On June 8, 2015, personal injury lawyers for two mothers filed the most recent complaint against GlaxoSmithKline, claiming that prenatal exposure to the anti-nausea drug Zofran caused their children to develop major birth defects. These women say that GlaxoSmithKline unlawfully promoted Zofran as a “safe and effective” treatment for morning sickness while hiding evidence that the drug increases the risk for birth defects.
Zofran birth defect cases continue to mount, and these women have added their voices to a litigation that now includes at least 8 individually-filed personal injury lawsuits.
Plaintiffs filed their claim in the US District Court for the Western District of Louisiana under case number 15-1815. A copy of the complaint can be found on ZofranLegal.com.
In Louisiana, Two Mothers Claim Zofran Exposure Led To Severe Heart Defects
Like many American women, plaintiffs were prescribed Zofran as an “off label” treatment for morning sickness, and they note that Zofran has never been approved for use during pregnancy. As they state, GlaxoSmithKline has never conducted any studies to investigate the drug’s effects in pregnant women, or the risks it may pose to unborn children.
Without conducting such studies, and receiving FDA approval specifically for Zofran’s use as a morning sickness treatment, it would be unlawful for GlaxoSmithKline to promote the drug for use during pregnancy.
But plaintiffs allege that the company has been promoting Zofran as a morning sickness treatment for years.
Plaintiffs claim that GlaxoSmithKline promoted Zofran directly to obstetricians and gynecologists as a safe drug for pregnant women to take, without being granted, or even seeking, FDA approval first.
To support this allegation, plaintiffs cite a lawsuit filed by the US Department of Justice against GlaxoSmithKline in 2012. In this landmark case, the federal government charged the world’s seventh largest pharmaceutical manufacturer for marketing a number of drugs for unapproved uses. The government’s complaint specifically named Zofran, and alleged that GSK had promoted the anti-nausea drug as a morning sickness treatment in violation of federal law.
While GlaxoSmithKline has always denied this allegation, the company eventually pled guilty to three other criminal charges and entered a settlement agreement totaling $3 billion.
In this joint complaint, the first plaintiff says that she was prescribed Zofran in January 2010, during the first trimester of pregnancy.
Plaintiff’s daughter, named L.D. in court documents, was born on July 15, 2010. Immediately after her birth, L.D. was diagnosed with multiple congenital heart defects, including:
Ventricular Septal Defect
Atrial Septal Defect
So-called “hole in the heart” defects, ventricular and atrial septal defects occur when barriers that would separate chambers of the heart fail to form properly. Proper blood flow is impeded, and severe defects of this nature often require surgical intervention. Indeed, plaintiff claims that her daughter’s ventricular septal defect necessitated surgical repair. Congestive heart failure is another frequent result of “hole in the heart” defects, and plaintiff notes that intermittent tachypnea, or abnormally rapid breathing, is “reflective of congestive heart failure.”
Plaintiff claims that there is no history of birth defects in her family. Previous to delivering L.D., she gave birth to a healthy boy in 2005.
Like the first plaintiff, the second mother also claims that she was prescribed Zofran as an “off label” morning sickness treatment during early pregnancy. She says that she began taking Zofran around February of 2005, and eventually delivered her daughter V.P. on August 9th of that year.
Soon after birth, V.P. was diagnosed with accelerated ventricular arrhythmia, a form of ventricular tachycardia. In children born with this condition, something is wrong with the heart’s electrical system that causes the organ’s lower chambers, the ventricles, to pump out of rhythm with its lower chambers.
According to the complaint, this congenital heart defect “nearly caused V.P. to die shortly after birth.” Plaintiff says that her daughter has “required intense and regular medical monitoring and testing for the first five years of her life.”
Both plaintiffs claim that they were “unaware of the dangers posed by ingesting Zofran during pregnancy” and that, if they had known of the drug’s association to increased birth defect risks, they “would not have elected to use Zofran.”
Plaintiffs note a series of epidemiological studies that have found a significant increase in the risk of congenital heart defects among babies exposed to Zofran prenatally. After learning of Zofran’s widespread “off label” usage among pregnant women, researchers from Denmark and Sweden pored over hundreds of thousands of birth records to determine the drug’s possible effects on fetal development.
These studies all found that babies exposed to Zofran during early pregnancy were significantly more likely to be born with congenital heart defects.
Data from a review of every birth record filed in Denmark between 2004 and 2011 indicated that women who ingested Zofran were 22% more likely to deliver children with cardiac septal defects and 41% more likely to deliver children with a ventricular septal defect.
Plaintiff’s daughter L.D. was born with a ventricular septal defect, and her other heart abnormality, atrial septal defect, is included in the category of cardiac septal defects.
Further research would only strengthen the association. Using a larger collection of Danish birth records, a second team of researchers found that mothers prescribed Zofran during the first trimester were between two and four times more likely to deliver babies with a septal cardiac defect. A team in Sweden identified every Swedish woman who had been prescribed Zofran between 1998 and 2012. They found that these women were 62% more likely to deliver babies with a cardiovascular defect and more than twice as likely to have babies with a cardiac septal defect.
Plaintiffs claim that GlaxoSmithKline has been aware of Zofran’s “unreasonable risk of harm” during pregnancy for more than two decades.
They say that as early as 1992, the company began receiving reports of birth defects associated with prenatal exposure to Zofran. To date, GlaxoSmithKline has received more than 200 of these reports, they claim, but has failed to “disclose [these severe adverse events] to pregnant women or their physicians.”
Even earlier, GlaxoSmithKline was aware that Zofran crosses the placental barrier, entering fetal tissue at substantial concentrations. This knowledge was gleaned from a series of studies conducted on pregnant animals in the 1980s. While GlaxoSmithKline told the FDA that these tests revealed no evidence of “harm to the fetus,” plaintiffs claim that the study data in fact demonstrated “clinical signs of toxicity,” including fetal malformations and intrauterine deaths. These mothers say that GSK withheld this information from federal regulators and the public.
Plaintiffs claim that GSK was obligated by federal law to inform physicians and patients of Zofran’s association to increased birth defect risks. Joined by the claims of at least seven other parents, these women say that GlaxoSmithKline chose to neglect that obligation, leaving patients with “no way of knowing that their use of Zofran” could potentially harm their unborn children.
If these allegations are true, any woman who was prescribed Zofran as an “off label” morning sickness treatment and then delivered a child with major birth defects may be eligible to file a claim against GlaxoSmithKline.