[House Report 106-977]
[From the U.S. Government Publishing Office]
Union Calendar No. 575
106th Congress, 2d Session - - - - - - - - House Report 106-977
_______________________________________________________________________
THE VACCINE INJURY COMPENSATION PROGRAM: ADDRESSING NEEDS AND
IMPROVING PRACTICES
__________
SIXTH REPORT
by the
COMMITTEE ON GOVERNMENT REFORM
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
October 12, 2000.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
__________
U.S. GOVERNMENT PRINTING OFFICE
67-193 CC WASHINGTON : 2000
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS III, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, District of
MARK E. SOUDER, Indiana Columbia
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
HELEN CHENOWETH-HAGE, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
JOHN L. MICA, Florida, Chairman
BOB BARR, Georgia PATSY T. MINK, Hawaii
BENJAMIN A. GILMAN, New York EDOLPHUS TOWNS, New York
CHRISTOPHER SHAYS, Connecticut ELIJAH E. CUMMINGS, Maryland
ILEANA ROS-LEHTINEN, Florida DENNIS J. KUCINICH, Ohio
MARK E. SOUDER, Indiana ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
DOUG OSE, California JANICE D. SCHAKOWSKY, Illinois
DAVID VITTER, Louisiana
Ex Officio
DAN BURTON, Indiana HENRY A. WAXMAN, California
Sharon Pinkerton, Staff Director and Chief Counsel
Steve Dillingham, Special Counsel
Lisa Wandler, Professional Staff Member
Ryan McKee, Clerk
Sarah Despres, Minority Counsel
Paul Kim, Minority Counsel
?
LETTER OF TRANSMITTAL
House of Representatives,
Washington, DC, October 12, 2000.
Hon. J. Dennis Hastert,
Speaker of the House of Representatives,
Washington, DC.
Dear Mr. Speaker: By direction of the Committee on
Government Reform, I submit herewith the committee's sixth
report to the 106th Congress. The committee's report is based
on a study conducted by its Subcommittee on Criminal Justice,
Drug Policy, and Human Resources.
Dan Burton,
Chairman.
C O N T E N T S
_____________
Page
I. Summary..........................................................1
II. Background.......................................................2
National Childhood Vaccine Injury Act................... 2
National Vaccine Injury Compensation Program............ 3
Advisory Commission on Childhood Vaccines............... 4
National Vaccine Advisory Committee..................... 4
Vaccine information statements.......................... 4
Assessments of causality................................ 5
Childhood vaccine studies............................... 5
Compensation procedures................................. 6
Standards of proof...................................... 7
Vaccine injury table.................................... 8
Vaccine Adverse Event Reporting System.................. 9
Vaccine Safety Datalink Project......................... 9
III. Compensation program issues.....................................10
Table changes........................................... 10
Compensation determination and award delays............. 12
Adversarial process..................................... 12
Sovereign immunity...................................... 14
Compensation trust fund................................. 14
Vaccine Adverse Events Reporting System................. 15
Dual and conflicting responsibilities................... 16
IV. Legislative proposals...........................................16
Proposals of the Department of Health and Human Services 16
Additional proposals.................................... 17
V. Congressional hearings..........................................18
Subcommittee hearings................................... 18
Full committee hearings................................. 19
Union Calendar No. 575
106th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 106-977
======================================================================
THE VACCINE INJURY COMPENSATION PROGRAM: ADDRESSING NEEDS AND IMPROVING
PRACTICES
_______
October 12, 2000.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Burton, from the Committee on Government Reform submitted the
following
SIXTH REPORT
On October 5, 2000, the Committee on Government Reform
approved and adopted a report entitled, ``The Vaccine Injury
Compensation Program: Addressing Needs and Improving
Practices.'' The chairman was directed to transmit a copy to
the Speaker of the House.
I. Summary
Responding to the complaints of families reporting vaccine
injury and pursuant to its authority, the Subcommittee on
Criminal Justice, Drug Policy, and Human Resources (the
subcommittee) initiated an oversight investigation into the
implementation and operation of the National Childhood Vaccine
Injury Act of 1986 (the Act) as administered jointly by the
Department of Health and Human Services [HHS], the Department
of Justice [DOJ] and the U.S. Court of Federal Claims (the
Court).
The Act serves three purposes: (1) Provide fair, expedited
compensation to those who suffer vaccine injury through the
National Vaccine Injury compensation ([VICP] or the Program);
(2) Enhance the operation of our system of childhood
immunizations; and (3) Protect the Nation's vaccine supply by
shielding manufacturers from liability.
The Act has been highly successful in some of its
objectives. The vaccine supply is stable and over 1,500
petitioners and their families have been compensated. But the
program has received criticism that it does not operate as
efficiently or equitably as intended by Congress. Designed as a
``no-fault'' alternative to litigation against vaccine
manufacturers, the program was envisioned by Congress to
compensate ``quickly, easily and with certainty and
generosity'' those individuals who are injured or die as a
consequence of our universal vaccination policy.
Based on testimonial and documentary record, the
subcommittee finds that the program under the direction of HHS
has approved changes that substantially restrict compensation
coverage. Furthermore, avoidable, protracted and adversarial
litigation of claims has resulted, thereby undermining the
remedial nature of the program as intended by the Congress.
Accordingly, recommendations are made to:
Review the Vaccine Injury Table (the Table) to
ensure that it reflects current science and epidemiology;
Continue developing and implementing speedy and
fair informal dispute resolution options and practices; and
Determine a reasonable alternative standard for
non-Table cases.
II. Background
Vaccination is a foundation of modern public health
programs and is considered one of the most effective public
health initiatives ever undertaken. Since immunization programs
began, the number of people contracting vaccine-preventable
diseases in the United States has been reduced by more than 95
percent.\1\ Morbidity and mortality attributable to smallpox,
measles, mumps, rubella, polio, diphtheria, pertussis and
tetanus has almost been eliminated.
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\1\ ``Vaccine Injury Compensation: Program Challenged to Settle
Claims Quickly and Easily,'' GAO/HEHS-00-8 (December 1999), p. 1.
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Over 12 million vaccinations are given to children
annually, and many millions of vaccines are given to adults.\2\
States now require that virtually all children be vaccinated
prior to entering school.
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\2\ Ibid., p. 4.
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The benefits of vaccination are measured in terms of
prevented disease in individuals and in the population to be
protected against infectious disease. The risks are measured as
potential side effects and injuries. Both are monitored as part
of the U.S. public health system. In some instances, the
differences in the ways that immune systems react to vaccines
on rare occasions may result in severe side effects, including
death or disabling conditions requiring lifetime medical care.
Despite these rare instances, it is the overwhelming view
of the medical and public health community that the risks of
vaccine reactions, both mild reactions and rare serious ones,
are far outweighed by the public health benefits of current
vaccination practices. Maintaining public support for
immunizations is critical for preventing outbreaks of vaccine
preventable diseases.
National Childhood Vaccine Injury Act
Every year, a number of children are seriously injured by
adverse reactions to vaccines. When such a tragedy befalls a
family, they are faced with devastating emotional and financial
consequences. As the devastation of adverse reactions can lead
to paralysis, permanent disability and death, families without
adequate insurance can face enormous expenses, including
residential care, therapy, medical equipment, and drugs.
Following a nationwide initiative to raise immunization
levels among children in the late 1970's, lawsuits in the
1980's stemming from adverse reactions threatened to negatively
affect availability, cost and development of vaccines.
Before the VICP was established, families experiencing
vaccine related reactions had to rely upon traditional tort
litigation. Families were often unable to obtain the scientific
and legal resources needed to substantiate vaccine-related
injuries in legal proceedings. Scientific studies and medical
evidence needed to definitively link vaccines with various
medical conditions were often unavailable or insufficient to
establish the traditional level of proof required for
compensation in the civil tort system. As lawsuits increased,
vaccine manufacturers also were burdened with the time and
expenses of litigation, as well as the availability and
affordability of liability insurance. As the number of vaccine
manufacturers fell and prices rose, physicians and public
health professionals warned of the potential return of epidemic
infectious diseases.\3\
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\3\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, pp. 4 and 5.
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In response, Congress passed the National Childhood Vaccine
Injury Act of 1986 (Public Law 99-660) (the Act) to establish a
simple system of compensation for children suffering injuries
related to routine pediatric immunizations. The Act created a
National Vaccine Program and VICP, including advisory
committees for each. The Act specifies remedies available to
persons suffering vaccine-related injuries, establishes
requirements regarding recordkeeping and reporting on vaccine
administration and adverse effects, and calls for increased
studies of vaccines. The new system for vaccine compensation
was intended to be ``fair, simple, and easy to administer.''
\4\
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\4\ Ibid., p. 5.
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National Vaccine Injury Compensation Program
Under the Act, the National Vaccine Injury Compensation
Program ([VICP] or Program) was created to provide compensation
to those who suffer vaccine-related injury or death. The
Program is designed as a ``no fault'' alternative to civil
litigation intended to be ``fair, simple, and easy to
administer'' and ``to compensate persons with recognized
vaccine injuries without requiring the difficult individual
determinations of causation to injury.'' \5\
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\5\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 5.
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Vaccines currently covered under the Program include
diphtheria, tetanus, pertussis (DTP, DTaP, DT, TT or Td),
measles, mumps, rubella (MMR or any components) and polio (OPV
or IPV). Hepatitis B, Haemophilus influenza type b (Hib), and
varicella (chickenpox) vaccines were added for coverage,
effective August 6, 1997. Rotavirus was added effective October
22, 1998. Eight years of retroactive coverage from the
effective date is provided for vaccine-related adverse events
associated with any vaccine newly added to the Program.
Since enactment, the Program has paid out approximately
$1.17 billion in awards for vaccine injuries and attorney's
fees. Disbursement for injuries related to vaccines
administered after October 1, 1988 are provided by the trust
fund supported by an excise tax of 75 cents on every dose of
vaccine sold that is covered by the Program. Retrospective
claims are paid from general fund appropriations.\6\
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\6\ Ibid., pp. 3-9.
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Advisory Commission on Childhood Vaccines
The Advisory Commission on Childhood Vaccines [ACCV] is
charged with monitoring the VICP and making recommendations to
the Secretary of HHS on its implementation. It is composed of
nine members appointed by the Secretary for 3-year terms. Three
are healthcare professionals, of whom at least two must be
pediatricians; three are members of the public, of whom at
least two must be parents or guardians of vaccine injured
children; and three are attorneys, of whom at least one is
counsel to a petitioner and one represents manufacturers. The
Commission meets four times a year and is required to submit
recommendations on the Program to the Secretary of Health and
Human Services.
One of the primary responsibilities of the Commission is
advising on modifications to the Table. According to the
statute, ``The Secretary may not propose changes to the Vaccine
Injury Table or any revision thereof, unless the Secretary has
first provided to the Commission a copy of the proposed
regulation or revision, requested recommendations and comments
by the Commission and allowed the Commission at least 90 days
to make such recommendations.''
Controversy continues over whether, after reviewing
proposed regulations but undergoing a substantial change in
membership, the Commission had the opportunity to reconsider
fully the final version of the March 1995 regulations to the
ACCV prior to their effective date. Critics contend the
Commission was unable to address the appropriateness of the
amendments, in particular the definitional change of the word
``encephalopathy'' in the ``Aids to Interpretation.'' Moreover,
the ACCV proposed certain additions to the Table that
subsequently were rejected by the Secretary. In contrast, HHS
argues that the Commission reviewed the change. In 1996, HHS
won a legal decision regarding this matter.\7\
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\7\ O'Connell v. Shalala, 79 F.3d 170 (1st Cir. 1996).
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National Vaccine Advisory Committee
The National Vaccine Advisory Committee [NVAC] has a broad
mandate for reviewing and making recommendations concerning
vaccine research, production, delivery, safety and efficacy.
Recommendations have included ad hoc committee reviews of risks
associated with each of the vaccines listed on the injury
table.
NVAC is comprised of representatives from State and local
health departments, vaccine companies, academia, and consumer
groups.\8\
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\8\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 13.
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Vaccine Information Statements
In an effort to establish adequate risk communication, the
Act requires that all healthcare providers who administer
vaccines must provide a Vaccine Information Statement [VIS] to
the vaccine recipient, their parent or legal guardian prior to
each dose. Each VIS contains a brief description of the disease
as well as the risks and benefits of the vaccine. The VIS is
developed by the Centers for Disease Control and Prevention
[CDC] and distributed to State and local health departments as
well as individual providers.
Criticisms have been expressed that the VIS advisements may
be incomplete and, in practice, there may be failures to inform
recipients of appropriate circumstances for considering
modification to the normal vaccination schedule or to opt out
of receiving the vaccine. The subcommittee agrees that
pediatricians and health care providers should fully inform
patients about vaccine risks and benefits.
Assessments of Causality
Vaccine reactions can be classified by frequency (common,
rare), extent (local, systemic), severity (hospitalization,
disability, death), causality, and preventability (intrinsic to
vaccine, faulty production, faulty administration).
Because of the large number of vaccine exposures, it is
clear that temporal associations with adverse outcomes will
occur even when there is no causal association. Many health
problems in infancy will occur in children who have been
vaccinated, and some of these problems will by chance occur in
recently vaccinated children.
An adverse event can be causally linked to a vaccine more
readily if: 1) the event conforms to a specific clinical
syndrome whose association with vaccination has strong
biological plausibility (such as anaphylaxis immediately
following vaccination); 2) a laboratory result confirms the
association (i.e. viral culture and genetic sequencing show
virus is a vaccine and not a wild strain); 3) the event recurs
on re-administration of the vaccine (positive rechallenge); or
4) a controlled clinical trial or carefully designed
epidemiological study shows greater risk of adverse events
among vaccinated than control groups.
Because few of the adverse events reported meet any of the
first three criteria and clinical trials are almost always too
small to provide useful information on serious rare events,
epidemiological evidence is the basis for assessing vaccine-
relatedness for most serious adverse events that are
investigated. Still, much remains unknown about possible
adverse events that may be associated with past and present
vaccination practices.
Childhood Vaccine Studies
The Act called for the Institute of Medicine [IOM] to
review existing studies and medical literature and provide a
foundation for recommendations on vaccine injury causation. In
reports issued in 1991 and 1994, IOM published several
conclusions regarding the scarcity of knowledge about vaccine
safety, citing severe limits in data and research capability.
Of the 76 adverse events IOM reviewed for a causal
relationship, 50 (66 percent) had no or inadequate research.
Specifically, IOM Committees identified the following
limitations of existing knowledge: 1) Inadequate understanding
of biologic mechanisms underlying adverse events; 2)
Insufficient or inconsistent information from case reports and
case series; 3) Inadequate size or length of follow-up of many
population-based epidemiological studies; 4) Limitations of
existing surveillance systems to provide persuasive evidence of
causation, and 5) Few published epidemiological studies.
IOM warned that ``if research capacity and accomplishments
[are] not improved, future reviews of vaccine safety [will be]
similarly handicapped.'' \9\ IOM recommends: ``More research
could be done on potential long-term adverse effects from
vaccines as well as the potential of vaccines to induce or
worsen immune disorders.'' CDC agrees that there remains
``uncertainty about estimates of the risk associated with
vaccination'' and that to ``continue research to improve the
understanding of vaccine risks is critical.'' \10\
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\9\ Research Strategies for Assessing Adverse Events Associated
with Vaccines (National Academy Press, 1994).
\10\ 1996 IOM Vaccine Safety Forum.
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Despite concerns of IOM, parents, public health authorities
and other stakeholders, research needed to develop additional
scientific evidence that conclusively addresses many issues of
causality has not been completed. Concerns have been expressed
that additional research is needed to address the effects of
vaccines on chronic diseases, adverse events reporting, the
delivery of multiple vaccines and increased rates of childhood
vaccinations.\11\ While vaccines must be demonstrated to be
safe and effective prior to marketing, agencies including NIH,
FDA and CDC contend they are constrained by limited resources.
However, in part as a response to the concerns of this
subcommittee, HHS has recently contracted with IOM to undertake
further vaccine safety studies.
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\11\ Vaccines--Finding the Balance Between Public Safety and
Personal Choice, hearing before the House Committee on Government
Reform, 106th Cong., 1st sess., serial No. 106-84 (1999).
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Compensation Procedures
An individual claiming injury or death from a vaccine must
file a claim or petition with the U.S. Court of Federal Claims
(the Court). To qualify, injury claims must be filed within 36
months after initial onset of symptoms, and claims for deaths
must be received within 2 years of death and 4 years after the
onset of the vaccine-related injury from which the death
occurred. The Secretary of HHS, as overall administrator of the
Program, is named Respondent on behalf of the government and is
represented by the Department of Justice [DOJ].
A physician assigned by HHS has 90 days to review the
petition and make a non-binding recommendation as to
compensability, based primarily on medical records. This
recommendation is then provided to the Court through the DOJ
attorney assigned to the case. If the court concurs with an
entitlement recommendation, it may obviate the need for a
hearing.
Those cases that are not conceded usually proceed to a
hearing before an assigned Special Master, who acts in a
capacity similar to an administrative law judge. Both the
petitioner and the DOJ present testimony, including expert
witnesses, and decisionmaking authority is vested in the
Court's assigned Special Master.
To expedite proceedings, formal civil discovery and rules
of evidence have been relaxed in favor of a more informal
process, and timelines have been established. The Special
Master is required to issue a judgement within 240 days
(exclusive of suspended time) from the date a claim is filed,
or the petitioner may withdraw from the Program.
The Special Master's decision may be appealed by either
party to a judge of the Court, then to the U.S. Federal Circuit
Court of Appeals, and then to the U.S. Supreme Court.\12\
Following adjudication, if compensation is awarded, damages are
negotiated and future needs assessed, typically in consultation
with medical professionals, life care planners and other
experts. For compensable injuries, awards may take the form of
an initial lump sum plus an annuity providing a stream of
benefits for lifetime costs of care not covered by insurance.
The Program does not pay punitive damages. Successful claims
are eligible to receive reasonable compensation for past and
future unreimbursable medical, custodial and rehabilitation
costs; a $250,000 limit for actual and projected pain,
suffering and emotional distress; and lost earnings. A cap of
$250,000 was legislated as payment for compensable deaths.
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\12\ ``Commonly Asked Questions About the NVICP,'' HRSA.
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To ensure access, the Program also pays attorneys fees and
costs for the petitioner regardless of adjudication, assuming
there is a reasonable basis for the petition and it was filed
in good faith. While not required, most petitioners do seek
legal counsel to help navigate the program's procedures and the
need for complex medical evidence.
No petition may be filed under the Program if a civil
action is pending for damages related to the vaccine injury, or
if damages were previously awarded to the petitioner by a court
or in a civil settlement against the vaccine manufacturer or
administrator. However, lawsuits may be filed against
manufacturers or health care providers under State law in some
circumstances, such as when a petition is dismissed or judged
noncompensable, or when the vaccine is not covered under the
Program, or if the petitioner is not satisfied with the amount
of awarded compensation.\13\
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\13\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 5.
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Since the program's date of inception, October 1988,
approximately 6,000 petitions have been filed, 75 percent
involving injury allegations from vaccines administered prior
to the law's enactment. Of those cases, more than half (3,500)
have resulted in dismissal. To date: 71 percent of the claims
are for DTP/DTP-Hib; 2 percent for tetanus/Td/DT; 15 percent
for MMR or components, 10 percent for OPV/IPV; and the
remaining 2 percent are for new vaccines, vaccines not covered
under the VICP, or unspecified vaccines. Awards have ranged
from $120.00 to $7.9 million, with the average approximately
$800,000.\14\
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\14\ ``Commonly Asked Questions About NVICP,'' p. 4.
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Standards of Proof
Petitioners may become eligible to receive compensation in
three ways. First, the claimant must prove, by a preponderance
of the evidence, that an injury listed on the Table occurred
within the prescribed time.
Second, if the injury is not listed on the Table or did not
occur within the prescribed timeframe, pursuant to present
adjudication practices, a petitioner is held to traditional and
more difficult tort standards, and must prove traditional
causation or ``causation-in-fact.'' Congress' guidance on
``causation-in-fact'' cases is as follows, ``Simple similarity
to conditions or time periods listed in the Table is not
sufficient evidence of causation; evidence in the form of
scientific studies or expert medical testimony is necessary to
demonstrate causation for such a petitioner.'' \15\ Only a
small percentage of claims found not to be covered on the Table
receives compensation (only 13 percent).\16\
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\15\ House of Representatives Rept. No. 99-908 (1986), p. 5.
\16\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, p. 12.
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Finally, the petitioner may receive compensation if he or
she demonstrates that the vaccine significantly aggravated a
pre-existing condition. Children who do not receive
compensation from the fund may be required to rely on other
Federal health services that provide limited medical coverage
and home health assistance.
Vaccine Injury Table
A unique mechanism is used in the Program to provide
petitioners with a rebuttable presumption of causation. This
mechanism is the Table of Compensable Events, known as the
Vaccine Injury Table (the Table) and its complementary
Qualifications and Aids to Interpretation, which provides
definitions for injuries and the specific circumstances under
which the Table injuries must occur. Originally enacted in 1988
by Congress and subsequently revised by HHS with the advice of
experts, the Table identifies serious adverse events that
certain experts considered to be caused by vaccines.\17\
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\17\ ``An Overview of Vaccine Safety,'' CDC.
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The Table serves to eliminate some of the uncertainty
caused by gaps in medical knowledge by listing vaccines covered
by the program and the injuries, disabilities, illnesses, and
conditions (including death) for which compensation may be
paid. It also defines the period of time during which the first
symptom or substantial aggravation of the injury must appear.
Provided that no ``factor unrelated'' can be established by
the government as the cause of injury, adverse events that
occur within the Table are presumed to be related to and caused
by the vaccine.
By creating a framework to allow for a presumption of cause
and effect to exist for the claimant, the Table is intended to
remove much of the burden of proof required in traditional tort
proceedings. By contrast, under traditional civil litigation
practices, the injured party bears the burden of proving that
the vaccine caused injury. This presumptive feature is crucial
to the integrity of a no-fault, expedited vaccine injury
compensation system, and this approach to vaccine relatedness
was intended as a guiding principle for the Vaccine
Compensation Program.
Alternative presumptions of cause and effect procedure
already exist in other Federal health and benefit programs. For
example, the Veterans Health Care Eligibility Reform Act of
1996 (Public Law 104-262) (Veterans Health Care Act) requires
the Department of Veterans Affairs [VA] to furnish hospital
care and medical services, and may furnish nursing home care to
veterans exposed to herbicides in Vietnam. For an Agent-Orange-
based claim by a Vietnam veteran for service-connected
benefits, the Veterans Health Care Act requires:
A medical diagnosis of a disease which VA
recognizes as being associated with Agent Orange [specified
diseases];
Competent evidence of service in Vietnam or
offshore in the adjacent waters between 1962 and 1975; and
Competent medical evidence that the disease began
within the deadline (if any).\18\
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\18\ Agent Orange Review, Department of Veterans Affairs, Vol. 16,
No. 1 (May 2000).
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Vaccine Adverse Event Reporting System
The Act mandates that all health care providers report
certain adverse events following vaccination to the Vaccine
Adverse Event Reporting System [VAERS]. VAERS was established
by the Food and Drug Administration [FDA] and CDC in 1990 to
provide a unified mechanism for the collection and analysis of
adverse events associated with vaccines currently licensed in
the United States. Reportable vaccine adverse events are
defined as health effects that occur after immunization that
may or may not be related to the vaccine.\19\ 16
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\19\ ``An Overview of Vaccine Safety,'' CDC, p. 4.
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VAERS is a passive surveillance system, a repository for
voluntarily submitted reports. An active surveillance system,
by contrast, would follow all individuals in a defined
population to determine their responses to vaccinations. The
VAERS reporting form is designed to allow a narrative
description of adverse events.
To encourage reporting of any possibly vaccine-induced
adverse event, the criteria for reporting to VAERS is
nonrestrictive; the system accepts and includes any report
submitted, no matter how tenuous the possible connection with
vaccination might seem. All persons, including patients,
parents and health professionals can report to VAERS with no
restrictions on onset intervals or requirements for medical
care.
The Act does require that physicians report--directly to
VAERS or to the manufacturer--certain categories of serious
outcomes defined for regulatory purposes as an event resulting
in death, life-threatening illness, hospitalization,
prolongation of existing hospitalization, or permanent
disability.
VAERS is intended to serve as the ``front line'' of vaccine
safety, since this type of national reporting system can
rapidly document possible effects and generate early warning
signals that can then be more rigorously investigated in
focused studies. VAERS is considered especially valuable in
assessing the safety of newly marketed vaccines.
Vaccine Safety Datalink Project
The gaps that exist in the scientific knowledge of rare
vaccine side effects prompted the CDC to develop the Vaccine
Safety Datalink [VSD] project in 1990. This project involved
forming partnerships with four large health maintenance
organizations [HMOs] to continually monitor vaccine safety. VSD
is an example of a large-linked database [LLDB] and includes
information on more than 6 million people.
All vaccines administered within the study population are
recorded. Available data includes vaccine type, date,
manufacturer, lot number concurrent vaccinations (those given
during the same visit) and injection site. Medical records are
then monitored for potential adverse events.
The VSD project allows for planned vaccine safety studies
as well as timely investigations of hypotheses. At present, the
VSD project is examining potential associations between
vaccines and 34 serious conditions. The database is also being
used to test new vaccine safety hypotheses and issues from the
medical literature, VAERS, changes in the immunization schedule
or from the introduction of new vaccines.
III. Vaccine Injury Compensation Program Issues
Vaccine Injury Table Changes
The Childhood Vaccine Injury Act of 1986 (the Act)
established the first Vaccine Injury Table (the Table) as an
interim compromise until more scientific information became
available, and granted the Secretary rulemaking authority to
amend the Table at such time, bringing it more in line with
current science. It also called for IOM to assist the Secretary
in making changes by conducting a review of medical studies.
HHS exercised its rulemaking authority to amend the Table
and the Aids to Interpretation in 1995 and again in 1997,
following the publication of IOM studies in 1991 and 1994,
respectively. In the reports, IOM identified certain conditions
that were 1) consistent or inconsistent with a causal
relationship; 2) those that favored or did not favor a causal
relationship; and 3) those where evidence was insufficient to
indicate the presence or absence of a causal relationship. Most
conditions fell in the third category, as IOM concluded there
was insufficient medical evidence to prove or disprove a
relationship between vaccines and two-thirds of the 75 medical
conditions studied.
In conjunction with public policy considerations provided
by the ACCV, scientific issues raised by the NVAC, and input
from the public, the Secretary added seven injuries and removed
three others from the Table while altering definitions in the
Aids to Interpretation. These revisions made it easier for some
petitioners to obtain compensation, but more difficult for a
larger number of petitioners.
Far more claims were associated with the injuries removed
from the Table than were associated with the injuries that were
added. Prior to the Table revisions, three quarters of the
claims alleged injuries on the Table, after the revisions were
implemented, more than half of the claims filed were Table
injuries. Of note, almost half of past claims awarded
compensation were for injuries subsequently removed from the
Table.\20\
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\20\ ``Vaccine Injury Compensation Program,'' GAO/HEHS-00-8, p. 13.
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Under current practices, modifications of the Table largely
determine the types of claims for which compensation will be
awarded. Historically, injury claims not covered under the
Table tend to be approved for compensation far less often than
Table injuries, and the compensation amounts are considerably
lower.\21\ Thus, in administering and refining the Table, HHS
defines the parameters of compensation coverage, and is able to
limit liability through administrative changes. The
justifications for some changes have been criticized by some
patients, members of the petitioner's bar, and others.
---------------------------------------------------------------------------
\21\ ``Vaccine Injury Trust Fund,'' GAO, p. 19.
---------------------------------------------------------------------------
Recently, GAO concluded, ``Where science is insufficient to
determine causal relationships between a vaccine and injuries,
it is not clear that HHS' criteria and approach to making
injury table changes are consistent.'' \22\
---------------------------------------------------------------------------
\22\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, p. 19.
---------------------------------------------------------------------------
Discussing amendments to the Table, HHS cites the following
four factors: IOM findings (and subsequent medical studies);
biologic plausibility; recommendations from the Advisory
Council on Childhood Vaccines [ACCV] and the National Vaccine
Advisory Committee [NVAC]; and prevalence of the condition in
the population attributable to vaccines. However, GAO findings
conclude that: ``In communicating its decisions to the public,
HHS does not uniformly discuss each of these factors, and the
reasons why the relative importance of each factor varies among
the decisions is not apparent in all cases.'' \23\ GAO noted:
---------------------------------------------------------------------------
\23\ Ibid., p. 22.
The Institute of Medicine (IOM) found that existing
scientific evidence favored acceptance of a causal
relationship between tetanus vaccines and brachial
neuritis, and HHS added that condition to the injury
table. On the other hand, the Institute also found
evidence of a causal relationship between the tetanus
and oral polio vaccines and Guillain-Barre syndrome,
but HHS did not add this condition to the injury table.
The IOM found the evidence inadequate to accept or
reject a causal relation between vaccines and residual
seizure disorder, and HHS removed this condition from
the injury table. The Institute also found evidence
inadequate to accept or reject a causal relation
between the measles and mumps vaccines and
encephalopathy, yet HHS left this condition on the
injury table.
HHS stated in the Federal Register that decisions not
to add injuries, such as Guillain-Barre syndrome, or to
remove injuries, such as residual seizure disorder,
were based to some extent on the level of risk in
compensating an inordinate number of non-vaccine-
related cases for the extremely rare vaccine-related
case. In applying this criterion, however, HHS'
assumptions about the number of potential claims and
thresholds for deciding the reasonable level of
financial risk for compensating non-vaccine-related
injuries were not defined.\24\
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\24\ ``Vaccine Injury Compensation,'' GAO/HEHS-00-8, p. 15.
Accordingly, criticisms have been expressed that certain
procedural actions taken by HHS in revising the Table were
inconsistent with the intent of Congress. Some changes have
been made to the Table restricting compensation coverage for
reasons of both science and policy. It is the view of many in
the medical community that the Table, with its near-
determinative effect in practice upon compensation, reflects
some of the best available scientific and epidemiological
research. Finally, current adjudication practices generally
assume that the Table reflects existing science and place
unduly restrictive causation burdens on petitioners who seek to
make claims not covered by the Table. Congress intended that a
petitioner be given a reasonable opportunity to present
evidence of vaccine injury relatedness even when the injury
does not fall within the Table.
Compensation Determination and Award Delays
The compensation process continues to take much longer than
Congress intended. The original legislation required a
judgement within 1 year and was subsequently amended to require
a decision by the Court's Special Master within 240 days. GAO
found that 30-40 percent of claims filed each year was
processed within 2 years.\25\ However, of the more than 5,000
claims filed from October 1, 1988 through February 1999, only
about 14 percent received judgment within 1 year, most did not
receive judgment within 2 years, and almost a third received
judgment in 5 or more years.\26\
---------------------------------------------------------------------------
\25\ Ibid., p. 9.
\26\ Ibid., p. 7.
---------------------------------------------------------------------------
Significant delays in adjudication reportedly resulted from
the volume of claims received for injuries that occurred prior
to October 1, 1988. As the January 31, 1991 deadline to file
these retrospective claims drew near, the number of petitions
jumped from 125 in 1989 to 3,263 in 1990, creating an immediate
and substantial backlog that continues to impact HHS.\27\
---------------------------------------------------------------------------
\27\ Ibid., p. 9.
---------------------------------------------------------------------------
Although the number of claims filed since the 1991 deadline
has dramatically decreased, the number of claims adjudicated
also has declined. The continued procedural delays, which
include suspensions at the request of petitioners, reportedly
are attributed in some instances to the government's desire to
execute a vigorous defense.
According to DOJ, the most common cause of delay is
petitioner's inability to provide required medical records that
permit a proper review of their claims. HHS data show that more
than half of all petitioners were requested to provide
supplementary medical records or other information, and most
took at least a year to do so. After all the information was
received, in most cases, it took the court over another year to
reach its decision.\28\
---------------------------------------------------------------------------
\28\ Ibid., p. 10.
---------------------------------------------------------------------------
Petitions claiming injuries ``off Table,'' or not listed on
the Table, account for some delays. According to the Chief
Special Master, whether cases proceed under the Table or as
causation-in-fact cases correlates directly to the amount of
time, the number of issues presented, and the cost of
processing cases. He explains that, prior to the enactment of
the Table changes, the vast majority of cases (well over 90
percent) proceeded pursuant to the Table and were resolved
quickly. ``Causation'' cases take longer as more specialized
experts are required, more legal and medical issues are
presented, hearings are longer, concessions are fewer, and
decisions are far more difficult, lengthy and time intensive.
The duration of case proceedings and adjudications could
increase if the number of non-Table injury cases increases.
Adversarial Process
As the DOJ has pursued aggressive defenses in compensation
cases, entitlement and compensation determinations have been
perceived by some petitioners as being inappropriately
adversarial in nature. According to a GAO report, the
availability of more funds has enabled DOJ to ``establish a
cadre of attorneys specializing in vaccine injury.'' According
to DOJ, there are 16 trial attorneys in the vaccine
compensation program. HHS ``established an expert witness
program'' to challenge claims.\29\ It is also important to note
that Program procedural changes may need approval from the
Court.
---------------------------------------------------------------------------
\29\ ``Vaccine Injury Trust Fund,'' GAO/HEHS-0067, p. 10.
---------------------------------------------------------------------------
During our September 28, 1999 hearing, the Subcommittee on
Criminal Justice, Drug Policy, and Human Resources (the
subcommittee) received testimony from petitioners, their
experts and attorneys charging that the governments' defense
has, in the words of one witness, ``become increasingly
stubborn and aggressive, to the point that in its spirit, it is
now indistinguishable from the adversarial manner in which some
civil lawsuits are conducted.''
DOJ asserts that many attorneys in the petitioners' bar
speak highly of the compensation process and the cooperative
efforts of government counsel. Contrary to DOJ's views, critics
cite a number of questionable practices by DOJ, even with the
sanction of the Court, appeals resulting in multiple
entitlement hearings, aggressive use by government of expert
witnesses and investigators, and highly adversarial conduct
aimed at impeaching petitioner experts. Other criticisms are
noted below:
DOJ attorneys make full use of the apparently
limitless resources available to them. They substitute
one expert for another if the opinion rendered by the
first is unfavorable or seems not to impress the court,
essentially replacing one theory for another, or
recruit multiple experts for a single case. Multiple
entitlement hearings result. According to DOJ, the
Government has only appealed one case to the Federal
Circuit Court of Appeals since 1995, and also contends
that petitioner's experts are numerous.
If a Court decision is unfavorable, DOJ may
repeat arguments during the Damages Hearing that fail
during the entitlement phase, thus making the process
of awarding due compensation unnecessarily contentious
and burdensome.\30\
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\30\ Hearing statement by Dr. Marcel Kinsbourne.
---------------------------------------------------------------------------
Marks v. Sec. HHS has been criticized. ``In
the special master's view, [respondent's] counsel's
abrasive, tenacious, obstreperous litigation tactics
were inappropriate in a program that is intended to be
less adversarial; and hindered greatly a fair,
expeditious resolution of the case. In addition,
counsel lacks simply tact and compassion. Quite
frankly; the special master is embarrassed that
respondent's counsel and respondent's life care planner
represented the United States Government in this
case.'' \31\ DOJ claims this case was highly
exceptional, and the attorney's conduct was reviewed.
---------------------------------------------------------------------------
\31\ Decision of Special Master Edwards, Marks v. Sec HHS, p. 15.
---------------------------------------------------------------------------
Finally, DOJ indicated to the subcommittee that no DOJ
attorneys handling vaccine injury cases had received formal
training in Alternative Dispute Resolution [ADR] techniques and
practices prior to the subcommittee hearing on this topic.
Since the hearing, DOJ reports that all attorneys assigned to
vaccine compensation cases have been trained in ADR and that
efforts are underway to utilize ADR more fully. DOJ also has
suggested the addition of a Court rule requiring consideration
of voluntary ADR in all cases.
Sovereign Immunity
The doctrine of sovereign immunity generally prevents the
Federal Government from being sued without its consent. In
interpreting legislation, courts may consider whether there has
been a waiver of immunity with respect to a particular type of
litigation against the United States.
One canon of statutory construction is that a waiver of
sovereign immunity must be definitively and unequivocally
expressed. A second one is that the statutory language setting
forth a waiver is to be construed strictly in favor of the
government. Yet another principle of statutory construction
regarding remedial or ``welfare'' legislation is that courts
give a liberal interpretation to further the remedial or
humanitarian purposes underlying the statute.
Because the Act authorizes suits and monetary awards
against the United States, the doctrine of sovereign immunity
has been interpreted and applied by Special Masters. With
respect to the Act, which is ``remedial'' in nature and waives
the Federal Government's immunity from suit, the sovereign
immunity doctrine has been used to ``trump'' competing remedial
constructions and provide a rationale for restricting
compensation awards.\32\
---------------------------------------------------------------------------
\32\ Decision of Special Master Hastings in Childers v. HHS, pp. 3-
11.
---------------------------------------------------------------------------
Petitioners' representatives argue that the remedial intent
of the Act to provide generous compensation should prevail.
Some argue that the waiver of sovereign immunity is not
applicable technically since the Secretary simply administers a
trust funded through a vaccine tax. Some critics of current
practices have called for an express provision to nullify the
application of the doctrine of sovereign immunity. The
committee is concerned that the doctrine should be applied in
an appropriate manner, consistent with the remedial purposes of
the Act.
Compensation Trust Fund
Historically, the vaccine injury compensation trust fund
(the Trust fund) has received more in vaccine excise taxes than
it has paid out for claims and related administrative costs.
Because the fund has spent only about $347 million of the $1.37
billion accrued through fiscal year 1999; the remaining
approximately $1 billion was loaned to the Treasury and used
for other Federal programs and activities in exchange for
Treasury securities. Interest on these securities now totals
approximately $435 million. The interest in addition to the $1
billion loaned to the Treasury make up the $1.46 billion
balance accrued by the end of fiscal year 1999, representing a
very substantial unused reserve.
Unless changes in the administration of the Program are
implemented or new scientific research findings become
available, this trend of revenue exceeding expenditures could
continue, while compensation awards are increasingly difficult.
At current rates, the Congressional Budget Office projects that
in the next 10 years, the fund will double in size.
The limited number of compensation awards and growing fund
balance have become controversial, with various options being
considered to address the unused funds. Vaccine manufacturers
view the growing balance as an indicator that the excise tax
rate is too high and should be lowered. Petitioner families
cite the fund as evidence of the government's unwillingness to
compensate vaccine injuries and advocate a less restrictive
injury table and less burdensome compensation practices. While
the administration has not articulated a clear position on this
issue, officials from HHS have considered the fund as a
potential source of revenue for vaccine-related research or
surveillance.\33\
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\33\ ``Vaccine Injury Trust Fund,'' GAO/HEHS-0067, p. 18.
---------------------------------------------------------------------------
In the 106th Congress, Representative Ron Lewis (R-KY)
introduced H.R. 1337, the ``Vaccinate America's Children Now
Act,'' a bill to amend the Internal Revenue Code of 1986 to
reduce the tax on vaccines to 25 cents per dose. The bill has
66 cosponsors, 40 Republicans and 26 Democrats, of which 27 are
members of the Ways and Means Committee. Senator Bunning (KY)
introduced the companion bill, S. 85.
While the trust fund contains a significant sum of money,
efforts to reduce funding sources raise serious concerns. The
worldwide vaccine market is estimated soon to top $7
billion.\34\ In the United States alone, there are currently
vaccines in development against almost 60 diseases caused by
bacteria, viruses, fungi and parasites, including AIDS, malaria
and tuberculosis. Coverage for new vaccines could negatively
affect the future trust fund balance.\35\
---------------------------------------------------------------------------
\34\ ``When Vaccines Do Harm to Kids: Autism and More,'' Insight
Magazine, Feb. 4, 2000, p. 3.
\35\ ``Commonly Asked Questions About the NVICP,'' HRSA, p. 2.
---------------------------------------------------------------------------
Similarly, changes in the recommended schedule of
vaccinations, the increasing use of combination vaccines, and
the potential for emerging knowledge linking vaccines to
adverse reactions makes risk assessment increasingly difficult.
HHS has warned that the fund should not be considered an
impenetrable reserve of funds.
Options to control the growth of the trust fund could have
revenue and spending implications for the overall Federal
budget. The Budget Enforcement Act of 1990 mandates that
Congress offset the cost of legislation that reduces revenue or
increases spending by establishing new or higher taxes
elsewhere or by decreasing spending for other programs.\36\
---------------------------------------------------------------------------
\36\ ``Vaccine Injury Compensation Fund,'' GAO report, p. 19.
---------------------------------------------------------------------------
Vaccine Adverse Events Reporting System
Typically, vaccine safety studies that are epidemiological
based make inferences from the absence of specific problems.
Therefore, it is important to examine and consider surveillance
and risk management systems and practices.
While the Vaccine Adverse Events Reporting System [VAERS]
may be lauded as the ``front line'' of vaccine safety, the lack
of enforcement provisions and effective monitoring of reporting
practices preclude accurate assessments of the extent to which
adverse events are actually reported. Former FDA Commissioner
David A. Kessler has estimated that VAERS reports currently
represent only a fraction of the serious adverse events.
The quality of VAERS data has been questioned. Because
reports are submitted from a variety of sources, some
inexperienced in completing data forms for medical studies,
many reports omit important data and contain obvious errors.
Assessment is further complicated by the administration of
multiple vaccines at the same time, following currently
recommended vaccine schedules, because there may be no
conclusive way to determine which vaccine or combination of
vaccines caused the specific adverse event.
As a database for epidemiological studies, VAERS has
serious weaknesses. One major problem is that since
unvaccinated people experiencing adverse events are not
reported to VAERS, there is no control group to study. Given
that over 10,000 reports are filed annually, it is difficult to
assure the accuracy and completeness of the database. IOM
recognizes that there are limits to the detection and response
systems currently in use. In a forum convened on this subject,
they concluded: ``[E]fforts can be made to improve the
quantity, quality, accessibility, and usefulness of VAERS
reports.'' \37\
---------------------------------------------------------------------------
\37\ ``Detecting and Responding to Adverse Events Following
Vaccination: Workshop Summary,'' by Cynthia J. Howe, Richard B.
Johnston, and Gerald M. Fenichel, editors, November 1995.
---------------------------------------------------------------------------
Conflicting Roles and Responsibilities
Within Congress, there is bipartisan concern over dual
responsibilities and potential conflicting interests in HHS
drug development and delivery. Regarding vaccines, HHS conducts
and encourages vaccine research on the one hand and is the lead
agency within the Federal Government for the promotion of
vaccination programs. HHS also administers the Vaccine Injury
Compensation Program ([VICP] or the Program). Critics charge
these responsibilities may conflict.
Under HHS, the CDC Advisory Committee on Immunization
Practices [ACIP] makes recommendations for the routine
administration of vaccines along with schedules regarding
appropriate periodicity, dosage, and contraindications. The
ACIP recommends vaccine purchases by CDC. The Food and Drug
Administration's Vaccine and Related Biological Products
Advisory Committee [VRBPAC] is responsible for supporting
applications for licensure of vaccines.
Because of the importance of preserving the public health
through the use of safe and effective vaccines, maintaining the
highest level of integrity over the entire spectrum of vaccine
development and implementation is critical, and opportunities
for conflicting roles and interests should be avoided whenever
possible.
IV. Legislative Proposals
Proposals Endorsed by HHS and DOJ
The Advisory Commission on Childhood Vaccines [ACCV] has
recommended that the HHS Secretary propose changes to the
Public Health Service Act and the Internal Revenue Code that
would improve the VICP. One of these proposals, the elimination
of the requirement that claimants must have incurred non-
reimbursable expenses in excess of $1,000 to file a petition
for compensation, was signed into law on October 22, 1998. The
remainder of the recommendations have been incorporated into a
bill and sent to the Congress for its consideration. These
include:
Extend the current statute of limitations from
3 years for injury claims and 2 years for death claims,
to 6 years for those claiming injury or death resulting
from a covered vaccine.
Allow for the inclusion of family counseling
expenses in VICP awards.
Add a phrase to specifically allow for the
inclusion of reasonable fees and costs associated with
the establishment of a guardianship or conservatorship
in the definition of ``other costs.''
Allow for an interim payment of costs incurred
in adjudicating a post-1988 claim under the VICP after
a finding as to entitlement is established. Such an
interim payment would be made prior to entry of a final
judgment and upon a finding that there was good faith
and a reasonable basis for the claim.
Establish a specific method of calculating
lost earnings under VICP.
Eliminate requirement that ACCV meet at least
four times annually.
Change the rulemaking process for amending the
Table by reducing the period for public comment from
180 days to 60 days, and eliminating the requirement
for a public hearing.
Clarify the Scope of the term ``Factors
Unrelated'' as it applies to determining eligibility
and compensation.
Expand criteria for one of the two reserved
general public seats on the ACCV under Section
2119(a)(1)(B) of the Public Health Service Act to
include individuals who have suffered a vaccine-related
injury either as children or as adults.
Allow the U.S. Court of Federal Claims the
discretion to provide for a check for attorneys' fees
and costs awarded under section 2115(e) to be made
payable solely to the attorney for the petitioner.
Increase to $10,000,000 the limitation on the
amount that may be expended for payment of
administrative expenses related to the operation of the
VICP from the Vaccine Injury Compensation Trust Fund.
The following amendment, which the ACCV did not have the
opportunity to review, was added to the Department's proposed
bill by the Department of Treasury:
Allow use of the Vaccine Injury Compensation
Trust Fund to pay expenses incurred by the Bureau of
the Public Debt in providing financial services to the
Trust Fund.
Additional Proposals
Among recently recommended legislative reforms brought to
the attention of the subcommittee are the following:
Senator Daschle (D-SD) introduced a bill, S. 992, ``to
provide technical amendments to the Vaccine Injury Compensation
Trust Fund.'' The bill repealed certain mutually conflicting
amendments within Public Law 105-277, ``Omnibus Consolidated
and Emergency Supplemental Appropriations Act of 1999.'' The
change eliminates confusion regarding compensability of
petitions based on certain administrations of any of the three
vaccines added to coverage under the program in 1997. In
addition, the bill removes the requirement that at least $1,000
in non-reimbursable expenses be incurred prior to acceptance of
the petition for consideration.
Representative Ron Lewis (R-KY) introduced H.R. 1337, ``a
bill to amend the Internal Revenue Code of 1986 to reduce the
tax on vaccines to 25 cents per dose.'' This is identical to
the bill introduced as H.R. 1337, entitled the ``Vaccinate
America's Children Now Act.'' This bill has 66 cosponsors, 40
Republicans and 26 Democrats, of which 27 are members of the
Ways and Means Committee. Strong support for this proposal also
was seen in the 105th Congress within the Ways and Means
Committee and the Senate Finance Committee. Senator Bunning (R-
KY), introduced a companion bill in the Senate, S. 85, with six
cosponsors and more expected.
Representative Marcy Kaptur (D-OH) introduced H.R. 1003,
``a bill to amend the Public Health Service Act to revise the
filing deadline for certain claims under the National Vaccine
Injury Compensation Program.'' The language in the bill is the
same as in the bill she introduced in the 105th Congress as
H.R. 3778. Her proposal is to amend the criteria defining the
starting point for the time period in which a petition for
compensation may be filed. Currently, the timeframe is 36
months beginning with ``the date of the occurrence of the first
symptom or manifestation of onset or of the significant
aggravation of such injury.'' This bill retains the 36-month
time period, but allows the period to commence on the date a
diagnosis of vaccine injury is made. Eight other Democrats were
added as cosponsors.
Representative Nancy Pelosi (D-CA) introduced H.R. 1274, a
bill to ``amend the Internal Revenue Code of 1986 to provide a
credit for medical research related to developing vaccines
against widespread diseases.'' The ``Lifesaving Vaccine
Technology Act of 1999'' would provide a tax credit equal to 30
percent of the qualified vaccine research expenses for the
taxable year. The vaccine research covered would include
development of vaccines and microbicides for malaria,
tuberculosis, HIV, or any infectious disease (of a single
etiology) which, according to the World Health Organization,
causes over 1 million human deaths annually. This bill had
eight cosponsors, all Democrats, including five members of the
Ways and Means Committee.
On May 26, Senator Roth (R-DE) introduced S. 1134, the
``Affordable Education Act of 1999.'' This original measure was
reported out of the Finance Committee and placed on the Senate
Legislative Calendar under General Orders. Section 410,
``Inclusion of Certain Vaccines Against Streptococcus
Pneumoniae to List of Taxable Vaccines,'' would amend Section
4132(a)(1) of the Internal Revenue Code by adding a new
subparagraph as follows: ``(L) Any conjugate vaccine against
streptococcus pneumoniae.'' The standard excise tax would be
collected on all sales of such vaccines on the day after the
date on which the Centers for Disease Control and Prevention
officially recommends routine administration of this vaccine to
children. The vaccine has yet to be licensed by the Food and
Drug Administration.
V. Congressional Hearings
Subcommittee Hearings
On May 18, 1999, the Subcommittee on Criminal Justice, Drug
Policy, and Human Resources held the first of its two hearings
on vaccines entitled, ``Hepatitis B Vaccine: Helping or Hurting
Public Health?'' The hearing examined the safety of the
hepatitis vaccine, the adequacy of disclosure prior to vaccine
administration and the efficacy of the FDA's Vaccine Adverse
Event Reporting System. The subcommittee heard testimony from
Congressman John Joseph Moakley (D-MA) who has experienced
hepatitis B, and from other individuals and families claiming
vaccine injuries. Witnesses included: Michael Belkin; Judy
Converse; Marilyn and Lindsay Kirschner; Barbara Haun; Karen w/
PKIDS; and Betty Fluck. Medical experts included: Dr. Sam Katz,
Infectious Disease Society; Dr. Burton Waisbren, Sr., F.A.C.P.;
and Dr. Bonnie Dunbar, molecular biologist, Baylor College of
Medicine. Advocates of vaccine reform included: Thelma Thiel,
chairman and CEO of the Hepatitis Foundation International; and
Barbara Loe Fisher, president, National Vaccine Information
Center. Representing the government were: Harold Margolis,
Chief, Hepatitis Branch, CDC; and Susan Ellenberg, Director of
Bio-Statistics and Epidemiology Division, Food and Drug
Administration.
On September 28, 1999, the subcommittee convened a hearing
entitled, ``Compensating Vaccine Injuries: Are Reforms
Needed?'' The hearing examined the Program's operations
including: adversarial procedures, evidentiary and adjudicative
standards, and funding. Testimony was received from:
petitioners (Michele Clements and Linda Mulhauser); reform
advocates (John Salamone, president, Informed Parents Against
VAPP, and Cliff Shoemaker, attorney, Shoemaker & Horn); medical
experts (Dr. Marcel Kinsbourne, Tufts University, and Dr.
Arnold Gale, Stanford University); and government witnesses
(Thomas E. Balbier, Jr., Director, National Vaccine Injury
Compensation Program, Department of Health and Human Services,
and John L. Euler, Deputy Director Torts Branch, Civil
Division, Department of Justice).
The House Committee on Government Reform Hearings
The Committee on Government Reform conducted the following
hearings relative to vaccines, which are not discussed in this
report:
``Vaccines--Finding the Balance Between Public Safety and
Personal Choice,'' August 3, 1999;
``Defense Vaccines: Force Protection or False Security?''
October 12, 1999;
``Autism--Present Challenges, Future Needs--Why the
Increased Rates?'' April 6, 2000;
``FACA: Conflicts of Interest and Vaccine Development--
Preserving the Integrity of the Process?'' June 15, 2000; and,
``Mercury in Medicine--Are We Taking Unnecessary Risks?''
July 18, 2000.