Mass immunizations: legal problems and a proposed solution.

Abstract

The legal impasse which delayed the swine flu immunization program and which may impair similar community health programs was temporarily resolved by a federal law that provides that all injury claims be filed directly against the government. Drug companies, which declined to produce vaccine unless protected against suit, and other participants (such as state agencies and health personnel administering inoculations without charge) are immune from liability, unless proven negligent. This law is essentially defensive. It does not provide a plan for compensating those who may be adversely affected by inoculations. Persons instituting suits must base their claims on negligence, strict liability, or warranty, in accordance with state principles. Looking ahead, the law requires a one-year study to consider long-term solutions and propose alternative approaches. The proposal presented here would establish a voluntary, contractual no-fault program to eliminate such suits and to assure safe, preventive health care, appropriate compensation and other means for recovery for vaccine-associated injury. Similar to worker compensation systems, the recompense would be based on (a) the nature of the relationship, i.e., participation in an immunization program and (b) an adverse result related thereto, without regard to any fault in the manufacture or administration of the product. The proposal would permit suits or arbitration. These options would be detailed in advance as a part of the explanation of risk and the consent agreement.