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”

Vaccine informed consent – mandates and liability

vaccine informed consent

Several people have asked me whether having school mandates is in tension with the idea of vaccine informed consent . The answer is no. While school mandates have some effect on parental autonomy, the doctrine of informed consent should not be conflated with autonomy.

For a somewhat different reason, imposing sanctions on those who do not vaccinate is also not a violation of informed consent. Continue reading “Vaccine informed consent – mandates and liability”

Vaccine injury compensation and mitochondrial disorders

Vaccine injury compensation and mitochondrial disorders

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the first of two claims (see second one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and mitochondrial disorders – while the second one will cover an NVICP decision with respect to a form of an autoimmune syndrome.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

Continue reading “Vaccine injury compensation and mitochondrial disorders”

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”

Anti-vaccine slogan being pushed – close but no cigar

anti-vaccine slogan

A recurrent anti-vaccine slogan that activists use to claim strong immunization mandates should not be passed is “when there’s a risk there must be a choice.” The slogan is wrong generally, and even more wrong in this context. Let’s take a look at it.

Risk and Choices?

Not all risks are equal. And when the risks are clearly bigger on one side than the other states can and do impose requirements that impose the smaller risk while preventing the larger.

For example, each year people are harmed from seatbelts in the United States. But the state mandates them – because they save many more than they harm. The risks are smaller than the benefits.

For example, surgery carries risks. But a court can order life-saving surgery over parental opposition, in appropriate circumstances (e.g., In re Phillip B., 92 Cal. App. 3d 796 (1979) and here). Also, while courts don’t always go this way, a court can order chemotherapy for a child with cancer over parental opposition, although chemotherapy is not risk free.

Antibiotics carry a small risk of an allergic reaction. But a court can legitimately order antibiotics be given to a child with bacterial meningitis. Because the risk on the other side is larger.

So no, there’s not always a choice when there’s a risk. In the case of vaccines, the risks of modern vaccines are very small. The risks of not vaccinating an order of magnitude larger for each vaccine on the schedule, for all children or adults without medical contraindications. The state can require parents to vaccinate their child on that alone. Even more so, since not vaccinating risks not just the child, but others. As said in a Supreme Court case, in words that ring through the decades:

[a parent] cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds. The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death. (See Prince v. Massachusetts, 321 U.S. 158, 166-69 (1944)).

anti-vaccine slogan

 

Mandates?

The above strongly suggests that states can actually require that parents vaccinate their children, period. But in the United States, no state does. States use, instead, the less coercive tool of school immunization requirements.

School immunization requirements without non-medical exemptions tell parents that if they want their child to attend public (or private, in virtually all states) school they need to vaccinate the child. In other words, they give parents a choice between protecting the child from disease and keeping the child at home. It’s not an easy choice for many families that have been scared and misled by anti-vaccine misinformation. Some families may find homeschooling difficult, practically or financially. But it’s not as coercive as criminalizing non-vaccinating or coming to a home with police to vaccinate. It can be a very hard choice, but it is a choice.

Furthermore, a parent that sends an unvaccinated child to school is no longer deciding only for their child. Their child is no longer the only forced to bear the risk of infectious disease. The parent is forcing a risk on other children and their families, as well as on school personnel. First, directly, because the vaccine-deprived, unprotected child is much more likely to get an infectious disease if exposed, and may then transmit it to her peers (or they are too young to vaccinate newborn siblings, as parents pick up their children). Second, less directly – by undermining herd immunity, which reduces the group of protected children and increases that of the susceptible people, non-vaccinating parents are making an outbreak more likely, putting everyone who is not protected at risk. In fact, unvaccinated people in an area with high rates are less at risk than vaccinated people in an area with low ratesHere (pdf) is a list of studies that examine both parts of this issue.

 

Conclusion about the anti-vaccine slogan

No, when there’s a risk there must not always be a choice. When you’re choosing the bigger risk for your child over the smaller risk, the state doesn’t have to allow it. States do, however: they use school immunization mandates rather than direct coercion. Parents have a choice – though they may not like the alternatives. Hard choices are still a choice. More than that: when a parent is choosing for other children and their families, there’s even less justification to give free reign. By using school immunization mandates the state prevents parents from forcing a risk on other people who didn’t choose it.

Merck shingles vaccine lawsuit – what are the facts?

Merck shingles vaccine lawsuit

In 2016, a Merck shingles vaccine lawsuit was filed in the Court of Common Pleas in Philadelphia claiming that the plaintiff was injured by the Merck’s shingles vaccine. Since the shingles vaccine is not administered to children, it’s not covered by the National Childhood Vaccine Injury Compensation Act. Injury claims, therefore, do not go through the National Vaccine Injury Compensation Program (NVICP) before going to court.

That is a mixed bag for plaintiffs: on one hand, they can go directly to state courts, something anti-vaccine activists clamor for in relation to all suits.  On the other hand, they need to meet the more demanding requirements of regular courts, including showing that there was fault on the part of the manufacturer with one of the tools lawyers use to sue product manufacturers, meet the more demanding causation requirements that govern the process in state courts, and follow the rules of evidence in those courts.

To remind readers, in NVICP, a petitioner (as they are referred to, while claimants in state courts are “plaintiffs”) would only need to show that the vaccine caused their harm, and their damages, and pretty much any evidence is allowed, though the Special Masters may give unreliable evidence little weight. This Merck shingles vaccine lawsuit can suggest what these claims would have to demonstrate if they actually had to go to regular courts. Continue reading “Merck shingles vaccine lawsuit – what are the facts?”

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”

Index of articles by Prof. Dorit Rubinstein Reiss

Dorit Rubinstein Reiss

Editor’s note – this index of articles by Dorit Rubinstein Reiss has been updated and published here. The comments here are closed, and you can comment at the new article. 

 

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. Of course, she has written articles about vaccines and legal issues in other locations, which I intend to link here at a later date. This article will be updated as new articles from Dorit are added here.

Continue reading “Index of articles by Prof. Dorit Rubinstein Reiss”

Vaccine injury compensation and autoimmune syndromes

Vaccine injury compensation and autoimmune syndromes

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the second of two claims (see first one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and autoimmune syndromes.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

Continue reading “Vaccine injury compensation and autoimmune syndromes”

Dr. Jim Meehan anti-vaccine rant – examining his claims

Jim Meehan

Recently, an anti-vaccine doctor from Oklahoma, Dr. Jim Meehan, wrote an online post about why he would no longer vaccinate his children. It’s pretty clear that his post is not so much a discussion of his own children (most of whom are adults) as an attempt to deter other parents from protecting their children from preventable diseases. His post is basically a set of claims trying to convince parents that vaccinating is very dangerous.

The claims used to do so are nothing new: they are strictly out of the anti-vaccine playbook. But the post has received some attention in the anti-vaccine world, and was shared several thousand times, likely because many people treat an MD as an authority on the subject. So I decided to take a few minutes to explain why his claims are not good reasons to reject expert opinion and not protect children from disease.

Dr. Meehan’s claims fall into several categories (which will be discussed individually below):

  1. The diseases we vaccinate against are not dangerous, and it’s okay, even good, to encounter them naturally.
  2. Vaccines have toxic ingredients.
  3. Vaccines are dangerous to children.
  4. The science behind vaccines is corrupt because the pharmaceutical industry controls it and corrupts it.
  5. We should listen to him because he is a doctor and knows what he is talking about.

Note: Dr. Meehan’s post doesn’t present these claims in that order. I have changed the order, because I want to address the claims in a logical order, that is, first his claims about vaccine safety, then the conspiracy theory that underlies them, and finally, his appeal to authorityContinue reading “Dr. Jim Meehan anti-vaccine rant – examining his claims”