On Feb. 4, 2020, then-Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness (PREP) Act which granted the manufacturers of Covid vaccines immunity from lawsuits. The 2005 law empowers the HHS secretary to provide legal protection to companies making or distributing medical supplies such as vaccines and treatments unless there’s “willful misconduct” by the company.
Americans also were prohibited from suing the Food and Drug Administration for authorizing a vaccine for emergency use, and employers who mandated inoculation as a condition of employment.
Steve Kirsch, founder of the Vaccine Safety Research Foundation, noted in a series of tweets on Saturday that it appears Americans are now able to sue mRNA Covid vaccine manufacturers.
Why?
"Adulteration. The plasmid bioactive contaminant sequences were NOT pointed out to the regulatory authorities. It's considered adulteration. I just got off the phone with Professor Byram Bridle and Dr. Robert Malone on this," Kirsch wrote.
Kirsch noted that Malone had messaged him to say: “Yes I think that this DNA adulteration issue could be the wedge we have been looking for. Use of a plasmid with SV40 sequences as the template for manufacturing the pseudo-mRNA is, at a minimum, reckless and I can see no logical justification.”
Kirsch wrote that "the SV40 promoter is found in all the vials and it was in the gene sequence that was provided to the regulators. There is no mistake. The problem was that neither drug company ever pointed it out to the regulators. It's an unapproved contaminant that doesn't meet the standards set. So the regulators are off the hook. But if the regulators don't take action, then they dig themselves into a very deep hole."
The FDA, Kirsch said, "is now at a crossroads. Either they admit that they knew about the plasma contamination, and failed to disclose that to the public and to the outside committees, or they can claim that they didn’t know about it in which case Pfizer is liable. But we have the Pfizer documents that were given to the FDA so we know what the FDA got. And I seriously doubt there’s any disclosure of SV40 contamination. That means we have an adulterated vaccine and the FDA has to remove it from the market until the adulteration is fixed. If the FDA doesn’t do that, they should face criminal prosecution for endangering the public, and not following the law."
Kirsch continued: "If people in government were interested in science and your health, they would have been hammering the CDC and the FDA asking why this was never investigated when it was first discovered.
"I can tell you that all of my scientific friends want to see this work done ASAP. If it is discovered that this integrates into your DNA, no one will want to take it willingly. Our government will then need to mandate it to get people to comply, just like they did before."
A key case comes out of Michigan, where a judge in August ruled for the first time that a drug manufacturer is not protected by the PREP Act in a case where a man suffered two strokes and a leg amputation after receiving a contaminated Covid medication.
Court records state that Dan Nowacki, who had a lawsuit filed on his behalf by Ven Johnson Law, suffered a stroke after receiving Remdesivir that was contaminated with glass particles.
In November 2021, Nowacki was admitted to St. Joseph Mercy Hospital in Chelsea with Covid and was administered Remdesivir intravenously, according to the lawsuit.
Two lots containing 55,000 vials of the drug were recalled after it was found they were contaminated with glass particles. During his stay, Nowacki was administered five doses of Remdesivir and at least two of those doses belonged to the contaminated lot, the lawsuit states.
Days later, he suffered a massive stroke and other serious complications.
Nowacki developed hematomas and swelling on his face, thighs and arms.
According to the lawsuit, around December 16, 2021, Nowacki suffered another stroke, which left him permanently bedridden and in need of 24/7 round-the-clock care.
Judge Carol Kuhnke ruled that Congress did not plan to extend the PREP Act immunity to a drug that substantially deviated from FDA approval and included glass particles.
The defendants, Gilead Sciences, Inc., the drug manufacturer and St. Joseph Mercy Chelsea Hospital, Inc., now must stand trial.
Breaking: You can now sue the mRNA COVID vaccine manufacturers for damages and the FDA is required to take the COVID vaccines off the market. Why? Adulteration. The plasmid bioactive contaminant sequences were NOT pointed out to the regulatory authorities. It's considered…
— Steve Kirsch (@stkirsch) October 21, 2023
