U.S. GOVERNMENT PRINTING OFFICE

67–173 CC WASHINGTON : 2000

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

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS III, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, District of

Columbia

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

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

BENJAMIN A. GILMAN, New York

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

ASA HUTCHINSON, Arkansas

DOUG OSE, California

DAVID VITTER, Louisiana

PATSY T. MINK, Hawaii

EDOLPHUS TOWNS, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

JANICE D. SCHAKOWSKY, Illinois

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.

(III)

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

(V)

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

2

1 ‘‘Vaccine Injury Compensation: Program Challenged to Settle Claims Quickly and Easily,’’

GAO/HEHS–00–8 (December 1999), p. 1. 2 Ibid., p. 4.

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.

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.

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.

3

3 ‘‘Vaccine Injury Compensation,’’ GAO/HEHS–00–8, pp. 4 and 5.

4 Ibid., p. 5.

5 ‘‘Vaccine Injury Compensation Program,’’ GAO/HEHS–00–8, p. 5.

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

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 vaccinerelated 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

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

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 ProVerDate 11-MAY-2000 20:01 Oct 12, 2000 Jkt 067173 PO 00000 Frm 00007 Fmt 6659 Sfmt 6601 E:\HR\OC\HR977.XXX pfrm01 PsN: HR977
4

6 Ibid., pp. 3–9.

7O’Connell v. Shalala, 79 F.3d 170 (1st Cir. 1996). 8 ‘‘Vaccine Injury Compensation Program,’’ GAO/HEHS–00–8, p. 13.

gram. Retrospective claims are paid from general fund appropriations.6

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

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

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

5

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

6

9 Research Strategies for Assessing Adverse Events Associated with Vaccines (National Academy Press, 1994). 10 1996 IOM Vaccine Safety Forum. 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).

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

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.

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.

7

12 ‘‘Commonly Asked Questions About the NVICP,’’ HRSA. 13 ‘‘Vaccine Injury Compensation Program,’’ GAO/HEHS–00–8, p. 5. 14 ‘‘Commonly Asked Questions About NVICP,’’ p. 4.

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.

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

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

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-infact.’’ 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 sciVerDate 11-MAY-2000 20:01 Oct 12, 2000 Jkt 067173 PO 00000 Frm 00011 Fmt 6659 Sfmt 6601 E:\HR\OC\HR977.XXX pfrm01 PsN: HR977
8

15 House of Representatives Rept. No. 99–908 (1986), p. 5. 16 ‘‘Vaccine Injury Compensation,’’ GAO/HEHS–00–8, p. 12. 17 ‘‘An Overview of Vaccine Safety,’’ CDC.

entific 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

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

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];

9

18 Agent Orange Review, Department of Veterans Affairs, Vol. 16, No. 1 (May 2000). 19 ‘‘An Overview of Vaccine Safety,’’ CDC, p. 4.

• 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

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

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, lifethreatening 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.

10

20 ‘‘Vaccine Injury Compensation Program,’’ GAO/HEHS–00–8, p. 13. 21 ‘‘Vaccine Injury Trust Fund,’’ GAO, p. 19.

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

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

11

22 ‘‘Vaccine Injury Compensation,’’ GAO/HEHS–00–8, p. 19. 23 Ibid., p. 22. 24 ‘‘Vaccine Injury Compensation,’’ GAO/HEHS–00–8, p. 15.

criticized by some patients, members of the petitioner’s bar, and

others.

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

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:

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

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

12

25 Ibid., p. 9. 26 Ibid., p. 7. 27 Ibid., p. 9. 28 Ibid., p. 10.

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

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

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

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 nonTable injury cases increases.

ADVERSARIAL PROCESS

As the DOJ has pursued aggressive defenses in compensation

cases, entitlement and compensation determinations have been perVerDate 11-MAY-2000 20:01 Oct 12, 2000 Jkt 067173 PO 00000 Frm 00016 Fmt 6659 Sfmt 6601 E:\HR\OC\HR977.XXX pfrm01 PsN: HR977
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29 ‘‘Vaccine Injury Trust Fund,’’ GAO/HEHS–0067, p. 10. 30 Hearing statement by Dr. Marcel Kinsbourne. 31Decision of Special Master Edwards, Marks v. Sec HHS, p. 15.

ceived 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.

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

• 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.

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

14

32Decision of Special Master Hastings in Childers v. HHS, pp. 3–11.

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

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 conVerDate 11-MAY-2000 20:01 Oct 12, 2000 Jkt 067173 PO 00000 Frm 00018 Fmt 6659 Sfmt 6601 E:\HR\OC\HR977.XXX pfrm01 PsN: HR977
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33 ‘‘Vaccine Injury Trust Fund,’’ GAO/HEHS–0067, p. 18. 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. 36 ‘‘Vaccine Injury Compensation Fund,’’ GAO report, p. 19.

sidered 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

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

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

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 imVerDate 11-MAY-2000 20:01 Oct 12, 2000 Jkt 067173 PO 00000 Frm 00019 Fmt 6659 Sfmt 6601 E:\HR\OC\HR977.XXX pfrm01 PsN: HR977
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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.

portant 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

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:

17

• 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.

18

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

19

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.

Æ