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”

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”

Vaxxed misinformation – legal remedies for those harmed?

vaxxed misinformation

The documentary Vaxxed uses misrepresentation to scare people from vaccinating and protecting their kids from disease. For example, it strongly suggests that MMR causes autism, and doesn’t mention that studies from all around the world show otherwise. Scientific research solidly refutes any link between vaccines and autism. I think it is time to examine if there are any legal remedies for those harmed by Vaxxed misinformation.

The documentary claims that there is a conspiracy by the CDC to hide the link between MMR and autism, even though the documents supposed to support that conspiracy do not support such accusations. In spite of the fact that even if the CDC wanted to hide such a link, it couldn’t control studies done in other countries looking at the issue (and finding no link). It makes untrue statements about vaccine testing, like falsely claiming that vaccines are not tested in combination.

In addition, in several cities, the Vaxxed team – discredited scientist Andrew Wakefield, his collaborator Polly Tommey, and producer Del Bigtree, and occasionally others – followed certain screenings with a question and answer session. In those sessions they made false claims that could mislead parents away from protecting their children by vaccinating.

The Vaxxed team claimed that preventable diseases were not prevented by vaccines. Among other things they claimed that vaccines were both ineffective and unsafe, ignoring abundant research showing the opposite: modern vaccines are extremely safe and effective.

Del Bigtree falsely described the hepatitis B vaccine – that protects against a virus that can cause liver disease and cancer – as “injecting a sexually transmitted disease”, potentially scaring parents off protecting their children against this dangerous infection. Finally, the Vaxxed team warned listeners against seeing pediatricians, because they can’t be trusted (see here and here for more of their misrepresentations and misinformation).

If a viewer watches Vaxxed and listens to the team’s advice, decides not to vaccinate based on this misleading information, and their child gets a preventable disease and is harmed by it, can they sue for money damages in torts?

What if their unvaccinated child infected a third party who was harmed?  Continue reading “Vaxxed misinformation – legal remedies for those harmed?”

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”

Vaccine legislation in the USA – a state by state analysis

vaccine legislation

One of the most successful pieces of vaccine legislation in recent years has been SB277 in California, which eliminated personal belief exemptions (PBE), that allowed a parent to exclude a child from immunization requirements for school based on the parent’s personal beliefs, including religious objections.  These PBEs had been used and abused by anti-vaccine parents to exempt their school-aged children from most, if not all, vaccines.

Other than California, only West Virginia and Mississippi have such strict prohibitions on these PBEs that they are effectively not allowed as a method to refuse vaccines before a child enters school. But many other states are considering vaccine legislation that could improve vaccine uptake. Unfortunately, there are also states on the other side of the equation that are considering laws that reduce restrictions on personal belief exemptions.

The National Vaccine Information Center (NVIC), which seems to conflate “information” with misinformation about vaccines, claims that there are 134 vaccine bills being considered in 35 states. I wish!

I thought we would could take a look at current vaccine legislation being considered by various states that could potentially increase vaccine uptake in those states. Then we’ll take a look at those states pushing legislation that might decrease vaccine uptake. This should provide real information about what’s going on with these laws, instead of the alternative facts from the vaccine deniers at NVIC.

Continue reading “Vaccine legislation in the USA – a state by state analysis”

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?”

Vaccine court jury – is there a constitutional right in NVICP cases?

vaccine court jury

In 1986, Congress Passed the National Childhood Vaccine Injury Compensation Act, which, among other things, created the National Vaccine Injury Compensation Program (NVICP), commonly called the Vaccine Court. The program requires those claiming harm from vaccines to submit their claims first to adjudication through it, before suing in state (or federal) court. For one type of claims – design defects, where the claim is that the vaccine’s design was unreasonably dangerous – you cannot sue in state court at all. In 2011, the Supreme Court decided in Bruesewitz v. Wyeth, 562 U.S. 223 (2011) that Congress, in passing the act, intended to bar claimants from bringing any design defect claims against vaccine manufacturers to state courts. This post will examine the constitutionality of the lack of a vaccine court jury to decide claims.

The result is that some claims can go to state courts after going through NVICP, others can go to court without going through NVICP, but some claims cannot reach state courts.

One argument some anti-vaccine activists make is that the liability protections mean there’s no accountability. I have dealt with this argument in the past, and the simple answer is that there is substantial accountability. Another – and at first glance more plausible – argument is that requiring claimants to use NVICP rather than a court violates their right to a jury, a right protected by the Seventh Amendment. Our jurisprudence about the limits of the Seventh Amendment is confusing. But in this case, it is pretty clear that the claim is incorrect. Requiring people claiming that vaccine harmed them to go to NVICP does not violate the seventh amendment. That is because the right to a jury does not apply to public rights, i.e. rights between an individual and government that derive from a statutory scheme, which Congress has determined should be adjudicated outside the courts.

In creating NVICP, Congress did two things, and both of them are constitutional. First, it limited the right to sue manufacturers in tort for harm caused by vaccines. Second, it created a public right to be compensated for harms caused by vaccines – an entitlement for those who can meet the program’s criteria to be paid by the government for their damages — and that public right does not trigger the right to a jury, when administered outside a court.

 

The seventh amendment and its jurisprudence

The Seventh Amendment to the United States Constitution states:

“In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.”

Notice that the language is limited to suits at common law. This language is more complicated than this post requires. The short and simple version is that when there’s a common law right to sue a private party, there are limits on Congress’ ability to remove the case from the jurisdiction of regular courts. Most recently, this was applied to a claim for tortious interference in the context of an inheritance dispute, and in 2011 the Supreme Court ruled that Congress cannot authorize a specialized forum, bankruptcy court, which has no juries, to resolve that dispute, because that authority belongs to the regular Courts (pdf).

But that’s not the case here.

 

Congress (and state legislatures) can impose liability limits

Tort law, even today, derives to a large extent from court decisions, not statutes. The basic causes of actions in torts – especially at the state level –  were created by courts. But while the courts are the more active partner in much of torts, the legislature is still the senior partner where it does choose to act. In other words, legislatures can set the limit and extent of causes of action, and change the substantive rights in tort law.

Congress has done this in several contexts. For example, Congress limited the ability of companies issuing credit cards to sue card holders in some situations of unauthorized use (15 U.S.C. §1643). Congress limited liability of railroads to passengers. Section 408 of the Air Transportation Safety and System Stabilization Act (“ATSSSA”) limits the liability of air carriers to passengers.

More similar to vaccine suit claims, the Supreme Court found that the Medical Device Amendment completely bars (“preempts”) suits against manufacturers of devices in state courts (Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)).

There is nothing preventing Congress from limiting the ability to bring many other types of suits. It’s perfectly constitutional to do so, and the Seventh Amendment is not triggered by it. The Seventh Amendment is relevant when Congress does not change existing substantive rights, but merely tries to remove the right to a jury, which would be available otherwise.

In short, Congress could limit or completely bar the ability to sue vaccine manufacturers with no violation of the Seventh Amendment. In Bruesewitz v. Wyeth, the Supreme Court interpreted Congress to have done just that for design defects, to have completely removed the ability to sue for them in state courts. That is constitutional – the Breueswitz court clearly saw no issue with it – and does not violate the Seventh Amendment.

For the other suits, for example, a manufacturing or warning defect claim, the situation is a little more complicated. In a sense, the common law right here is not being eliminated entirely. The right still exists. But its use is conditioned on prior use of a regulatory scheme. In a sense, this is an exhaustion requirement – exhaust other remedies. It’s used in other administrative context and is a traditional requirement, with no problem. I don’t see how it violates the right to a jury when access to a jury is not barred, it’s just that a person would have to go through the program first.

 

Public rights are not subject to the seventh amendment

Congress could constitutionally (though not politically) have completely limited liability for vaccine harms claims, leaving no remedy. But Congress didn’t. Congress created a no-fault compensation program funded by an excise tax on each vaccine. The program provides compensation to claimants who meet its requirements. In other words, Congress created a statutory scheme entitling certain people to compensation from the government for harms caused by certain vaccines.

This is a classic public right: a right against the government created by a statutory scheme. (See Crowell v. Benson, 285 U.S. 22, 52 S.Ct. 285, 76 L.Ed. 598 (1932), and Granfinanciera, S.A. v. Nordberg, 492 U.S. 33 (1989)). The Seventh Amendment doesn’t apply to such cases:

“When Congress creates new statutory ‘public rights,’ it may assign their adjudication to an administrative agency with which a jury trial would be incompatible, without violating the Seventh Amendment’s injunction that jury trial is to be ‘preserved’ in ‘suits at common law.’ That Amendment was never intended to establish the jury as the exclusive mechanism for factfinding in civil cases, but took the existing legal order as it found it, and hence there is little or no basis for now interpreting it as providing an impenetrable barrier to administrative factfinding under otherwise valid federal regulatory statutes.” Atlas Roofing Co. v. OSHA. 430 U.S. 442 (1977)

And it does not apply to NVICP. There is no right to a jury trial in this compensation program, and hence, no violation.

Decisions by the Special Masters in NVICP are subject to multiple appeals – by a judge in the United States Court of Federal Claims, then by the Circuit Court, and potentially by the Supreme Court, as well. The program’s procedures and the multiple appeals provide claimants with the due process they are entitled to.

In short, no constitutional rights are violated by National Vaccine Injury Compensation Program with respect to a vaccine court jury.

California vaccine uptake – big increase because of new law

California vaccine uptake

About two years ago, California’s governor, Jerry Brown, signed SB277 into law, which mandated that all school age children must have all vaccines appropriate for their age before they could enter private or public schools. The law nearly eliminated the ability to get personal belief exemptions (PBE), which allowed parents to object to vaccinations for almost any reason. The new law does allow for medical exemptions, that is, children who have some medical condition that contraindicates a vaccine may be exempted from these rules. As a result of this law, it was predicted that the California vaccine uptake for school age children would increase substantially, while reducing the incidence of vaccine preventable diseases.

Those of us who have been keen observers and supporters of SB277 were hoping for the best – that the vaccination rate in the state would show increases quickly. And it did.

Data released this week (pdf), from the California Department of Public Health, showed an exceptional increase in the percentage of California’s kindergarteners who were fully vaccinated (for their age group) – it rose from 92.8% to 95.6%. But, there’s even more astonishing data underneath that. With the advent of the new law, 97.3% of California’s kindergartners have received both MMR vaccinations, up from 94.5% in 2016 and 92.6% in 2014. The same was shown for diphtheria, tetanus and pertussis (whooping cough) vaccine – it went from 94.2% in 2015 to 96.9% in 2016. There should be cheering in the streets of California for the success of SB277.

The increase in vaccine uptake for all mandated vaccines is dramatic – not only does it show that SB277 has stemmed the overuse of personal belief exemptions that was slowly reducing California vaccine uptake, but it also has increased that uptake to levels far above historical. This graph illustrates how well the law has worked in a short period of time:

California vaccine uptake

The best part of the law is that it’s increasing vaccine uptake in areas of the state where the overuse of PBEs was pushing the vaccination rate down. Most California’s counties have vaccination rates above 95%, which is considered the level at which the herd effect for measles vaccinations prevent the rapid spreading of the disease. Furthermore, only 4 relatively small counties in California have rates below 90%.

California vaccine uptake

California state Senator Richard Pan (D-Sacramento), who is also a pediatrician and who was one of the primary supporters of SB277, tweeted out “Great News.” Obviously he’s ecstatic with this data on California vaccine uptake across the state.

Dr. Pan was interviewed by the Los Angeles Times, and said,

Measles certainly hasn’t gone away. We need to be sure to have our immunization levels high enough. The fact that this class and the state overall has now achieved this level is one further step to restore the community immunity we had before.

He also noted that the data shows the significant increase in very young children, kindergartners. He mentioned that there are still significant number of older children who are not vaccinated because of the lax requirements in previous vaccine laws, which made PBEs very easy to get. SB277 also requires 7th graders to be completely up-t0-date on their vaccines, so all children should eventually be caught up with their vaccines. Unfortunately, many students who have passed that 7th grade vaccination checkpoint may be insufficiently vaccinated. Or not vaccinated at all.

The University of California (UC) system has stated that it will require vaccines for all new enrollees at its 10 campuses (along with the UC Hastings College of Law which has decided to comply with the UC requirements). Like the state law, it eliminates all personal belief exemptions, but does allow medical ones. Eventually, this mandate will cover the over 230,000 students in the system.

The anti-vaccine forces have tried several tactics to block implementation of the new law. Opponents of SB277 filed a lawsuit last summer claiming the law violated California children’s right to an education under the state’s Constitution. A judge denied their demand for an injunction against the law –  the plaintiffs eventually withdrew their case. These opponents also failed to gather enough signatures last year to put a referendum on the November ballot to overturn the law.

There are reasons to cheer all of this news out of California regarding immunization rates. But that’s just one state, albeit the largest and arguably the most influential state in the country. Other than California, only two other states have laws that have eliminated personal belief exemptions for immunizations – Mississippi and West Virginia, both of which have high vaccine uptake. And the easy availability of personal belief exemptions have lead many states to have vaccination rates of the MMR vaccine that are far below the 95% target. This graphic shows which states have significant deviations from the 95% standard for MMR vaccine (thanks to BuzzFeed News):

Sadly, it may not be possible for a lot of states to copy California’s success with vaccines. One of the worst performing states for the MMR vaccine is Colorado, and, according to BuzzFeed News,

Vaccine advocates in Colorado are envious of their counterparts in California. “We are watching California very closely, and kudos to them for getting that bill through,” Stephanie Wasserman, executive director of the Colorado Children’s Immunization Coalition, told BuzzFeed News.

She believes it would be very difficult to enact similar legislation in Colorado, which has libertarian conservatives who reject government mandates on vaccines, as well as liberal enclaves like Boulder where many parents seek out alternative health care and see vaccines as a tool of Big Pharma.

Libertarian conservatives and liberals on the same side of the fence on vaccines? The problem with both groups is that they ignore the health of children just to be “politically virtuous” about vaccines. Except they are scientifically and medically wrong.

So let’s give an ovation for hard working politicians of California, who decided that the health of the state’s children was the paramount consideration for vaccinations. Dr. Pan and many other state legislators decided that the most effective way of increasing the California vaccine uptake was to reduce the availability of personal belief exemptions. And they were right – California’s immunization rate has increased appreciably because of SB277.

Vaccines save lives.