Pfizer False Claims Case

Pfizer False Claims Case

Pfizer False Claims Case

Re: the Legality of Making False Safety & Efficacy Claims of the Pfizer Covid Injection

 

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Facts of the Case

  • Dates: Jan 8, 2021 (filed)
  • Location: USA
  • Court: Eastern District of Texas, Beaumont Division
  • Case #:  1:21-cv-00008-MJT
  • Plaintiff: USA ex rel  Brook Jackson
  • Plaintiff’s Lawyer: Warner Mendenhall
  • Defendant: Ventavia Research Group, Llc; Pfizer Inc; Icon Plc
  • Trial Type: Federal False Claims Act
  • Judge:
  • Status: Ongoing
  • Verdict: TBD


*updated Aug 31, 2022

Background

Brook Jackson is a Clinical Research Auditor turned whistleblower who worked for Ventavia company (a contractor for Pfizer) on the phase III clinical trial of Pfizer Covid-19 vaccine.

Jackson commenced her employment with Ventavia on 8th September 2020 as a Regional Director, supervising two of three trial sites involved in the clinical. Immediately after starting her work she observed several glaring quality outages in the way the trials were being performed, including the following:

all trial participants had been unblinded from July to September 2020 in the in the randomised double blind trials, thus invalidating the protocol (1)

  • Ventavia staff were not following the patient informed consent procedure
  • Required signatures were not being obtained and sometimes being forged
  • Vaccines were not being stored under the specified low temperature conditions
  • A dominant culture of sloppiness, rushing the work and falsifying records existed in the company
  • Adverse events were not being properly recorded

Brook explains that when the unblinding error was discovered, Ventavia staff were asked to remove the evidence and lie to Pfizer about the unblinding.

Brook subsequently shared all her findings with Ventavia expecting that they would take corrective action. However since there was no action, she anonymously reported her findings to Pfizer, again without results. Finally on the morning of 25th September she informed the FDA.

I took it to a regulatory authority that I believed and trusted … was there to protect patient safety and  look at the big picture.

Ventavia fired her 6 hours later giving as the only reason that she was not a good fit with the company.

Her lawyer, Warner Mendenhall said of her termination: This is really remarkable that the Federal government apparently has reached out to Pfizer and revealed / unblinded the whistleblower who has come forward. I mean, we actually do have a process to blind and protect whistleblowers in the country for a reason. Its so that this stuff can come forward and the information be shared with the Federal government and collected. . When I first started in the 90s I felt like the federal government was very protective of   whistle blowers  to preserve their anonymity and now, recently, I see the Federal government reaching out , in two instances recently, and unblinding the whistle blower which causes them to be fired and lose the capacity to continue to investigate.  (2)

Even after being fired, Jackson had expected that following her whistleblowing action would at least result in an inspection of the Ventavia site by FDA auditors. However, after three months waiting for this without any action from the FDA, Jackson decided to file a false claims lawsuit  against Pfizer and its associates Ventavia and ICON (3)

The lawsuit (4) was filed in Texas on Jan 8 2021. It was held under seal for 60 days during which Jackson could not talk publicly about the lawsuit. Jackson has actually said that she has been prevented from talking about the filing for a year (5).

 

Significance

First legal challenge in USA of Pfizers product safety and efficacy claims

 

Plaintiff’s Argument

Brook Jackson argues that Pfizer and its associates involved in the clinical trials are in breach of the False Claims Act because they knowingly brought the Covid-19 vaccine onto the market while making safety claims which could not be supported based on Jacksons observation of quality outages in the running of the clinical trials.

 

Defendant’s Argument

Pfizer, Ventavia and ICON have argued that the case should be dismissed because the government already knew about the fraud based on Jacksons whistleblowing actions. Therefore, they argue, a legal action under the False Claims Act is not supportable or appropriate. (5)

 

Relevant Prior Judgements/ Cases

…More information is needed…

 

Decision

This case is ongoing

 

Aftermath

This case is ongoing 

 


Further Research

Court Documents:
In the news:

 

Media


Ventavia Unblinded Randomised Trial Participants -Aug 13 2021

source: Odysee/shortXXvids


Federal Gov. Revealed Jackson’s Identity to Pfizer -Aug 13 2022

source: Odysee/shortXXvids


False Claims Act Lawsuit Filing -Aug 13 2022

source: Odysee/shortXXvids


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Child Vaccination Case

Child Vaccination Case

Child Vaccination Case

Re: the Legality of which Parent may decide if their child(ren) should be vaccinated or not

 

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Facts of the Case

  • Dates: (heard) Feb 18, 2022
  • Location: Ontario, Canada
  • Court: Ontario Superior Court of Justice
  • Case #: J.N. v. C.G., 2022 ONSC 1198 (CanLII)
  • Plaintiff: Father
  • Plaintiff’s Lawyer: Jesse Herman
  • Defendant: Mother (Self-Represented)
  • Trial Type: Family Court
  • Judge: A Pazaratz
  • Status: Decided (Feb 22, 2022)
  • Verdict: for the Defendant


*updated March 11, 2022

 

Background

A father applied for an order that his two children, LEG age 12 and MDG age 10, receive covid vaccinations, while their mother opposed this. [1] Here, the parents, both in their mid-30s, separated more than seven years ago.

The oldest, a 14-year-old boy, lives primarily with his father and chose to vaccinated against COVID-19 last fall – a decision both parents supported, the ruling says. [2]

The two younger children, a 12-year-old girl and a 10-year-old boy, live primarily with their mother. Both were interviewed twice by a social worker and explained why they didn’t want to be vaccinated, with the youngest also expressing fears that his father would force him to get the shots, the document says. [2]

The mother stressed she is not against vaccines overall, adding all three have received their regular immunizations, the ruling says. She also stated she would be open to having the younger two – who have already had the virus and recovered – get COVID-19 shots at a later date “if safety concerns can be better addressed,” it says. [2]

 

Significance

This case makes significant the importance of evidence, and careful judgment

 

Plaintiff’s Argument

The mother’s material included an article by Dr. Robert Malone, the inventor of the mRNA vaccine; a Pfizer fact sheet; a peer-reviewed article entitled “Immunization with SARS Coronavirus Vaccines Lead to Pulmonary Immunopathology on Challenge with the SARS virus”; and an article from the Centers for Disease Control and Prevention (CDC) entitled “Clinical Considerations: Myocarditis and Pericarditis after Receipt of mRNA Covid-19 Vaccines among Adolescents and Young Adults”. [1]

 

Defendant’s Argument

Finally, the Court considered information obtained from the internet including a “Position Statement” from the Canadian Paediatric Society;  a document from the Government of Canada entitled “Vaccines for Children: Deciding to Vaccinate”; and an article from the Canada Communicable Disease Report entitled “COVID-19 Cases and Hospitalizations Surge Among Children”, all proffered by the father.  [1]

The father, meanwhile, submitted fact sheets issued by the government and the Canadian Paediatric Society, as well as “numerous downloads” from the mother’s social media accounts on allegations she was promoting conspiracy theories, the ruling says. [2]

 

Relevant Prior Judgements/ Cases

Other similar cases have ruled in favor of the children being  vaccinated

 

Decision

The judgement

The decision was in favor of the mother who presented more evidence. [1]

Superior Court Justice Alex Pazaratz rejected a father’s motion to have his two younger children – ages 12 and 10 – vaccinated despite their mother’s and their own objections, and cautioned against dismissing certain viewpoints without evidence. [2]

The Judge stated that the children’s mother has the responsibility to make decisions for the children in her care; and that she has consistently made informed and child-focused decisions. He says she is not a bad parent, simply by virtue of asking questions of the government. The father’s application to vaccinate the children is dismissed [1]

The Ontario judge says he is not prepared to accept as fact that vaccinating children against COVID-19 is what’s best for them simply because it’s encouraged by the government, noting a number of factors – including the children’s own preferences – must be taken into account. [2]

Weighing the Evidence

The mother’s evidence focused entirely on medical and scientific evidence while the father focused on labelling and discrediting his children’s mother in a dismissive attempt to argue that her views were not worthy of consideration. Why? Because she had a political affiliation with the People’s Party of Canada led by Maxine Bernier; had perpetuated covid-related conspiracy theories and vaccine hesitancy on social media; and failed to wear a mask at a large rally. [1]

Puzzled by this evidence, Justice Pazaratz queries how any of these allegations and many similar ones are relevant and how far is one to take “guilt by association”? [1]

He remarks that “it is of little consequence that an individual litigant chooses to advance such dubious and offensive arguments. Even though the father may not admit this, this is still a free country and people can say what they want…including him. But there’s a bigger problem here. An uglier problem.” [1]

the children’s views took centre-stage in the analysis. A Views of the Child Report indicated that neither child wished to be vaccinated, and Justice Pazaratz agreed that their views were not determinative, but also could not be completely ignored, relying on Article 12 of the United Nations Convention on the Rights of the Child and the list of factors to be considered as set out in Decaen v. Decaen 2013 ONCA 218. The Court reviewed the children’s histories of regular immunizations, and their consistent reasons for rejecting a covid vaccination, which did not appear to be frivolous, superficial, or poorly thought out. [1]

Finally, the Court considered information obtained from the internet including a “Position Statement” from the Canadian Paediatric Society;  a document from the Government of Canada entitled “Vaccines for Children: Deciding to Vaccinate”; and an article from the Canada Communicable Disease Report entitled “COVID-19 Cases and Hospitalizations Surge Among Children”, all proffered by the father. [1]

Justice Pazaratz noted that information obtained from the internet can be admissible if it is accompanied by indicia of reliability, including whether it comes from an official website from a well-known organization, whether the information is capable of being verified and whether the source is disclosed so that the objectivity of the person or organization can be assessed. [1]

However, he also remarked that in almost all cases in Canada where COVID vaccinations have been ordered the court has made a finding that on the face of it, the internet materials presented by the objecting parent have been grossly deficient and at times, dubious. “The lack of an equally credible counter-point to government recommendations may have well been determinative in those earlier cases”. [1]

 

Notably, the Court recited the warning from Pfizer, a company that makes the vaccine, as follows: [1]

“There is a remote chance that the Pfizer vaccine could cause severe allergic reaction… Signs of an allergic reaction include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash, dizziness and weakness. Inflammation of the heart have occurred in some people who have received the Pfizer vaccine….” [1]

Justice Pazaratz also quotes from Dr. Robert Malone who warns that [1]

“therapeutic approaches that are still in the research phase are being imposed on an ill-informed public” and that  “public health leadership has stepped over the line and is now violating the bedrock principles which form the foundation upon which the ethics of clinical research are built.” [1]

‘Anyone reading even some of the articles presented by the mother would likely conclude that these are complicated and evolving issues, and there can be no simplistic presumption that one side is right and that the other side is comprised of a bunch of crackpots. That’s why the court should require evidence rather than conclusory statements.” [2]

The father, meanwhile, provided no evidence that the mother’s views had been debunked, the judge wrote. [2]

 

On Government Mistakes

Justice Alex Pazaratz found that the vaccines’ potential side effects justified her caution. He cited a long list of rights abuses to explain why courts should not simply defer to government experts. [3]

Justice Pazaratz points out other areas of life and the law where the government was wrong, including the Motherrisk expert evidence that turned out to be disastrous for families; the residential school system; the sterilization of Eskimo women; and the thalidomide crisis of the 1950’s. [1]

“What about the residential school system? For decades the government assured us that taking Indigenous children away – and being willfully blind to their abuse – was the right thing to do. We’re still finding children’s bodies,”[3]

“How about sterilizing Eskimo [sic] women? The same thing. The government knew best. Japanese and Chinese internment camps during World War II? The government told us it was an emergency and had to be done. Emergencies can be used by governments to justify a lot of things that later turn out to be wrong.” [3]

 

on “Judicial Notice”

Taking judicial notice means recognizing certain facts as indisputable, so they can be introduced as evidence by one side or the other without having to verify them. The Supreme Court of Canada has said courts may take judicial notice of facts that are so generally accepted as to be beyond debate among reasonable persons. [5]

Should judges sit back as the concept of ‘Judicial Notice’ gets hijacked from a rule of evidence to a substitute for evidence,” he wrote (emphasis in the original). [5]

“After considering all of the evidence– or often the lack of evidence—can the court just fill in the blanks and take judicial notice of the fact that all children should get vaccinated?… Because if “all judges just “know” that children should be vaccinated, then we should clearly say that that’s what we’re doing”. [1]

 

on tolerance

Justice Pazaratz then identifies the intolerance, vilification, and dismissive character assassination in family court. He presumes that he is seeing more of it because it is “rampant outside the courtroom” and appears to be socially acceptable to denounce, punish and banish anyone who doesn’t agree with you. An example? A recent case where a mother sought to terminate a father’s equal parenting time with their child because he was “promoting anti-government beliefs”. Judge Pazaratz declares: “…in Communist China that request would likely have been granted”. But not in Canada, [1]

 

On Previous Cases

The ruling represents a departure from earlier Canadian cases involving disputes over COVID-19 vaccinations, where courts have taken what’s called “judicial notice” – essentially accepting statements as fact – that immunization is beneficial for children, said Alyssa Bach, an associate lawyer at Shulman & Partners LLp. [2]

We now have cases where judges have taken that judicial notice that the vaccine is in the best interest, and now one where it was decided that that wasn’t the case. And so it’s a reminder that each family’s circumstances, and the circumstances of the children, are going to be taken into consideration on a case-by-case basis,” she said Tuesday. [2]

“It’s notable that Justice Pazaratz, in his decision, did go through the other cases where this judicial notice had been taken and distinguished it and how this case was different than the other cases.” [2]

  • In most of the previous cases, the children were younger, so their views on COVID-19 shots were “either unascertainable or less relevant because of the child’s lack of maturity,” the judge wrote in his ruling. [2]
  • And in the cases where the children’s preferences were overridden, the court found the parent seeking vaccination had presented more reasonable information to the children and made more compelling arguments in court, Pazaratz said. [2]
  • As well, the court in many of those cases found the materials presented by the parent opposed to vaccination were “grossly deficient, unreliable and – at times – dubious. This lack of an equally credible counterpoint to government recommendations may well have been determinative in those earlier cases,” he said. [2]
  • Not so in the case at hand, the judge noted. [2]

 

Aftermath

The parties agreed in Minutes of Settlement that each party would have sole-decision making authority for the child(ren) in their care and control, however, their agreement also stated that: “The issue of LEG and MDG receiving a covid vaccine shall remain a live issue and shall be determined at a later date. The child CBG can determine whether or not he wants to be vaccinated now”. [1]

Jesse Herman, who represents the father, declined to say whether his client would seek to challenge the ruling. [2]

‘At this time, all I can comment is that we strongly disagree with the decision that was made,” he said in an email. [2]

 


Further Research

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

 

Media


……

source: ….


Child Vaccination : Dr. Julie Ponesse

source: CanadianCovidCareAlliance


….

source: ….

 

References

  1. Ground-Breaking Covid Decision in Family Law
  2. What? There ‘s A Common Sense Judge In The House , And The Mainstream Media Carried It?
  3. Ontario judge rules mother doesn’t have to vaccinate children against COVID-19

 

Keyword

Canada, Child, Children, China, Communist, ethics, Family, Father, Heart, Inflammation, Justice, Malone, mis-information, Mother, Motherrisk, myocarditis, Ontario, Parents, Pazaratz, Pfizer, sterilization of Eskimo women, thalidomide, United Nations Convention on the Rights of the Child, Vaccination


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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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