Influenza vaccine mandate – court strikes down regulations

On 6 October 2016, the Appellate Division of New York’s Supreme Court held invalid an influenza vaccine mandate that required that children attending certain child care, prekindergarten and kindergarten programs in the city receive an influenza vaccine each year in order to attend. While the decision may appear, on first glance, as a loss for public health and the children of New York City, in reality it gives city health authority broader powers to act for children’s health than did the decision appealed, and offers the board guidance – albeit confusing, and somewhat tricky guidance – for future actions that can withstand scrutiny. If the board chooses to take advantage of this opportunity, it can pass a much more far-reaching regulation.

Influenza vaccine mandate – the decision appealed

 

As I discussed in a previous post, on December 16, 2015 Justice Mendez struck down the mandate, based on his finding that the City did not have the authority to add vaccines based on his interpretation of language in the Health code according to which “nothing in the provisions ‘shall authorize mandatory immunization of adults or children, except as provided in sections twenty-one hundred sixty-four and twenty-one hundred sixty-five of this chapter.’”

I saw the Justice’s decision as well reasoned and well supported.

The New York City Department of Health and Mental Hygiene, naturally enough, did not see the decision as well based. It appealed. On October 6, 2016, the invalidation of the regulation was upheld – but on very, very different grounds.

Appellate Decision – City has authority for additional vaccines

 

The appellate division disagreed with Justice Mendez and found that the New York City Board of Health did have the authority to impose vaccine mandates beyond what is in the state’s Public Health code. When a state law prevents a local authority from regulating an issue, we can say that state law preempts local law. The appeal used this terminology, asking whether the state law forbade – preempted – local regulation aimed at preventing infectious diseases.

The Appellate Division explained that a state law can preempt local law only in one of two ways. One is through “field preemption” – when the legislature is seen to have acted to completely prevent local regulation of a certain field or area. The appellate division found that the legislature did not intend to prevent New York city from acting to control disease or regulate vaccines. The state legislature, in fact, indicated the intent to share the power by legislating in ways that preserve a role for local government in disease prevention and in containing communicable diseases.

A second way state law can preempt local law is when there is direct contradiction between state law and local law. This is called “conflict preemption”, suggesting that if state law directly conflicts with local law, state law wins.

But the appellate division found no direct conflict here. It said:

[infobox icon=”quote-left”]The absence of the flu vaccination from the mandated list does not present a conflict because the statute contains no language prohibiting localities from requiring additional vaccinations not mandated by the state.[/infobox]

The court rejected the view – the reasonable view, in my opinion – of Justice Mendez that the language in the law saying no mandates restrict the city’s authority. The appellate court said:

[infobox icon=”quote-left”]Although both statutes state that ‘[n]othing in this [provision] shall authorize mandatory immunization of adults or children, except as provided in [Public Health Law §§ 2164 and 2165],’ that prohibition applies, and is directed, to state immunization efforts. Nothing in either statute expressly or impliedly limits the authority of local governments to implement additional vaccination requirements.[/infobox]

Absent express and clear limit on local government’s authority to mandate vaccines, the Appellate Division was unwilling to categorically find that New York City lacks authority to mandate vaccines beyond what is required by the state. It found that “state law sets the floor, not the ceiling, for local health regulations.” Local governments can add additional regulations, including requiring vaccines.

This is good news for the city. It means that it can regulate to prevent infectious diseases and require vaccines. However, the decision did not end there.

The City misused its discretion

 

Why, then, did the Appellate Division strike down the regulation? Because, it found, the Board overstepped its regulatory authority. In legal parlance, the appellate division applied what we call a non-delegation doctrine. The theory behind non-delegation is that the democratically elected legislature was entrusted by the citizens of – in this case – the state of New York with the power to make primary policy decisions and set general standards. It may empower administrative agencies – the state bureaucracy – to fill in the details of these policies. But it cannot give agencies the power to make primary policy, and the appellate division found that the regulation creating the influenza mandate was making general policy.

New York state’s courts have been aggressively using this doctrine to strike down other public health initiatives – most famously and recently, to strike down a regulation limiting portion size of sodas (pdf).

There, as here, the Court engaged in aggressive examination of the Board’s decision.

The court explained that the question whether a regulation oversteps the boundaries into forbidden legislative policy making is determined by general application of a four part test set in Boreali v Axelrod, 71 NY2d 1, 9 [1987] (pdf). The four parts – which are not exactly requirements, but more guidelines assessed as a package to see if the agency overstepped – are:

  1. Did the agency make value judgment entailing difficult and complex choices between broad policy goals to resolve social problems, or just balance costs and benefits according to preexisting guidelines?
  2. Did the agency fill in details of a broad policy or create its own set of rules on a clean slate, with no legislative guidance?
  3. Had the legislature tried unsuccessfully to reach agreement  on the issue? If yes, that indicates, according to the court, that this is a policy question the legislature should decide.
  4. Did the agency use its special expertise to address the case?

Applying the standard to this case, the court found that:

1. The Board made a value judgment:

 

The Appellate Division based this on the fact that the Board’s scheme created exceptions that, it said, were “not grounded in public health”. The heart of the criticism appears to be that unlike school mandates, which completely bar unvaccinated children who do not have an exemption, the regulation just has daycares choose between two options – enforcing the mandate, or paying a fine. The opt-out was seen as undermining the public health. The Appellate Division said:

[infobox icon=”quote-left”]Creating a policy whereby unvaccinated children are allowed to stay in child care or school flies in the face of respondents’ claim that the challenged amendments are meant to promote the public health by reducing transmission of the flu virus. Not surprisingly, respondents are unable to point to any health-related reason supporting the opt-out provision.[/infobox]

This decision is essentially preventing the board from using the less coercive means of financial incentives to increase vaccination rates and protect the public health, rather than the more coercive direct mandate. We could see the choice to use financial incentives as a value judgment; but it can just as legitimately be seen as the procedural way to achieve compliance – with a fine rather than a complete bar. There are good reasons to allow agencies to use less coercive means, if these are effective, when regulating. By using this as the grounds to strike down the regulation, the Appellate Division limited the ability of agencies to experiment with less coercive enforcement methods that may be just or more effective, potentially to the detriment of good administration in New York.

In addition, the court criticized the fact that the mandate applies:

[infobox icon=”quote-left”]…only to the 2,283 larger licensed child care facilities in New York City that the Board regulates, and does not cover the 9,241 providers that fall under State regulation.  Thus, less than 20% of child care facilities in the city must abide by the flu vaccine mandate. Further, the vaccine requirement does not apply to more than 20,000 legally exempt child care providers. Respondents maintain that the Board of Health targeted its efforts only on those child care providers it licenses because it already possesses regulatory expertise with respect to those facilities. But that rationale is based on administrative convenience, not health-related concerns. The decision to place economic burdens on only a fraction of licensed child care facilities, albeit the larger ones, while not placing the same burdens on other facilities shows that the Board of Health was “making policy, and therefore was operating outside of its proper sphere of authority.” (footnotes omitted)[/infobox]

This, too, is problematic – applying the mandate as a first step to the daycares the Board licenses, and on the larger ones, seems like a rationale first step, and it’s not clear how the Board could impose a mandate on the child care centers under the state’s authority. It’s not clear why making over 2,000 large child care centers safer from influenza does not serve the public health. This does not seem like making policy: the policy decision is require the vaccine for attendance, something the legislature did for other vaccines, and the Appellate Division found the Board has the authority to extend by adding other vaccines. Applying it to those centers the city has the authority to regulate is simply a matter of feasibility – and again, protecting over 2,000 large centers seems like a big step to protect public health, and well in line with the legislative mandate of other vaccines.

2. The Agency Acted with Legislative Guidance, not on a clean slate

 

Since there are legislative provisions giving the city the power to fight communicable diseases and make provision for vaccination, the Board was asking within the legislative guidance.

 

3. There is mixed evidence on whether the legislature repeatedly failed to reach agreement on this

 

There are some things supporting the plaintiffs – rejecting one attempt to pass a flu mandate by the legislature, and struggles surrounding passing a bill encouraging an influenza vaccine mandate. But there are also things supporting defendants – for example, the fact that the New York City Council never discussed such a mandate and that there is only one attempted bill like this that failed the legislature. I would also think that the fact that the legislature did pass the meningococcal  requirement and did end up legislating to encourage influenza vaccines – even if after a while – suggests legislative support for vaccines, and would work for the appellants (the city).

4. The Board could have used its expertise here, but did not

 

The Appellate Division acknowledged that the mandate itself relied on the Board’s medical and scientific expertise and scientific sources, and then said:

[infobox icon=”quote-left”].Nevertheless, this Boreali factor supports petitioners, because no special expertise was relied upon to develop the unique scheme that was adopted here. The notice of adoption does not contain any health-related basis supporting either the opt-out provision or the decision to apply the vaccination requirement to only a fraction of the city’s child care facilities. Likewise, the affidavit of the First Deputy Commissioner of the Department of Health, submitted before the motion court, is silent on these issues. Although we do not dispute that this type of health-related regulation can be based upon medical and scientific considerations, respondents have not established how this specialized knowledge led to this specific regulation.[/infobox]

This suggests that the Board could win on this factor if it addressed directly the reasons for this scheme. It’s not clear why the expertise used needs to be medical – after all, the Board also has administrative expertise. If a regulation is justified on the Board’s administrative expertise it should also be able to stand. At any rate, this suggests the Board needs to elaborate on a link between its expertise and the decision chosen.

Frankly, the application of the factors was problematic. The Appellate Division rejected the Board’s attempt to enforce the scheme with a less coercive method than direct ordering; it ignored the limits the state’s regulatory power place on it; and its analysis of the expertise issue did not give proper weight to the fact that expertise did, in fact, play a role here.

 

Challenges & opportunities to regulate further

 

What happens next? New York City can request permission to appeal to the Court of Appeals. It can also choose to pass another regulation instituting a mandate, changing it in light of the court decision. These are not in conflict: the City can go down both routes simultaneously, and maybe should.

The Appellate Division’s decision is probably a mixed bag for the city. On one hand, the mandate was struck down based on an intensive – and problematic – analysis of the use of its discretion. The Appellate Division did not give particularly clear guidance on what kind of mandate will survive scrutiny, and more generally, on how the Board can use its authority in permissible ways.

On the other hand, the Appellate Division overturned the most restrictive part of Justice Mendez’ decision, by finding that the Board’s authority was not preempted by the state legislature. New York City is, under this decision, authorized to mandate vaccines for schools. And the decision does offer some guidance, though that guidance may not be ideal, from a public administration point of view.

The decision strongly suggests that if the city wants to implement an influenza vaccine mandate, the mandate needs to be a mandate, with no opt-out provision beyond the medical or religious exemptions that parallel the New York State mandate.

It suggests that the Board needs to regulate as broadly as it can, to support the argument that the mandate is aimed at the public health, and to explain clearly in the regulation that it is, in fact, regulating to the extent possible.

And it suggests the Board needs to clearly explain, using its expertise, how the mandate will help public health, including addressing the specific scheme chosen – for example, explain that even a mandate covering only the child care centers the state is regulating can dramatically help the public health.

Justice Mendez’ decision closed off the City’s ability to require additional vaccines, not required at the state level. The Appellate Division reopened that possibility. As discouraging as this decision is in the short term, in the long term, it probably provides the City of New York and its Board and opportunity to act strongly to protect children from infectious diseases. I hope the City takes advantage of this opportunity.

Full court decision – Garcia v New York City Department of Health and Mental Hygiene 2016 (pdf)

 

 

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.