NVICP compensation for Guillain-Barré Syndrome – facts

A recent article that came up in my Google Alerts – regarding NVICP compensation for Guillain-Barré Syndrome – gives me a chance to address a few important misconceptions about NVICP and its decisions. The headline read:

[infobox icon=”quote-left”]U.S. Court Of Federal Claims Finds In Favor Of Petitioner Represented By Associate Attorney Vanessa Brice In Vaccine Injury Case.[/infobox]

The headline is misleading in a number of important ways. I thought that this was a good lead-in to examine the decision and the surrounding issues.

Vaccine court did not find in favor of anyone

 

First, carefully looking at the decision,  it was a settlement, not a decision on causation, by the National Vaccine Injury Compensation Program (NVICP, the administrative no-fault program created to compensate vaccine injuries), and not by the United States Court of Federal Claims that houses the program.

That is important. A settlement is not a finding by the court: no objective third party looked at the data and decided that yes, the petitioner met even the NVICP’s lax standards for showing causation. Parties settle for many reasons, including a view that the case isn’t large or important enough to be worth the effort to litigate, uncertainty about what the court will do, and sympathy for a plaintiff. All a settlement shows us is that the parties agree that the respondent (the NVICP), in this case, will pay a certain amount – not why.

In this case, as in most cases, the respondent made it clear the settlement does not mean it agrees that the vaccine caused GBS:

[infobox icon=”quote-left”]Respondent denies that the flu vaccine is the cause of petitioner’s GBS or any other injury or his current condition.[/infobox]

This language is standard and common in vaccine settlements – and it means exactly what it says: respondent does not agree that the vaccine caused the harm. If the respondent agrees, we have, instead of a settlement, a concession. In concessions, the language is, for example (pdf):

[infobox icon=”quote-left”]Respondent has conceded that Petitioner is entitled to compensation due to Evelyn Botan suffering a diphtheria, tetanus, acellular pertussis (DTaP) Vaccine Table presumptive injury of encephalopathy.[/infobox]

In this case, there is a presumption of causation, so respondent only concedes that the petitioner has shown there was an encephalopathy within the set timeframe.

In another case (pdf), the NVICP also provided a concession:

[infobox icon=”quote-left”]Respondent has conceded that petitioner has satisfied all legal prerequisites for compensation under the Vaccine Act and recommends that compensation be awarded.[/infobox]

As is easy to see, that’s very different from the denial of causation in a settlement. A settlement, therefore, not only is not a decision, it cannot be used to claim the vaccine caused the harm in question.

Little evidence that flu vaccine cause GBS

 

The press release regarding the settlement stated:

 

[infobox icon=”quote-left”]Guillain-Barre syndrome causes the body’s immune system to attack the nerve cells, resulting in muscle weakness and paralysis. According to the Centers for Disease Control and Prevention, some patients experience long-term nerve damage as a result of Guillain-Barre syndrome. Although the flu vaccine is generally safe and the benefits outweigh the risks, particularly for the elderly and immune-compromised, an extremely small percentage of people have developed Guillain-Barre syndrome after getting the flu vaccine,” Brice said.[/infobox]

The fact that the flu vaccine is generally safe and its benefits outweigh the risks is right. So is the fact that very rarely people develop GBS after it. But GBS occurring after the flu vaccination does not imply causation.

There is evidence that the 1976 swine flu vaccine was connected to GBS. There is some evidence of a slight increase in the risk of GBS after the H1N1 vaccines of 2009.

But there really isn’t good evidence that the annual influenza vaccine increases the risk of GBS. In fact, a relatively recent large scale study found the opposite. In a discussion of the issue as part of a recently closed rulemaking to change the Table of Injuries, the Department of Health and Human Services explained that there was a clear but very small risk (1.6 per million people vaccinated) in the 6 weeks after the H1N1 monovalent – standalone – vaccine.

What about annual flu vaccines that contain H1N1? The document explained:

[infobox icon=”quote-left”]Presently, there is no scientific evidence demonstrating that current formulations of the seasonal influenza vaccine, which contain the H1N1 virus, can cause GBS. However, the degree of surveillance needed to detect an increased risk of one case per million vaccinations, as was seen with the monovalent 2009 H1N1 vaccine, is unlikely to be routinely performed as the strains in the flu vaccines change from year to year.

Nonetheless, numerous studies have been conducted in order to determine whether a possible association between seasonal influenza vaccines and GBS exists, and almost all have not shown any causal relationship. The IOM reviewed literature concerning such studies and concluded that the evidence was inadequate to accept or reject a causal association for all versions of seasonal influenza vaccines since 1976.[/infobox]

What we see is that there is no scientific evidence showing a link between GBS and annual flu vaccine – but because of a potential doubt, the secretary goes ahead and adds the injury to the Table for policy reasons. Because NVICP is set up to offer generous compensation, and when there is a doubt, even a slight one, it should be resolved in favor of petitioners. So the proposed rule says:

[infobox icon=”quote-left”]…the Secretary proposes to add the injury of GBS to the Table for seasonal influenza vaccines. Although the scientific evidence does not show a causal association for current formulations of seasonal flu vaccines and GBS, the Secretary proposes including the injury of GBS for seasonal influenza vaccines on the Table in accordance with the ACCV Guiding Principles, acknowledging the fact that seasonal influenza vaccine formulations, unlike other vaccines, change from year-to-year and that enhanced surveillance activities may not occur with each virus strain change.

This is done even though it appears that any instances of GBS caused by seasonal influenza vaccines, if they exist at all, are very rare. The Secretary proposes adding GBS to the Table for seasonal influenza vaccines and recognizes that this will create a presumption of causation that will result in compensation for numerous instances of GBS that are not vaccine-related.[/infobox]

There’s no good evidence annual flu vaccines cause GBS, and there’s evidence against it. If they do, it’s very rare. You are much more likely to get GBS after an influenza infection rather than from the vaccine, even if the vaccine might cause it.

But because NVICP was designed to be generous, and because it’s hard to test every year for causation to GBS, the Secretary is creating a presumption of causation for GBS that will lead to cases being compensated. It’s important to remember the reasons behind doing that, and remember that this does not show the vaccine causes GBS, and compensations and settlement do not show otherwise.

The NVICP compensation for Guillain-Barré Syndrome shows that our system for compensating vaccine injuries does what it’s supposed to do – compensate generously, including where there are cases of doubt.

Dorit Rubinstein Reiss
This article is by 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, medical issues, social policy and the law. 

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. 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.