Families across the country have chosen to file lawsuits against the manufacturer of Zofran, a drug they believe causes birth defects. But until now, few have given voice to their experiences publicly.
Two brave plaintiffs recently spoke out, becoming one of the only families to do so openly. Jon and Clara Rickman, parents from Alabama, spoke with a reporter at Birmingham-based Fox News affiliate WBRC for a story published February 18, 2016.
“Every Day, You See His Scar”
In the article, titled Zofran: Looking beyond the label, the parents say their child was born with congenital heart defects after Clara took a generic version of Zofran during early pregnancy. They’ve chosen to go to the media, according to reporter Lydia Hu, “because they believe they can prevent a similar fate for others.”
I don’t want other mothers to go through what I’ve been through. And I don’t want them to feel guilty for the rest of their life, like I do.
– Clara Rickman
Their son survived the first of three major surgeries at just five days old, the parents say. Clara told the reporter: “every day, you see his scar. And I can’t never fix it and I think it’s my fault.”
There’s little doubt that no mother should feel guilty for her child’s birth defects, especially Clara, who says she was never told that Zofran had not been approved as a treatment for morning sickness or tested in pregnant women for safety purposes. That lack of transparency is a major problem, according to the family’s attorney, one made more glaring by widespread allegations that the drug’s manufacturer illegally marketed it for use during pregnancy. But it’s not entirely unforeseeable.
Off-Label Use Rises, As Do Birth Defect Reports
Doctors, as the story notes, are well within their legal rights prescribing drugs for “off-label” purposes, uses not approved by the Food & Drug Administration. The agency does, however, monitor adverse event reports associated with the use of a drug, no matter the indication specified.
In her article, Hu writes that “the FDA has more than 5,000 adverse events involving Zofran reported by a patient, health care provider, or manufacturer.” In our own research, we found far more than 5,000 reports.
In April of 2015, our attorneys sent a Freedom of Information Act request to the FDA, requesting every adverse event report involving Zofran recorded between January 1, 1991 and April 30, 2015. The file we were eventually sent contained 8,682 individual reports, 475 of which linked the drug to congenital anomalies or other “adverse fetal outcomes,” like prematurity and stillbirth.
James Reichmann, Concerned Citizen, Speaks Up
On January 4, 2013, James P. Reichmann, who was then senior vice president of a home healthcare supply company, submitted a citizen’s petition to the FDA, asking the agency to down-grade Zofran’s pregnancy risk category. Pregnancy risk categories, which have now been phased out, were a short-hand way for the FDA to publicize the amount, quality and results of research investigating a drug’s effect on fetal development. At the time of Reichmann’s petition, Zofran was listed in category B, signifying that:
“animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”
That wasn’t enough, according to Reichmann, who noted a study published online in 2011 by the journal Birth Defects Research which found a more than twofold increase in the rate of cleft palate among babies exposed to Zofran. The real problem, however, is that ondansetron, Zofran’s active ingredient, “is one of the most commonly prescribed medications in pregnancy.” Beyond its lack of approval for that indication, evidence to support Zofran’s off-label use in pregnant women, Reichmann wrote in 2012, was “sorely lacking.” That remains true today.
“Scant” Safety Info Merits Warnings, Reichmann Says
Where Zofran and pregnancy were concerned, safety data is “scant” as well. At the time, Reichmann could cite only animal studies, which are never used to infer a drug’s effects in human patients, a trial so small that it could rule out only a 500% or more increase in the risk of congenital malformations and the cleft palate study. Today, more than 3 years after Reichmann, submitted his petition, at least three more studies have found a link between Zofran and major birth defects.
With significant questions about the drug’s safety, and use among pregnant women apparently skyrocketing, doctors should be informing their patients fully about the drug’s history, Reichmann argued. But that wasn’t happening. Changing the drug’s pregnancy category would help, he advised, as would proactively informing OB/GYNs about the lack of scientific evidence supporting Zofran’s use during pregnancy.
FDA Denies Petition, But Calls For “Continued Vigilance”
It took the FDA more than two years to answer Reichmann fully, denying his petition in a letter dated October 27, 2015. The agency’s reviewers questioned the cleft palate study’s results, but then, citing a more recent study of Swedish birth records, conceded that a “signal for cardiovascular malformations […] may or may not be causal.”
While the studies under review “suffer from various methodological limitations that preclude definitive conclusions about the safety of ondansetron use in pregnancy,” according to the FDA, “a potential association between ondansetron use during pregnancy and cardiovascular malformations warrants continued vigilance.” As for the results of any “continued vigilance,” they haven’t been made public yet.
Dr. Peter J. Hughes, a professor at Samford University who spoke to Lydia Hu for the Fox News article, reviewed the FDA’s denial letter himself. It didn’t include, Hughes says, any results from a “medical study initiated by the FDA” itself. Another potential flaw was noted by Judge F. Dennis Saylor IV, the federal judge currently presiding over the Zofran lawsuits, which have been consolidated in the US District of Massachusetts. The FDA’s choice to leave the drug’s warning label unchanged was based solely on medical evidence presented in Reichmann’s citizen’s petition. Out of necessity, that petition couldn’t have included any study results that may still be the private property of GlaxoSmithKline, Zofran’s manufacturer.
That’s why Saylor denied the company’s motion to dismiss the lawsuits, which was largely based on the denial of Reichmann’s plea to alter Zofran’s warning label. For the Rickmans, along with more than 200 other families, their lawsuits will be allowed to progress. Clara Rickman’s final words, however, weren’t about the litigation, or study results, or GlaxoSmithKline’s potential liability – they were about her son:
“I want him to know that he’s a really strong baby, that he’s a fighter, and that he should be proud about it,” she says.
The Rickmans’ lawsuit (PDF) was initially filed on October 27, 2015 in the US District Court for the Northern District of Alabama. It was transferred to the US District Court for Massachusetts on November 13, 2015 and given the case number 1:15-cv-13830-FDS.