Mr. ROGERS. Thank you.

Do you have any information that there are other influenza vaccines that place pregnant women at risk?

Ms. GREENBERGER. Mr. Rogers, the clear problem is that there have been no studies at all indicating the safety

Mr. ROGERS. What I am saying is, Have we had this problem develop for pregnant women under influenza vaccine programs?

Ms. GREENBERGER. No one has looked and made studies of past influenza vaccination programs to see whether there were problems. There has been no reporting system set forth and there have been no prospective studies to see whether there were problems with past influenza programs.

Mr. ROGERS. It is not that there has been. It is simply that you are not sure whether they have or not.

Ms. GREENBERGER. That is exactly the kind of information we would hope women would be made aware of.

Mr. ROGERS. We will take this up with the Department and try to get some reaction from them.

Thank you for bringing this to the attention of the committee. Thank you for your presence.

That concludes the oversight hearing on the swine influenza program.

The committee stands adjourned.

[The following letters were received for the record:]

SOUTH FLORIDA HOSPITAL ASSOCIATION, INC.,
Miami, Fla., June 24, 1976.

Congressman PAUL ROGERS,
House of Representatives,
Washington, D.C.

DEAR CONGRESSMAN ROGERS: Several weeks ago, Joel Nitzkin, M.D. of the Dade County Health Department called this office for the purpose of discussing the general plans for implementing the Swine Flu Vaccination Program in this county. Dr. Nitzkin asked that I survey our member hospitals in this county to determine those that would be willing to participate and to adhere to the general guidelines established by the Health Department and the Community Advisory Committee which was created ro assist the department.

By detailed letter I contacted all Dade County hospitals (38 in number) and as of this date I have received responses from 20 stating their willingness to provide space, personnel, and equipment for the administration of the vaccine.

After receiving these responses, it became known that there was no provision for liability insurance coverage and even if there was such available, the cost would range from $1.76 per patient to an amount in excess of $2.00. Insurance companies contacted in this area flatly refuse to extend the coverage necessary to protect the hospital regardless of the premium involved.

Dr. Nitzkin has been quoted publicly that it is this opinion that the vaccine program cannot be successful unless the major hospitals are involved.

As an Association, we cannot request or encourage our hospitals to become involved until or unless they can be assured that they will not become liable for their acts as a part of a community service program.

I respectfully request that this letter be made a part of your sub-committee hearings which I understand will be held during the week of June 28, 1976. I personally feel that it is very unfortunate that our area hospitals are essentially being prohibited or effectively discouraged from providing a community service which will be so vitally needed.

Cordially,

IVAN O. HARRAH, Executive Director.

FEDERATION OF AMERICAN HOSPITALS,
Washington, D.C., June 28, 1976.

Hon. PAUL G. ROGERS,
Chairman, Subcommittee on Public Health and Environment, Interstate and Foreign
Commerce Committee, 2125 Rayburn House Office Building, Washington, D.C.
DEAR MR. CHAIRMAN: At the June meeting of the Board of Directors of the
Federation of American Hospitals, a resolution was adopted expressing the active
support of the nation's investor-owned hospitals in the mass immunization pro-
gram against swine-type influenza. That resolution is appended.

In response to the President's request for provider cooperation, we have recommended to our member hospitals that they dispense the vaccine voluntarily without charge and otherwise assist in community efforts designed to meet the goals of the program. As you know, we represent approximately 1,100 hospitals with over 111,000 beds. In a number of cases, investor-owned facilities offer the only care available to communities in the rural south and southwest. We believe, therefore, that we can make a substantial contribution should the immunization program go into effect.

One area of concern addressed by the resolution is that of professional liability. As you know, this is a common concern shared by both manufacturers of the vaccine as well as direct providers. Although we stand ready to volunteer our efforts, if the program is to be a success, it is essential that those active in its implementation are protected. Because of the massive nature of this undertaking, we urge that concommitant with passage of the swine-flu legislation, an indemnification provision be included. Individuals receiving the innoculation should be required to sign an informed consent document waiving the provider from all responsibility.

I ask that this cover letter, as well as the attached formal resolution of the Federation's Board of Directors, be included in the record of the hearings on swine-flu.

Thank you for this opportunity to present the support of investor-owned hospitals in this public service undertaking.

Sincerely,

Attachment.

MICHAEL D. BROMBERG,
Director, National Offices.

RESOLUTION ADOPTED BY BOARD OF DIRECTORS, FEDERATION OF AMERICAN HOSPITALS, JUNE 21, 1976

Whereas scientists have now identified the cause of an outbreak of influenza at Fort Dix, New Jersey in February 1976 as a swine-like influenza virus which in some ways is similar to the virus suspected to be the cause of the great 1918 influenza which resulted in a world wide death toll of more than 20 million; and Whereas science has now given us the ability to effectively prevent the disease through vaccines; and

Whereas in March 1976, the President of the United States requested Congress to appropriate funds to implement a mass immunization campaign against the swine-flu influenza in the United States; and

Whereas the Congress of the United States in April 1976 enacted and the President signed into law a Special Appropriation bill of $135 million to finance the National Influenza Immunization Program, of which amount about $100 million will be used to purchase vaccine with the remainder to be spent on public education, influenza research, and distribution of vaccine to those who administer it; and Whereas all public and private health providers and health facilities have been requested by the President and the Secretary of HEW to cooperate in the distribution and the administration of the vaccine; and

Whereas an obstacle to industry cooperation in such a program is concern over potential malpractice insurance premium increases or policy cancellations: Therefore be it

Resolved, That the Federation of American Hospitals and its member hospitals, representing the investor-owned hospital industry, speaking through its duly elected Board of Directors, do hereby endorse and pledge our support to this program designed to protect every individual against a potentially serious health threat by recommending to our membership that where practical their facilities be offered voluntarily without charge for the administration of the vaccine and that their hospital staff and others in the communities be encouraged to donate their time to assist in this public service undertaking; and be it further

Resolved, That the Federation of American Hospitals and its membership do hereby urge the Congress of the United States and where required the legislatures of the several states to pass legislation to indemnify both manufacturers of vaccines and health providers and their agents assisting in its distribution and administration against claims attributable to innoculation with the vaccine, and that possession by the health provider of a signed "informed consent" document from the person receiving the innoculation shall relieve the health provider of all responsibility for claims attributable to inoculation of the vaccine.

Hon. PAUL G. ROGERS,

AMERICAN ACADEMY OF PEDIATRICS,
DEPARTMENT OF GOVERNMENT LIAISON,
Arlington, Va., June 30, 1976.

Chairman, Subcommittee on Public Health and Environment, House of Representatives, Washington, D.C.

DEAR MR. ROGERS: This communication and the enclosures are submitted for the record of the Subcommittee proceedings on the subject of the national effort directed toward protecting the nation from the A-New Jersey-76 influenza virus. The Executive Board of the American Academy of Pediatrics at its April 1976 meeting considered the planned nationwide program of immunization against the A-New Jersey-1976 influenza virus, particularly the program's implications for children. The Executive Board is concerned about the "liability" problems involved in this nationwide program. A policy was adopted stating that "unavoidable side effects which follow immunization procedures given at the recommendation of public health officials, for the public good, shall be regarded as a public responsibility" and that the Academy will "support the concept of government indemnification" for unavoidable accidents resulting from such immunization programs, along with a "hold harmless" provision for medical personnel involved with the actual administration of the vaccine to children.

The testimony before the Subcommittee on Monday, June 28, made it clear that drug manufacturers and/or their insurers will face substantial outlays in defense of any and all legal actions which may arise as a result of the swine flu program. Since it is common practice among the legal profession to join all possible responsible parties, it should be clear that the medical and other personnel participating in the nationwide mass immunization program also face a substantial problem in regard to the defense of actions—especially in instances where such personnel have not been negligent. Should the Congress decide to adopt an indemnification program, it is recommended that such measure not be limited to drug manufacturers but indeed include the participating personnel and sponsoring agencies.

During the hearings some concern and reservation was expressed regarding the possible precedent setting value which the matter of indemnification might have in regard to other vaccine programs. Appended to this communication is a copy of a Commentary from Pediatrics on the matter of patient compensation for those suffering untoward reaction to vaccines. If it is a national policy that all citizens should receive the swine influenza vaccine, and the Assistant Secretary for Health has testified that the program goal is to innoculate 95 per cent of the population, then it seems appropriate that individuals participating in this effort of the federal government should not be penalized for their participation-neither the patients who may suffer severe disabling reactions nor the professional who followed established protocol.

Also appended to this letter is a draft of four options which the Subcommittee may wish to explore as the need for a policy regarding "immunization accidents" is addressed.

Sincerely yours,

Enclosures.

ROBERT G. FRAZIER, M.D.,
Executive Director.

[From Pediatrics, August 1975]

IMMUNIZATION "DYSPRACTICE": THE NEED FOR "NO FAULT" INSURANCE We are on a collision course in many areas of the United States. A number of states have passed compulsory immunization laws for school children, yet the majority of the vaccines required in fulfillment of these laws have a specific incidence of adverse reactions. These range from mild fever or irritability to encephalitis or paralysis. True, the incidence is small, but it is real. For live oral

trivalent poliovirus vaccine, for example, the package insert cautions that "the possible low level of risk to the vaccinated subject or to close contacts [should] be considered at all times."

Yet what recourse does the one person in tens of thousands suffering an adverse reaction have? Is the paralyzed vaccinee the victim of medical malpractice by the physician or drug company? Rather than malpractice, the resulting adverse reaction would appear to be "dyspractice." As used in this context, dyspractice pertains to an undesirable, yet unavoidable, result of practice in contrast to malpractice which implies reprehensible ignorance, negligence, or criminal intent. It would be difficult to support a charge of malpractice against the physician in the package insert, especially if he is carrying out a legal mandate to immunize. Is the drug company at fault? It would be unfair to judge it liable if the manufacturer has complied with the rules specified in the Code of Federal Regulations for the preparation of the product. If the federal government has approved the safety and efficacy of the vaccine and the state government has required its use, is it fair to have the manufacturer sued for the rare but expected adverse reactions?

Is the patient at fault? The government has required the immunization and sponsored programs to carry out its regulations. No shot, no school! Presently the only recourse the patient has is to sue the manufacturer, physician, or government. Should a patient who has been paralyzed, for example, suffer the trials of his misfortune for years while his case is tied up in the courts, or should he receive prompt settlement based on a fair scheule of compensation? And even if he wins a law suit, should he have to pay out a significant amount of the judgment for legal fees?

The answer to all of the questions posed above is "no." Of course, if malpractice has occurred (e.g., improper manufacture, improper administration) then a suit may be justified. In the majority of cases, however, there is no one at fault, and dyspractice, not malpractice, has occurred.

If society is to benefit from immunization practice, as it obviously doeswitness the dramatic decline in poliomyelitis, measles, diphtheria, and other diseases-then society, through its government, should logically be responsible for immunization dyspractice. Society-not the manufacturer, the physician, or the patient should support those who suffer the adverse consequences of our laws. Other countries have done so. Denmark, Germany, and Japan have enacted legislation to reimburse those who are the victims of the immunization laws. The Danish law calls for "indemnification from the Treasury" to those who have had a "loss or reduction of economic capacity caused by disablement or for loss of supporter if the cause, with reasonable probability, can be ascribed to immunizations which presently are enforced or recommended by the Danish Health Authorities." 1

The magnitude of the problem is not enormous but it is of great significance to those involved. Government agencies such as the Social Security Administration or Workman's Compensation Boards could serve as the means of initiating and carrying out a program of "no fault" insurance coverage for accepted routine immunization procedures. A one cent (or less) surcharge on each dose of all vaccines manufactured would probably be sufficient to create an adequate trust fund to carry out this program.

We should not wait for a series of expensive legal suits to be filed before acting. We immunize our children to prevent disease. We should do no less than to immunize ourselves with preventive legislation for "no fault" insurance against immunization dyspractice.

RICHARD D. KRUGMAN, M.D., University of Colorado Medical Center.

"HOLD HARMLESS" OPTIONS FOR PHYSICIANS-SWINE FLU PROGRAM

AUTHORIZE SECRETARY OF HEW TO PURCHASE LIABILITY INSURANCE Amend the Public Health Service Act to include: The Secretary shall provide liability insurance for any medical, nursing, or other licensed health care personnel (performing within the scope of such license) for damages for personal injury, including death, which may result from the administration or use of any vaccine or biological product purchased by, or provided to the general public at the recommendation of, the Secretary or his designee.

1 International Symposium on Vaccination Against Communicable Diseases, Monaco, 1973: Symposia Series in Immunobiological Standardization. London: S. Karger, 1974, vol. 22, pp. 328 and 329.