In the latest Zofran birth defect lawsuit, a family from Ohio claims that prenatal exposure to Zofran caused their daughter’s congenital heart defect, an abnormality that would prove fatal only three days after her birth.
Filed in the United States District Court for the Northern District of Ohio, Western Division on June 10, 2015, these parents have become the most recent plaintiffs in an ongoing litigation that now includes at least ten individual personal injury lawsuits.
You can read their complaint, filed under case number 3:15-cv-1166, by clicking the link below:
Parents Claim Newborn Daughter “Died As A Result” Of Heart Defects Caused By Zofran
Plaintiff claims that she took Zofran during pregnancy, “based on GlaxoSmithKline’s off-label promotion of [the drug] as a safe solution for pregnancy-related nausea.”
In making this allegation, plaintiffs cite a lawsuit filed by the US Department of Justice against GlaxoSmithKline in 2012. After an investigation of at least eight years, the federal government charged GlaxoSmithKline for promoting a number of drugs “off-label,” for unapproved uses. Promotion of this nature is illegal under federal law.
The government specifically named Zofran in its complaint, writing that “GSK knowingly […] promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea).”
As plaintiffs’ complaint notes, GlaxoSmithKline “opted” to enter a settlement agreement to resolve the government’s civil and criminal allegations, including those in relation to the company’s alleged “off-label” promotion of Zofran. Plaintiffs write that “GlaxoSmithKline negotiated the right to deny the facts and liability surrounding the settlement agreement, but paid $3 billion to resolve these claims.”
Plaintiffs insist that GlaxoSmithKline did in fact promote Zofran for unapproved use during pregnancy, in violation of federal law.
Zofran Exposure Led To Deadly “Right Ventrical Heart Defect,” Plaintiffs Allege
Plaintiff says that she was prescribed and took Zofran as a treatment for the symptoms of morning sickness. Her pregnancy “was otherwise unremarkable until nine days before delivery when the baby’s heart rate began to decelerate,” or slow down.
Plaintiff’s daughter was born on March 17, 2006, and immediately diagnosed with what court documents refer to as a “right ventrical heart defect.” Plaintiffs say that their newborn daughter was kept in the hospital’s Intensive Care Unit (ICU) until, only three days after birth, she “crashed and physicians could not revive her.” Their daughter died on March 20, 2006, plaintiffs say.
Court documents relate that since their daughter’s passing, plaintiffs have “devoted their time and money to bringing awareness and understanding to heart defects” like their child’s.
“The Einarson Study”: Plaintiffs Say GlaxoSmithKline “Ignored” Warning Signs
The complaint is also notable for mentioning an early study that has not yet been cited by other plaintiffs.
Court documents call this the “Einarson study” after the article’s lead author. Completed in September of 2004 and published by BJOG: An International Journal of Obstetrics & Gynecology, this small study was conducted to investigate the potential effects of Zofran on fetal development. It was also funded by a grant from GlaxoSmithKline, the manufacturer of Zofran.
Spurred by Zofran’s increased use as an “off-label” morning sickness treatment, researchers analyzed the birth outcomes of 176 pregnancies in which mothers had ingested Zofran during the first trimester. They then compared those birth outcomes to a group of 176 pregnancies that had not been exposed to Zofran.
As the complaint states, 3.5% of the women prescribed Zofran gave birth to children with major malformations, almost double the rate of 1.8% observed in the unexposed group. But even with this two-fold increase in major birth defects, the study “could not call that change statistically significant because of the small sample size of only 176,” plaintiffs write.
They contend that the Einarson study’s results were a “danger sign[…],” but one that GlaxoSmithKline “ignored.” They also cite a 2012 study, in which researchers at Harvard linked Zofran to a 2.37 times increase in the rate of cleft palate.
Plaintiffs claim that GlaxoSmithKline failed to “commission[…] larger stud[ies]” to investigate the risks demonstrated by these research initiatives. After each of these studies was released, GlaxoSmithKline chose to continue promoting Zofran as a safe morning sickness treatment, plaintiffs allege.
In relation to their own daughter’s heart defect, plaintiffs note a Swedish study performed in 2004 that associated prenatal exposure to Zofran with more than a two-fold increase in the risk for congenital heart defects.
Under the weight of what plaintiffs consider mounting evidence, “GlaxoSmithKline maintains its position that it is unaware of any link [between Zofran and birth defects] and continues to refuse to update the Zofran label.” According to these plaintiffs, and at least nine others, GlaxoSmithKline failed to warn the health community and public of Zofran’s potential association with major birth defects.
Zofran Birth Defect Lawsuits In Ohio
Case number 3:15-cv-1166 is the first Zofran-related lawsuit to be filed in Ohio. Families interested in finding more information on the ongoing Zofran litigation in Ohio can visit our page dedicated to birth defect statistics in the state here.