Dorit Rubinstein Reiss – an index of contributions to this website

Dorit Rubinstein Reiss

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 (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations. I know a lot of writers out there will link to one of her articles here as a sort of primary source to tear down a bogus antivaccine message.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. 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.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. This article will be updated as new articles from Professor Reiss are added here.

Continue reading “Dorit Rubinstein Reiss – an index of contributions to this website”

Michigan vaccine regulations – Court decides on religious exemptions

Michigan vaccine regulations

On 7 November 2017, the 6th Circuit Court of Appeals mostly upheld a Federal District’s Court decision (pdf) to grant a motion to dismiss a lawsuit challenging Michigan vaccine regulations that require parents seeking an exemption from school immunization requirements have an interview with health department personnel first. The decision reinforced the strong support our courts have provided states’ efforts to increase vaccines rates.

Continue reading “Michigan vaccine regulations – Court decides on religious exemptions”

National Vaccine Injury Compensation Program facts

national vaccine injury compensation program

In this post I explain how one goes about proving a case in the  National Vaccine Injury Compensation Program (NVICP), and how that differs from proving a case in the civil courts, focusing on what it means to have a no-fault program and proving causation. I will use a case that started with the tragic death of a young child after a vaccine to illustrate the complexity and operation of the program, and also to address the idea of federal preemption, and how it limits the ability of those claiming vaccine injuries to use state courts for their claims.

Continue reading “National Vaccine Injury Compensation Program facts”

Michigan mom jailed – not because of vaccines UPDATE

Michigan mom jailed

A mother signed a custody agreement that included her agreement to vaccinate her son. For over a year, the mother did not do so. For this refusal, and after giving her a last chance to comply, a judge had the Michigan mom jailed for seven days. She was jailed for ignoring a court order, not because she refused to vaccinate.

Getting to the point of contempt is likely not particularly common, but it’s not unheard of in family law disputes. So far, none of the facts make this case particularly extraordinary.

What appears to be unusual in this case is that the news coverage accepted the mother’s version and painted her as a principled martyr standing up for the sacred principle of, apparently, going to jail rather than protecting her child from disease. Orac discussed the false balance in the reporting. And that’s not what the case really embodies. Continue reading “Michigan mom jailed – not because of vaccines UPDATE”

California SB277 lawsuit appeal – bad arguments against vaccines

California SB277 lawsuit appeal

On September 30, 2017, the team behind the Buck lawsuit posted their appellate brief regarding the California SB277 lawsuit appeal on Facebook. The initial lawsuit was very badly reasoned, and the brief is no better.

It does not meet its primary goal of convincing the appellate judges that the trial court judge was wrong to dismiss the case, since it does not counter the arguments at the basis of the dismissal, and especially does not give a reason to overturn a hundred years of jurisprudence upholding school immunization requirements. It makes many inaccurate legal and factual claims; it also uses extreme language and bad formatting.

This post will not cover all the problems in the 47 page document. I will try, however, to highlight the main issues.

The case

To remind readers, Buck v. California is one of the first lawsuits filed to block implementation of SB277, which eliminates vaccination personal belief exemptions for students. The lawsuit was brought by eight plaintiffs represented by attorney T. Matthew Philips. The group is openly and extremely anti-vaccine.

Their earlier lawsuit involved bad arguments, was badly written, and ended when a superior court judge sustained the state’s demurrer – in lay terms, the judge dismissed the  plaintiffs’ complaint because it was legally and factually inadequate. Moreover, the trial judge dismissed without leave to amend because the inadequacies in the complaint could not be fixed. The main arguments in the state’s demurrer were that plaintiffs ignored the extensive jurisprudence supporting immunization requirements, which goes back 100 years, they did not properly make a religious freedom claim, their claims that SB277 violates the right to education or equal protection were legally unfounded, and their claim that the medical exemption is too vague was  mistaken.

The plaintiffs appealed to the California Court of Appeal of the Second Appellate District, and after lengthy procedural delays filed an appellate brief with the court on October 11, 2017 (substantially later than the Facebook post). The brief is problematic both in what it does not do and in what it does do. This post will shortly address why the brief did not, in fact, make a case for overturning the trial’s court decision.

The standard of appellate review in this instance is called de novo.   The appellate court will reexamine the contentions made in the parties’ briefs and decide independently whether the legal standards for sustaining a demurrer (dismissing the lawsuit) were met. The question of whether the lower court should have given the plaintiffs leave to amend their complaint is subject to a more deferential standard – that decision will only be overturned if the lower court abused its discretion (id).

Usually, issues not raised at the trial level will not be examined by the court of appeal for the first time, though that court can make an exception if there are good reasons for doing so.  (Wood v. Milyard, 566 U.S. 463, 473, 132 S. Ct. 1826, 1834, 182 L. Ed. 2d 733 (2012)). The plaintiffs’ appellate brief raises several issues not raised at the trial stage, and the appellate court would be well justified in not addressing those additional issues. However, I will touch on them, since I cannot be sure what the court will do.

California SB277 lawsuit appeal – omissions

The first problem with the appellate brief is that it simply does not respond to the major issues raised in the demurer. The task of the lawyer on appeal is  to convince the appellate court that he did, in fact, state a valid cause of action in the complaint he filed on behalf of his clients. The demurrer, which the trial court sustained, suggested grounds why he did not. The appellate brief, for the most part, did not counter those reasons.

The first basis for sustaining the demurer was that for over 100 years courts – state and federal – have upheld state immunization requirements. But the appellate brief does not directly grapple with that. It does suggest a narrow interpretation of the seminal case of Jacobson v. Massachusetts, 197 U.S. 11 (1905): it suggests that Jacobson only allowed use of police power to protect health during a public health emergency. While it’s true that the ordinance addressed in Jacobson was passed in the context of an outbreak, and that the case does contain language emphasizing the necessity in this case, and suggesting that there might be circumstances in which the use of police force would be extreme, most of the case uses much broader language, and clearly is not limited only to immediate emergencies.

More important, even if that interpretation of Jacobson was initially plausible, the jurisprudence since created a much broader principle. In Zucht v. King 260 U.S. 174 (1922), the U.S. Supreme Court upheld an ordinance imposing a school immunization requirement not during an outbreak – making it clear police powers are not limited to a public emergency. California’s Supreme Court upheld school immunization requirements in spite of the constitutional right to education in the 19th century, in Abeel v. Clark, 84 Cal. 226 (1890). The brief does not suggest any reason to ignore or overturn that jurisprudence; it simply does not mention or address it.

This puts the appellate court in a position of having an extensive jurisprudence against the claims in the complaint, and no good basis in the complaint or appellate brief for rejecting it. The brief attempts to claim it’s a case of first impression – a new case, without governing jurisprudence because it’s making a new argument about mandates and unavoidably unsafe products – that, as I will discuss, is based on a misunderstanding of product liability law – but the issue is not one of first impression: school immunization mandates were extensively adjudicated. Suggesting new grounds to change existing jurisprudence does not make that jurisprudence vanish and does not make a previously decided issue one of first impression.

The brief also does not cure the two problems with religious exemptions mentioned in the demurrer. It does not make a strong claim that the parents have religious opposition to vaccines. It does not even attempt to show it made the claim in the complaint or the trial record. It simply ignores the issue. Nor does it address the jurisprudence according to which neutral laws do not have to provide a religious exemption. Again, it does not even attempt to address this issue.

It does not answer the criticism of the claim of right to education that was made at the trial level – that preventing outbreaks protects the right to education, and that protecting public health is a compelling public interest. It repeats the same arguments it made that the law violates the right to education, and that it’s more important to educate children than to vaccinate them – but it does not provide an answer to the state’s explanation why that’s not a good argument. It does not point to anything in the complaint that counters that.

And it still does not provide any authority for the claim that vaccination status should be a protected category, or even a good argument for it. Here, too, it does not address the arguments in the demurrer.

Basically, the appellate brief ignores its primary mission: to convince the court of appeal that the demurrer was wrongly sustained by the trial judge. It does not even try to accomplish that key task.

Unavoidably unsafe

The appellate brief’s opening argument is that because all vaccines are legally and factually unavoidably unsafe, the state cannot require vaccines as a precondition to school. This claim is based on a set of misunderstandings of product liability law and relevant jurisprudence, as well as on incorrect factual assertions.

In terms of the law, a major confusion in the complaint is that it claims that unavoidably unsafe products are necessarily defective products – which is completely wrong. This needs some context. In 1964, the Restatement (Second) of Torts (a very influential legal source) reflected new developments in state courts by saying that manufacturers will be strictly liable for defective products. This was adopted by all states, and became the basis for our modern product liability law.

Restatements are structured with a general rule followed by explanatory comments. In this case, the brief is trying to refer to comment K. Comment K created an exception to the usual rule for a special category of products, which it called “unavoidably unsafe” products. The name of this category has unfortunately led lay anti-vaccine activists, and some lawyers with, apparently, little knowledge of the subject matter, to wrongly conclude that these products were defectively less safe than others. In reality,  Comment K explained that “such a product, properly prepared, and accompanied by proper directives and warnings, is not defective, nor is it unreasonably dangerous.”

When the appellate brief equates an unavoidably unsafe product, such as a vaccine, with a defective design, the appellate brief is simply wrong. In fact, falling into the category of unavoidably unsafe products would mean that the product is not defective by design (and as a corollary, is not unreasonably dangerous, because its risks are far outweighed by its benefits). Nor is there any other basis to see all vaccines as defective in design.

Generally, the brief also seems to assume that the fact that vaccines have inherent risks makes them defective by design – it spends quite a lot of words on trying to emphasize vaccines risks. But the law does not work that way. If any product with a risk was defective by design, sharp knives,  cars, and life-saving drugs would all automatically be found defective – and they are not: it is not easy to show a design defect in a product. Many products have risks, and that does not make them defective. To be defective, you have to actually show more than a risk. Here, too, the brief shows a lack of understanding of product liability. (Because this post is already long, I am not going into further detail – for a more detailed discussion, see here.)

The appellate brief tries to make a distinction between pharmaceutical drugs which, it says, “come with a possible risk of adverse side-effects while vaccines come with a presumed risk of adverse side-effects.” It’s not clear what, exactly, the brief was trying to say here. Both vaccines and drugs have risks, and either can cause, occasionally, side effects.

If the brief is trying to claim that vaccines cause more side effects than drugs, that is a broad and unjustified generalization: drugs vary, and realistically, most vaccines likely have fewer side effects than many or most drugs. This is even more true for serious harms: serious harms from vaccines are extremely rare . The low rate of compensation in the National Vaccine Injury Compensation Program – less than one per million – further reinforces what science shows on this: serious harms from vaccines are very rare.

The brief claims that:

With 100% certainty, SB277’s vaccine mandate has already killed California school children.

It provides no actual details of deaths, no specific allegations to support that claim. While at the demurrer stage material facts in the complaint are supposed to be presumed true, there really are not a lot of facts in this sentence. There’s an expression of belief, with no facts or support behind it. There is no evidence, or even claims, of deaths related to SB277 – even anti-vaccine groups have not pointed to one. It’s not clear where this belief comes from.

Finally, the appellate brief misrepresents the Supreme Court decision in Bruesewitz vs. Wyeth, LLC, 562 U.S. 223 (2011), that it draws on. The case did not state that design defects are unavoidable, or suggest all vaccines are defective in design. And it clearly rejected the application of the unavoidably unsafe category to vaccines

California SB277 lawsuit appeal – equal protection

The brief also makes glaring legal errors in its discussion of equal protection.

The brief states that “Plaintiffs identify eight (8) separate and distinct bases of disparate treatment; in all instances, the disparate treatment is based on “medical status,” a suspect class requiring heightened scrutiny.” Most of these categories were not in the initial brief and are new claims.

Since the categories include such things as home v. school based students, or different grades, they are clearly not all based on medical status, however the term is defined. But the problem runs deeper.

Under the Fourteenth amendment, a state may not deny people “equal protection of the laws”. But that does not mean laws cannot treat people differently. All or most laws make distinctions, and for the most part, that’s fine. Laws treat jaywalkers different than non jay walkers, give licenses to people who meet criteria and not others, and regulate homeschoolers differently than students in school.

The appellate brief’s treatment of equal protection ignores two fundamental principles of equal protection analysis. The first is that equal protection means treating those similarly situated alike; it’s fine, and often appropriate, to treat those who are not in similar circumstances differently. The second is that even when there are arguable similarities, not all classifications are held to the same standard.

Most legal distinctions are held to a rational basis standard, under which the state just has to show the distinction is reasonably related to a legitimate interest. The brief tries to argue the state should apply strict scrutiny, a much higher standard applied to cases where a classification is based on a protected category (such as race) – but fails to show one.

Let’s go over the plaintiffs’ claims one by one (I am collapsing the discussion of the two categories of distinctions based on grades into one).

  1. Vaccinated v. Unvaccinated students – as pointed in the decision denying a preliminary injunction in the better-reasoned Whitlow lawsuit, unvaccinated children are not similarly situated in comparison to their protected peers: they are at higher risk of preventable diseases, and when they congregate, they increase the risk of outbreaks. It’s not illegal discrimination to treat different cases differently.
  2. Homeschool v. classroom students – again, these children are not similarly situated. The risk of disease transmission is higher in the close school environment than in casual contacts, and homeschooled children do not pose the same level of risk to others.
  3. Children at checkpoint grades v. children at other grades – again, these children are not similarly situated. The complaint emphasizes that there is a differential treatment here, and suggests there is no basis for that – but the goal of checkpoints was to allow for gradual implementation of the law, to reduce the administrative burden on schools and allow transition to as many families as possible. The distinction is temporary, and rationally based on the legitimate interest in gradual implementation of a new requirement. There’s nothing unusual about allowing for gradual implementation of a new regime. (The Affordable Care Act is a major recent example.) In a few years, all children will have gone through one of the checkpoints.
  4. Children not at a checkpoint whose parents filed an exemption before January 2016 – again, there is a rational basis, when you implement a law gradually, to treat children with exemptions on file differently from those who are not. The difference here is based in action, just as the law treats differently those who file tax returns on time and those who do not.
  5. Medically exempt students v. others – again, these students are not similarly situated. Children with medical reasons not to vaccinate are not like children without such reasons. This is not illegal discrimination, because it’s not treating like cases differently.
  6. Children infected with hepatitis B v. children not vaccinated against it – children with a medical condition, like disabled children, are not similarly situated to children who do not have a medical condition, but whose parents chose not to vaccinate. The parents of children with hepatitis B do not have a choice, nor do the children. The parents of the unvaccinated children are choosing not to protect their children from disease.

The brief suggests – wrongly – that these categories discriminate based on medical status, which it equates to vaccination status. The brief refers to section 51 of the Civil Code, The Unruh Act, as a source for medical status. That section prohibits discrimination based on, among other things, “disability, medical condition, genetic information.”

In contrast, parents choosing not to vaccinate their children is not a disability (though it can lead to one if the child gets a preventable disease), not a medical condition, and not genetic. The brief suggests that “vaccination status” should be a protected category – but does not give a single argument or a single relevant case in support of that suggestion. On p. 36 it refers to Brown v. Board of Education, 347 U.S. 483 (1954), and claims that segregation based on vaccination status is as bad as race based discrimination – but Brown is not a case of point – it does not address vaccination status. The brief does not explain which similarities it sees between race based discrimination and distinction based on vaccination status, and the statement is pretty jarring. There is an obvious difference between an immutable characteristic like race and the choice not to vaccinate a child.

The brief does not make a valid equal protection claim, and suggests misunderstandings.

Even if strict scrutiny was the standard, the brief does not make a good case that it was violated. The brief doesn’t address the state’s compelling interest here – which is protecting all children from disease, as stated in the state’s argument in support of its demurrer. Further, the brief’s  argument against narrowly tailored is mistaken because of a misunderstanding of the reason for SB277, discussed below.

Misunderstanding or misstating scenario and facts

The appellate brief seems to radically misunderstand the context for SB277 and its purpose. It describes the measles outbreak – an outbreak that spread to seventeen states and two countries, and that included over 125 cases –  as “a few dozen tourists reportedly contracted measles in Disneyland in Anaheim. This event lasted just a few weeks and fizzled-out all by itself.” (p. 8) This is a gross mischaracterization of the outbreak, in which most cases were in California residents, and most of the cases were unvaccinated.

More than that, the brief misunderstands the role the measles outbreak played in enacting SB277. It suggests the only reason for the bill is to handle the measles outbreak. That is obviously not the case. By the time the bill was signed into law in summer 2015, the outbreak was long over. The measles outbreak served as a warning call – to warn California residents that non-vaccination has reached a danger point, where herd immunity is at risk.

A study of the outbreak showed it was mostly concentrated in counties with low immunization rates. The legislature reacted to this danger by passing SB277 – with the goal to protect California children from disease not during the outbreak, not just from measles, but more generally. In light of that, the brief’s claim that SB277 should be limited to measles is incorrect. Nor would restricting the measure to Anaheim, as the brief suggests as a less restrictive alternative, solve the problem of low rates in several districts in California. Nor would quarantining children during the outbreak prevent future outbreaks.

The brief also suggests quarantining immune compromised children, which would also not prevent outbreak, and would mean punishing children who do not have a choice in deference to  the voluntary choices of the plaintiffs. The final option – “allowing free-thinking citizens to decide for themselves whether it’s safe to visit Disneyland” – would not even help with the measles outbreak, since visitors could transmit the virus to others not in Disneyland, and would certainly do nothing for future outbreaks, which could occur anywhere in the state.

The brief also claims that “nobody know how vaccines work”, drawing on a quote from Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). It uses this claim as part of the argument for why vaccines are unsafe. The quote is misused: the case talks about the fact that the standard of causation in NVICP is low to “allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body” – it does not say that we have no understanding of how vaccines work. It points out that we do not have absolute knowledge of that. There is an extensive literature on vaccine safety and effectiveness. Literally tens of thousands of studies. We may not know everything, but we know quite a bit. Dr. Paul Offit from The Children’s Hospital of Philadelphia, who runs the Vaccine Education Center there, said, in relation to that:

I think it that it is fair to say that the public often doesn’t understand how vaccines work. However, the scientists and researchers who created vaccines do understand how they work.

California SB277 lawsuit appeal – badly written

Although this is not the main issue with the appellate brief, I would add that it is not well written. Among other things, it has a very high degree of repetition. It makes no references to the trial court record, something it is required to do. The references to cases are often taken out of context and used for points that are not the actual points in the case. It also, occasionally, makes extreme and unwarranted statements.  Here is one of many examples. On p. 27, the brief says:

The Slippery Slope: It starts with mandatory vaccination of schoolchildren, then mandatory vaccination for school employees, then mandatory vaccination for government employees, then mandatory vaccination for all adults … and then mandatory blood and organ donations … then mandatory genetic modification purportedly to prevent illness … then mandatory sterilization of the poor and disabled … then mandatory euthanasia for the ill and elderly. It’s a slippery slope; SB277 demonstrates how holocausts get started.

This is problematic on several levels. First, it’s extreme. Describing SB277 as “how holocausts get started” is inappropriate. There is a glaring difference between requiring immunization for school and race or disability-based discrimination, violence or mass-murder. Second, it doesn’t make sense. School immunization requirements aim to make children safe from disease; they do not lead by any logical progression to euthanasia or sterilization.

Slippery slope implies a constant slope on which law moves naturally from a higher to a lower height. That’s not the situation here. Here we have completely separate hills that the plaintiffs suggest the law will jump between as goats would. I do not think any court has ever struck down a law because of a jumping goat concern.

In short, the appellate brief for this California SB277 lawsuit appeal does a pretty bad job at arguing that the plaintiffs have a valid claim under law. There does not seem to be a very good reason for an appellate court to overturn the demurrer based on anything in this brief.

 
 
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Child custody and vaccines – reviewing two disputes in Michigan

There have been two cases involving child custody and vaccines, where the vaccination status was being addressed in custody agreements, in Michigan. I am going to update one case, and discuss a new one.

On October 5, 2017 I addressed the case of Rebecca Bredow, a Michigan mother who signed a consent agreement to vaccinate her child, refused to follow through, and after apparently trying the judge’s patience one too many times – she apparently repeatedly violated orders relating to custody, and in this case, the judge ordered her jailed for seven days for contempt of court.

Another case was heard in the same Michigan court by the same judge on Monday, October 9. This post addresses both cases and provides an update. Continue reading “Child custody and vaccines – reviewing two disputes in Michigan”

Natural News is wrong about mandatory vaccinations – Part 2

natural news

Natural News has had a long history of vaccine denial, which always garners laughter from the scientific skeptic crowd. Occasionally, however, Natural News takes its anti-science beliefs to a whole new level, one that requires a double-pronged rebuttal and refutation.

Recently, Natural News published an article that criticizes mandatory vaccinations of healthcare workers both from the scientific and legal point of view.  In that article, Natural News is wrong about mandatory vaccinations – again.

This article is the second part of a two-part series about that Natural News article, examining some of the legal issues of mandatory vaccination. Part 1 examines where Natural News gets the science wrong about mandatory vaccination. Continue reading “Natural News is wrong about mandatory vaccinations – Part 2”

Informed consent, vaccines and package inserts – examining the facts

informed consent

Informed consent is important. For vaccines, as it is for all other medical treatments. But there appears to be some misunderstandings about what constitutes informed consent in this context.

This article addresses a few misconceptions that come up in relation to informed consent, for example, that doctors need to give inserts, or a list of vaccine ingredients, to get informed consent for vaccines, or discuss VAERS and VICP (I’ve addressed some of it in the past ). It does not address the claim that mandates violate informed consent or that liability protections do – I have also addressed both in the past. Continue reading “Informed consent, vaccines and package inserts – examining the facts”

Custody, parental rights and vaccines in Maine

parental rights and vaccines

This article examines a recent Maine Supreme Judicial Court ruling on parental rights and vaccines – they upheld a decision to vaccinate a child in the custody of the state over a mother’s objections. This post explains the decision, explains why the lone dissenting judge was wrong, and reminds the reader that this decision is consistent with the majority of states deciding the issue – for good reasons.

Continue reading “Custody, parental rights and vaccines in Maine”

Vaccine Court – causation and administrative discretion

vaccine court

A recent case provides insight into how the decisions of the Special Master in the National Vaccine Injury Compensation Program – also known as the Vaccine Court – are reviewed by the appeals system. There are two issues I hope readers can take from this story:

  1. There is an elaborate system for appealing NVICP decisions. Next time someone tries to claim there is no appeal, or that the petitioners are not given a hearing, remind them they’re very wrong.
  2. The legal standard used to assess the Special Master’s findings of facts – what it is and how it works. What we see is that both the judge in the US Court of Federal Claims and the Circuit Court gave the Special Master’s decision pretty close scrutiny. 

Continue reading “Vaccine Court – causation and administrative discretion”