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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations administrator. The Vaccine Act is ambiguous in how it handles such injuries, and in the Departments view there are strong reasons to exclude them from coverage under the Acts compensation scheme.
The Act creates a compensation program for a vaccine-related injury or death. 42 U.S.C. 300aa11a1. Under the Act, only . . . a person who has sustained a vaccine-related injury or death can recover. 42 U.S.C. 300aa 11a9. The Act defines vaccinerelated injury or death as an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine. 42 U.S.C. 300aa335
emphasis added; see also Dean v.
HHS, No. 161245V, 2018 WL 3104388, at 9 Fed. Cl. Spec. Mstr. May 29, 2018 defining vaccine as any substance designed to be administered to a human being for the prevention of 1 or more diseases quoting 26 U.S.C.
4132a2. Thus, the compensation program covers injuries associated with the vaccine itself.
SIRVA is not a vaccine, and it is not an injury caused by a vaccine antigen, but by administration of the vaccine by the health care provider. The Department does not think the term associated with was meant to sweep in injuries caused by negligent administration of the vaccine. Although the Act permits petitioners to recover for Vaccine Table injuries without demonstrating causation in individual cases, the term associated with nevertheless requires that the injury, in general, be causally related to the vaccine itself. This is clear both from dictionary definitions of associated, which means related, connected, or combined together MerriamWebster.com Dictionary, MerriamWebster, https www.merriamwebster.com/dictionary/associated.
Accessed 10 Jul. 2020, and from the text of the Act itself, see, e.g., 42 U.S.C.
300aa22b1 focusing on injuries that resulted from vaccine side effects; 42
U.S.C. 300aa13a1B & 2B
excluding trauma that has no known relation to the vaccine involved.
Importantly, in the key operative provisions discussed above, the phrase associated with is linked to the vaccine itself, not to the technique in administering the vaccine. See Decker v.
Nw. Envtl. Def. Ctr., 568 U.S. 597, 611
2013 in interpreting phrase associated with industrial activity,
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the key consideration is the scope of industrial activity; the statute does not foreclose a more specific definition by the agency and a reasonable interpretation . . . could . . . require the discharges to be related in a direct way to operations at an industrial plant ; Chevron, U.S.A., Inc. v. Nat.
Resources Def. Council, Inc., 467 U.S.
837, 861 1984 The meaning of a word must be ascertained in the context of achieving particular objectives, and the words associated with it may indicate that the true meaning of the series is to convey a common idea..
That basic requirement is not met with SIRVA and vasovagal syncope.
While the act of being vaccinated may be a but-for cause of those injuries, the injury is not associated with the vaccine itself because, with proper administration technique, those injuries will not result from the vaccine. Rather, SIRVA and vasovagal syncope result from the use of improperthat is, negligentadministration technique.
There are several indicators in the language and structure of the Vaccine Act that show it was not meant to cover negligent administration of the vaccine.
First, as the Federal Circuit has explained, troubling issues arise if the Act were to apply to negligence facially unrelated to the vaccines effects. Amendola v. Sec., Dept. of Health & Human Servs., 989 F.2d 1180, 1187 Fed. Cir. 1993. It could include, for example, the doctors negligent dropping of an infant patient or use of contaminated equipment. Id. at 1186
87. The better reading of the statute is that it does not reach this far.
Second, the definition of vaccinerelated injury carves out an adulterant or contaminant intentionally added to such a vaccine. 42 U.S.C. 300aa335
emphasis added. By excluding from the definition those injuries associated with an adulterant or contaminant intentionally added to the vaccine, Congress indicated its intent to permit suit only where the injury was caused by the components of the vaccine itself, not individual fault. Relatedly, in the provisions setting forth the standard for awarding compensation, Congress specified that an award is not appropriate when injury was due to factors unrelated to the administration of the vaccine, and further defined that phrase to include trauma . . . which have no known relation to the vaccine involved. 42 U.S.C. 300aa13a1B
& 2B. In other words, Congress excluded compensation for injuries that were not related to the vaccine involved.
Third, the statutory scheme requires that the patient received a vaccine set
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forth in the Vaccine Injury Table, 42
U.S.C. 300aa11c1A, tying compensation to the receipt of a specific listed vaccine. See 42 U.S.C. 300aa 11c1Ci speaking to an injury aggravated in association with the vaccine referred to on the Vaccine Injury Table; 42 U.S.C. 300aa 11c1CiiI for conditions not on the Vaccine Injury Table, allowing proof that the condition was caused by a vaccine on the Table; 42 U.S.C.
300aa11c1CiiII same. But negligent administration can occur without regard to the specific vaccine and, as noted above, can encompass anything from negligent needle placement to the doctors negligent dropping of an infant patient.
Amendola, 989 F.2d at 118687.
Congress strongly signaled that it was focused on compensation for harm caused by the vaccine by requiring that the Table list the vaccines themselves and the types of injuries the vaccines themselves would cause.
Fourth, in the provision preempting state tort liability, Congress protected manufacturers from liability when the injury resulted from side effects that were unavoidable even though the vaccine was properly prepared . . . 42
U.S.C. 300aa22b1. This language shows Congress wanted to preserve a state tort remedy for certain avoidable injuries, such as those caused by negligent vaccine administration. Given that the Vaccine Act seeks to replace state tort remedies for the injuries it covers, this reinforces the conclusion that the Act does not reach SIRVA and vasovagal syncope.
Fifth, Congress provided for health care providers who administer vaccines to record detailed information about the vaccination, including the date of administration; the manufacturer; the name of the provider; and other identifying information. 42 U.S.C.
300aa25. This information is well suited to a program designed to compensate for injuries associated with the vaccine itself, since it provides the key details about the vaccine provided and when. But this reporting requirement is woefully inadequate if the Program was designed to compensate for negligence by the provider, which would require maintaining careful records regarding the actual administration of the vaccine.
In setting up the original Vaccine Injury Table, Congress referenced conditions resulting from the administration of such vaccines. 42
U.S.C. 300a14a. But this phrase was not designed to define the scope of the program or the Table; instead, Congress directed the Secretary to add conditions
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