OK, it’s time to get into it: This will be a neutral overview to give a basic understanding of the law based on three critical distinctions: federal vs. state, EUA vs. vaccine licensure, and state vs. private party.

The Feds vs. the State (and counties and municipalities)

Question: Since Joe Biden has already said he doesn’t think the vaccine should be mandatory, doesn’t that end the discussion?

Answer: Unfortunately not, because of relevant legal principle No. 1.  Public health mandates emanate from the government’s police power, and that is mostly a state law concept. There is no general federal police power. Whatever power the feds have to regulate things come from other powers specified in the Constitution like the power to regulate interstate commerce which comes from the commerce clause. This principle was first articulated almost two hundred years ago in Gibbons v Nash.  For the legally inclined, here is the decision. https://scholar.google.com/scholar_case?case=1173503503763993716&q=Gibbons+v.+Ogden&hl=en&as_sdt=6,33.  For everyone else, here is Chief Justice Marshall’s description of the state’s police powers meaning  that “immense mass of legislation,” as he put it, “which embraces everything within the territory of a State, not surrendered to the federal government,” includes “quarantine laws” and “health laws of every description.”

The Bottom line, as powerful as he may be when he becomes president, I don’t think he has the power to keep the COVID vaccine voluntary.  Similarly, if he were to change his mind, I don’t think he (or Congress) has the right to make it fully mandatory, at least for citizens who do not cross state lines. Since the feds regulate interstate commerce, if the federal government was so inclined, I suppose it could require the vaccine for interstate travel. While that might be subject to constitutional attack, I think it would at least be arguably within their powers under the commerce clause to do it. Again, leaving aside the issue about whether it would violate another constitutional right (like the right to bodily integrity or privacy). Also, the commerce clause sometimes gets stretched pretty far, so if for example, the pandemic took a really ugly turn, who knows what the feds could try to do.

In support of this view -of the state-based police power and the right to mandate vaccines – think about every case you can recall on vaccine mandates. Every single one I can think of which was filed in federal court dealt with a municipal or state mandate.

The bottom line for me is that I don’t think that the federal government can order that the COVID vaccine be voluntary or mandate that every resident of every state must take it.

State vs. Private Party mandates

The simple of it is that the relevant constitutional rights and protections only restrict governmental action. Originally, these protections (the first 10 Amendments) only applied to and limited the Federal government. The 14th Amendment made the protections afforded by the earlier amendments applicable to the states.

That means that an employee of a private company can’t sue her employer for a violation of her federal constitutional rights like the right to bodily integrity/privacy. That’s just not a thing. However, there are various federal and state statutes that accord some of the same protections, like unlawful employment or housing discrimination and disability-based discrimination.

It is black-letter Federal employment law that while an employer can mandate its employees to take a vaccine, employers are required to offer a “reasonable accommodation” if feasible, on religious and disability grounds. That happens a lot in the flu vaccine context and usually takes the form of a mask requirement (prior to the pandemic anyway). Of course, as a result of the pandemic, some health care facilities have eliminated that accommodation.  I am not aware of any successful lawsuits challenging a private employer’s vaccine mandate in the pandemic time frame. I suspect there might be some litigation that will challenge an employer’s finding that a reasonable accommodation cannot be made for empolyee health reasons.

Emergency Use Authorization vs. Full Vaccine Licensure: Can the State or a private party  (private school or non-government employer) force people to take the COVID vaccine?

I have previously posted about EUA. https://wp.me/p7pwQD-PB

In short, a product approved by the FDA under EUA is still investigational and not approved under a New Drug Application or licensed as a biologic (as in the case of vaccines).

Let’s start with the relatively straightforward question of whether after COVID vaccines are licensed, can they be made mandatory?

Right now, I’d have to say yes, both for government and private employers, at least based on existing precedent, starting with Jacobson.  Government employees can raise constitutional claims, private party employees cannot. All employees have accommodations for religious and disability. But contrary to what some have said, these are accommodations not exemptions. The accommodation (at least in the case of the flu shot) is a mask. However, the employer has the right to claim that an accommodation cannot safely or practically be made. It wouldn’t surprise me if some employers take that position if the pandemic continues after the vaccines are licensed.  The above is the status of the current law.

Can the law change? Possibly, and I predict there will be such challenges which attempt to distinguish Jacobson and the smallpox vaccine (which had been used for over 120 years by the time Jacobson was decided) from the current situation and a newly approved COVID vaccine which I assume will have thousands of documented and publicized adverse events and is based on a new technology which appears to modify a person’s genetic material (or so I am told).

What about the Nurenberg Code, the Helsinki thing, and all the other international proclamations covering human experimentation? Can’t they be used to stop my employer from forcing me to get a Covid vaccine? 

None of these codes have the force of law in the US, and I am not aware of a US decision that reached a result based on any of these codes. Could a court look to one of these codes for guidance in a newly licensed COVID vaccine? Possibly. Will that be argued in challenges to the licensed vaccine if it is mandated? Absolutely.

Now let’s consider legal challenges to a mandatory EUA status vaccine

There are informal indications that the feds do not think a EUA product should be mandatory, but as indicated above, mandatory vaccination is almost exclusively a matter for state or local governments (or private employers). I am already hearing rumblings that some private employers are considering mandating the COVID vaccine, and not necessarily after they are fully licensed.  That situation would directly implicate the Nurenberg code and the other doctrines, but as stated, none of these have the force of law, until there is a US decision rejecting a EUA mandatory vaccination policy, all or in part based on these international codes.

If you live in California, you’re in luck, because California has actually formally codified the Nuremberg Code into its state law. Here it is: http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=20.&title=&part=&chapter=1.3.&article

The statute would seem to apply to an investigational drug or vaccine, even one with EUA status, but there is no relevant case law yet. This is where I see the next vaccine battle in California for sure. I also see legal challenges in New York if a governmental entity or an employer attempts to force citizens or employees to take the EUA vaccine.   However, given the short supply of the vaccine, I don’t think the issue will come up until late spring at the earliest. Let’s hope not anyway. Until then, let’s see how the safety and AE profile plays out in the next few months.

Happy holidays to all.

Rick Jaffe, Esq.