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Appendix
F
PROPOSED VACCINE-INJURY COMPENSATION SYSTEMS
This appendix summarizes a range of proposed vaccine injury
compensation schemes, including the revised National Childhood
Vaccine-Injury Compensation Act (1985) introduced by Sen. Paula
Hawkins (S. 827, 99th Congress);1 the National Childhood Vaccine-
Injury Compensation Act (1985) introduced by Rep. Edward R. Madigan
(H.R. 1780, 99th Congress); the American Medical Association's
(AMA) proposal for a National Pediatric Vaccine-Injury Compensation
Act, 1984;3 a 1983 proposal by the American Academy of Pedia-
trics;4 the proposed Vaccine-Injury Compensation Act of 1983,
introduced in the Senate by Lloyd Bentsen;5 model state legislation
proposed by the AMA in 1980;6 and al plan to create a Federal
Immunization Insurance Corporation.
Because the first two proposals were made public just prior to the
printing of this report, time was not available for comprehensive
analysis. The summaries below were derived from materials prepared by
the offices of Sen. Hawkins and Rep. Madigan, respectively.
S. 827--NATIONAL CHILDHOOD VACCINE-INJURY COMPENSATION ACT
This bill is a revised version of the National Childhood
Vaccine-Injury Compensation Act of 1983 (S. 2117, H.R. 5810, 98th
Congress) which was introduced by Sen. Hawkins and Rep. Henry Waxman
but was not enacted. It would establish a no-fault, national
program to compensate individuals who suffer permanent adverse
reaction to any of the seven mandated childhood vaccines. This
program would be an alternative to Compensation through litigation.
The bill would establish a nine-member advisory commission on
childhood vaccines to be comprised of three members who are health
professionals, including two pediatricians; three members who are from
the general public, including two who represent parents of children
inured-by vaccines; and three members of the field of law. The
advisory commission would advise the Secretary of Health and Human
Services (HHS) on the implementation of the program; recommend changes
in the Vaccine Injury Table; recommend ways to improve the~safety,
efficacy, and supply of vaccines; and recommend changes in surcharge
and research priorities.
~3
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The bill would require each health care provider administering
vaccines to record and make available to patients information about
the date of vaccination, the vaccine manufacturer, the lot number, and
serious events occurring within 30 days after vaccination. It also
would require each health care provider who administers a vaccine and
becomes aware of a listed reaction occurring within a designated
period after vaccination to enter all relevant information on the
patient's permanent medical record and report it to the Centers for
Disease Control.
Under this bill, the Secretary of HHS (after conducting broad-based
studies) would be required to issue regulations regarding
circumstances in which a vaccine should not be administered or should
be delayed beyond its normal time of administration; and the groups,
categories, or characteristics of potential recipients who may be at
significantly higher risk of adverse reactions. This information
would be disseminated to physicians, professional health associations,
and state and local governments.
The bill also would require the Secretary to develop parent
information materials containing information on the frequency,
severity, and potential risks of both the vaccine and the disease to
be prevented by the vaccine. The materials should include information
regarding the symptoms and reactions to vaccines that should be
reported to physicians, precautionary measures that should be taken to
reduce the risk of adverse reactions, when and how and to whom parents
can report any major adverse reactions; and a summary of relevant
state and federal vaccination laws, including information about the
availability of the National Vaccine-Injury Compensation Program.
Other Major Points
The proposed legislation contains several other major points:
1. Compensation would be limited to vaccine reactions resulting in
complications or residual effects lasting at least 1 year, or in death.
2. The claimant would be required to make a binding election
between the tort system and the compensation system at the time of
filing of the lawsuit or compensation claim. In the case of a current
lawsuit, parties would have 2 years after enactment to decide whether
to drop their lawsuit in favor of the administrative remedy.
3. A manufacturer could not be held liable in a lawsuit solely
because of failure to warn the parent directly. (This would not
affect the manufacturer's duty to warn the health care provider or the
health care provider's duty to warn the patient.)
4. HHS would be authorized, but not required, to provide
reinsurance, pooling assistance, and even direct insurance to vaccine
manufacturers. HHS could do this only if it found that adequate
insurance was not available from the private sector and determined
that the insurance arrangement would not undermine the incentives for
development of safer products.
5. The administrative system would have a 270-day deadline to
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reach a decision after the date of filing, and any appeals would be
required to be briefed, argued, and decided on an expedited schedule.
6. The bill would establish a National Vaccine-Injury Compensation
Trust Fund. The fund initially could borrow from general revenues,
but within 18 months of enactment, the Secretary of HHS would be
required to establish a uniform or variable annual surcharge on the
manufacturer of each vaccine covered by the act. The Secretary could
consider a variety of factors in determining the amount of each
surcharge, including the amount of compensation paid resulting from
injury or illness associated with each vaccine.
Revisions
Major differences between the new bill and S. 2117 include: the
nature of the vaccine injury table; the timing of the election of
remedies; the treatment of the statutory duty to warn; the institution
of a reinsurance provision; the setting of a deadline for the
compensation decision; the range of permissible items for
compensation; the authority for citizen suits; the mandate for a
review of manufacturers' warnings; the authority to fund facilities
for the adult multiply handicapped; the procedures for reporting of
adverse reactions; the provisions for recordkeeping and reporting of
test results by manufacturers; and the authority of the Food and Drug
Administration to recall vaccines and other biologics when warranted.
H.R. 1780--THE NATIONAL CHILDHOOD VACCINE-INJURY COMPENSATION ACT
Under the bill introduced by Rep. Madigan and Rep. James Broyhill,
all claims for vaccine-related injuries would have to be filed with
the Secretary of HHS, who would arrange for the convening of a hearing
panel. Respondents, including both manufacturers and health care
providers, would be asked to make an irrevocable election to
participate in the hearing and be bound by any award. Private hearing
panels, chosen by the parties from lists of experts compiled by the
Secretary, would consider all claims. Hearing panels would determine
whether the alleged injury was caused by a covered vaccine and would
calculate the amount of damages. Respondents would pay all costs.
The claimant must go to the panel first; if the respondent refuses to
go, the claimant can sue in court and no ceilings would apply.
Compensation
for:
Hearing panels would enter a binding award compensating claimants
· actual and projected out-of-pocket expenses, including costs
of medical and custodial care and special education and therapy
· actual and projected losses of earnings
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· pain and suffering
reasonable attorneys' fees
Compensation would be capped at $1 million per claim, with SloO,OOO
of this available for pain and suffering.
Claimants who accepted the hearing panel decision could receive
immediate compensation from respondents (jointly and severally);
disputes about their appropriate shares of the award would be handled
in separate litigation for contribution or indemnity, without delaying
payment to the claimant.
Claimants could reject hearing panel decisions for any reason or
for no reason. Claimants who rejected hearing panel decisions could
file civil actions for damages, but they would have to meet the
standards of liability and proof set by otherwise applicable state or
federal laws. The hearing panelts decision would be admissible in
evidence. The statutory ceilings on awardable compensation would
apply to any such actions, but they would not apply with respect to
respondents who had declined to participate in the hearing panel
proceedings.
AMA' S PROPOSED NATIONAL PEDIATRIC VACCINE-INJURY COMPENSATION ACT
The purposes of this proposal are:
1. To assure the continued development and availability of
pediatric vaccines;
2. To assure the continued participation of physicians and other
qualified persons in the administration of pediatric vaccines;
3. To encourage and assure appropriate immunization of all
children; ~
4. To promote the identification and equitable compensation of
persons severely injured by reactions to pediatric vaccines; and
5. To provide assurances to parents and their children and to
producers and providers of vaccines, that the public at large, which
benefits SO greatly from the prevention of disease and disability,
will accept responsibility for equitable payment of the.cost of caring
for those to whom government-mandated immunization results in severe
disease or disability [Title XXI, Section 21011.
To meet these ends, the following would be established:
.
National Vaccine-Injury Advisory.Committee
. , ,
Office of Vaccine-Injury Compensation
Vaccine-Injury Compensation Committee
National Vaccine-Injury Compensation Trust Fund
National Vaccine-Injury Advisory Committee This committee,
. .
comprised of 15 members.appointed by the Secretary of HHS from the
fields of pediatrics, neurology, epidemiology, public health, and
related disciplines, would prepare and revise as necessary a list of
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severe adverse reactions (defined as "any injury from a vaccine which
results in the long-term disability or death of the vaccine
recipient, and would designate clinical criteria for severe adverse
reactions.
Office of Vaccine-Injury Compensation Directed by an appointee of
the Secretary of HHS r this office would review claims for
determination of a compensable injury. A compensable injury is one
that results from a severe adverse reaction to a mandatory pediatric
vaccine or that is contracted from a child who received live polio
vaccine. The clinical criteria must be in accordance with those
designated by the National Vaccine-Injury Advisory Committee. To be
eligible for compensation, the claimant must satisfy the requirements
above and file a claim within 2 years of the date of immunization.
Amount of compensation shall be provided for:
a. reasonable expenses incurred or likely to be incurred for
medically necessary products, services, and accommodations
reasonably needed for medical care, training, and other remedial
treatment and care of an injured individual, including expenses for
a procedure or treatment for rehabilitation and rehabilitative
occupational training if the procedure, treatment, or training is
reasonable and appropriate for the particular case, the expenses
are reasonable in relation to the probable rehabilitative effects
and the compensation benefits otherwise payable, and it is likely
to contribute substantially to rehabilitation, even though it will
not enhance the injured individual's earning capacity;
b. economic loss to persons eligible . . . from any work that
the injured individual was unable to perform due to the
individual's having been injured; and
c. noneconomic, general damages arising from pain, suffering,
inconvenience, physical impairment, mental anguish, emotional pain
and suffering, and all other noneconomic, general damages, except
that no person shall receive such damages in an amount in excess of
$100,000' and any such damages shall be payable only to the injured
individual for his or her pain and suffering [Title XX, Section
21051.
Vaccine-Injury Compensation Committee ThiS committee, comprised of
15 members appointed by the Secretary of HHS from the fields of
actuarial science, economic analysis of financial loss from personal
injury or death, and evaluation of medical impairment and disability,
would prepare and revise as necessary a methodology for use by the
. .
Office of Vaccine-Injury Compensation to determine appropriate amounts
of awards. The method would incorporate appropriate regional..cost-.
differentials and differences in individual need.
. .
National Vaccine-TniurY:Compensation Trust Fund This fund.would be
. . .
established within the Treasury of the United States, which would
appropriate any necessary funds for the payment of awards.
This proposal represents an exclusive remedy--under no conditions
would a person eligible for compensation be entitled to pursue civil
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action against any party involved in the manufacture, distribution, or
administration of the vaccine. The Secretary of HHS may bring such
civil action against any of the above parties in cases of probable
negligence. All damages may be recovered (whether or not previously
paid to the claimant) including costs of litigation.
Claimants denied compensation may appeal to the U.S. Court of
Appeals for District of Columbia Circuit. This appeal must be filed
within 60 days of the Secretary's ruling and the Secretary must be
notified of such action.
A PROPOSAL BY THE AMERICAN ACADEMY OF PEDIATRICS
Need for Legislation to Establish a Federal Compensation
Program for Vaccine-Related Injuries in Childhood
Immunization Programs
The proposed legislation, which was never enacted, suggested
creation of a national program to compensate for injuries from
vaccines used in state or federal childhood immunization programs.
This would have included an incidence of contraction of polio by an
adult due to contact with a child recently vaccinated against polio.
The system would have compensated for medical and rehabilitative
costs, projected loss of income, and custodial and special education
costs in cases of major adverse reactions manifested within a
designated period of time and identified as vaccine related. No
compensation would have been provided for pain and suffering, or for
punitive damages.
The legislation would have specified which vaccines and adverse
reactions would be compensable, but the Secretary of HHS would have
been authorized to modify these lists when appropriate. Appropriate
time limitations also would have been established.
The compensation system would have been optional, but the claimant
would not have been allowed to seek award through both the compensa-
tion system and the existing judicial system.
This program would have considered only those cases not involving
negligence. It would have considered as non-negligent inadequate
warning of risks or lack of informed consent. The program would not
have considered cases involving negligence in the manufacture or
administration of vaccine. Such cases would have had to seek tort
remedy.
Under the proposed legislation, the Secretary of HHS would have
appointed a National Vaccine-Injury Compensation Commission or
designated an existing body to adjudicate claims within 180 days of
the date on which the claim was filed.
The procedure for making a claim would have involved documentation
of the following: (1) that the claimant had received a vaccine
covered under the compensation system; (2) the date of vaccine
administration and date of manifestation of adverse reaction; and (3)
that the claimant had suffered a major adverse reaction on the list
(the claimant would have had to demonstrate a causal connection
between vaccine and an adverse reaction not specified on the list).
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The Secretary would have been responsible for final review of
decisions by the commission, as well as prescribed rules and
regulations concerning all aspects of its operation. Claimants who
were denied compensation would have been able to appeal within 60 days
of notification through the U.S. District Court. The appeal would
have involved only the court's determination that the commission was
acting lawfully.
Funds for operating the system would have been generated from a
dosage surcharge on vaccines assessed against vaccine manufacturers.
Surcharges would have been developed and implemented by the Secretary
of HHS, who periodically would have reviewed and revised the amount of
surcharge.
PROPOSED VACCINE-INJURY COMPENSATION ACT OF 1983
This proposed legislation, which was never enacted, would have
required that the President of the United States design a government
vaccine-injury program to compensate victims seriously injured by
government-coordinated or government-sponsored vaccination programs.
The program would have ensured that victims of episodic or mandated
childhood vaccination programs would receive compensation.
It was proposed that prior to establishing a compensation program,
the President would conduct an evaluation of the following issues:
n (1) vaccines to be covered; (2) injuries to be covered; (3) type and
size of compensation to be provided; (4) administrative structures;
and (5) the relationship of this program with existing compensation
options, such as lawsuits, private insurance, government medicare,
medicaid, and social security programs, or state programs. n
The resulting vaccine-injury compensation program would not have
involved the creation of a new federal agency or required additional
personnel. It would have ensured that victims of episodic vaccination
programs were eligible for compensation and that participants in all
childhood vaccination programs were eligible for compensation.
The proposed options would have included the imposition of a fee on
vaccines to create a compensation trust fund. The program would have
ensured that state governments participated in the administration of,
and if appropriate, the expense of the compensation program.
AMA ' s PROPOSED MODEL STATE LEGISLATION ON VACCINE COMPENSATION
.
. .
This legislation, proposed in 1980, was intended to "provide some
compensation for costs of care, including medical, institutional,
supportive, and rehabilitative care, necessitated because of adverse
reaction to any immunization mandated by state law where the person
would be otherwise uncompensated for such vaccine-related injuries
because of lack of liability of the manufacturer and person
administering the vaccine. n It was never enacted, primarily because
the states showed little interest.
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According to the proposal, a state's department of health would
have compensated past, present, and future costs of a vaccine-related
injury manifested within 90 days after vaccination, through an
Immunization Adverse Reaction Fund established within the state's
treasury. Reasonable legal expenses resulting from a successful
administrative action pursuant to this act also would have been
compensated.
A person filing a claim according to the established procedure
would have received a hearing before the department of health, which
would have determined eligibility based on whether the person would
otherwise have been compensated. Any compensation received from the
fund would have been offset by existing insurance entitlements.
This would not have been an exclusive remedy for persons sustaining
vaccine-related injuries. Injured parties could have been compensated
through tort awards as well. A determination by the department of
health would not have been admissible in any court action. The state
could have claimed reimbursements from third parties for the amount of
compensation.
PROPOSED FEDERAL IMMUNI ZATION INSURANCE CORPORATION
Prepared by Hans H. Neumann, M.D., and endorsed by the Connecticut
Public Health Association in 1977, this proposal was intended to
create a Federal Immunization Insurance Corporation that would have
provided funds to compensate persons who suffered permanent injuries
from mandatory or recommended immunizations. A summary of the
suggested legislation, written by the bill's author, is presented.
It is proposed to create a Federal Immunization Insurance
Corporation [FIIC] whose purpose it shall be to insure the'
public against permanent adverse effects from immunizations and
to provide specific benefits under this Act.
The management of the fund shall be vested in a board of
directors consisting of three members: one shall be a physician
and a member of the Centers for Disease Control, one shall be
an attorney, and one shall be appointed by the Secretary of HEW
from a consumer groupe
Every vaccine manufacturer shall be entitled to apply to
become a member of the FIIC and shall contribute a percentage
of the listed price of each lot of vaccines released for
distribution. Any manufacturer of vaccines may be approved or
disapproved by the board for specific vaccines.
All products approved for coverage should include a
reference to membership in the FITC'on the label of each vial
of vaccine. ' '
Through the regulations of the FlIC, the function of
providing benefits for any permanent damage from approved
vaccines covered under this act shall be assumed by the U.S.
government and compensation shall be provided for such damages,
under a predetermined schedule.
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Notwithstanding the assumption of this function by the U.S.
government, the government itself may have legal recourse to
claim reimbursement from the manufacturer or providers of the
vaccine in cases of negligence.7
REFERENCES
1. U.S. Senate. 198S. S. 827. National Childhood Vaccine-Injury
Compensation Act. Congressional Record, April 2, 1985,
S3843-S3847.
2. House of Representatives. 1985. H.R. 1780. National
Childhood Vaccine-Injury Compensation Act. Congressional
Record, March 27, 1985, H1587-H1589.
3. American Medical Association. 1984. Draft Federal
Legislation, Vaccine Injury Compensation. Chicago, Ill.
4. American Academy of Pediatrics. 1983. Need for Legislation
to Establish a Federal Compensation Program for
Vaccine-Related Injuries in Childhood Immunization Programs.
Evanston, Ill.
U.S. Senate.
Act of 1983.
S14378.
1983. S. 1987. Vaccine-Injury Compensation
Congressional Record, October 21, 1983, S14377
6. American Medical Association. 1980. Model State Legislation
on Vaccine Compensation. Chicago, Ill.
7. Neumann, H.H. 1984. Personal communication, Wilton, Conn.
8. U.S. Senate. 1983. S. 2117. National Childhood
Vaccine-Injury Compensation Act. Congressional Record, Nov
17, 1983, S16620-S16621. U.S. House of Representatives.
1983. H.R. S810.
.
Representative terms from entire chapter:
adverse reactions
