Katherine, you are something! (BTW, thank you so much for your very thorough reply to my query related to this topic. My bad for failing to thank and acknowledge you for taking the time to provide such a thorough answer to my question about all of this unlawful gobbledygook.)
Aside from all of this appearing to me to be completely unconstitutional, PREP does have its provision related to willful misconduct. If any part of any of the crap carried out in the name of PREP can be shown to qualify as willful misconduct, all of the protections are out the window, yes?
Under the PREP Act terms, the only entities in a legal position to pursue and prove willful misconduct, are DOJ and HHS.
Whose leaders are in on the crimes.
Before any civil lawsuits by individual plaintiffs can be filed, first the Health and Human Services Secretary or the Attorney General has to file a criminal prosecution, mandatory recall or other “enforcement action” against the defendant(s), and has to win that case, as a baseline to establish willful misconduct for use in subsequent civil suits.
See
42 USC 247d-6d(c)(5). “Exclusion for regulated activity of manufacturer or distributor
(A) In general If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], such act or omission shall not constitute “willful misconduct” for purposes of subsection (d) if—
(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or
(ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.
Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action.
(B) Definitions
For purposes of this paragraph, the following terms have the following meanings:
(i) Enforcement action The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title.”
—-
Unless there is a major change in political leadership, replacing President and all of the cabinet secretaries with people interested in restoring the Constitution and prosecuting war criminals for willful misconduct,
Or replacing Congress with members interested in repealing the PREP Act and related laws,
Or replacing federal judges with judges interested in reviewing and nullifying PREP Act and related laws as unconstitutional,
Or replacing state governors and legislatures with people interested in pursuing secession and/or state level nullification of PREP Act and related laws,
Then there can’t be individual civil cases successfully filed against manufacturers and others in the chain of distribution and administration for ‘willful misconduct.’
Thanks for wading through this Katherine. I think I speak for many of your readers when I say we really appreciate the time and effort you put into clarifying this mess. Like you pointed out, I got bored with my earlier efforts because it took so much time just to wade through everything to try and make sense of it all.
Hear hear. And we will never be able to thank you enough...for educating us not only to the law, but how these laws might be repealed. I think that should be a major platform in any new government that might possibly squeak by the total control of our voting machines and win.
Until/unless we take the significant power of money out of the processes needed to hold people accountable, we won't ever see justice for these crimes. $10 TRILLION, appropriated during the covid, can be spread in infinite ways, and that amount of public money can virtually guarantee that every politician, prosecutor, media personality, Federal employee, doctor, hospital, etc., will be unable to resist the bribes that keep them all in line. People of character and integrity nowadays are hard to find, especially those in positions that matter. I wish that were not so, but it appears to be the reality.
In the early '80's, I concluded the only way to reform the system is through campaign finance reform and term limits for all elected offices. Eliminate all contributions outside the natural constituency of the office. No PAC money. No corporate money. No national political party money. A reasonable limit on individual contributions. All elected offices should be for one year, with instant recall at any time. All pay and benefits should come from the states, not the feds. The problem with these reforms is the people in power will never do these things. Sorry for the off topic ramble. It just strikes me as obvious that it is career politicians and their financial backers that slipped all of this garbage into the laws over many decades. The people are kept fighting each other in the matrix of dialectics.
Katherine, you are something! (BTW, thank you so much for your very thorough reply to my query related to this topic. My bad for failing to thank and acknowledge you for taking the time to provide such a thorough answer to my question about all of this unlawful gobbledygook.)
Aside from all of this appearing to me to be completely unconstitutional, PREP does have its provision related to willful misconduct. If any part of any of the crap carried out in the name of PREP can be shown to qualify as willful misconduct, all of the protections are out the window, yes?
Yes, but with a major hurdle.
Under the PREP Act terms, the only entities in a legal position to pursue and prove willful misconduct, are DOJ and HHS.
Whose leaders are in on the crimes.
Before any civil lawsuits by individual plaintiffs can be filed, first the Health and Human Services Secretary or the Attorney General has to file a criminal prosecution, mandatory recall or other “enforcement action” against the defendant(s), and has to win that case, as a baseline to establish willful misconduct for use in subsequent civil suits.
See
42 USC 247d-6d(c)(5). “Exclusion for regulated activity of manufacturer or distributor
(A) In general If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], such act or omission shall not constitute “willful misconduct” for purposes of subsection (d) if—
(i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or
(ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.
Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement action.
(B) Definitions
For purposes of this paragraph, the following terms have the following meanings:
(i) Enforcement action The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title.”
—-
Unless there is a major change in political leadership, replacing President and all of the cabinet secretaries with people interested in restoring the Constitution and prosecuting war criminals for willful misconduct,
Or replacing Congress with members interested in repealing the PREP Act and related laws,
Or replacing federal judges with judges interested in reviewing and nullifying PREP Act and related laws as unconstitutional,
Or replacing state governors and legislatures with people interested in pursuing secession and/or state level nullification of PREP Act and related laws,
Then there can’t be individual civil cases successfully filed against manufacturers and others in the chain of distribution and administration for ‘willful misconduct.’
Thanks for wading through this Katherine. I think I speak for many of your readers when I say we really appreciate the time and effort you put into clarifying this mess. Like you pointed out, I got bored with my earlier efforts because it took so much time just to wade through everything to try and make sense of it all.
Hear hear. And we will never be able to thank you enough...for educating us not only to the law, but how these laws might be repealed. I think that should be a major platform in any new government that might possibly squeak by the total control of our voting machines and win.
Thank you!!
You're welcome!
Thank you for reading!
Until/unless we take the significant power of money out of the processes needed to hold people accountable, we won't ever see justice for these crimes. $10 TRILLION, appropriated during the covid, can be spread in infinite ways, and that amount of public money can virtually guarantee that every politician, prosecutor, media personality, Federal employee, doctor, hospital, etc., will be unable to resist the bribes that keep them all in line. People of character and integrity nowadays are hard to find, especially those in positions that matter. I wish that were not so, but it appears to be the reality.
In the early '80's, I concluded the only way to reform the system is through campaign finance reform and term limits for all elected offices. Eliminate all contributions outside the natural constituency of the office. No PAC money. No corporate money. No national political party money. A reasonable limit on individual contributions. All elected offices should be for one year, with instant recall at any time. All pay and benefits should come from the states, not the feds. The problem with these reforms is the people in power will never do these things. Sorry for the off topic ramble. It just strikes me as obvious that it is career politicians and their financial backers that slipped all of this garbage into the laws over many decades. The people are kept fighting each other in the matrix of dialectics.