Orientation for new readers.
Notes:
I’m
sorting through my “Notes” files from the last couple of years, because
I want to stop focusing on public health emergency/emergency use
authorization/medical countermeasures/PREP Act/chemical and biological
warfare law for Bailiwick readers. New focus is still taking shape, and
has been for the last several months.
The decision to move in a new direction work-wise is partly related to my view of the legal field at this time.
If
there are private attorneys who understand the EUA-PHE-PREP Act kill
box laws and are using that knowledge to develop civil cases, I don’t
know who they are.
The
private attorneys I’ve become aware of, have briefed by video or phone
call, or corresponded with since April 2022, either don’t understand the
kill box laws, or understand them but don’t want to incorporate the
knowledge into their civil litigation plans. I’ve had initial
conversations with a half-dozen or so, and no follow-up conversations. I
can offer information to people who are looking for it and willing to
look at it. I can’t compel anyone to see something he doesn’t want to
see, or use something he doesn’t want to use.
The
public prosecutors I’ve become aware of for the last two years either
don’t understand the kill box laws, or understand them but don’t want to
incorporate the knowledge into their criminal prosecution plans.
There
may be private civil attorneys and public prosecutors who are
developing, or have already filed, civil and criminal cases that
incorporate their knowledge of the kill box laws, and I simply don’t
know about those legal teams and their work.
I hope there are. The information I’ve compiled is public and I want it to be used.
I’m
interested in seeing civil and criminal cases challenge kill box laws;
seeing the kill box laws nullified and repealed; seeing the killing
programs come to an end; and someday seeing some of the responsible
lawmakers held accountable for the ongoing public-health-military
murder-and-sterilization programs their willed acts enabled to begin,
and their willed omissions now continue to authorize and fund. If asked
in the future to support credible legal teams and provide information
from my base of knowledge and my document collection to help bring those
events about, I will.
In
the process of shifting my attention and preparing for new work, I’ve
been sorting through notes files, and found one about the differences
between the zero scientific evidence required for EUA countermeasures
deployment into human targets, and the high standards of evidence
required for victims of EUA countermeasures injury and death to obtain
financial compensation under the Countermeasures Injury Compensation
Program (established in 2005 through the PREP Act and modeled on the
Vaccine Injury Compensation Program set up in 1986), and also for
victims of military toxic exposures to obtain financial compensation
under the PACT Act (Promise to Address Comprehensive Toxics Act, 2022).
Some relevant sections of the three laws below.
Emergency use authorization/EUA
21 USC 360bbb-3(c), Criteria for issuance of authorization.
The
Secretary [of Health and Human Services] may issue an authorization
under this section with respect to the emergency use of a product only
if, after consultation with the Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health, and the
Director of the Centers for Disease Control and Prevention (to the
extent feasible and appropriate given the applicable circumstances
described in subsection (b)(1)), the Secretary concludes—
(1)
that an agent referred to in a declaration under subsection (b) can
cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or preventing—
(i) such disease or condition; or
(ii)
a serious or life-threatening disease or condition caused by a product
authorized under this section, approved or cleared under this chapter,
or licensed under section 351 of the Public Health Service Act [42
U.S.C. 262], for diagnosing, treating, or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks
of the product, taking into consideration the material threat posed by
the agent or agents identified in a declaration under subsection
(b)(1)(D), if applicable;
(3)
that there is no adequate, approved, and available alternative to the
product for diagnosing, preventing, or treating such disease or
condition...
No standards of evidence, data collection or analysis specified, required or enforceable.
Data,
evidentiary and decisional review (judicial, state/local/tribal,
Congressional) preempted under 42 USC 247d-6d(b)(7); 42 USC
247d-6d(b)(8); 42 USC 247d-6d(b)(9).
Under
EUA law, “adequate and well-controlled” and all other clinical trials
are precluded; they cannot occur; no clinical trial data can become
“available.”
CICP, Countermeasures Injury Compensation Program
42 USC 247d-6e(5), Covered countermeasure injury table
(A)
In general. The [HHS] Secretary shall by regulation establish a table
identifying covered injuries that shall be presumed to be directly
caused by the administration or use of a covered countermeasure and the
time period in which the first symptom or manifestation of onset of each
such adverse effect must manifest in order for such presumption to
apply. The Secretary may only identify such covered injuries, for
purpose of inclusion on the table, where the Secretary determines, based
on compelling, reliable, valid, medical and scientific evidence that administration or use of the covered countermeasure directly caused such covered injury.
42 USC 247d-6e(4) Determination of eligibility and compensation
...In
making determinations, other than those described in paragraph (5)(A)
as to the direct causation of a covered injury as to the direct
causation of a covered injury, the Secretary may only make such
determination based on compelling, reliable, valid, medical and scientific evidence.
PACT Act - Promise to Address Comprehensive Toxics Act.
38 USC 1173(b), Evidence, data and factors
The [Veterans Administration] Secretary shall ensure that each formal evaluation under subsection (a) covers the following:
(1) Scientific evidence, based on the review of available scientific literature, including human, toxicological, animal, and methodological studies, and other factors.
(2) Claims data, based on the review of claim rate, grant rate, and service connection prevalence, and other factors.
(3) Other factors the Secretary determines appropriate, such as—
(A) the level of disability and mortality caused by the health effects related to the case of toxic exposure being evaluated;
(B) the quantity and quality of the information available and reviewed;
(C) the feasibility of and period for generating relevant information and evidence;
(D) whether such health effects are combat- or deployment-related;
(E) the ubiquity or rarity of the health effects; and
(F) any time frame during which a health effect must become manifest.
38 USC 1173(c) Conduct of evaluations
(1) The [VA] Secretary shall ensure that each formal evaluation under subsection (a)
(A) reviews scientific evidence in a manner that—
(i) conforms to principles of scientific and data integrity;
(ii) is
free from suppression or distortion of scientific or technological
findings, data, information, conclusions, or technical results...
(2) A formal evaluation [of toxic exposure injury claim] shall include reviewing all relevant data to determine the strength of evidence for a positive association based on the following four categories:
(A) The ‘sufficient’ category, where the evidence is sufficient to conclude that a positive association exists;
(B) The ‘equipoise and above’
category, where the evidence is sufficient to conclude that a positive
association is at least as likely as not, but not sufficient to conclude
that a positive association exists;
(C) The ‘below equipoise’
category, where the evidence is not sufficient to conclude that a
positive association is at least as likely as not, or is not sufficient
to make a scientifically informed judgment;
(D) The ‘against’ category, where the evidence suggests the lack of a positive association.
38 USC 1176(d), Scientific determinations concerning diseases.
For
each disease reviewed under subsection (c), the [National Academies of
Sciences, Engineering, and Medicine] shall determine, to the extent that
available scientific data permit meaningful determinations—
(1) whether an association exists between toxic exposures and the occurrence of the disease, taking into account the strength of the scientific evidence and the appropriateness of the statistical and epidemiological methods used to detect the association;
(2)
the increased risk of the disease among those reporting toxic exposures
during active military, naval, air, or space service;
(3) whether there exists a plausible biological mechanism or other evidence of a positive association between the toxic exposure and the occurrence of the disease; and
(4) determine the strength of evidence for a positive association.
The Garden of Eden with the Fall of Man. Painting by Jan Brueghel the Elder
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