be noted that indemnification agreements are strictly construed against a party claiming indemnification against his own negligence, and agreements which contain broad and all-inclusive language may be interpreted not to include indemnification for negligence. [316]

As an alternative to avoid the negative implications of the Davis decision, an indemnification agreement offers the possibility of reducing the impact of unlimited and unpredictable liability upon the drug manufacturer. The parties to the proposed agreement would be the drug manufacturer, as indemnitee and the federal, state, and local governmental or medical authorities which sponsor the mass immunization clinic, as indemnitor.

Since it would be desirable for the drug manufacturer to obtain idemnification against all liability arising from an immunization program including liability for negligence, the agreement should so specify. The following suggested provision is provided solely for illustrative purposes to show part of a typical indemnification contract:

Indemnitor undertakes to indemnify indemnitee from any and all liability, loss or damage indemnitee may suffer as a result of claims, demands, costs, or judgments against it arising out of [the use of indemnitee's vaccine at a designated mass immunization clinic] whether the liability, loss, or damage is caused by, or arises out of, the negligence of the indemnitee or of its officers, agents, employees or otherwise. [317]

Other provisions of the agreement, if desired, could specify a maximum amount beyond which the indemnitor would not be liable, provide for notice to the indemnitor from the indemnitee of claims made against it, and obligate the indemnitor to undertake the defense of the indemnitee against any claims covered by the contract. [318]

It is not essential that all of the potential parties participate in the indemnification agreement; the contract could include only the drug manufacturer and any desired combination of the federal, state and local sponsors. An agreement which includes all of the parties and in which some portion of the liability is designated to remain with the drug manufacturer, however, would be the most equitable because a certain degree of responsibility should be shared by all concerned parties. The degree of responsibility to be assumed by any individual party could be proportional to such factors as: (1) the extent of control and involvement in the mass immunization program; (2) the amount and nature of benefit accruing to the party; and (3) financial resources.

The advantage of the indemnification agreement when applied to the mass immunization clinic is evident. No longer would the drug manufacturer be singularly exposed to unlimited liability under the Davis decision, because, pursuant to the proposed agreement the feceral, state, and local sponsors would share an equitable degree of the liability for injuries arising out of the program. Indemnification would at least mean that the drug manufacturer would not have to consider withdrawal from participation in mass immunization programs as the only way to avoid the possibility of financial disaster. Mass immunization clinics would no longer be subject to the manufacturer's possible refusal to supply the necessary vaccines.

The indemnification agreement might not, however, completely eliminate the problem of unlimited and unpredictable liability. Several large judgments, even though shared by the program's various levels of sponsors, could still leave the drug manufacturer with diminished economic returns from participation in mass immunization programs. Moreover, the federal, state and local agencies may be incapable of indemnifying the manufacturer or unwilling to place themselves in a position of having to share financial responsibility for excessive judgments and may limit the amount of indemnification which they may be required to pay under the agreement. The potential of unlimited and unpredictable liability may be no more acceptable to state and local public health and medical authorities than it is to drug manufacturers. Ultimately, the federal agency involved may prove to be the only party able to accept such responsibility.

As an alternative to the present situation, however, indemnification does appear to be a viable method of lessening the negative effects of the Davis decision. An indemnification agreement could eliminate the problem of unlimited and unpredictable liability by shifting the burden from the manufacturer to the sponsoring federal, state, and local governmental or medical sponsoring societies or agencies. If the sponsors are unwilling or unable to assume the entire burden, the risk of unlimited and unpredictable liability upon the manufacturer could still be substantially reduced by an agreement requiring the sponsors to indemnify up to a certain limit. As mentioned above, indemnification is compatible with the existing

system of recovery for personal injuries through litigation. Finally, in the absence of congressional approval of federal legislation addressing the problem, indemnification may be the only alternative available as a viable method of resolving the problems created by the Davis decision.

3. FEDERAL LEGISLATION "THE MASS IMMUNIZATION COMPENSATION ACT"

(a) The Need, Philosophy and Advantages of Federal Legislation

The problems created by the Davis decision present a social dilemma involving the medical profession, the public health goals of the United States Department of Health, Education, and Welfare, the pharmaceutical firms, and the nation's consumer citizens. Such a situation involves competing public policies and suggests the appropriateness of federal legislation in order to achieve uniformity and predictability. In order to appreciate the significance of the legislation to be discussed, it is necessary to first understand the changes to be contemplated and issues resolved by such legislation.

The legal issues stemming from a claim resulting from mass immunization programs are not unique and can be found in any area of personal injury litigation. Essentially the burden is on the consumer-claimant to prove: (1) existence of a duty on behalf of the drug manufacturer; (2) breach of that duty; (3) a direct causal link between the established breach of duty and any alleged injury suffered by the claimant; and (4) damages to the claimant as a result of the injury. These factors constitute the basic elements of what is commonly known as the “faultrecovery system." [319] The crux of the fault-recovery system today is the same as it was in 1850, when it was first announced in this country. [320] The system concentrates upon the defendant and his conduct and not upon the victim and his situation.

The most evident and impressive factor of the fault system is the "spectacular legal lottery into which it thrusts the plaintiff." [321] The victim's ultimate recovery depends upon his successfully meeting and proving the aforementioned issues a task which involves expensive and prolonged litigation and no small number of fortuitous circumstances. Under the fault rules several identical victims may have suffered identical injuries, yet one may recover thousands of dollars while an equally innocent victim recovers nothing. [322] Such results are contrary to both established concepts and recent developments in legal philosophy recognizing society's desire to treat victims who suffer like harm alike. [323]

Evidence of society's wish to shift the focus from the defendant and his conduct to the victim and his plight is found in such well established legislation as workmen's compensation. Workmen's compensation statutes existed in Germany in 1884, and were introduced in England in 1897 and in the United States for government employees in 1908. [324] By 1921, all but a few states had enacted such legislation and it is now in effect in all of the states. [325] Because workmen's compensation acts are a good example of an alternative to the fault-recovery system and in fact provide an excellent model upon which to base a federally legislated "mass immunization compensation act," the major concepts of workmen's compensation acts will be briefly discussed.

A workmen's compensation act may be defined as a plan or system for compensating workmen injured and physically disabled as a direct result of their employment, regardless of the question of fault or negligence. In the event of the employee's death, compensation or death benefits are provided for his or her dependents. This definition applies generally to all such acts, though they vary considerably in the details of their provisions. [326] The main purpose of the acts is to provide prompt compensation for the employee [327] without delay or expense,[328] to simplify all proceedings under law,[329] and compensate injured employee claimants at rates which the law itself directly or indirectly fixes.[330] In order to accomplish this purpose the workmen's compensation acts did away with the issues of negligence, unavoidable accident, assumed risk, and contributory negligence.[331] In essentially abolishing the concept of fault,[332] the compensation laws constitute a statutory departure from the common law and are, as commonly stated, in derogation of the common law. They are not supplemental, amendatory, or declaratory of the common law, but wholly substitutional of it.[333] It has been said that "no subject of labor legislation ever has made such progress or received such general acceptance of its principles in so brief a period" [334] as have the workmen's compensation acts. Workmen's compensation acts are not the only legislative schemes which have adopted the concept of no-fault liability. The most recent legislative extension of the concept has been in the field of no-fault automobile insurance.[335] There is

also a strong legislative emphasis on security for victims of accidents and illness in such measures as social security, disability insurance, unemployment compensation, and medicare.[336] Fault or negligence in the causation of harm is irrelevant in all of these systems; stress is placed instead on the loss inflicted upon the victim and his family as a result of the injury or death.[337]

The plight of the various parties involved, as a result of participation in a mass immunization clinic and the problems created by the fault-recovery system in dealing with such claims, [338] would seem to suggest the desirability of a federally legislated plan based upon a concept of no-fault liability. The advantages of such an approach would benefit all concerned parties and certainly should be considered as a possible alternative.

A federally legislated program would provide a systematic and uniform plan for handling mass immunization injury claims. Such legislation would eliminate the multifarious schemes of dealing with claims which result from the existence of fifty independent state jurisdictions, and all consumer-claimants would be afforded the same remedies regardless of geographic location. Drug manufacturers would not be subjected to an array of divergent and unpredictable liabilities depending upon the whims and sympathies of judges and juries and the laws of each jurisdiction in which the mass immunization program has been conducted. In addition to establishing a more predictable liability, federal legislation could provide a more equitable means of meeting the liability determined. Financial gain does accrue to the drug manufacturer participating in a mass immunization program, and he should therefore bear some degree of financial responsibility in relation to personal injury claims. However, the drug manufacturer's participation also significantly contributes to the public welfare. The participation of the pharmaceutical firm is essential to achieving the public health goal of the control and eradication of communicable diseases. A federally legislated alternative could institute a means by which to involve the federa land, if provident, the state and local governments and agencies in the sharing of the determined liability. The federal government is the composite representative of the nation and responsible for the protection and perpetuation of national interests. A sound public health program is necessarily in the nation's best interests. There is no logic which dictates that the drug manufacturer alone should absorb the financial liability resulting from a program designed to effectuate national health goals. The present threat of sole liability is the major reason for the drug manfacturer's reticence to continue involvement with mass immunization programs. Federal legislation could achieve a more equitable means of meeting liability without lessening the drug manufacturer's responsibility for its own actions.

Furthermore, a program based upon a no-fault concept would provide an additional factor to be considered by the potential participant. The warning required by the Davis decision raises two potentially contrary public policy considerations: (1) the individual's right to be informed, and (2) the achievement of a public health objective which would be frustrated if a warning were to deter the participation of a significant number of consumers. [339] The possibility of deterrence would be mitigated by a no-fault compensation act. The existence of a warning would not function or be interpreted to deprive an injured person of his right to compensation, which is the case under the fault-recovery system.

In summary, legislation, based upon the no-fault concept, should be considered as an alternative to the Davis dilemma.

(b) A model Act [340]

(1) Construction and operation of law:

(a) Title.-The Mass Immunization Compensation Act.

(b) Purpose.

(i) To recognize the necessity and effectiveness of mass immunization programs in the efforts of the Department of Health, Education and Welfare in controlling and eradicating communicable disease.

(ii) To provide for a method of compensating an individual who suffers injury as a result of chemotherapeutic treatment received as a participant in a mass immunization program.

(iii) To provide similar treatment for similarly situated persons suffering similar injuries.

(c) Definitions.

(i) "Mass immunization clinic": Any clinic or program designated as such by the Department of Health, Education and Welfare. [341]

(ii)" Individual": Any citizen of the United States or any of its territories or posessions.

(iii) “Injury”: Any personal injury or disability resulting from the chemotherapeutic aspect of a mass immunization program.

(iv) "Injured person": An individual who suffers injury due to his participation in a mass immunization program.

(v) "Survivors": Those entitled to bring a wrongful death action for the death of any injured person. [342]

(vi) "Board," "Fund": These terms are collective nominatives used to designate the administrative body and its total resources.

(d) Effect on existing law.

(i) Warnings: The non-fault concept of this act shall not function or be interpreted to absolve any drug manufacturer or pharmaceutical firm, its principals or agents, or any federal, state or local agency or society, their principals or agents, involved with mass immunization programs, from the duty to warn individuals of any dangers attendant to participation in any mass immunization clinic. The existence and substance of a warning shall not function or be interpreted to deprive an injured person of his right of compensation, but shall be considered by the board in the assessing of remedial sanctions against the drug manufacturer.

(ii) Scope of act: This act shall not relieve any drug manufacturer, or federal, state or local agency of any penalty for failure or neglect to perform any other duty, statutory or otherwise, imposed by law, the Department of Health, Education and Welfare, the Surgeon General, or government contract except as specifically provided for within this act. (iii) Injured person's right to collateral action.-The remedies provided within this act shall be considered a complete and total replacement of an injured person's right to sue a drug manufacturer, or any principal, agent or party involved with a mass immunization program to which an injured person would otherwise have legal recourse. [343]

(iv) Operation of act in epidemic conditions: This act and all attendant provisions shall be applicable and in full force and effect regardless of the public health condition, situation or dilemma necessitating the implementation of a mass immunization program.

(2) Terms and conditions:

(a) Basis for payment.—The fund is liable to pay to an injured or his representative without consideration of fault, benefits for economic loss resulting from chemotherapeutically induced injury received in a mass immunization program.

(b) Economic loss. [344]

(i) Medical and hospital expenses: All medical expenses incurred by an injured person for necessary surgical, x-ray, dental, and medical expenses, including professional nursing and hospital services and funeral services. But reasonable expenses shall not include charges in excess of semiprivate hospital accommodations except when the injured person required special or intensive care.

(ii) Work loss: Work loss shall consist of loss of income from work an injured person would have performed had he not have been injured, and expenses reasonably incurred in obtaining ordinary and necessary services from others not members of the injured person's household in ieu of services that, had the individual not have been injured he would have performed, not for income but benefit of the household. [345]

(c) Survivor's loss.-Survivor's loss benefits shall be payable to the survivor or survivors of an injured person who dies as a result of chemotherapeutic injury received in a mass immunization clinic. [346]

(d) Taxable significance. Any money paid to an injured person or his survivors pursuant to this act shall not be considered gross income for purposes of federal or state taxation.

(3) Claims and notice of injury:

(a) Claims not assignable.-No claim for compensation under this act shall be assignable and all claims therefore shall be exempt from all claims of creditors.

(b) Notice of injury.—Written notice of injury is required to be given as soon as possible, but mere delay of notice is not a bar to any reparations and notice does not designate the beginning of the period for which reparations shall run, the compensatory provisions of this act being retroactive to time of injury. (c) Contents of notice.

(i) The written notice provided for in the foregoing subsection shall state: the name and address of the claimant; the time, place and manner in which the drug was administered; the name of the immediate clinic sponsor; and shall be signed by the claimant, or in the event of his inability or death, by his representative or a person in his behalf or in behalf of the survivors.

(ii) The notice shall be accompanied by a physician's medical examination report stating: the name and address of the physician; date of examination and nature of examination; and include a statement and analysis of symptoins and conclusions.[347]

(d) Time of filing claim.

(i) The right to compensation under this act shall be forever barred unless a claim is filed within one year after the injury has been medically diagnosed or death occurs.[348] Failure to comply with the said time limit results in the forfeit of all remedies provided for by this act or remedies for which this act is substitution of.

(ii) Exception: No limitation of time provided for within this act shall run against any person who is mentally incompetent or a minor dependent.

(e) Claim by guardian or trustee of minor or mentally incompetent.—If an injured person is mentally incompetent or under the age of eighteen at the time any right or privilege accrues to him under this act, his guardian or trustee may claim or exercise such right or privilege in his behalf. (4) Discovery and examination of injured persons:

(a) Financial.

(1) Discovery of facts about an injured person from injured person's employer: Every employer shall, in a form approved by the board, furnish a sworn statement of the earnings of an injured person since the time of injury and for a two year period prior to the injury of the person upon whose injury the claim against the fund is based.

(ii) Discovery of claimant: the claimant must furnish copies of his state and federal income tax returns for the two most recent tax years upon which his tax reports are based.[349]

(b) Medical.

(i) General scope of medical discovery: Every physician, hospital, clinic or other medical institution providing before or after an injury upon claim for reparations is based, any products, services or accommodations, including funeral services, in relation to that or any other injury, or in relation to a condition claimed to be connected to that or any other injury, shall if requested to do so by the board: Furnish forthwith a written report of the history, condition, treatment, dated, and costs of such treatment of the injured person; and, produce forthwith and permit the inspection and copying of his or its records regarding such history, condition, treatment, services or products of any type.

(ii) Privilege: No fact learned by any physician shall be privileged before the board.

(c) Disputes as to rights of discovery.—

(i) Compelling discovery: In the event of any dispute regarding the right to discovery of facts about the claimant's earnings or about his medical condition, history, treatment, dates and costs of such treatment, a judge of a United States District Court may enter an order for such discovery.

(ii) Limited discovery: A United States District Court, in order to protect against annoyance, embarrassment, or oppression, as justice requires, may enter an order refusing discovery, and may order payments of costs and expenses of the proceedings, including reasonable fees for the appearance of attorneys at the proceedings. (5) Amount, computation and payment of compensation:

(a) Medical expenses.—

(i) Extent of compensation: An injured person shall be totally and completely compensated for all medical expenses as defined under section B.2. (a) of this act.

(ii) When payable: Compensation for medical expenses is payable periodically as thI accrue.

(b) Workloss.

(i) Extent of compensation: Any work loss as defined in section B.2. (b) shall be fully compensated up to five hundred dollars ($500,00) per week,