BEAUMONT, Texas—Attorneys for a whistleblower alleging violations occurred during the Pfizer–BioNTech COVID-19 vaccine clinical trial argued in federal court on March 1 that their case should advance to the discovery phase.
Attorneys for the defendants—Pfizer and two subcontractors, Ventavia Research Group and ICON—tried to convince the judge to dismiss the case. If successful, their clients would avoid depositions under oath.
Defense attorneys told the judge Wednesday that whether protocol violations occurred was ultimately irrelevant because the federal government was made aware of them but still granted emergency authorization to Pfizer’s vaccine.
They pointed out that the federal government backed the defendant’s motions, asserting that even if rules were violated, the problems only affected a small number of trial sites.
Lawyers for Brook Jackson, the whistleblower, countered by saying the U.S. Food and Drug Administration (FDA) authorized the vaccine before reviewing the information Jackson provided.
U.S. District Judge Michael Truncale, the Trump appointee overseeing the case, said he would not issue a ruling from the bench, and a decision has not been handed down as of March 2.
Truncale said he did not usually allow oral arguments on motions to dismiss but felt it was necessary for due process in a case that had captured the public’s attention.
Violations
Ventavia ran some of the sites for Pfizer’s COVID-19 vaccine Phase 3 clinical trial. The company didn’t properly report adverse events and failed to keep all participants blinded, according to internal communications revealed by Jackson.Ventavia and other companies were hired by the clinical research company ICON, which Pfizer hired to oversee trial sites.
Jackson was hired by Ventavia in September 2020. She worked on clinical trials for 18 years and has been described as an expert. She was fired the same day she alerted the U.S. Food and Drug Administration (FDA) of trial irregularities, 18 days after starting the new job.
Jackson sued Ventavia, Pfizer, and ICON in 2021 for violating the False Claims Act, a law that prohibits knowingly making a false or fraudulent claim for payment or approval from the government. She also accused Ventavia of illegal retaliation.
Before the hearing, Jackson told The Epoch Times that she would appeal the case if the judge dismissed it because the public deserves the truth—that the vaccines are not safe or effective because the data was manipulated.
“I did this on behalf of the American people,” she said.
FDA Decision
Truncale questioned attorneys for both sides during oral presentations.The judge asked whether the FDA’s decision not to pursue the issue impacted the claim’s validity.
He said there could be many reasons why the FDA may have decided not to get involved, including “political” ones.
“So if the FDA gets it wrong, they just get it wrong and we live with it?” Truncale asked.
“Exactly,” said Pfizer attorney Carlton Wessel, adding that if the government doesn’t think it’s been defrauded, that should end the case.
The judge posed a hypothetical situation as to whether the court could act in cases where the government may hide things or cover them up.
“There’s no big conspiracy here,” Wessel said. “The vaccine is not a political thing.”
Wessel said the government continued to purchase the vaccine and expressed “full confidence in the data.” He said that the experts in the government should make the decisions on the vaccine, not Jackson.
But Robert Barnes, one of Jackson’s attorneys, said that just because the government was still paying for the vaccine didn’t mean there wasn’t a problem.
“The government under that contract has no right to withhold payment,” added Warner Mendenhall, another attorney for Jackson.
The FDA says the vaccine is safe and effective, Barnes told the judge, but now the whole world “knows the consequences.”
Mendenhall argued that the case warrants further investigation through discovery.
He refuted that the FDA knew the gist of Jackson’s complaint before issuing vaccine authorization. Evidence indicates the FDA authorized the vaccine before reviewing the information she provided, he said.
Mendenhall claims there were concerns about fraudulent data from some within the FDA.
‘Interest of the People’
The case was unsealed in 2022 after the U.S. government declined to back Jackson. It has instead filed in support of the motions to dismiss.Mendenhall said Jackson reported that signatures on consent forms weren’t obtained until after the placebo or trial vaccine was administered, temperature controls weren’t maintained, and patients weren’t monitored.
He said the public deserves to know what happened with the vaccine trials.
“That’s the interest that matters here—the interest of the people,” Mendenhall said.
After the hearing, Jackson said she believes her case is important to those who have been injured by the vaccine and hopes that any funds recovered through the litigation will go into a fund to help them. She added that she felt the judge was aware of the case’s significance.
Discovery
Jackson hopes the case will move forward, allowing her lawyers to depose principal investigators at each clinical trial site and even Dr. Anthony Fauci if possible. Fauci, the former National Institute of Allergy and Infectious Diseases director, widely promoted the COVID-19 vaccines as safe and effective.
Although critics have called her anti-vaccine, Jackson noted she had worked on clinical trials for almost two decades.
“I love my country. I’m anti-corruption,” she said. “It’s all about the vaccine-injured for me and taking down pharma.”
Mendenhall said before the hearing that Jackson’s team looked forward to getting materials through discovery if the case was allowed to move forward.
“We get Pfizer’s internal documents, and we can really dig into what happened to these 44,000 trial participants that they had,” Mendenhall told NTD.
Mendenhall believes the materials would show that “many other trial sites were actually being run in a manner that is not appropriate for getting good data.”
“And if they don’t have good data, then that emergency use authorization is then pulled back by the FDA,” Mendenhall said. “They don’t have enough data to support it, and if that happens, this whole thing is over. The mandates are over; the shot is over,” he added.
Ventavia has accused Jackson of entering the company with “an agenda,” noting that she recorded conversations with employees and went into certain areas it suggested she should not have.
Jackson said she was compelled to document what she encountered, including patient information being left out in the open, hazardous material being stored improperly, and other violations.
“I was the first one there, and I was the last one to leave from pretty much day one,” Jackson said. “Just really trying to get a handle on the chaos is the only way that I can describe it.”
