In
exchange for receiving billions of dollars in COVID relief funds,
Tennessee hospitals have a clear directive for treating COVID patients.
Tennessee hospitals must follow COVID treatment protocols declared in
the Coronavirus Disease 2019 (COVID-19) Treatment Guidelines:
"The COVID-19 Treatment Guidelines have been developed to provide
clinicians with guidance on how to care for patients with COVID-19."
The
Guidelines claim (page 21) that remdesivir (marketed as Veklury), an
antiviral agent, is the only FDA-approved drug for the treatment of
COVID-19 (for emergency use), and the document provides all instructions for administering remdesivir to hospitalized COVID patients.
Here is what we know:
- Remdesivir was stopped after kidney failures occurred in COVID
drug trials and it previously failed in trials against Ebola. (Source: Medical Buyer)
- In clinical trials and case series, adverse effects such as acute
kidney injury (AKI) and renal replacement have been linked to the use of
remdesivir. Kidney injuries, including proximal tubular epithelial cell
necrosis, have also been observed in animal studies during the drug’s
development. (Source: Planet Today News, A Final Warning)
- The World Health Organization (WHO) recommended against the use of remdesivir in COVID patients. (Source: WHO, NBC News, Forbes)
- Remdesivir costs in the range of $2,600 to $3,500 for a five- to ten-day course. (Source: ABC News, NPR)
- Approval of remdesivir for the exclusive treatment of COVID raises
red flags. Gilead Sciences’ remdesivir was cleared by the FDA for the
treatment of COVID-19. The FDA authorization occurred two days after
Gilead revealed it was aware of “positive data”
from a clinical trial of remdesivir by the US National Institute of
Allergy and Infectious Diseases (NIAID). The NIAID and the trial are
both led by Anthony Fauci.
Only
a handful of physicians and other healthcare professionals are brave
enough to speak out against the use of remdesivir on COVID patients for
fear of losing their licenses and being tried and hung in the court of
public opinion. Dr. Bryan Ardis is not afraid to share information about remdesivir. In this video, Dr. Ardis explains how hospital protocols are murdering Americans by prescribing remdesivir, which causes renal failure.
We also know:
- The Public Readiness and Emergency Preparedness (PREP) Act provides immunity from liability
(except for willful misconduct) for claims of loss caused by, arising
out of, relating to, or resulting from administration or use of countermeasures to
diseases, threats, and conditions; and to entities and individuals
involved in development, manufacture, testing, distribution, administration, and use of such countermeasures.
******Pay close attention to the wording here ... (Source: Congressional Research Service; 23 Sep 2021.)
Scope of Immunity from Liability
1.
The PREP Act defines a covered person to include (i) the United States;
(ii) manufacturers and distributors of covered countermeasures; (iii)
“program planners”; and (iv) “qualified persons” who prescribe, administer, or dispense covered countermeasures.
2. PREP Act immunity reaches “all claims for loss” under
federal and state law. Loss is broadly defined to mean “any type of
loss,” including (i) death; (ii) physical, mental, or emotional injury,
illness, disability, or condition; (iii) fear of such injury, including
medical monitoring costs; and (iv) loss of or damage to property,
including business interruption loss.
3. The loss must have a causal relationship to the administration and use of a covered countermeasure.
4.
The medical product at issue must be a covered countermeasure. The PREP
Act specifies four types of covered countermeasures: (i) a qualified
“pandemic or epidemic product”; (ii) a “security countermeasure”; (iii) a drug, biological product, or device that the U.S. Food and Drug Administration (FDA) has authorized for emergency use; and (iv) a “respiratory protective device” that is approved by the National Institute for Occupational Safety and Health (NIOSH).
A pandemic or epidemic product includes any drug, biological product, or device
developed “to diagnose, mitigate, prevent, treat, or cure a pandemic or
epidemic” or used “to limit the harm such pandemic or epidemic might
otherwise cause.” In addition, drugs, biological products, or devices
used to treat the side effects of a pandemic or epidemic product, or to
enhance their effects, may themselves be covered countermeasures. In
either case, to
be a covered countermeasure, the pandemic or epidemic product must be
approved, licensed, or authorized for emergency use by FDA.
Security
countermeasure refers to a drug, biological product, or device used “to
diagnose, mitigate, prevent, or treat harm from any biological,
chemical, radiological, or nuclear agent” identified by the Secretary of
Homeland Security as a material threat to national security.
The
emergency use category of covered countermeasures includes drugs,
biological products, and devices that FDA has authorized for use outside
its ordinary regulatory processes via an Emergency Use Authorization
(EUA). FDA has made wide use of its emergency authorities in
response to the COVID-19 pandemic, issuing EUAs for certain in vitro
diagnostic products (i.e., tests for COVID-19), antibody tests, personal
protective equipment (e.g., respirators and face shields), ventilators, therapeutic drugs, and vaccines.
Section
6005 of the Families First Coronavirus Response Act and Section 3103 of
the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
amended the PREP Act to add a fourth covered countermeasure category for
certain respiratory protective devices (such as N95 respirators). To be
covered by the PREP Act, the respiratory protective device must be (i)
approved by NIOSH under 42 C.F.R. Part 84; and (ii) determined by the
Secretary to be a priority for use during a public health emergency. FDA
issued an EUA on March 2, 2020, for the use of NIOSH-approved filtering
respirators intended for general use to protect health care personnel
against COVID-19.
The “Willful Misconduct” Exception
If
a claim is within the PREP Act’s scope, a covered person is generally
immune from legal liability. The “sole exception” to immunity is when a
covered person proximately causes death or serious physical injury to
another person through willful misconduct. A serious physical
injury must be life threatening, permanently impair a body function,
permanently damage a body structure, or require medical intervention to
avoid such permanent impairment or damage. Willful misconduct requires
that the covered person acted (i) intentionally to achieve a wrongful
purpose; (ii) knowingly without legal or factual justification; and
(iii) 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.
In
other words, remdesivir (Veklury) is the ONLY drug FDA approved under
an EUA for the treatment of COVID-19. Use of remdesivir and ventilators
are covered countermeasures under the PREP Act, which provides liability
immunity to all doctors and hospitals that prescribe, administer, or
dispense these two countermeasures.
Not
only are hospitals making money off COVID diagnoses of patients, but
hospitals also make money off the use of ventilators and remdesivir, AND
hospitals are immune from all liability if they use these covered
countermeasures.
This
is why hospitals tell patients and families remdesivir and ventilators
are the ONLY treatment protocols they have for COVID-19. No other
"off-label" treatments, despite their effectiveness and safety, pay
dividends for every patient. No other treatments offer immunity from
liability in case of injury or death.
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