The National Vaccine Injury Compensation Program and the Office of Special Masters

The National Vaccine Injury Compensation Program and the Office of Special Masters

September 14, 2022
The National Vaccine Injury Compensation Program and the
Office of Special Masters
In 1986, Congress passed the National Childhood Vaccine
manufacturer or administrator for damages arising from a
Injury Act (NCVIA; 42 U.S.C. §§ 300aa-10–300aa-34),
vaccine-related injury or death until after a petition has
which created the National Vaccine Injury Compensation
been filed and judgment entered through the VICP.
Program (VICP). The VICP is a no-fault compensation
program that allows individuals to file a petition (i.e., a
Once a claim has been adjudicated through the VICP,
claim for money damages) against the Secretary of Health
judgment is entered, and a petitioner must choose to accept
and Human Services (the Secretary) to receive
or reject the judgment. If the petitioner accepts the
compensation for an injury or death allegedly caused by a
judgment, the petitioner is entitled to any damages awarded
covered vaccine. Congress created the Office of Special
by the special master. In return, however, the petitioner is
Masters (OSM), situated within the U.S. Court of Federal
barred from filing a claim in court against a vaccine
Claims, to adjudicate petitions filed under the VICP.
manufacturer or administrator for the same injury. If the
petitioner rejects the judgment, he or she is not entitled to
This In Focus describes the OSM’s creation, authority, and
money damages but may sue the manufacturer or
unique jurisdiction. It then identifies several issues related
administrator in court for the alleged injury or death. The
to the VICP that may be of interest to Congress.
NCVIA limits the types of civil actions that can be brought
against manufacturers and administrators; for example, it
Jurisdiction and Authority
generally bars claims for damages for unavoidable side
The OSM has exclusive jurisdiction to adjudicate petitions
effects.
filed under the VICP. To seek compensation through the
VICP, individuals or their designees (also called
Court Proceedings
petitioners) file petitions with the OSM against the
Secretary (the respondent). The Secretary is represented by
Special Masters
attorneys from the U.S. Department of Justice. Petitioners
A special master is an officer of the court who is appointed
often retain an attorney to represent them in the
by the judges of the U.S. Court of Federal Claims to
proceedings.
adjudicate vaccine petitions. The judges appoint special
masters for four-year terms and designate a Chief Special
The VICP currently covers 16 vaccines that are
Master (CSM). The CSM is responsible for assigning
recommended by the Centers for Disease Control and
petitions for adjudication by the special masters and for
Prevention (CDC) for routine administration to children or
carrying out the OSM’s administrative business. By statute,
pregnant women. The list of covered vaccines may be
the OSM is limited to eight special masters. Like the U.S.
found on the Vaccine Injury Table (the Table). The most
Court of Federal Claims, it has nationwide jurisdiction and
current version of the Table may be found on the Health
may hear cases in all states and territories.
Resources and Services Administration’s (HRSA’s)
website: https://www.hrsa.gov/vaccine-compensation.
Special masters function much like judges in adjudicating
VICP petitions. In cases where the Secretary contests
Currently, the VICP does not include any COVID-19
whether the vaccine caused the alleged injury, the special
vaccines. Individuals seeking compensation for alleged
master may recommend alternative dispute resolution
injuries related to COVID-19 vaccines must instead file a
proceedings. Special masters conduct telephonic status
request for benefits under the Countermeasures Injury
conferences between the parties, ensure the record is
Compensation Program (CICP), also administered by
complete, and hold hearings. The special master may also
HRSA.
decide a vaccine petition on the record without a hearing.
The Liability Shield
Proving Causation
Congress created the VICP to limit the liability of
To prevail on a claim, a vaccine petitioner must show that it
manufacturers and administrators for vaccine-related
is more likely than not that the vaccine the petitioner
injuries, while providing a process by which individuals
received caused the petitioner’s injuries or death. A
injured by certain vaccines could receive compensation.
petitioner may demonstrate causation by either
The Program also addresses the concern that tort lawsuits
(1) demonstrating that the petitioner’s injury is on the Table
against vaccine manufacturers could result in vaccine
and manifested within the time period specified in the
shortages. The NCVIA shields manufacturers and
Table; or (2) by demonstrating causation in fact, meaning
administrators from liability for injuries related to a covered
that the vaccine was the “but for” cause of the petitioner’s
vaccine by generally barring individuals from filing civil
injury or death.
claims in excess of $1,000 against a covered vaccine
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The National Vaccine Injury Compensation Program and the Office of Special Masters
For each vaccine, the Table describes the injuries and onset
of 2,060 filings. As of September 30, 2021, there were more
period known to be associated with that vaccine. The
than 4,000 pending vaccine petitions. In FY2021, the OSM
Secretary may modify the Table via regulation as outlined
disposed of just more than 1,000 vaccine petitions.
in the statute. According to established case law, petitioners
may demonstrate causation in fact by providing each of the
Issues for Congress
following: (1) a medical theory causally connecting the
vaccination and the injury; (2) a logical sequence of cause
Expansion of OSM
and effect showing that the vaccination was the reason for
Congress may consider whether the number of special
the injury; and (3) a showing of a proximate temporal
masters, which is presently capped at eight by statute, is
relationship between the vaccination and the injury.
sufficient for the OSM’s caseload. The number of vaccine
petitions filed in FY2021 (2,060) represented a 433%
Damages Awards and Attorney’s Fees
increase from the number filed 10 years earlier in FY2011
A petitioner who prevails on a VICP claim may receive
(386). To address the increase in petitions filed in recent
monetary compensation for actual and reasonable projected
years, Congress could amend the Vaccine Act to allow the
expenses resulting from the vaccine-related injury or death,
U.S. Court of Federal Claims to increase the number of
including compensation for past and future medical care,
special masters who may adjudicate petitions.
pain and suffering, and lost earnings. In the case of a
vaccine-related death, the deceased petitioner’s estate
COVID-19 vaccine injury claims are currently addressed
receives an award of $250,000. Under the Act, petitioners
through the CICP. If the COVID-19 vaccine were added to
are not entitled to punitive or exemplary damages, and the
VICP—which would require an act of Congress in addition
OSM may not award them.
to regulatory changes—that may affect VICP’s caseload.
As of August 2022, there have already been more than
The special master may also award the petitioner reasonable
6,000 COVID-19 vaccine injury claims filed in the CICP.
attorney’s fees and other costs. If a petition is denied, the
special master may still award reasonable attorney’s fees
Vaccine Tax
and costs if the special master finds the petition was
VICP compensation may only be paid for injuries from
brought in good faith and a reasonable basis existed for the
vaccines subject to the $0.75 excise tax. When a new
claim. Attorneys who receive fees from the program are not
vaccine is recommended by the CDC for routine
permitted to charge their clients any additional fees or costs.
administration to children and/or pregnant women,
however, that vaccine is not automatically subject to the
Awards made by the program are paid from the Vaccine
$0.75 excise tax. At that point, Congress would face a
Injury Compensation Trust Fund, which is funded by a
decision to amend the Internal Revenue Code in order for
$0.75 excise tax on each dose of a covered vaccine.
the vaccine to be taxed. Any amendment to the Table to add
Congress also appropriates VICP-related funds for (1) the
the vaccine is not effective, and the Program may not make
OSM and its staff; (2) the Department of Justice, which is
compensation awards, until the vaccine becomes subject to
tasked with defending VICP cases; and (3) HRSA, which
the tax. To facilitate the process of adding new vaccines,
provides medical review of the cases.
Congress may consider subjecting to the tax any vaccine
recommended for routine administration by the CDC.
A significant percentage of vaccine petitions are resolved
via settlements, wherein the Secretary agrees to
Changes to the Vaccine Injury Table
compensation without conceding that the vaccine was
The Secretary has discretion to amend the Table based on
responsible for the petitioner’s injuries. Settlements are
evolving science and data, as well as changes in policy. For
particularly common for Table injuries.
example, in 2017, the Secretary amended the Table to
include shoulder injuries related to vaccine administration
Appeals
(SIRVA). In January 2021, reflecting a change, the
Under the Act, both petitioner and respondent may appeal
Secretary published a final rule removing SIRVA from the
an OSM decision to the U.S. Court of Federal Claims by
Table, stating it is not an injury “associated with” the
filing a motion for review within 30 days of the special
vaccine, in accordance with the statutory requirements. This
master’s decision. A party may appeal a decision of the
action drew public controversy, and the Secretary later
U.S. Court of Federal Claims to the U.S. Court of Appeals
rescinded this final rule; SIRVA remains on the Table at
for the Federal Circuit by filing a motion within 60 days of
this time.
the date judgment is entered by the U.S. Court of Federal
Claims.
Currently, more than half of the petitions filed in the OSM
allege SIRVA and vasovagal syncope (VS). Omitting
The U.S. Courts of Federal Claims and the Federal Circuit
SIRVA could have a substantial impact on OSM’s
conduct de novo review on questions of law, but they defer
jurisdiction to review, could affect whether petitioners can
to special masters regarding factual findings. The courts
recover damages, and could influence public confidence
typically uphold the special master’s findings of fact unless
regarding vaccine safety. Future efforts to remove SIRVA
they are arbitrary or capricious.
and VS from the Table may be challenged in court.
Recent Caseload Statistics
Hannah-Alise Rogers, Legislative Attorney
In FY2021 (October 1, 2020-September 30, 2021), vaccine
IF12213
petition filings increased by 72.9% over FY2020 for a total
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The National Vaccine Injury Compensation Program and the Office of Special Masters

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