pfizer

Pfizer Defense Against Vaccine Fraud Case: Does the ‘Other Transaction Authority’ Contractual Exemption Grant Pfizer a Pass?

by Staff at TrialSite | Jun 11, 2022

Pfizer has proposed in their defense in a lawsuit charging them with vaccine study fraud that there cannot be any legal culpability associated with the charged violations associated with certifications to the federal government as part of their contract in response to the COVID-19 pandemic. Why? Because a federal contract status offers them immunity from such claims. As part of the whistleblower Brook Jackson’s lawsuit against Pfizer, the pharmaceutical company seeks to dismiss the case.

According to the legal defense, Pfizer could effectively lie to the government about safety or efficacy issues “because the government was in on it with them,” reports attorney Robert Barnes. The lawsuit is associated with the whistleblower Brook Jackson, who was interviewed by Sonia Elijah on TrialSite. While Ms. Jackson worked for a contract research organization called Ventavia Research Group (Ventavia) on the pivotal Phase 3 Pfizer COVID-19 vaccine study, she alleges that she witnessed many critical, compliance-violating anomalies needing immediate attention. Ms. Jackson emailed the complaint concerning alleged violations of good clinical practices as well as various compliance frameworks and laws to the U.S. Food and Drug Administration (FDA) in September 2020, however, the executive branch agency in charge of enforcement of alleged violations opted to not even open an investigation. The study continued, and Pfizer didn’t make any adjustments working with Ventavia. But the CRO did sack Ms. Jackson for alleging that they were involved with fraudulent manipulation of data and other allegations.

As TrialSite reported, Ms. Jackson opted to take legal action, filing a lawsuit in the United States District Court for the Eastern District of Texas, Beaumont Division. Alleging a violation of the False Claims Act, the plaintiff sought action for the violation of federal laws and associated compliance standards, such as good clinical practice. The U.S. Department of Justice opted to pass on any involvement. During the case, Ms. Jackson violated a gag order and lost her attorneys. However, she was picked up by attorney Robert Barnes. Pfizer argues that thanks to a procurement clause known as the “Other Transaction Authority” associated with Department of Defense-related contracts, for example, the pharmaceutical company isn’t liable for the standard federal procurement rules governing such contracts. But the plaintiff’s attorney Barnes reports in an interview that they will be allowed to continue with discovery associated with Pfizer’s motion to dismiss the case. Does Pfizer get a pass from the rule of law for violating laws and rules as alleged by the plaintiff and her attorney in a recent interview? According to Ms. Jackson’s attorney, this case could be the biggest False Claims Act whistleblower case in U.S. history.

Some Background

Back in November 2021, TrialSite reported that the prominent medical journal The BMJ, to its credit, reported on the Jackson situation with Ventavia and Pfizer. In fact, The BMJ was even censored by Facebook for doing so! In “The BMJ to Facebook—Stop Censoring Us and Shut Down Your Incompetent Fact-Checkers,” this media reported that the “Trusted News Initiative” moved again to censor content—this time, an elite medical journal! Why? Because they reported on the allegations of fraud, including the prospect of data manipulation associated with the COVID-19 vaccine trials. This apparently triggered Zuckerberg’s algorithms, suggested TrialSite.

TrialSite has also followed the lawsuit to compel disclosure of research and development and regulatory documentation associated with the Pfizer-BioNTech vaccine. Initiated by a Freedom of Information Act (FOIA) request by the Public Health and Medical Professionals for Transparency, the non-profit sued after rejection, thanks to the support of attorney Aaron Siri of the law firm Siri Glimstad.

At one point during the dispute to compel document disclosure, the FDA proposed holding the documentation for an outrageous 75-year period, releasing only 500 pages per month, reported TrialSite. This meant that the documents wouldn’t be ready till 2096! But then in the first week of January, the judge in a surprise move quoted John F Kennedy and compelled the release of the documents in batches of 55,000 pages per month over the next several months.

Sonia Elijah, writing for TrialSite, covered the release of artifacts from the trove of Pfizer documentation. By March 7 of this year, Ms. Elijah reported on a series of problems in “First Look at Newly Released Pfizer Docs Part 1: Case Report Errors and Anomalies” as well as the subsequent “First Look at Newly Released Pfizer Docs Part 2.” Writing for TrialSite on May 6, Ms. Elijah further probed documentation, including BNT162b2 and Comirnaty FDA documents in “On What basis are pregnant women being encouraged to take the Pfizer vaccine?” providing a chronology of events showcasing potential risks associated with the vaccine. This article covers important risk factors that were not widely disseminated to the public during the ongoing vaccination program communication.

The Right Moves in—and a ‘Feminist’

Other groups pounced on the Pfizer document dump situation such as the DailyClout led by Naomi Wolf, a feminist activist turned medical research detective. Interestingly, resistance to the federal approach to COVID-19 has made for strange bedfellows. For example, Wolf who would traditionally be considered more to the political left has aligned with more right-leading fringe groups such as Steve Bannon and his WarRoom. Of course, Bannon was closely aligned with former President Donald Trump, now under scrutiny for the January 6 riot or insurrection, according to some.

Other examples of the political right embracing and reporting on a critical view of the COVID-19 response include The Epoch Times (more on that outlet below), a far-right leading group founded by practitioners of Falun Gong in resistance to mainland China’s communist rule. The Epoch Times gained a serious audience during the Trump years as this media tailored news to appeal to the “Make America Great Again” crowd, leading to serious revenue growth.

Brooks’ Lawsuit

Debra Heine, writing for the Tennessee Star, recently wrote a piece updating the Jackson case for those interested in this important matter. While Heine reports that Ms. Jackson was subject to a gag order from discussing the case due to the pandemic emergency countermeasures, including the need to not disrupt the vaccination process, Jackson went public anyway—of course, this media was one of the platforms she shared her story with.

But because Jackson went public despite the orders not to, her attorneys Berg and Androphy abandoned the case, writes Heine, “leaving her without counsel.” Apparently, the lawyers told the plaintiff that if she violated the gag order, “the government will come after you,” writes Heine based on an email shared from a right-leading media called American Greatness. Her current attorney, Mr. Barnes joined the pursuit.

Pfizer Stance—We get a Pass

Pfizer made a move recently to strike down this lawsuit filing a motion to dismiss, declaring that it cannot be at fault for misrepresentation, misuse, and other claims associated with the BNT162b2 clinical trials due to its accord with the U.S. government itself. This permitted them to bypass guidelines as well as Health and Human Services administrative regulations associated with standard government contracts. But could this be true?

The Epoch Times, again right-leaning news media, embraced critical coverage of the COVID-19 vaccine, mandates, and safety, especially among conservative groups in the United States. They recently reported on Pfizer’s move to dismiss the case, declaring that the regulations raised as standards during the lawsuit simply don’t apply to them. The deal Pfizer inked with the U.S. Department of Defense actually falls under the “Other Transaction Authority” or “OTA,” enabling those contractors to evade many of the normal laws, rules, and policies that apply to government contracts.

According to the government research organization, MITRE OTAs include:

“procurement instruments other than contracts, grants, or cooperative agreements enabling flexible business arrangements to acquire research and development to support technology advancement or to quickly develop a prototype. Many laws and regulations governing federal contracts do not apply to OTs (i.e., Federal Acquisition Regulation (FAR) and the Competition in Contracting Act (CICA)), however, the Procurement Integrity Act applies, and competitive practices are applicable. OTs may be protested to the U.S. Court of Federal Claims, and GAO has limited jurisdiction to review OT decisions. GAO ruled on proper use of an OT in these cases: GAO B-416061 and GAO B-416752.”

In court, the defendant (Pfizer) declared that the demand that they comply with Federal Acquisition Regulations was “simply wrong,” reports The Epoch Times. But what does Ms. Jackson’s lawyer have to say about the recent legal proceedings?

Jackson’s Lawyer Speaks

Jackson’s attorney Robert Barnes picked up this case after Ms. Jackson was abandoned by her other lawyers. They bolted when Brook continued to “whistleblow” despite the gag order. Barnes recently interviewed with “ViaFrey” as shared by the Tennessee Star. During that interview, the plaintiff’s attorney shared that Jackson’s allegations exposed that Pfizer’s clinical trials were riddled with error and fraudulent and false certifications to the U.S. government.

The attorney declares in the interview:

“What is fascinating is that  Pfizer has moved to dismiss the case, and their ground to dismiss as they repeated in the scheduling conference we had this week is that it doesn’t matter if they submitted fraudulent certifications  to the government, it doesn’t matter if they submitted false statements under penalty of perjury to the government; it doesn’t matter if they lied about the safety and efficacy of the drugs,  mislabeled in my opinion as vaccines, because the government was in on this with them.”

In what is truly a bombshell situation, the attorney continued, “The government knew what was going on, and the government is going to give them a check anyway; so, is it really fraud if the government is a conspirator? That is the essential Pfizer defense so far.”

In what is considered a victory for the plaintiff, Barnes reports that the judge has declared the plaintiff is entitled to discovery in relation to the motion to dismiss. Barnes shared in his interview posted online that Pfizer “went ballistic” because the plaintiffs, according to the judge, have rights to discovery in a timely and material way.

Barnes suggests that Ms. Brook’s case could be the biggest whistleblower False Claims Act case perhaps in U.S. history.

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