This article about the employee lawsuit against the Texas Methodist Hospital COVID vaccine mandate 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.
In June 2021, employees of Methodist Hospital filed a lawsuit in a Texas court challenging the hospital’s decision to mandate the COVID-19 vaccine. Although the lawsuit does raise one issue of legal uncertainty – whether you can mandate a vaccine under an Emergency Use Authorization (EUA) – its claim there is weak, and its other claims are a combination of incorrect factual claims and implausible legal claims.
The suit should have little chance of success – but because of the timing, this may be the first legal decision we have on the question of mandating EUA vaccines. The hospital’s mandate has a deadline of June 7, 2021. It seems like most of the plaintiffs – as far as I can tell from the complaint – have already been dismissed, so the deadline may not require fast handling, but the fact that there is a very near deadline may affect scheduling.
On March 31, 2021, Methodist Hospital in Texas instituted a COVID-19 vaccine mandate, asking management to lead by getting vaccinated first. On April 14, 2021, according to the lawsuit, the mandate was extended to all employees. The mandate followed years of requiring influenza vaccines, and the decision, apparently, went through “a scientific and medical committee made up of some of the nation’s best experts who have made recommendations” and different independent medical staffs.
The employees were called on to get the first dose of any two-dose vaccine by May 7, 2021 to allow them to comply with getting the full series by the deadline of June 7, 2021. The policy offered medical exemptions and religious exemptions, though according to the lawsuit, some of requests for such exemptions were denied.
According to the hospital, over 99% of their 26,000 employees have already been vaccinated. News coverage says the lawsuit includes 117 plaintiffs, and I admit I did not count them. The plaintiffs include a nurse that was vocal against the vaccine and, ironically, the company’s corporate risk manager (which would raise questions about his capability, if he is unable to compare the vaccine’s low risks to the risks of not vaccinating but my reading is that he is not a doctor or scientists, and the risks he specializes in are business risks. He may be very good at assessing those.).
Although the initial policy was published in March, the COVID vaccine mandate lawsuit was only filed on Friday, May 28, 2021. It is unclear what was the reason for the delay. It may have taken time to find a lawyer and recruit plaintiffs, or it may be that the people involved filed requests for exemptions and denial took time.
Two months is not that long, but delay in filing is something that is considered in requests for interim measures, like a preliminary injunction that will put the policy on hold until the case is decided. If employees were supposed to get the first dose by early May, filing late May may count against them. It depends. The lawsuit itself says nothing about this and does not provide any reason for filing in late May.
The timing makes this case likely to see at least some movement early. The deadline, after all, is June 7.
The lawsuit’s strongest argument is the lack of clarity around the meaning of the act empowers the FDA to issue emergency use authorizations. But in this complaint, the argument was not well made and was surrounded by a lot of extreme, inaccurate claims that should weaken the case. Because those other parts should be relevant to a court evaluating the case I will not – as I normally would – start with their stronger claim, but follow the lawsuit’s structure and explain what it says – and why it’s problematic.
The COVID vaccine mandate lawsuit
The COVID vaccine mandate lawsuit opens with extreme, inaccurate language, stating:
For the first time in the history of the United States, an employer is forcing an employee to participate in an experimental vaccine trial as a condition for continued employment. On or about March 31, 2021, Defendants The Methodist Hospital (“Methodist”) and Houston Methodist The Woodlands Hospital (“Woodlands Hospital”) became the first major health care system in the country to force it employees to be injected with an experimental COVID-19 mRNA gene modification injection (“experimental vaccine”) or be fired. Methodist Hospital is forcing its employees to be human “guinea pigs” as a condition for continued employment.
(This is copied and pasted from the complaint, which generally appeared not to have been carefully edited. For example, the complaint consistently refers to an emergency use authorization as an “EAU”, rather than “EUA”).
It then sets out its facts, which hinge almost completely on describing the vaccines as experimental and overstating – in fact, misrepresenting – their risks.
The complaint correctly notes that the first EUA for a vaccine was issued on December 14, 2020. It then says that “The first reported use of the experimental vaccine was December 14, 2020”. I think the lawyer meant the first use of the vaccine after authorization because since the vaccine has been in stage III trials since July, after previously undergoing stage I trials, it clearly has been used before December.
The complaint correctly notes that the vaccine has not yet been approved by the FDA. But then it goes on to say that “the clinical trials the FDA will rely upon to ultimately decide whether to license these and other COVID-19 vaccines are still underway and designed to last for approximately two (2) years..” That is partly right, but not completely. It is right that data from trial participants will continue for two years.
But both Pfizer and Moderna have, at this point, filed for full licensure, for a biologics license application (BLA), so that is clearly not contingent on completing the trials. And the EUA process drew on extensive data, as will be discussed below. The complaint says that there is much that FDA does not know about the vaccines use at authorization, “including their effectiveness against infection, death, and transmission of SARS-CoV-2, the virus that is allegedly the cause of the COVID disease.”
This is partially inaccurate, and generally misleading. The FDA EUA was granted in part on evidence about the effectiveness of the vaccines against COVID-19 – high effectiveness, including against death. And although at that point we did not have good data about transmission, we have increasingly robust data on that. The language in this paragraph also implies, to me, at least, that the lawyer doubts that SARS-CoV-2 causes COVID-19, which raises real questions about the lawyer’s acceptance of science.
The complaint correctly mentions that the EUA letter says that the vaccine is “an investigational vaccine not licensed for any indication” and that promotional materials need to say that the product was not approved or licensed, but authorized for emergency use.
The next two sections do address claims made in other complaints about statements by administrative agencies. These claims issued points made by attorney Aaron Siri, who serves, among others, the anti-vaccine organization Informed Consent Action Network, in an editorial on the topic. These claims are less well made here than in other complaints, and would likely work better if combined with the other arguments about the ability to mandate a EUA vaccine, but they are not there.
First, the complaint mentioned without linking to it, an FDA guidance that states that the conditions of a EUA preempt state or local law. Here is the guidance. Actually looking at it would suggest that a better reading of the guidance would be that FDA reads the act to preempt requirements about using the product, as stated, “requirements on prescribing, dispensing, administering or labeling,” rather than mandates.
The complaint also mentioned that Dr. Amanda Cohn from CDC has said, in an August 2020 committee meeting, that EUA vaccines cannot be mandatory. Dr. Cohn did say that, but although I deeply respect Dr. Cohn, her opinion, stated orally, has little authoritative weight. IN the time since, CDC has, on its website, suggested that mandates are a matter of state, local government, or employer law – clearly indicating it is not preempted. That, too, is not very authoritative; there is no deep discussion of the reasoning behind the agency’s interpretation, but generally, an agency’s written position has, in several contexts, been given more weight than previous oral comments of an official, especially before the issue was operational.
The next sections of the complaint try to claim that COVID-19 vaccines are rushed and unsafe. The first sets out the usual process of usual approval, and that it would normally take years, which is true – but it ignores the factors that made fast development possible without cutting steps – the combination of concentrated scientific and corporate focus, the infusion of government money, the high rates of the disease in the population, that made testing effectiveness possible – and the ability to build on decades of research into coronaviruses and decades of research into mRNA technology.
The second section openly draws on anti-vaccine lore by misusing the VAERS data. VAERs is a federal passive database to which anyone can report anything. It is one of four monitoring systems the federal government uses to oversee vaccine safety, and it is used to generate signals that can then be investigated. It is thanks to VAERS that the extremely rare blood clots after J&J vaccines were discovered.
But VAERS also has drawbacks: anyone can report anything to it, and the reports themselves can – and are – misused by anti-vaccine activists. In the context of COVID-19, the government made a concentrated effort to increase reporting to VAERS of issues after vaccines, to make sure that signals are found, and anti-vaccine activists misused it – both to file fake reports (for example, an obviously fake report of the death of a two-year-old).
This complaint follows the anti-vaccine lore by presenting VAERS death and injuries reports as reflecting the vaccines’ risks, which is simply a misuse, as explained in Vaxopedia, and by trying to suggest that the fact that we are seeing more reports this year indicates the vaccines are more dangerous, ignoring the concentrated vaccine campaign and a concentrated effort to increase reports to VAERS. It also ignores the fact that these deaths are investigated and no pattern or link to vaccines has been found for most of them – in other words, it presents as linked to vaccines reports of deaths that have not been actually shown linked.
In passing, in footnote 5, it also makes an untrue claim (citing a new false authority, Dr. McCullough, recently discussed by Orac) that suggests COVID-19 vaccine numbers are higher than the annual flu vaccination. Flu vaccination numbers are generally below the current rate of COVID-19 vaccines distributed (over 168 million people have gotten at least one dose as of June 3, 2021), though they have risen to match that in 2018-2019 and 2019-2020. Further, that number includes children, while COVID-19 is only for adults.
The next section goes back to arguing that the vaccines are experimental. It basis that on the fact that the vaccines have not been approved by FDA. That part is true, but that does not make the vaccines experimental. COVID-19 vaccines have undergone clinical trials in tens of thousands of people – as larger or larger than most routine vaccines, and that alone would make describing them as experimental problematic, as pointed out by immunologist Akiko Iwasaki.
They have been authorized on the basis of this data, and the data was extremely strong. The vaccines have since been given to over 150 million people in the United States alone, with strong safety and effectiveness data. Describing the vaccines as “experimental” on that data distorts the meaning of the word.
The strongest argument the complaint has against the vaccines is specific language in the section allowing for EUA. But rather than focus on that language, the complaint takes a detour through the Nuremberg Code and the Declaration of Helsinki, and goes in detail into their historical background, explaining that both these international sources prohibit forcing people to participate in an experiment without consent.
That’s no doubt right, but it’s also irrelevant. A workplace mandate for an authorized vaccine is not forcing people to participate in an experiment in any meaningful sense. First, people can choose whether or not to work for a particular employer; and when they choose to work for an employer, they accept workplace rules. If they disagree with a workplace rule they can leave; but generally, they cannot refuse the employer to change the workplace rule. Part of agreeing to work for an employer is agreeing to abide by their rules.
It is certainly not that simple; people need to work for a living, and the choice to leave a job is a hard one. But it is very different than the events that led to the Nuremberg Code, which involved physical coercion and literal forcing of people to participate in experiments. Trying to say the workers asked to vaccinate as a work condition is similar to people held down and experimented on or experimented on at gunpoint discounts and misrepresents the latter situation. The comparison is false.
And as pointed above, describing authorized vaccines tested in tens of thousands of people and given to over a hundred and fifty millions as experimental really misuses the word.
The next section makes a set of claims about mRNA COVID-19 vaccines based on an opinion piece in an open-access journal, more than a little dubious journal, with no data, claims of risks that have not actually been seen in the data. It also tries to allege, again, the vaccines are unsafe. Ironically, even though the section is devoted to mRNA vaccines, the footnote addressing several of the issues – footnote 16 – talks about the JNJ vaccine, which is not an mRNA vaccine and was not addressed by the article the complaint is relying on (footnote 17 is empty; the complaint, again, seems to have not undergone careful editing).
The next pages list the plaintiffs and set out the history of the vaccine mandate described above. Most of it has already been addressed, but worth raising is the fact that on pp. 26-27 the complaint tries to argue that the hospital is prioritizing profit over people. To do so, it quotes what it describes as “marketing materials” telling potential customers that the mandate is there to protect the customers/patients safety and the safety of their families.
Describing a measure aimed to protect patients and their families as prioritizing profits over people is strange. Patients and their families are, in fact, people, and the vaccine mandate – making the hospital safer from COVID-19 – would protect them, as well as the employees. This section seems to disprove itself.
The causes of action – the plaintiffs’ attempt to claim the law is on their side – start on p. 28. They are as problematic as the rest.
The first cause of action argues that the plaintiffs were wrongfully discharged. Normally in the United States employees can be dismissed “at-will”, meaning, for almost any reason (limited by anti-discrimination laws), but the complaint argues that the Texas Sabine Pilot exception applies here. The Sabine Pilot exception says that a discharge of an employee “ for the sole reason that the employee refused to perform an illegal act” is illegal. The case itself also emphasizes that this should be applied narrowly – to cases where the employee really was fired just for refusing to perform an illegal act, and later cases reiterate that. (The complaint in mentioning this cites this case, which appears unrelated.)
This is a strange claim here. It is not illegal to get a COVID-19 vaccine. The mandate did not require plaintiffs to commit an illegal act. It seems a very bad fit.
The second cause has the strange title of “violation of at-will employment doctrine/public policy exception”, but this is fact the discussion of the limits from the EUA act, and the one reasonable argument. As quoted in that section, the act says that the Secretary of Health and Human Services shall:
…to the extent practicable given the applicable circumstances…ensure that individuals to whom the product is administered are informed…
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
(Note: the numbering in the complaint is wrong, and I corrected it here).
The complaint alleges that the hospital
“violated at least two quoted sections (ii and iii). The Defendants did not advise Plaintiffs of the “known and potential benefits and risks of such emergency use of the product, and of the extent to which such benefits and risks are unknown” of the COVID-19 experimental vaccine.
Additionally, Plaintiffs are not provided “the option to accept or refuse administration of the…” experimental vaccine as a condition for employment. Such conduct is in violation of the public policy of this state and is the basis for an exception to the at-will employment doctrine.”
This is in part plausible and in part simply wrong. Respected scholars have read the EUA act to prohibit mandates because of the requirement to inform recipients that they can accept or refuse the product. Even there, there are problems with that argument, as my co-authors and I said elsewhere:
“On the legal side, the EUA statute says nothing directed at employers or universities. Instead, it addresses the actions of federal officials, such as the HHS secretary and the president — not private actors. Private employees are generally “at will,” meaning they can be terminated for any reason that is not explicitly illegal. Those arguing that the EUA statute prohibits mandates by at-will employers are claiming that this federal law is changing existing state employment law on the topic by mere implication. They are reading in a broad prohibition covering all employers and universities in the U.S. that is not, in fact, in the statute. Such broad preemption would require, at a minimum, clearer language.”
The law does not tell defendants anything, and reading into it a prohibition on private employers mandating vaccines is interpreting it very broadly.
Further, the complaint is simply wrong in suggesting that it’s the employer’s responsibility to give the risks and benefits – even ignoring the fact that what they think should be said is simply incorrect. That information needs to be given to the recipient – at least, the correct information about risks and benefits should be – by those administering the vaccine. The language of the statute cannot be read to impose such a requirement on employers. Employers do not give the vaccine, and it is not their responsibility to go through the informed consent process with employees.
If the EUA act prohibits mandates, it prohibits mandates, though tying it to the public policy exception is strange. But there is a good argument it does not prohibit employers from requiring the vaccine.
Count three simply asks the court to declare that the mandate is illegal under the EUA act, though the language is awkward.
Count four asks for an injunction against the mandate, again in language that is inaccurate and more than a little extreme – specifically, it says “Plaintiffs have been threatened for choosing not to take an FDA unapproved experimental vaccine which federal law states cannot be mandated because insufficient trials have been conducted and its long-term effects are not known..”
But the EUA act, even if you read it – a problematic reading – to say that it prohibits mandates does not say “insufficient trials have been conducted.”
There is a real legal question about whether you can mandate a vaccine under a EUA. My view, as stated in several places, is that employers have a good argument that they can mandate a vaccine, but that is a legally open question. This complaint does raise it, but it does so by tying the argument to a set of inaccurate and sometimes simply incorrect factual claims and an unpersuasive, not well-presented legal analysis. This should work against it. If the only way to justify arguing against the mandate is by saying incorrect things, the case against mandates is not very strong.
Update 7 June 2021
On June 7, 2021, a federal judge denied the lawsuit against the Methodist Hospital. The lawsuit was, apparently, moved to federal court on June 1. The judge ruled that even assuming the plaintiffs have a likelihood of success on the merits, the plaintiffs have enough remedy at law by suing for wrongful termination to recover monetary damages.
The Judge ruled that “a temporary restraining order will disserve the public interest. The public’s interest in having a hospital capable of caring for patients during a pandemic far outweighs protecting the vaccination preferences of 116 employees. The plaintiffs are not just jeopardizing their own health; they are jeopardizing the health of doctors, nurses, support staff, patients, and their families.”
This does not sound promising for the plaintiffs, but the case is moving on.
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