Last updated on December 15th, 2019 at 11:23 am
On July 18, 2018, a Judge of the Court of Federal Claims overturned the NVICP SIDS vaccine decision that awarded compensation to Mr. and Mrs. Boatmon for the death of their baby, JB. The Court found that the Special Master’s decision was arbitrary and capricious because it ignored previous decisions and applied a too-low standard of proof to the case.
The NVICP SIDS vaccine decision
On 10 July 2017, Special Master Gowen awarded a decision to compensate the parents for the death of little JB. JB tragically died the day following his four months vaccines. His death was ruled to be a SIDS.
In a previous post, I criticized the decision for its incorrect discussion of the epidemiological evidence that examines whether vaccines cause SIDS (they don’t), for preferring the opinion of a general pathologist over an immunologist on a question of immunology, for accepting an ill-founded theory, and for deviating from previous NVICP cases.
Delving deeper into the science, Orac concluded:
Never forget that Special Master Gowen’s ruling in the case of Boatmon vs HHS is a legal, not a scientific, ruling. Once you accept that, you can understand how it happened. In fact, the ruling is profoundly unscientific in that it turns the methodology used in science-based medicine to determine causation of disease on its head by valuing a plausible-sounding “theory” of how causation might occur over actual existing clinical and epidemiological evidence showing that causation very likely does not occur.
The appeal of the NVICP SIDS vaccine decision
The state asked the Court of Federal Claim to review the decision. The Court of Federal Claim is a congressional court made up of judges appointed by the President and confirmed by the Senate for a period of fifteen years. It’s not part of the usual judicial branch; it is, however, highly independent from the executive, as its structure shows.
The National Vaccine Injury Compensation Program (NVICP) is under the jurisdiction of the Court of Federal Claims, and the first appeal from NVICP decisions goes to the Court of Federal Claims (pdf).
The standard, quoting from the decision, is that the Court of Federal Claims “…will only set aside findings of fact or conclusions of law found to be “arbitrary, capricious, an abuse of discretion or otherwise not in accordance with the law.”
Applying this standard, the Court of Federal Claims overturned the Special Master’s decision. The Court examined several NVICP decisions on similar facts that rejected compensation. The Court pointed out that “Petitioners were not able to cite a single Vaccine Program opinion finding that vaccinations had caused SIDS.”
The Court said:
A Special Master is not bound to follow the opinions of other Special Masters; however, when issuing an opinion extending vaccine causation to previously uncharted areas, a clear explanation would be expected, if not critical. The Special Master here made no acknowledgment of the other cases reaching opposite conclusions and made no attempt to distinguish the instant case from any of the others.
This is well in line with general administrative law principles. Agencies do not have to follow their own precedents; but if they wish to deviate from a line of precedent, they need to explain their actions. (for example, Davila-Bardales v. Immigration and Naturalization Service, 1st Circuit 1994; Federal Communications Commission v. Fox Television Stations, Inc, 556 U.S. 502 (2009)).The Special Master here did not even try – he completely ignored previous decisions. Further, says the Court:
This departure from the conclusions of other Special Masters can only be explained by improper application of the standard of proof required in vaccine cases. While scientific certainty is not required to establish causation under the Vaccine Act, the theory must be supported by a “sound and reliable” medical or scientific explanation. Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). In Moberly, 592 F.3d at 1322, the Federal Circuit noted that a Petitioner must provide a “reputable medical or scientific explanation” for causation, and that this standard requires more than mere “plausibility,” which is “not the statutory standard.”
In the case at bar, the theory embraced by the Special Master has not been accepted by any other experts in the field of SIDS research. The Moberly Court cited with approval the standards for assessing expert reliability set forth in Daubert v. Merrell Dow Pharm., Inc,, 509 U.S. 579 (1993). Among the Daubert considerations is whether the theory at issue has been subjected to peer review and publication. Id. at 593. With respect to Petitioners’ burden of proof, the Special Master in this case has applied a standard so low as to constitute clear error.
In other words, a theory cannot be just plausible – just somewhat convincing. It actually has to have something behind it, some reputable medical or scientific explanation – either via supporting literature, or a strong expert opinion. In this case, the literature is against the link, the SIDS experts do not agree with the theory:
… even though extension of the Triple Risk Theory to vaccine causation has not been advanced by Dr. Kinney or her colleagues, nor has it been accepted by any other medical authorities outside those testifying in the Vaccine Program, the Special Master describes Petitioners’ theory to be “reasonable and persuasive.
In other words, the Special Master accepted the theory because it sounded good, even though there was no data behind it and data against it, and the stronger expert in court and the experts outside it opposed it.
The court ended by expressing sympathy to the bereaved parents, but explaining that that, alone, does not justify accepting a speculative, counter-evidence explanation for the death:
Loss of a child in a sudden and seemingly senseless manner can only be described as heartbreaking. For this reason, research to find clear answers must continue, and premature unsupported conclusions cannot be relied upon.
Exactly. We can all feel for the parents here. Their loss was horrible. We can all understand the search for answers. Incorrectly blaming vaccines, however, does not help – it can prevent the search for more accurate answers and provides ammunition to anti-vaccine activists seeking to scare others from protecting children from disease. The Court of Federal Claims did the right thing in correcting the Special Master’s unsupportable decision here.
Update 12 November 2019
The Court of Appeals of the Federal Circuit affirmed the decision of the judge of the Court of Federal Claims and agreed that compensation was not warranted.
Chief Judge Sharon Prost wrote the opinion. Judge Evan J. Wallach wrote a concurring opinion and Judge Pauline Newman dissented. Judge Newman, who has already written one problematic, ill-founded dissent in a vaccine case would have upheld the decision on the temporal proximity to the vaccine alone, in spite of the epidemiological data and the immunologist opinion in the case that explained why such a link is unfounded.
Notes
This article was originally published on January 2019. It was updated to add the recent ruling affirming the decision.
This article 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.
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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.
