Children’s Health Defense (CHD) is appealing the dismissal of a federal lawsuit challenging the authority of the U.S. Food and Drug Administration (FDA) to grant Emergency Use Authorization (EUA) of COVID-19 vaccines for children.

CHD on Tuesday filed an appeal in the U.S. Court of Appeals for the 5th Circuit, seeking to reverse the decision by a lower federal court, the U.S. District Court for the Western District of Texas, which dismissed the suit in November 2022. The complaint initially was filed in January 2022.

The FDA, along with its commissioner, Dr. Robert Califf, are named as defendants in the lawsuit. Aside from CHD, five parents of children “who are directly threatened by FDA’s authorizations and the false advertising of its EUAs” are named as plaintiffs.

According to the appeal:

“This case is about the FDA’s 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. …

“This case asks one basic question: in the critical context of mandated vaccines, is the FDA above the law? For example, can FDA use its 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 coercively administered to children and infants as young as 6 months old?

“The District Court ruled yes, finding that the FDA cannot be sued by citizens and is beyond judicial review for any of its actions in this context. …

“The FDA claims it is above the law and denies any remedy to children aged 6 months to eleven years (including those in foster care), from its arbitrary and capricious authorization of COVID-19 injections.”

According to Lexis Anderson, an associate attorney with Barnes Law, a Los Angeles-based firm representing the plaintiffs, “This appeal seeks to correct a grievous wrong: preventing dangerous agency action from being judicially redressed as the Constitution clearly embraces and intends. The least protected, most vulnerable lives of children and infants in this country depend on it.”

Anderson added:

“The appeal argues that the District Court erred in finding that CHD, an organization dedicated to the health of children and that worked tirelessly to expose the dangers of the COVID-19 biologic, and the parents whose children are in direct threat from FDA’s actions, are not entitled under the Constitution to bring this suit.

“Furthermore, plaintiffs have clearly alleged an actionable violation of federal law due to the FDA’s inadequate agency review and decision making, and subsequent false advertising of COVID-19 shots.”

Kim Mack Rosenberg, acting outside general counsel for CHD, described the case against the FDA as “critically important.” She told The Defender:

“The plaintiffs ask a fundamental question here: 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.

“The Constitution intended that courts could review the actions of government agencies. By its decision, the district court shut the courthouse doors and insulated the FDA from liability.

“This is the opposite of the system of checks and balances the Constitution requires. Because of these high stakes, literally life and death in some cases, it is very important for us to appeal this decision.”

Also remarking on the appeal, Mary Holland, CHD president on leave, told The Defender:

“More and more science is now confirming that the FDA’s authorization of the COVID shot for children aged 5 to 11 was arbitrary. It is critical that the appeals court review the lower court’s decision rigorously and do justice.”

Parents ‘directly threatened’ by EUAs allowing COVID vaccines for children

The lawsuit was preceded in May 2021 by a citizen petition, filed by CHD with the FDA, in which CHD asked the FDA “to revoke the existing EUAs for the COVID-19 vaccine.” In a 52-page response dated Aug. 23, 2021, the FDA denied CHD’s petition.

The denial led CHD and the other plaintiffs to sue the FDA on Jan. 24, 2022. They filed an amended complaint on July 1, 2022, alleging the FDA violated the Administrative Procedure Act (APA).

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.”

Anderson told The Defender the plaintiffs hope “to hold the FDA accountable for its arbitrary and capricious authorization of a harmful drug that has and continues to injure children.”

She said the lower court’s dismissal may create a dangerous constitutional precedent. “The District Court for the Western District of Texas dismissed the complaint on the grounds that Plaintiffs lacked constitutional standing to sue the FDA and therefore could not bring this claim,” Anderson said.

The appeal states the secretary of the U.S. Department of Health and Human Services determined on March 27, 2020, that “circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.”

Subsequently, in December 2020, the FDA issued EUAs for COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, while later EUAs were granted to Johnson & Johnson and to Novavax.

The appeal notes that on Oct. 29, 2021, “FDA revised the EUA to authorize administration of the Pfizer vaccine to children ages five to eleven.” Later, on June 17, 2022, “the FDA further revised the EUA to authorize the administration of the Pfizer vaccine to children ages 6 months to 4 years.”

According to the appeal, “The FDA states on its website that ‘there is an option to accept or refuse receiving the vaccine’ [and] The FDA also states that ‘[s]hould you decide for your child not to receive it, it will not change your child’s standard medical care.’”

However, the five parents who are plaintiffs in the lawsuit are “directly threatened by FDA’s authorizations and the false advertising of the EUAs,” the appeal argues, adding that “FDA’s alleged misrepresentations regarding the safety of their EUAs have led to continuous and even daily coercion, propaganda, and advertisements aimed directly at those children.”

The appeal cites several examples. For instance, “Appellant Deborah Else attests to enduring vaccine propaganda from school administrators and pediatricians aimed directly at her children.”

And Sacha Dietrich declared under oath “that her children experience constant harassment from directives and pressure to receive the COVID-19 biologic from the media and other children.”

Else and Dietrich, who are Texas residents, also face an additional threat. According to the appeal, “state law and policy puts their children in imminent risk of being injected with FDA’s vaccine against their parents’ wishes.”

According to the appeal: “This is due to the fact that under certain circumstances the applicable provisions of the Texas Family Code expressly provide that any number of persons (and even non-persons) other than a child’s parents may indeed provide consent to be injected with the EUAs at issue.”

“Such non-parental persons and entities include but are not limited to a child’s guardian, a non-parental family member, a stepparent, any adult in actual care of the child, and even an educational institution or a court of law,” the appeal notes.

Regarding the threat Texas parents face, Ray Flores, senior counsel to CHD, told The Defender:

“It appears the district court wrongly dismissed the first amended complaint since plaintiffs alleged more than a speculative threat of harm from vaccination by a non-parent.

“Minors’ consent to vaccination is one of CHD’s gravest areas of concern. Texas law provides insufficient safeguards to prevent vaccination without parental knowledge or consent.”

Flores said several Texas counties only require a “consenting adult” to provide permission for vaccination. He told The Defender:

“Waco County’s consent form requires only the signature of a ‘consenting adult.’ This is not inconsistent with Texas state law that allows for relatives, educational institutions, courts and peace officers to consent when a parent cannot be contacted.

“Each county within the Western District of Texas has a COVID-19 vaccine consent form that must be completed for a child’s receipt of a COVID-19 vaccine. However, for minors, there is no provision on the form that assures that the adult consenting for the minor is indeed the child’s parent or legal guardian, or even one of the individuals authorized under Texas statutes to consent.”

According to the appeal, “Appellants’ children have repeatedly and continually faced the unrelenting and looming threat of being pushed out of society as the culture of mass vaccination and medical mandates, now directed at children as young as 6 months, continues as a result of FDA’s issuance of EUAs that violate the APA.”

“The Administrative Procedures Act protects the public from arbitrary and capricious executive branch action by requiring an agency ‘to engage in reasoned decision making,’” Anderson told The Defender.

She argued this was not the case when the FDA granted EUAs for the administration of the COVID-19 vaccines to children:

“FDA’s granting of these EUAs for children violated the APA because in doing so, the FDA abused its power under the emergency use statute as no emergency existed for children, redefined the term ‘vaccine’ to encompass these new COVID-19 biologics in violation of procedural due process and marketing them as such, failed to articulate any standard for assessing the safety, efficacy, and necessity of the biologics, and failed to examine relevant data such as inadequacies in the clinical trials, copious evidence adverse events, effectiveness of alternative treatments, and lack of efficacy.”

“The FDA has failed to engage in a pluralistic, critical, open, transparent and scientific dialogue with the public based on careful, deliberative evaluation of all relevant research and experience,” Flores said. “On the contrary, it recklessly rushed these shots without proper evaluation in violation of the APA.”

In addition to the APA violations alleged in the lawsuit, the appeal states that the appellants suffered other injuries, including “their inability to rely on FDA marketing any longer; resultant health uncertainty for their children; risk of involuntary childhood injection of dangerous biologics; and enormous costs to CHD to correct FDA’s misinformation.”

As a result, the appeal argues that the lower court’s order of dismissal was erroneous and must be vacated.

“Amidst unprecedented governmental mandates, global shutdowns and unleashing of worldwide vaccination campaigns by central authorities, one would be hard pressed to present issues of more sweeping importance before this court, than the ones offered by this appeal,” the appeal states.