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?”

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.

RFK Jr vaccine beliefs – why experienced journalists don’t take him seriously

rfk jr vaccine tucker carlson

On April 20, 2017, Tucker Carlson from Fox News interviewed Robert F. Kennedy  Jr. on his show, and they talked about vaccines. Mr. Kennedy pointed out that this is only his second interview on the topic in ten years, and blamed it on advertising dollars (which, apparently, did not prevent Mr. Carlson from hosting him). So why are RFK Jr vaccine beliefs ignored by the mainstream press?

The reality, however, is that journalists familiar with Mr. Kennedy’s past utterances on vaccines avoid him is because of his history of saying things that are blatantly wrong, and journalists who give him credence may well end up with egg on their face. This interview is a good example.

Robert F. Kennedy Jr. is an environmental lawyer. Best as I can tell he started speaking on vaccines in 2005, with an embarrassingly wrong article posted on both Salon and Rolling Stone that claimed that the CDC was engaged in a conspiracy to hide the fact that the vaccine preservative thimerosal was linked to autism.

After five corrections of the blatant errors in Kennedy’s article, Salon also retracted it, explaining that critics’ exposure of further problems “further eroded any faith we had in the story’s value. We’ve grown to believe the best reader service is to delete the piece entirely.”

Kennedy has repeated the same grossly inaccurate statements – claiming a conspiracy to hide the fact that thimerosal in vaccines causes autism – since, and has not recanted, most recently publishing a book making the claim ironically named “Thimerosal: Let the Science Speak,” and also pushing a challenge to science supporters on the topic, following in the footsteps of holocaust deniers, climate change deniers, anti-vaccine activists, evolution deniers, and others.

In the intervening years studies from all around the world looked at thimerosal in vaccines and did not find a link between it and autism. More recently see publications here and here. The global nature of these studies means that even if the CDC wanted to conspire to hide a link, it wouldn’t be able to, not without controlling the rest of the world. No serious scientific source today really thinks that the tiny amounts of thimerosal in vaccines (and as a reminder, all childhood vaccines, with the exception of multi-dose influenza, contain no, or almost no, thimerosal) causes autism or other neuropsychological problems – or any other serious, long-term harms. But Kennedy does. Because conspiracy.

RFK Jr vaccine statements are hostile, and also very, very extreme.  In a famous quote, he said:

They can put anything they want in that vaccine and they have no accountability for it,[…] They get the shot, that night they have a fever of a hundred and three, they go to sleep, and three months later their brain is gone…This is a holocaust, what this is doing to our country.

Not only is this untrue, but it’s highly offensive to children with autism to say their brain is gone, as is the comparison to the holocaust. Unsurprisingly, science supporters were dismayed by Kennedy’s claims – denied by the Trump transition team – that President Trump offered him the position of leading a vaccine commission.

 

Continue reading “RFK Jr vaccine beliefs – why experienced journalists don’t take him seriously”

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.

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”

Vaccine lawsuits – overview of litigation across the USA

vaccine lawsuits

The goal of this overview is to tell you about vaccine lawsuits in the federal and state courts (but not in the National Vaccine Injury Compensation Program). As an overview, the discussion of each case will be very short. If you want more information, please let me know in the comments section. If you know of cases I have missed, also mention that in the comments.

The vaccine lawsuits overview is arranged by topic, and without topic by states, and within states in alphabetical order. I have chosen August 1, 2016 as a starting point to keep this manageable.

Note that the “claims” section provides a summary of what a complaint is claiming – what it is trying to do – and not an analysis of the claims’ validity. Where available, I link to a post discussing the claim’s merits more in detail. Where not, I add some comments about the validity. But the claims section just provides what the plaintiffs are claiming – it doesn’t mean their claims, hold water. Continue reading “Vaccine lawsuits – overview of litigation across the USA”

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”

Debunking myths about vaccine testing and safety

The goal of this article is to respond to a number of recurring myths raised by anti-vaccine activists regarding vaccine testing and safety – a common trope used against vaccines.

The bottom line is that vaccines are extensively and carefully tested for safety, and that vaccine safety is shown by many, many studies from a variety of sources, reinforcing each other and all pointing to the same result – serious problems from vaccines are possible, but extremely rare. And those small, rare risks are far outweighed by the benefits vaccines provide by protecting us against much larger risks.

Continue reading “Debunking myths about vaccine testing and safety”