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”

Vaccines cause SIDS? Not supported by Boatmon vs HHS case

vaccines cause SIDS

This is about the case of little J. B. Boatmon, who was born 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”

California SB277 lawsuit update – judge rejected Torrey-Love

California SB277 lawsuit

On August 15, 2017 Judge Charles D. Wachob from the Placer County Superior court granted the state’s demurrer to the California SB277 lawsuit (known as Torrey-Love).  In lay terms, dismissed the suit without leave to amend. Demurrer is generally granted when, assuming all the facts plaintiffs claimed are true, the court sees no legal basis for the suit, in technical terms, no cause of action. Continue reading “California SB277 lawsuit update – judge rejected Torrey-Love”

Japan bans Gardasil – debunking myths about the HPV vaccine

Japan bans Gardasil

One of the most popular zombie memes and tropes of the anti-vaccination movement is that Japan bans Gardasil – oh noes! Of course, like a lot of the junk information passed along by the anti-vaccine crowd, it’s completely false, unless you’re willing to take anything they say on faith.

There are a couple of consistent trends in the anti-vaccine movement. They claim that vaccines cause autism (disproved with the highest quality of evidence); and they maintain that the HPV vaccines cause all kinds of harm to teens and young adults. And there are literally mountains of data derived from numerous huge epidemiological studies that the Gardasil cancer preventing vaccine is one of the safest vaccines on the market (and that’s a high bar to exceed, given the high safety profiles of all vaccines).

So if you really want to prevent cancer, one of the best ways available to you is getting the HPV vaccine. The idea is so simple, yet is clouded by the myths about HPV vaccines – one of the most popular, of course, is that Japan bans Gardasil. Let’s examine this fable with a critical and skeptical eye.

The tl;dr version – Japan did no such thing.

Continue reading “Japan bans Gardasil – debunking myths about the HPV vaccine”

Religious exemption to vaccines – Indiana court rules against mother

On July 26, 2017 a Court of Appeals in Indiana interpreted a custody decree to require an unvaccinated child to be vaccinated. In doing so, it overturned an earlier, problematic ruling by a trial court. This case has important lessons for families in this situation, including the importance of the content of custody decrees, and – although it’s not clear from the decision – the importance of countering anti-vaccine, unreliable experts.  It also rejected the use of a religious exemption to vaccines to prevent the child from being vaccinated. Continue reading “Religious exemption to vaccines – Indiana court rules against mother”

SB277 RICO lawsuit – Bad arguments and conspiracy theories updated

SB277 RICO lawsuit

In previous posts I addressed three of the lawsuits filed against SB277, all of which suffered defeats, at least for the moment: WhitlowBuck, and Torrey-Love. There was a fourth lawsuit, however, filed in July 2016 that I did not address until now – the SB277 RICO lawsuit from Travis Middleton.

This lawsuit had, in my view, the lowest chances from the start, and I was not sure how to cover it in the best manner, given its writing. But I think it’s time, since although a formal decision has not come down, a recommendation to dismiss the SB277 RICO lawsuit was filed.  Continue reading “SB277 RICO lawsuit – Bad arguments and conspiracy theories updated”

Immunization mandates case law – UC Hastings project

Immunization mandates case law

In the past year, I offered a course in University of California, Hastings College of Law allowing students to work on immunization-related legal research projects that can help members of the immunization community understand legal issues. I am now ready to present our first publicly available project, for anyone’s use, on immunization mandates case law.

This project, done by two UC Hastings’ students under my guidance, is a summary and overview of litigation on vaccine mandates – school mandates and influenza workplace mandates.

It includes a short memo summarizing the jurisprudence on these topics and a list of cases, federal and state (and if you come across any cases we have missed, please let me know and we will add them).

The memo can be found here. The cases are directly here (by category).

Florida vaccine laws – court says church school can ban unvaccinated kids

On 27 June 2017, in a Florida vaccine laws case, a Florida Court of Appeals – The District Court of Appeal of the First District – rejected Patrick Flynn’s appeal against a lower court decision that found that a Catholic diocese had a constitutional right to exclude unvaccinated children if its interpretation of religious law supports doing so. The Court affirmed that the church autonomy doctrine, under which the state will not interfere in a church’s interpretation of religious law, prevents application of state vaccination law to this case.

From a public health perspective, this is a good news/bad news case. On one hand, the case made it clear there is no constitutional right to a religious exemption, and allowed religious private schools to reject non-vaccinated students when that rejection is religiously motivated. On the other hand, it also made it clear that other private schools cannot, under Florida law, reject unvaccinated students if their parents file a religious exemption, and neither can religious schools when their policy is based on secular reasons.

Florida vaccine laws – the case

Patrick Flynn is a Catholic father of eight. All his children were educated in Catholic schools in the Catholic Diocese of St. Augustine, Florida (“The Diocese”). At some point of his life he decided that vaccinating was against his religious beliefs, and began providing a letter expressing his religious objection to vaccine, to fulfill the requirements of Florida’s religious exemption.

After accepting religious exemptions for years, the Diocese, through its leader, Bishop Felipe de Jesús Estévez, decided not to accept them anymore, starting with the 2015-2016 school year. The court decision (pdf) explained that

Bishop Estevez’s legal position as Bishop is that immunizations of children attending Catholic schools is an issue of faith, discipline, and Catholicism which can only properly be determined by the church and not by the civil courts.

The Diocese did not point to any specific tenet that supported its position on immunization – in fact, it did not provide any materials that explained its previous position that allowed exempt children in or its current position that refused them. It did state the basis of its opposition was religious.

Mr. Flynn’s youngest son has just finished Kindergarten in 2015. Mr. Flynn submitted a letter of religious exemption, but under the new policy was refused admission to the school unless his parents vaccinate him.

Naturally, his family was unhappy. The father opened a GoFundMe campaign, and sued the Diocese, first in the trial court and after losing the case there, appealed.

The basis for his appeal was the claim that under Florida’s statute about religious exemptions, that says:

“that immunization requirements do not apply if “[t]he parent of the child objects in writing that the administration of immunizing agents conflicts with his or her religious tenets or practices.” § 1003.22(5), Fla. Stat.” (opinion, p. 4)

Private schools have to accept religious exemptions, and cannot reject unimmunized children exempt under them.

The Ruling

The court of appeals affirmed the trial court’s ruling, which basically held that when the church’s constitutional right conflicts with a parent’s legal right to an exemption, the constitutional right trumps. There were three slightly different decisions in the appeal court (pdf).

Judge Makar wrote the main opinion. It basically said:

  1. The church autonomy doctrine prevents civil courts from deciding matters that involve those courts in theological controversy, church discipline, ecclesiastical governance, or conformity with moral standards set by the church – on those issues, the courts will defer to the highest ecclestial authority. The doctrine is ground in Article I of the United States constitution – both the free exercise clause (it protects churches’ freedom of religion) and the establishment clause (by preventing excessive government entanglement with religion). It gives churches a constitutional right to autonomy.
  2. In Florida, it’s a jurisdictional bar. That means that when a matter that involves one of the issues above – for example, here, stepping into a theological controversy – comes before a court, a court does not have jurisdiction over the issue and may not hear it.
  3. There are limits on the application of the doctrine when it comes to clearly neutral laws that do not require deciding secular matter, but they do not apply here (said with caution by the main opinion, less carefully by the other opinions).
  4. Neutral state laws requiring immunization are constitutionally valid even without a religious exemption. This means that the right to a religious exemption here is created by statute – Mr. Flynn does not have a constitutional right to a religious exemption from the school mandate.
  5. Here, we have a religious debate on immunization. Mr. Flynn is asking the courts to prefer his religious exemption over the Diocese’s – directly to step into a religious disagreement. In the Court’s words:

    “The Diocese has a religiously-based immunization policy with which one of its members disagrees; Mr. Flynn seeks the power of the State to compel the Diocese to depart from its point-of-view and admit his non-immunized son. But doing so would further his own religious views at the expense of the Diocese’s on the topic of immunizations. We are convinced that a secular court should not be making the judgment as to which side’s religious view of immunization is to be respected.” 

  6. Immunization is a basis for religious debates as well as secular ones, which is why most jurisdictions offer a religious exemptions. So this can fairly be seen as a religious debate between the parties, and courts should not step in. That is even more clearly the case here. This is a case where the church autonomy doctrine is in full force.
  7. Mr. Flynn complains that the Diocese did not provide an explanation – but under the jurisprudence of Florida’s courts, private people do not have to explain their religious objections, just state that they have one, and it’s unfair for Mr. Flynn to demand more  from the Diocese than a private person would have to give.

    In the Court’s words:

    Courts are in no more of a position to compel the Diocese to provide a sufficient quantum of passable proof that its view of immunization is consistent with the Catholic faith than to do so as to Mr. Flynn’s personal views of Catholic doctrine on the very same subject. … Mr. Flynn points out that he has no duty to prove that his objection is religious, citing Curry, yet he insists that the Diocese must provide adequate proof that sufficiently grounds its religious viewpoint in specific church tenets. We can’t help but note the incongruity of giving primacy to a parishioner’s religious viewpoint that is contrary to that of his mother-church on the same topic; respectfully, it would be an odd role reversal—a devotee’s tail wagging the corpus of church leadership—to do so.

  8. Even more generally, “the Catholic Church’s governance of its parochial schools is inherently religious, its obvious mission being the transmission of its religious values,” so courts are careful not to interfere in such religious governance.

In short, the statutory right to send a child unvaccinated to any school the parent wants has to give way before the constitutional right of a church to autonomy.

Judge Bilbrey joined the opinion, making it the majority opinion, but added a concurrence – an opinion in agreement that makes additional point – of his own. He wanted to make it clear that the focus here isn’t that it was a dispute between a Catholic member of the Diocese and the Diocese itself. He explained:

All that is required for application of the doctrine is for a church or ecclesiastical body to take a position on religious grounds; it matters not that the opponent of the church have a religious basis in opposition. As Judge Makar observes, “the Catholic’s Church governance of its parochial schools is inherently religious, its obvious mission being the transmission of religious values. . . .” (Maj. Op. at 21). In my view, that is all that is needed in order to invoke the “church autonomy doctrine.””

Judge Kelsey agreed with the result, but offered a different reasoning. Since his reasoning is not the majority, I’ll just say shortly that he analyzed the theology and found that the church’s position was based in valid religious principles, and courts should not get caught in the religious debate between the Diocese and its believer, under the church autonomy doctrine.

Florida vaccine laws conclusion

This decision means that religious private schools in Florida that refuse to accept unimmunized children on religious grounds are constitutionally protected from having to accept religious exemptions. In that, it protects the right of these schools to require immunization (and protect their pupils – and the community – from outbreaks).

Note the limits, though. This applies only to religious schools; the court made it clear that the law requires private schools, generally, to accept religious exemptions. Private schools that are not religious cannot refuse unimmunized children if their parents file a religious exemption – and the parents don’t even have to explain their religious objections, making it very easy for parents whose opposition is not religious to use this exemption.

Religious schools, too, cannot refuse unvaccinated children unless their reasons are religious. A question arises whether that could incentivize such a school concerned about outbreaks to cloak a secular reason to refuse unvaccinated children in religious language – and whether incentivizing people and religious schools to present secular objections as religious is good public policy.

Nonetheless, upholding the fact that the constitution does not require a religious exemption from immunization requirements, and allowing Catholic schools to keep their schools safe by refusing unimmunized children, do help protect the public from disease.

European court vaccine ruling – the vaccine deniers think they won

European court vaccine ruling

On 21 June 2017, the European Court of Justice ruled in favor of the plaintiffs in a case that examined whether Sanofi-Pasteur’s hepatitis B vaccine caused multiple sclerosis (MS) in a patient. Although the ruling might, on the surface, be considered bad for vaccines, we need to look more carefully at that European court vaccine ruling.

There are several questions that we need to answer. First, what did the court actually rule? What can courts say about science? And, is there any evidence that the hepatitis B vaccine causes multiple sclerosis? Continue reading “European court vaccine ruling – the vaccine deniers think they won”

European court vaccine decision – a legal analysis

European court vaccine decision

On June 21, 2017 the European Court of Justice (ECJ) decided a product liability case (N.W. et al v. Sanofi Pasteur MSD SNC, C-621/15) described by news articles as allowing plaintiffs to be compensated for alleged vaccine harms, even when there is no scientific evidence of a causal connection (in the most extreme versions, “with no proof”). This description is incorrect. More nuanced analyses were provided by Orac and Steve Novella, but I think they, too, did not exactly capture what the decision does. This post explains the European court vaccine decision.

Three take-home points are important:

  1. If there is no scientific consensus as to whether a vaccine causes a particular kind of injury, member state courts can allow plaintiffs to use circumstantial evidence to prove a vaccine injured them. Defendants, of course, can use scientific evidence to counter the plaintiff’s circumstantial evidence. This decision does not mean that science doesn’t matter in the courts or that anti vaccine activists can win even when the science is against them.
  2. Member courts cannot treat circumstantial evidence as creating a presumption of causation. The plaintiff bears the burden of proving the vaccine cause the injury, and each case must be examined on its facts.  For example, a temporal connection alone does not automatically mean there’s causation.
  3. In a referral like this, the ECJ does not reexamine the facts. It is answering the specific questions of law, and basing its decision on the description of the facts sent up from below. The ECJ was acting on a mistaken premise that the science, in this case, was unclear. That premise came from the lower courts, and the ECJ did not err in following it: it did not reexamine the facts, and did not decide the case in front of it, it only addressed a specific legal question. In the lower courts that now will be expected to rule according to the ECJ’s decision, Sanofi Pasteur – the defendant – should provide the scientific evidence, and we can hope the court, as did the Court of Appeals who ruled on the case last, will follow it. It’s unclear how the case will end.

This is a complex decision. To explain it, I will start with some background on product liability law and European Union law with respect to the European court vaccine decision. Then I will address this case, and then the ruling itself. If you are short of time you can skip the background and go directly to the case, but I think those who want to really understand this will benefit from it. Continue reading “European court vaccine decision – a legal analysis”