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Pafford v. Secretary of Health and Human Services

    Brief Fact Summary. Pafford(P) sued the federal government under the federal vaccine program, arguing that the various vacccines she received resulted in her developing Juvenile Rheumatoid Arthritis. As far as the parameters of the federal vaccine injury program went, she was injured by the vaccine, and so satisfied the eligibility criteria for causation-in-fact for off-table claims.

    Synopsis of Rule of Law. If an off-table case is brought under the provisions of the federal vaccine injury program, a but-for level of causation must be proved between the vaccinations and the resulting disease or injury by a majority of the available evidence, if the case is not to be dismissed.

    Facts. Pafford  (P) was vaccinated with DTaP, MMR and OPV following which she developed Still’s disease or Juvenile Rheumatoid Arthritis. She then claimed that the cause of her condition was the vaccination. The evidence presented in favor of her claim did not support the causation theory as the time frame was not medically acceptable to decide that the vaccine triggered off the disease condition. There were other possible causative events during the same time as well, like a positive Mycoplasma test, X-ray evidence suggestive of sinus infection, an episode of tonsillitis some time prior to this and an earlier cold accompanied by diarrhea. A Special Master denied the claim, on the ground that but-for causation was not proved. The Court of Federal Claims allowed a plea for review.

    Issue. In an off-table case brought under the federal vaccine injury program, can a claim be denied on the basis that the existing evidence did not show a but-for causation between vaccination and illness or injury?

    Held. (Rader, J.) Yes. In an off-table case making use of the provisions of the federal vaccine injury program, a claim may be rejected if it does not have evidence to prove a but-for causation between the vaccination and the illness. If the illness fits into the Vaccine Injury Table, the petitioner first needs to prove a time-related causation of the injury by the vaccine. Once this is done, the causation is presumed. The burden then rests on the respondent to prove that vaccine-independent factors caused the illness or injury. In a case like the present, which does not allege an injury listed in the table, it is an off-table injury and a causation-in-fact claim. The causation is not presumed here, but needs to be proved by the petitioner by presenting relevant evidence. The majority of the evidence should support the petitioner’s claim that her illness was substantially due to the vaccination, and that but for the vaccination the illness or injury would not have occurred. If not, the petitioner has another option, which is to present (1) a medical theory of pathogenesis connecting injury with vaccination; (2) a logical cause-effect relationship between vaccination and injury; and (3) a clear relationship in nearness between the time of injury and time of vaccination. In this case, the Special Master correctly used these tests to determine that while a biologically plausible theory could be offered linking Pafford’s disease (Still’s disease) to the vaccination, the second criterion, of proving that but for the vaccination the illness would not have developed. This was the more true in that she could not set a specific  time period within which the onset of the disease might be expected to follow the triggering event. In some other cases of the same sort, this but-for causation was established linking vaccination with the injury as one of several essential factors. Here, this is lacking. The main fault in the evidence lies in its not demonstrating a medically acceptable time frame supporting the causative role of the vaccine in Pafford’s disease, which weakens the but-for side of the analysis. This is even more damaging in the light of other medical events which happened in the same time period which could plausibly have been independent causes of the disease. Thus the Special Master rightly concluded that a but-for causation had not been proved in Pafford’s case. The verdict was affirmed.

    Dissent. (Dyk, J.) The law in this case is clear that the fact of an event being causative may be established in off-table cases without there being a demonstrable and medically acceptable time relationship between injury and vaccination. The majority view is that lack of this element automatically disqualifies the petitioner from being able to prove,prima facie, that an event causally related to an injury would not have occurred without the injury. This opinion is therefore not consistent with the law.

    Concurrence. N/A

    Discussion. The statute being considered here is the National Childhood Vaccination Injury Act of 1986 (NCVIA). It was basically intended to prevent vaccine makers from being forced to shut down production or marketing as a result of vaccine injury claims on them. Thus it would ensure a no-fault legal protection system which would enable the vaccine supply to be stabilized and vaccine injury claims to be disposed of in a cost-effective manner.

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