Florida Ends Mask Mandate Case

Florida Ends Mask Mandate Case

Florida Ends Mask Mandate Case

Re: the Legality of CDC’s authority to mandate masks

 

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Facts of the Case

  • Dates: (filed) July 12, 2021
  • Location: Tampa, Fla, USA
  • Court: US District Court, Middle District of Florida, Tampa Div
  • Case #: 8:21-cv-01693 \ 8:21-cv-1693
  • Plaintiff: HFDF, Ana Carolina Daza & Sarah Pope
  • Plaintiff’s Lawyer: Hadaway
  • Defendant: Joe Biden, CDC, HHS
  • Trial Type:
  • Judge: Kathryn Kimball Mizelle
  • Status: Decided (April 18, 2022)
  • Verdict: for the Plaintiff


*updated April 27,2022

Background

The lawsuit – challenging the validity of Mask Mandates–  was brought by two Florida residents who argued that being required to wear masks on airplanes aggravated their anxiety—a condition that is not exempted from forced masking under the mandate. They are represented by the Health Freedom Defense Fund (HFDF). [3]

HFDF is a not-for-profit public benefit Wyoming corporation with its headquarters in Sandpoint, Idaho. HFDF is a member organization that seeks to advocate for and educate the public on the topics of medical choice, bodily autonomy, and self-determination, and
that opposes laws and regulations that force individuals to submit to the administration of medical products, procedures, and devices against their will. [5]

The CDC is not a nationwide police force, and is not empowered to make laws,” said Leslie Manookian, Founder and President of Health Freedom Defense Fund. “Nevertheless, with no legal authority to do so, these unelected, unaccountable technocrats have forced every citizen in America to wear a mask when they travel. We believe that Americans have the right to think for themselves and make their own health care choices without the meddling of government. Americans must not be dictated to in this manner by anyone, let alone unelected, unaccountable technocrats at CDC.” [4]

 
the order

The mask-wearing requirement had been initially imposed in early 2021, shortly after President Joe Biden took office in an effort to slow the spread of COVID-19. [1] – Executive Order Number 13998 issued by Defendant Biden on January 21, 2021 [5].

Shortly thereafter, the nationwide mask mandate was issued by the CDC  –  a department of HHS, on January 29, 2021, entitled, “Requirement for Persons to Wear Masks While on Conveyances and at Transportation Hubs” (the “Mask Mandate”), 86 Fed. Reg. 8025, [5]

Just last week, the (CDC) agency extended the transportation mask mandate (which had been set to expire originally on April 18) through May 3 — allowing officials to take more time to study the BA.2 subvariant of COVID-19. [1]

 
The Problem with Mask Mandate

“The fact is that the police power — that is the power to regulate the health, safety and welfare of Americans — was specifically reserved to the States by our Constitution,” said George Wentz of the Davillier Law Group, legal counsel for the Plaintiffs. “With the mask mandate, not only does the CDC usurp the role of the States by attempting to exercise general police powers, but at the same time it steps into the shoes of Congress and makes a nationwide law. We are confident that the CDC is way out of bounds here, and the Court will strike down the mask mandate.” [4]

Masks have been approved for use by the general public under an emergency use authorization (EUA) and are considered investigational products under the law. Their efficacy has not been proven, and their short and long-term side effects have not been studied. Recent studies have shown that masks do more harm than good, and expose the wearer to levels of carbon dioxide well above levels permitted by OSHA in the workplace. [4]

Members of Health Freedom Defense Fund feel strongly that they should not, and cannot, be forced to wear masks and that no one should have the power to force another person to cover their airway. [4]

 
Airline CEO’s Call to End Masks

Last month (March 2022), governors from 21 states sued the Biden administration to end the federal public transportation mask mandate, arguing that the continued enforcement “harms the states” and interferes with some local laws. [1]

In an open letter released by the travel-industry lobbying group Airlines for America, the group is calling on the Biden administration to “sunset federal transportation travel restrictions.” The group argues that the restrictions no longer reflect the “realities of the current epidemiological environment.” [2]

The letter was signed by the leaders of 10 U.S. companies, including six of the largest airlines in the country: Alaska Airlines, American, Delta, JetBlue, Southwest and United. [2]

It makes no sense that people are still required to wear masks on airplanes, yet are allowed to congregate in crowded restaurants, schools and at sporting events without masks, despite none of these venues having the protective air filtration system that aircraft do,” wrote the CEOs of all major airlines in a letter to the Biden administration. [3]

 
21 States Challenge the Mask Mandate

Governors from 21 states are suing to end the federal public transportation mask mandate, claiming the continued enforcement “harms the states” and interferes with some local laws. [7]

“President Biden’s shortsighted, heavy-handed and unlawful travel policies are frustrating travelers and causing chaos on public transportation,” Florida Attorney General Ashley Moody, who is leading the states’ effort, said in a statement. “It’s long past time to alleviate some of the pressure on travelers and those working in the travel industry by immediately ending Biden’s unlawful public transportation mandates.” [7]

Joining the mostly Republican-led effort are three states with Democratic governors — Kansas, Kentucky and Louisiana. [7]

Last month (Feb 2022), leaders in Texas filed their own, similar complaint against the Biden administration. [7]

  • The Centers for Disease Control and Prevention’s (CDC) mandate was unlawfully issued. It was not authorized by Congress, and the CDC did not put the mandate up for notice and comment, which is ordinarily required for regulations like this. Yet a person’s failure to comply with the Administration’s mask mandate carries criminal penalties. [8]

Biden’s repeated disregard of the individual liberties of Texans is not only disrespectful to the U.S. Constitution, it is also troublesome that any president thinks they can act above the law while hardworking Americans standby,” said Attorney General Paxton. “President Biden cannot continue governing through executive edicts. Now is the time to strike down his administration’s air-travel mask mandate. I’m proud to stand alongside my friend Congresswoman Van Duyne and her counsel at TPPF to protect Texans’ liberty and the rule of law.” [8]

(Read a copy of the Texas complaint here)

Many states and cities have already lifted COVID-19 restrictions as they’ve seen a decline in cases and hospitalizations locally. [7]

The states’ lawsuit says the CDC should end its mandate in light of this trend. [7]

“More recently, even lockdown States like California have announced the end of their mask mandates. Still, the CDC unabashedly leaves its mandate intact,” their complaint says. [7]

 

Significance

This challenge could undo the power of the Federal government to enforce Mask Mandates

 

Plaintiff’s Argument

(from the original complaint) [5]

5. Plaintiffs challenge the Mask Mandate pursuant to 5 U.S.C. § 706(2) of the Administrative Procedure Act (the “APA”) on grounds that it:

a. is not in accordance with and exceeds the CDC’s statutory and regulatory authority under 42 U.S.C. § 264(a) and 42 C.F.R. §§ 70.2,
71.31(b), and 71.32(b);

b. is a rule that was enacted without observance of notice and comment procedures required by the APA; and/or

c. is arbitrary and capricious, in that it exempts children under age 2 without regard to scientific evidence of the impact of prolonged mask use on persons of all ages.


6. Alternatively, if the Mask Mandate does not exceed Defendants’ statutory and regulatory authority, then 42 U.S.C. § 264 (a) constitutes an unlawful delegation of legislative authority.


7. As well, Plaintiffs challenge the Executive Order on grounds that it constitutes an improper exercise of legislative authority by the Executive Branch, and that it further improperly asserts a general police power that has traditionally been relegated to the States, in derogation of the Separation of Powers under the United States Constitution.

Case 8:21-cv-01693 Document 1 Filed 07/12/21 Page 3 of 28 PageID 3

 

Defendant’s Argument]

…More information is needed…

 

Relevant Prior Judgements/ Cases

a Florida Federal Court has struck down the CDC’s cruise line order as unsupported by law, and five justices of the Supreme Court recently appear to have agreed that the CDC over reached with its nationwide eviction moratorium. [4]

 

Decision

U.S. District Judge Kathryn Kimball Mizelle ruled that the federal mask mandate on planes, trains, buses and other modes of public transportation is “unlawful.” [1] and Vacates It [3]

“Within the past two years, the CDC has found within § 264(a) the power to shut down the cruise ship industry, stop landlords from evicting tenants who have not paid their rent, and require that persons using public conveyances wear masks. Courts have concluded that the first two of these measures exceeded the CDC’s statutory authority under §264. … [9]

No court has yet ruled on the legality of the third. At first blush, it appears more closely related to the powers granted in§ 264(a) than either the sail order or the eviction moratorium. But after rigorous statutory analysis, the Court concludes that§ 264(a) does not authorize the CDC to issue the Mask Mandate….” [9]

“Our system does not permit agencies to act unlawfully even in pursuit of desirable ends,” writes Judge Kathryn Kimball Mizelle. [3]

Mizelle wrote in a summary that the Centers for Disease Control and Prevention had exceeded its authority and failed to follow proper rulemaking procedures. [1]

In a 59-page ruling, Mizelle argues that the mandate violates the Administrative Procedure Act, as the agency failed to prove its decision regarding implementing the mandate [1]

The ruling was detailed in analyzing the language of the CDC’s authority as written by Congress in 1944. In particular the meaning of words such as sanitation were scrutinized as to their original meaning– not the re-interpretation by the CDC today. [9]

“One definition it relies upon is even broader, defining “sanitation” as the “applying of measures for preserving and promoting public health.” If Congress intended this definition, the power bestowed on the CDC would be breathtaking. And it certainly would not be limited to modest measures of “sanitation” like masks. It would also justify requiring that businesses install air filtration systems to reduce the risks from airborne contagions or install plexiglass dividers between desks or office spaces. So too, a power to improve “sanitation” would easily extend to requiring vaccinations against CO VID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins….” [9]

Further the infringement on the powers of the state was important. As were the guidance in the statute that Congress authorised the CDC to deal with foreign travel and not domestic\interstate travel. It was also found illegal that the public were not allowed a voice which is required by law.

Finally the judge found the claim by the CDC that masks were needed without providing any evidence to prove this, extremely troubling and highly insufficient to restrict the liberties of all people including the healthy [9]

“Although a closer question than the failure to properly invoke the good cause exception, the Mask Mandate fails this reasoned-explanation standard. Beyond the primary decision to impose a mask requirement, the Mask Mandate provides little or no explanation for the CDC’s choices. Specifically, the CDC omits explanation for rejecting alternatives and for its system of exceptions. And there are many, such that the overall efficiency of masking on airplanes or other conveyances could reasonably be questioned.” [9]

“…the Mask Mandate fails this reasoned-explanation standard. Beyond the primary decision to impose a mask requirement, the Mask Mandate provides little or no explanation for the CDC’s choices. Specifically, the CDC omits explanation for rejecting alternatives and for its system of exceptions. And there are many, such that the overall efficiency of masking on airplanes or other conveyances could reasonably be questioned.” [9]

“The Mandate does not address alternative (or supplementary) requirements to masking, such as testing, temperature checks, or occupancy limits in transit hubs and conveyances. It also does not explain why all masks – homemade and medical-grade – are sufficient. Nor does it require “social distancing [or] frequent handwashing,” despite finding these effective strategies for reducing CO VID-19 transmission…” [9]

“Even if these alternatives were not so obvious that the CDC had to explain its decision to reject them, the Mandate fails to explain other significant choices. For example, the Mandate relies on studies explaining that “universal masking” reduces transmission of COVID-19 at the community level. 86 Fed. Reg. at 8028.” [9]

“But the Mandate does not require universal masking. It exempts individuals who are “eating, drinking, or taking medication” and a person who is “experiencing difficulty breathing” or who is “feeling winded.” It also excludes individuals who cannot wear a mask due to an ADA-recognized disability and all children under two years old. The Mandate makes no effort to explain why its purposes-prevention of transmission and serious illness-allow for such exceptions. Nor why a two-year-old is less likely to transmit COVID-19 than a sixty-two­ year-old….” [9]

“In sum, irrespective of whether the CDC made a good or accurate decision, it needed to explain why it acted as it did. Since the CDC did not explain its decision to compromise the effectiveness of its Mandate by including exceptions or its decision to limit those exceptions, the Court cannot conclude that the CDC “articulated a ‘rational connection between the facts found and the choices made.”[9]

 

Aftermath

Government Reaction

“The agencies are reviewing the decision and assessing potential next steps. In the meantime, today’s court decision means CDC’s public transportation masking order is not in effect at this time,” according to a Biden administration official. [1]

“Therefore, TSA will not enforce its Security Directives and Emergency Amendment requiring mask use on public transportation and transportation hubs at this time.” [1]

 
Defendant’s Response

“The court agreed with our main arguments and rejected the CDC’s justifications for the mask order,” said Daviller Law Group attorney Brant C. Hadaway. “The judge found that the CDC exceeded its statutory authority, and that the CDC’s interpretation of its authority was not entitled to deference.” [6]

“An agency is also supposed to provide notice and comment and reasonably explain itself,” Hadaway said. “The CDC’s mask order fell short of both requirements.” [6]

“Without any public comment, or serious scientific justification, CDC bureaucrats imposed a sweeping Travel Mask Mandate applying to every American over the age of two,” said HFDF President Leslie Manookian. “There are laws that set boundaries for federal agencies to protect individual freedom and the Court clearly found that CDC exceeded those limits. Unelected officials cannot do whatever they like to our personal freedoms just because they claim good motives and a desirable goal.” [6]

 
Airlines Response

United Airlines has put out an official statement that clarified that it will no longer be enforcing masks on airline travel. [10]

Effective immediately, masks are no longer required at United on domestic flights, select international flights (dependent upon the arrival country’s mask requirements) or at U.S. airports,” UA said in a statement. [10]

Alaska Airlines has also reportedly lifted its mask mandate. [10]

The TSA announced it was no longer enforcing it. [10]

Admin Official: “Today’s court decision means CDC’s public transportation masking order is not in effect at this time. Therefore, TSA will not enforce its Security Directives and Emergency Amendment requiring mask use on public transportation and transportation hubs at this time” [11]

Both United and American Airlines tell @ABC  they will continue to require masks on board aircraft for customers and employees, “despite the decision by a federal judge on Monday that struck down the federal mask mandate” as they await on more guidance from the US government. [12]

 
more

Liberty Counsel Founder and Chairman Mat Staver said,

“Since the beginning of the COVID pandemic the CDC has unlawfully exceeded its authority and discredited the agency by its contradictory and ever-changing statements. This court decision is yet another blow to the CDC and the Biden administration. Many people have been harassed, punished, and fined over the travel mask mandates stemming from the CDC’s unlawful policy. Any traveler who was punished over this mask mandate should have that punishment reversed. The CDC should be the watch dog to protect public health. However, like the FDA, it has become the lapdog for the pharmaceutical industries and specials interest groups. Liberty Counsel is continuing the fight to get all the shot mandates overturned.” [13]

 


Further Research

Court Documents:
In the news:

 

Media


VICTORY! Meet The Team Behind The CDC Mask Mandate Repeal

source: Odysee\theAmericanJournal


Court Defeats CDC Mask Mandates -Apr 22, 2022

source: odysee\shortXXvids


Masks Off! Should we Applaud?

source: Ron Paul Liberty Report


HFDF Lawyers Discuss Mask Suit & more on CA61

source: Odysee\Corona-Ausschuss


SouthWest Airways Passengers Cheer End of Mask Mandate

source: capitalismmagazine.com


Mask Science according to the Industrial Hygienists

source: tyscienceguy.com


Why Masks Don’t Work Pt. 1 -Apr 5 2022

source: odysee\shortXXvids


Why Masks Don’t Work Pt. 2 -Apr 5 2022

source: odysee\shortXXvids


US Army Doctor Vaccine Whistleblower -Apr 13, 2022

source: odysee\shortXXvids


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ICAN Placebo FOIA

ICAN Placebo FOIA

ICAN Placebo FOIA

Re: the data & proof of placebo control studies during vaccine clinical trials

 

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Facts of the Case

  • Dates: (filed) Oct 12, 2017
  • Location: New York, USA
  • Court: U.S. District Court for the Southern District of New York
  • Case #:
  • Plaintiff: ICAN
  • Plaintiff’s Lawyer: Robert F. Kennedy, Jr.
  • Defendant: HHS, FDA
  • Trial Type: FOIA
  • Judge:
  • Status: Decided
  • Verdict: for the Plaintiff


*updated: April 16, 2022

 

Background

The Department of Health and Human Services (HHS) was sent a 19-page legal notice on October 12, 2017 by the Informed Consent Action Network (ICAN) requesting confirmation that certain obligations regarding vaccine safety required under the 1986 Act had been fulfilled or will be fulfilled. [1]

Specifically at issue is the use of placebo’s (inert substances) during clinical safety trials

The notice asked (HHS) to “[p]lease explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?” [3]

ICAN sought copies of the reports HHS was required to submit to Congress every two years, starting in 1988, detailing improvements it made to vaccine safety. ICAN was represented by Robert F. Kennedy, Jr. [2]

ICAN was founded by Del Bigtree who hosts the weekly live online news program “The HighWire,” and is an Emmy-award winning producer of the CBS medical talk show “The Doctors.” He is producer of the groundbreaking documentary “Vaxxed: From Coverup to Catastrophe.” [2]

“The 1986 National Childhood Vaccination Injury Act granted economic immunity to pharmaceutical companies for vaccine injuries and hence eviscerated their economic incentive for them to take responsibility for vaccine safety,” says Bigtree. “Market forces driving vaccine safety were simply eliminated.” [2]

Congress therefore charged the Secretary of HHS with the explicit responsibility to assure vaccine safety. Biannual reports of HHS’s progress in improving vaccine safety were to be submitted to Congress. Yet, as ICAN has now proven, these reports were never created. [2]

The request included over 55 organizations whose members exceed five million Americans also voicing concern about vaccine safety. Freedom of Information Act (FOIA) documents show that the agency took the notice very seriously calling upon all internal departments and resources to craft their response. According to the FOIA documents, all HHS operating divisions, The National Vaccine Program Office, Assistant Secretary for Financial Resources, and The Office of the Assistant Secretary of Health all took part in the response. In Addition, FOIA email documents also state, “The National Vaccine Program Office staff has pulled together a draft response and is requesting that it be cleared with CDC, OGC, FDA, HRSA, NIH, and AHRQ for review prior to signature.”  [1]

Despite nine different government entities working on the response, their eventual January 18, 2018 reply was both lackluster and telling. Their brief 9-page response was unable to provide solid answers to the eleven questions asked of the agency concerning vaccine safety. The flimsily HHS reply triggered a deeply thorough 88-page response from ICAN laying out every detail concerning the problems and issues happening in regards to vaccine safety stemming from HHS. Its opening page writes: [1]

Given the gravity of HHS’s responsibility, it is deeply troubling that the majority of HHS’s letter contains little more than broad unsupported conclusory assertions. Most of these conclusory assertions do not withstand basic scrutiny. HHS’s responses even often contradict its own source materials.”  [1]

Among several concerning points, HHS choose to began their January reply by writing, “…many pediatric vaccines have been investigated in clinical trials that included a placebo.” [1]

As defined by the CDC, a “placebo” is: “A substance or treatment that has no effect on human beings.” [1]

HHS’s response also claimed that safety in these trials was reviewed for a significant duration, without specifying any duration. [3]

Recently on his show The HighWire, host Del Bigtree began publicly unpacking ICAN’s 88-page response by focusing on pre-licensure vaccine safety trials. The HHS reply contradicted itself by first admitting,

Inert placebo controls are not required to understand the safety profile of a new vaccine, and are thus not required. In some cases, inclusion of placebo control groups is considered unethical.

Later in their same letter, HHS states, “Vaccines are held to strict standards of safety.” [1]

Bigtree stated: “They’ve now printed it. So now you know for a fact that they just admitted those products you’re injecting into your kids have never been compared to a control. An inert saline injection.”​ [1]

Furthermore, according to HHS’s childhood vaccine schedule, babies receive 3 injections of each of the following vaccines between day one and 6 months of life all untested against a placebo control. [1]

 

 

Even pro-vaccine luminaries like Dr. Stanley Plotkin, vaccine authority and author of Plotkin’s Vaccines, appears to be in agreement with ICAN. Emails from a recent FOIA request show Plotkin wrote in June 2018 correspondence, “One point I do agree with [Robert F] Kennedy [Jr] about: there should be more safety studies…”​ [1]

 

 

Significance

Vaccine manufacturers insist that their products are safe and effective, despite many in the public reporting otherwise (injuries). Control experiments are essential to understanding how a medical product performs. Until this FOIA request, there has not been a public disclosure of this information casting doubt as to the “Science” underpinning the safe and effective claim. This information could harm the faith in one or all vaccines, and could be potentially destructive to this industry.

 

Plaintiff’s Argument

Given the conflicting information coming from HHS, ICAN’s 88-page response pressured their assertions writing: [1]

It is troubling that HHS chose to begin its response by misstating that prior to licensure for children “ many pediatric vaccines have been investigated in clinical trials that included a placebo.” At worst, HHS knowingly perpetuated this inaccurate claim but at best, HHS was unaware this claim was incorrect. This leaves the public to wonder what other critical assumptions underpinning HHS’s confidence in vaccine safety are incorrect.” [1]

ICAN’s original HHS notice directly pointed to concerns about the two Hepatitis B vaccines licensed for injection into one-day-old babies. Namely that the vaccines, according to the FDA’s own vaccine insert included in the original HHS notice, show that not only were the shots not tested against inert placebos, both vaccines were licensed after trials that solicited adverse reactions for only four days [Merck] and five days [GlaxoSmithKline] respectively after vaccination. To this point, HHS responded by referring back to the same inserts which contained the concerning data by simply writing, “Data relied upon in licensing infant use of hepatitis B vaccines is summarized in the respective package inserts.” [1]

ICAN’s response included a detailed chart containing every pediatric vaccine, citing to FDA documents, which indisputably proves that it was categorically false for HHS and the FDA to claim that “many pediatric vaccines have been investigated in clinical trials that included a placebo.” [3]

Perhaps one of the most damning findings referred to in ICAN’s 88-page HHS letter was titled HHS’s “Safety” Pyramid Scheme. Since inert placebo controls are not required and rarely used in vaccine safety testing, other vaccines take that role in what are referred to as “active controls.”  ICAN’s 88-page response to HHS points out to the agency the following: [1]

HHS’s own industry guidance for drug testing explains that an active control is only appropriate if it is a “drug whose effect is well-defined,” which means “historical placebo-controlled trials are available to define the active control effect.” Despite its own policy and guidance, HHS does not require this minimal assurance for vaccines.” [1]

 

 

 [SOURCE] Page 14 ICAN Response December 31, 2018

[SOURCE] Page 14 ICAN Response December 31, 2018

 

Defendant’s Argument

…More information is needed…

 

Decision

The US Department of Health and Human Services (HHS) settled a court-ordered stipulation  admitting that they could not produce 30 years of required evidence showing they have made improvements in the manufacturing, testing, warning, field surveillance, adverse reaction reporting and research on vaccines in order to reduce the risk of adverse reactions as mandated by the 1986 National Childhood Vaccine Injury Act (1986 Act). [1]

LOS ANGELES, Sept. 14, 2018 /PRNewswire/ — The U.S. Department of Health and Human Services (HHS) has admitted that, in direct violation of Federal law, it failed to provide a single vaccine safety report to Congress for thirty years, according to Informed Consent Action Network (ICAN).

HHS conceded that those reports do not exist and the Court entered an order confirming this concession. [2]

 

Aftermath

ICAN’s response:

“It is apparent that HHS doesn’t have a clue as to the actual safety profile of the now 39 doses, and growing, of vaccines given by one year of age, including in utero,” said Bigtree. “In 1986, a one-year old child received eleven doses. [2]

“HHS spends billions annually promoting vaccines and generates a steady stream of reports promoting vaccines,” Bigtree says. “Yet, when, despite Federal law, HHS cannot bother to complete the simple task of preparing a biennial report on vaccine safety, there is little hope HHS is tackling the much harder job of improving vaccine safety.” [2]

The 1986 Act shifted financial liability for vaccine injuries to the U.S. Government which has since 1986 paid over $3.9 billion for serious vaccine injuries. [2]

The reality is that none – save one – of the pediatric vaccines was licensed based on a placebo controlled clinical trial! … No proof has ever been provided. [3]

 
Further ICAN Lawsuits
  • ICAN also sued the FDA numerous times to force it to release clinical trial reports for other vaccines, including, for example, the chicken pox vaccine, which we explained in another recent legal update.
  • when the Phase III trial for AstraZeneca and the University of Oxford’s COVID-19 vaccine was underway in England using another vaccine (Menveo) as a control (instead of a placebo), ICAN filed a forceful petition demanding that the FDA mandate that all clinical trials of COVID-19 vaccines use a placebo control as well as track safety long-term in a properly sized trial.

Nine days after ICAN filed its petition, on June 30, 2020, the FDA changed course and issued emergency guidance to industry that all COVID-19 clinical trials must use a placebo control.

  • On July 17, 2020, ICAN sued the FDA in federal court demanding the entire clinical trial report for Menveo, just in case the agency was considering permitting this vaccine as a control in the AstraZeneca trial to be conducted in the United States.  On July 20, 2020, ICAN also filed a forceful amended petition with the FDA thanking it for requiring a placebo control group but demanding, among other things, that it also require that these clinical trials track all adverse events during the entire duration of the trial – not just for a limited time period.
  • Not long thereafter, in mid-September, in a highly unusual move, the full clinical trial protocols for the COVID-19 vaccines for which ICAN filed its petitions were released to the public.  See copies for each of the manufacturer’s vaccines: AstraZeneca, Pfizer, Moderna, and Johnson & Johnson.  Those protocols revealed that some of ICAN’s demands regarding the duration for tracking vaccine safety had been met.

 

Media


Tucker Carlson’s Explosive Interviview with RFK jr 26/11/2021

source: Odysee\AussieFighter


ICAN Lead Attorney, Aaron Siri on recent legal wins

source: theHighWire.com


Pandemic of the VACCINATED—75 Athletes Collapse from Heart Failure

source: Youtube\apidta

 

References

  1. The US Government Loses the Vaccine Debate
  2. ICAN vs. HHS: Key Legal Win Recasts Vaccine Debate
  3. ICAN v. FDA – ICAN Brings Lawsuit Related to “Placebo” in COVID-19 Clinical Trial

 

Keyword

1986, Adverse Reaction, Babies, Bigtree, Congress, Control, Del, Experiment, FDA, Field Surveillance, FOIA, Freedom of Information Act, GlaxoSmithKline, Health and Human Services, Hepatitis B, HHS, HighWire, ICAN, Informed Consent Action Network, Injection, Kennedy, Manufacturing, Merck, National Childhood Vaccine Injury Act, Nonprofit, Placebo, Plotkin, Reporting, RFK, Risk, Testing, US Department of, Warning 


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