Pfizer Sued for Misleading Claims About Its COVID Shot
- by Carolyn Hendler, JD
- Published
- Federal & State Courts
The State of Kansas has sued Pfizer, Inc. over its mRNA (messenger ribonucleic acid) COVID-19 shot, Comirnaty. Kansas attorney general Kris Kobach alleges that the pharmaceutical giant labeled and marketed the novel biologic as, “safe and effective,” while knowing that the product could cause, “serious adverse events,” including myocarditis and pericarditis, failed pregnancies and death.”1 Texas attorney general Ken Paxton filed a similar lawsuit against Pfizer.2
The 69-page Complaint filed in Thomas County District Court points out the misrepresentations that Pfizer made to the public, including claiming that (1) the shot prevented infection, despite knowing that any potential protection waned over time; and (2) the shot prevented transmission of the SARS-CoV-2 virus, even though the shot was never tested for its ability to prevent transmission.
The Complaint alleges that the drug company’s actions and statements violated the Kansas Consumer Protections Act. The State of Kansas maintains that Pfizer must be held accountable for their obfuscation of the true nature of its product, which led to a $75 billion windfall profit for the drug company.3 4
Allegation That Pfizer Took Advantage of Kansas Residents’ Fear of COVID
According to the Complaint, after Pfizer advertised about its “life-saving vaccines” on Facebook, 3,355,518 doses of Comirnaty were administered to Kansas residents as of February 2024.5
The Complaint reads:
Pfizer took advantage of Kansans’ fear of COVID-19 and desire for safety by offering a “safe and effective” COVID-19 vaccine, while concealing, suppressing, and omitting material information that undermined its safety and effectiveness claims.6
Pfizer Hid Key Safety Data
Kansas further alleges that, while Pfizer made unsupported claims about Comirnaty, it concealed critical information about the safety and efficacy of its shot by implementing confidentiality agreements with governments across the globe and delaying access to patient safety data. To further hide the truth about the safety of Comirnaty, Pfizer purposefully destroyed health outcomes of the control group in clinical trials by eventually giving them the shot, which prevented any meaningful comparison of long term health outcomes between vaccinated and unvaccinated participants in the clinical trials.7
Attorney General Kobach highlights that Pfizer’s Comirnaty safety information is limited as it only used healthy individuals and excluded unhealthy people for the product’s trials. The trials excluded anyone who was immunocompromised, vulnerable to COVID, had COVID, or was pregnant or breastfeeding. Furthermore, Pfizer hid this fact from the public when Comirnaty was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).8
The Complaint alleges that, despite Pfizer and the U.S. government being aware of safety concerns and safety signals such as myocarditis and pericarditis, Pfizer CEO Albert Bourla stated on CNBC…
We constantly review and analyze the data. We’ve seen not a single [safety] signal although we have distributed billions of doses.9
Pfizer Knew But Failed to Disclose That Any Protection Provided by COVID Shot Waned
The Complaint alleges that Pfizer reported that Comirnaty was 95 percent effective in preventing COVID 28-days after the initial dose and Bourla said that this protection remained robust even after six months. However, the Complaint states that there was insufficient data to support these claims and Pfizer was aware that its product’s effectiveness waned, but the company hid this fact from the public.10
Pfizer Misrepresented That Its COVID Shot Prevented Transmission of SARS-CoV-2 Virus
Kobach asserts that Bourla made multiple representations to Kansas that Comirnaty prevented transmission of the SARS-CoV-2 virus, going so far as to call people who received the shot “Everyday Heroes.” The people of Kansas relied on these representations when they received the shot. Pfizer Board of Directors member and former FDA commissioner Scott Gottlieb, MD said:
And final point, I mean, some of the optimism is also being driven by growing science, suggesting that these vaccines, all the vaccines not only prevent COVID disease, prevent symptoms, but also prevent transmission. So they could have a dramatic effect on reducing the overall tenor of the epidemic.11
Pfizer Violated Previously Filed Consent Judgments
The Complaint further contends that Pfizer breached previous consent judgments with the State of Kansas regarding consumer protection claims. A Consent Judgment entered into by Pfizer in 2008 due to its marketing and promotional practices for the prescription drugs Celebrex and Bextra set forth that the company would not make any false, misleading or deceptive claims pertaining to any FDA approved Pfizer product.
The Consent Judgment also provided that when communicating information about clinical studies, Pfizer will present accurate information according to explicit criteria set forth. Pfizer did not comply with this Consent Judgment and Kansas Attorney General put Pfizer on notice that they were in violation of the Consent Judgment in April 2024. The Complaint alleges that Pfizer has also violated similar Consent Judgments from 2012 and 2014.12
In response to the lawsuit, Pfizer said:
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 believes that the state’s case has no merit and will respond to the suit in due course.13
Pfizer stock shares fell two percent after news of the lawsuit was released after having a decrease of 31 percent of their value over the past year.14
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