On February 12, 2015, a parent from Alexandria, Minnesota filed the first claim in a litigation that has since grown to at least seven lawsuits. Families have brought claims for compensation against GlaxoSmithKline, the manufacturer of Zofran, an anti-nausea drug that these parents say causes major birth defects.
Jun 01, 2015 /prREACH/ -- On February 12, 2015, a mother from Minnesota filed the first lawsuit to allege that GlaxoSmithKline’s anti-nausea drug Zofran causes birth defects. Her complaint was registered as case 2:15-cv-00709-PD in the United States District Court of the Eastern District of Pennsylvania. Since this initial lawsuit, at least six other parents have brought their own claims against the pharmaceutical conglomerate.
Plaintiff seeks damages for congenital heart defects that she says were caused by prenatal exposure to Zofran, a drug whose active ingredient, ondansetron, is now sold as a generic by 26 companies. Unlike subsequent plaintiffs, this mother claims that she was prescribed Zofran as a morning sickness treatment during two separate pregnancies, and that both of her daughters were born with heart defects as a result.
In her complaint, plaintiff notes that Zofran is not FDA approved for use during pregnancy. On the contrary, the drug has only been approved for the treatment of severe nausea and vomiting during chemotherapy, radiotherapy and surgical procedures in which anesthesia is administered. But citing a US Department of Justice lawsuit, plaintiff says that GlaxoSmithKline has unlawfully promoted Zofran to physicians for use during pregnancy. In 2012, the federal government leveled identical allegations against GlaxoSmithKline, charging the company for making “unsubstantiated and false representations about the safety and efficacy of Zofran concerning” its use as a morning sickness treatment. As plaintiff is quick to note, GlaxoSmithKline has “never once undertaken a single study” to investigate Zofran’s effects during pregnancy.
While GlaxoSmithKline ultimately agreed to pay $3 billion to resolve the government’s claims, the company continues to deny that it promoted Zofran for “off label” use. But plaintiffs in recent Zofran birth defect lawsuits have insisted that GlaxoSmithKline unlawfully marketed Zofran, effectively “plac[ing a drug with unknown consequences for fetal development] into the hands of unsuspecting pregnant women.”
Plaintiff claims that she was one of those unsuspecting pregnant women. Prescribed Zofran during the first trimester of two pregnancies, she says that both of her daughters were born with congenital heart defects. Upon delivery, her younger child “was unable to breathe adequately and required 24-hour monitoring.” Her older daughter, named as B.F. in court documents, was ultimately forced to undergo surgery in 2011 to “repair the hole in her heart.” Court documents do not specify the diagnoses of these heart defects. But “hole in the heart” is a common phrase used to describe cardiac septal defects, a range of conditions in which heart walls fail to form properly during early fetal development.
Plaintiff notes that morning sickness is most likely to occur during the period in which an unborn child’s organs begin to form. She also cites early studies, conducted by GlaxoSmithKline on pregnant animals, which revealed that Zofran readily crosses the placental barrier. According to plaintiff, these studies also “revealed evidence of toxicity, intrauterine deaths and malformities in offspring.” Plaintiff claims that these results indicated that Zofran “was unsafe for ingestion by expectant mothers,” but says that GlaxoSmithKline failed to disclose this evidence to the medical community or pregnant women.
In fact, plaintiff alleges that GlaxoSmithKline has been aware of Zofran’s potential risks for decades. She says that the company began receiving “reports of birth defects associated with Zofran” as early as 1992. Plaintiff claims that GlaxoSmithKline has received more than 200 reports to date, but has failed to revise the drug’s labeling with information on these severe adverse events.
Next, plaintiff turns to a series of studies that have sought to investigate the effects of prenatal exposure to Zofran. She cites three major papers published by European researchers, all of which found that women prescribed Zofran’s active ingredient are at an increased risk of delivering children with congenital heart defects. These studies’ indicated that prenatal exposure to Zofran increased the likelihood of an unborn child developing a cardiac septal defect by between 200% and 400%.
Plaintiff claims that GlaxoSmithKline has received mounting evidence of Zofran’s potential to cause congenital heart defects. But according to her complaint, the company has failed to warn the public of these increased risks. On the contrary, if her allegations are true, the company has actively concealed this evidence in order to market Zofran as a morning sickness treatment.
Spurred by these recent developments, a coalition of plaintiffs’ attorneys has joined forces to advocate for the rights of families. Led by Monheit Law, these lawyers have begun to investigate the claims of parents who believe that exposure to Zofran may have caused their children to be born with birth defects. Any parent who was prescribed Zofran as an “off label” morning sickness treatment, and then delivered a baby with birth defects, may be eligible to file a claim against GlaxoSmithKline. The attorneys are offering free consultations and case eligibility evaluations. More information can be found at ZofranLegal.com.