CHD Asks Appeals Court to Allow Lawsuit Challenging FDA’s Authorization of COVID Shots for Kids to Move Forward
Children’s Health Defense attorneys today asked the U.S. Court of Appeals to reverse a lower court’s dismissal of CHD’s lawsuit challenging the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization of COVID-19 vaccines for children and babies, arguing the FDA misused the emergency power to push dangerous biologics on minors.
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Children’s Health Defense (CHD) attorneys today asked the U.S. Court of Appeals for the 5th Circuit in New Orleans to reverse a lower court’s dismissal of CHD’s lawsuit challenging the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) of COVID-19 vaccines for children and babies.
The arguments came more than a year after a U.S. District Court in Texas dismissed CHD’s lawsuit on grounds CHD and five Texas parents lacked standing to sue the FDA.
CHD and the five parents sued the FDA on Jan. 24, 2022, alleging the FDA violated the Administrative Procedure Act (APA) and hoping to “hold the FDA accountable for its arbitrary and capricious authorization of a harmful drug that has and continues to injure children.” The plaintiffs filed an amended complaint on July 1, 2022.
The parents alleged risks to their children from COVID-19 vaccines including severe adverse reactions and “the unrelenting and looming threat of being pushed out of society” by “the culture of mass vaccination and medical mandates.”
CHD and the parents alleged that “the FDA abused its emergency powers, eliminated the notice-and-comment process, ignored citizen petitions, abandoned traditional safety mechanisms for assessing drugs injected into interstate commerce and the arms of American children, ignored express legislative limits on their actions” and misused this emergency power to push dangerous biologics on minors, mislabel and misbrand them to the public, with the express knowledge that their mislabeling would lead to them being coerced on children and infants as young as 6 months old.”
The lower court dismissed the lawsuit on Nov. 18, 2022, “on the grounds the Amended Complaint failed to sufficiently allege that any of the Appellants had standing to sue FDA.”
On May 15, 2023, CHD appealed the motion to dismiss.
Robert Barnes, a Los Angeles-based civil rights and constitutional law attorney who is the CHD attorney of record in the case, argued today before a three-judge panel that the harm to the five parents included the concern that Texas law allows adults other than parents to grant permission to vaccinate a child.
Sean R. Janda, an attorney with the U.S. Department of Justice in Washington who represented the FDA in court today, argued CHD does not have standing to sue the FDA just because CHD’s entire purpose as an organization is to protect children’s health and disseminate accurate information to the public, and because it devoted massive resources to disseminating accurate information about the risks of mRNA vaccines to children.
Janda also argued the five parents who are also plaintiffs in the CHD lawsuit lack standing because the FDA did not require children to take the COVID-19 vaccine, and the plaintiffs have not alleged sufficient injury.
U.S. Appeals Judge Catharina Haynes challenged Barnes to justify why CHD and the other plaintiffs were suing the FDA, which did not require COVID-19 vaccines for children, instead of schools that did require the shots, or the state of Texas for allowing adults other than parents to permit vaccines?
Haynes also said she believed CHD wants to remove the rights of parents to give their children the COVID-19 vaccine if they choose. “That’s what you all are saying, right?” Haynes asked.
“No, your honor,” Barnes replied. Barnes told the judges:
“What Children’s Health Defense is seeking is solely that the information given to parents is correct about what is scientifically proven to be safe and effective and medically necessary.
“For example, to this day the Emergency Use Authorization is the only basis by which children under the age of 12 are subject to the vaccine. How is there still a public health emergency facing kids concerning COVID when there isn’t for anyone else?”
U.S. Appeals Judge Edith H. Jones was sympathetic to the CHD lawsuit’s point that children had extraordinarily low risk from COVID-19, but urged Barnes to “flesh out” his case that CHD and five parents were harmed by the FDA and thus had standing to sue it.
Barnes said a central question of the case was the misuse of emergency powers by the FDA.
“This case goes far beyond I believe the question of COVID or even COVID vaccines,” Barnes argued. “This is a precedent-setting case where the FDA can claim Emergency Use Authorization and escape all judicial review.”
Government-coerced censorship also harmed the plaintiffs and is an issue in the case, Barnes said.
“When the FDA started using Big Bird and Elmo to promote this vaccine,” which “was not scientifically proven to be safe and effective,” CHD went on social media to inform the public, Barnes said.
But the FDA responded by saying to social media, “Shut them down, don’t even allow them to use Facebook to the own their members to correct this misinformation.”
Kim Mack Rosenberg, CHD general counsel who followed the hearing audio streamed from the New Orleans court, said, “I thought Robert did a phenomenal job. He kept the court focused on the standing issue, which is the issue before the court” that must be determined to allow CHD to move forward in a lawsuit that addresses the merits of the case.
Rosenberg said Barnes “asked what I think is the fundamental question here — if these plaintiffs don’t have standing, who does? Is the FDA essentially free from scrutiny if citizens impacted by the FDA and by an Emergency Use Authorization can’t sue the FDA?”
The issue of censorship is also important, Rosenberg said. “It’s censorship on the part of the government, encouraging social media such as Facebook to censor Children’s Health Defense.”
Rosenberg couldn’t predict when the three-judge appellate panel would rule on today’s hearing.
“There’s no timetable on rulings,” she said. Before it rules, the court asked both sides to make short submissions on the question of standing using an earlier case the 5th Circuit ruled on last December.
At the heart of CHD’s quest for standing, Barnes said today, was its diversion of massive resources during the pandemic to rebut the bad information supplied by the FDA.
After the FDA issued two EUAs for the Pfizer and Moderna vaccines to prevent COVID-19 in December 2020 for people in their mid-teens and older, and then began lowering the ages of vaccination to ages 12 through 15 and then 5 through 11, CHD in May 2021 submitted a petition to the FDA asserting that safety concerns required the agency to revoke its EUAs for the COVID-19 vaccines.
CHD President and then-General Counsel Mary Holland filed the Citizen Petition to then-FDA Acting Commissioner Janet Woodcock, on behalf of Dr. Meryl Nass, CHD scientific advisory board member, and Robert F. Kennedy Jr., then-CHD board chair and chief litigation counsel, requesting “the FDA revoke Emergency Use Authorizations for existing COVID vaccines and refrain from approving and licensing them.”
“The current risks of serious adverse events or deaths outweigh the benefits,” Nass and Kennedy wrote, “and … existing, approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the EUAs.”
The FDA denied CHD’s petition in a 52-page decision on Aug. 23, 2021.
Barnes concluded his argument this morning with “wise words” from another decision by the 5th Circuit, which ruled that it is of vital public interest to ensure that a government agency “‘turns square corners in dealing with the public to whom it is subservient.’”
“If these plaintiffs don’t have standing, nobody does,” Barnes said this morning, “and the FDA is above the law.”
Listen to the oral arguments here.
The Defender on occasion posts content related to Children’s Health Defense’s nonprofit mission that features Mr. Kennedy’s views on the issues CHD and The Defender regularly cover. In keeping with Federal Election Commission rules, this content does not represent an endorsement of Mr. Kennedy, who is on leave from CHD and is running as an independent for president of the U.S.
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