Claim Zofran Caused Bicuspid Aortic Stenosis
- Case number: CGC-15-544524
- Filed on March 5, 2015 in the Superior Court for the State of California, County of San Francisco
In America’s fourth Zofran complaint, parents from San Francisco claim that their son was born with bicuspid aortic stenosis, a congenital heart defect, after being exposed to Zofran during the first trimester. They say that their child “will require continued monitoring and future surgeries to repair or replace his damaged valve.”
Montana Parents Allege Zofran Caused Cleft Palate & Lip
- Case number: 1:15-cv-00026-SPW-CSO
- Filed on April 3, 2015 in the United States District Court, District of Montana, Billings Division
In this claim, a family from Montana alleges that their daughter was born with a cleft lip and palate in 1998, after her mother took Zofran to alleviate the symptoms of morning sickness during early pregnancy.
Orofacial clefts occur in early fetal development, and are the result of soft tissues in the lip and roof of the mouth that fail to fuse together properly. These congenital defects often require multiple rounds of surgery, and plaintiffs say that their daughter “has been forced to undergo ten surgeries within her first sixteen years of life and more are planned and likely.”
Their lawsuit is notable for being the first to name cleft palate, a birth defect that researchers at Harvard and Boston Universities found was 2.37 times more likely to occur in babies who had been exposed to Zofran or its generic equivalent in the first trimester.
Texas Mother Claims Zofran Caused Heart Murmur, “Fluid On The Brain,” Thickened Arteries, Developmental Delays
- Case number: 5:15-34
- Filed on April 17, 2015 in the United States District Court for the Eastern District of Texas, Texarkana Division.
In this complaint, a mother from Texarkana, Texas, claims that her son was born in 2014 “with numerous congenital defects.” She says that her son “has been diagnosed with:
- heart murmur,
- fluid on the brain,
- thickened arteries and
- multiple developmental delays.”
This is the first Zofran birth defect lawsuit to present an extensive overview of how harmful chemical substances are often able to transfer from a mother’s blood to that of her unborn child.
Mother In Massachusetts Alleges Zofran Caused Abdominal Malformation That Forced Her To Terminate Pregnancy
- Case number: 1:15-11627
- Filed on April 17, 2015 in the United States District Court for the District of Massachusetts, Eastern Division
In the most recent Zofran birth defect lawsuit, a mother living in Randolph, Massachusetts claims that she became pregnant in 2013. The plaintiff was prescribed Zofran to treat her nausea and vomiting early in pregnancy.
But in October, six months after becoming pregnant, a routine diagnostic test revealed that her unborn child had developed “severe and life-threatening abdominal defects.” As a result, the mother was forced to terminate her pregnancy. She says that if her physicians had been aware of Zofran’s increased association with birth defects, she would not have taken the drug “and her pregnancy would have progressed to term with a healthy child.”