NVICP SIDS vaccine decision overturned on appeal – the facts

SIDS vaccine

On July 18, 2018, a Judge of the Court of Federal Claims overturned the NVICP SIDS vaccine decision that awarded compensation to Mr. and Mrs. Boatmon for the death of their baby, JB. The Court found that the Special Master’s decision was arbitrary and capricious because it ignored previous decisions and applied a too-low standard of proof to the case. Continue reading “NVICP SIDS vaccine decision overturned on appeal – the facts”

Vaccines cause SIDS? Not supported by Boatmon vs HHS case

vaccines cause SIDS

This is about the case of little J. B. Boatman, who was born four weeks prematurely, at the 36th week.  However, he rebounded from his early start, and at his four-months, well baby pediatric visit, on September 2 was doing very well and found healthy.  At that visit, J.B. had the routine 4 months vaccines. Tragically, the next day (September 3) little J.B. was found lifeless in his crib. His death was ruled to be the result of Sudden Infant Death Syndrome (SIDS). But did vaccines cause SIDS in J.B.?

His parents filed suit under the National Vaccine Injury Compensation Program (NVICP). The case was decided on July 10, 2017. Special Master  Thomas L. Gowen with the National Vaccine Injury Compensation Program granted J.B’s parents compensation.

In August 2017 the Boatmon decision was shared on anti-vaccine sites as evidence that vaccines cause SIDS. The decision does not, however, support the claim because it is flawed internally in several ways. It misuses and discounts the epidemiological evidence, accepts a problematic theory over the objection of a more qualified expert, and ignores several of the important factors of the case. In addition to its internal flaws, the decision is in tension with many other decisions of NVICP – in fact, it seems an outlier – and it is interesting that the same sites that tout this problematic decision ignore other decisions that ruled otherwise. Continue reading “Vaccines cause SIDS? Not supported by Boatmon vs HHS case”

Michigan court supports vaccines – finds in favor of child’s health

Michigan court

On 17 December 2018, a Michigan family law court hearing a case in which divorced parents disagreed on vaccines, decided that the child should be vaccinated. In that decision, the Michigan court followed in the footsteps of most courts deciding such issues and upheld both the previous agreements between the parents and the child’s best interest.  Continue reading “Michigan court supports vaccines – finds in favor of child’s health”

Vaccine exemptions and private schools – what are the facts?

vaccine exemptions

As measles outbreaks – centered on unvaccinated children – continue to pop up in areas with low vaccine rates,  one approach private schools and daycares reach to is keeping out unvaccinated children. An Ohio Jewish school announced it will not accept unvaccinated children, and I know other private facilities are considering this. So what does this all mean with respect to vaccine exemptions within private schools?

Note that this is a separate issue than the question of whether unvaccinated children can be kept home during an outbreak. All states have a provision in law to keep unvaccinated children at home during an outbreak, and some of the affected states – like New York – are doing that.  Continue reading “Vaccine exemptions and private schools – what are the facts?”

Another SB277 lawsuit rejected – anti-vaccine Voice for Choice loses

SB277 lawsuit rejected

On 20 November 2018, the California court of appeal for the third appellate district, in a strong decision, rejected a challenge by the anti-vaccine organization A Voice for Choice and three individual plaintiffs to SB277, California’s law removing the personal belief exemption to school immunization mandates. The decision included scathing criticisms of the arguments and a powerful endorsement of school vaccines mandates. This article will examine yet another SB277 lawsuit rejected by courts.

Background

The first iteration of the lawsuit in question here was first discussed in November 2016, and it was then filed with a federal district court. After the initial rejection of that lawsuit, it was refiled with a state court, and after that was rejected, the plaintiffs appealed. 

The court opened by stating that “Plaintiffs’ arguments are strong on hyperbole and scant on authority.” Its decision drew extensively on the California Court of Appeal, Second Appellate District’s decision in Brown v. Smith, and on the federal district’s court decision in Whitlow v. California (discussed here). 

The Court opened with the California Supreme Court decision in Abeel v. Clark (1890) 84 Cal. 226, in which the Court upheld a school immunization requirement, and the extensive jurisprudence, state and federal, that upheld vaccines mandates since. It reminded us that for over a century, courts upheld school mandates in the face of challenges, and cited Brown v. Smith to explain that “[t]his is another such case, with a variation on the theme but with the same result.” 

Setting the ground, it explained the act, and its purpose “to provide “[a] means for the eventual achievement of total immunization of appropriate age groups against [certain] diseases.” (§ 120325, subd. (a).)” It explained the need for the act – the measles outbreak centered on Disneyland and the warning it provided that vaccine rates are too low, and exemption rates increasing too fast, and in some areas are dangerously high.

It set out the standard of review for a demurrer. A demurrer is a claim that the complaint does not raise a cause of legal action – in some jurisdictions, it would be titled a motion to dismiss. Because sustaining – accepting – a demurrer means a case is kicked out without going through fact-finding, without plaintiffs having their full day in court, the standard is pretty high, and appellate review is aggressive: 

We review the complaint de novo to determine whether it alleges facts sufficient to state a cause of action. For purposes of review, we accept as true all material facts alleged in the complaint, but not contentions, deductions or conclusions of fact or law. We also consider matters that may be judicially noticed.” (Brown v. Smith, supra, 24 Cal.App.5th at p. 1141.) We may affirm a trial court judgment on any basis presented by the record whether or not relied upon by the trial court. 

De novo means the appellate court is not bound by the finding and conclusions of the court below but reevaluates the claims from scratch. As the court explained, it is assuming factual claims are true, though if there’s judicial notice of well known, external facts, it can reject clearly implausible claims.

Note that a demurrer is usually sustained with a “leave to amend” because the court thinks it is possible for the plaintiff to state facts sufficient to constitute a cause of action. In this case, the demurrer was sustained without leave to amend because the court believes that the plaintiffs’ claim is so weak that no amending of the complaint will solve the fundamental problems.

SB277 lawsuit rejected – substantive due process

A substantive due process claim argues that the government overstepped in interfering with individual rights, beyond a legal standard. 

Here, there are three parts to this argument, as addressed by the Court – plaintiffs claim that SB277 violates their right to bodily autonomy, conditions their right to attend school on giving up bodily autonomy, and interferes with their parental rights. The court rejected the argument both because plaintiffs did not provide any legal authority supporting it (they couldn’t – there are none) and because they did not succeed in convincing the court that the law violates either of the possible legal standards. A substantive due process claim that affects a fundamental right (like bodily autonomy) would be held to the high standard of strict scrutiny. Under it, a law is “upheld only if it is narrowly tailored to promote a compelling governmental interest.” In other claims, a much lower bar – rational-basis review – applies. The court found SB277 would meet either standard. The court said that:

“It is well established that laws mandating vaccination of school-aged children promote a compelling governmental interest of ensuring health and safety by preventing the spread of contagious diseases.”

It cited multiple cases upholding vaccine mandates and criticized the plaintiffs for not addressing them and responding to them. I’m not sure that’s completely fair – the plaintiffs did try to address at least one of the cases the court pointed to, Zucht v. King and the decision later responded to that. But the court is completely right that plaintiffs did not succeed in providing a convincing reason to reject that abundant jurisprudence. 

Addressing bodily autonomy, the court rejected plaintiffs’ effort to argue that the vaccine cases are before cases upholding bodily autonomy, and therefore invalid. The court said: “We are aware of no case holding mandatory vaccination statutes violate a person’s right to bodily autonomy.”

I agree with the court’s conclusion, but I would support it differently. First, at least one famous bodily autonomy case – Schloendorff v. Society of New York Hospital  dates to 1914, while Zucht is a 1922 case, so the timing does not fit the plaintiffs’ claim. But more importantly, while I think the bodily autonomy cases would be important if a state were to impose an adult mandate, that’s not the issue here. These are children who are required to be vaccinated – and bodily autonomy does not work quite the same way. The children are not capable of making autonomous decisions, and the issue is not their autonomous choice not to be protected from diphtheria, measles, hib, etc. – it’s their parents’ choice not to protect them.

There are other arguments against the cases, but I want to keep this short, so I will not go into detail about them. 

The more tricky prong of the strict scrutiny standard for this purpose is that a law limiting rights has to be narrowly tailored. Here, plaintiffs – as they should have – argued that there are other, less aggressive means to prevent outbreaks. And the court – correctly, in my view – rejected it, drawing on Brown v. Smith and Whitlow again. The court pointed out that the state’s objective – total immunization of the relevant age groups – is ambitious, and lesser means won’t achieve it. It then quoted language from Brown strongly endorsing mandates (pdf):

“This argument fails, of course, as compulsory immunization has long been recognized as the gold standard for preventing the spread of contagious diseases. As is noted in the legislative history, studies have found that ‘when belief exemptions to vaccination guidelines are permitted, vaccination rates decrease,’ and community immunity wanes if large numbers of children do not receive required vaccinations.”

The court gave short shrift to the plaintiffs’ claim that SB277 violates privacy, because when dealing with health matters, the review is under rational-basis review, and the desire to prevent dangerous diseases trumps it (to those interested in a longer analysis, I engaged in one here).

Probably the strongest claim plaintiffs had is the claim that SB277 violates the right to education – though even that is not particularly convincing. But the Court rejected this claim easily, too, because the two previous decisions – Brown v. Smith and Whitlow – already dealt with the issue. The court found that the precedent enshrining the right to education – Serrano – did not apply, for two reasons.

First, it was not applicable on the facts:

[quoting Brown] “Serrano struck down a public school financing scheme as violating equal protection guaranties ‘because it discriminated against a fundamental interest — education — on the basis of a suspect classification — district wealth — and could not be justified by a compelling state interest under the strict scrutiny test thus applicable.’ ” (Brown v. Smith, supra, 24 Cal.App.5th at p. 1145.) Like the plaintiffs in Brown, the plaintiffs here “cite Serrano to support their claim that Senate Bill No. 277 . . . violates their constitutional right to attend school, but fail to explain its application here. There is no ‘suspect classification’ underlying Senate Bill No. 277.”

Second, and just as important, even assuming the statute was held to strict scrutiny because education is a fundamental right, the court already explained that it can pass strict scrutiny. 

Finally, in a very short statement, the court agreed with the Brown court that SB277 did not violate religious freedom. 

In short, this decision agreed with previous jurisprudence that school mandates are constitutional and valuable.

SB277 lawsuit rejected – what next?

A Voice for Choice has two choices. It can accept the loss and go home, or it can try and appeal to the California Supreme Court. Not appealing has advantages: this is an unpublished decision, and as such, does not serve as a precedent – it cannot be cited or relied on. It is, however, binding on the parties to the case. A Supreme Court decision, if one happens, could well echo the strong endorsement of mandates, based on strong evidence that they work and an extensive jurisprudence, and would change the legal situation for the worse – it would end the issue in terms of California law (since the claims in this lawsuit are mostly state claims, the California Supreme Court is the last word on them). On the other hand, not appealing gives up a chance to change the legal situation, leaves SB277 intact, and leaves in place the other appellate court decision – Brown v. Smith – supporting it. 

If A Voice for Choice appeals, the Supreme Court will get to decide whether to take the case. The California Supreme Court takes very few civil law cases, and this one is based on extensive jurisprudence rather than breaking new ground – so there is a strong chance it will not be taken up. On the other hand, the court may want to address the question of immunization mandates in current times. 

We will see. 

8 December 2018 Update

The state requested that the court’s decision be published. On December 6, 2018, the court granted the request, giving the decision precedential force.

Getting the adult HPV vaccine – Dorit Rubinstein Reiss’ story

adult-hpv-vaccine

On 5 October 2018, the FDA expanded the licensing Gardasil 9 – currently the only HPV vaccine marketed in the United States – to men and women up to the age of 45. If up till now getting the adult HPV vaccine was not a realistic option for me, now it was. But at this point, the vaccine is not yet recommended for my age group – the Advisory Committee on Immunization Practices has not made any additional recommendations after licensing. Which raised the question: should I get it?

On one hand, I am in a committed monogamous relationship. I am a married mother of two young children, I have no plans of changing partners, and I’ve already probably been exposed to anything my husband had. I have never had an abnormal pap smear. That means that I am likely pretty low risk for getting a new HPV infection and that I have cleared any I ever had (almost all sexually active people in the United States have had HPV). If you are in a relationship, including marriage, and if you had children, you likely had sex at some point.

So the benefits of the adult HPV vaccine for me are low – but not non-existent. You never know what will happen, and while I hope to stay with my partner forever, bad things can happen – like death or sexual assault. One hopes for the best, but it’s reasonable to also plan for the worst (for example, while we do not plan to die, we have a will written out with provisions for caring for our kids if we do) – and the vaccine is age-limited. There are nine cancer-causing HPV strains in the vaccine, and I am fairly certain that I have not been exposed to all of them. 

The risks of the adult HPV vaccine are extremely minor. I’m likely to get a sore arm, may get other mild reaction like fever, and have a theoretical reaction of an allergic reaction (or fainting, though not being a teen, I think that’s unlikely). Studies pretty much rule out other risks.

In spite of anti-vaccine claims, getting the vaccine after being exposed to HPV does not increase your risk of cancer (but the vaccine won’t protect you against strains you were already exposed to).

So the adult HPV vaccine has low benefits but minuscule risks, at least for me. Still, it seemed to me to make sense to go for it, if possible. Especially because I speak up about HPV vaccines and encourage others to go for them, I thought it’s fair to get them myself, too. Show I mean it when I say that they are safe. 

To be sure, I emailed Dr. Paul Offit, who I trust completely on vaccines. He recommended going for it. 

I did not know, however, if my provider will give me the vaccine or if my healthcare insurance will cover it at my age (most health insurance in the USA does cover all vaccines, including the HPV vaccine, for children). In spite of what anti-vaccine people believe, I do not have secret ties to pharma or special access to vaccines. 

So I emailed my doctor:

Dear Dr. X,

Since the FDA approved HPV vaccines for people up to 45, I would like to get the vaccine, if possible.

I emailed Dr. Paul Offit, a vaccine expert,  for his opinion, and he recommended getting it.

Can you help me do that?

Best,
Dorit.

My doctor said: “Sure, let me see what our protocol is here and get back to you.”

After I did not hear back for over a week, I emailed again. My doctor answered:

Sorry that I could not repond in a timely manner.
I had forwarded your request to Dr. Y [details omitted to preserve my providers’ – and my own – privacy] but did not hear from them. I have ordered the shots. You can call your … health plan to see if it will be covered just to be sure.

You can go to ### injection clinic Mon-Fri 9am-12pm, 1:30-4:30 pm for the shot (ordered already).

Okay. All that was left was to actually get the vaccine. I wanted a picture – so I asked my eight-year-old son if he will act as photographer and come with me. He agreed. We went together, waited, and went in. I told him to take a lot of pictures all through, and he did. 

Dorit adult HPV vaccine

The nurse asked if I was feeling okay, if I ever had a reaction to a vaccine, if I was allergic to latex or anything else I knew of (yes, no, no). She explained what the shot was, and gave me the Vaccine Information Statement. We also wrote out the schedule for the next two doses. Then she cleaned the area, told me to take a deep breath and let it out, and done. I barely felt the needle. 

She told me my arm will hurt for a day or two. It didn’t, actually. Not complaining. I’m okay with less pain. But I would have been okay (not happy, but okay) with a sore arm for a few days, too. 

My son did a great job taking a lot of pictures. I posted several of those pictures on Facebook and Twitter, because, again, I think it’s important to make it clear I stand behind what I say on HPV vaccines specifically, and vaccines generally. 

So that’s my adult HPV vaccine story. One dose down, two to go. Maybe my arm will hurt next time. 

Plus ça change – anti-vaccine activists revive the Hannah Poling case

Hannah Poling

Following a pattern we have seen repeatedly, anti-vaccine activists have tried to claim a conspiracy to hide a link between vaccines and autism. The latest effort, reviving the Hannah Poling case, follows the pattern we have seen in previous cases – anti-vaccine activists claim that the government knew of evidence that vaccines cause autism (in this case, through mitochondrial disorders), that the government committed fraud to hide that information, and that the combination of fraud and evidence should be a game changer.

As with those past events, the claims cannot withstand scrutiny. In this case, another claim was added – a denial of due process for claimants in the Omnibus Autism Proceedings generally and in one family’s case specifically. This claim, too, does not hold. 

In contrast to the claims in the latest set of anti-vaccine articles, there was no fraud by the government, the behavior they complain about did not decide the fate of the Omnibus Autism Proceedings, they provide no new evidence that vaccines cause autism, the mitochondrial claim is neither new nor strong, and there was no denial of due process to the claimants in the Omnibus Autism Proceeding or in the specific case in question. Continue reading “Plus ça change – anti-vaccine activists revive the Hannah Poling case”

Nick Catone son dies tragically – blaming vaccines with no evidence

Nick Catone

On May 12, 2017, the son of retired UFC fighter Nick Catone, Nicholas Catone, by all accounts a healthy, sweet, happy, child, died in his sleep. It’s horrible to lose a child, and I want to start by extending my condolences to the family.

Sadly, I can’t stop there. His parents blame vaccines. The story is being spread in mom groups and understandably scares moms from vaccinating. But Nicholas’ tragic death is not a good reason to refuse vaccines. First, the alleged link to vaccines is extraordinarily weak. There is no good reason to blame vaccines for the boy’s tragic death. Second, even if this was linked to vaccines – and there’s no evidence of that – it’s still safer to vaccinate.  Continue reading “Nick Catone son dies tragically – blaming vaccines with no evidence”

Italian vaccine mandate – implementation delayed – another UPDATE

Italian vaccine mandate

On Monday, the Italian Senate passed a large bill that, among other things, delayed the implementation of the Italian vaccine mandate passed in 2017 until the 2019-2020 school year. This short post explains what this means – and does not mean.

In response to a large measles outbreak in Italy that killed about 1:1000 (around 8 in the past year) and hospitalized thousands, the Italian government then in power passed a law that mandates that children 0-6 be vaccinated with ten vaccines (before that, four were required) before attending daycare or school. It also imposed fines on parents of children 0-16 who were not vaccinated with these vaccines.

In the 2018 election, two anti-establishment parties joined the coalition government. One, the 5 Star Movement, includes people who are openly anti-vaccine. It’s not clear to what extent their anti-vaccine views affected their election results, but among other things, the party promised to roll back the Italian vaccine mandate.

As a first step, the new health minister allowed parents to self-certify vaccines for the 2018-2019 school year – to declare whether or not their children were vaccinated (in a sense, rewarding dishonest anti-vaccine parents over honest ones). 

The new Italian Senate law included many things, but the most important issue is that they delayed the implementation of the mandate for the school year 2019-2020. Importantly, the law will not become effective until it passes Italy’s lower house, which is on recess until September 11, 2018, so it will not apply in the school year 2018-2019.

During the current year, the mandate still applies, as does the self-certification decree, probably. But if it becomes law, it will mean that the law is not applicable the following year, giving the new government a chance to try and overturn the mandate completely. 

Naturally, medical societies – as well as politicians from other parties – are concerned about the repeal of the Italian vaccine mandate.

The measles outbreak, which was the impetus for the original law, is still going strong. In fact, the CDC has issued a level 1 travel warning for Italy because of this ongoing outbreak.

Several people in Italy have died recently from the measles, and many were hospitalized. Almost all the cases are in the unvaccinated, including those too young to be vaccinated. This is not a great time to roll back the Italian vaccine mandate intended to protect children and contain the outbreak. 

Update – 6 September 2018

Italy today reaffirmed that the vaccine mandate applies in 2018-2019 and children 0-6 need to be vaccinated. It also removed the option of self-certification, requiring that parents provide a doctor certificate showing children are vaccinated.

However, the government still announced its intent to revisit the mandate in future.

Update – 9 September 2018

The Italian Parliament relaxed its change of direction – self-certification will be allowed during the current school year. The mandate, however, is still in force, at least until March 2019.

Israel vaccine law proposal – seeking balance to improve vaccination rates

With the support of a local pro-vaccine non-profit made of parents and professional volunteers, two parliament members are proposing an Israel vaccine law to improve immunization rates. This and other proposals are a response to a measles outbreak made up mostly of unvaccinated individuals. The proposal explicitly seeks to improve disease prevention while minimizing the effect on autonomy. It does so with a mix of measures that mirror laws existing in other countries and new ideas. 

While the proposal is likely to face criticism from both immunization opponents and those seeking stronger measures, the proposed Israel vaccine law has potential to improve immunization rates in Israel and may be a better fit for Israel’s situation than alternatives. It is clear that a lot of thought went into it. Continue reading “Israel vaccine law proposal – seeking balance to improve vaccination rates”