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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LAUSD School Vaccine Case

LAUSD School Vaccine Case

LAUSD Vaccine Case

Re: the Legality of Mandating the Covid “Vaccine” to Children & Segregating those who Refuse

 

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Facts of the Case

  • Dates: Oct 8, 2021 (filed)
  • Location: Los Angeles, CA, USA
  • Court: Superior Court of California- Civil Division
  • Case #: 21STCP03381
  • Plaintiff: Father & Son
  • Plaintiff’s Lawyer:
  • Defendant: LAUSD Schools
  • Trial Type: Civil
  • Judge: Mitchell L. Beckloff
  • Status: Decided (July 5, 2022)
  • Verdict: for the Plaintiff


*updated July 11, 2022

 

Background

A parent of a 12-year-old student at the Science Academy STEM Magnet school filed court papers challenging the Los Angeles Unified School District’s mandate that all students aged 12 and older be fully vaccinated against the coronavirus by Jan. 10 to enter campus unless they have a medical or other exemption. [1]

The plaintiff is identified only as G.F. in the lawsuit brought on behalf of the parent and the student, who is identified only as D.F. [1]

The district’s mandate requires all eligible students aged 12 and older to be vaccinated against the coronavirus by Jan. 10 to enter campus unless they have a medical or other exemptions. [2]

 

The Science Academy STEM Magnet school, located in North Hollywood, is a seven-year, college-preparatory public school that incorporates science, technology, engineering and mathematics. G.F.’s court papers state that D.F. studied hard to pass the entrance exam to be admitted to the school and does not want to have to leave because he and his parent choose to not have him receive the COVID-19 vaccine. [1]

“Losing his spot at the school would devastate D.F. and potentially foreclose future educational opportunities,” G.F’s court papers state. [1]

G.F. presented a notice to the LAUSD on Sept. 24 demanding that the vaccine mandate be rescinded, but the district did not respond, according to G.F.’s court papers. [1]

The following statement comes from September 9, 2021, from the Interim Superintendent of the LAUSD Megan K. Reilly: [5]

All students who are 12 years of age and older and are part of in-person extracurricular programs, must receive their first vaccine dose by no later than October 3, and their second dose by no later than October 31, 2021. All students who are 12 years of age and older must receive their first vaccine dose by no later than November 21, 2021, and their second dose by no later than December 19, 2021. All other students must receive their first vaccine dose by no later than 30 days after their 12th birthday, and their second dose by no later than 8 weeks after their 12th birthday.”

A spokesperson for the LAUSD released the following statement to City News Service: [5]

“In April of this year (2022), the Los Angeles Unified School District aligned with the state’s timeline for implementation of the governor’s student vaccine mandate wherein any vaccine requirement would not take effect until after full FDA approval and no sooner than July 1, 2023. Accordingly, the district’s alignment with the governor’s student vaccine mandate has allowed Los Angeles Unified students to enroll and attend in-person instruction. Los Angeles Unified will continue to take measures to ensure the health and safety of its students, employees, and school community.”

 

Significance

This case follows the San Diego ruling which ended the vaccine in that city’s schools. A similar decision could see more such rulings.

 

Plaintiff’s Argument

G.F. maintained the state and not the LAUSD is authorized to issue vaccination mandates and that the district’s requirement that unvaccinated pupils 12 years old and over attend independent learning classes outside campus violates the state Education Code. [3]

Coronavirus cases in the LAUSD have declined since teachers and children returned to in-person instruction in August, G.F.’s court papers state. In addition, the U.S. Centers for Disease Control has found that children with the coronavirus have mild symptoms or none at all and that they rarely spread the virus, according to the court papers. [1]

Healthy children who have a natural immunity to COVID-19 and have not received the vaccine should not be discriminated against by the LAUSD, G.F.’s court papers state. In addition, keeping healthy children out of the classroom is contrary to state law and the students affected will not be able to make up for lost in-person learning, according to G.F.’s court papers. [1]

D.F., who has received all other required childhood immunizations, will suffer irreparable harm if not allowed to continue with his in-person learning and his two extra-curricular activities, G.F.’s court papers state. [1]

In a sworn declaration, G.F. says he believes the vaccine could irreparably harm his son, who has already contracted and recovered from the coronavirus and may have strong natural immunity. [3]

“Further, I worry that vaccinating him could prove even more dangerous now that he has had COVID-19,” G.F. says. “Among other things, I fear that the vaccination could overexcite his immune system and antibodies.” [3]

Having weighed those risks against what he believes to be a “statistically minuscule risk” that his son will contract the coronavirus again, G.F. says he “vehemently objects to LAUSD’s attempt to force his (son’s) vaccination.” [3]

 

Defendant’s Argument

In their court papers, LAUSD lawyers maintain that the court relief sought by G.F. and his son “fails on every conceivable level” and should have been denied. [3]

The relief sought by G.F. “asks this court to ignore the life-threatening risks presented by COVID-19 and the corresponding threat it poses to public education,”  the LAUSD attorneys argued in their court papers. [3]

 

 

Relevant Prior Judgements/ Cases

The group Let Them Breathe filed a lawsuit against the district in October 2021 in an attempt to enjoin the state from enforcing the mandate for students ages 12 and older, asserting that the requirement violates the law. [7]

San Diego Superior Court Judge John Meyer ruled in favor of the anti-mask group, determining that the vaccine requirement was in breach of state law. School staff, however, will still have to abide by the mandate. [7]

Meyer ruled that the state legislature, not the school districts themselves, has the power to enforce a vaccine mandate for school attendance. [7]

“The statutory scheme leaves no room for each of the over 1,000 individual school districts to impose a patchwork of additional vaccine mandates, including those like the [San Diego Unified vaccine] Roadmap that lack a personal belief exemption and therefore are even stricter than what the [state health department] could itself impose upon learned consideration,” Meyer wrote in a ruling, according to The San Diego Union-Tribune. [7]

Meyer said that though the California legislature has granted the state public health department authority to mandate the COVID-19 vaccine for schools, with the requirement that allowances be made for personal belief exemptions, the body did not give school districts the same power. [7]

See here for more “Let Them Breathe” Legal Actions

 

Proceedings

During a hearing in April (?) Los Angeles Superior Court Judge Mitchell Beckloff said he was initially inclined to find in favor of the LAUSD [3]

 

Decision

Finding that the Board of Education’s authority is “great, but not unlimited,” Los Angeles Superior Court Judge Mitchell Beckloff ruled in favor of the father of a 12-year-old student who challenged the Los Angeles Unified School District’s student COVID vaccine mandate, finding that the resolution approving the directive clashes with state law. [3]

The judge noted in his ruling that if D.F. remains unvaccinated, he will be forced to leave the academy and be subjected to a different curriculum. Beckloff further said that while the Board of Education’s authority is “great,” it is not unlimited. He found that the student vaccine resolution approved Sept. 9 conflicts with state law and clashes with the state Health and Safety Code by not allowing exemptions for personal beliefs. [3]

“While LAUSD argues the court’s ruling should apply to D.F. only, the court finds no justification for such a limitation given the board’s lack of authority to adopt the resolution,” Beckloff wrote. [3]

In his decision, Beckloff wrote that, with the exception of 10 vaccines that the state Legislature previously required of children to attend school in person, any new childhood immunization mandate must include a personal belief exemption clause. He noted that LAUSD’s COVID-19 vaccine mandate does not allow for that exemption. [6]

“That LAUSD’s resolution does not exempt the COVID-19 vaccine for personal beliefs is in direct conflict with (state) Health and Safety Code,” Beckloff wrote. [6]

He went on to say the Legislature “intended to preclude local legislation on a matter of state concern.” [6]

The district had also sought to have the court’s ruling apply only to D.F., instead of all students, but the judge disagreed. [6]

“The court finds no justification for such a limitation given the board’s lack of authority to adopt the resolution,” Beckloff wrote. [6]

 

Aftermath

Reaction from the Plaintiffs:

Arie Spangler, attorney for the plaintiff, said in a statement that the ruling “confirms that individual school districts do not have the authority to impose vaccination requirements in excess of statewide requirements.” [6]

“We are very pleased with the ruling, as it ensures that Los Angeles Unified School District cannot force children out of the classroom due to their Covid-19 vaccination status,” she stated. [6]

 
Reaction from the LAUSD:

The district, in its own statement, noted that the district bumped its timeline for implementing any student vaccination mandate to align with the state’s mandate and that any such requirement won’t take effect before full approval of a vaccine by the U.S. Food and Drug Administration and no sooner than July 1, 2023. [6]

“Accordingly, the District’s alignment with the Governor’s student vaccine mandate has allowed Los Angeles Unified students to enroll and attend in-person instruction,” the district said. “Los Angeles Unified will continue to take measures to ensure the health and safety of its students, employees and school community.” [6]

 
Reaction from Supporters:

Following the Judge’s ruling in favor of the child’s father, parents Tweeted about the results of the hearing.  Suzanne Bird @Skylar1 reminded parents, that they could, “now file for damages from illegal vaccine mandates.” [5]

The news was celebrated online by the activist group “Let Them Breathe”: 

Ruling against LAUSD vax mandate follows Let Them Breathe win against SDUSD vax mandate. We expect to prevail against Granada Hills & New West Charter schools. Schools like Willows & Mirman should immediately end mandates. Kids have a right education & we will uphold that right! [3]

Reopen California added

“HUGE NEWS: A judge ruled this morning that LASchools’ student Covid vaccine mandate was illegal, blocking LAUSD from sending kids to independent study for not getting the Covid vaccine,” Reopen California tweeted. [3]

“Even though LAUSD delayed their mandate to align with the state timeline, they still intended on excluding kids from in-person instruction if they did not get the Covid vaccine,” [3]

 
Los Angeles Daily News: [6]

A judge has struck down the Los Angeles Unified School District’s COVID-19 student vaccination mandate, finding that only the state can force students in California to get the vaccine to attend school in person. [6]

In a decision issued Tuesday, July 5, L.A. Superior Court Judge Mitchell Beckloff dealt a blow to the nation’s second-largest school district when he determined that the LAUSD school board’s authority is “great, but not unlimited,” and sided with the father of a 12-year-old student who last fall sued the district over its student vaccination mandate. [6]

While the decision marks a major win for opponents of vaccine mandates, it has no immediate bearing on families in LAUSD. The school board had already voted in May to delay its vaccine mandate for students – which requires students 12 and older to get the COVID-19 shot – for at least one school year to align with the state’s timeline for implementing its own mandate. [6]

The district’s vaccination mandate for employees remains in effect. [6]

Nevertheless, the judge’s ruling this week was received as an encouraging sign to those who have been pushing back on COVID-19-related school mandates. [6]

Beckloff’s ruling also comes after LAUSD recently ended its weekly COVID-19 testing program of all students and staff on campus. At this point, only students or staff on campus will be required to test based on need, such as if they’re experiencing symptoms or are exposed to an infected person. [6]

 


Further Research

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

 

Media


Judge rules against San Diego Unified in vaccine mandate lawsuit -Dec 20221

source: CBS 8 San Diego


OSHA Vaccine Mandate Supreme Court Ruling -Jan 2022

source: the John Birch Society


Parents vs LAUSD vaccine mandate have their day in court (Dec 2021)

source: FOX 11 Los Angeles


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PDF-Sexton-Letter7

PDF-Sexton-Letter7

M Sexton: Open Letter

Re: Request for investigation into the Wrongful Deaths & Adverse Reactions caused by the covid vaccines with the aim to stop it asap

 

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Mark Sexton Open Letter to Sir Stephen House, acting commissioner of The Metropolitan Police and Mr Andy
Cooke, Chair of Her Majesty’s Inspector of Constabulary
from June 28, 2022


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