Vaccine consent for minors — Federal judge puts DC law on hold

This article about a DC law that allowed vaccine consent for minors 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 diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On March 18, 2022, a federal district judge — Judge Trevor N. McFadden — issued a preliminary injunction, that is, an order putting on hold DC’s law allowing minors to consent to a vaccine. The judge did it based on a flawed reading of the federal law the National Childhood Vaccine Injury Act (NCVIA), and although the federal law the judge was interpreted was passed at a time when multiple states allowed minors to consent to medical treatments, including vaccines, and the law nowhere indicated that it intended to deny states the power to allow minors to do that.

In doing so, the judge helped anti-vaccine activists reduce the choices available to teens in DC, and barred teens from being able to protect themselves from disease, putting them at risk with no real benefit (except to anti-vaccine activists who could use the decision to claim a win, and who quickly turned it to increase fundraising).

If the decision is not overturned on appeal and other judges follow this very flawed reasoning, other minor consent laws – many of them longstanding – could be put at risk. 

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The case of minor vaccine consent in Washington, DC

On October 20, 2020, the Council of the District of Columbia passed a law allowing minors to have the ability to consent to a vaccine. The law allowed minors vaccine consent if:

  1. The minor met the informed consent standard, that is, they could provide informed consent.
  2. The vaccine is recommended for a minor by the Advisory Committee on Immunization Practices (ACIP) and given on the recommended schedule. 

The law also instructed the department of health to create age-appropriate “alternative vaccine information sheets”, which will be given to providers to use in the informed consent process. The law also protected the confidentiality of the minor’s choice by allowing the provider to bill the insurer without notifying the parent, telling the insurer not to send the parent an explanation of benefits, and telling the provider to directly notify the minor’s school if the minor’s parents filed a religious exemption. 

All of these are reasonable provisions, well in line with what scholars recommended, (for full disclosure – my coauthor Prof. Weithorn and I also recommended this), and well in line with practices in multiple states like, for example, Idaho and Alaska (see table 1). 

Unsurprisingly, anti-vaccine activists were not happy that children in DC could now choose to get a vaccine without parental consent. The anti-vaccine organization Children’s Health Defense went out to look for parents who would feature as litigants and help them fight against giving teens the choice to vaccinate. The decision here combined two cases that included two families, one anti-vaccine and one less clearly, represented by anti-vaccine lawyers.

Joshua Mazer from Maryland claimed that his teenage daughter went to get vaccinated in DC without his permission but at the last minute changed her mind. Mr. Mazer is a longstanding anti-vaccine activist. His son has autism, and Mr. Mazer blames his autism on vaccines – as we know from the fact that he was part of the Omnibus Autism Proceeding that examined (and rejected) the claim that vaccines cause autism.

Mr. Mazer’s claim was dismissed in 2011 for “insufficient proof”. In 2016 Mr. Mazer has also written an article that set out his story of why he blamed his son’s autism on vaccines and described a vaccine reaction for his younger child – by the age (then 11) the child featured in the lawsuit – that will be discussed again here. Mr. Mazer was – maybe still is – on the board of the anti-vaccine organization IPAK. He is fairly described as anti-vaccine. 

For full disclosure, Mr. Mazer and I have clashed in the past on social media several times.

Mr. Mazer is represented by anti-vaccine attorney Aaron Siri and other members of Siri’s law firm. 

Victor Booth, the other plaintiff, does not have similar anti-vaccine credentials. As far as I can tell, what brought him into the lawsuit is a view that parental rights should govern. That said, in the lawsuit Mr. Booth attributes one of his children to “autoimmunity, alopecia, asthma, and eczema” — things anti-vaccine activists often wrongly blame on vaccines – and alleges that these conditions appeared after vaccinating and that they stopped when the family stopped vaccinating. 

This suggests a link to the anti-vaccine movement. And Mr. Booth is represented by the Children’s Health Defense, an anti-vaccine organization, though the lawsuit is also n behalf of the “Parental Rights Foundation”.

The lawyers in both cases, therefore, are coming from an anti-vaccine direction – and the arguments are clearly anti-vaccine. 

The court found that the parents have standing, that the D.C. law conflicts with federal law and therefore is preempted, and that the provision violates Mr. Booth’s first amendment free exercise of religion rights. Each part is problematic. Let’s take them in turn. 

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Standing

Unlike some other countries, courts in the United States are not allowed to adjudicate abstract or hypothetical questions, and for a case to go forward, there needs to be a party that is directly affected – that has the standing to bring a case.

The Booth family likely has the better case on standing, and even their case is shaky. The main problem the families have on standing is that to have standing, they need to show a direct injury to their interests – which practically means that they need to show that there is a high likelihood their children will get vaccinated if the law remains.

The Booth’s case draws on evidence that there is pressure on their son, L.B., to get vaccinated and that he feels the pressure – based on the father’s testimony, and on a drawing the boy made that describes peer pressure to vaccinate. D.C.’s lawyers pointed out that the boy never said he will try to get vaccinated or that an official offered him vaccines, but there may be enough there to allow the case to go forward (standing does not mean the family has a case; just that their interest is sufficiently affected to let them make a case). Even there, the case is tricky, again, because the boy did not express any intent to get the vaccines, and has not so far gotten the vaccine, and whether he will get one is speculative. 

Much trickier is Mazer’s case. In Mazer’s case, his daughter went to a doctor in DC, said she wanted to get a vaccine for a summer camp, and then left without receiving the vaccines. This is tricky, because the girl did not get the vaccines, and there is no good basis to think she would, especially now that her parents are aware of the event, talked to her, and are likely to watch her more closely. The risk of her getting a vaccine is very speculative. 

For what it’s worth, the whole scenario is a little strange. It’s not impossible, but the fact that after all these events the Mazer family clearly knows of the story, and the fact that the child went, talked but did not get the vaccine makes me suspect that this was set up to create this lawsuit and that the child was sent to do what she did.

Mazer claims that he learned of the visit because his daughter “put the doctor’s business card on a bulletin board in her room,” but again, that seems strange, if she wanted it hidden. At the least, the child is bound to know that her parent is anti-vaccine, that this is a contentious issue – something her father has been very active on for years – and that this would be an issue.

At this stage, this was not investigated, but at any rate, Mazer’s case appears very speculative, based, as it is, on a risk to a child that has refused vaccines when she had a clear opportunity to get them. Standing appears to be on shaky grounds for this family. 

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Preemption

The main claim of the plaintiffs is that the DC law conflicts with federal law – the National Childhood Vaccine Injury Act (NCVIA) and that under our constitution when there is such a clash, federal law wins because it’s the supreme law of the land. In legal terms, this is called preemption.

The judge, correctly, opens with the idea that there is a presumption against preemption – that preemption requires a clear indication of Congress’ intent to preempt historic powers that used to belong to the state. In my view, the court does not seriously apply this, though. 

Two preemption claims are addressed in the decision, and on both, the judge’s analysis is deeply flawed. 

The first is that the law conflicts with this provision, §300aa-26(d) of the act:

…each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives of any child or to any other individual to whom such provider intends to administer such vaccine a copy of the information materials developed pursuant to subsection (a)…

The argument is that since vaccination is done without parental consent or knowledge, the parent would not be given the Vaccine Information Statement (VIS) before vaccinating, and hence the DC law conflicts with the federal requirement.

There are several problems with this argument, and the way the judge supported it in this decision makes them worse. Let me go through the judge’s arguments one by one. The district’s argument, as quoted by the judge, was that if a minor is legally empowered by law to receive the vaccine, the minor is “any other individual” to whom such provider gives a vaccine – and does not need a legal representative.

I would (and did, in p. 853 here) have argued this a bit differently, arguing that a child who can consent is her, his or their legal representative, but the point stands, that the law acknowledges that it’s not just the legal representative of the child that can get the VIS, that people who are empowered to get a vaccine can get the VIS. 

To reject that argument, as a first step, the judge argues that “If Congress did not mean for the legal representative to receive a VIS when his child receives a vaccine, then the phrase ‘the legal representatives of any child’ would be superfluous. All Congress would have needed to say is that a healthcare provider should give a VIS ‘to any individual to whom such provider intends to administer such vaccine.’”

That is a really bad argument since many childhood vaccines are given to an infant that cannot accept the VIS. Allowing the legal representative to accept the VIS is crucial for a young child or infant, and the law makes provision for that, broadening the recipient of the VIS from the vaccine recipient to also include a legal representative when needed. So the phrase does do work, even if a teen qualified to consent is the one given the VIS.

More plausibly, the judge points out that the word “other” in the paragraph seems to contrast with the word “child” in the first sentence. This is a better argument, suggesting that the “other individual” is someone who is not a child. Of course, my interpretation – that the “legal representative” of a child empowered to consent is the child – would negate that problem.

But even with the district’s interpretation, this is not the only interpretation, and it has its own problem. For example, does that mean that an emancipated teen – living alone – cannot receive the VIS? That teen would not have a legal representative. It is reasonable to interpret the act to mean that “other” refers to the person getting the vaccine if that person does not have a legal representative – whether or not they’re below 18. 

The judge also points out that the NCVIA does not define a child. This matters, because another (good) argument of the district is that “child” here would not include a teen who may consent. The judge concludes that the child should be 18 and below federally, regardless of state law.

But the judge’s interpretation is substantially less convincing than the district’s strong argument. That argument is that since the paragraph is about providing information to the person vaccinated before being vaccinated if a minor can consent to a vaccine, a minor is not a “child” for this purpose — that “child” here is someone who, under state law, must have a legal representative consent. 

The judge’s counters to this, too, are problematic. First, the judge says that there is no plain indication that Congress intended to make this dependent on state law. But as the decision itself acknowledges later, at the point when NCVIA was passed, multiple states had minor consent laws, allowing minors to agree to medical treatments.

The breadth of minor consent provisions was pointed out in an amicus brief by the American Academic of Pediatrics, which pointed out that federal law does allow minors to consent to treatment in some circumstances, and that 14 states had laws that permit minors to consent to vaccination. To give one example, Alabama’s minor consent law dates to 1971. On that background, the view that Congress in 1986 decided to overturn those state laws in silence, with no indication, in a way that was not noticed until 2022 is unpersuasive. 

The judge’s second argument is that interpreting the NCVIA to allow states to regulate minor consent would undermine “the uniform application of NCVIA”. But this, too, is unpersuasive. There is nothing in allowing different minor consent laws that would undermine any part of NCVIA.

First, these laws do not overturn the main part of the act, the compensation program; in fact, these laws leave it untouched. Second, minor consent laws do not undermine the consent provision, either. The consent provision that is being used here focuses on making sure materials prepared by the secretary are given before vaccination to ensure informed consent.

The materials can be given to whoever can consent to be vaccinated. Who consents is affected by state laws – even if minor consent laws are seen as invalid, and as mentioned, they predated NCVIA, emancipated minors are going to have to consent, and emancipation of minors is determined by state law. 

The judge says that “Congress passed the NCVIA to ‘stabilize the vaccine market’” and different approaches by states would undermine that. That is true in one sense, wrong in the other. One of NCVIA’s goals was to create a compensation program that would stabilize the vaccine market by limiting state lawsuits.

But that is not the only thing the act does. In addition, it has provisions to improve vaccine safety monitoring and improve informed consent. It’s a big act that does several things. The provision in question – §300aa-26 (d) – addresses informed consent, not the compensation program. To some degree, it does federalize the informed consent process, by creating materials that would be given to each vaccine recipient. But it’s not complete: states can have additional or other requirements for informed consent, and yes, states can have minor consent laws that affect consent to vaccination – and as long as the VIS is given, that would not affect consent.

The court then raises the question of a child with a previous severe vaccine reaction that does not know this and expresses concern that that would undermine the parent’s ability to protect the child. The court uses the example of Mr. Mazer’s daughter, J.D., who allegedly did not know that she had a reaction to past vaccination. The case itself is problematic, first, since the teen’s reaction – which, according to Mr. Mazer, was swelling of her leg after a DTaP vaccine, would not be a contraindication even to future DTaP vaccines, let alone other vaccines. (See under table 4-2, “Conditions incorrectly perceived as contraindications or precautions to vaccination,” i.e., vaccines may be given under these conditions).

Second, the chances that a teen old enough to give consent that wants to be vaccinated would not know about a contraindication seem remote. Among other things, a natural first step before going behind the parent’s back appears to ask the parent why the child is not given the vaccine they want. In those circumstances, if the parent does not inform the child of the medical reason, the parent has some responsibility for the lack of knowledge. The concern appears unrealistic – and needs to be balanced with the risk to the child from being refused protection from a dangerous disease. Further, and again, minor consent laws existed during NCVIA, and Congress did not choose to overturn them. 

Finally, the judge says that not being given a VIS would prevent the parent from being able to file a claim with the compensation program if the child is harmed – based, apparently, on a combination of the judge’s assuming the parent will not know that the child is harmed if there’s a problem after the vaccine, that the parent will not know it’s vaccine-related, and the parent will not know of the program. This is the least convincing argument so far.

I do not think I am unfairly describing the judge’s argument. The judge says that: 

The Vaccine Injury Table says that for “Vaccines containing tetanus toxoid,” anaphylaxis could occur in less than four hours. See Health Res. and Svcs. Admin., Vaccine Injury Table.11 A shoulder injury related to vaccine administration could manifest within 48 hours. Id. A parent who did not know his child had been vaccinated would not know to be on the lookout for adverse reactions. Nor would he have any reason to suspect that an adverse reaction, if he noticed one, was because of the vaccine.

First, it is certainly concerning if a child has anaphylaxis or a severe shoulder injury and the parents do not notice. However, these are not subtle conditions that are easy to miss. This is true for other serious vaccines side effects. If there’s a serious problem, whether it’s vaccine-related or not, reasonable parents are likely to notice it.

Second, it is true that the parent may not immediately know it’s vaccine-related. But why is that important? If the child has a serious problem, the parent should get it treated. Many of these problems should be treated the same way whether or not they’re vaccine-related. And if the child is taken to a doctor, the child can tell the doctor about the vaccine – even after the fact.

To go to the program, a parent will eventually need – or the child needs, and I don’t agree with the judge that in the appropriate circumstances the child cannot go to court, if only through a guardian ad litem – to know about the vaccine. But there are three years to file a lawsuit. It does not need to be immediately known, and if there’s a serious problem, it should be investigated. And on the other side of the parent’s ability to sue for unlikely and extremely rare vaccine harm is the question of harm to the child from a disease vaccines protect from. 

Finally, if the parent knows the child was harmed, and has made the connection to the vaccine, finding the program is not hard even without a VIS. It is the first non-ad link that comes up if you google “vaccine compensation.” Finding the VIS online is not hard, either. It’s the first google result for “Vaccine Information Statement”.  Parents can also ask a lawyer, who should be able to do that research for them. As the court acknowledges but dismisses.

The court concludes the statute “shows Congress did not intend for minors to take control of their own vaccination decisions.” There is nothing in the statute to support that claim. The statute did not directly permit minors to consent, but it was enacted when several states did permit minors to consent to vaccines, and it did nothing to prevent that. A better reading is that the statute left the minor consent issue to the states – where it was until it was enacted. 

The judge’s last argument is that he does not like the idea of defining an 11-year-old – who may consent to vaccines under the act – as a “child”. That is not a good argument against states’ freedom to set minor consent laws. The DC statute did not define 11-year-olds as adults generally; only to consent to protect themselves from diseases according to expert recommendations, and only if they can also meet the standard of being able to give informed consent. That is not absurd. 

The second argument refers to the fact that the DC law says that the DC department of health will make an alternative VIS – vaccine information statement – that’s age-appropriate. The court reads it as in tension with the statute’s requirement to provide the VIS to the vaccine recipient.

First, if I were DC, I would solve that by directing providers in regulations to give both documents. But even if an alternative VIS was given that included the same information, I am not as sure that it would violate the act. To give one example, Michigan gives its own VIS, and to my knowledge, that has never been challenged, since it covers the same ground.

Adapting the VIS to teens’ level of understanding meets the statute’s requirement of informed consent better, it does not undermine it, as long as the same content is included. After all, VISs are translated to many languages, and translation always involves some changes – and that’s not an issue, in fact, it bolsters informed consent. But even if there was tension, there is no indication this adaptation was done. I don’t see anything on the DC department of health to say that there is an alternative VIS right now that can be given. The only thing available right now is the federal VIS, so this appears to be a non-issue.

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First Amendment claim

The court concludes that DC law violates the first amendment because it tells providers that if the parents have a religious exemption, they should report directly to the school that the child was immunized, and not fill the child’s immunization certificate with the vaccine. 

The court concludes that this is a law targeting freedom of religion and that since the Booth family argued vaccines are against their religion, they have a claim there. I will start by openly saying that I have doubts about whether the Booths’ opposition to vaccines is religious, because they start by alleging their child has medical problems related to vaccines, and the religious claims seem added as a cover. This is in line with my previous experience that most people who use religion to avoid vaccines are acting out of safety concerns, not religious beliefs. But obviously, that is something that the court decision alone would not resolve, and is not the core of the issue.

I think the judge’s conclusion should fail to go in because there is no freedom of religion claim implicated by the statute. The statute creates a right for the minor to consent to vaccines. The minor is not claiming a violation of religious freedom.

The parents are claiming that not informing them prevents them from forcing a risk of disease on the minor by submitting a religious exemption. This is a very weak freedom of religion argument, first, because the person the law finds qualified to make the decision – the minor – is not allowed to act freely, and in fact, religious freedom is used to coerce the minor, to bar an option for them.

And second, parental religious freedom does not historically extend to putting the child at risk, and a long jurisprudence allows the state to override parental freedom to provide vaccines through school immunization.

This claim should not be allowed to advance at all.

The judge’s main argument here is that the DC law is not neutral on its face because it only allows for hiding the information if there is a religious exemption, not a medical contraindication. Under our jurisprudence, still, neutral on their face, inapplicable laws do not have to provide a religious exemption.

The judge seems to misunderstand the district’s argument. The district explained to the judge that if a child is entitled to a medical exemption in the doctor’s judgment, the child would not be getting the vaccine. If the child tells the doctor they are medically exempt, the child should not be vaccinated.

And therefore, there will be no immunization record to file. In other words, the issue does not come up. It only comes up for religious exemptions because those children can, medically, get vaccinated. There is no medical exemption in the minor consent law; for that matter, there is no religious exemption. There is a provision for not reporting the vaccine in the only case the vaccine would be given when there is an exemption on file, and that would be a religious exemption. The law is still general and neutral. 

The next arguments seem to confuse provisions in the general school immunization law (which creates medical and religious exemptions, something the minor consent law does not do).

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The rest of the decision

The other two parts of the decisions address the other two requirements of granting a preliminary injunction, that the plaintiffs will be “irreparably injured” and that the balance of harms supports granting it, staying the law.

Here, the judge relies on harm to their first amendment freedoms – which as I said is unconvincing – to justify finding harm. He also claims that the plaintiffs showed their children are likely to get a vaccine any day, which isn’t convincing. The judge also does not consider the COVID-19 pandemic as supporting the district’s argument that they need the law, first because it was not the impetus for the minor consent law (true, but not an answer; the law can still help with the pandemic) and that infections are trending downwards and rates are high. The court said that stopping the law would not “prevent children from being vaccinated” – but where parents do not consent, that is exactly what putting the law on hold will do. 

Conclusion

This decision combines unconvincing, badly founded arguments with a clear dislike of D.C.’s choice to allow minors to protect themselves from disease. The legal arguments are weak, and the policy choice will prevent children from choosing the safer course if their parents object. Bad affair all around. 


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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.