A Gambit to Allow Covid Vaccine Lawsuits

by | Jan 24, 2024 | FDA, FOIA, Law Firms, Litigation, Pharmaceuticals

In FOIAengine, a Law Firm’s Strategy Takes Shape

When we tallied the hundreds of thousands of Freedom of Information Act requests filed with the federal government last year, one law firm stood out.

According to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows, the plaintiff’s law firm Siri & Glimstad filed at least 162 FOIA requests with the Food and Drug Administration in 2023 – the most by any law firm.

Covid-19 vaccine makers were the law firm’s main targets.  Fifty Siri & Glimstad requests included the term “vaccine”; 22 mentioned “Moderna;” 16 asked about “Pfizer;” and five name checked “Johnson & Johnson.”

No surprise, so far.  Siri & Glimstad, with offices in New York, Los Angeles, and five other U.S. cities, specializes in vaccine litigation.

What is more interesting is how the law firm’s strategy is unfolding.  FOIA requests can be an important early warning of litigation to come.  And that’s what we see here.  Siri & Glimstad’s FOIA requests appear to be part of a broader game plan, with the law firm seeking an end-around the federal law inoculating the Big Three vaccine makers from Covid-vaccine lawsuits.

Key to the law firm’s gambit:  an attempt to have the pharma companies’ Covid litigation safe harbor declared unconstitutional.  The challenge is pending in federal district court in Monroe, Louisiana.

We’ll explain more about the constitutional challenge after we provide a brief history of the safe harbor, which we first described last April.  (See “Pfizer and Moderna Are FOIA Targets,” April 5, 2023.)

Days after the onset of the Covid pandemic in March 2020, the government invoked a 2005 law called the PREP Act – the acronym stands for Public Readiness and Emergency Preparedness – to prevent vaccine makers from being sued for making or distributing the coronavirus vaccines.  The act provided a safe harbor from litigation to Pfizer and Moderna for their mRNA vaccines, as well as to Johnson & Johnson for its viral vector vaccine.  The idea was to give the vaccine makers every incentive to move quickly to fight the deadly virus.

And it worked.  Vaccines came out in record time, hundreds of millions of Americans were protected, and the share prices of Pfizer and Moderna soared to all-time highs.

For Pfizer and Moderna, that success came with another kind of protection – from lawsuits.  For at least the ensuing four years, Pfizer and Moderna couldn’t be sued over injuries related to the administration or use of their products to treat or protect against Covid.  The only exception was willful misconduct.  Shot recipients who had an adverse reaction couldn’t go to court, but instead were given the option of filing a claim with the federal Countermeasures Injury Compensation Program (CICP), the PREP Act’s litigation alternative for injuries experienced during public health emergencies.

But CICP claims almost never succeed.  Once shunted into that program, a Covid claimant’s odds of victory are about 2 in 100; it’s the Bermuda Triangle of injury claims.

To win compensation, petitioners must convince the CICP that there is “compelling, reliable, valid, medical and scientific evidence” that their injury was the “direct result” of the Covid vaccine.

According to the most recent data available, through the end of 2023 the  CICP received more than 12,854 Covid-related claims. Thus far, 40 have been deemed eligible for compensation and 2,174 (98%) have been denied. Only 11 claimants have been paid.

The CICP was designed to handle claims stemming from countermeasures used to treat smaller public health emergencies like anthrax and Ebola, not a wide-spread emergency like Covid. As the payer of last resort, the CICP offers limited compensation for unreimbursed medical expenses, lost employment income, and survivor death benefits. There are no provisions for other damages or legal fees.

Siri & Glimstad’s clients — eight individuals and a vaccine-victim non-profit named React19 — are asking the U.S. District Court in Western Louisiana to declare unconstitutional the law that established the CICP, and to prohibit its provisions from being enforced until all Covid vaccine injury claims are allowed to be brought to the U.S. Court of Federal Claims.

The lawsuit alleges that the CICP program violates the Fifth and Seventh Amendments by failing to provide “basic due process protections, transparency, and judicial oversight.”  According to the complaint, petitioners don’t have the chance to review evidence used against them, question the government’s expert witnesses, get copies of their reports, obtain discovery from the vaccine makers, present their own expert witnesses, or appeal adverse decisions in a court of law.

Siri & Glimstad’s complaint describes the CICP as “akin to a Potemkin village; it is an elaborate façade designed to hide an undesirable reality. CICP is the epitome of a kangaroo court or a star chamber — a proceeding that ignores recognized standards of law and justice, is grossly unfair, and comes to a predetermined conclusion.”

Aaron Siri, a name partner at Siri & Glimstad, says the forum “is the equivalent of a black hole.” According to the complaint, four of the eight individual plaintiffs filed claims for compensation with the CICP but were told there is “no timeline” for adjudicating their cases. Another plaintiff had his claim denied. Three others said they were initially unaware of the program’s existence and missed the strict one-year deadline to bring a case.

The federal district court’s consideration of the Siri & Glimstad complaint is in its early stages.  The plaintiffs filed an amended complaint on October 31, and District Judge Elizabeth E. Foote has scheduled a hearing for May 17, 2024 on their motion for a preliminary injunction.

Our review of Siri & Glimstad’s 2023 FOIA requests reveals that the firm has been using FOIA requests to support its arguments.  During 2023, the law firm sought studies of the impact of Covid vaccines on U.S. children aged 6 months to 17 years (FOIA requests dated October 23 and 24); the impact on persons aged 65 years and older (December 29); the impact of Covid on pregnancy and infant outcomes (August 21); and adverse-event records concerning vaccines given to animals (July 26).

Many of the requests were quite broad, such as a request for “all protocols, press reports, interim reports, monitoring reports, final reports and communications concerning Pfizer studies” (June 6).  Another sought all requests for death certificates and autopsy reports made by CDC following any post-Covid vaccination deaths reported to VAERS — the Vaccine Adverse Event Reporting System (March 31).  An August 11 request sought “all records concerning any manufacturing process changes” for all Moderna and Pfizer Covid vaccines.  A group of requests asked for “all communications” to and from specific FDA staff members relating to Pfizer, Moderna, or Johnson & Johnson.

Aaron Siri told us in response to questions during research for our earlier article that FOIA requests are “extremely useful” tools for his clients. He added that data already produced under FOIA showed “troubling numbers of people reporting that they had to seek medical care after their Covid vaccine.”

To see all the requests mentioned in this story, log in or sign up to become a FOIAengine beta user.

Next from FOIAengine:  Media inquiries to the Federal Trade Commission.

Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law.  FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins.  Learn more about FOIAengine hereSign up here to become a beta user of FOIAengine.  

Write to Randy E. Miller at [email protected].