Control Group lawsuit – alternative facts and bad science about vaccines

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This article about the Control Group lawsuit 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.

Making its way through our court is a lawsuit against the President of the United States by a group that calls itself The Control Group. Our friend Orac already pointed out that the group’s claims are scientifically unsound. This post points out that the lawsuits are also legally unsound, in more ways than one. 

Photo by CDC on Unsplash

The Control Group lawsuit

The Control Group lawsuit was filed on December 14, 2020. With an amended complaint – that will be the focus of this post – filed on January 25, 2021. The lawsuit is brought on behalf of three families, two of them California families, and one a military family, against the President of the United States. The lead plaintiff is Joy Garner, who appears to be the brains behind the survey of the Control Group, and the grandmother of one of the families.

It appears to be demanding three things, based on a series of factual allegations: 

  1. That the President order an end to all vaccines mandates across the United States and all forms of what they see as “discrimination” against people based on their vaccination status. In a very real sense, the lawsuit seems to try to get around the fact that every court that looked at state-level vaccine mandates, so far, found them constitutional, by asking the President to just order them away. 
  2. That the President order a largescale study of unvaccinated people in the United States, to follow on their survey. 
  3. That the President, apparently, protect them from a threat they think exist that they be grabbed, quarantined, and have their unvaccinated children taken and vaccinated by force.

The complaint consists of 74 pages that can be fairly described as a legal mess. It lists a set of factually incorrect or irrelevant claims, a set of legal claims that just don’t work, and has a number of simply strange things. 

Unsurprisingly, a district court rejected the claims in the Control Group lawsuit. The district court put aside the factual claims, put aside the question of whether the plaintiffs actually showed a personal injury, and instead, rejected the complaint on the basis that it is, in essence, against the wrong person. To show standing to bring a claim plaintiffs need to show that they have a personal “injury in fact”, that the conduct by the defendant caused the harm, and that a court decision in their favor would redress – fix – the injury.

As the Court points out, 

The first amended complaint contains no allegation that any department or agency of the federal government, much less the President, is responsible for any of their alleged injuries. To the contrary, plaintiffs even note that there is no mandatory vaccine federal  requirement and that the Center for Disease Control (“CDC”) recommended vaccine schedules are not mandated. Instead, plaintiffs allege throughout their first amended complaint that the actions complained of are the result of independent actions by third parties not before the court.

The Court stated that the main claims are against the states that have mandates, and they’re not being sued. It also pointed out that an order against the President wouldn’t remove California’s mandate.

Plaintiffs appealed to the Ninth Circuit, but since the court is – well – right, their chances are not very good.

This post will discuss the plaintiffs’ factual claims, their legal claims, such as they are, and the other issues with the complaint. I am not going to touch on every single issue in the 74 pages complaint, but you should get a good sense of why it’s not a very strong case. 

Photo by Prasesh Shiwakoti (Lomash) on Unsplash

Factual claims: vaccines, the alternative facts version

Large parts of the Control Group lawsuit are dedicated to claiming vaccines are bad, and this is mostly based on the group’s survey. Orac addressed the issues with the group’s survey in detail. The short version is that the alleged survey is a one-page questionnaire that simply asks people who claim they’re unvaccinated to list any “chronic diseases” they have and the date of them.

Although the form asks for age and sex, it collects no other demographic information. There is no verification of the claims through any records, and the analysis does not control for any potentially confounding factors besides receiving vitamin K or the mother receiving prenatal vaccines.

The respondents were also recruited through anti-vaccine sites. So the basis of the claims is a clearly non-scientific survey of a biased population without minimum valid controls, leading to results that are, for all intents and purposes, unreliable. The survey is vouched for as statistically strong by an expert who is, apparently, Dr. Vicky (Debold) Pebsworth who does, in fact, have a Ph.D., and several publications but is not an academic.

Dr. Pebsworth is, instead, an officer of the anti-vaccine organization the National Vaccine Information Center (NVIC). Searching PubMed found three publications by her, the latest from 2014, which suggests Dr. Pebsworth is not an active researcher, and she clearly has anti-vaccine views. The group stated that it had no intention to try and publish its study in peer-reviewed journals, and it was not subject to external quality control by a qualified, independent researcher, as far as I can tell.

Based on that unreliable survey, the group members decided that they had grounds to claim that getting vaccines creates a 60% of getting a chronic disease. This is based on a series of problematic claims.

The Control Group lawsuit starts with the CDC’s page stating that 6 out of 10 adults in the United States has a chronic disease (listing heart disease, cancer, chronic lung disease, stroke, Alzheimer’s disease, diabetes, and chronic kidney disease) – but then ignores the risk factors mentioned on the same page for these diseases, tobacco use, poor nutrition, lack of physical activity, and excessive alcohol use, in its quest to blame vaccines.   

It also ignores the data that shows no link between vaccines and these issues – here, for example, is a discussion of vaccines and diabetes. As far as I can guess, the 60% number comes from pointing to the 6 in 10 here and deciding, with no evidence or against the evidence, vaccines caused it. 

The Control Group lawsuit also repeats a common claim that the current generation of children is the “sickest,” based on a misrepresentation of a 2011 study that defined chronic illness extremely broadly, to include, for example, obesity (though the complaint does try to link vaccines and obesity, and links, in service of that, to a study that has nothing to do with vaccines). 

The complaint asserts that the “vast majority of health problems suffered by Americans today are the consequence of, and/or are directly related to, a dysfunctional immune system.” It provides no evidence of that interesting claim. It then asserts that vaccines alter the immune system, again with no evidence except for a declaration by plaintiff Joy Garner, a non-expert, and tries to blame adjuvants.

Vaccines do not, however, change the immune system; instead, they work with it, getting it to react as if it were infected by a virus or bacteria – without the risks of the pathogen.

The complaint tries to dismiss the existing body of literature by, without irony, referring to a review by anti-vaccine activist Dr. James Lyons-Weiler who alleged that he was assigning study an “objective evaluation score” he himself made up, that is not an accepted standard in any relevant field, as far as I know. The evaluation was not peer-reviewed, and apparently not passed through any quality control by experts.

The complaint goes so far as to claim in a footnote that “No governmental agency has ever provided epidemiological evidence to support vaccine safety claims. The only evidence relevant to answering this particular question is a numerical accounting of the health outcomes between exposed and unexposed.” But there is epidemiological evidence looking at the risks of vaccines, for example, examining rates of severe allergic reactions, or rates of autism.

There is more, but this is likely enough to make the point that the complaint approaches the issue based on unfounded, problematic assumptions, and uses them to draw conclusions that its unreliable survey cannot support.

It then makes extravagant claims about this set of implausible assumptions supported by unreliable data, for example, alleging that “the unvaccinated population has exponentially higher overall chances of survival than those who’ve been exposed to vaccination” or that its survey “provides profound proof that vaccine exposure is in fact the primary cause of this Nation’s current public health crisis.” [capitalization and italics in the original]

Photo by Wesley Tingey on Unsplash

Incorrect legal claims

The lawsuit’s legal claims are even less founded than the complaint’s factual claims. This is a bit strange since while I’m not familiar with attorney Ray Flores, who is one of the Control Group’s attorneys, I have come across attorney Greg Glaser before, in a variety of contexts.

Attorney Glaser is clearly anti-vaccine, but he is highly competent and he is smart. I just don’t see him writing a complaint as badly written, badly argued, and legally unsound as this one. My suspicion – one I obviously cannot check on – is that Joy Garner herself wrote the complaint, and Mr. Glaser, at least, had little input into it. At any rate, the complaint does not set out a valid legal case.

The complaint tries to argue that lack of action by the President would cause them “immediate and irreparable harm… if they are not protected from coerced vaccination through discrimination…” But just the fact that if the government does not step in to save you bad things will happen to you does not create a duty on the part of the government to do anything. Here are two examples. In DeShaney v. Winnebago County, 489 U.S. 189 (1989), the government did not step in to protect a child that was abused by his father. The child was left brain damaged from the abuse.

The Court found no violation of rights in the state’s non-intervention. Similarly, in Castle Rock v. Gonzales, 545 U.S. 748 (2005), a police department failed to enforce a restraining order on an abusive husband, and the husband abducted and murdered the children. Here, too, no duty to intervene was found. There just isn’t a general “the President has to come to save me” rule in the United States, even if there should be one – even when the risk is real and documented and painfully glaring (which it is not here). Plaintiffs actually have to point to a duty on the President to act, and they don’t.  

Further, the plaintiffs here are demanding that the President act to suspend state mandates. The President does not actually have the authority to unilaterally abolish state law. He just does not. In our federal system, federal law is supreme, but states have the authority to act in their own sphere.

However much the plaintiffs want to believe that vaccination is a national emergency, they cannot just ask the President to strike down state laws they think are a bad idea. If Presidents could do that, federalism would have little meaning. In fact, there are even limits to the degree the federal government can use the spending powers it clearly has to convince the states to act – it can’t once the power becomes “coercive”.

The legal reasoning the Control Group lawsuit uses to try and build an argument otherwise is… strange.

The complaint starts, at s. 76., by arguing that the judiciary has power to, among other things, order the President to use his discretion. The cases it links to for that, assuming they want to use it to argue the courts can order the President to strike down state laws (something the President does not have the power to do), are not actually on point.

The first case is a case that found that President Truman does not have the authority to seize steel mills during a war – basically, limiting, not broadening, the President’s powers.

The second case is a case that found that the President’s powers do not go beyond what Congress granted.

The third is mentioned, but it’s not clear why it’s relevant – it’s a case that found plaintiffs did not have the standing to challenge the ACA. None of these cases would help the plaintiffs argue that the Courts have the authority to order the President to strike down state laws, or that the President has that power. 

The next two sections argue respectively that vaccines are “therapeutic human experimentation” and “biological alteration”, without connecting this to anything specific they want the President to do.

It is not clear why these claims (which are also incorrect) are legally relevant. Then the plaintiffs argue that “public health authorities claim they do not know the cause of the chronic illness pandemic.” This too is incorrect – again, the first page the plaintiffs start with, the CDC’s “Chronic Diseases in America” page, which claims that 6 in 10 adults have a chronic disease – also sets out factors contributing to them, including nutrition and lack of exercise. It’s also not tied to any legal claims.

Neither are the next two sections, trying to claim that studying the unvaccinated is ethical and important, and that because of all they said before, it’s up to the President now to show vaccines do not cause the chronic diseases the data shows they do not cause. In a well written complaint, sections should fit together to support the basic arguments of the complaint and provide a basis for the legal claims. These do not. 

Then the plaintiffs set out a number of legal “counts”:

  1. The President’s oath of office and oath to take care that the laws are faithfully executed requires him to use his discretion to do what plaintiffs want because otherwise, things will be really, really bad. Yes, that’s the argument. They compare the nation to a cancer patient (really, they do) and argue that the President, that they compare to a hospital’s director and physician, has to do “something defensible to save the patient’s life” and has no discretion there.

    This is not, actually, a valid legal argument. In essence, plaintiffs want to say that they think the United States is in a bad condition, and if the President does not do what they think is a good idea, the President is acting illegally. That’s not how it works. The remedy for people who think the President should do a different job is political, not legal. There is no constitutional duty on the President to do what plaintiffs want him to do because they think it’s important. 
  2. This count tries to argue that the First Amendment requires a religious exemption from vaccine mandates. That’s a fair argument to raise in a challenge to a state vaccine mandate – and one that so far has been rejected by the courts, for reasons I address in detail here – but it has nothing to do with this complaint since the President cannot add a religious exemption to a state school vaccine mandate any more than he can strike the whole thing down.
  3. This count tries to argue that vaccine mandates violate bodily integrity, protected, in their view, by the fifth amendment.
  4. Count four tries to claim that they violate the liberty protected by the same amendment. These claims were rejected in 1905 by the Supreme Court in Jacobson v. Massachusetts, and the plaintiffs are trying to argue against it by claiming that Jacobson was bad because it led to forced sterilization in Buck v. Bell and abortion in Roe v. Wade.

    I’ve pointed elsewhere that I think Jacobson was misused in Buck, but again, that’s beside the point – while these arguments may be raised in a case against a state vaccine mandate (and they have been raised in that context by other anti-vaccine activists, and have had little success there so far), they have nothing to do with this complaint because the President does not have the authority to strike down state mandates.
  5. Count five tries to attack mandates by referring to the fourth amendment and suffers from the same issue. 
  6. This count argues that something (it never quite sets out if this is about mandates or about general “states don’t like unvaccinated people) violates the Eighth Amendment based on the claim that parents who don’t vaccinate are “frequently threatened by child protective services that their parental rights will be stripped and their children will be taken away and given to strangers”. This is factually incorrect, to my knowledge: children are not taken from their parents just because parents won’t vaccinate. It’s also not a punishment when children are taken but generally done in the child’s interests. The count goes on to argue that “mandatory and coerced biological alteration is cruel and unusual”, based, apparently, on the view that vaccines change the DNA and that’s bad. But vaccines don’t change the DNA. 
  7. This count argues that because vaccines are experimental, forcing people to “participate in human experiments” is, apparently, involuntary servitude which violates the Thirteenth Amendment prohibition on slavery.  The problem, of course, is that vaccines are not experimental – vaccines undergo extensive testing before and after licensing, and licensed vaccines have already gone through the experimental stage – and people are not “forced” to take them in the United States. The Thirteenth Amendment  just does not translate into “you can send your unvaccinated child to school and risk others because saying otherwise is slavery.” And seeing school mandates that give parents the choice between homeschooling and vaccinating as similar to actual slavery reeks of privilege, of someone who does not really understand actual oppression. 
  8. Count eight argues that vaccine mandates cause segregation and discrimination, and hence they violate equal protection. That argument, too, has been raised – and rejected – in challenges to state vaccine mandates. It also has nothing to do with a case against the President, because, again, the President does not have the authority to just strike down state vaccine mandates.

It does not get better. I will stop this section here, because I do have one more thing I want to cover, and you probably get the point.

Other issues

This Control Group lawsuit is not only problematic factually and legally, but is very strangely put together. For example, pp. 18-26 describing the plaintiffs’ minor, unvaccinated children include such things as describing several of the children in these terms:

All American Athlete: J.S. is an exceptional athlete, especially in dance and gymnastics where she has won multiple awards.”

Personality: J.S. is ethical and honest. She is very confident, sociable, and articulate. She is clever and has a great sense of humor. She has a good reputation among parents and children in the community for these character qualities.”

These are strange things to include, and it is not quite clear why the complaint saw a need to include them. What is the legal relevance? 

In another example, Section IX, titled “Vaccine Licensing as Therapeutic Human Experimentation” (Yes, it’s called that) explains that “this case is expressly not dependent upon vaccine licensing status, such as the following legal positions of Petitioners that are expressly omitted from this particular case in regards to relief (and lack thereof) from” FDA, CDC and other HHS sub-divisions. But after saying that it’s expressly omitting certain propositions, the complaint not only goes on and spells out the allegedly seven omitted propositions, but later relies on them. And the propositions are… interesting. 

The first one is:

A. The FDA approves a vaccine after testing for efficacy and short-term safety by comparison to concurrently harmful and falsely labeled “placebos”. Afterward, a vaccine is licensed as a biologic for general public use because of an FDA waiver/approval based upon a “therapeutic” privilege classification, whereby the FDA waiver/approval is deemed legal because the vaccine continues to be regulated by monitoring (i.e., post-market surveillance).” This is wrong in a number of ways, among other things that the FDA does not license vaccines based on therapeutic privilege, and the licensure is legal because, well, the Public Health Service Act gives the FDA the authority to license biologics, including vaccines.

The second one includes the following language – “By classifying vaccines as ‘therapeutic’ the FDA has wrongly classified all Americans as diseased and needing ‘treatment’.” But FDA does not classify vaccines as “therapeutic.” FDA also licenses and regulates therapeutic cancer vaccines, for example, but those are not routine preventive vaccines. Here is the main page for vaccines on the FDA website, leading to other pages. Note that the word “therapeutic” is not on it.

It does not get better. 

The propositions are followed by the statement that:

“Petitioners suffer discrimination for refusal to submit to medical experiments; loss of nation, loss of their own bodies, and even their lives themselves, are at risk.”

It’s unclear quite this means, and I do not sure how one loses one own’s body, but it does sound dramatic.  

In short, this Control Group lawsuit can fairly be described as a mess. It tries to ask the President to overturn state law in the name of a set of implausible assertions and a legal theory that amounts to “it’s a crisis and you need to do what we want to get out of it”. It is not well written, it’s hard to understand the main points, it is legally unsound, factually unsound, and contradicts itself. I am not surprised that the district court kicked it out, and I will be surprised if it goes anywhere at the other levels. 


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Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), 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 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.