On April 4, 2015, a family from Montana filed America’s fifth personal injury lawsuit against GlaxoSmithKline, alleging that the pharmaceutical manufacturer’s anti-nausea drug Zofran caused their child to be born with a birth defect.
The case is notable for being the first lawsuit claiming compensation for a child’s cleft palate. The four lawsuits previously filed against GlaxoSmithKline seek damages primarily for congenital heart defects allegedly caused by Zofran.
Plaintiffs Allege That Zofran Caused Child’s Cleft Palate
Filed in the Federal District Court of Montanta, plaintiffs’ complaint was registered under case number 1:15-cv-00026-SPW-CSO. They claim that their child, named as M.M. in court documents, was born with both cleft lip and palate after her mother was prescribed and took Zofran to alleviate the symptoms of morning sickness during her first trimester.
Plaintiffs claim that “M.M. has been forced to undergo ten surgeries within her first sixteen years of life” and that “more are planned and likely.” In court documents, the family states that M.M.’s “birth defect impairs her development and enjoyment of a normal life at home and at school.”
Montana Family Claims That GlaxoSmithKline Fraudulently Marketed Zofran As A Treatment For Morning Sickness
Citing an investigation begun by the US Department of Justice (DOJ) as early as 2004, plaintiffs claim that GlaxoSmithKline (“defendant”) marketed Zofran as a treatment for morning sickness in pregnant women.
It is a matter of public record that the pharmaceutical manufacturer has never sought FDA approval for Zofran’s use in pregnant women, and has never conducted clinical trials to determine Zofran’s safety during pregnancy.
The complaint states that, in order to lawfully market the drug as a morning sickness treatment, such clinical trials would be required.
In 2012, the DOJ brought a number of civil and criminal charges against GlaxoSmithKline. Two of their civil charges involved Zofran. The DOJ alleged that the company had marketed Zofran to physicians for an unapproved use, specifically, as a safe and effective treatment for nausea and vomiting of pregnancy. The other charge suggested that the company had paid kickbacks to physicians who prescribed Zofran.
While the company continues to deny these allegations, GlaxoSmithKline eventually entered a settlement agreement, and paid a total of $3 billion to resolve its civil and criminal liabilities.
In this new complaint, plaintiffs allege that, rather than submitting Zofran for approval as a potential treatment for morning sickness, defendant “illegally circumvented the FDA-approval process.” The complaint notes that “this practice is known as ‘off-label’ promotion” and further alleges that “in this case [defendant’s alleged actions] constitute fraudulent marketing.”
Without appropriate clinical trials, plaintiffs allege that the defendant lacked sufficient evidence upon which to base any claims that Zofran was a safe and effective treatment for morning sickness.
Plaintiffs Claim That Defendant Received Evidence Of Zofran’s Allegedly “Unreasonable Risk Of Harm”
The complaint continues by alleging that defendant had in fact received “mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy.”
Animal Studies Allegedly Revealed Evidence Of Risk
Court documents begin by referring to a series of studies that the defendant allegedly conducted on pregnant rats and rabbits beginning in the 1980s. The complaint states that one of these tests found that ondansetron, Zofran’s active ingredient, passes the placental barrier. In other words, once injected into the pregnant animals, ondansetron was able to enter “fetal tissues.” This “placental transfer” was independently confirmed in pregnant human subjects by researchers in Hong Kong in 2006.
The complaint then notes four additional studies that the defendant allegedly performed: two involving intravenous doses of ondansetron and two involving ondansetron in an oral tablet form. Court documents claim that defendant informed the FDA that these tests presented no evidence of “harm to the fetus.”
In contrast to defendant’s alleged characterization of the study results, plaintiffs claim that each of these studies in pregnant animals actually “revealed clinical signs of toxicity,” including “premature births, intrauterine fetal deaths, and impairment of ossification (incomplete bone growth).”
The complaint then continues by noting that the results of animal studies are never considered “predictive of human response.” In other words, even if the defendant’s animal studies had revealed no evidence of fetal harm, that evidence would not have been enough to support any claims that Zofran was either safe or effective for pregnant women to take as a treatment for morning sickness.
Defendant Allegedly Received Reports Of Birth Defects With Suspected Link To Zofran
On the contrary, plaintiffs claim that the defendant “began receiving reports of birth defects associated with the use of Zofran by pregnant women” as early as 1992. By 2000, the complaint alleges that defendant “had received at least 32 reports of birth defects arising from Zofran treatment in pregnant women.”
Plaintiffs claim that these reports included:
- “congenital heart disease,
- intrauterine death,
- kidney malformation,
- congenital diaphragmatic anomaly,
- congenital musculoskeletal anomalies,
- and orofacial anomalies.”
Cleft lip and palate, the birth defects suffered by M.M. and that plaintiffs claim were caused by Zofran exposure, are forms of orofacial anomaly.
Plaintiffs Note Epidemiological Studies That Have Found Increased Incidence Of Birth Defects
The complaint then continues by summarizing several recent studies that have sought to investigate the possible effects of exposure to Zofran on developing babies. You can find a detailed overview of this research here.
Taken together, the complaint claims that:
- the “hundreds of reports of major birth defects associated with prenatal Zofran exposure” defendant has allegedly received and
- the epidemiological studies that have found an increased incidence of birth defects among babies exposed to Zofran
constituted sufficient evidence of Zofran’s potential to cause fetal harm. Plaintiffs claim that the defendant “concealed this knowledge from healthcare providers and consumers in the United States.” Moreover, the complaint alleges that defendant continued to market Zofran as a safe and effective treatment for morning sickness in the face of evidence to the contrary.
Have Any Studies Found An Association Between Zofran & Cleft Palate?
In 2012, researchers from Harvard and Boston Universities found that cleft palate was more than twice as likely to occur in babies born to women exposed to Zofran’s active ingredient (ondansetron) during the first trimester.
You can read that study’s abstract at the US National Library of Medicine’s website.