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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
comments.49 However, the Department found the ACCVs comments not adequately persuasive. The Department has also considered public comments from a wide variety of perspectives during the two public hearings and 180day public comment period on the proposed rule.
Comment: A few commenters stated that they believe the reason for HHSs policy change is to reduce the Departments workload, which has increased due to the large number of SIRVA cases. Commenters stated that workload concerns are not a valid reason for making a policy change.
Some commenters added that the change would not actually make the system more efficient, but would rather shift the burden of SIRVA cases to the civil tort system.
Response: The Department has set forth herein and in the proposed rule a series of legal and policy reasons for finalizing this final rule. The Department believes based on the examined data that any additional burden on the civil tort system, which would be dispersed across States and not concentrated in any one or few States, from removing SIRVA and vasovagal syncope from the Table and reverting to the status quo as of January 2017 will be minimal.50
Comment: One commenter warned that this rule could result in the increase in the cost of vaccines, as more medical providers are exposed to liability.
Response: With respect to SIRVA and vasovagal syncope, this final rule will revert to the status quo as of January 2017. In addition, certain pharmacists are already immune from suit and liability for claims for loss caused by, arising out of, relating to, or resulting from the administration of certain childhood vaccines to individuals ages three through 18 for the duration of the Secretarys Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID19.51
Comment: One commenter disagreed with the Departments contention that by excluding from the definition those injuries associated with an adulterant or contaminant intentionally added to the vaccine, Congress intended to permit suit only where the injury was caused by the components of the vaccine itself.
The commenter states that the Department is applying the doctrine of ejusdem generis i.e., where general words follow an enumeration of two or 49 See 85 FR 43,80102 discussing the ACCVs comments in depth.
50 85 FR 43,804.
51 See 85 FR 52,136, 52140 Aug. 24, 2020.

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more things, they apply only to persons or things of the same general kind or class specifically mentioned. However, here, an adulterant and contaminant are exceptions instead of enumerations.
Therefore, the commenter contends that the Departments interpretation of Congress intent is not supported.
Response: The Department respectfully disagrees. 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.52
Comment: One commenter stated that the Department mischaracterized current SIRVA cases when it said petitioners in such cases often prevail because of the low burden of proof and because it is not necessary to prove causation. The commenter said that litigation records show complex cases in which the Department of Justice vigorously advocated for the DHHS.
Response: The Department agrees that the Department of Justice generally vigorously advocates for the Department. But the burden of proof on petitioners is low, and petitioners generally need not prove causation.
Comment: One commenter stated that the proposed rule change may disproportionately and severely affect minority communities, since many do not have the same access to quality care;
the time, energy, and know-how to navigate a complex legal system; and the resources to access compensation.
Response: Aiding minority communities was not posited as a reason to add SIRVA or vasovagal syncope to the Table when they were added in 2017.53 In any event, this final rule will alleviate the Departments significant legal concerns about whether the current Table comports with applicable law.
Comment: Some commenters stated that HRSA is attempting to undo the lengthy and thorough legal and medical analysis it performed when it promulgated the Rule that put both vasovagal syncope and SIRVA on the Vaccine Injury Table in 2017.
Response: This final rule is the product of a lengthy and thorough legal and scientific analysis, including an analysis of scientific literature published after finalization of the 2017
Final Rule.
Comment: One commenter argued that the Vaccine Act has a subrogation clause which permits the Federal government to seek recompense if the VICP compensates a claim, but determines later that a health care 52 See 53 See
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professional was negligent in administering a vaccine. Thus, injury claims resulting from the administration of vaccines should still be eligible for VICP compensation.
Response: This subrogation provision does not properly incentivize the vaccine administrator, since it is unlikely that the Federal government would assert many claims against administrators, given the burden and expense compared to the relatively small potential recovery for the Federal government. Individuals would have a greater incentive to assert such claims if the administrator were negligent.
Comment: Some commenters stated that the Department incorrectly relies on Amendola v. Sec., Dept. of Health &
Human Servs., 989 F.2d 1180 Fed. Cir.
1993 to say that issues would arise if the Vaccine Act were interpreted to cover injuries caused by negligent administration. Commenters contend that the Federal Circuit Judge stated Congress clearly intended by the amendment to apply the Act to pediatricians who administered a vaccine as well as to the manufacture who made it, and we see no basis for drawing a bright line that excludes erroneous judgment calls by the administrator, as well as negligent contamination. One commenter concludes that Amendola, in fact, confirms that the Vaccine Act protects both vaccine administrators and manufactures.
Response: The Department respectfully disagrees with this characterization of Amendola. 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 118687. The better reading of the statute is that it does not reach this far.
Comment: One commenter argued that the state tort liability preemption in Subpart B merely covers the remedies available to patients after they have gone through the VICP, not that Congress intended to preserve a state tort remedy for certain avoidable injuries, such as those caused by negligent vaccine administration.
Response: 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
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