Texas Attorney General Ken Paxton on Monday contested Pfizer’s motion to dismiss the state’s lawsuit accusing the drug giant of “false, misleading, or deceptive” marketing of its COVID-19 vaccines and trying to intimidate critics who questioned those claims.
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Texas Attorney General Ken Paxton on Monday contested Pfizer’s motion to dismiss the state’s lawsuit accusing the drug giant of “false, misleading, or deceptive” marketing of its COVID-19 vaccines and trying to intimidate critics who questioned those claims.
According to the lawsuit, filed Nov. 30, 2023, Pfizer’s claims about the efficacy, duration of protection and ability of its COVID-19 vaccine to prevent transmission violated the Texas Deceptive Trade Practices Act.
The lawsuit also alleged Pfizer cited misleading statistics, concealed negative data and made unsupported statements about the vaccine’s efficacy against variants like Delta, and that those actions negatively affected Texas citizens.
Paxton is seeking over $10 million in civil penalties, plus injunctive relief barring Pfizer from making claims about vaccine efficacy similar to those challenged in the lawsuit.
Pfizer denied the allegations last year when the lawsuit was filed, telling Reutersthe case had no merit, and defending its claims about the vaccine as “accurate and science-based.”
Last month, Pfizer moved to dismiss the lawsuit. The company argued that under the Public Readiness and Emergency Preparedness Act (PREP Act), Pfizer was protected from liability claims regarding its COVID-19 vaccine “medical countermeasure,” authorized for emergency use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
In its motion to dismiss, Pfizer reiterated its claim that “since the beginning of the COVID-19 pandemic tens of millions of lives were saved by vaccination,” quoting a recent JAMA article by the U.S. Food and Drug Administration’s (FDA) Dr. Robert Califf and Peter Marks, M.D., Ph.D.
Pfizer said that without the protection afforded to vaccine makers under the PREP Act, the company would not have been able to distribute its life-saving vaccine.
The company also argued that Texas can’t bring a claim under the Deceptive Trade Practices Act — which protects consumers — “because the so-called ‘consumers’ in this case received their vaccines from the federal government for free.
‘Best piercing of the PREP Act I’ve ever seen’
According to Paxton, Pfizer’s claims and censorship scheme were misleading, deceptive and illegal under Texas law. Also, the consumer protection law is not preempted by the federal PREP and FD&C acts, as Pfizer contends.
“They are bread-and-butter violations of the Texas Deceptive Trade Practices Act (DTPA) and not subject to dismissal,” based on Pfizer’s arguments, Paxton argued in his opposition to Pfizer’s motion to dismiss.
Paxton said the immunity protection provided under PREP and invoked by Pfizer in this case extends only to possible personal injury claims.
It does not extend to “deceptive marketing parens patriae claims brought by a sovereign,” the motion said. Under parens patriae, a state has the right to protect its citizens and can file lawsuits on their behalf.
Paxton also said Pfizer incorrectly alleged that the lawsuit contested the FDA’s regulatory decision to authorize the vaccine.
But according to the motion, the state did not challenge the FDA’s emergency authorization of Pfizer’s vaccine. In fact, the state agreed with the FDA’s evaluation that the vaccine authorized for emergency use had limited efficacy data and would require further evaluation as the drug was rolled out.
Texas’ concerns were not with the FDA’s authorization and later approval, but with Pfizer’s actions following the authorization, the motion said.
‘Right on the mark’
Ray Flores, senior outside counsel to Children’s Health Defense, told The Defender Paxton’s strong opposition to Pfizer’s motion to dismiss “is right on the mark.”
He said that because the PREP Act extends to marketing and promotion of a countermeasure, it is true that a private citizen can’t bring a false advertising or fraud claim against Pfizer.
“Texas contends it can bring a parens patriae claim that PREP won’t cover. I agree.” Flores said. “This is the best piercing of the PREP veil I’ve ever seen.”
Flores said Texas made a strong case, which he believes will prevail.
Still, people should not “get their hopes up for disclosure of bombshell documents,” Flores said, because the court yesterday also signed a protective order, agreed to by both parties in the lawsuit, that no confidential or proprietary information revealed in the proceedings would be made public.
The order stipulated that “documents, testimony, or information containing or reflecting confidential, proprietary, trade secret, or commercially sensitive information … likely to be disclosed or produced during the course of discovery” will be protected from disclosure.
Pfizer ‘enriched itself based on these misleading statements’
The Texas lawsuit alleged that Pfizer made false or misleading claims about the vaccines in three areas — efficacy and duration of protection offered by the vaccine, protection from transmission, and protection from new variants.
The FDA’s authorization explicitly stipulated that it was “not possible” to know how effective the vaccine was beyond the two months of data Pfizer presented at the time and that the pharmaceutical giant “needed” more evidence to prove its vaccine protected against transmission, according to the original complaint and reiterated in the motion Paxton filed yesterday.
Paxton also noted that the clinical trial data assessed vaccine efficacy only against the original virus strain.
Yet within weeks, “Pfizer’s CEO, Albert Bourla, went on major news networks promoting that the company’s vaccine possessed the very qualities FDA told Pfizer it had not shown,” the motion alleged — misrepresentations outlined in “great detail” in the original complaint.
As a result, it said, Texans heard that the vaccine prevented transmission, protected against the Delta strain and was 95% effective. And unvaccinated Texans were subjected to “a public culture of fear and shame,” created by claims that their own vaccination status would affect those around them, the motion stated.
The suit also alleged Pfizer’s claim that its vaccine was 95% effective against infection was “highly misleading from day one” because it represented only the “relative risk reduction” instead of the “absolute risk reduction.”
In its calculation of relative risk reduction, Pfizer compared only the small subsets of the vaccine and placebo groups who developed COVID-19 systems during the trial — 8 versus 162 people, respectively — instead of considering the entire cohort of nearly 35,000 trial participants, according to the original petition.
Even the FDA, the petition said, prefers that drug manufacturers advertise absolute risk reduction — the actual decrease in risk between getting a treatment or not.
“Pfizer’s clinical trial showed absolute risk reduction of only 0.85%,” according to the motion. “In other words, the Pfizer vaccine reduced a person’s risk of getting COVID-19 by less than one percent,” the motion said, but Pfizer never mentioned that fact.
Pfizer also publicly touted the vaccine’s effectiveness in a way that was materially different from what it tested for in the trial. The company claimed the vaccine prevented COVID-19 — but it only measured whether trial participants tested positive and displayed certain symptoms, according to the motion.
“It is now also beyond cavil that Pfizer’s unsubstantiated claims ultimately turned out to be false. Countless vaccine recipients contracted COVID, many died, and at least some data shows that the vaccinated experienced worse outcomes than the unvaccinated,” according to the motion.
When it became apparent that its vaccine was failing, many scientists tried to push back on Pfizer’s claims, Paxton wrote.
In response, “Pfizer engaged in a scheme to censor those individuals — all to gain and maintain market share for a vaccine that earned it tens of billions of dollars in profit,” according to the motion.
It did so by using its “unique access to prominent social media companies,” to urge censorship of critics.
“Taken together, Pfizer’s misrepresentations and censorship scheme were misleading and deceptive, and they harmed Texas and its citizens,” Paxton wrote.
The motion stated:
“This is a case about how Pfizer’s misstatements led Texas consumers to make choices they would not have otherwise made, and Pfizer’s censorship of scientists that set the record straight.
“Pfizer enriched itself based on these misleading statements to the tune of billions of dollars. … Pfizer is not immune.”
Paxton and his co-counsel in the attorney general’s office urged the court to refuse Pfizer’s motion to dismiss the case.
peckford42 
Give them hell as this is where they have emerged from.
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