PREP

Pharma’s Gatekeeper: How the PREP Act Protects Everyone Except Those Injured by Vaccines

Parents, plaintiffs, activists and even some attorneys were shocked to learn late last year that school officials would get away scot-free after a Vermont Superior Court judge ruled that a Vermont school couldn’t be held liable for vaccinating a 6-year-old student against the parent’s wishes.

In dismissing a lawsuit filed by the child’s parents against the Windham Southeast School District, the State of Vermont and others, Judge Michael Kainen cited the Public Readiness and Emergency Preparedness (PREP) Act.

The PREP Act, which authorizes the secretary of the U.S. Department of Health and Human Services (HHS) to declare that “a disease or other health condition or other threat to health constitutes a public health emergency,” grants a “covered person” immunity from legal liability for all claims for loss relating to the administration or use of covered “countermeasures,” such as drugs, biological products, medical devices and vaccines.

“A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.”

PREP provides liability protection to what is termed a “covered person”; the U.S. government; a manufacturer, a distributor, a program planner; and one who administers, or dispenses such countermeasures.

Additionally, a manufacturer or distributor can’t be the defendant unless the HHS secretary or the U.S. attorney general has initiated an enforcement action.

The liability protections for covered countermeasures in the current PREP emergency expire Oct. 1, 2024.

PREP trumps state law in most cases

In the Vermont case, the PREP Act left the parents of the 6-year-old injected with a COVID-19 vaccine at a West Brattleboro elementary school with zero recourse, even though the parents clearly indicated in advance they did not consent to their child being vaccinated, even though the child protested the injection — and even though school officials admitted they put the wrong student’s name tag on during a school-based, state-sponsored clinic.

According to the Brattleboro Reformer, School officials issued this statement:

“We are deeply sorry that this mistake happened, and have worked internally to improve our screening procedures. … The Health Department has worked to evaluate its procedures to ensure that this does not happen again.

“Thankfully, we are not aware of any harm to the student because of this mistake. We take our responsibilities to students and families very seriously, and we respect parent’s rights to make health care decisions for their children.”

According to the court, the parents’ lawsuit, filed May 13, 2022, sought:

“damages for their alleged injuries based upon the following theories: (1) violation of Vermont’s Healthcare Bill of Rights, 18 V.S.A. § 1852(a)(5); (2) gross negligence; (3) negligent undertaking; (4) premises liability; (5) battery of a minor; (6) consumer fraud; (7) common law fraud; (8) negligent infliction of emotional distress.”

However, despite these violations of the family’s state-protected rights, the court found the school is not liable — because even though the PREP Act doesn’t preclude all state law actions, it typically does override state law when the harm arises from the administration of a covered countermeasure.

In his ruling, Judge Kainen said state law may be completely preempted when “it has been by federal law — but this happens because federal law takes over all similar claims:

“Under the definition [of administration of a countermeasure], these liability claims are precluded if they allege an injury caused by a countermeasure, or if the claims are due to manufacture, delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.”

In other words, all state law protections (other than workers’ compensation) essentially disappear under the PREP Act.

The Vermont ruling is clear and short. It’s also unique and important in that it summarizes the fine line between the PREP Act and state-based negligence not involving pandemic and epidemic products and security countermeasures by providing examples around the U.S. in both state and federal courts.

In state courts, cases involving injuries that did not stem from the administration of covered countermeasures are usually successful. These involve cases, as one court put it, “garden-variety negligence” — for example, if a roof caves in, or if the ventilation (not the ventilator) malfunctioned, or if a patient or nursing home resident was not adequately protected against contracting COVID-19.

Avenues of compensation are limited, involve high hurdles

As of Jan. 27, there are 278,727 reported serious injuries and 34,122 deaths from COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS).

Not a single penny has been paid to any of those injured or to the families of the deceased.

Under the PREP Act, people injured by a COVID-19 vaccine or countermeasure can seek compensation under the Countermeasures Injury Compensation Program (CICP) — the only program available for U.S. citizens injured by a COVID-19 vaccine or countermeasure.

As of Jan. 1, CICP received 11,065 claims seeking compensation for COVID-19 vaccine and countermeasures injuries.

Of those, 496 claims were denied, 10,569 are “pending review” and 14 were determined to be eligible for compensation — but have not yet been compensated. The statutes of limitations for filing a lawsuit in other states are different than CICP’s one-year filing cutoff.

Unlike the National Childhood Vaccine Injury Act of 1986 (NCVIA), the compensation program for vaccine injuries other than COVID-19 vaccines, the CICP is an administrative procedure, which doesn’t award attorney fees — that means vaccine lawyers, in general, don’t want any part of COVID-19 vaccine injury cases.

CICP compensates, in theory at least, for serious physical injury or death, whereas NCVIA is designed to compensate for injuries with symptoms lasting for more than six months or that resulted in “inpatient hospitalization and surgery, or deaths” — which wasn’t the case with the 6-year-old child.

But what happens if the 6-year-old in Vermont develops a serious medical condition a year, three years or maybe even 10 or more years from now?

When a CICP claim is denied, or the injured person is denied a settlement, or if more than 240 days have passed since the claim was filed, the person’s last recourse, under the PREP Act, is to file a lawsuit in U.S. District Court for the District of Columbia.

For this type of lawsuit, there are heightened standards, including that the injured person must demonstrate clear and convincing evidence, the case must be brought before a three-judge panel, and willful misconduct must be clearly pled.

The PREP Act’s only exception to legal immunity is “willful misconduct that results in serious injury or death.”

Time to put limits on immunity

There must be a limit to this complete immunity. What about constitutionality, or the right to a jury trial under the Seventh Amendment?

In the Vermont case, it is another student’s name tag. But what about a doctor who force-vaccinates a child without parental consent? Or one who defrauds a child by saying he or she must get the vaccine to attend school?

The law — if applied literally, without deference to common sense — conceivably could go so far as to grant immunity to a crazed governmental official running down the street and injecting people at random with impunity.

Indeed PREP is a sentry not only for pharma, but for all those overzealous proponents and purveyors caught up in the madness.

On Jan. 24, the parents of the 6-year-old in Vermont filed an amended complaint, and on Feb. 1, the school district filed another motion to dismiss. We will keep you posted.

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