Pfizer FOIA Case

Pfizer FOIA Case

Pfizer FOIA Case

Re: the Legality of Pfizer taking 75 years to release the data on its covid vaccine

 

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Facts of the Case

  • Dates: Jan 6, 2022
  • Location: USA
  • Court: US District Court for the Northern District of Texas, Fort Worth Div.
  • Case #: 4:21-cv-1058-P
  • Plaintiff: PHMPT, Plaintiff
  • Defendant: FDA
  • Trial Type: FOIA Request
  • Judge:
  • Status: Dedided
  • Verdict: for the Plaintiff


 

Background

The Firm of Attorney Aaron Siri, on behalf of Public Health and Medical Professionals for Transparency (PHMPT), and an unnamed client made a request : that the FDA produce all the data submitted by Pfizer to license its Covid-19 vaccine. [1]

The FDA asked the Court for permission to only be required to produce at a rate of 500 pages per month, which would have taken over 75 years to produce all the documents. [1]

 

This case involves the Freedom of Information Act (“FOIA”). Specifically, at issue is Plaintiff’s FOIA request seeking “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System” from the Food and Drug Administration (“FDA”). See ECF No. 1. As has become standard, the Parties failed to agree to a mutually acceptable production schedule; instead, they submitted dueling production schedules for this Court’s consideration. Accordingly, the Court held a conference with the Parties to determine an appropriate production schedule.[1] See ECF Nos. 21, 34. [2]

 

Significance

According to Siri, this case about the importance of transparency and the excessive role of : government federal “health”  authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission. [1]

 

Plaintiff’s Argument

The Plaintiff argued that the documents should be made public as it has a right to know what it has bought and paid for.  The issue is about transparency and the ability of scientists and everyone involved in the management of a crisis to have the best information available in order to serve the society as efficiently and usefully as possible. [1]

No person should ever be coerced to engage in an unwanted medical procedure. And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead. That form of governance is destructive to liberty and antithetical to the openness required in a democratic society. [1]

 

Defendant’s Argument

…More information is needed…

 

Relevant Prior Judgements/ Cases

The Court order discussed the following cases: [2]

  • “[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “
  • FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’” Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep’t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)).
  • And “Congress has long recognized that ‘information is often useful only if it is timely’ and that, therefore ‘excessive delay by the agency in its response is often tantamount to denial.’” Open Soc’y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)).
  • When needed, a court “may use its equitable powers to require an agency to process documents according to a court-imposed timeline.” Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014).

 

Decision

A federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month! [1]

The Judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities. He then aptly quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.” [1]

According to the order: [2]

“[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’”
there may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . .” ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance. [2]
“[S]tale information is of little value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary.[2]
Accordingly, having considered the Parties’ arguments, filings in support, and the applicable law, the Court ORDERS that:
[2]

  1. The FDA shall produce the “more than 12,000 pages” articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022.
  2. The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.
  3. To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted.
  4. The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.

Aftermath

…More information is needed…

 


Further Research

Court Documents:
In the news:
  • …More information is needed…

other:

 

Media

……

source: ….

….

source: ….

 

References

  1. Court Orders FDA to Produce Pfizer Covid-19 Data at a rate of 500 pages per month
  2. The Judge’s Ruling / Order

 

Keyword

Aaron, Adverse reactions, CDC, Data, FOIA, Informed Citizenry, JFK, Kennedy, License, Madison, Pfizer, Secrecy, Siri, Transparency, Trial, usa, Vaccine, VAERS


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Tenerife Child Vaccination Case

Tenerife Child Vaccination Case

Tenerife Child Vaccination Case

Re: the decision of which parent has precedence in administering or withholding a new medical prophylactic treatment to their child

 

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Facts of the Case

  • Dates: Dec 1, 2021
  • Location: Santa Cruz de Tenerife, Spain
  • Court: Court of First Instance
  • Case #: 0000482/2021
  • Plaintiff: Mother of child

  • Defendant: Father of child
  • Trial Type: Family Law Resolution
  • Judge: ??
  • Expert: Sergio Pérez Olivero- PhD Chemical Sciences
  • Status: Ruled Dec 10 2021
  • Verdict: For the Plaintiff


 

Background

This case involves adjudication of a dispute between a mother and father living on the island of Tenerife, Spain. The father wished for the vaccination of his 15-year-old son with the Covid-19 vaccine because he simply trusted that it would be good for his child. The mother, on the other hand, had done independent research into the vaccine and considered that the potential risks of vaccination to the child’s present & possible future health outweighed any potential benefits. (1 & 2)

This case was initiated by the father, who on 13th September 2021 submitted a written request for a legal judgement in a family dispute. He indicated that the mother of his minor child did not agree that the son should be inoculated with the Covid-19 vaccine. He did not share this view and considered it harmful to his child’s health. No medical report or any document in support of his request was attached to the application, only a fax document sent by the mother explaining the reasons why she objected to her son receiving the vaccine, the birth certificate of the son and the divorce decree. (1& 2)

The application was admitted to court on 2nd November 2021, a statement was taken from the minor on 30th November 2021. The case was heard on 1st December 2021.

 

Significance

This appears to be the first case in a European court of justice where a successful challenge has been made against a broad based mainstream / political imperative to vaccinate children in the absence of a detailed scientific / epidemiological rational that has broad acceptance among experts. In fact the whole policy of vaccination of children is a highly contested area.

 

Plaintiff’s Argument

The mother’s arguments against giving her son the covid vaccine were based upon the principle of prudence because the effects of the vaccine in the medium and long term are unknown, as the clinical trials have not been completed.

One of the documents provided by the mother was an independent scientist’s report provided by Mr. Sergio Pérez Olivero, PhD Chemical Sciences.  The judge considered this fulfilled legal requirements to be viewed as expert opinion, without it being necessary for the expert to appear at the hearing, and without prejudice to the fact that even if it were not considered an expert report, its probative value as documentary evidence may be deployed. (1)

 

Defendant’s Argument

The father’s arguments for giving the vaccine to his son were based on his understanding that this would be the best thing for his son. He considers that the Covid vaccine is good and will protect the son.

 

Relevant Prior Judgements & Considerations 

  • Judgment 377/2003 handed down by the 2nd Section of the 2nd Chamber of the Castile and León High Court of Justice on 7 October 2003 (and subsequently confirmed by the Supreme Court), upheld a claim for financial liability for injuries suffered by a man (born in 1971) as a result of compulsory vaccination against smallpox in 1975, which caused him to suffer from post-vaccination encephalitis when he was four years old, which has degenerated over time, giving rise to the ailments he suffers today, which have meant that he is unable to work in the profession for which he was training as a Tourism Technician.
  • It is also worth highlighting the well-known case of thalidomide, a drug that was given to pregnant women in Spain in the 1960s, under the belief that it was good for them, and which more than fifty years later, given the malformations of children whose mothers ingested the drug during pregnancy, led to the publication of Royal Decree 1006/2010, of 5 August, which regulates the procedure for granting aid to people affected by thalidomide in Spain during the period 1960-1965. (Judgment no. 426/2014 of the High Court of Justice of Madrid, Litigation Section 10, handed down on 6 June 2014).

 

Decision

  • The judge dismissed the application made by the father and conferred the power to decide on the inoculation of the child to the mother. The power is conferred for a period of 2 years from the decision date (the maximum period available).

Some key excerpts from the judges statement / summation (English translation) of the case: (2)

The present controversy between two parents must be resolved in accordance with the evidence and what has been accredited in this case, leaving aside the opinions or personal considerations that each one may have regarding the controversial issue of the Covid vaccine. And in this sense, we must emphasize that the [mother] parent provided, prior to the hearing, abundant medical and scientific documentation on the vaccine, which has been passed on to the other parties, and that the father [parent] and the Public Prosecutor’s Office have not provided or proposed any evidence, except for the interrogation of both parents.

And so, let us now focus on what is at issue in this dossier, which is the vaccination of a specific 15-year-old child.

First of all, as it is a minor we are dealing with here, we are going to look at the incidence of Covid in minors. In this regard, the latest report of the Carlos III Institute (an autonomous public body attached to the Ministry of Economy and directed by the Ministry of Science and Innovation), which reveals that from 22 June 2020 to 9 June 2021, 22 children under 19 years of age have died in Spain as a result of SARS-CoV-2 infection, and 229 have been admitted to the Intensive Care Unit for this age group, has been brought to the proceedings by the parent. Thus, it can be concluded from this report that the mortality rate due to COVID-19 in Spain in children under 19 years of age in the year analysed was 0.00023861% and the rate of hospitalisation in the ICU in the same period was 0.002484%.

Therefore, what we intend to highlight by pointing out this case law is that the risks and adverse effects of the Covid vaccine, like those of any medicine, drug or vaccine, can appear many years after its ingestion or inoculation and that the fact that they appear late does not mean that they will be mild effects or sequelae, as there is nothing to prevent them from being serious ailments. In addition, and although We do not know what will happen in the medium or long term, according to the documentation provided by the mother, serious adverse effects have already been documented in the short term, such as myocarditis and pericarditis, which suggests, at the very least, extreme caution in the inoculation of children with the vaccine.

Another of the points that have been dealt with in the present case is that of informed consent, which the mother claims is non-existent. In fact, the administration of a drug must be preceded by a weighing up of possible risks and expected benefits, and this weighing up must be carried out by the doctor (to determine the “prescription or therapeutic indication”), by the health administration itself and, of course, by the user of the health services (in this case, the parents of the minor). In the case at hand, such weighing is not carried out by any medical practitioner, given that there is no requirement that the Covid vaccine be prescribed or prescribed or issued as a referral or similar by any medical practitioner.

 

Aftermath

The judge has noted that the ruling may be appealed against.

 


Further Research

Court Documents:
In the news:
  • …More information is needed…

 

Media

……

source: ….

….

source: ….

 

References

  1. Summary of the hearing (in Spanish): PDF document

(The authenticity of this copy can be checked at https://sede.justiciaencanarias.es/sede/tramites-comprobacion-documentos , using the following electronic document number: A05003250- 3856938a0cb315530cdb3d37bbd1639135515269)

  1. A working English translation from the Spanish Summary (created by CoronaCases)

 

Keyword

Child, Parents, Spain, Tenerife, Vaccination, Vaccine, Vaccines, risk-benefit analysis, adverse reactions, child vaccination, precautionary principle, long-term effects, family dispute


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DrWhiteCensureCase

DrWhiteCensureCase

Dr White Censure Case

Re: Legality of Censuring & Ostracizing Employment based on giving professional expert opinions regarding Covid

 

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Facts of the Case

  • Dates: (Hearing) Nov 4 2021
  • Location: Royal Courts of Justice, London, England
  • Court: The High Court of Justice, Queen’s Bench Division Administrative Court
  • Case #: CO/3095/2021
  • Plaintiff: Dr. Sam White
  • Defendant: The General Medical Council
  • Trial Type: Decision Review of the Interim Orders Tribunal
  • Judge: The Honourable Justice Dove
  • Status: Final Ruling
  • Verdict: For The Plaintiff

** This case was reviewed & edited by the plaintiff Dr White

 

Background

Dr. Sam White is a UK General Practitioner with over 17 years experience. He now practices independently in functional medicine. In 2020, he was working as a doctor and partner in a Hampshire medical practice. Shortly after the announcement of the pandemic he became concerned about the entire government narrative, and the medical measures being recommended by NHS England for Covid19. He felt it was antithetical to all of his prior understanding of what medicine is, and should be.

He realized that the testing was grossly unreliable and the agenda was moving very rapidly toward experimental anti-Covid immunization injections, referred to as vaccines- developed and brought onto the market under EUA (Emergency Use Authorization). Dr. White’s own research into these gene based therapies had led him to believe they were not safe or efficacious as advertised, and that to administer them to his patients would cause a personal ethical conflict with his doctor’s Hippocratic Oath to ‘first, do no harm’. There had never been a successful Coronavirus vaccine brought to market and the SARS-CoV-1 animal studies (in which all of the animals developed antibody dependent enhancement) had convinced him that the proposed vaccine schedule would be extremely dangerous. He did not want any part of it.

In these circumstances, Dr. White felt he had to resign from his practice in early 2021. He had already written detailed submissions on his research in his five year re-validation and re-licensing with the GMC in late 2020. He had said he would resign if experimental mRNA vaccines were introduced, while safe and proven therapeutics continued to be suppressed. Neither the NHS or GMC took any notice whatsoever and they certainly were not concerned about the content of what he had written. In April 2021, Dr White’s re-licensing for a further 5 years was approved by a ‘Responsible Officer’ acting on behalf of the GMC. Dr White’s concerns only became a problem for NHS England and the GMC when he subsequently posted a video on social media (see below) in June 2021 (1) explaining to the public why he resigned. Dr White’s reasons for resigning only became of concern to the regulator once over 1 million members of the public were privy to his views. Dr White was first suspended by NHS England by emergency order (by the same ‘Responsible Officer’ who just two months prior had recommended his re-licensing) and subsequently also by the GMC.

Among other reasons he explained that …

He could no longer work in his previous roles ‘because of the lies’ surrounding the NHS and government approach to the pandemic which have been ‘so vast’ he could no longer ‘stomach or tolerate’ them. He claimed doctors and nurses were ‘having their hands tied behind their backs’ preventing them from using treatments that had been established as being effective both as prophylaxis from Covid19 infections and as treatments for it.

Once this video went viral,  both the NHS and GMC made allegations that Dr White might be suffering a profound mental health disorder and being disinhibited. They felt able to make such allegations, without any medical assessment whatsoever.

Dr White’s law firm wrote a complaint letter (3) to the Chief Executive of NHS England on 2nd July stating (among other points) that:

My client has instructed me to write to you setting out the complaint that he has been

victimized and harassed for telling the truth by the organization you head.

Clinicians should feel able to voice genuine concerns relating to alleged malpractice

without fear for their ability to practice within the NHS being suspended.

The truth that Dr White is telling may be uncomfortable for you to hear. But hear it you

must. I am instructed to copy this letter to the relevant regulators as well as law enforcement.

No reply was ever received to this letter.

Dr. White’s license to practice was later reinstated, but made conditional on a number of measures with instructions from the Interim Orders Tribunal (IOT) hearing on 17th Aug 2021. Prior to this hearing, Dr White had submitted hundreds of pages of evidence to the tribunal including both expert witness testimony and peer reviewed literature detailing all of the reasoning for each of his claims. By comparison, the GMC relied merely on 18 (out of over 1 million) anonymized complainants citing allegations of ‘misinformation-’ without any evidence that it was indeed, ‘misinformation.’ The IOT commenced proceedings that day by announcing that they were not there to determine ‘matters of fact.’ Despite this, they sided entirely with the GMC, repeating the claim that Dr White was citing misinformation.

These conditions required that he refrain from posting further information about his pandemic views on social media for a period of at least 18 months. The orders were vague and not specified. His solicitor sought clarification but this was denied.

The controversial conditions at the heart of the IOT to impose conditions on his registration were as follows:

“4. He must not use social media to put forward or share any views about the Covid-19 pandemic and its associated aspects.

5. He must seek to remove any social media posts he has been responsible for or has shared relating to his views of the Covid19 pandemic and its associated aspects.”  (6)

In several respects, treatment by his professional body bore remarkable similarities to the fate of Swiss cardiologist, Dr. Thomas Binder, who spoke out in April 2020 and was arrested and subjected to a psychiatric examination while held in custody for one week (2 & 5).

Although Dr. White has fully explained, for example during testimony given to the German Corona Investigative Committee (4), that his views are evidence based and founded on his considerable scientific research, the GMC maintained that he was spreading misinformation that could present a risk to patients.

 

Significance

First case in the UK to overturn an illegal gag order placed on a UK doctor censured by his professional body for posting his scientifically researched views on the Covid crisis on social media.

 

Plaintiff’s (Claimant’s) Argument

Dr White’s lawyers, led by Francis Hoar instructed by PJH Law, appealed under Article 10 of the Human Rights Act 1998, which states that everyone has the right to freedom of expression, although the law may be subject to conditions or restrictions necessary in a democratic society. Surely doctors should never be silenced in a democratic society? 

Dr White said: “If I lose my ability to speak freely, so will other doctors.” (5)

Important to understand is that the rights and wrongs of Dr. White’s treatment were argued not on the basis of the views he expressed but on the basis of his fundamental human right to free speech.

 

Defendant’s Argument

The GMC’s argument was represented by Alexis Hearnden

The defendants argument was based on the assertion that Dr. White was spreading ‘misleading information’ that could present a risk to patient health. This extract from the Judge’s summation of the court decision is illustrative of the content:

“- Through a social media video, Dr White spread misinformation and inaccurate details about the Coronavirus and how it is diagnosed and treated, including saying the vaccine is a form of genetic manipulation which can cause serious illness and death and that he advised against wearing masks.

 

Relevant Prior Judgements

…More information is needed…

 

Decision

The judgement passed by The Honourable Justice Dove on 3rd Dec 2021 restored Dr White’s freedom of speech and the IOT conditions were nullified (5)

(See below for) Sam White’s video to his followers, 3rd Dec. 2021  (7)

 

Aftermath

This case is not over as far as Dr. White and his lawyers are concerned. Dr. White is  determined to be vindicated in his evidence based scientific assessment of what is the best medical practice for Covid19 prevention / treatment. His lawyers have sent a number of questions addressed to the CEO of NHS England. (8)

This case is not over as far as Dr. White and his lawyers are concerned. Dr. White is determined to be vindicated in his evidence based scientific assessment of what is good for his patients.

  •  

His lawyers have sent a (a letter with a) number of questions addressed to the CEO of NHS England … Amanda Pritchard explaining how many of his June predictions had now been proved right. (8)

The letter (8) says that:

the public have had their health, wellbeing and lives put at risk because the NHS adhered to government diktat by cutting the role of primary care and keeping GPs out of the loop with Covid cases throughout 2020. As a consequence of that decision, early diagnosis and treatment was denied to many patients and prophylactic therapeutic treatments, used elsewhere to great effect, were being denied to NHS patients.’

The 12-page letter goes on to say how the introduction of the vaccine passport will compromise informed consent and could prevent patients exercising free will in consenting to vaccination.

It also criticizes masks and says: ‘Wearing face coverings in health care settings had not been properly risk-assessed. There is evidence that masks do harm, particularly children.’ (7)

Dr White’s focus will now: be on protecting children from the experimental mRNA vaccines made by Pfizer and Moderna, as they can cause myocarditis.

He said: ‘The outcomes for myocarditis are not “mild”, as the government like to tell us. It’s a condition that has a 50 per cent mortality rate after five years and 20 per cent after one year. It is extremely serious. It can kill and is a problem for healthy young men who get the vaccine who are at virtually no risk from Covid.

But the guilt has now lifted. I can tell people what’s going on and share the peer review evidence I have. One of the most important bits of information is if you’ve had Covid, your immunity is long lasting and robust, whereas Pfizer vaccine immunity for example, begins to wane after six months. People should be told this before they are vaccinated as part of informed consent, but it is generally ignored.’

  •  

Further, a complaint letter (9) was sent on 7th Dec addressed to Charlie Massey, Chief Executive of the General Medical Council. The complaint is about a Doctor Hilary Jones registered with the GMC, who regularly appears on Good Morning Britain news show. The specific question is whether Dr Jones made misleading and untrue statements which posed a risk to patient safety and whether the GMC took sufficient action to establish this or not following an anonymous complaint (E2-7599ZL) lodged with them on 12th August 2021. (ref link).

Further actions are also planned soon.

 

Further Research

 

Media

Dr. White Interview -Jan 16, 2022

source: TLA-Vagabond

Dr. White’s Social Media Post, June 4 2021

**banned video**

source: shortXXvids

Dr White’s Testimony to Corona-Ausschuss

source: longXXvids

Dr White Announces Verdict

source: shortXXvids


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