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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article-VaccineAR-data

article-VaccineAR-data

Article: Vaccine AR Data

Re: the under-reporting & risks of covid vaccine injury in Germany

 

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English Translation from CoronaCases of original article: (as reported on achtung.com Feb 19, 2022)


The Revealing Accounting of Vaccine Damage

by Ulrich Adam

Since 1 April 2021, numerous cases of adverse reactions in connection with Covid-19 vaccinations have been documented in Germany and billed to health insurers – the picture painted there testifies to a comparatively poor safety profile. Who doesn’t know the obligatory slogan after every TV or radio advertisement for non-prescription drugs? At the end it always says in unison: “For risks and side effects, read the package leaflet and ask your doctor or pharmacist.”

The package leaflet is rarely seen with Covid 19 vaccines, and enquiries with doctors and pharmacists about possible side effects are often not very meaningful or informative. In view of the fact that the substances have only been on the market for just under 14 months,
longer empirical values are of course not available.

At the same time, there are a large number of articles and reports on side effects on the internet, most of which are anecdotal and suggestive and do not necessarily help to make a sober scientific assessment.

So where can an interested layperson start? One of the official pieces of information from the Federal Ministry of Health already makes one wonder: the risk of myocarditis is given here as 1:5000, an extremely poor value for a vaccine in terms of safety profile – both in
comparison to other classic inactivated vaccines and under medical ethical and regulatory aspects. After all, vaccines are usually administered to healthy persons and must therefore rightly meet the highest safety requirements. The latest report of the Paul Ehrlich Institute on reported suspected side effects is complex, but points in a similar direction: severe side effects are estimated in a similar order of magnitude (2/10,000).

Worrying data

It is good that there is the INEK database, which contains the services documented and billed in German hospitals. Unfortunately, there are no regular reliable summaries regarding the frequency and severity of Covid-19 vaccination reactions registered there. But as long as
you know that since 1 April 2021 the code U12.9 can be used for such adverse event diagnoses, you can do a little research yourself in the publicly accessible database.

The picture that emerges there for the period from 1 April to 31 December 2021 confirms the comparatively poor safety profile, and the full extent of toxicity does not yet seem to be covered.

Even taking into account the high number of Covid-19 vaccine doses administered in total during this period (around 110 million), the frequency and severity of side effects is considerable. 14,367 cases were treated in German hospitals, 1,652 of which involved a stay
in intensive care, and 170 people died.

In addition to the deaths, the intensive care stays are worrying, since it was precisely the avoidance of a potential temporary overload situation in intensive care units in Germany that was cited as the primary justification for the measures – and vaccinations – taken.
The breadth and (in some cases) severity of the adverse events recorded is also worrying.

Many of the primary diagnoses recorded in association with U12.9 as a secondary diagnosis (369 in total) are consistent with those in the emerging scientific literature. For example, the available data show significant adverse events in seven prominent areas (myocarditis,
pericarditis, non-pyogenic thrombosis, Guillain-Barré syndrome, tachycardia, hypoaesthesia/paraesthesia of the skin, pulmonary embolism) – in addition to the numerous others (many of which, however, are also mild and temporary, such as headache).

Urgent data research needed

A comparison with the data for the previous year’s period also indicates a possible under-recording/under-use of the U12.9 code. For myocarditis (codes I40.8, I40.9, I51.4), an 80% increase in total cases compared to the previous year is reported. 4,478 cases in the last 9
months of 2021 were compared to 2,481 cases in the same period in 2020. Of the 4,478 total cases, 618, or about 30 per cent of the increase, were associated with a Covid 19 vaccine adverse event.

Although it cannot be excluded that other factors may have played a role in the massive increase in myocarditis cases in 2021, a possible under-reporting seems plausible. Further data research is urgently needed to clarify the situation in order to prevent possible harm to people.

Slogans and slogans can no longer help to overcome the existing uncertainties. Risks and side effects are not a banality, certainly not in the context of a mass vaccination campaign. A broader discussion and more extensive educational work on risks and side effects appear to be urgently needed.

Ulrich Adam studied history and political science in Tübingen and Cambridge (UK).

He has lived in Belgium for many years and worked, among other things, on EU regulatory issues of prescription drugs and vaccines.


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Keywords

accounting, article, Data, deaths, evaluation, germany, INEK, Insurance, myocarditis, risks, Safety, side effects, Ulrich Adam, underreporting, Vaccination, Vaccine


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