On March 5, 2015, a mother from Oakland, California filed the nation’s fourth lawsuit in an ongoing litigation that surrounds the powerful anti-nausea drug Zofran and its association with increased risks for major birth defects.
Her complaint, filed in the Superior Court for the State of California, County of Alameda, was registered under case number RG15761042.
Mother Alleges Prenatal Exposure To Zofran Caused Supraventricular Tachycardia, A Serious Congenital Heart Defect
According to her complaint, plaintiff became pregnant and was soon prescribed Zofran, an anti-nausea drug that is often used as an “off label” treatment for the symptoms of nausea and vomiting that commonly arise during the first trimester.
In 2010, plaintiff’s son, referred to as J.S. in court documents, was born. J.S. was quickly diagnosed with a congenital heart defect called supraventricular tachycardia, or SVT. Presenting symptoms that included “rapid breathing, shortness of breath, and shallow breathing,” plaintiff’s son was prescribed Digoxin to manage the effects of his congenital defect.
Supraventricular Tachycardia: Was This Congenital Heart Defect Caused By Zofran?
Plaintiff claims that her son’s congenital heart defect was caused by prenatal exposure to Zofran.
While other Zofran birth defect lawsuits have involved congenital heart defects, this is the first to name supraventricular tachycardia, an abnormality that affects the heart’s electrical functioning.
Healthy human hearts beat at a relatively consistent rate. Between 60 and 100 times every minute, electrical impulses beginning in the heart’s upper chambers, or atria, initiate a complex process that results in the regular contractions of cardiac tissue known to the layperson as a heartbeat.
But in patients with SVT, faulty connections in this electrical system cause episodes of accelerated contraction. For some, the heart rate can rise as high as 300 beats per minute. Atrial fibrillation, a condition in which the heart’s contractions become uncoordinated, and ineffective in pumping blood, are a common result. Over time, these episodes of abnormally fast contraction put significant strain on the heart. Heart failure is possible in the absence of adequate treatment.
US Families Say GlaxoSmithKline Marketed Drug With Potential To Harm Fetal Development For Use During Pregnancy
This recent claim brings a number of serious allegations against Zofran’s manufacturer, the international pharmaceutical giant GlaxoSmithKline. In filing her lawsuit, the mother from Oakland adds her voice to a litigation that now includes at least seven individual personal injury lawsuits.
Her claims echo allegations that other plaintiffs have made in previous complaints.
To briefly summarize their claims, plaintiffs say that Zofran has the potential to cause major birth defects, and that GlaxoSmithKline has been aware of this risk for more than two decades.
But instead of notifying the medical community to mounting evidence of the drug’s association with increased risks of fetal harm, plaintiffs say that Zofran’s manufacturer concealed vital safety information from the public. In fact, these families claim that GlaxoSmithKline actively marketed its anti-nausea product to doctors as a “safe and effective” treatment for morning sickness, in the face of substantial evidence to the contrary.
Epidemiological Studies Find Association Between Zofran & Increased Risks Of Congenital Heart Defects
Plaintiffs begin by reviewing a series of epidemiological studies that have found an increased risk of major birth defects associated with exposure to Zofran during early pregnancy.
While additional studies have also linked Zofran to increased rates of cleft palate and kidney defects, the plaintiff in case number RG15761042 limits her discussion to current research that has found an association between the drug and congenital heart defects.
Her complaint summarizes three specific studies.
The first, performed by a team of researchers in Denmark, reviewed every Danish birth record filed between 2004 and 2011. According to court documents:
“the study’s supplemental materials indicated that women taking Zofran during the first trimester, compared to women who did not take Zofran, were 22% more likely to have offspring with a septal defect, 41% more likely to have offspring with a ventricular septal defect and greater than four-times more likely to have offspring with atrioventricular septal defect.”
This cluster of congenital heart defects, commonly referred to as “cardiac septal defects,” involve inadequately formed barriers between the heart’s four chambers.
Next, the mother turns to a second Danish study, one that included more pregnancies over a longer time period than the first. In total, researchers reviewed more than 900,000 live births, and found that women who had been prescribed Zofran were “more likely than mothers who [had not been prescribed the drug] to have a child with a congenital heart defect.” Like the previous Danish study, these researchers found that mothers prescribed Zofran were anywhere from two to four times as likely to deliver babies with cardiac septal defects.
Plaintiff concludes her summary of scientific findings by noting a Swedish study performed in 2014. Reviewing birth records filed in Sweden between 1998 and 2012, researchers found “that the mothers who took Zofran during early pregnancy had a 62% increased risk of having a baby with a cardiovascular defect.” Supporting the results of earlier studies, these women were more than twice as likely to deliver babies with cardiac septal defects.
These studies were performed between 2013 and 2014. But plaintiffs have alleged that GlaxoSmithKline became aware of Zofran’s potential to adversely affect fetal development long before that.
Plaintiffs Claim That GlaxoSmithKline Has Received More Than 200 Reports Of Birth Defects With Suspected Ties To Zofran
In 1991, Zofran was approved by the FDA for the treatment of severe nausea and vomiting in cancer patients receiving chemotherapy. Plaintiffs say that almost immediately after this initial approval, GlaxoSmithKline began receiving reports of severe adverse events, but from an altogether different patient population. These reports, according to the complaints, were “of birth defects associated with the use of Zofran by pregnant women.” Plaintiffs say that these reports began in 1992 and claim that the company has received more than 200 such reports to date.
In their lawsuits, plaintiffs allege that GlaxoSmithKline had an obligation, under federal law, to include information on these severe adverse events in Zofran’s labeling information. But according to these American families, the company “has failed […] to disclose [the birth defect reports it has allegedly received] to healthcare providers or expectant mothers.”
It is true that Zofran’s warning label makes no reference to reports of associated birth defects.
Parents Allege GlaxoSmithKline Unlawfully Promoted Zofran As Safe & Effective For The Treatment Of Morning Sickness
Rather than warn the health community or public of Zofran’s association to increased birth defect risks, plaintiffs claim that the drug’s manufacturer has been actively promoting Zofran as safe for pregnant women to take.
In case number RG15761042, plaintiff notes that neither GlaxoSmithKline’s branded Zofran product, nor any of its generic equivalents, have been approved by the US Food & Drug Administration as “safe and effective” for the treatment of morning sickness. As the complaint makes clear, Zofran’s manufacturer has never even studied the drug’s effects in clinical trials involving pregnant women.
At the time of Zofran’s approval in 1991, the company had no scientific evidence to support claims of Zofran’s safety for pregnant women or their unborn children. And without an FDA approval for the drug’s use during pregnancy, it would have been unlawful for GlaxoSmithKline to promote Zofran as a morning sickness treatment. But according to the plaintiff, this is exactly what GlaxoSmithKline did.
Rather than investigate the drug’s effects during pregnancy in adequate and well-controlled studies, plaintiff alleges that GlaxoSmithKline chose to “illegally circumvent[…] the FDA-approval process,” promoting Zofran directly to doctors as a safe and effective morning sickness treatment.
To support her allegation, plaintiff cites a case brought against GlaxoSmithKline by the US Department of Justice in 2012. Among a litany of criminal and civil charges, the federal government alleged that GlaxoSmithKline had unlawfully promoted Zofran to doctors as a treatment for morning sickness, making “false representations about the safety and efficacy of Zofran [during pregnancy].” While GlaxoSmithKline continues to deny this allegation, plaintiffs are insistent that the company unlawfully promoted Zofran as a safe drug for pregnant women to take, in the absence of any scientific evidence.
As we’ve seen, plaintiffs claim that GlaxoSmithKline promoted Zofran as a safe “off label” morning sickness treatment in the face of mounting evidence to the contrary. These families say that the company disregarded evidence of Zofran’s potential dangers during early fetal development and failed to warn the public of the drug’s possible risks.
According to claimants, GlaxoSmithKline chose to “us[e] expectant mothers and their unborn children as human guinea pigs” in the name of increased profits. Now, plaintiffs say their children have been forced to suffer the consequences.
Can Other Families File Zofran Birth Defect Lawsuits?
If the allegations made in this, and six other Zofran lawsuits, are true, any mother who was prescribed Zofran during the first trimester and then delivered a child with major birth defects may be eligible to file a claim against the drug’s manufacturer.
Joined by an alliance of distinguished plaintiffs’ attorneys, Monheit Law has begun to investigate the claims of parents and birth defect survivors who believe they may have been harmed by GlaxoSmithKline’s potent anti-nausea drug Zofran. Together, these lawyers have developed Zofran.Monheit.com, an informational resource for families interested in learning more about the ongoing Zofran litigation. Monheit Law is currently offering free consultations: to learn more about case eligibility, call 1-877-620-8411 to discuss your situation with an experienced attorney.
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