| Background
In the early 1980's, 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 Department of Health and Human Services
(HHS), the U.S. Court of Federal Claims (the Court), and the 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 constant
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 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 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 are often represented by an attorney (which is not a
requirement). The Secretary of HHS is named as the Respondent. The time for filing
claims for injuries resulting from vaccines administered prior to October 1, 1988
has expired. 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:
- 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.
- 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
Respondent�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, please write to the National Vaccine
Injury Compensation Program, Parklawn Building, 5600 Fishers Lane, Room 8A-46,
Rockville, Maryland 20857, or visit our website at: www.hrsa.gov/bhpr/vicp, or contact us
toll-free at (800) 338-2382. For information on the Rules of the Court, including
requirements for filing a petition, write to the Clerk, U.S. Court of Federal Claims,
717 Madison Place, N.W., Washington, D.C. 20005, or telephone (202) 219-9657.
Vaccine Injury Table (effective 12/18/99)
|
|
|
Tetanus-containing
(DTaP, DTP, DT, Td, TT) |
Anaphylaxis or anaphylactic shock |
0-4 hours |
| Brachial neuritis |
2-28 days |
Pertussis-containing
(DTaP, DTP, P, DTP-Hib) |
Anaphylaxis or anaphylactic
shock |
0-4 hours |
| Encephalopathy |
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 |
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 (unconjugated) |
Early-onset Hib disease |
0-7 days |
| Hib (conjugate) |
No condition specified |
Not applicable= |
| Varicella |
No condition specified |
Not applicable= |
| Rotavirus |
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. |
| == |
Any new vaccine recommended by the CDC for routine
administration to children after publication by the Secretary,
HHS, of a notice of coverage. Please note: pneumococcal conjugate vaccines are
included in this category with an effective date of December
18, 1999. For additional information, please consult HHS� regulations governing
the VICP, located at 42 C.F.R. Part 100.
Last updated: September 27, 2001
|
|
