"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 bo…
"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:
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." https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx#immune3
Essentially, HHS can stop actions for willful misconduct if it "terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty" so it's really airtight - essentially there will be no recourse in law for people injured or killed by the "vaccines". At some point, perhaps in the case of popular uprising, they may wish that they had held out some avenues for legal redress, but that's not the case now.
Thank you very much for this comprehensive comment. Much to think about and I am greatful to you. Some questions. Are all aspects of distribution and instances of marketing toward vax implementation shielded? Is there a process or activity down line from manufacturing that is not covered? In the same vein, I’m wondering if the HHS has unlimited power to block redress of willful harms it has itself directed or follow from its violation of the 10th amendment? So the Fed lost recently when it usurped state powers regarding mandates —can the Fed shield a vax maker in an area where it has no business interfering? I believe Pharma executives are on the record for misinformation (sorry to use the term) and what might be called terrorizing advocacy. Is it possible that Pharma has shot its mouth off regarding matters beyond manufacturing and in collusion w the feds — to have created other zones of legal jeopardy? Finally, are we signatories to any treaties around human rights that supersede this Prep Act?
As to your first and second questions, I'm pretty sure they are - the vaccines could be contaminated by accident, or lack of monitoring of processing (negligence), or just a devil-may-care attitude (recklessness). If they were to knowingly contaminate the vaccines with poison, fully knowing the effects, and this could be proven with clear and convincing evidence, and HHS chose to follow up with real enforcement - in that agency's sole and absolute discretion - then something might happen. It does appear to have the power to block such redress, as the PREP Act was passed by Congress and signed into law, and that enlarges the scope of the powers delegated to that agency.
As to your 10th Amendment example, this does not be an example of commandeering, as set out in Printz. Of course, the existence of HHS and most of the rest of the Administrative State falls outside of the ambit of the 10th Amendment, see https://scholarship.law.nd.edu/cgi/viewcontent.cgi?article=1243&context=ndlr - at least in my mostly Antifederalist opinion. Advocates of Double Government, specifically the National Security State, might view the matter differently - https://fletcher.tufts.edu/sites/default/files/pubs_glennon-michael-national-security-double-government.pdf I think most of our present trouble lies in the existence of this Double Government. As to pharma advertising, that's covered by the First Amendment under the doctrine of corporate personhood, which could be remedied by legislative action, to reversion to status quo ante, see https://reclaimdemocracy.org/corporate-accountability-history-corporations-us/ Since these corporations effectively own the government(s) - and a consortium of corporations are trying to do the same for global governance via "stakeholder capitalism", "public-private patrnerships", and other such flotsam and jetsam floated by Klaus Schwab and his World Economic Forum - some changes which would strike at the root of this would have to occur...
"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:
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." https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx#immune3
Essentially, HHS can stop actions for willful misconduct if it "terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty" so it's really airtight - essentially there will be no recourse in law for people injured or killed by the "vaccines". At some point, perhaps in the case of popular uprising, they may wish that they had held out some avenues for legal redress, but that's not the case now.
Thank you very much for this comprehensive comment. Much to think about and I am greatful to you. Some questions. Are all aspects of distribution and instances of marketing toward vax implementation shielded? Is there a process or activity down line from manufacturing that is not covered? In the same vein, I’m wondering if the HHS has unlimited power to block redress of willful harms it has itself directed or follow from its violation of the 10th amendment? So the Fed lost recently when it usurped state powers regarding mandates —can the Fed shield a vax maker in an area where it has no business interfering? I believe Pharma executives are on the record for misinformation (sorry to use the term) and what might be called terrorizing advocacy. Is it possible that Pharma has shot its mouth off regarding matters beyond manufacturing and in collusion w the feds — to have created other zones of legal jeopardy? Finally, are we signatories to any treaties around human rights that supersede this Prep Act?
As to your first and second questions, I'm pretty sure they are - the vaccines could be contaminated by accident, or lack of monitoring of processing (negligence), or just a devil-may-care attitude (recklessness). If they were to knowingly contaminate the vaccines with poison, fully knowing the effects, and this could be proven with clear and convincing evidence, and HHS chose to follow up with real enforcement - in that agency's sole and absolute discretion - then something might happen. It does appear to have the power to block such redress, as the PREP Act was passed by Congress and signed into law, and that enlarges the scope of the powers delegated to that agency.
As to your 10th Amendment example, this does not be an example of commandeering, as set out in Printz. Of course, the existence of HHS and most of the rest of the Administrative State falls outside of the ambit of the 10th Amendment, see https://scholarship.law.nd.edu/cgi/viewcontent.cgi?article=1243&context=ndlr - at least in my mostly Antifederalist opinion. Advocates of Double Government, specifically the National Security State, might view the matter differently - https://fletcher.tufts.edu/sites/default/files/pubs_glennon-michael-national-security-double-government.pdf I think most of our present trouble lies in the existence of this Double Government. As to pharma advertising, that's covered by the First Amendment under the doctrine of corporate personhood, which could be remedied by legislative action, to reversion to status quo ante, see https://reclaimdemocracy.org/corporate-accountability-history-corporations-us/ Since these corporations effectively own the government(s) - and a consortium of corporations are trying to do the same for global governance via "stakeholder capitalism", "public-private patrnerships", and other such flotsam and jetsam floated by Klaus Schwab and his World Economic Forum - some changes which would strike at the root of this would have to occur...