The Stewart Case: Policy Support for a “Plausibility” Assessment on Prong 1

In Stewart v. Secretary of the Department of Health and Human Services, Special Master Millman grounds her reasoning and evidence assessment of Althen Prong 1 in part on a substantial amount of policy.

The policy discussion lays the foundation for her use of a “plausibility” assessment to support a finding for the petitioner on Prong 1. In order to satisfy Prong 1 the petitioner must establish by a preponderance of the evidence that there is “a medical theory causally connecting the vaccination and the injury.” (Althen v. Secretary of HHS, 418 F. 3d 1274, 1278 (Fed. Cir. 2005).)

What is the role of policy in such fact finding?

In the Stewart decision, Special Master Millman defines her metric for evaluating Prong 1: “To the undersigned, medical probability means biologic credibility or plausibility rather than exact biologic mechanism.” (Decision at 32.)

This Prong 1 “plausibility” metric is then followed by language from Knudsen, v. Secretary of HHS, 35 F.3d 543, 549 (Fed. Cir. 1994):

Furthermore, to require identification and proof of specific biological mechanisms would be inconsistent with the purpose and nature of the vaccine compensation program. The Vaccine Act does not contemplate full blown tort litigation in the Court of Federal Claims. The Vaccine Act established a federal “compensation program” under which awards are to be “made to vaccine-injured persons quickly, easily, and with certainty and generosity.” House Report 99-908, supra, at 3, 1986 U.S.C.C.A.N. at 6344.

The Court of Federal Claims is therefore not to be seen as a vehicle for ascertaining precisely how and why DTP and other vaccines sometimes destroy the health and lives of certain children while safely immunizing most others.

(Decision at 32, quoting and citing Knudsen.) The legislative intent and the Knudsen language underscore that Vaccine Act cases are focused on compensating the innocent victims of vaccine-related injuries and are not academic exercises concerned with exacting science. The Special Master continues with more policy from Althen that elaborates on the evidentiary standard that “the purpose of the Vaccine Act’s preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body.” (Decision at 33, citing Althen at 1280.) The Special Master points out that this burden can be met by the petitioner even when there is epidemiological evidence that “directly opposed causation from a vaccine.” (Decision at 33.)

As applied to the facts of Stewart the Special Master notes that respondent’s expert does not accept that attenuated viral vaccines can cause cerebellar ataxia; however, he does admit that it is “theoretically possible.” (Decision at 39.) The Special Master finds that: “It is unnecessary for the undersigned to determine whether the specific biologic mechanism is the presence of hepatitis A virus in inactivated form in the vaccine … or prior exposure to a protein that is similar or identical to a component of the vaccine in order for petitioners to prevail, according to the Federal Circuit in Knudsen, since petitioners do not have the burden of proving the specific biologic mechanism.” (Decision at 40.)

The application of policy to reasoning on Prong 1 supports Special Master Millman’s application of the “plausibility” metric in finding for the petitioner. Specifically, the legislative intent and language in the Knudson opinion provide that ascertaining “specific biological mechanisms” is not the concern of the “compensation program,” which aims at awarding “quickly, easily and with certainty and generosity.” Thus in Stewart: “The plausible medical theory for autoimmune cerebellar ataxia is that the body, sensing a protein to which it responds, misidentifies its own cells as a target for attack.” (Decision at 38.)

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