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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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184 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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185 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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186 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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187 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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188 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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189 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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190 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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191 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. .