COVID-19 injectable bioweapons as case study in legalized, government-operated domestic bioterrorism.
Or: why there won’t be any civil suits, or compensatory damages for injured victims or survivors of dead victims.
Posted June 9, 2022. Last updated June 24, 2022.
This is a reworking of information posted previously, including at the bottom of the American Domestic Bioterrorism Programpost.
Since first realizing the implications of the many Congressional statutes and Health and Human Services regulations adopted to create and operate the bioterrorism program, mostly between 1997 and the present, I’ve been intermittently finding the specific citations for each statement while researching related issues.
Some statements are simply logical deductions from the first premise, corroborated by the observable actions and inactions of Food and Drug Administration officials as the observable injuries and deaths mount up in the American people.
Others are specifically written into the laws, but I don’t yet have the citations because I’ve prioritized my research time investigating other issues related to the bioterrorism program.
I’m posting the information as I understand it today, despite those limitations, in case it’s useful for readers who also follow FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) reporting by Toby Rogers, Igor Chudov, Steve Kirsch, Jessica Rose, and others.
They continue to rightly raise public awareness and alarm about FDA’s ongoing failure to protect the public from the Emergency Use Authorized (EUA) products.
But they don’t address the main reason whyFDA is acting as it is.
FDA is not pulling the EUA products from the market or stopping the ‘vaccination’ campaign because Health and Human Services Secretary Xavier Becerra and FDA Commissioner Robert Califf are running the US government’s bioterrorism program jointly with Defense Secretary Lloyd Austin, Department of Justice Attorney General Merrick Garland, Department of Homeland Security Secretary Alejandro Majorkas, Pfizer CEO Albert Bourla, Moderna CEO Stephane Bancel, and World Health Organization Director-General Tedros Adhanom Ghebreyesus.
Main Premise
Use of EUA-covered medical countermeasure (MCM) products including masks, PCR tests, mRNA and DNA injections, and other drugs, devices and biologics, 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.
This is true no matter how untested, unmonitored, unsafe, or ineffective they are, no matter whether their harmfulness to human health and uselessness for infection-control are known before use, or discovered afterward.
Legal implications derived from the main premise:
There is no stopping condition.
EUA products are exempt from laws regulating researcher use of investigational, experimental drugs, devices and biologics on human beings.
EUA products are exempt from laws regulating physician use of approved drugs, devices and biologics as medical treatments for patients.
There are no manufacturers of experimental products (EUA products are not part of any clinical investigation, and therefore not experimental.)
There are no government or private contracts for purchase of experimental products; there are only contracts for ‘large scale vaccine manufacturing demonstrations.’
There is no act of administration of any experimental products.
There are no nurses or pharmacists administering experimental products.
There are no human subjects (of experiments) or patients (of physicians providing treatment) receiving experimental products: no victims.
There is no party responsible for the wellbeing of recipients after administration of EUA products.
There is no treatment group and no control group.
Human beings administering EUA products have no informed consent obligations to provide information about ingredients, risks, benefits, alternatives, or the option to accept or refuse the products. See 21 USC 360bbb-3(e)(1)(A)(ii)) waiving informed consent for unapproved products (2004); 21 USC 360bbb-3(e)(2)(A) waiving informed consent for unapproved use of an approved product (2004); 21 USC 355(i)(4) waiving informed consent for experimental products classified by HHS as ‘minimal risk’ drugs (2016); 21 USC 360j(g)(3) waiving informed consent for experimental ‘minimal risk’ devices (2016).
Human beings receiving EUA products have no informed consent rights to receive information about ingredients, risks, benefits, alternatives, or the option to accept or refuse the products. See citations, bullet point above.
There are no Institutional Review Boards supervising administration of the experimental products.
There are no safety standards for EUA products.
There are no efficacy standard for EUA products. See 21 USC 360bbb-3(c)(2)(A), 1997, 2004, re: ‘may be effective’
There are no clinical investigators studying the effects of EUA products on human subjects.
There are no doctors, nurses, or other treatment providers providing experimental treatment to their patients subject to the Hippocratic Oath (“first do no harm”) using EUA products.
There is no coordinated, public, federal government monitoring of recipients after receiving the products for adverse effects and deaths.
There is no coordinated, public, federal government data collection or analysis.
There is no legal requirement for medical supervision during product administration.
There is no legal requirement for recipient monitoring after product administration.
‘Real world evidence’ — mass administration of products to general public, followed by collection of private/proprietary information about the effects, from health insurance systems, government databases (Medicare, Medicaid, Defense Medical Epidemiology Database, Veterans Health Administration) and other private databases — is authorized for the purposes of FDA regulatory decisions. See 21 USC 355g. 2016.
There is no requirement for individual prescriptions to be written prior to dispensing EUA products, and products dispensed without prescriptions “shall not be deemed adulterated or misbranded.” See 21 USC 360bbb-3a(d). 2013.
Manufacturers, as contractors, are considered HHS employees for purposes of legal immunity under Federal Tort Claims Act. See 42 USC 247d-6a(d)(2)(A).
DOD is authorized to contract with pharmaceutical corporations to conduct ‘prototype’ experiments on the general public, and under such contracts, is exempt from legal obligation to comply with Good Clinical Practices or other FDA regulations. See 10 USC 2371b (2015), renumbered 10 USC 4022 (Jan. 1, 2021, effective Jan. 1, 2022)
One of the factors to be considered by HHS secretary in making determinations about EUA products (qualified security countermeasures) and use of Special Reserve Fund/Strategic National Stockpile appropriations to procure them is "whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure." See 42 USC 247d-6b (c)(5)(B)(iii)
There are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices. EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.” See 21 USC 360bbb-3a(c). 2013.
There are no labeling requirements regarding the contents or ingredients in EUA products. 21 USC 360bbb-3(e)(2)(B)(ii). 2004.
There is no limitation of administration of EUA products past their expiration dates.
There cannot be clinical trial fraud, because there are no clinical investigations, no investigational drugs, no investigators and no human subjects.
There are no marketing standards.
There cannot be consumer fraud, because the only legal parties to the financial transactions are the US government (DOD) as buyer; the US government (HHS) as regulator authorizing exemptions from consumer protection laws that otherwise apply to medical products; and the pharmaceutical corporations as sellers, contracted to develop and manufacture the products. There are no commercial pharmaceutical products, no commercial marketplace, and no commercial market consumers.
There is no access to courts for judicial review of the facts or law relating to HHS Secretary declarations of EUA products, which are committed to agency discretion. See 42 USC 247d-6d(b)(7). 2005.
There is no access for plaintiffs, to civil courts for judicial review, and no entity to whom civil liability can attach, for injuries and deaths caused by declared covered countermeasures, unless and until FDA/HHS and/or Attorney General/DOJ file enforcement action against manufacturers and prove willful misconduct proximate to injury or death, but HHS and DOJ have operated the EUA product program together with the manufacturers since inception, and will not prosecute their co-conspirators. See 42 USC 247d-6d. 2005.
Even if there were access to courts for judicial review, and a fact-finder found evidence of harms caused by administration of products to recipients, and even evidence that those who caused the harms, by developing, manufacturing, distributing and/or administering the EUA products, knew the EUA products were toxic and knew their own actions were harmful, “just following orders” is an authorized, legal defense. See 42 USC 247d-6d(c)(4). 2005.
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