This article about NVICP compensation and autoimmune syndromes was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who 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 a 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. She is also a member of the Vaccines Working Group on Ethics and Policy.
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 NVICP 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 protection 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 to provide any parent with a child with 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).
NVICP compensation and autoimmune syndromes
The second case discussed here, D’Angiolini v. DHHS, also implicates the Hepatitis B vaccine, but that’s the end of the similarities with the first case in this series.
Mr. D’Angiolini is an adult. His claim was that the hepatitis B vaccine caused him to have three conditions – chronic fatigue syndrome (“CFS”), systemic lupus erythematosus (“SLE” or “lupus”), and autoimmune syndrome induced by adjuvants (“ASIA”).
Mr. D’Angiolini was initially treated by Dr. Harold Buttram, who is strongly anti-vaccine, going so far as to blame Shaken Baby Syndrome on vaccines, as discussed by Orac. It’s hard not to suspect that it was Dr. Buttram who convinced Mr. D’Angiolini that the vaccines caused his symptoms. If that’s the case, he did Mr. D’Angiolini an injustice, leading him to file a badly supported case with NVICP, spend years and efforts on the litigation rejected here, something which is likely to leave Mr. D’Angiolini bitter and unhappy.
The Special Master rejected all three claims, again in a very detailed decision. D’Angiolini appealed to the United States Court of Federal Claims, and the Judge upheld the Special Master’s decision on all three claims. This post, however, will focus only on the ASIA decision.
ASIA is a hypothesis suggested and mostly supported by renowned Israeli doctor and scientist Yehuda Shoenfeld and his group. Schoenfeld is a serious, respected figure in Israel, a doctor with a respectable record that deservedly enjoys high esteem. But he seems to have concluded, with no good data – in fact, in the face of abundant data to the contrary, and against expert opinion – that vaccines cause autoimmune diseases.
He has published numerous articles on that. Among them are articles suggesting that there is a syndrome, ASIA, caused by aluminum adjuvants in vaccines. Orac previously addressed this, saying:
From what I’ve been able to tell, ASIA is basically a made-up syndrome that isn’t generally accepted. … Even more dubious are the clinical criteria, four major and four minor, that are used to “diagnose” ASIA. The idea is that either two major criteria or one major and two minor criteria are required for a diagnosis of ASIA. Out of curiosity, I went back to what appears to be the original article in which ASIA was defined by Yehuda Shoenfeld, who is known for testifying for “vaccine injury” victims and running a journal sympathetic to antivaccine views, even publishing works by quacks like Mark and David Geier. The “syndrome” appears to have been made up of whole cloth based on unfounded assumptions. He’s also been known to speak at antivaccine conferences and “vetted” the antivaccine propaganda movie The Greater Good for “accuracy,” and the movie’s producer promotes ASIA.
If you look at how ASIA is defined, it’s so vague that almost any immune abnormality can be so classified, as long as somewhere, somehow, the patient had exposure to an adjuvant, in this case in the form of the adjuvant used in Gardasil, which is amorphous aluminum hydroxyphosphate sulfate).
A recent review, by Hawkes et al., of ASIA which examined the syndrome’s definition and the data used to support it, concluded that ASIA is not, in fact, a valid diagnosis.
For unknown reasons, Dr. Shoenfeld seems to have decided vaccines are harmful, and cause autoimmunity; the theoretical framework he uses is ASIA. As explained, one of the claims Mr. D’Angiolini made was that he suffers from ASIA. Mr. Shoenfeld testified in his case as an expert witness – the foremost expert on ASIA. It didn’t help. After examining the evidence, the Special Master was similar to the conclusions by Orac and Hawkes et al. that ASIA cannot, at this point, be considered scientifically accepted or a basis for compensation. The decision explains that:
The Special Master found that the ongoing discovery and definition of the ASIA condition was problematic. .. He described the ASIA theory as “like a sapling” and concluded that it was not far along enough in its growth to provide a basis for recovery. Id. The Special Master referenced “many examples of where [Dr. Lightfoot] saw a lack of precision in the proposed diagnostic criteria. … In Dr. Lightfoot’s view, the criteria “are sufficiently ill-defined currently that is makes it very difficult to . . . make the diagnoses.” … The Special Master placed particular emphasis on Dr. Lightfoot’s testimony that the ASIA criteria, as currently constituted, cannot support accurate diagnoses.
The Special Master was persuaded by Dr. Lightfoot’s view and determined that “Dr. Shoenfeld [had] not made a persuasive case that ASIA is a legitimate and generally accepted medical condition.” .. For that reason, the Special determined the ASIA theory could not provide petitioner with a basis for recovery. (citations omitted)
The judge agreed:
The court rejects petitioner’s argument that the Special Master improperly disregarded Dr. Shoenfeld’s testimony and upholds the Special Master’s determination that the ASIA condition did not provide a reliable theory for recovery. As the Federal Circuit has observed, “[m]edical recognition of the injury claimed is critical.” Broekelschen, 618 F.3d at 1349. Although “general acceptance in the scientific or medical communities” is not required, a medical theory “must be supported by a sound and reliable medical or scientific explanation.” Andreu, 569 F.3d at 1378; Knudsen, 35 F.3d at 548.
It is within the ambit of a special master’s authority to reject a petitioner’s theory. See e.g., Porter, 663 F.3d at 1253-54; Moberly, 592 F.3d at 1322; Broekelschen, 618 F.3d at 1350-51.
The Special Master did not err by examining the conflicting expert testimony on the petitioner’s medical theory and determining that ASIA does not provide a biologically plausible theory for recovery. The Special Master based his decision on testimony that ASIA’s criteria were changing and imprecise and that, as currently formulated, ASIA’s criteria cannot distinguish between afflicted and un-afflicted patients. The Special Master’s determination that this evidence undercut the reliability of the condition as a sufficient basis for compensation under the Program was not arbitrary or capricious.
Both the Special Master and the judge, therefore, reject ASIA as a basis for vaccine injury – based both on its vague, less than usable definition, and its lack of acceptance in the medical community – directly attributable to the lack of evidence for its existence. In this, the legal conclusions fit the view of scientists outside the relevant groups on the syndrome.
What did we learn about NVICP compensation for autoimmune syndromes?
NVICP’s special masters carefully examine claims of vaccine injury. Their decisions, when they decide (as with regular courts, most NVICP claims settle – are elaborately reasoned. While science cannot be settled by courts, the special masters have to address the science and have to explain their reasoning – what they do and do not accept – transparently.
After careful consideration, they rejected both the claim that vaccines trigger mitochondrial disorders and the claim that ASIA and other autoimmune syndromes can be used as the basis of NVICP compensation. In these cases, they appropriately described the view in the scientific community – and pointed out the lack of basis of claims relying on these two beliefs.
Editor’s note: This article by Dorit Rubinstein Reiss was first published in December 2015. It’s been updated for readability and to make the title more clear.
- Hawkes D, Benhamu J, Sidwell T, Miles R, Dunlop RA. Revisiting adverse reactions to vaccines: A critical appraisal of Autoimmune Syndrome Induced by Adjuvants (ASIA). J Autoimmun. 2015 May;59:77-84. doi: 10.1016/j.jaut.2015.02.005. Epub 2015 Mar 18. Review. PubMed PMID: 25794485.
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