FDA approval moots terminated firefighters’ claims, assistant AG says

THE U.S. Food and Drug Administration’s approval of the Pfizer-BioNTech Covid-19 vaccine or Comirnaty impacts the plaintiffs’ constitutional procedural due process arguments, according to Assistant Attorney General Keith Chambers II.

He represents the Department of Fire and Emergency Medical Services and its commissioner, Dennis Mendiola who were sued by nine former firefighters.

The plaintiffs were terminated for insubordination for their refusal to take the Covid-19 vaccine as required by CNMI Governor’s Directive 2021-002.

In their lawsuit, the plaintiffs said the Commonwealth violated their procedural due process rights under the CNMI and U.S. Constitutions by mandating vaccination for Covid-19 as a condition for employment.

But Chamber said, “Comirnaty administration is not subject to Emergency Use Authorization or EUA rules.”

Therefore, 21 U.S.C. § 360bbb–3(e)(1)(A)(ii)(III) no longer requires adult patients receiving the Pfizer-BioNTech Covid-19 vaccine to be told that they have the “option to accept or refuse” vaccination, Chambers added.

He said, “The alleged legal impediment that allegedly prevented the Governor from mandating the Pfizer-BioNTech Covid-19 vaccine is now gone with respect to plaintiffs.”

“Pursuant to plaintiffs’ arguments,” he added, “plaintiffs can now be compelled to receive the Pfizer-BioNTech Covid-19 vaccine without having their procedural due process rights under the Commonwealth and the United States Constitutions being violated.”

Chambers said the plaintiffs “must effectively concede that they can no longer 1) rely on their procedural due process arguments to support their preliminary injunction or 2) rely on their procedural due process arguments to support their request for injunctive and declaratory relief on the merits.”

He said it is “of no consequence that the FDA’s approval of Comirnaty happened after plaintiffs filed their First Amended Complaint and motion for a preliminary injunction.”

The vaccine under the EUA and the FDA-approved Comirnaty has “the same formulation and can be used interchangeably to provide the Covid-19 vaccination series without presenting any safety or effectiveness concerns,” Chambers said.

“This means that the vaccine that was administered under the EUA is the exact same one that was given FDA approval and renamed Comirnaty. Therefore, the change in FDA approval does have an impact because it moots plaintiffs’ due process claims that are rooted in their arguments that the EUA required an option to accept or reject the vaccine,” he added.

“Now that the Pfizer-BioNTech Covid-19 vaccine is FDA approved for people in plaintiffs’ age range, the vaccine is no different than the other approved vaccines that have a longstanding tradition of being mandated across the country to combat measles, mumps, rubella, etc.”

As such, Chambers said, there are no “understandings that are recognized and permitted by society that would prevent the governor’s mandate with respect to plaintiffs.”

Chambers said the FDA’s recent approval of the Comirnaty shows that the vaccine is sufficiently safe for people in plaintiffs’ age range.

“Though plaintiffs may have their own personal beliefs regarding Comirnaty, the court is charged with weighing the reasonableness of plaintiffs’ beliefs. The court should now find in the wake of the Comirnaty’s approval that any fears plaintiffs had about the safety of the vaccine are unreasonable,” Chambers added.

In their lawsuit, the nine terminated firefighters are asking the Superior Court to declare their terminations invalid and unlawful, and to set their terminations aside.

The plaintiffs also want the court to issue an injunctive relief, reinstating them as firefighters, with back pay and cost of the suit.

Represented by attorney Joseph Horey, the plaintiffs are Paul Acebedo, Jose K. Angui, Allen T. Calvo, Cain C. Castro, Argenon A. Flores, Derek B. Gersonde, Shawn DLR Kaipat, Philip Kalen, and Adam J. Safer.

Associate Judge Joseph N. Camacho has taken under advisement the plaintiffs’ request to be reinstated in their previous positions while a decision on their lawsuit is pending.

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