Suing the Bads

Speaking with truth and integrity is different than saying something that is technically correct.

I have been looking into the structural legal changes that have happened, over the course of many decades, that have allowed for the situation we are currently in.

I have seen lawsuits happening, ostensibly for the purpose of holding accountable, those responsible for the devastating and deadly products and measures that were used to “combat” a supposed “pandemic”.

If you are reading this, then you are likely aware that these products were brought to market in a way that drastically departed from traditional methods. Additionally, you are likely aware that these products are not safe or effective. Yet they remain on the market, and are recommended by our regulatory agencies.

This evidence is easily observed, and exquisitely infuriating. I certainly would like to see these suits bring justice for the biologic weapons and measures that have been deployed to the innocent people of the world. For example when I see that the State of Texas is suing Pfizer, I want feel excited over the prospect of justice for the victims, and for all of us. I want to be optimistic that there will be accountability and punishment for the perpetrators.

Unfortunately, the “perpetrators” are not an entity available to receive blame, no matter how hard we want to blame them. The “perpetrators” operated under a legal shield that allowed them to deploy deadly countermeasures within the framework of the law.

THIS MUST BE UNDERSTOOD IF WE ARE TO MAKE ANY PROGRESS.

After careful consideration, it is my opinion that these lawsuits are at best, misguided. Considering the intricate legal web, they are more likely a distraction, in an effort to continue an ongoing “demonstration”.

A “demonstration” that began with a “public health emergency”, that wasn’t.

And a “pandemic” that qualified as no such thing, based on manipulated data and augmented information.

It continued on, with a public assumption that standard clinical trials happened, though a “demonstration” was always what was underway.

The rollout of the countermeasures furthered the “demonstration”; using the media, fear, and manipulative “mandates”, that were ultimately classified as a choice to elicit participation.

In my opinion, the current continuation of this “demonstration” is an effort quell the growing concern and/or rightful outrage from the public at large. I believe that any lawsuit attempting to hold accountable for wrongdoing, Pfizer, Moderna, Johnson & Johnson, or any entity or person involved in countermeasure deployment, is frivolous and directly calling attention away from the root problem. In fact, they addressed this very situation in the SPARS tabletop exercise.

In the following post, I am attempting to reduce this abundant legal “sauce” down to the very basics. The blocked quotes, are directly pasted from government sites, and linked for your reference. I have tried to interpret the legalese and make it more understandable. This is a cursory outline to familiarize those who might be interested, with some of the big bones of the structure that has allowed for this assault. There is much more that I haven’t covered. Please see the work of Katherine Watt and Sasha Latypova for a comprehensive explanation.

I’ve outlined → my synopses, to hopefully make it easily scanned. The supporting documentation follows each of my outlined sections.

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→I’ll begin here, just to be very clear that there is well articulated and documented intent….

Medical Countermeasures: From the Bench to the Bloodstream

HHS Workshop MCM Dispensing, EUA and the Postal Model

“EUA has a broader use beyond enabling the use of an unapproved product or extending the use of an approved product to populations for which it was not approved. In particular, it can also be used to address labeling requirements and other challenges that arise because of constraints inherent in a public health response.” ‘From a legal perspective, there are a lot of situations where EUA helps get past all those requirements,’ said [Susan E. Sherman, J.D., M.S., a senior attorney with the Office of the General Counsel, HHS] ‘You can change the labeling. You can change the information. You can change the dosage. You can give it to populations for which wasn’t approved.’ ”

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→The PREP Act was passed in the wake of 9/11.

→A PREP Act Declaration (Public Health Emergency) is declared/issued by the Secretary of the Dept of Health & Human Services (HHS).

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The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:

• of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions

• determined by the Secretary to constitute a present, or credible risk of a future public health emergency

• to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures

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→The purpose of issuing a PREP Act declaration (Public Health Emergency) is SPECIFICALLY to provide immunity from liability for claims relating to countermeasures.

→The Secretary of HHS may declare that Emergency Use Authorization (EUA) is appropriate. Under EUA, the FDA may then authorize unapproved medical products or unapproved uses of approved medical products, as we saw in the previous section.

→Additionally, authorization of medical products for use in emergencies will not be considered to constitute clinical investigation.

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About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Under Section 564 of the FD&C Act, the Commissioner of the Food and Drug Administration (FDA), acting under delegated authority from the Secretary of HHS, may issue an Emergency Use Authorization (EUA) authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product. (source)

21 USC 360bbb-3 Authorization for medical products for use in emergencies

…21 USC 360bbb-3(k) Relation to other provisions

If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

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→Under EUA, the FDA may also facilitate the use of Medical Countermeasures (MCMs).

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About MCMs

Medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease.

MCMs  can be used to diagnose, prevent, protect from, or treat conditions associated with  chemical, biological, radiological, or nuclear (CBRN) threats, or emerging infectious diseases.

MCMs can include:

• Biologic products, such as vaccines, blood products and antibodies

• Drugs, such as antimicrobial or antiviral drugs

• Devices, including diagnostic tests to identify threat agents, and personal protective equipment (PPE), such as gloves, respirators (certain face masks), and ventilators

Covered Countermeasures are:

(a) Any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured.

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→Other Transactions Authority (OTA) is a means by which the federal government is able to further sidestep regulation and oversight, particularly as it relates to spending. It is similar to a blank check, with very little explanation required.

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What is an Other Transactions Authority?

An Other Transactions Authority (OTA) allows for Federal Government agencies to enter into Other Transactions (OTs).

Reasons to use an OT may include a combination of the following, among others:

• Need for flexibility to negotiate terms and conditions appropriate for the specific program requiring fluid implementation;

• Nontraditional review and award management practices are needed because the science is expected to be highly evolving, with requirements for additional aims or expertise added to, or removed from, the project throughout the term of execution;

• Collaborative involvement by the NIH in the technical direction and oversight of the research, which can be akin to partnering (e.g., participation in progress reviews and decisions on future efforts or direction; government may be a voting or nonvoting member of the consortium);

• Negotiate intellectual property rights; and/or

• Participation sought by nontraditional research recipients, such as:

• Patient advocacy organizations, pharmaceutical companies, foreign entities, or other organizations that are typically not inclined to work with the Federal Government;

• Consortia comprised of various entities that collaborate as peers with the NIH to manage the project and share its costs;

• Nonprofit entities that have an interest in the goals of the program; or

• Individuals.

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→Under OTA, the directer of the Defense Advanced Research Projects Agency, DARPA, may carry out Prototype Projects. Prototype Projects further loosen regulatory statutes and processes. Standard government processes are sidestepped and private contractors are free to esentially do as they please.

→BTW, this is all covered by the sweeping liability shield that I’ll discuss next.

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(a)Authority.

Subject to paragraph (2), the Director of the Defense Advanced Research Projects Agency, the Secretary of a military department, or any other official designated by the Secretary of Defense may, under the authority of section 4021 of this title, carry out prototype projects that are directly relevant to enhancing the mission effectiveness of personnel of the Department of Defense or improving platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the armed forces.

Under 10 U.S.C. 2371b, most of the Federal Government acquisition statutes and regulations are not applicable, which gives the parties to the OT agreement greater freedom to negotiate and tailor these agreements more like private-sector or commercial contracts. The standard Government solicitation process need not be followed, the agreement looks more like a commercial contract, and the terms and conditions can be negotiated among the parties. Contractors will not be required to follow the Government accounting rules and will have the option to propose the use of their own systems and processes. Issues of intellectual property rights between the parties are also negotiable. (source)

What is a prototype project?

(5) The term “prototype project” includes a project that addresses— (A) a proof of concept, model, or process, including a business process; (B) reverse engineering to address obsolescence; (C) a pilot or novel application of commercial technologies for defense purposes; (D) agile development activity; (E) the creation, design, development, or demonstration of operational utility; or (F) any combination of subparagraphs (A) through (E).

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→Medical Countermeasures deployed during an emergency have broad protection, covering ANY liability, for EVERY ENTITY participating in the countermeasure deployment without geographical restriction. This coverage applies to organizers, developers, manufacturers, and distributors; including government officials, scientists, and policy makers, to doctors, nurses, and pharmacists.

→To be clear, this indemnifies the vaccine companies.

→To be even clearer, this means Pfizer, Moderna, and J & J. Oh, and Fauci, Wallensky, and the like.

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42 U.S.C. 247d–6d(a)(4), 247d–6d(b)(2)(C)

Liability protections are afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

42 U.S.C. 247d–6d(a)(4), 247d–6d(b)(2)(D)

Liability protections are afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability protections are afforded to manufacturers and distributors without regard to whether the Covered Countermeasure is used by or administered in any designated geographic area; liability protections are afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

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Soooo…. what about the lawsuits???

→Great question. Let’s review the immunity granted under the PREP Act…which is immunity for everyone, everywhere…except in the event of “willful misconduct”.

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The immunity under paragraph (1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure. (source)

Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party's exclusive remedy is an administrative remedy under section 319F–4 of the PHS Act. Through the PREP Act, Congress delegated to me the authority to strike the appropriate Federal-state balance with respect to Covered Countermeasures through PREP Act Declarations.

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→Stated several times, the SOLE EXCEPTION for this sweeping immunity exists in the event of WILLFUL MISCONDUCT.

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Here’s the wording from the Public Health Emergency government site:

Immunity from liability under the PREP Act is not available for death or serious physical injury caused by willful misconduct.  A “serious physical injury” is one that is life-threatening, or results in or requires medical or surgical intervention to preclude permanent impairment of a body function or results in permanent damage to a body structure.  Willful misconduct is misconduct that is greater than any form of recklessness or negligence.  It is defined in the PREP Act as an act or failure to act that is taken.

Thus, it is the Secretary's interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. (source)

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→Before we talk about “willful misconduct, let’s review what happened in Brook Jackson’s False Claims Act case. Brook Jackson is a whistleblower, formerly a clinical trial manager, for Pfizer. She sued Pfizer for defrauding the government under the False Claims Act. The case was dismissed. Let’s review:

“Because of pandemic-related exigencies, the agreement was not a standard federal procurement contract, but rather a ‘prototype’ agreement executed pursuant to 10 U.S.C. § 2371b[.]…

The [contract’s Statement of Work] describes a ‘large scale vaccine manufacturing demonstration’ that imposes no requirements relating to Good Clinical Practices (‘GCP’) or related FDA regulations.” (source)

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→What happened? CASE DISMISSED.

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It is therefore ORDERED that Defendants Pfizer, Inc., ICON, PLC, and Ventavia Research Group, LLC’s Motions to Dismiss [Dkt. 37; Dkt. 51; Dkt. 53] are hereby GRANTED. It is FURTHER ORDERED that Relator Brook Jackson’s presentment claim under 31 U.S.C. § 3729(a)(1)(A) and false record claim under 31 U.S.C. § 3729(a)(1)(B) are hereby DISMISSED WITH PREJUDICE. It is FURTHER ORDERED that Relator Brook Jackson’s retaliation claim under 31 U.S.C. § 3730(h) is hereby DISMISSED WITHOUT PREJUDICE. 23 The Court observes, however, that while Ms. Jackson has failed to state a claim for retaliation under the FCA, she may be able to bring her claim under another statute. The Court does not opine on the likelihood of success with respect to asserting retaliation under a different statute. ____________________________ Michael J. Truncale United States District Judge SIGNED this 31st day of March, 2023

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→SO….This case is one example of how it’s going, which is NOWHERE.

→There are others which I’m not going address here, however thus far, I have not come across a single, “OMG, THEY DID IT….WE WON…WE GOT THE BADDIES.”

→Moving on to the, SOLE EXCEPTION…“willful misconduct”.

What is willful misconduct as defined by the PREP Act?

Willful misconduct is misconduct that is greater than any form of recklessness or negligence.  It is defined in the PREP Act as an act or failure to act that is taken:

• intentionally to achieve a wrongful purpose;

• knowingly without legal or factual justification; and

• in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. 

  All three of these conditions must be proven with clear and convincing evidence.  Willful misconduct cannot be found against:

  • A manufacturer or distributor for actions regulated by HHS under the Public Health Service Act or the Federal Food, Drug and Cosmetic Act, if HHS chooses not to take an enforcement action against the manufacturer or distributor, or if HHS terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty; or

  • A program planner or qualified person who acts in accordance with applicable directions, guidelines, or recommendations issued by the HHS regarding administration and use of a countermeasure as long as HHS or the  State or local health authority is notified about the serious injury or death within seven days of its discovery.

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→Did you read that??? Not only do ALL THREE of the listed conditions have to be met to constitute “willful misconduct”; but HHS also has to CHOOSE to take enforcement action. AND if someone is following HHS directions, guidelines, or recommendations and something bad happens? As long as they report it, it’s not willful misconduct.

→Also, there’s this…just in case you were thinking that maybe something could be done retroactively. Nope.

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Even once vaccines, tests, and treatments move away from being distributed under a USG agreement as they transition to traditional pathways for procurement, distribution, and payment, PREP Act coverage will not automatically terminate in all instances. Rather, the duration of PREP Act coverage for COVID-19 countermeasures will be determined by the terms of the PREP Act declaration in place at the time.

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→By the way…the PREP Act declaration is still in effect as I write this, even though we’ve been inundated with headlines declaring that the “pandemic” is over.

→So all the cancer and all the dying…doesn’t matter. That’s covered too….by immunity from any liability.

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PREP Act - COVID-19 Related Information

On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.

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I would wager that anyone reading this right now would agree that actions and participation by many involved in the Covid Countermeasures should absolutely constitute willful misconduct. It feels like they should. However, nobody was hired to develop a medical product that was tested and proven to be safe and effective. A large scale Vaccine Manufacturing Demonstration was ordered. And that’s what was delivered.

Specifically not ordered, were clinical trials and manufacturing controls.

So, if Pfizer was hired for a “demonstration”, that would not constitute a clinical trial, with no requirement for safety or efficacy…and they delivered that; how could that possibly meet the requirements for willful misconduct?

And those organizing, managing, and delivering exactly what was ordered? Also not willfully misconducting anything. They delivered what was ordered.

It’s not pretty, and it’s not what I want either. But continuing to waste energy on suing the symptoms of the problem is getting us exactly nowhere.

And as long as the population at large has NO IDEA about any of this, and the people with the big platforms remain silent, nothing will change.

The first step is understanding what happened, and it’s complicated. WAY more complicated than Pfizer Bad, hang Fauci.

Promises to “prosecute those who broke the law”, from attorneys who are certainly aware of this legal predicament, should be met with much scrutiny.

The student body president running his campaign on Coca Cola in all the water fountains didn’t work out in grade school, but it sure as hell got him elected.

Coca Cola in the water fountains never happens. And it’s not going to start now.

Speaking with truth and integrity is different than saying something that is technically correct. Promising to hold accountable those who broke the law may be technically correct, but it is not speaking with truthful integrity.

Truthful integrity would sound like this:

Our government has employed a long planned, and systematically organized structure, allowing terribly tragic biological weapons, called countermeasures, to be deployed upon the citizens of our country, and the world. Although heinous and difficult to imagine, our government, along with the associated agencies, companies, departments, and people were able to do all of this within the framework of the law.

Here is Yeadon's Presentation to the UK