Kansas Sues Pfizer Over Misleading COVID Vaccine Safety and Efficacy Claims – Brenda Baletti, Ph.D. 6/20/24

Source: ChildrensHealthDefense.org

The State of Kansas on Monday sued Pfizer, alleging the pharmaceutical giant misled the public by marketing its COVID-19 vaccine as “safe and effective” while concealing known risks and critical data on limited effectiveness.

The lawsuit, filed by Kansas Attorney General Kris Kobach in the District Court of Thomas County alleges that beginning in 2021, shortly after the vaccine rollout, Pfizer covered up the fact that the vaccine was connected to serious adverse events, including myocarditis and pericarditis, failed pregnancies and deaths.

The complaint also alleges the company falsely claimed that its original vaccine retained high efficacy while knowing that efficacy waned over time and didn’t protect against new variants.

Pfizer also misled the public by claiming the COVID-19 vaccine would prevent transmission, even though the company never studied the vaccine’s capability to prevent transmission.

By marketing the vaccine as safe and effective despite its known risks, Pfizer violated the Kansas Consumer Protection Act because millions of Kansans heard those misrepresentations, the complaint alleges.

More than 3.3 million Kansans received the Pfizer shot, accounting for more than 60% of all vaccine doses given in the state.

Pfizer denied the allegations, telling The Hill, that the case has “no merit” and that the company plans to respond to the suit in “due course.”

“We are proud to have developed the COVID-19 vaccine in record time in the midst of a global pandemic and saved countless lives. The representations made by Pfizer about its COVID-19 vaccine have been accurate and science-based,” the company said.

Covering up data on vaccine’s safety for pregnant women

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) monitor adverse events in several ways, including through the Vaccine Adverse Event Reporting System (VAERS), a passive reporting system that healthcare providers and patients can use to report vaccine injuries.

A total of 1,898,829 reports of adverse events following COVID-19 vaccines have been submitted to VAERS between Dec. 14, 2020, and May 31, 2024. Of those, 983,178 are associated with the Pfizer’s COVID-19 vaccines.

The complaint said that in addition to VAERS, Pfizer maintained its own database that “contained more adverse event data than VAERS.” The data were obtained through a Freedom of Information Act lawsuit after Pfizer refused to release it publicly.

That database, the case alleged, contained 1,223 reported fatalities as early as Feb. 28, 2021.

Pfizer concealed or omitted data related to the vaccine’s safety for pregnant women, its association with heart conditions, its effectiveness against variants and its ability to stop transmission, the lawsuit alleges.

“Pfizer marketed its vaccine as safe for pregnant women,” Kobach said in a press statement posted on X. “However, in February of 2021 Pfizer possessed reports for 458 pregnant women who received Pfizer’s COVID-19 vaccine during pregnancy. More than half of the pregnant women reported an adverse event, and more than 10% reported a miscarriage.”

BREAKING: Kansas Attorney General sues Pfizer for “misleading Kansans on COVID vaccine.”

The announcement alleges Pfizer mislead Kansans on vaccine risks, such as with pregnant women and myocarditis, and that Pfizer claimed the vaccines protected against COVID variants when data… pic.twitter.com/RjNDTGrwg5

— Jason Blair (@JasonBlairNTD) June 17, 2024

Early reporting in 2021 by the CDC’s Dr. Tom Shimabukuro in the New England Journal of Medicine claiming the shots were safe for pregnant women based on the CDC’s own VAERS and vaccine safety monitoring system (V-safe) data has been shown to be statistically flawed.

Kobach also referred to Pfizer CEO Albert Bourla’s comment in January 2023 about myocarditis. Bourla said, “We have not seen a single signal, although we have distributed billions of doses.”

That was after internal documents showed the company had detected a safety signal and the FDA in June 2021 added a warning regarding myocarditis and pericarditis, both rare heart inflammation conditions, to Pfizer and Moderna’s COVID-19 vaccines.

The CDC has acknowledged that those conditions have most frequently been seen in adolescent and young adult males.

Kobach said that while Pfizer was claiming the vaccine was effective against variants, the company had data showing that effectiveness was less than 50%.

“Pfizer urged Americans to get vaccinated in order to protect their loved ones, clearly indicating a claim that Pfizer’s COVID-19 vaccination stopped transmission,” Kobach said. “Pfizer later admitted that it never even studied transmission after the recipients received the vaccine.”

Pfizer engaged in ‘civil conspiracy’ with government agencies

The lawsuit also alleges Pfizer engaged in censorship attempts with social media companies to silence people criticizing its safety and efficacy claims.

The lawsuit charges “civil conspiracy” between Pfizer, the U.S. Department of Health and Human Services (HHS), the Virality Project and others “to willfully conceal, suppress, or omit material facts relating to Pfizer’s COVID-19 vaccine.”

During a press conference, Kobach pointed to comments Bourla made on “Face the Nation,” explaining why Pfizer declined to accept government funding for developing the vaccines under Operation Warp Speed.

Bourla said he didn’t want to have to submit to the government oversight that would be required.

“When you get money from someone that always comes with strings,” Bourla said. “They want to see how we are going to progress, what type of moves you are going to do. They want reports. I didn’t want to have any of that.”

Similar case filed in Texas last year, more coming

Kansas isn’t the first state to sue Pfizer over alleged false marketing claims. Texas Attorney General Ken Paxton in 2023 sued the drugmaker alleging it 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 that 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.

Pfizer moved to dismiss the case, claiming it is protected under the federal Public Readiness and Emergency Preparedness Act (PREP Act), which grants protections to drugmakers who make “medical countermeasures” authorized for emergency use.

However, in his opposition to Pfizer’s motion, Paxton said the immunity protection provided under PREP and invoked by Pfizer in this case extends only to possible personal injury claims, not to deceptive marketing claims brought by a state.

Ray Flores, senior outside counsel to Children’s Health Defense, told The Defender the major difference in the Kansas case is that Kansas alleges a conspiracy with officials at the HHS and others to conceal or suppress information about the shot.

He also said the monetary damages Kansas seeks could be hundreds of times more than what is sought in the Texas suit.

Flores said Kansas has a strong case, based on the evidence of previous payments the company was ordered to make to multiple states for marketing violations related to other drugs.

He said:

“The exhibits alone should give pause to us all: the chronology of Pfizer’s false statements, a payout $137.9M to resolve previous violations, three separate stipulations that Pfizer not engage in deceptive promotions of its products, censorship and Pfizer’s denial of any wrongdoing.

“It is astonishing that the U.S. Government does business with Pfizer and grants special protections when Pfizer has a proclivity to flout the law.

“The allegations in the complaint are referenced-citation gems that every lawyer around the country should incorporate in this war for our health freedoms.”

Kobach told the press that five other states will be filing similar lawsuits, the Kansas Reflector reported.

“More suits may follow, depending on Pfizer’s reaction,” Kobach said.

As of April of last year, over 400,000,000 Pfizer COVID-19 shots had been administered in the U.S. according to Statista.