Vax Mandate Lawsuits

[GURPS]

New Suit Against NYC Mandate

https://cdn.locals.com/documents/47656/47656_sqyendmpjcwx4ot.pdf

CNS PARTNERS, INC. d/b/a CORNERSTONE REALTY, individually, and for all others similarly situated,

Plaintiff,


-against–

THE CITY OF NEW YORK, ERIC L. ADAMS, MAYOR OF NEW YORK CITY, IN HIS OFFICIAL CAPACITY, DEPARTMENT OF HEALTH AND MENTAL HYGIENE, and DAVE A. CHOKSHI, COMMISSIONER OF THE DEPARTMENT OF HEALTH AND MENTAL HYGIENE, IN HIS OFFICIAL CAPACITY

Defendants.



PRELIMINARY STATEMENT​

1. Plaintiff Cornerstone Realty and members of the Class are businesses in New York City that will be deprived of their interests under the DOHMH’s Order to Require COVID-19 Vaccination in the Workplace (Ex. A, the “DOHMH Order”), which requires private employers to verify its workers’ proof of COVID-19 vaccination.

2. This case is not about vaccines, but about an employer’s right to be heard when the DOHMH and the City pass a sweeping—and first in the nation—law meant to fight the COVID19 pandemic.

3. The DOHMH maintains that it is the employer’s decision whether to discipline or fire such workers who are not vaccinated against COVID-19 or, in the alternative, employers can require workers to work remotely (Ex. B, “FAQ on DOHMH Order”).

4. But in the practice, the DOHMH Order forces employers, such as Cornerstone Realty, a real estate company, to terminate its workers because remote work is impossible for every worker.

5. If Cornerstone Realty and other businesses have workers who cannot work remotely or be readily replaced, the only option—other than to retain unproductive workers on the payroll—is to terminate such workers.

6. As the last two years of the COVID-19 pandemic has shown, remote work is impossible for Cornerstone Realty’s agents, who must be physically present to show or list properties. Businesses like Cornerstone Realty are similarly situated across New York City.

7. The DOHMH Order does not provide a notice period for Cornerstone Realty or other businesses to enforce the DOHMH Order, which, if businesses are forced to terminate workers, harms such businesses.

8. Moreover, if a business fails to comply with the DOHMH Order, employers are subject—without any process for a hearing that takes into account a business’s operation—to a fine of $1,000 and escalating penalties thereafter if violations persist.

9. Nowhere in the process does the City or the DOHMH consider the employer’s liberty or property interests in its fight against the COVID-19 pandemic.

10. The DOHMH Order, therefore, deprives businesses a necessary right to be heard, which is guaranteed under the Procedural Due Process clause of the Fourteenth Amendment of the United States Constitution

[clip]


CLAIM FOR RELIEF

Violation of the Due Process Clause of the U.S. Constitution

36. Plaintiff realleges and incorporates into this cause of action the allegations of the of the Complaint set out above.

37. The Due Process Clause of the Fourteenth Amendment to the U.S. Constitution provides that no State can “deprive any person of life, liberty, or property, without due process of law.” U.S. Const. amend. XIV.

38. A procedural due process claim is composed of two elements: (1) the existence of a property or liberty interest that was deprived and (2) deprivation of that interest without due process. Narumanchi v. Bd. Of Trustees, 850 F. 2d 70, 82 (2d Cir. 1988).

39. Plaintiff has a property or liberty interest in maintaining its business through employment or contract with qualified real estate agents.

40. If Defendants enforce the DOHMH Order, Plaintiff and members of the putative Classes’ will be forced to terminate their employees who have chosen to receive the COVID-19 vaccination.

41. Defendants did not provide any notice to Plaintiff of the DOHMH Order.

42. Defendants, moreover, have not laid out any process to protest or appeal any decisions made in accordance with the DOHMH Order.

43. Termination of employees will result in Plaintiff and Class members being irreparably harmed without due process.

 

[Toxick]

 

[GURPS]

This State Is Defying Biden's OSHA Vaccine Mandate, Regardless Of What SCOTUS Decides





Whether Iowa and other states that potentially follow suit will be able to successfully defy the federal OSHA order, should it stand, remains to be seen. One expert, former OSHA chief of staff Debbie Berkowitz, told the Register that federal officials will likely try to take over enforcement of the mandate if state officials refuse to do so.

Still, if blue states can defy federal drug and immigration laws during a GOP administration, it seems that red states should at the least be able to shield their citizens from federal tyranny.



https://townhall.com/tipsheet/rebec...-dirty-tricks-n2601616?utm_campaign=inarticle

 

[GURPS]

 

[GURPS]

Great SCOTUS Amici Brief on the Real Facts of Omicron

Great data included in this brief filed with the Supreme Court.

https://cdn.locals.com/documents/47656/47656_dlxhpa3dqnwhfhu.pdf

ARGUMENT

I. OMICRON IS NOW THE DOMINANT VARIANT​

The Omicron variant now accounts for the majority of new SARS-COV2 infections in the United States, and is expected to represent substantially all new infections within weeks.

Below is the CDC official variant projection, called “NOWCAST,” which shows Omicron represented 95.4% of new cases for the week ending January 1 — and is still rising:2

This follows the trajectory in South Africa, where the Omicron variant was discovered in the Gauteng province on November 22, 2020.3 In South Africa, Omicron rose to 91% dominance by December 21.4

Given the Omicron trajectory in the United States and the unprecedented steep rise in cases nationally, driven by Omicron, it is likely that by the time the Court decides whether to grant a stay, Omicron will represent substantially all of the SARS-CoV2 infections in the United States. That fact renders nearly all of the fact evidence in the record obsolete.

II. OMICRON DOES NOT PRESENT A GRAVE DANGER ​

A recent analysis from the South African government's National Institute for Communicable Diseases provides some reason for optimism: S-Gene Target Failure (presumptive Omicron) cases are 80% less likely to be hospitalized.5

The latest data from Scotland also strongly suggests the same optimistic conclusion: “early national data suggest that Omicron is associated with a twothirds reduction in the risk of COVID-19 hospitalisation when compared to Delta.”6

Denmark’s data shows Omicron cases were three times less likely to end up with hospital admissions than the previous dominant variant, Delta.7

The United States has not published any comparable data. But, NIAID Director Dr. Anthony Fauci noted the global evidence of reduced severity at a December 29, 2021 White House briefing and indicated unpublished U.S. data show the same trend:

In the United States, we are getting accumulation of data. The spike in cases is out of proportion to the increase in hospitalization. So, if one looks at 14-day averages, the data, as of last night, indicate a plus 126 percent increase in cases [but only] an 11 percent increase in hospitalizations. Now, we must remember that hospitalizations and deaths are lagging indicators. However, the pattern and disparity between cases and hospitalization strongly suggest that there will be a lower hospitalization to-case ratio when the situation becomes more clear.8​

​

Hong Kong University researchers pointed to the likely reason, or mechanism, for Omicron’s increased infectiousness but reduced virulence: it replicates far more efficiently in the bronchus and upper respiratory tract than Delta, but less efficiently in the lungs:9 But the most compelling evidence of Omicron ending any grave danger from SARS-CoV2 comes from South Africa, particularly the Gauteng province (population 18 million) where the first recognized Omicron wave occurred. According to Dr. Harry Moultrie of the South African government's National Institute for Communicable Diseases, Gauteng cases peaked on December 9 at 97 percent of the delta wave. Even more reassuringly, deaths were only 13 percent of the delta peak:10

A recently published working paper by a South African team of scientists who were conducting a seroepidemiological survey in the Gautang Province confirms the conclusion that Omicron infection is substantially less likely to require hospitalization or induce mortality than infection with other strains. While cases may rise sharply as a wave of Omicron sweeps through a region, hospitalizations and deaths do not follow. The authors conclude:11

We demonstrate widespread underlying SARS-CoV-2 seropositivity in Gauteng Province prior to the current Omicron-dominant wave, with epidemiological data showing an uncoupling of hospitalization and death rates from infection rate during Omicron circulation.​

Based on their Omicron experience, some South African scientists have effectively declared the pandemic over, stating:12

All indicators suggest the country may have passed the peak of the fourth wave at a national level… While the Omicron variant is highly transmissible, there has been lower rates of hospitalisation than in previous waves. This means that the country has a spare capacity for admission of patients even for routine health services.

In other words, the first country to experience an Omicron wave has unambiguously concluded that the dominant variant presents no grave danger.

Early U.S. data is available in a preprint from a team at Case Western Reserve University, which used propensity matched-cohort analysis to find markedly reduced disease severity during the period from December 14 to December 24, 2021. On an age and riskmatched basis, they found ER visits were 70% lower than earlier cohorts, hospitalizations were 56% lower, ICU admissions were 67% lower, and ventilation were 84% lower.


As good as they appear, these reductions substantially understate the reduction of risk represented by Omicron, because this cohort included a non-negligible number of Delta infections. According to the authors:

The estimated prevalence of the Omicron variant during 12/15-12/24 was only 22.5-58.6%, suggesting that the outcomes for the Omicron variant may be found to be even milder than what we report here as the prevalence of the Omicron variant increases.​

Adding to the lack of any grave danger, there is also strong early evidence that Omicron infection offers robust protection against the Delta variant. This means that even if the Delta variant still presented a grave danger, it would be counterproductive to stop or slow the spreading of the presently dominant Omicron variant.

Research at the Africa health Research Institute found:

Importantly, there was an enhancement of Delta virus neutralization, which increased 4.4-fold. The increase in Delta variant neutralization in individuals infected with Omicron may result in decreased ability of Delta to re-infect those individuals. Along with emerging data indicating that Omicron, at this time in the pandemic, is less pathogenic than Delta, such an outcome may have positive implications in terms of decreasing the Covid-19 burden of severe disease.​

This substantial reduction of severe disease risk must be applied to a contextualized understanding of the already low-risk to working-age individuals. Since the start of the pandemic, there have been 206,156 COVID-associated deaths among the working age 18 to 64 population – overwhelmingly in those above age 50 with pre-existing health conditions – according to the preliminary death count at the CDC’s National Center for Health Statistics:13

Given substantial improvements in treatments, including therapeutics that can reduce the risk of hospitalization of death by more than 50 percent, we would expect that even if the virus had not attenuated deaths in this age group, and even in the absence of vaccination, deaths would be 50,000 or less per year going forward.

Case fatality rates might be an even better way to conceptualize the risk than other common measures. As Dr. Jay Bhattacharya of Stanford notes:

It is helpful to provide some context for how large the mortality risk is posed by COVID infection relative to the risk posed by other infectious diseases. Since seroprevalencebased mortality estimates are not readily available for every disease, in the figure immediately below, I plot case fatality rates, defined as the number of deaths due to the disease divided by the number of identified or diagnosed cases of that disease. The case fatality rate for SARS-CoV-2 is ~2% (though that number has decreased with the availability of vaccines and effective treatments). By contrast, the case fatality rate for SARS is over five times higher than that, and for MERS, it is 16 times higher than that.​

But the case fatality rate appears to be falling even more sharply than that. In South Africa, the case fatality rate plunged dramatically when Omicron became dominant. Pieter Streicher of the University of Johannesburg projects that for Gauteng Province: “C19 deaths are expected to total 640 for this wave, 25x lower compared to Delta (15,400).”14

The graph below tracks a 7-day moving average of the case fatality rate of COVID infection from September 1, 2020 to January 1, 2022 in South Africa with data from a well-known COVID data provider, Our World in Data.15 It confirms the collapse in the case fatality rate of COVID in South Africa as Omicron became the dominant strain.

With Omicron’s observed decline in severity, expected working-age deaths fall into a range comparable to — or even lower than — the CDC’s modeled 8,000 influenza deaths in 2017-18.16 Quite simply, the Omicron variant is now a normal respiratory virus, not an unusual, extraordinary, or grave danger. There is no evidence in the record specific to Omicron to support a grave danger finding.

III. VACCINES ARE INEFFECTIVE AT PREVENTING OMICRON INFECTIONS ​

Pfizer and BioNTech are the manufacturers of the current leading vaccine. They recently admitted that the existing vaccine does not provide robust protection against Omicron, saying:

Sera from individuals who received two doses of the current COVID-19 vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the Omicron variant compared to wild-type, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the Omicron variant.17 Moderna, the second-leading manufacturer, similarly admitted that its vaccine does not provide acceptable efficacy against Omicron, stating: All groups had low neutralizing antibody levels in the Omicron PsVNT assay prior to boosting.18​

Similarly, NIH-funded researchers at Duke university found in vitro that: "neutralizing titers to Omicron are 49-84 times lower than neutralization titers to D614G [wild-type SARS-CoV2] after 2 doses of mRNA-1273 [Moderna], which could lead to an increased risk of symptomatic breakthrough infections."19

Real-world evidence from at least four countries with significant experience with Omicron — Denmark, the United Kingdom, Germany, and Canada, all of which provide more detailed and transparent data than has been made available in the United States — evidences that these vaccines have substantially zero efficacy at preventing Omicron transmission, undermining the central rationale for mandating them in the workplace.

The Statens Serum Institut in Copenhagen, Denmark analyzed Danish data and found vaccine efficacy turned negative after 91 days following the second dose was administered. In other words, vaccinated Danes were even more likely than unvaccinated Danes to be infected with Omicron after 3 months:20

This may be because unvaccinated, COVIDrecovered patients have better protection versus Omicron than vaccinated patients who never previously had COVID.21

In Germany, the most recent detailed report from the Robert Koch Institute (the German equivalent of the CDC) found that 78.6 percent (4,020 of 5,117) of sequenced Omicron cases were in vaccinated Germans,22 despite a population vaccination rate of just 70 percent.23

In the United Kingdom, the UK Health Security Agency calculated preliminary vaccine effectiveness estimates remarkably like the Danish findings, with near-zero vaccine efficacy for both Pfizer-BioNTech and Moderna vaccines after 20 weeks following the second dose:24

Although the UK Health Security Agency clarifies "[t]hese results should be interpreted with caution due to the low counts and the possible biases related to the populations with highest exposure to Omicron (including travellers and their close contacts) which cannot fully be accounted for," these results are consistent with the epidemiological patterns we are seeing in the United States and globally.

In Ontario, Canada, the case rate per 100,000 fully vaccinated Ontarians has risen sharply above the case rate per 100,000 unvaccinated Ontarians, again suggesting negative vaccine efficacy:25

A test-negative control analysis of Ontario test data by researchers from Public Health Ontario and leading Canadian universities found: "observed negative VE against Omicron among those who had received 2 doses compared to unvaccinated individuals" (emphasis added).

As the following table shows, the Ontario researchers found that after day 60 following the second dose, vaccine effectiveness was negative, meaning a vaccinated person was more likely to be infected than an unvaccinated person:

Contemporaneous with this development, Ontario announced a major shift in strategy away from mass testing. On December 20, 2021, Ontario’s health officer Kieran Moore said:

We have to pivot, we know there's ongoing community activity, we know we'll have transmission risk, that data has to focus to screen those who need treatment and to protect those in high-risk settings.26 ​

In the United States, studies and data from last summer showing higher viral transmission in less vaccinated southern states is now completely obsolete. As the following CDC table demonstrates, in the Omicron wave there is no observable reduction in case rates based on vaccination rates:27

 

[OccamsRazor]

Just so everyone knows, it is perfectly OK to be FOR getting the vaccine and still be AGAINST the vaccine MANDATE. Its about personal choice. It is NOT an either/or position.

 

[Hijinx]

Well thee States either follow the mandates or they will get cut out of any Federal money.
That's the way the Feds enforce their rules.

That's where the seat belt and helmet mandate came in and they have used it for other things too.
They may even stop paying medicare in a state that doesn't bow to their lunacy.

 

[GURPS]

Following SCOTUS Ruling, GE Suspends Its Covid Vaccine and Testing Rules

Building a world that works actually requires employees to do the work.



General Electric announced that it has suspended Covid vaccine or test requirement for employees after this week’s U.S. Supreme Court ruling.

The Boston-based maker of jet engines, wind turbines, and medical scanners confirmed the decision Friday via e-mail. GE is the first major company to announce a halt after the court’s decision to block the centerpiece of Biden’s push to boost COVID-19 vaccinations.

GE holds a number of government contracts, so its 56,000 employees in the US originally fell under a separate vaccination mandate for federal contractors. The company paused that requirement in December — after a federal judge temporarily blocked the rule from going into effect — and then planned to comply with the vaccine-or-testing mandate for private employers.

 

[GURPS]

Biden Vaccine Mandate WINNING Despite SCOTUS Striking It Down, Dems CHEER As Companies REJECT SCOTUS

 

[GURPS]

Starbucks Cancels Vaccine Mandate After Supreme Court Ruling


“In Tuesday’s memo, Culver said the company continues to strongly encourage vaccinations and booster shots,” the Associated Press reported. “The company also told workers on Tuesday that they shouldn’t wear cloth masks to work, and should instead use medical-grade surgical masks.”

The move comes after Starbucks said during the first week of January that it was going to require all of its U.S. workers to get vaccinated.
General Electric announced last week that it was also suspending its coronavirus vaccine or test requirement following the Supreme Court ruling.

“The maker of jet engines, wind turbines and medical scanners confirmed the decision Friday via email,” Bloomberg News reported. “GE is the first major company to announce a halt after the court’s decision Thursday to block the centerpiece of President Joe Biden’s push to boost Covid-19 vaccinations.”

 

[GURPS]

New Lawsuit vs. Federal Employee Mandate


Highlighted, per usual. Borrows my theory about the ADA.

https://cdn.locals.com/documents/47656/47656_dite8b4siij9xdx.pdf

IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION


COMPLAINT​

On September 9, 2021, President Biden issued Executive Orders 14042 and 14043, mandating that federal employees and contractors provide proof of having been inoculated with an unlicensed COVID-19 vaccine, or face disciplinary consequences in their jobs. In rushing to force COVID-19 vaccinations on the federal workforce, the President’s edicts violate longstanding statutory prohibitions against inoculations with unlicensed vaccines; the individual rights of government employees and contractors under the Rehabilitation Act, the Americans with Disabilities Act, and the United States Constitution; and exceed the President’s statutory authority in regulating federal employees. Accordingly, plaintiffs who are representative of myriad Federal Agencies respectfully request relief from this Court in the form of injunctive relief stopping these illegal, and unnecessarily broad and wide-ranging mandates.

PARTIES ​

1. Plaintiffs1 are either employed by the named Defendant Agencies or employed as federal government contractors whose customers are the named Defendant Agencies, and who have been directed to provide their vaccination statuses and receive the COVID-19 vaccine under Executive Orders 14042 and 14043. Each Plaintiff either remains unvaccinated or has not provided his or her vaccination status to Defendant Agencies and faces either termination as a federal employee or removal from a federal government contract if he or she remains unvaccinated or refuses to provide his or her vaccination status.


1. Given the hostility present in recent speeches by the President and the recent real-world example of Plaintiffs successfully challenging a school district’s mask mandate, Plaintiffs have real concern for their safety should their names be made public, and have filed this matter under pseudonym. See, e.g. CNBC “Biden says unvaccinated Americans are ‘costing all of us’ as he presses Covid vaccine mandates” (Biden said unvaccinated people are hindering economic growth, costing jobs and putting unnecessary strain on the health-care system), Sept. 24, 2021, reported at https://www.cnbc.com/2021/09/24/bid...us-as-he-presses-covid-vaccine-mandates.htmlt (last visited Jan. 4, 2022); CNN, “Biden warns of winter of 'severe illness and death' for unvaccinated due to Omicron” (“We are looking at a winter of severe illness and death for the unvaccinated -- for themselves, their families and the hospitals they'll soon overwhelm.”), reported at https://www.cnn.com/2021/12/16/politics/joe-biden-warningwinter/index.html (last visited Jan. 4, 2022); Presidential Press Conference, Jan. 4, 2022 (“The unvaccinated are taking up hospital beds and crowding emergency rooms and intensive care units. That’s displaced other people who need access to those hospitals. …So there’s no excuse, no excuse for anyone being unvaccinated. This continues to be a pandemic of the unvaccinated …. And for parents with kids too young to be vaccinated, surround your kids with people who are vaccinated”), reported at https://www.rev.com/blog/transcripts/joe-biden-covid-omicron-spike-speech-transcript (last visited Jan. 5, 2022); Texas School Board Member Publicized Personal Info of Parents who Challenged Mask Mandate,” Dec. 6, 2021, reported at: https://www.nationalreview.com/news...l-infoof-parents-who-challenged-mask-mandate/ (last visited Jan. 4, 2022).

JURISDICTION AND VENUE ​

10.This action is brought under the Administrative Procedure Act (APA), 5 U.S.C. § 701, et seq., challenging the Executive Orders’ purposeful evasion of the statutory requirements set forth under Sections 501 and 503 of the Rehabilitation Act 1973, as amended (29 U.S.C. §§ 791, 793), Title I of the American with Disabilities Act (ADA) of 1990, as amended (42 U.S.C. § 12101, et seq.) and the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 360bbb-3, et seq.). The Executive Orders further impinge on constitutional rights, and were issued in excess of the President’s statutory authority to regulate federal employees.

11.Both the Rehabilitation Act and the ADA (together referred to as “the Acts”) preclude employers from discriminating against federal employees and federal government contractors on the basis of an actual or perceived disability. The Acts further preclude employers from conducting disabilityrelated inquiries of employees that are not shown to be “job-related and consistent with business necessity.” 29 C.F.R. § 1630.14(c). An inquiry is determined to be “job related and consistent with business necessity” when the employer has a “reasonable belief, based on objective evidence” that the “employee will pose a direct threat due to a medical condition.”2 “The determination that an employee poses a direct threat must be based on an individualized assessment of the employee’s present ability to safely perform the essential functions of the job.” 29 C.F.R. § 1630.2(r).

12.The FDCA authorizes the use of medical products not yet licensed by the Food and Drug Administration (FDA) under “emergency use,” but only when the individual is “informed of the option to accept or refuse the administration of the product, … and of the alternatives to the product that are available and of their benefits and risks.” 21 U.S.C. § 360bbb3(e)(1)(A)(ii)(III).

13.The Fifth Amendment to the United States Constitution confers rights of bodily integrity and autonomy, and occupational liberty.

14.The mandates were issued under the President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and 7301, which allow the President to prescribe regulations for the admission of civil servant applicants, the administration of positions in the competitive service, and the conduct of employees in the executive branch.

15.The APA permits judicial review of an Executive Order, as implemented by an Agency, which is arbitrary, capricious, not in accordance with law, contrary to constitutional right, in excess of statutory authority, and without observance of procedure required by law. 5 U.S.C. §§ 702, 704, and 706; see Chamber of Commerce of U.S. v. Reich, 74 F.3d 1322, 1328 (D.C. Cir. 1996). The declaratory relief requested herein is proper under 5 U.S.C. §§ 706(1)-(2).

STATEMENT OF FACTS
Development of Vaccines​

17.Upon best information and belief, the novel COVID-19 infection first arrived in the United States in or around January 2020. Just a few short months later, then President Trump directed the immediate development of a vaccine under Operation “Warp Speed.”

18.True to the Operation’s name and the novelty of the virus, equally novel mRNA vaccines were rapidly produced in short order. For the first time in vaccine history, a vaccine was created that did not introduce an inactive version of the virus into the human body, but rather was designed to “teach our cells how to make a protein—or even just a piece of a protein— that triggers an immune response inside our bodies.”3 From this endeavor were born three vaccines that were, and are, widely available in the United States: the Pfizer-BioNTech COVID-19 vaccine, the Moderna COVID-19 vaccine, and Johnson & Johnson’s Janssen COVID-19 vaccine.4 None of these vaccines are licensed by the FDA; rather, they have been authorized for emergency use under 21 U.S.C. § 360bbb-3 and remain under emergency use authorization as of the time of this filing.5

19.On August 23, 2021, the FDA licensed a COVID-19 vaccine originally developed by BioNTech Manufacturing GmbH, a German company, to be jointly manufactured with Pfizer. The companies were authorized to market the vaccine under the name “COMIRNATY.”6 Although comanufactured by Pfizer, COMIRNATY is “legally distinct with certain differences” from the Pfizer-BioNTech COVID-19 vaccine that was, and is, available in the United States; the Pfizer-BioNTech COVID-19 vaccine, which is the only Pfizer vaccine available in the United States, remains under emergency use authorization.7 COMINARTY is not available in the United States. 8




8 See FDA Vaccine Finder, available at: https://www.vaccines.gov/search/ (last visited Jan. 3, 2022), which does not list COMIRNATY as an option for searches seeking vaccination locations in the U.S.

Evolving Science: Vaccinated v. Unvaccinated
No Difference in Viral Load
​

33.In issuing the Executive Orders, the President asserted it was the unvaccinated, not the vaccinated, who were the sole source of COVID-19 spread. Scientific studies suggest otherwise. On September 29, 2021, a preliminary report from a study conducted by the Genome Center, University of California, Davis, stated that a review of both vaccinated and unvaccinated individuals resulted in the following:

A total of 869 samples, 500 from HYT and 369 from UeS, were included in the analysis. All analyzed samples from HYT were asymptomatic at the time of collection and 75% of the positive samples were from unvaccinated individuals (N=375). Positive samples from UeS were from both symptomatic (N=237) and asymptomatic individuals (N=132). The frequency of vaccine breakthroughs among the UeS samples (171 fully vaccinated, 198 unvaccinated) was greater than among the HYT samples reflecting the different types of populations sampled. The Delta variant was the predominant variant detected in both populations (Supplementary Table 1).​

There were no statistically significant differences in mean [cycle threshold] Ct-values of vaccinated (UeS: 23.1; HYT: 25.5) vs. unvaccinated (UeS: 23.4; HYT: 25.4) samples. In both vaccinated and unvaccinated, there was great variation among individuals, with Ct-values of 30 in both UeS and HYT data (Fig. 1A, 1B). Similarly, no statistically significant differences were found in the mean Ct-values of asymptomatic (UeS: 24.3; HYT: 25.4) vs. symptomatic (UeS: 22.7) samples, overall or stratified by vaccine status (Fig. 1B). Similar Ct-values were also found among different age groups, between genders, and vaccine types (Supplemental Figure 1).​

In all groups, there were individuals with low Ct-values indicative of high viral loads. A total of 69 fully vaccinated individuals had Ct-values <20. Of these, 24 were asymptomatic at the time of testing.​

Exhibit 1, at 6. The study goes on to note:

A substantial proportion of asymptomatic, fully vaccinated individuals in our study had low Ct-values, indicative of high viral loads. Given that low Ct-values are indicative of high levels of virus, culture positivity, and increased transmission [11], our detection of low Ct-values in asymptomatic, fully vaccinated individuals is consistent with the potential for transmission from breakthrough infections prior to any emergence of symptoms.​

Id. at 7. Even now, as the Omicron variant has spread, it is increasingly reported that the majority of those becoming infected with the variant are vaccinated, as opposed to unvaccinated.25

25 See, e.g. “Omicron is spreading at lightening speed. Scientists are trying to figure our why,” NPR, Dec. 31, 2021 (“Scientists who traced the superspreader event concluded it was evidence that omicron was ‘highly transmissible’ among fully vaccinated adults.”) reported at https://www.npr.org/sections/goatsa...dfire-scientists-are-trying-to-figure-out-why (last visited Jan. 5, 2022); “Covid Updates: Omicron Drives New U.S. Virus Cases to a Daily Record,” The New York Times, Dec. 29, 2021 (”[It] was increasingly clear that vaccinated people are being infected with Omicron, meaning that there was a reduction in the capacity of vaccines to neutralize the virus…”) reported at https://www.nytimes.com/live/2021/12/29/world/omicron-covid-vaccinetests (last visited Jan. 5, 2022); “Most reported U.S. Omicron cases have hit the fully vaccinated – CDC,” Reuters, Dec. 10, 2021, reported at https://www.reuters.com/world/us/mo...ases-have-hit-fullyvaccinated-cdc-2021-12-10/ (last visited Jan. 5, 2022). ​

34.The findings of the above study were consistent with others conducted in Massachusetts and Singapore, in which “individuals with vaccination breakthroughs caused by the Delta variant had similar Ct-values as unvaccinated individuals.” Id. Ultimately, this means the unvaccinated individual who contracts COVID-19 and has the same Ct-values as a vaccinated person who contracts COVID-19 is no more likely to spread the virus than the vaccinated individual. Based on this and other studies, CDC itself recently acknowledged that the vaccine is not effective at preventing the spread of the infection.26

35.The internet is replete with studies confirming the lasting immunity to COVID-19 experienced by individuals who have previously contracted the virus. One notable study is from the Cleveland Clinic, which found that individuals previously infected with COVID-19 did not suffer reinfection, and that ultimately, “Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination.” Exhibit 2, at 2.

Genetic Variance ​

36.For purposes of the ADA and Rehabilitation Act (which require “individual assessments” to determine “direct threat”), one of the most informative studies (published in July 2021) researched why some individuals, to include those living in the same households, had drastically different reactions to the virus, with some contracting the illness and becoming sick and/or symptomatic, and others not contracting the virus at all. The study found that it is the “genetic makeup of an individual [that] contributes to susceptibility and response to viral infection.” Exhibit 3, at 1.

FIRST CAUSE OF ACTION

(Administrative Procedure Act)

Agency Implementation of Executive Orders 14042 and 14043 Require Employers to Conduct Unlawful Medical Inquiries in Violation of the Rehabilitation Act and ADA.​

37.All preceding paragraphs are incorporated by reference as though fully set forth herein

38.The APA permits federal District Courts to review final agency action. This review includes Presidential Executive Orders as they are implemented by the Agencies (with the final agency action being the Agencies’ implementation of the Executive Orders). The federal District Courts have authority to enjoin the Agencies from enforcing unlawful

Executive Orders.​

39.Both Orders are in violation of statutes, as they require the Agencies to conduct unlawful medical inquires.

40.Employers cannot make disability-related inquiries of employees that are not shown to be job related or consistent with business necessity. An inquiry is determined to be job related and consistent with business necessity when the employer has a reasonable belief, based on objective evidence, that the employee will pose a direct threat due to a medical condition.

41.“The determination that an employee poses a direct threat must be based on an individualized assessment of the employee’s present ability to safely perform the essential functions of the job.” 29 C.F.R. § 1630.2(r).

42.“This assessment shall be based on a reasonable medical judgment that relies on the most current medical knowledge and/or on the best available objective evidence.” Id.

43.Factors for this consideration include:

(1) The duration of the risk;​

(2) The nature and severity of the potential harm;​

(3) The likelihood that the potential harm will occur; and​

(4) The imminence of the potential harm.​

44.Under the mandates, as implemented by the Agencies, no such individual can, or will, be conducted, thus making the requirement to inform of one’s vaccine status in the first instance an unlawful disability-related inquiry. 45.A disability-related inquiry is one that seeks to determine if the individual

45.A disability-related inquiry is one that seeks to determine if the individual has a disability. Communicable diseases are considered disabilities. School Bd. of Nassau County, Fla. v. Arline, 480 U.S. 273, 289 (1987). By its very nature, requiring an individual to be vaccinated assumes that at some point the unvaccinated individual will contract COVID-19, a communicable disease.

46.But this inquiry cannot be deemed job related because there is no individual assessment being performed to determine individual threat. The rigidity of the vaccination mandate—i.e., receive the vaccine or face termination—does not allow for this necessary, individualized assessment

THIRD CAUSE OF ACTION

(Administrative Procedure Act)

Executive Orders 14042 and 14043, as Implemented by the
Agencies, Violate the FDCA by Requiring Individuals to
Involuntarily Receive an Unlicensed Vaccine.​

61.The FDCA clearly proscribes that a vaccine which has been authorized for emergency use only may not be administered to an individual unless the individual is given an option to refuse or accept the vaccine. In other words, the individual must be given the opportunity to engage in informed consent to the vaccine, and to be able to refuse the shot without consequences to his or her job.

62.By requiring each federal employee and contractor to receive an unlicensed vaccine that has been authorized for emergency use only, the Orders, as implemented by the Agencies, have simply bypassed this statutory requirement.

 

[TPD]

New Lawsuit vs. Federal Employee Mandate


Highlighted, per usual. Borrows my theory about the ADA.

https://cdn.locals.com/documents/47656/47656_dite8b4siij9xdx.pdf

IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION


COMPLAINT​

On September 9, 2021, President Biden issued Executive Orders 14042 and 14043, mandating that federal employees and contractors provide proof of having been inoculated with an unlicensed COVID-19 vaccine, or face disciplinary consequences in their jobs. In rushing to force COVID-19 vaccinations on the federal workforce, the President’s edicts violate longstanding statutory prohibitions against inoculations with unlicensed vaccines; the individual rights of government employees and contractors under the Rehabilitation Act, the Americans with Disabilities Act, and the United States Constitution; and exceed the President’s statutory authority in regulating federal employees. Accordingly, plaintiffs who are representative of myriad Federal Agencies respectfully request relief from this Court in the form of injunctive relief stopping these illegal, and unnecessarily broad and wide-ranging mandates.

PARTIES ​

1. Plaintiffs1 are either employed by the named Defendant Agencies or employed as federal government contractors whose customers are the named Defendant Agencies, and who have been directed to provide their vaccination statuses and receive the COVID-19 vaccine under Executive Orders 14042 and 14043. Each Plaintiff either remains unvaccinated or has not provided his or her vaccination status to Defendant Agencies and faces either termination as a federal employee or removal from a federal government contract if he or she remains unvaccinated or refuses to provide his or her vaccination status.


1. Given the hostility present in recent speeches by the President and the recent real-world example of Plaintiffs successfully challenging a school district’s mask mandate, Plaintiffs have real concern for their safety should their names be made public, and have filed this matter under pseudonym. See, e.g. CNBC “Biden says unvaccinated Americans are ‘costing all of us’ as he presses Covid vaccine mandates” (Biden said unvaccinated people are hindering economic growth, costing jobs and putting unnecessary strain on the health-care system), Sept. 24, 2021, reported at https://www.cnbc.com/2021/09/24/bid...us-as-he-presses-covid-vaccine-mandates.htmlt (last visited Jan. 4, 2022); CNN, “Biden warns of winter of 'severe illness and death' for unvaccinated due to Omicron” (“We are looking at a winter of severe illness and death for the unvaccinated -- for themselves, their families and the hospitals they'll soon overwhelm.”), reported at https://www.cnn.com/2021/12/16/politics/joe-biden-warningwinter/index.html (last visited Jan. 4, 2022); Presidential Press Conference, Jan. 4, 2022 (“The unvaccinated are taking up hospital beds and crowding emergency rooms and intensive care units. That’s displaced other people who need access to those hospitals. …So there’s no excuse, no excuse for anyone being unvaccinated. This continues to be a pandemic of the unvaccinated …. And for parents with kids too young to be vaccinated, surround your kids with people who are vaccinated”), reported at https://www.rev.com/blog/transcripts/joe-biden-covid-omicron-spike-speech-transcript (last visited Jan. 5, 2022); Texas School Board Member Publicized Personal Info of Parents who Challenged Mask Mandate,” Dec. 6, 2021, reported at: https://www.nationalreview.com/news...l-infoof-parents-who-challenged-mask-mandate/ (last visited Jan. 4, 2022).

JURISDICTION AND VENUE ​

10.This action is brought under the Administrative Procedure Act (APA), 5 U.S.C. § 701, et seq., challenging the Executive Orders’ purposeful evasion of the statutory requirements set forth under Sections 501 and 503 of the Rehabilitation Act 1973, as amended (29 U.S.C. §§ 791, 793), Title I of the American with Disabilities Act (ADA) of 1990, as amended (42 U.S.C. § 12101, et seq.) and the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 360bbb-3, et seq.). The Executive Orders further impinge on constitutional rights, and were issued in excess of the President’s statutory authority to regulate federal employees.

11.Both the Rehabilitation Act and the ADA (together referred to as “the Acts”) preclude employers from discriminating against federal employees and federal government contractors on the basis of an actual or perceived disability. The Acts further preclude employers from conducting disabilityrelated inquiries of employees that are not shown to be “job-related and consistent with business necessity.” 29 C.F.R. § 1630.14(c). An inquiry is determined to be “job related and consistent with business necessity” when the employer has a “reasonable belief, based on objective evidence” that the “employee will pose a direct threat due to a medical condition.”2 “The determination that an employee poses a direct threat must be based on an individualized assessment of the employee’s present ability to safely perform the essential functions of the job.” 29 C.F.R. § 1630.2(r).

12.The FDCA authorizes the use of medical products not yet licensed by the Food and Drug Administration (FDA) under “emergency use,” but only when the individual is “informed of the option to accept or refuse the administration of the product, … and of the alternatives to the product that are available and of their benefits and risks.” 21 U.S.C. § 360bbb3(e)(1)(A)(ii)(III).

13.The Fifth Amendment to the United States Constitution confers rights of bodily integrity and autonomy, and occupational liberty.

14.The mandates were issued under the President’s statutory authority under 5 U.S.C. §§ 3301, 3302, and 7301, which allow the President to prescribe regulations for the admission of civil servant applicants, the administration of positions in the competitive service, and the conduct of employees in the executive branch.

15.The APA permits judicial review of an Executive Order, as implemented by an Agency, which is arbitrary, capricious, not in accordance with law, contrary to constitutional right, in excess of statutory authority, and without observance of procedure required by law. 5 U.S.C. §§ 702, 704, and 706; see Chamber of Commerce of U.S. v. Reich, 74 F.3d 1322, 1328 (D.C. Cir. 1996). The declaratory relief requested herein is proper under 5 U.S.C. §§ 706(1)-(2).

STATEMENT OF FACTS
Development of Vaccines​

17.Upon best information and belief, the novel COVID-19 infection first arrived in the United States in or around January 2020. Just a few short months later, then President Trump directed the immediate development of a vaccine under Operation “Warp Speed.”

18.True to the Operation’s name and the novelty of the virus, equally novel mRNA vaccines were rapidly produced in short order. For the first time in vaccine history, a vaccine was created that did not introduce an inactive version of the virus into the human body, but rather was designed to “teach our cells how to make a protein—or even just a piece of a protein— that triggers an immune response inside our bodies.”3 From this endeavor were born three vaccines that were, and are, widely available in the United States: the Pfizer-BioNTech COVID-19 vaccine, the Moderna COVID-19 vaccine, and Johnson & Johnson’s Janssen COVID-19 vaccine.4 None of these vaccines are licensed by the FDA; rather, they have been authorized for emergency use under 21 U.S.C. § 360bbb-3 and remain under emergency use authorization as of the time of this filing.5

19.On August 23, 2021, the FDA licensed a COVID-19 vaccine originally developed by BioNTech Manufacturing GmbH, a German company, to be jointly manufactured with Pfizer. The companies were authorized to market the vaccine under the name “COMIRNATY.”6 Although comanufactured by Pfizer, COMIRNATY is “legally distinct with certain differences” from the Pfizer-BioNTech COVID-19 vaccine that was, and is, available in the United States; the Pfizer-BioNTech COVID-19 vaccine, which is the only Pfizer vaccine available in the United States, remains under emergency use authorization.7 COMINARTY is not available in the United States. 8




8 See FDA Vaccine Finder, available at: https://www.vaccines.gov/search/ (last visited Jan. 3, 2022), which does not list COMIRNATY as an option for searches seeking vaccination locations in the U.S.

Evolving Science: Vaccinated v. Unvaccinated
No Difference in Viral Load
​

33.In issuing the Executive Orders, the President asserted it was the unvaccinated, not the vaccinated, who were the sole source of COVID-19 spread. Scientific studies suggest otherwise. On September 29, 2021, a preliminary report from a study conducted by the Genome Center, University of California, Davis, stated that a review of both vaccinated and unvaccinated individuals resulted in the following:

A total of 869 samples, 500 from HYT and 369 from UeS, were included in the analysis. All analyzed samples from HYT were asymptomatic at the time of collection and 75% of the positive samples were from unvaccinated individuals (N=375). Positive samples from UeS were from both symptomatic (N=237) and asymptomatic individuals (N=132). The frequency of vaccine breakthroughs among the UeS samples (171 fully vaccinated, 198 unvaccinated) was greater than among the HYT samples reflecting the different types of populations sampled. The Delta variant was the predominant variant detected in both populations (Supplementary Table 1).​

There were no statistically significant differences in mean [cycle threshold] Ct-values of vaccinated (UeS: 23.1; HYT: 25.5) vs. unvaccinated (UeS: 23.4; HYT: 25.4) samples. In both vaccinated and unvaccinated, there was great variation among individuals, with Ct-values of 30 in both UeS and HYT data (Fig. 1A, 1B). Similarly, no statistically significant differences were found in the mean Ct-values of asymptomatic (UeS: 24.3; HYT: 25.4) vs. symptomatic (UeS: 22.7) samples, overall or stratified by vaccine status (Fig. 1B). Similar Ct-values were also found among different age groups, between genders, and vaccine types (Supplemental Figure 1).​

In all groups, there were individuals with low Ct-values indicative of high viral loads. A total of 69 fully vaccinated individuals had Ct-values <20. Of these, 24 were asymptomatic at the time of testing.​

Exhibit 1, at 6. The study goes on to note:

A substantial proportion of asymptomatic, fully vaccinated individuals in our study had low Ct-values, indicative of high viral loads. Given that low Ct-values are indicative of high levels of virus, culture positivity, and increased transmission [11], our detection of low Ct-values in asymptomatic, fully vaccinated individuals is consistent with the potential for transmission from breakthrough infections prior to any emergence of symptoms.​

Id. at 7. Even now, as the Omicron variant has spread, it is increasingly reported that the majority of those becoming infected with the variant are vaccinated, as opposed to unvaccinated.25

25 See, e.g. “Omicron is spreading at lightening speed. Scientists are trying to figure our why,” NPR, Dec. 31, 2021 (“Scientists who traced the superspreader event concluded it was evidence that omicron was ‘highly transmissible’ among fully vaccinated adults.”) reported at https://www.npr.org/sections/goatsa...dfire-scientists-are-trying-to-figure-out-why (last visited Jan. 5, 2022); “Covid Updates: Omicron Drives New U.S. Virus Cases to a Daily Record,” The New York Times, Dec. 29, 2021 (”[It] was increasingly clear that vaccinated people are being infected with Omicron, meaning that there was a reduction in the capacity of vaccines to neutralize the virus…”) reported at https://www.nytimes.com/live/2021/12/29/world/omicron-covid-vaccinetests (last visited Jan. 5, 2022); “Most reported U.S. Omicron cases have hit the fully vaccinated – CDC,” Reuters, Dec. 10, 2021, reported at https://www.reuters.com/world/us/mo...ases-have-hit-fullyvaccinated-cdc-2021-12-10/ (last visited Jan. 5, 2022). ​

34.The findings of the above study were consistent with others conducted in Massachusetts and Singapore, in which “individuals with vaccination breakthroughs caused by the Delta variant had similar Ct-values as unvaccinated individuals.” Id. Ultimately, this means the unvaccinated individual who contracts COVID-19 and has the same Ct-values as a vaccinated person who contracts COVID-19 is no more likely to spread the virus than the vaccinated individual. Based on this and other studies, CDC itself recently acknowledged that the vaccine is not effective at preventing the spread of the infection.26

35.The internet is replete with studies confirming the lasting immunity to COVID-19 experienced by individuals who have previously contracted the virus. One notable study is from the Cleveland Clinic, which found that individuals previously infected with COVID-19 did not suffer reinfection, and that ultimately, “Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination.” Exhibit 2, at 2.

Genetic Variance ​

36.For purposes of the ADA and Rehabilitation Act (which require “individual assessments” to determine “direct threat”), one of the most informative studies (published in July 2021) researched why some individuals, to include those living in the same households, had drastically different reactions to the virus, with some contracting the illness and becoming sick and/or symptomatic, and others not contracting the virus at all. The study found that it is the “genetic makeup of an individual [that] contributes to susceptibility and response to viral infection.” Exhibit 3, at 1.

FIRST CAUSE OF ACTION

(Administrative Procedure Act)

Agency Implementation of Executive Orders 14042 and 14043 Require Employers to Conduct Unlawful Medical Inquiries in Violation of the Rehabilitation Act and ADA.​

37.All preceding paragraphs are incorporated by reference as though fully set forth herein

38.The APA permits federal District Courts to review final agency action. This review includes Presidential Executive Orders as they are implemented by the Agencies (with the final agency action being the Agencies’ implementation of the Executive Orders). The federal District Courts have authority to enjoin the Agencies from enforcing unlawful


Executive Orders.

39.Both Orders are in violation of statutes, as they require the Agencies to conduct unlawful medical inquires.

40.Employers cannot make disability-related inquiries of employees that are not shown to be job related or consistent with business necessity. An inquiry is determined to be job related and consistent with business necessity when the employer has a reasonable belief, based on objective evidence, that the employee will pose a direct threat due to a medical condition.

41.“The determination that an employee poses a direct threat must be based on an individualized assessment of the employee’s present ability to safely perform the essential functions of the job.” 29 C.F.R. § 1630.2(r).

42.“This assessment shall be based on a reasonable medical judgment that relies on the most current medical knowledge and/or on the best available objective evidence.” Id.

43.Factors for this consideration include:

(1) The duration of the risk;​

(2) The nature and severity of the potential harm;​

(3) The likelihood that the potential harm will occur; and​

(4) The imminence of the potential harm.​

44.Under the mandates, as implemented by the Agencies, no such individual can, or will, be conducted, thus making the requirement to inform of one’s vaccine status in the first instance an unlawful disability-related inquiry. 45.A disability-related inquiry is one that seeks to determine if the individual

45.A disability-related inquiry is one that seeks to determine if the individual has a disability. Communicable diseases are considered disabilities. School Bd. of Nassau County, Fla. v. Arline, 480 U.S. 273, 289 (1987). By its very nature, requiring an individual to be vaccinated assumes that at some point the unvaccinated individual will contract COVID-19, a communicable disease.

46.But this inquiry cannot be deemed job related because there is no individual assessment being performed to determine individual threat. The rigidity of the vaccination mandate—i.e., receive the vaccine or face termination—does not allow for this necessary, individualized assessment

THIRD CAUSE OF ACTION

(Administrative Procedure Act)

Executive Orders 14042 and 14043, as Implemented by the
Agencies, Violate the FDCA by Requiring Individuals to
Involuntarily Receive an Unlicensed Vaccine.​

61.The FDCA clearly proscribes that a vaccine which has been authorized for emergency use only may not be administered to an individual unless the individual is given an option to refuse or accept the vaccine. In other words, the individual must be given the opportunity to engage in informed consent to the vaccine, and to be able to refuse the shot without consequences to his or her job.

62.By requiring each federal employee and contractor to receive an unlicensed vaccine that has been authorized for emergency use only, the Orders, as implemented by the Agencies, have simply bypassed this statutory requirement.

Since the beginning people have been citing HIPPA. During my legal battle with SMCHD I cited ADA because that is what was protecting me and my employees. ADA law is what won the case for us.

 

[GURPS]

Since the beginning people have been citing HIPPA. During my legal battle with SMCHD I cited ADA because that is what was protecting me and my employees. ADA law is what won the case for us.

2 things ...

As stated in the above court case Experimental medicine cannot be mandated .....

also

COMIRNATY is “legally distinct with certain differences” from the Pfizer-BioNTech COVID-19 vaccine that was, and is, available in the United States; the Pfizer-BioNTech COVID-19 vaccine, which is the only Pfizer vaccine available in the United States, remains under emergency use authorization.7 COMINARTY is not available in the United States. 8

The Covid Tests are also under EUA ... and as such cannot be mandated


but no one is willing or can afford to challenge businesses against their Vax or Test Polices in court

 

[GURPS]

Walmart Sued for Denying Ivermectin Px

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA WILLIAM SALIER, KARLA SALIER,

Plaintiffs,

Dkt. No.: 0:22-cv-00082

v.

WALMART, INC.; HY-VEE, INC.,
Defendants.
January 13, 2022​

COMPLAINT 1. This is an action for compensatory and punitive damages against two pharmacies who substituted politics and corporate policies for a doctor’s judgment as to what was best for her patients and denied them life-saving medicine, forcing them to take horse paste to save their lives.



15. Dr. James quickly realized that William’s condition was extremely serious and that he was on the verge of requiring intensive care unit treatment, which would leave him with less than a 50% chance of survival, unless he received effective treatment immediately.

16. She wrote William a prescription for several treatments including Ivermectin, and she sent it to the Walmart pharmacy in Albert Lea, Minnesota.

17. Walmart’s pharmacist called Karla Salier to inform her that Walmart refused to fill Dr. James’ prescription of Ivermectin, stating that it was not appropriate to treat COVID-19 patients with it.

18. Karla Salier informed him that her husband was seriously ill and pleaded with him to fill the prescription according to their doctor’s orders. Instead of responding politely, Walmart’s pharmacist proceeded to lecture her about how Ivermectin was dangerous for her husband despite his doctor’s prescription, and he again refused to fill the prescription.

19. Karla Salier informed Dr. James who called the Walmart pharmacist herself and asked him to fill the prescription, explaining that it was safe to treat COVID19 patients and that he was interfering with her treatment of a critically ill patient. The Walmart pharmacist continued to refuse to fill the prescription and attempted to lecture Dr. James about how she was imperiling the Saliers’ health. He then hung up on her.

20. Karla Salier also fell sick with COVID-19, and Dr. James prescribed her ivermectin and hydroxychloroquine, which the same Walmart refused to fill for the same reasons at the same time that it declined to fill William’s prescriptions.

21. The Saliers then attempted to have their prescriptions filled at a Hy-Vee supermarket in Albert Lea, Minnesota. Hy-Vee’s pharmacist told them that it was its corporate policy to refuse Ivermectin and hydroxychloroquine prescriptions to treat COVID-19. Hy-Vee’s pharmacist, however, filled every other prescription that Dr. James issued.

22. With no other options, his doctor warning that his sickness was placing his life in danger, and facing potential death if he did not follow his doctor’s instructions, William Salier did what Marines are trained to do: He improvised. Relying on his farming experience, he and Karla purchased the veterinary version of Ivermectin - a tube of horse paste with Ivermectin as its only active ingredient

23. After calculating the appropriate dosage according to the guidance that Dr. James gave them, Salier and his wife mixed the dosage of horse paste into dishes of apple sauce and consumed it in multiple doses just as they would consume a regular mediciation.

24. Within 24 hours of regularly consuming Ivermectin horse paste, Salier and his wife noticed a rapid and significant improvement in their conditions

25. After a week of consistently self-treating themselves with Ivermectin horse paste, both had recovered sufficiently to resume their normal activities with some moderate limitations. 26. After two weeks, both had resumed their normal lives. 27. Neither William or Karla Salier experienced any negative health problems from Dr. James’ prescriptions.

Prescriptions For “Off-Label” Use Are Common And Relatively Non-Controversial In The United States ​

28. Prescriptions for “off-label” use occur when a doctor prescribes an FDAapproved drug for an unapproved use.1

29. No federal law prohibits physicians for issuing prescriptions for “off-label” use.

30. The U.S. Federal Drug Administration (FDA) takes the position that healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patients.2

31. In fact, it has taken the position in formally issued guidance that “[g]ood medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement.”3

32. According to a February 23, 2021 Congressional Resarch Service Report, data from 2006 shows that approximately 21% of prescriptions in the United States are issued for off-label uses. See Exhibit A, p. 2. A 2016 Canadian study founds that approximately 12% of prescriptions are issued for off-label uses. Id. at p. 2. A 2018 study estimated that the number was closer to 38%. Id. at p. 3. Finally, according to another 2018 study, the number is much higher in the field of oncology where 56% of prescriptions were for off-label uses. Id. at p. 3.

Data Shows That Ivermectin Is Safe & Effective. ​

35. The FDA gave full approval to ivermectin as a safe drug in 1996, and the World Health Organization includes it on its List of Essential Medicines.

36. In 2015, Ivermectin’s discoverers won the 2015 Nobel Prize for Physiology or Medicine for discovering Avermectin, which they then modified to create Ivermectin.

37. More than 4 billion doses of Ivermectin have been administered worldwide, and only 28 cases of serious adverse reactions to it have been reported. See Pierre Kory, et al., Review of The Emerging Evidence Demonstrating The Efficacy Of Ivermectin In The Prophylaxis And Treatment Of COVID-19, American Journal of Therapeutics, Vol. 28, Issue 3, pp. e299-e318 (May/June 2021).

38. Ivermectin is effective in inhibiting at least 21 viruses, including HIV-1, dengue, Zika, the West Nile Virus, and COVID-19. See David A. Jans and Kylie M. Wagstaff, The Broad Spectrum Host-Directed Agent Ivermectin As An Antiviral For SARS-COV-2? Biochemical and Biophysical Research Communications, Vol. 538, pp. 163-172 (Jan. 29, 2021).

39. While the National Institute of Health has delayed its stamp of approval to Ivermectin as a COVID-19 treatment for political reasons, studies have demonstrated Ivermectin’s overwhelming efficacy against COVID-19, including studies that have shown that it reduces the active viral load of COVID-19 in cells by 99.8% in 24 hours and 99.98% in 48 hours. See Leon Caly, et al., The FDA-approved Drug Ivermectin Inhibits The Replication Of SARS-COV-2 In Vitro, Journal Of Antiviral Research, Vol. 178 (Jun. 2020); see also Pierre Kory, et al., Review of The Emerging Evidence Demonstrating The Efficacy Of Ivermectin In The Prophylaxis And Treatment Of COVID-19, American Journal of Therapeutics, Vol. 28, Issue 3, pp. e299-e318 (May/June 2021).

 

[Hijinx]

There has to be a reason that the Government denies Americans the use of a medicine that works.
What is that reason? I can only give my opinion.

Big Pharma does not make enough money off of it, and they have produced their own medication that is expensive, and they want it sold.
Big Pharma pays a lot of bribe money to politicians to get the to do their bidding, and politicians are earing those bribes by making the use of Ivermectin and HCQ unavailable. Instead they push a vaccine that does not work.

 

[GURPS]

There has to be a reason that the Government denies Americans the use of a medicine that works.
What is that reason? I can only give my opinion.

The Gov PROMISED America WE WILL SAVE YOU

So the narrative became Vax or NOTHING ..... if there is a treatment - no EUA for Vax's or Tests

no one is making money off of Ivermectim or HDQ

 

[Hijinx]

The Gov PROMISED America WE WILL SAVE YOU

So the narrative became Vax or NOTHING ..... if there is a treatment - no EUA for Vax's or Tests

no one is making money off of Ivermectim or HDQ

The old rule.
Follow the Money. It never fails.

 

[GURPS]

Judge Blocks Biden Vax Mandate For Federal Workers


A federal judge on Friday blocked a Biden administration order mandating that federal employees be vaccinated against COVID-19.

U.S. District Judge Jeffrey Brown ruled against the Biden administration, arguing that President Joe Biden lacked authority to “mandate that all federal employees consent to vaccination against COVID-19 or lose their jobs.”

“The court notes at the outset that this case is not about whether folks should get vaccinated against COVID-19—the court believes they should. It is not even about the federal government’s power, exercised properly, to mandate vaccination of its employees,” Brown wrote.

“It is instead about whether the President can, with the stroke of a pen and without the input of Congress, require millions of federal employees to undergo a medical procedure as a condition of their employment. That, under the current state of the law as just recently expressed by the Supreme Court, is a bridge too far,” the judge said.

 

[TPD]

Judge Blocks Biden Vax Mandate For Federal Workers


A federal judge on Friday blocked a Biden administration order mandating that federal employees be vaccinated against COVID-19.

U.S. District Judge Jeffrey Brown ruled against the Biden administration, arguing that President Joe Biden lacked authority to “mandate that all federal employees consent to vaccination against COVID-19 or lose their jobs.”

“The court notes at the outset that this case is not about whether folks should get vaccinated against COVID-19—the court believes they should. It is not even about the federal government’s power, exercised properly, to mandate vaccination of its employees,” Brown wrote.

“It is instead about whether the President can, with the stroke of a pen and without the input of Congress, require millions of federal employees to undergo a medical procedure as a condition of their employment. That, under the current state of the law as just recently expressed by the Supreme Court, is a bridge too far,” the judge said.

Great news! Now what happens to those who were already fired!

 

[my-thyme]

Or got vaccinated to keep their job? I know a few who were cussing the entire time they were filling in the paperwork and getting jabbed.

Where's the vindication for them?