There is unfortunately another twist to the PREP Act:
"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."
Becasue Prizer, Moderna et al are subject to FDA regulation (under the Food, Drug and Cosmetic Act), this is a problem. If the Attorney General or HHS has not initiated an enforcement action on the same issues alleged as willful misconduct, it's not "willful misconduct." Of course tthey will never initate such an action. This clearly unconstitutional provision can (we hope) be overcome, but it is a huge hurdle.
Joel Smalley just did a substack post on safe and effective and it's been an annoyance of mine for some months.
Stick to the basics and they have nowhere to hide and challenge the officials who supported it.
Statistics are always open to interpretation🥴
Safe and effective was a marketing slogan to push a product on people that had been manipulated by governments and state propaganda 🍻It was all a scam👍
Wouldn’t want to discourage anyone from pursuing an action, but it seems to me that not only will the burden of proof be squarely on the shoulders of the Plaintiff, but Defendants will likely argue that in a fast moving and ever changing emergency situation, what in hindsight looks like ‘fraud’ was the best attempt possible in the circumstances.
There is currently a heated discussion on Twitter about the actual ‘real’ Infection Fatality Rate (IFR) in the US at the beginning of the Pandemic in 2020. It is data such as this which will inform the background to any claim for liability. If we can’t even agree on something as basic as IFR what hope is there for agreeing the mass of contradictory information which will form part of any litigation.
This enterprise will require considerable research, effort, and money, all of which will be dwarfed by what Government and the pharmaceutical industry will bring to bear on the issue, if they even consider it a credible challenge.
Don’t misunderstand me. I’m totally positive about the intention, but it’s going to be coordinated grunt work which will take this over the line, not clever interpretation, conceptualisation or slick words.
"Defendants will likely argue that in a fast moving and ever changing emergency situation, what in hindsight looks like ‘fraud’ was the best attempt possible in the circumstances."
Of course they will try to defend their position, but there's quite a lot of evidence to show fraud has and is still occurring (95% effective claim despite admitting to MEP that no transmission studies were conducted, the trial fraud whistleblower case, Bourla on record as lying to the FDA, etc).
Plus there's evidence they are intentionally ignoring a landslide of evidence showing harms.
There's also major story developing relating to the EMA leaks that proves fraud began right at the very start. I intend to cover that after I've laid out the groundwork on the legal aspects. Part 2 is more explosive than Part 1.
There is unfortunately another twist to the PREP Act:
"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."
Becasue Prizer, Moderna et al are subject to FDA regulation (under the Food, Drug and Cosmetic Act), this is a problem. If the Attorney General or HHS has not initiated an enforcement action on the same issues alleged as willful misconduct, it's not "willful misconduct." Of course tthey will never initate such an action. This clearly unconstitutional provision can (we hope) be overcome, but it is a huge hurdle.
Joel Smalley just did a substack post on safe and effective and it's been an annoyance of mine for some months.
Stick to the basics and they have nowhere to hide and challenge the officials who supported it.
Statistics are always open to interpretation🥴
Safe and effective was a marketing slogan to push a product on people that had been manipulated by governments and state propaganda 🍻It was all a scam👍
The safe and effective byline is a joke about the legal immunity.
They're going to find the legal protections aren't completely 'safe and effective'.
I'll update the byline to avoid confusion.
I think with the recent Project Veritas hidden camera snafu, it’s gonna be pretty easy to claim fraud.
Wouldn’t want to discourage anyone from pursuing an action, but it seems to me that not only will the burden of proof be squarely on the shoulders of the Plaintiff, but Defendants will likely argue that in a fast moving and ever changing emergency situation, what in hindsight looks like ‘fraud’ was the best attempt possible in the circumstances.
There is currently a heated discussion on Twitter about the actual ‘real’ Infection Fatality Rate (IFR) in the US at the beginning of the Pandemic in 2020. It is data such as this which will inform the background to any claim for liability. If we can’t even agree on something as basic as IFR what hope is there for agreeing the mass of contradictory information which will form part of any litigation.
This enterprise will require considerable research, effort, and money, all of which will be dwarfed by what Government and the pharmaceutical industry will bring to bear on the issue, if they even consider it a credible challenge.
Don’t misunderstand me. I’m totally positive about the intention, but it’s going to be coordinated grunt work which will take this over the line, not clever interpretation, conceptualisation or slick words.
I look forward to Part 2 with interest.
"Defendants will likely argue that in a fast moving and ever changing emergency situation, what in hindsight looks like ‘fraud’ was the best attempt possible in the circumstances."
Of course they will try to defend their position, but there's quite a lot of evidence to show fraud has and is still occurring (95% effective claim despite admitting to MEP that no transmission studies were conducted, the trial fraud whistleblower case, Bourla on record as lying to the FDA, etc).
Plus there's evidence they are intentionally ignoring a landslide of evidence showing harms.
There's also major story developing relating to the EMA leaks that proves fraud began right at the very start. I intend to cover that after I've laid out the groundwork on the legal aspects. Part 2 is more explosive than Part 1.