Smallpox liability: Who pays? Who can be sued?

Editor’s note: This is the third of three parts of a commentary on the benefits and risks of the nation’s smallpox vaccination plan.

The question of compensation for lost wages and for illnesses, morbidity and complications from smallpox vaccination is one of the most vexing but remains unanswered to everyone’s satisfaction. Basically it is who pays for what and who can get sued. As far back as Oct. 3, 2002, the liability question was raised in an editorial in The Wall Street Journal with the obvious question, “Who will be liable in the case of an adverse reaction?”

The Homeland Security Bill was being developed then and now the law addresses some of those questions by essentially absolving vaccine manufacturers, physicians, hospitals and other licensed individuals who are agents of the federal government of liability related to the administration of the smallpox vaccine. One wonders how tort lawyers will view this law.

Dr. Julia Gerberding, director of the Centers for Disease Control and Prevention, was quoted in The New York Times on Jan. 18 that the CDC “was working with all partners to sort out this issue [liability compensation].” But she added, “We are certainly not going to delay this program because of concerns about compensation.” Why not?

Concerns about compensation are stopping this program in its tracks. Few volunteers are stepping forward. A specific recommendation from the Jan. 17 Institute of Medicine’s report on smallpox vaccination was to carefully consider compensation, and the report even suggests that if this is not done the program may not be able to proceed as anticipated due to lack of volunteers. There seem to be plans to introduce more legislation to address the problem of compensation for morbidity and lost time and wages but the situation is murky and changes by the week.

In addition to the Institute of Medicine report to move more slowly, certain hospitals have chosen not to participate in the program. At least one factor is the unresolved compensation and certain liability issues. Grady Memorial in Atlanta, the hometown of the CDC, chose not to participate. The Boston Globe reported Jan. 17 that physicians at the Cooley Dickinson Hospital in Northampton announced that they would not volunteer to receive smallpox vaccination.

It is my understanding that Eastern Maine Medical Center will not participate in the program at this time. The Boston Globe also reported Jan. 15 that the Massachusetts Nursing Association was not encouraging its members to participate in the program. A recent USA Today poll showed at least 80 major hospitals over the country have elected to delay administering smallpox vaccine to their staff. However, the Bangor Daily News carried an Associated Press story in its Feb. 8-9 edition stating the Maine Medical Hospital had committed to developing the hospital-based program desired by the CDC.

I began to wonder about the science and the medical discussions revolving around the program when President Bush received a smallpox vaccination. His physician made a mistake in allowing this. There was no threat to his health.

There was no smallpox attack imminent. He would have received a vaccination in a timely fashion if the event happened and could have been protected. The president could have suffered an adverse reaction or complications for vaccination. Such an untoward reaction was highly unlikely because I assume he has already been vaccinated years ago. Nevertheless the decision to vaccinate the president was made and it was not a medical one but rather a public relations decision.

A debate about the smallpox vaccination program has really started to emerge in the past few weeks. A bit too late, in my mind. The theme of the debate revolves around risks, complications, liability, compensation, safety, costs, implementation, timing and compliance, informed consent and even patriotism.

The Jan. 30 edition of the New England Journal of Medicine contains seven articles on the smallpox question. One article considers data related to differing mathematically modeled scenarios of a smallpox attack. The results and the efficiency of vaccination varying based upon multiple factors but mainly the size and extent of exposure are the main factors. Another article focused on educating the public on all aspects of the smallpox question. Thomas Mack, M.D. gives a measured view of the true infectious nature of smallpox, pointing out that in past outbreaks of the disease it was mainly transmitted at the patients’ bedside. He warns that containing the spread of smallpox after an attack will rest in large part on isolating cases in the appropriate environment, not necessarily a hospital.

At a recent U.S. Senate hearing on the initiative during the last week of January hospital administrators express their reluctance to initiate vaccination based on concerns for complications and compensation. Nursing union representatives echoed these concerns. State health officials pointed out the funds and staff used to implement the program may take away funds and staff needed in other areas.

Dr. Gerberding gave a lucid and forceful argument for the program at the hearing. I did not hear her repeat her statement that the program would not be delayed because of “concerns for compensation.” Apparently there was no mention of Israel’s experiences. (I did not hear the whole session on C-SPAN 2.) She was unwilling, or unable based on security issues, to detail the results of recent vaccinations in the U.S. military. Col. John Grabenstein, U.S. Army Medical Corps, gave a partial analysis of the military’s experience with smallpox vaccination to the Institute of Medicine as recently as Feb. 13. He related that after more than 100,000 smallpox vaccinations in the military recently there were two cases of encephalitis and one case of a “heart infection.” All cases recovered and were back on duty. He also stated they were seeing a “rash of rashes.”

Needless to say this data needs to be clarified and the details expanded. One might note that two cases of encephalitis in 100,000 translates to 20 cases in 1 million (not 2.9 cases in a million as noted before).

The debate about the smallpox vaccination program is really just starting. The rhetoric is starting to outstrip the limited science. Two articles that appeared on the editorial pages of The Wall Street Journal just inflamed the debate. On Feb. 11 an editorial titled “Dark Smallpox Winter” combines sloppy statistics, a flawed attack scenario and sensational language to make a point that people should get vaccinated and those who don’t are subtly considered unpatriotic. Two days later an even more outrageous article appeared on the op-ed page. Dr. Cary Savitch of the Infectious Disease Association of California paints an even more frightening picture – “this highly communicable virus would race across the planet, infecting most of the world’s population.”

While the debate concerning the smallpox vaccination program may be just starting, I feel unfortunately that the science and necessary intelligence (both emanating from the people and that gathered by the government) may be faulty, conflicted, inaccurate and driven by agendas.

After all the work, effort and honest reflections it is extremely difficult for governments, experts and individuals to say, “We made a mistake.” The health of Americans will suffer if the smallpox vaccination program progresses as it is now planned.

William Gallagher, M.D., is a Bangor dermatologist. He is a member of the American Academy of Dermatology.