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Texas Attorney General Ken Paxton on Thursday sued Pfizer alleging the drugmaker made “false, misleading and deceptive claims” about its COVID-19 vaccine and tried to intimidate and censor critics who questioned those claims or cited facts that countered them.
According to the lawsuit, Pfizer’s marketing 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 alleges Pfizer cited misleading statistics, concealed negative data and made unsupported statements about efficacy against variants like Delta.
“We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies,” Paxton said in a press release. “The facts are clear. Pfizer did not tell the truth about their COVID-19 vaccines.”
When the failure of its product became apparent, “Pfizer then pivoted to silencing truth-tellers.”
The suit cites complaints made by former U.S. Food and Drug Administration (FDA) official Scott Gottlieb on X (formerly Twitter) about vaccine skeptics.
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, telling Forbes it believed the “state’s case has no merit.” Defending its claims about the vaccine as “accurate and science-based,” Pfizer said its vaccine “demonstrated a favorable safety profile in all age groups, and helped protect against severe COVID-19 outcomes, including hospitalization and death,” according to Reuters.
“Pfizer has so far escaped accountability about the potential health problems like myocarditis, thanks to sweeping liability protections granted to pharmaceutical companies” by the PREP (Public Readiness and Emergency Preparedness) Act, wrote The Federalist, which argued Paxton’s legal strategy of “fraudulent activity” may succeed because it “falls outside the scope of legal immunity.”
Ray Flores, senior outside counsel to Children’s Health Defense, told The Defender Paxton’s investigation of vaccine manufacturers announced in May “evidently bore fruit.”
“In my opinion and consistent with existing case law, this suit correctly pleads that state laws such as the Texas Deceptive Trade Practices Act are not barred by the PREP Act,” Flores said.
“I believe that other suits, including other consumer fraud and shareholder derivative suits, as well as other law and motion pleadings, will greatly benefit from the complaint’s details,” he said. “Depositions and other discovery will produce even more gems.”
Flores said his greatest hope is that information in the Texas suit will prompt the U.S. Department of Health and Human Services or the U.S. Attorney General “to finally initiate an enforcement action against the vaccine manufacturers for not being completely forthright with the FDA on the safety and efficacy of the vaccines.”
Under the PREP Act, plaintiffs are prevented from suing vaccine manufacturers unless an enforcement action has been completed, Flores said.
Terri Burke, executive director of The Immunization Partnership in Houston, told the Texas Tribune the lawsuit is “just another attempt to erode confidence in all vaccines.”
The Texas Tribune said some experts argued the lawsuit’s assertion “that vaccinated people were more likely to die from COVID-19” was “completely unsubstantiated,” and framed its coverage of the suit as the attorney general trying to hold Pfizer to blame because “the pandemic did not end soon enough.”
Pfizer’s marketing ‘bore no resemblance to reality’
The suit alleges Pfizer’s claim 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 petition.
Using Pfizer’s Phase 2/3 data, the absolute risk reduction calculation “is performed by subtracting the post-treatment risk rate of 0.04% (8/17,411 persons) found in the vaccine group from the baseline risk rate of 0.9% (162/17,511 persons) found in the placebo group, which after rounding yields 0.85%,” the petition states.
A vaccine recipient’s absolute risk reduction is the “FDA’s preferred efficacy metric,” the petition states.
“According to Pfizer’s own data, preventing one COVID-19 case required vaccinating 119” people, the petition states, “But Pfizer’s fusillade of public representations bore no resemblance to reality.”
The petition outlines three main areas of deception related to the “95% effective” representation:
- The FDA had only two months of Pfizer’s data before it authorized the vaccine, stating it was “‘not possible’ to know how effective the vaccine would remain beyond” that time.
- When the FDA told Pizer it needed additional information to determine whether the vaccine protected against transmission, Pfizer engaged in a “fear-mongering campaign, exploiting intense public fears by insinuating that vaccination was necessary … to protect their loved ones from contracting COVID-19.”
- Pfizer made false and unsupported claims about vaccine effectiveness against variants, specifically the Delta variant, when its own data showed otherwise.
The complaint also states that by late 2021, “a greater percentage of vaccinated persons contracted, and even died from, COVID-19 than unvaccinated.”
As a result of Pfizer’s deceptive conduct, the suit alleges, the vaccine maker was able to sell hundreds of millions of doses to the U.S. government “and its vaccine quickly penetrated the market through widespread public adoption.”
Dr. Naomi Wolf, whose organization Daily Clout has performed detailed analyses of the Pfizer documents, told Steve Bannon that Pfizer’s own documents show they knew, “within two months of rollout, that the vaccine did not work … and that the third most common side effect was COVID[-19].”
Pfizer’s campaign of censorship, intimidation
When it became apparent that its vaccine was failing, Pfizer responded “by intimidating those spreading the truth, and by conspiring to censor the vaccine critics” by coercing social media platforms to silence them, the lawsuit alleges.
The FDA authorization, according to the petition, “did not afford Pfizer with a blank check to seriously disseminate misrepresentations … to enrich itself at the expense of a frightened public.”
Gottlieb, who led Pfizer’s regulatory and compliance committee, more than once contacted Twitter over “perceived violations of Twitter policy,” the suit states. In one case, Gottlieb discussed journalist Alex Berenson’s tweets, where he stated the vaccine did not stop infection or transmission and had a limited window of efficacy.
“These were indisputably true statements based on the scientific record at that time, including data from Pfizer’s own studies, as well as FDA’s own findings,” according to the suit.
On multiple occasions Pfizer employed methods “with the intent to provoke and ultimately cause censorship on social media platforms of content adverse to sales or consumption of its vaccine,” including through a front group called the “Public Good Projects,” the suit alleges.
The petition also calls out Pfizer CEO Alfred Bourla for saying on Nov. 9, 2021, that persons who spread so-called “misinformation” about the vaccines were “criminals” who have “literally cost millions of lives.”
The same day, Pfizer posted the claim of “misinformation” on its Twitter account, according to the suit:
‘An artificial and flawed consideration’ of benefits and risks
The complaint goes into considerable detail discussing the difference between normal drug and vaccine approval versus Emergency Use Authorization (EUA) by the FDA.
Because EUA products “will likely have inferior guarantees of safety and efficacy,” the complaint states, Congress mandated that the FDA inform healthcare professionals administering EUA products of any “significant known and potential benefits and risks” to ensure that “individuals receiving the product obtain the same information.”
FDA advice states patients are “are unduly influenced when risk information is presented using a relative risk approach,” and that such information results in “suboptimal decisions,” according to the petition.
Noting the FDA’s review of Pfizer’s formal application concluded that “FDA and CDC [Centers for Disease Control and Prevention] identified serious risks for myocarditis and pericarditis following administration” of its vaccine, the suit alleges Pfizer’s misrepresentations resulted in “the public engaging in an artificial and flawed consideration and balancing of … benefits and risks.”
Without Pfizer’s deceptive marketing practices and its coercive attempts to silence true information about the efficacy and dangers of the vaccine, a “substantial portion would likely have opted for an alternative or foregone inoculation altogether,” the suit alleges.
“The complaint seeks $10 million in damages plus costs of investigation and attorney fees,” Flores said, adding, “Unfortunately, that is just a drop in the bucket for Pfizer. Nonetheless, it is a giant step forward towards accountability.”
Second Texas lawsuit against Pfizer in under 2 weeks
This is the second time in under two weeks that Texas has sued Pfizer. On Nov. 20, Paxton unveiled a lawsuit against the vaccine maker and its drug manufacturer, Tris Pharma, alleging the companies sold medication to children even though they knew the drug was ineffective and potentially unsafe.
The suit, filed in the Harrison County District Court, alleges Pfizer knowingly distributed a drug used for treating attention-deficit/hyperactivity disorder (ADHD) to children on Medicaid — despite the drug’s pattern of failing quality control tests.
The drug, Quillivant XR, is a stimulant that affects brain and nerve chemicals involved in hyperactivity and impulse control.
From 2012-2018, “Pfizer and Tris continually manipulated Quillivant testing to hide poor manufacturing practices and defraud the Texas Medicaid program,” according to a press release.
During those years, many families complained that the medication failed to work. According to the complaint:
“At no point did Defendants warn Texas Medicaid providers or decision-makers that Quillivant had known manufacturing issues affecting its efficacy, thereby depriving the Medicaid program of the crucial information it relies on. … As a result, thousands of Texas children received an adulterated Schedule II Controlled Dangerous Substance.”