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James Uthmeier

TALLAHASSEE – Florida Attorney General James Uthmeier has filed a lawsuit against Pfizer claiming the drug company misled Americans about the safety of its COVID-19 vaccine.

The complaint, filed October 1 in St. Lucie County Circuit Court, says Pfizer and CEO Albert Bourla marketed the vaccine while concealing safety risks for pregnant women, known adverse effects and the risk of myocarditis.

“Weeks ago, we learned (former federal official Anthony) Fauci and the biomedical state knew the COVID jabs were dangerous but hid it from us,” Uthmeier said Thursday in announcing the lawsuit. “While that investigation continues, today we sued Pfizer for deceptively marketing the products as safe –  making billions – while pregnant women were miscarrying their babies and teenagers were having heart attacks.”

The 49-page complaint seeks civil penalties, disgorgement of profits, attorney fees and a permanent injunction under the Florida Deceptive and Unfair Trade Practices Act.

Uthmeier’s filing comes at a time when he and other Republicans continue to question vaccine safety and protocols taken during the pandemic by the Trump administration and its allies.

The lawsuit alleges Pfizer’s public campaign from 2020 through 2023 falsely portrayed its vaccine as having no material safety concerns while the company possessed or had access to reports involving myocarditis and pericarditis, pregnancy-related concerns, strokes, deaths and other adverse events.

Pfizer and Bourla also are accused of misleading Floridians by suggesting vaccination was necessary to prevent transmission of COVID-19 to loved ones, although the company’s original clinical trial did not test whether the vaccine prevented transmission.

“Pfizer’s marketing campaign that drove record-breaking profits rested on deception and falsehoods,” the complaint says.

The filing cites statements by Bourla, including a January 2023 CNBC interview in which he said Pfizer had seen “not a single (safety) signal” despite distribution of billions of doses. The complaint argues that statement conflicted with known evidence, including federal warnings concerning rare cases of myocarditis and pericarditis after mRNA vaccination, particularly among adolescent and young adult males.

The lawsuit does not seek damages on behalf of individual vaccine recipients. Instead, it alleges Pfizer’s promotional claims, omissions and business conduct violated Florida’s consumer protection law regardless of whether consumers chose to be vaccinated.

The state alleges Pfizer publicly described its COVID-19 vaccine as safe and repeatedly emphasized the absence of serious safety concerns while not disclosing adverse-event information and other data it possessed.

The complaint focuses heavily on myocarditis and pericarditis, inflammatory heart conditions later included in warnings accompanying Pfizer-BioNTech COVID-19 vaccines. It says Pfizer knew by 2021 of reports connecting mRNA vaccination with those conditions and cites government health agencies’ subsequent recognition of a causal association.

It also alleges Pfizer had reason to believe its vaccine might pose risks for women vaccinated early in pregnancy and their unborn children, while lacking sufficient evidence to assure consumers that first-trimester use was safe.

The complaint cites internal and post-authorization reports involving pregnant women, as well as a rat study. It also notes the current Comirnaty package insert says there are no available data on use before 24 weeks of pregnancy sufficient to inform risks of major birth defects and miscarriage.

The complaint further cites Pfizer’s post-authorization adverse-event reports through February 28, 2021. It says Pfizer’s database then contained 158,893 adverse events from 42,086 case reports, including 1,223 deaths reported after vaccination. The filing acknowledges Pfizer had not made causality determinations for those deaths.

An adverse-event report does not by establish a vaccine caused the event, but the complaint argues Pfizer’s possession of such reports conflicted with its broad public safety assurances.

Florida also alleges Pfizer improperly used appeals about protecting loved ones and communities to persuade consumers that its vaccine would stop transmission.

The complaint quotes Bourla saying in December 2020 that a decision not to vaccinate would affect “the lives of the people you love the most,” and cites similar remarks he made in interviews during 2021. It alleges those statements reasonably conveyed that vaccination prevented transmission.

But Pfizer’s clinical trial protocol did not list transmission as an objective, according to the complaint. The filing also points to a December 2020 Food and Drug Administration document that said there was no evidence at that point the vaccine prevented person-to-person transmission.

The complaint cites remarks by Pfizer executive Janine Small during a 2022 European Parliament hearing in which she answered “no” when asked whether the vaccine had been tested before market authorization for its ability to stop transmission.

The lawsuit alleges Pfizer used that message because it was effective at building demand. It quotes Bourla as saying in a 2021 interview that explaining how reluctance to vaccinate could affect loved ones was the argument that “mostly works.”

The state’s second count targets what it calls Pfizer’s “profiteering” through allegedly unfair market practices and vaccine pricing.

The complaint says Pfizer invested at least $1.5 billion in COVID-19 vaccine development and later generated more than $80 billion in vaccine revenue. It alleges that Pfizer attained about 70% of the U.S. and European COVID-19 vaccine markets and raised the private-sector price of its vaccine after the pandemic emergency period, from about $30 per dose to a range of $110 to $130.

The filing says the private sector price of Pfizer’s Comirnaty vaccine is now $169.84 per dose.

It also alleges Pfizer sought to protect market share by encouraging social media platforms to remove vaccine criticism, opposing intellectual property waivers that could have aided generic vaccine production and funding presentations that suggested a competitor’s vaccine could cause cancer.

Bourla is named individually because, the state alleges, he personally made deceptive statements, had authority over Pfizer’s conduct and benefited from the company’s profits. The filing says Bourla received about $101.8 million in compensation from Pfizer between 2020 and 2023, excluding any stock-sale proceeds.

The complaint also cites a November 2020 sale in which Bourla sold roughly $5.6 million in Pfizer stock on the day the company announced positive clinical-trial news.

Florida is seeking a court declaration that Pfizer and Bourla violated the state consumer-protection law, known as FDUTPA, along with a permanent injunction barring deceptive or unfair statements to Florida consumers about Pfizer’s COVID-19 vaccine.

The attorney general also seeks civil penalties of up to $10,000 for each willful violation and up to $15,000 for each violation involving a senior citizen or a person with a disability. The final amount, if any, would depend on how a court defines individual violations.

The state further seeks attorney fees, costs and equitable relief, including disgorgement of profits.

The filing says Pfizer has been registered to do business in Florida since 1996 and maintains a “Global Capability Hub” in Tampa. It alleges millions of Floridians heard or saw the company’s disputed messaging and says 6,745,860 Pfizer vaccine doses had gone to Florida as of September 6.

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