US: DNA Sequence in Pfizer COVID-19 Vaccine Could Spur New Lawsuits: Lawyers

The Public Readiness and Emergency Preparedness Act, known as the PREP Act, largely shields COVID-19 vaccine manufacturers from lawsuits, but companies can be sued for “willful misconduct,” which includes acts taken “intentionally to achieve a wrongful purpose.”

“I think what we have here is willful misconduct,” Mat Staver, chairman of Liberty Counsel.

The Pfizer-BioNTech, in testing by outside scientists, was discovered to contain a Simian Virus 40 (SV40) DNA sequence despite the public never being told about the sequence.

Regulators in Canada and Europe have since acknowledged that the companies did not highlight the sequence and that they should have, although regulatory submissions did show the full DNA sequence of the vaccine plasmid.

The U.S. Food and Drug Administration (FDA) has refused to disclose whether the companies highlighted the sequence.

The FDA alleged no safety concerns have been identified from the residual DNA left behind by the SV40 sequence, though the agency provided no evidence on the matter.

“I can’t imagine that the FDA knew about this. There’s nothing in the FDA documents that would that I am aware of yet where they knew about this contaminant,” Mr. Staver said.

Under a declaration by then-Health Secretary Alex Azar in 2020, COVID-19 vaccines fall under the PREP Act. That act is aimed at allowing a quicker response to a health emergency and grants widespread immunity to manufacturers of vaccines and treatments, as well as administrators of the drugs.

The protection remains in place to this day thanks to extensions through both the Trump and Biden administrations.

The PREP Act has largely prevented lawsuits concerning the COVID-19 vaccines, but several recent developments could change that.

In August, a Michigan judge ruled that the drug manufacturer Gilead Sciences was not protected by the act in the case of a man who needed his leg amputated after receiving Gilead’s drug remdesivir, used as a treatment for COVID-19. The administered drug was said to be contaminated with glass particles.

The other is the revelation that Pfizer’s shot contains the SV40 sequence.

That could help plaintiffs “pierce that legal immunity that’s otherwise provided by the PREP Act,” Mr. Staver said.

He said he’s heard from personal injury firms and organizations who are exploring suits and that Liberty Counsel is considering bringing some as well in light of the developments.

Liberty Counsel has been involved in multiple major suits concerning COVID-19 vaccines, including some with military members who were denied in form letters requests for religious exemptions from the military’s COVID-19 vaccine mandate. The firm helped win orders blocking the military from discharging those members.

Pfizer and BioNTech have not returned requests for comment.

Warner Mendenhall, another American lawyer, said on a recent call that lawyers are talking about taking a different approach.

“The latest conversation that we’ve been talking about … is whether we have access right now, at least for some people, to prove battery,” he said.

Informed consent requires having information, “and nobody knew about the SV40,” he said.

Without such knowledge, vaccine recipients could not properly give consent, according to Mr. Mendenhall.

“And if you haven’t consented, and somebody does something to you without being informed and given proper consent, it’s called battery. So, there is some opening for battery cases. And we’re in discussions right now, and those may be able to be brought as as what are called mass torts or mass cases. So we’re working on that.”

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