HPV vaccine consent case in New York – a review

HPV vaccine consent case in New York – a review

On March 3, 2017, a complaint was filed with a federal court in New York attacking a rule that allows children to consent to HPV vaccines if they were exposed to a sexually transmitted disease. The complaint is competently written, but its arguments are unconvincing legally and deeply flawed factually. It may proceed past summary judgment, since the court is required to assume the factual premises in it are correct; but it should ultimately fail. This article will review the HPV vaccine consent case, as it stands.

The New York HPV vaccine consent case

In May 2016, New York created a rule – Section 23.4 to Title 10 of the New York Codes, Rules and Regulations – allowing minors who were exposed to a sexually transmitted disease to be given “medical care related to other sexually transmitted diseases without the consent or knowledge of the parent or guardian.”

The rule draws on the authority of section 2305(2) of New York’s Public Health Law that allows the treatment of a minor infected with, or exposed to, a sexually transmitted disease. While the rule does not specifically mention HPV vaccines, the complaint quotes language from the proposed rule which made it clear that in the circumstances in the rule – a teenager exposed to or infected with a sexually transmitted disease – the goal is to allow providers to administer HPV vaccines without requiring parental notification or consent.

The lawyer bringing this suit is Aaron Siri, who has brought other suits against vaccine mandates in the past, most specifically getting two New York state courts – a Superior Court and an Appellate Division – to strike down New York City’s Daycare influenza vaccine mandate. Attorney Siri is clearly very competent, and – as this complaint should show – appears willing to base claims on anti-vaccine tropes.

The plaintiffs are a group of parents expressing concerns about the possibility that their children will be administered HPV vaccines without their knowledge. They raise three types of complaints: claims that the rule contradicts federal statute and state statute, claims that the rule violates the federal constitution, and concerns about adverse events. Let’s look at each in turn, though for reasons that will become clear, I will address the factual claims before the constitutional ones.

One potentially preliminary challenge defendants could raise is that the plaintiffs lack standing. Under our federal constitution, to sue in the courts plaintiffs need to show – among other things – that they suffered an injury. These parents have teenagers who might become sexually active before they reach the age of emancipation and who might then contract a sexually transmitted disease and then might be offered HPV. That is pretty remote, and may be too hypothetical to constitute an actual injury. The rest of the analysis assumes that the plaintiffs overcame this hurdle, and the court moved on to examine the merits of their claims.

 

Statutory claims

The complaint opens by suggesting that the rule goes beyond New York’s Public Health Law. It interprets the statute as determining that “the exigent need to treat a child for a sexually transmitted disease that the child either had contracted or had been exposed to, outweighed a parent’s right to participate in the decision making process for their child’s medical care”. It suggests that allowing actions related to other potential sexual transmitted diseases goes beyond what it sees as a narrow exception to parental consent.

Arguing that the rule oversteps the statutory bounds is legitimate but the complaint’s reading is certainly not the only, or even the best way, to interpret the statute. A better reading may be that the Public Health Law’s purpose is to protect sexually active minors from sexually transmitted diseases.  §2305 of the Public Health Law suggests that the legislature assumes – correctly – that requiring parental consent can mean that these minors will not get the care they need, since they will be reluctant to get that consent.

The situation governed by the new rule is one where a teen was found to have contracted or been exposed to a sexually transmitted disease that is not HPV, and the provider wants to add HPV vaccine to protect them. This is not a particularly broad mandate: it doesn’t apply to all teens anywhere. Exposure to one disease shows that these are at-risk teens, and it is therefore justified to protect them against more than the disease they have already been exposed to. Specifically, in relation to HPV, the CDC says: “HPV is so common that nearly all sexually active men and women get it at some point in their lives.”  Since these teens are sexually active, they are at risk of exposure to HPV. Waiting until after they are exposed to HPV before allowing them to consent to protecting themselves via the vaccine misses the point: the best time for the vaccine is before exposure. The narrower interpretation of §2305 of the Public Health Law does not achieve the purpose of protecting teens against disease. It’s not a huge stretch to say that teens who have already showed themselves at risk and are getting medical treatment against particular sexually transmitted diseases should be allowed to consent to protection against other diseases.

In addition, the complaint argues that New York State’s rule violates 42 U.S.C 300aa-26 – a part of the National Childhood Vaccine Injury Compensation Act that also created the National Vaccine Injury Compensation Program (NVICP). Since federal law is the Supreme Law of the land, if there is a real contradiction to a constitutional federal law – and I have seen no good argument this section is unconstitutional – the state law has to give. This particular clause requires that

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) of this section, supplemented with visual presentations or oral explanations, in appropriate cases. Such materials shall be provided prior to the administration of such vaccine.

The complaint claims that “under Federal law, a healthcare professional must provide the VIS [Vaccine Information Statement – the handout created under the law to give to parents or patients] and appropriate supplemental explanations to the legal representative of a child prior to injecting the child with Gardasil or Gardasil-9”, and that the parent is the legal representative of the child for this purpose.

I think this interpretation is problematic in the context of §2305 of the Public Health Law, which provides the authority for the rule. Nobody argues against the fact that in most circumstances, the parent is the legal representative of the child for the purpose of giving consent to treatment. But that’s not always the case, and the entire purpose of a statute allowing the child to consent to treatment against sexually transmitted diseases is to make the child their own legal representative for that limited purpose. Any other interpretation would negate the purpose of the act, which is to empower the sexually active child to avoid harm from sexually transmitted diseases by consenting to treatment.

The concern that such children will choose simply not to inform their parents of the risk and remain unprotected is a very real one.  The risks to the child from not being able to obtain protection without parental consent and knowledge are also very, very real. That is why minors were given the ability to consent in the law, and that is why they should be seen as their own representatives for the purpose of such consent. This principle would apply to 42 U.S.C. §300aa-26 too: for the purpose of the federal act, children empowered to consent are their own legal representative within the limited scope of the act. They need to receive the VIS, not their parents.

 

Factual claims

To support the claim that informed consent is violated when parents don’t receive the VIS the complaint argues that children cannot make an informed decision about getting HPV vaccines, which, the complaint claims, carry real risks. Here is where the complaint turns to very, very problematic factual claims, which the defendants should strongly counter. Note that these claims would not be grounds for a motion to dismiss; but they draw on anti-vaccine tropes that the defendant can and should counter strongly, and a court should dismiss.

One set of factual claims in the complaint is that the plaintiffs’ children are all victims of past vaccine injuries. There is no way to assess whether that is true from the complaint, and I won’t attempt to, but it is worth reminding people that such claims should be approached with caution: real and  serious harms from vaccines do happen, but they are extremely rare, and most internet stories of vaccine injuries turn out to be cases where the harm may be real enough, but the cause is not, actually, vaccines.

Putting that aside, the main factual claim in the complaint is that HPV vaccines “can have serious adverse reactions including permanent disabilities and death.”

The problem is that the claim of vaccines risks draws directly on anti-vaccine sources that do not, in fact, show that. First, the complaint refers to VAERS reports as showing the vaccine has frequent harms. This in spite of the fact that raw VAERS reports show nothing of the sort: VAERS is a passive reporting system where anyone can report anything, and the raw numbers are meaningless. For example, the complaint mentions that “since 2007 HPV vaccines have been associated with at least 48,601 cases of adverse events, including: 300 deaths.”

Here is an example of a VAERS report that would count as one of those death reports:

VAERS #379570: “…patient accidentally fell in open well (granite quarry filled with water), drowned and expired. This event occurred 49 days of receiving first dose of GARDASIL.”

It’s glaringly obvious that this sad event was not caused by the vaccine, and the other reports are also problematic.  But the complaint cites the number, without any qualification or warning, implying that the vaccines did, in fact, cause 300 deaths. This is highly misleading. This is especially problematic since in 2009 the CDC reviewed VAERS HPV reports – and found that most were minor, and the serious ones did not, for the most part, show serious risks.

The complaint also mentions the vaccines’ Vaccine Information Statement (VIS). Here is what that source says about the vaccines’ risks:

This HPV vaccine has been used in the U.S. and around the world for about six years and has been very safe.

However, any medicine could possibly cause a serious problem, such as a severe allergic reaction. The risk of any vaccine causing a serious injury, or death, is extremely small.

Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.

Several mild to moderate problems are known to occur with this HPV vaccine. These do not last long and go away on their own.

Reactions in the arm where the shot was given:

Pain (about 8 people in 10)

Redness or swelling (about 1 person in 4)

Fever:

Mild (100° F) (about 1 person in 10)

Moderate (102° F) (about 1 person in 65)

Other problems:

Headache (about 1 person in 3)

Fainting: Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. Tell your doctor if the patient feels dizzy or light-headed, or has vision changes or ringing in the ears.
Like all vaccines, HPV vaccines will continue to be monitored for unusual or severe problems.

Note that the only serious risk mentioned here is the potential of a severe allergic reaction, mentioned as a theoretical possibility that applies to any medicine – and even that is very small.

Lastly, the complaint mentions that the insert lists a set of “adverse events following injection of Gardasil or Gardasil-9: death, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy.” The complaint omits the fact that these are mentioned in the insert’s adverse reaction section, and are accompanied by the following language: “The following adverse events have been spontaneously reported during post-approval use of GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.” In other words, these are reported events without showing of a causal relationship (pdf).  Using inserts this way is a common tactic of anti-vaccine activists – and it’s deeply flawed, because that list in the insert simply doesn’t show causation.

In this case, especially, these sources are problematic since they directly contradict the available research on HPV vaccines which, to give one example, finds no link to autoimmune diseases. Let’s be clear: there is a lot of actual scientific data about HPV vaccines’ safety. Studies following more than a million people looked at HPV vaccines. Those studies show a very, very high degree of safety. They don’t show that the vaccine has serious risks. Monitoring of over a hundred million doses in the United States alone also failed to discover serious risks. The claim that the vaccine has serious risk flies directly against the evidence. These issues have been covered that literature in detail in the past.

So, what we have is a law created to protect minors from sexually transmitted disease, leading to a rule allowing a very safe vaccine against a very common infection that can cause cancer, to be given to highly at-risk minors. The only way for the complaint to create an appearance that this rule is problematic on policy grounds is to use sources often used by anti-vaccine activists to inflate the vaccines’ risks. Those claims should be countered strongly, and rejected.

 

Constitutional claims

The last claim of the complaint is that the rule violates the Fourteenth Amendment because it interferes with parental liberty to make medical decisions for their children. It’s clear that the rule does interfere with parental ability to make medical decisions for sexually active minors who have been infected with a sexually transmitted disease or exposed to one, by allowing such teens to receive HPV vaccines without parental consent. It’s also clear that the Fourteenth Amendment protects parental liberty to raise their children, and that generally fit parents (and there’s no reason to see plaintiffs as unfit) have extensive freedom to make decisions for their minor children. But that such protection is not absolute, and never was (pdf). It is well accepted that the state can step in to protect a child’s welfare and life. §2305 to the Public Health Law creates an exception to that authority for sexually active teens, allowing them to consent to medical procedures to protect themselves against sexually transmitted disease. The rule continues that tradition, and the extension – allowing at-risk teens to protect themselves against HPV via the vaccine – is not a dramatic expansion. If §2305 is constitutional –  and the complaint doesn’t argue it’s not – so is the rule.

 

Conclusion

Teens exposed to any one sexually transmitted disease, or infected with one, have clearly shown they’re at risk of sexually transmitted diseases in general. HPV is one of the most common ones – and it causes tens of thousands of cancers and thousands of deaths each year. Two very safe vaccines can prevent most of those cancers. New York’s rule allows these at-risk minors to protect themselves from a common infection without parental consent, which fulfills the goal of the law it is implementing, to protect teens from disease – something that won’t happen if parents are required to consent.

It’s reasonable policy, and the legal arguments against it are not strong. Hopefully, the defendant’s lawyers will present the case strongly, and a court will uphold it.

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.