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SMALLPOX VACCINE CASUALTIES: WHO PAYS?
Professor Edward P. Richards
Louisiana State University School of Law
JURIST Guest Columnist

Imagine a disease rapidly sweeping the world, infecting most of the population, killing 30% of humanity and leaving many of the survivors scarred for life.

This is the worst case scenario for smallpox. Post 9/11 and the anthrax letters, smallpox has become the number one bioterrorism issue. Anthrax does not spread from person to person and has simple, effective treatments if diagnosed in time. Smallpox spreads from person to person and has no proven treatments.

There is an effective vaccine for smallpox that was used to eradicate the disease in the 1970s, but that vaccine is itself a disease as much as a cure: it is a live virus - vaccinia, not smallpox itself - which must grow in the body to give immunity. Genetic analysis shows that vaccinia is not the cowpox of Jenner, but an unidentified virus, possibly horsepox, that is close enough to smallpox to convey significant immunity to smallpox. The virus is put on a small forked needle, which is jabbed into the patient's upper arm 15 times. The virus grows, producing a small sore which scabs over. In about two weeks the sore heals. Before it heals, it contains live virus which can be spread to others. Old vaccination methods were based on taking material from an active sore and using it to immunize others. This spread other blood borne diseases such as syphilis and also spread bacterial infections.

A person's immune system fights this weak virus and prevents it spreading to the rest of the body. If the immune system is impaired, the virus can spread. This spread ranges from an enlarged vaccine sore, to sores over larger areas of the body, to whole body infection. This whole body infection is called disseminated vaccinia and is often fatal. (The terminology is variable - some sources uses the disseminated vaccinia to encompass all virus spread, not just the lethal whole body disease.

In 1970, smallpox vaccine killed about 1/1,000,000 persons. A larger number had serious side-effects which generally resolved with no permanent injury. All of the current models of smallpox vaccine injury are based on this number.

There were, however, very few immunosuppressed persons in 1970. With HIV/AIDS, powerful cancer drugs, immunosuppressive drugs used for transplant patients, and to treat other diseases, the population of immunosuppressed persons may now exceed 1% of the population, and several % in subpopulations such as in San Francisco.

Existing official government recommendations are to not immunize such persons unless they have been exposed to smallpox. They also recognize that there may be a risk of vaccinia spreading from an immunized person to a family member, co-worker, or patient of a health care provider who is immunosuppressed.

The problem is that the vaccination guidelines do not address the reality that many persons do not know their immune status or whether they are infected with HIV. The official recommendations leave it to the persons being vaccinated to know their own immune status, despite the data that 25-50% of persons with HIV do not know it. Immune system testing is not required, and there is little attention to the risk of spread to others. These recommendations make sense if the risk of vaccine injury to immunosuppressed persons is not much higher than 1/1,000,000. If the risk of injury to immunosuppressed persons is much higher, perhaps 1/100, or 1/10, and 1/1 for severe immunosuppression, then relying on self-screening is a dangerous policy, especially given the stigma of refusing the vaccine if you are part of a frontline emergency response team.

Given this approach to immunizations, it is probable that in the event of a mass US vaccination program such as that for health workers and first responders soon to be announced by the White House, there will be vaccine related injuries - perhaps a lot of them if the immunization programs are rolled out quickly to many hospitals. The just-signed Homeland Security Act of 2002 includes provisions which severely limit liability for smallpox vaccine related injuries, perhaps leaving only worker's compensation available to injured employees and nothing to others. Section 304 states:

"For purposes of this section, and subject to other provisions of this subsection, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of administration of a covered countermeasure against smallpox to an individual during the effective period of a declaration by the Secretary under paragraph (2)(A)."
The Section goes on to define persons as including health care institutions, so this provision applies to hospitals and health departments as well as the employees. Deeming them to be employees of the Public Health Service means that any claims against them must be filed under the Federal Tort Claims Act (FTCA), subject to its defenses as discussed below. The Federal Government is substituted for the defendant in such cases, which provides nearly complete legal protection for the hospital or individual who is the real subject of the claim. (FTCA cases in general)

The most difficult question posed by this provision is its scope. It applies to "... liability arising out of administration of a covered countermeasure against smallpox to an individual ...". This clearly applies to a person suffering a vaccine complication who wants to sue for either medical malpractice or products liability related to bad vaccine or negligent administration. It does not appear to apply to worker's compensation claims by hospital employees injured by vaccination. Worker's compensation is not a liability claim but a statutory trading of liability claims for an insurance system that does not require a showing of fault for compensation. A court constructing this section would also have a strong policy reason for finding that it does not apply to worker's compensation clams. As discussed below, if this provision applies, the injured person will receive no compensation at all. Thus the court will likely find a manifest injustice if the employee is injured in the course and scope of his/her job yet has no avenue for compensation for medical costs and lost wages.

Unlike the compensation system for Swine Flu, which specifically broadened the compensable events under the FTCA, the Homeland Security Act uses the standard FTCA, with its broad discretionary authority defenses. If the government is careful in articulating the policy rationale for decisions such as not screening for HIV, there is little chance of recovery under the FTCA. If private insurers also decline coverage because this is a military action, many injured persons will be denied all compensation. This is not an acceptable policy result and may result in massive refusal of immunizations, in the absence of a credible threat of a smallpox outbreak. Ironically, the government, through the National Childhood Vaccine Injury Act, compensates for injuries due to childhood illness vaccines, which are much safer than smallpox vaccine. The best public health policy would be to modify the Homeland Security Act, preserving the immunity provisions for health care workers and institutions, but providing federal compensation for vaccine related injuries.


Professor Edward P. Richards is Director of the Program in Law, Science, and Public Health at Louisiana State University School of Law. He provides more legal materials on smallpox issues on his Medical and Public Health Law website.

November 29, 2002

GUEST COLUMNIST

JURIST Guest Columnist Edward P. Richards is Director of the Program in Law, Science, and Public Health at Louisiana State University School of Law. Professor Richards practiced health and public health law in Houston, Texas, before entering legal education. Prior to joining the faculty at LSU, he was professor of law and executive director for the Center for Public Health Law at the University of Missouri 訪ansas City School of Law. He maintains a website on biotechnology and medical law issues.

Professor Richards has published extensively, including the books Medical Care Law (Aspen 1999) and Law and the Physician: A Practical Guide (Little, Brown 1993). He received his undergraduate degree in biology and behavioral science from Rice University. He conducted graduate work in human physiology and medicinal chemistry at Baylor College of Medicine and the University of Michigan. He received his J.D. from the University of Houston and his M.P.H., focusing on disease control and risk analysis, from the University of Texas School of Public Health.