Outline for writing today. Synopsis of proposed Jackson v. Pfizer argument

Clinical trial documents are just props in a theatrical production; clinical investigators are fooled performers and in the fooled audience; playwright and director is DOD.

I sent the following to attorney-warrior Warner Mendenhall, whistleblower-warrior Brook Jackson and a couple of others this morning by email.

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I've been working on a draft response for Brook's case for the last few days. I understand […] that the [Robert] Barnes' team's theory of the case is leading the team to focus on [a different legal strategy]. I don't think that's a fruitful direction to go, and am providing these alternative arguments in case they turn out to be useful to Brook's case or future cases.

Attached is the current very rough draft. Yesterday I wrote what became the footnotes in the section about statutory and executive order history. Most of the rest of the draft is different versions and sections of argument, plus a draft affidavit for Francis Boyle.

Today I'm working on the procedural history and argument analysis sections. Outline below and draft attached.

I'm unlikely to get it finished today, but wanted to send the outline in case it's useful as you think through your plans for responding to US Government.

The key is the difference between the sponsor clinical trial/FDA regulatory framework and EUA frameworks which are explicitly not clinical-trial based.

I wrote about it in the spring as I began to understand the implications of 21 USC 360bbb-3(k): "the use of such [EUA] product within the scope of the [EUA] authorization shall not be considered to constitute a clinical investigation."

• June 9, 2022 - COVID-19 injectable bioweapons as case study in legalized, government-operated domestic bioterrorism

Everything I've found in my legal research since then has confirmed those initial conclusions.

Best wishes to you both and if I can help in any way as you prepare Brook's response for filing tomorrow, please let me know.

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PROCEDURAL HISTORY/ARGUMENT SYNOPSES-

Outline: 

A. July 2020 contract key points (as cited by Pfizer and Gov in Motion to Dismiss and statement of interest) Base Agreement. Technical Letter.

B. Sept. 2020 - What Brook witnessed at Ventavia and how she reported to Ventavia, Pfizer and FDA, resulting in firing.

C. Jan. 2021 - Brook's False Claims Act case -

1. Explanation of 1982 False Claims Act law, qui tam, ex rel.

2. Explanation of provision 31 USC 3730(e)(2), which states that if the evidence trail leads to members of Congress, members of judiciary or senior executive branch officials, "no court shall have jurisdiction."  Also (e)(1), once evidence trail leads to members of armed forces, "no court shall have jurisdiction." Congress and Presidents (through statutes) preemptively stripped federal judiciary of all oversight and review power, to pre-cover-up Congressional and executive crimes. Congress and President above the law. Judicial branch immaterial, as long as judges go along with the destruction of Constitutional separation of powers and usurpation of judicial power by Congress and presidents. 
   

D. Jan. 2021 - Brook's complaint overview 

1. Her FCA argument was based on her (erroneous) understanding that she was involved in a clinical trial subject to CFR regulations and terms of 21 CFR 50, 21 CFR 56, 21 CFR 312, and FDA-1571, FDA-1572 and Institutional Review Board reporting. Such that Ventavia's failure to comply with the protocols and Pfizer's failure to ensure compliance were fraud as the results were conveyed to FDA and DOD. 

2. By law [the illegitimate laws set up to enable mass murder under public health pretext], the activities at Ventavia and all the other sites were not "clinical investigations," because under 21 USC 360bbb-3(k), use of EUA-covered medical countermeasure (MCM) products, once designated as such by the Secretary of Health and Human Services (March 10, 2020, retroactive to February 4, 2020) “shall not be considered to constitute a clinical investigation.” 21 USC 360bbb-3(k). EUA law, adopted 1997 and amended 2003, 2004, 2005, 2013, 2017.  “(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].” 

3. Unbeknownst to the investigators and subjects, the clinical trial documents were scripts and props for a show with no legal or regulatory significance. And the people were merely actors playing roles, children 'driving' a Home Depot shopping cart.  

4. Those legal facts were known to Pfizer executives who signed the July 2020 contracts, and also known to DOD/ATI and HHS officials signing those contracts, and FDA officials playing their role by pretend-"authorizing" the products.  

5. Those facts were not known to the audience for the performance — the investigators, subjects and world public who were told that these were authentic clinical investigations and that the results were showing the products to be "safe and effective."  

6. The fraud was not committed by Pfizer against US Government. The fraud was committed by Pfizer and US Government against Brook Jackson and all the other investigators and subjects who were falsely led to believe they were part of a clinical trial that was really happening when in fact they were not, because there was no clinical trial. And fraud by Pfizer and US Government against entire world, falsely led to believe valid clinical trials were happening.

E. Jan. 2021-Jan. 2022 - abortive AG/DOJ investigation 

F. Jan. 2022 - DOJ declines  

G. Feb. 2022 - Brook files amended complaint 

H. April 2022 - Pfizer Motion to Dismiss on basis of DOD OTA prototype for large scale manufacturing demo and DOD control of ultimate FDA decisions, with FDA clinical trial regulatory frame irrelevant and immaterial, and clinical trial results not causally related to FDA decision. 

I. Aug. 2022 - Brook opposition to motion to dismiss - goes back to False Claims Act, FDA regulatory, clinical trial fraud frame. 

J. Sept. 2022 - Pfizer Reply in further support MtD - goes back to OTA again - clinical trials as related to FDA regulation both immaterial to DOD purchasing contract with Pfizer. 

K. Oct. 2022 - US Gov. statement of interest: Concurs with Pfizer, FDA regulatory framework irrelevant and immaterial. Only terms with legal causality and materiality were DOD control of fraudulent FDA authorization process, as per OTA prototype manufacturing demonstration contracts.

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Ron Suskind Oct. 17, 2004 New York Times report "Faith, Certainty and the Presidency of George W. Bush", citing an unnamed George W. Bush administration official:

The aide said that guys like me were 'in what we call the reality-based community,' which he defined as people who 'believe that solutions emerge from your judicious study of discernible reality.' [...]

'That's not the way the world really works anymore,' he continued.

'We're an empire now, and when we act, we create our own reality. And while you're studying that reality — judiciously, as you will — we'll act again, creating other new realities, which you can study too, and that's how things will sort out.

We're history's actors...and you, all of you, will be left to just study what we do'.

The quote is often attributed to Karl Rove, but Suskind has not confirmed.

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Madonna of the Book. Painting by Sandro Botticelli.