This article about the anti-vaccine group, America’s Frontline Doctors, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.
On July 19, 2021, an attorney named Thomas Renz, representing America’s Frontline Doctors, claimed that he has a whistleblower who has found that there have been over 45,000 deaths from COVID-19 vaccines and that he is filing a lawsuit over it.
In reality, in a badly founded lawsuit that started in May, America’s Frontline Doctors filed a motion for a preliminary injunction that included, among other things, a two-page affidavit by an anonymous person who speculated about the Vaccine Adverse Events Reporting System (VAERS) reports. There is no indication this person is a whistleblower, and the claims are, at best, speculative.
America’s Frontline Doctors case
On May 19, 2021, America’s Frontline Doctors – a group of people who have not, in spite of the name, served on the COVID-19 frontline, but who appear more as a political lobbying group, and who have a history of claims without foundation – filed a “petition for a temporary restraining order” in the federal court for the Northern District of Alabama, demanding that FDA not grant an emergency use authorization for children under the age of 16.
This was more than a little strange, since America’s Frontline Doctors did not, at the time, file any complaint. In fact, the request for a TRO said “Plaintiffs will bring suit in the near future. The case will challenge the EUAs for the injections on several counts.” This is not how these things work. Generally speaking, you file your complaint and then move for a TRO, or file the TRO together with the complaint, but you cannot start with the TRO alone. In addition to America’s Frontline Doctors (who use the initials AFLDS), the complaint included a list of people, some of whom alleged vaccine injuries, some of whom simply thought the vaccines were bad, some who had concerns about mandates.
On May 24, 2021, the court rejected the TRO request because it “has reviewed the Doctors’ motion and finds no specific facts in the motion or attached affidavits that “clearly show that immediate and irreparable injury, loss, or damage will result to the [Doctors] before [the Government Defendants] can be heard in opposition.” [citing to the rules of federal civil procedure]
The lengthy (80 pages) request for a TRO did not go anywhere in court, but it did generate press releases and tweets.
Then, on June 10, 2021, AFLDS filed a lengthy complaint (113 pages) arguing that the COVID-19 vaccines Emergency Use Authorization (EUA) should be terminated because there was no real public health emergency due to COVID-19, the disease is not dangerous, there are alternative treatments, so, therefore, the requirements for the EUA were not met. They also argued that the known risks of the vaccines are downplayed and not really tracked and that recipients generally were not actually given information about the vaccines.
Basically, the complaint was trying to argue away the pandemic. Its legal argument is not very strong.
This complaint is trying to argue that an administrative agency made a bad decision. It is trying to argue about the application of law to facts: not to challenge the legal standard, but to argue that the FDA did not meet it. But while it mentions the applicable standard – the Administrative Procedures Act Arbitrary and capricious clause, 5 U.S.C. 706 (2)(A) – the complaint does not really make a very good arbitrary and capricious argument.
The effort to argue that there is no emergency is going to be hard to win, given the hundreds of thousands of deaths and millions of hospitalizations from COVID-19 in the United States alone. And the courts are not likely to be receptive to the plaintiffs challenging public health agencies on the facts about COVID-19 vaccines and the pandemic. The kind of conspiracy theories in the complaint – like claiming everybody else in the world misused or misread polymerase chain reaction (PCR) tests, that the vaccines are gene therapy, or challenging the way experts calculate vaccine effectiveness is not going to work well in court.
And the complaint, while long on anti-vaccine claims and conspiracy theories, is very short on legal argument and any tying of these claims to facts.
I think the complaint also does not make a clear standing argument – it does not show that these plaintiffs have the required stake in the outcome – because while it does argue some plaintiffs have suffered harm from the vaccine, it nowhere shows how revoking the EUA would help any of the plaintiffs.
I addressed the TRO and the complaint relatively shortly because this complaint has been filed, as I mentioned, on June 10, 2021. Nothing happened until June 30, when the court issued a summons to the defendants that it told the plaintiffs to serve to defendants – provide them – basically notifying them that the lawsuit is going on.
Then, on July 19, attorney Thomas Renz spoke at an event called Reawakening America, alleging that he’s filing papers in federal court today” (then threatening those who “censor” him that he will “sue them again and again and again”) because a woman “we are calling Jane Doe for now” told him some things.
She’s an insider, a whistleblower. We are submitting to federal court today, under threat of perjury this woman attested to this, and she’s an expert, we know, based on what she said, there have been at least 45,000 deaths from this vaccine.”… “there have been 45,000 deaths based on how many people died within 3 days of the vaccines in just one system that’s reporting to the federal government.
In writing, America’s Frontline Doctors made its own statement about this. The title, in all caps, said “AFLDS FILES LAWSUIT SEEKING IMMEDIATE INJUNCTIVE RELIEF REVOKING THE EMERGENCY USE OF COVID-19 VACCINES BASED ON DISTURBING NEW MORTALITY DATA.”
A credible whistleblower has come forward, alleging deaths occurring within 72 hours of a COVID 19 injection are significantly under reported in the publicly available VAERS database maintained by the FDA. This is shocking, and informed consent, which is required under the law, is impossible when safety data is so misleading. As of July 9th, reported deaths in VAERS totaled 10,991. Of those 4,593 were within 72 hours of vaccination. The CDC whistleblower has made a sworn statement that the actual number of deaths are conservatively five-times higher, meaning as of this date we are approaching at least 55,000 vaccine related deaths.
Initially, I was not sure if this is a new lawsuit. Luckily, some of the anti-vaccine activists I’m watching shared documents, so I looked it up via Pacer, and it was the same lawsuit for which the TRO was filed. Since the lawsuit started in May and the complaint was filed in June, the claim that this is a new lawsuit based on new data is, well, inaccurate. What was actually filed on July 19, 2021 – so over a month after the complaint was filed, and almost three weeks after the court told the plaintiffs to notify defendants that there was a lawsuit – was a request for a preliminary injunction.
The request asked the court to put a hold on emergency use authorization for COVID-19 vaccines for:
- Anyone under 18.
- Anyone who were already infected with SARS-CoV-2 before vaccinating.
- Until such time as the Defendants have complied with their obligation to create and maintain the requisite “conditions of authorization” under Section 546 of the Food, Drugs and Cosmetics Act, 21 U.S.C. § 360bbb– 3(e), thereby enabling Vaccine candidates to give truly voluntary, informed consent.
That last complaint, that people are not informed that the vaccines are authorized, argues that the Secretary of Health and Human Services has not determined that vaccines are safe and effective. Basically, the complaint demands that the vaccines be put on hold until what they believe – that the vaccines are dangerous – is told to everyone.
In short, the complaint demands that the vaccines’ emergency use authorization be temporary halted, in the middle of a pandemic, as cases are rising in the U.S. until they can litigate based on their arguments that there is no pandemic, that COVID-19 is not dangerous, and that there are alternative treatments to vaccines.
Most of this is repeating the claims in the complaint and suffers from the same issues. For example, the complaint or the motion to preliminary injunction does not actually make a serious argument about how giving the requested remedy will address any injury allegedly suffered by any plaintiff. But what the motion adds is a discussion of the new evidence alleged by Attorney Renz and in the press release of the alleged whistleblower that was supposed to show that there were 45,000 deaths from vaccines. So let us focus on that. What is this new and allegedly explosive evidence? Does it have any weight? The short answer is no.
The little affidavit that couldn’t
Apparently, the evidence consists of Exhibit D to the complaint, which can be found here. As you can see, it is a two-page affidavit by an anonymous person. This raises all kinds of problems. First, if the plaintiffs want to rely on this person’s expertise, the court needs to be able to evaluate her expertise. And the plaintiffs do want to rely on her expertise. The motion for preliminary injunction says:
Plaintiffs’ expert Jane Doe is a computer programmer with subject matter expertise in the healthcare data analytics field, and access to Medicare and Medicaid data maintained by the Centers for Medicare and Medicaid Services (CMS) (see Declaration of Jane Doe at Exhibit D). Over the last 20 years, she has developed over 100 distinct healthcare fraud detection algorithms for use in the public and private sectors.
This is nice, but the witness is actually going to need to demonstrate that expertise, and defendants are actually going to get to question her about it under oath. You cannot rely on the authority of someone – presenting them as an expert and asking others to take their claims at their word – without showing they are, in fact, experts. The motion for preliminary injunction alleges in a footnote:
Plaintiffs’ expert Jane Doe is a whistleblower who fears for her personal safety and that of her family, and reprisal, including termination and exclusion from her chosen profession for the duration of her working life, for disclosing the evidence contained in her Declaration at Ex. D. Plaintiffs will present the Court with a motion for an appropriately tailored protective order seeking to preserve the confidentiality of Jane Doe’s identity. In the meantime, Defendants are not prejudiced, since they can respond to the substance of Jane Doe’s Declaration and challenge her expert qualification without knowing her true identity. Plaintiffs’ counsel have in their possession a copy of this same Declaration of Jane Doe, signed by the witness in her actual name.
But this kind of claim is problematic. No, defendants cannot challenge her qualification without, for example, a CV, without knowing what her alleged experience is. Anonymous experts in litigation are not generally used for good reason. I will add that, conspiracy theories aside, there may be good reasons this person wants to remain anonymous since there is at least a chance this person misused her access to Centers for Medicare and Medicaid Services and may well face sanctions for it, but her personal fear of potential sanctions for actually misusing her access to private data is not a good reason for her to get anonymity.
Either she is an expert, in which case she needs to show her credentials, or she is just someone who wrote her own opinion. The court may allow her to be deposed privately without her name being made public, though there would likely have to be a stronger argument than the generalized claim above. But the defendants will need a chance to depose her, so they will have to know who she is. The federal rules of civil procedure set out requirements for expert witnesses. Generally, the identity of experts must be disclosed to the other parties, and in this case, that means the government will, in fact, know who she is.
Further, there is nothing in the description in the complaint to make Jane Doe in any serious way a whistleblower. If she has any private access, it is to Medicaid and Medicare (CMS) data she mentioned working with above. CMS is not a vaccine monitoring system (and likely would not make a good one). Her vaccine claims draw on her claims about VAERS, and there’s nothing indicating she has any internal knowledge of it. So in what way is she a whistleblower?
In her affidavit, under penalty of perjury, Jane Doe describes herself thus:
I am a computer programmer with subject matter expertise in the healthcare data analytics field, an honor that allows me access to Medicare and Medicaid data maintained by the Centers for Medicare and Medicaid Services (CMS). I earned a B.S. degree in Mathematics and have, over the last 25 years, developed over 100 distinct healthcare fraud detection algorithms, both in the public and private sector. It has been my mission to protect federal tax dollars by preventing and detecting healthcare fraud, a process which leads to both recovery of overpayments and law enforcement leads. A large part of what I do is focused on the quality of care for the beneficiary; for example, I identify providers who prescribe an egregious amount of opioids to patients with a history of overdosing.
Note that none of this gives Jane Doe any knowledge of understanding of vaccine monitoring or any access to it or insider information about it. And as will become clear in a moment, she has not, in fact, written an algorithm to detect fraud here – at least not from what she says she did.
Then, Jane Doe says: “When the COVID-19 vaccine clearly became associated with patient death and harm, I was naturally inclined to investigate the matter.” Note that this makes it clear that Jane Doe went into investigating the vaccine with a belief the vaccine caused death and harm and went looking for support for her belief. Looking for information to confirm your existing belief predisposes someone to confirmation bias, a logical fallacy.
Jane Doe then gives us her opinion:
It is my professional estimate that VAERS (the Vaccine Adverse Event Reporting System) database, while extremely useful, is under-reported by a conservative factor of at least 5.
This is where anonymity is an issue. Jane Doe wants us to accept her opinion based on her expertise (as will be clear when I describe what she said she did, she is very short on methods, and is basically asking us to believe she knows what she is doing and did it right). To do that, readers – and defendants – actually do need a strong look into her actual credentials and experience. Her anonymity makes that impossible.
So what did she tell us she did? She said:
On July 9, 2021, there were 9,048 deaths reported in VAERS. I verified these numbers by collating all of the data from VAERS myself, not relying on a third party to report them. In tandem, I queried data from CMS medical claims with regard to vaccines and patient deaths, and have assessed that the deaths occurring within 3 days of vaccination are higher than those reported in VAERS by a factor of at least 5. This would indicate the true number of vaccine-related deaths was at least 45,000.
In other words, this person took unverified, raw VAERS reports. She said she did her own searches and got to 9,048 deaths, but she gives us no details on how she did the search, so we do not know if it’s true. She basically asks us to take it on trust – and again, her anonymity makes trusting her tricky. But at any rate, what she did was look at all the reports to VAERS that had a death reported after a COVID-19 vaccination, then assumed:
- That they are all true: that the people actually died.
- That all the deaths resulted from COVID-19 vaccines.
That is wrong in multiple ways. First, you can’t make either assumption for VAERS, and the site itself tells you that. The site warns you that:
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable.
Second, we know Jane Doe’s assumptions are not true. We know that during COVID-19 alone there were at least some reports that appeared in VAERS, on their face suspect and likely never happened.
We know from past experience that deaths have been reported to VAERS because people read about a death on the internet, and even if there was another cause.
And we know that VAERS reports of deaths after COVID-19 vaccines are investigated and examined by agencies that report on them. As are other harms reported after COVID-19 vaccines. And these investigations do not show alarming rates of death.
So, looking at VAERS data and claiming it shows deaths from COVID-19 vaccines is already incorrect, and an expert should know that.
But it gets worse. Jane Doe alleged that she looked at the data she says she had access to through her career, Centers of Medicaid and Medicare claims data. First, as pointed out by people who have worked with medical claims before, this at least sounds like she illegally accessed private data she did not have access to for this purpose.
This might be why she is anonymous, to avoid accountability for violating her job requirements and who knows which laws. Further, she is asking us to assume the claims deaths reflect everyone’s vaccine status and death information – but not all deaths will lead to claims to Medicaid and Medicare.
Maybe she looked at something that included full death and vaccine information, but she does not really tell us. Nor does she tell us how she calculated the death rate, or why she assumed causality. And she is using this to claim a five times greater rate of death from VAERS – while VAERS itself does not show causation.
In other words, on this affidavit, there is no good reason to assume this person could do what she said, or in fact, did it. There is a basis to suspect she did something that violates multiple rules and abused her access to data. That does not increase her credibility. And when she is used this way, Federal rule 26(a)(2) demands more in terms of the data provided. The section says:
“The report must contain:
(i) a complete statement of all opinions the witness will express and the basis and reasons for them;
(ii) the facts or data considered by the witness in forming them;
(iii) any exhibits that will be used to summarize or support them;…”
A conclusory statement like the one above is unlikely to meet these requirements. On this affidavit there is no basis to accept her claim that VAERS reports are underreported by a factor of 5. Basically, her assessment is unsupported.
Performative Legal Action
The alleged important revelation is a two-page anonymous statement by someone who claims expertise without evidence, who makes claims that are problematic on their face – like assuming causation for VAERS reports – and who by her own admission likely violated rules and patient data and abused access she had. It’s very thin, unconvincing gruel for anything. It is not evidence of a high rate of deaths from the vaccines, and certainly not a counter to the actual data from agencies. It’s not likely to go anywhere in court.
And it has been filed in support of a motion for a preliminary injunction that lacks a strong legal argument, that is full of claims that are not going to go anywhere because judges are not going to accept that a pandemic that has already killed 600,000 people in the United States alone is not an emergency.
To a large extent, the America’s Frontline Doctors’ complaint is not even trying. It does not have a strong standing argument; it does not set out any sort of argument that the agency action was arbitrary and capricious. So why do it?
My opinion is that the goal of the lawsuit is not to be successful in court at all. America’s Frontline Doctors know they do not have a plausible case. That’s not their audience. Their goal is to create fear, uncertainty, and doubt by using alternative media to spread claims they know their listeners will not – or may not be able to – fact check. The court is a vehicle to make those claims sound like there is something to them like they are going anywhere.
It is part of America’s Frontline Doctors efforts to promote misinformation. And is a cynical, and probably unethical, use of courts. It may be against rule 11 to the rules of civil procedure. Although rarely used in practice, it exists, and several lawyers who brought problematic cases against the 2020 elections are currently facing potential sanctions under it. This case may be another one where it is worth asking if sanctions are appropriate.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
