Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.

On Jan. 8, 2024, nearly two years after Children’s Health Defense (CHD) sued the U.S. Food and Drug Administration (FDA) over the agency’s authorization of COVID-19 vaccines for children, CHD attorneys will be in court to argue that the lawsuit should be allowed to go forward.

CHD attorneys will ask the New Orleans-based 5th U.S. Circuit Court of Appeals to reverse the decision by a lower federal court, the U.S. District Court for the Western District of Texas, which in November 2022 dismissed the amended lawsuit brought by CHD and five parents on grounds the plaintiffs lacked standing to sue the FDA.

CHD filed an appeal in the 5th Circuit in May 2023.

“We’re excited to have our day in court and have counsel for CHD and the other plaintiffs” make the case “that we have standing to sue the FDA and that the FDA violated the Administrative Procedures Act (APA) in approving these vaccines for young children,” said CHD Acting General Counsel Kim Mack Rosenberg.

Robert Barnes, attorney of record in the case, filed the appeal against the FDA and FDA Commissioner Robert M. Califf on behalf of CHD and five parents — Deborah L. Else, Sacha Dietrich, Aimee Villella McBride, Jonathan Shour and Rebecca Shour.

The plaintiffs alleged a variety of 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.”

The appeal accuses the FDA of “misuse and misappropriation of emergency powers to market an unsafe, dangerous biologic to little children in order to deny them informed consent. The Constitution intended courts to address precisely this kind of case or controversy.”

Rosenberg, quoting from the appeal, said the case goes to the heart of a fundamental question:

“When it comes to mandated vaccines, is the FDA above the law? The District Court, by its decision dismissing the complaint, answered that question in the affirmative.

“The District Court decision opens the door to FDA continuing essentially unchecked misuse of its emergency powers to push dangerous products on some of the most vulnerable members of society: infants and young children.”

CHD lawyers will argue the merits of three main points, Rosenberg said, to rebut the lower court dismissal: whether the individual plaintiffs have standing to sue the FDA, whether the plaintiffs suffered an injury “in fact”’ and whether CHD has standing as an institutional plaintiff.

The overarching question in the case, whether the FDA is “above the law,” is “a question for other agencies as well, and in a lot of the litigation in which CHD is involved,” Rosenberg said.

“We’re really asking fundamentally what role does the government writ large have in what has happened in the last three years in the pandemic?”

CHD has been committed since the outset of the COVID-19 vaccine rollout to stop authorization of the vaccines for children.

On May 16, 2021, CHD President and then-General Counsel Mary Holland filed a 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-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. CHD sued the FDA on Jan. 24, 2022.

On July 1, 2022, CHD and parents Else and Dietrich, who said their children were threatened by possible mRNA vaccination, filed an amended complaint alleging the FDA violated the Administrative Procedure Act.

The amended complaint alleged the FDA “abused its emergency powers, eliminated the notice-and-comment process, ignored citizen petitions,” and “abandoned traditional safety mechanisms for assessing drugs” 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.”

In the complaint, Else, a resident of Bell County, Texas, pharmacist and CDH member, and Dietrich, also a resident of Bell County, said their children were “at imminent risk of immediate harm from this Emergency Use Authorization (EUA) biologic, including but not limited to coercion and pressure to receive the biologic, impending mandates, severe adverse reactions should they receive the drug, and immunization without parental informed consent.”

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.