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NATIONAL
VACCINE INJURY COMPENSATION PROGRAM FACT
SHEET Background In
the early 1980s, reports of harmful side effects following the DTP (diphtheria,
tetanus, pertussis) vaccine posed major liability concerns for vaccine companies
and health care providers, and caused many to question the safety of the DTP vaccine.
Parents began filing many more lawsuits against vaccine companies and health care
providers. Vaccination rates among children began to fall and many companies that
develop and produce vaccines decided to leave the marketplace, creating significant
vaccine shortages and a real threat to the Nation's health. The
dilemma facing the nation was so great that Congress decided to act. A coalition
of physicians, public health organizations, leaders of industry, government representatives
and private citizens developed the idea of a no-fault alternative to the tort
system for resolving vaccine injury claims. Lawmakers passed the National Childhood
Vaccine Injury Act of 1986 (P. L.99-660), which established the National Vaccine
Injury Compensation Program (VICP). The
VICP is administered jointly by the U.S. Department of Health and Human Services
(HHS), the U.S. Court of Federal Claims (the Court), and the U.S. Department of
Justice (DOJ). The VICP is located in the Division of Vaccine Injury Compensation,
Health Resources and Services Administration, HHS. Overview
Congress created
the VICP to ensure an adequate supply of vaccines, stabilize vaccine costs, and
establish and maintain an accessible and efficient forum for individuals thought
to be injured by childhood vaccines. The VICP, which went into effect on October
1, 1988, is a no-fault alternative to the traditional tort system for resolving
vaccine injury claims, whether the vaccine is administered in the public or private
sector. Since its inception, the VICP has been a key component in stabilizing
the U.S. vaccine market by providing liability protection to both vaccine companies
and health care providers, by encouraging research and development of new and
safer vaccines, and by providing for a more streamlined and "less adversarial"
alternative to the traditional tort system for resolving claims. The VICP covers
all vaccines recommended by the Centers for Disease Control and Prevention for
routine administration to children. The vaccines currently covered include: diphtheria,
tetanus, pertussis (DTP, DTaP, DT, TT or Td), measles, mumps, rubella (MMR
or any components), polio (OPV or IPV), hepatitis B, haemophilus influenza
type b (Hib), varicella, rotavirus, and pneumococcal conjugate.
The 9-member
Advisory Commission on Childhood Vaccines (ACCV) provides oversight of the VICP.
Members recommend ways to improve the VICP, including changing the Vaccine Injury
Table, proposing legislation, covering new and safer childhood vaccines, gathering
information about vaccine-related injuries from Federal, State, and local immunization
programs, and revising vaccine information statement and adverse reaction reporting
requirements. The
Vaccine Injury Table There
are three means of qualifying for compensation: 1) a petitioner must show that
an injury listed on the Vaccine Injury Table (the Table) occurred; 2) a petitioner
must prove that the vaccine significantly aggravated a pre existing condition;
or 3) a petitioner must prove that the vaccine caused the condition. The
Table (see page 3) lists specific injuries or conditions and the time frames in
which they must occur after vaccine administration. The Table is a legal mechanism
for defining complex medical conditions and allows a statutory "presumption
of causation." The Table serves as the basis for presumptions of causation
for vaccines covered under the VICP. It is much easier to demonstrate a Table
injury than to prove that the vaccine caused the condition. However, if an adverse
event is not listed on the Table, an individual may still file a claim but must
prove that the vaccine did "in fact" cause the alleged injury. Compensation
may not be awarded if the Court determines that the injury or death was due to
an alternative cause unrelated to the vaccine, even if a Table injury is demonstrated. Filing
a Claim An
individual claiming a vaccine-related injury or death files a petition for compensation
with the Court, and is often represented by an attorney (which is not a requirement).
The Secretary of HHS is named as the Respondent. As of February 1, 1991, the time
has expired for filing claims for injuries resulting from vaccines administered
prior to October 1, 1988. Any claims filed for that time period are subject to
dismissal by the Court. For injuries or deaths resulting from a vaccine administered
on or after October 1, 1988, the following restrictions apply:
a. In the case of an injury,
the claim must be filed within 36 months after the first symptoms appeared. The
effects of the injury must have lasted at least 6 months after the vaccine administration,
or the injury must have resulted in inpatient hospitalization and surgical intervention.
b. In the case of a death, the claim must be filed within 24 months of the death,
and within 48 months after the onset of the vaccine-related injury from which
the death occurred. An
HHS physician reviews each petition to determine whether it meets the medical
criteria for compensation. This recommendation is provided to the Court through
a Responden's report filed by the DOJ. The HHS position is presented by an attorney
from the DOJ in hearings before a "special master" who makes the decision
for compensation under the VICP. A special master is an attorney appointed by
the judges of the Court. Decisions may be appealed to the Court, then to the Federal
Circuit Court of Appeals, and eventually to the U.S. Supreme Court. If
a case is found eligible for compensation, the amount of the award is usually
negotiated between the DOJ and the petitioner's attorneys. If the attorneys can't
agree, the case is scheduled for a hearing for the special master to assess the
amount of compensation. Compensable claims, and even most claims found to be non-compensable,
are awarded reimbursement for attorney's fees and costs. A petitioner may file
a claim in civil court against the vaccine company and/or the vaccine administrator
only after first filing a claim under the VICP and then rejecting the decision
of the Court. Contact
Information For
further information regarding the VICP: National
Vaccine Injury Compensation Program
Parklawn Building
5600 Fishers Lane
Room 16C-17
Rockville, Maryland 20857
800-338-2382
For information on the Rules of the Court, including requirements for filing a
petition visit the Court's Website at http://www.uscfc.uscourts.gov/osmPage.htm
or contact: Clerk,
U.S. Court of Federal Claims
717 Madison Place, N.W.
Washington, D.C.
20005
202-219-9657 Vaccine
Injury Table (Effective August 26,2002)
| Vaccine |
Adverse
Event | Time
Period | | Tetanus-containing(DTaP,
DTP, DT, Td, TT) | Anaphylaxis
or anaphylactic shock | 0-4
hours | | Brachial
neuritis | 2-28
days | | Pertussis
antigen-containing (DTaP, DTP, P, DTP-Hib) | Anaphylaxis
or anaphylactic shock | 0-4
hours | | Encephalopathy
(or encephalitis) | 0-72
hours | | MMR
or in any combination (MMR, MR, M, R) | Anaphylaxis
or anaphylactic shock | 0-4
hours | | Encephalopathy | 5-15
days | | Rubella-containing
(MMR, MR, R) | Chronic
Arthritis | 7-42
days | | Measles-containing
(MMR, MR, M) | Thrombocytopenic
purpura | 7-30
days | | Vaccine-strain
measles viral infection in an immunodeficient receipt | 0-6
months | | OPV | Paralytic
polio (recipient and community contact cases) | 0-30
days/0-6 months* | | Vaccine-strain
polio viral infection | 0-30
days/0-6 months* | | IPV | Anaphylaxis
or anaphylactic shock | 0-4
hours | | Hepatitis
B | Anaphylaxis
or anaphylactic shock | 0-4
hours | | Hib
(conjugate) | No
condition specified | Not
applicable** | | Varicella | No
condition specified | Not
applicable** | | Rotavirus | No
condition specified | Not
applicable** | | Live,
oral, rhesus-based rotavirus vaccine | Intussusception | 0-30
days | | Pneumococcal
conjugate vaccines | No
condition specified | Not
applicable** | | New
vaccines | No
condition specified | Not
applicable** | *Time
intervals for immunocompetent/immunodeficient individuals who receive OPV. Contact
cases have no time limit.
**No condition has been identified requiring inclusion
on the Vaccine Injury Table; and therefore, compensation for alleged injuries
must be pursued on a causation in fact basis. Last
updated: November 2002
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