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Smallpox Vaccine Injury Law Project

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Senate Bill 15 (S15) - A Flawed Compensation Plan

On March 11, 2003, Senators Gregg, Frist, Alexander, Warner, Enzi, Sessions, Roberts, and Graham introduced Senate Bill 15, which, among other things, establishes a smallpox vaccine injury compensation fund. This fund is intended to encourage smallpox vaccinations by addressing the fears of health care workers and others that they will not have any insurance coverage if they are injured by the smallpox vaccine. As discussed below, the fund proposed by this bill is very restrictive and may not go far enough to address the concerns of health care providers and their institutions.


Until the 1970s, there was no expectation of compensation if someone was injured by a vaccine. There had been some tort claims based on impure vaccines, but these were exceptional. Most people supported vaccinations for themselves and their children because they were frightened of catching the diseases for the vaccines were developed. While there have always been persons who opposed vaccination, they were in the minority and legal policy reflected the majority view that vaccine injuries were the cost of reducing one's risk of contracting a deadly disease. As these diseases were eradicated or reduced to only sporadic outbreaks, people became less tolerant of vaccine injuries, which lead to the discontinuance of smallpox vaccinations in the early 1970s. As these diseases faded from memory, tort lawyers and vaccine opponents convinced people that vaccines were dangerous, fueling resistance to vaccinations and a tsunami of litigation. Congress responded with the National Childhood Vaccine Injury Compensation Fund, which provided compensation for children allegedly injured by vaccines. This fund was good politics, if not good policy, and created the expectation that the federal government should provide compensation if it wants people immunized for communicable diseases. This expectation of compensation was heightened for the smallpox vaccine, which is much more dangerous than any other approved vaccine. Most health care providers have baulked at being vaccinated because of their own fear of injury and because patients inadvertently injured through secondary transmission have no avenue for compensation under the Homeland Security Act.

Review of the Act

S15 begins with the definition of a covered person:

(i) a health care worker, a law enforcement officer, a firefighter, a security-related worker, an emergency medical worker, or a public safety worker who is identified in a State, local, or Department of Health and Human Services plan that is approved by the Secretary; or
(ii) an individual with respect to whom the Secretary determines and declares that it is advisable to administer the vaccine (not including any individual to whom the Secretary determines only that such vaccine should be made available)

Section (i) raises the issue of what is an approved plan and what does identification mean - must each vaccinated person be identified, and what if the plan is not approved? Section (ii) appears to cure this by expanding the class of covered persons to at least cover all those described in the Secretary's declaration, but it clearly excludes persons for whom vaccination is available but not recommended by the Secretary.

The definition of a covered injury is handled effectively and the Secretary is directed to flesh this out with regulations. The next problem is in Section 5, the definition of an eligible individual, i.e., those covered persons with covered injures who are eligible for compensation. The problem comes for persons who are secondarily infected by vaccinia, which can include fellow health care workers, patients, and family members. Compensation is only available for one:

"who has resided with, or has been in close contact with, a covered individual"

This is based on the CDC's view that vaccinia is hard to transmit and thus only close contacts can catch it. The literature on vaccinia does not support this, finding instances of casual transmission. More importantly, since the government controls all the vaccine, the only way an injured person could be exposed to vaccinia is through contact with a person immunized under the program. This provision would exclude most patients and fellow workers injured by secondary spread.

S15 provides that the Secretary of HHS may review and approve, deny, or modify determinations of eligibility under the Act and that the Secretary's decision is final and unreviewable:

(A) SECRETARY'S REVIEW AUTHORITY - The Secretary may review a determination under this subsection at any time on the Secretary's own motion or on application, and may affirm, vacate, or modify such determination.
(B) SECRETARY'S ACTION NOT JUDICIALLY REVIEWABLE. - The determinations of the Secretary under this subsection shall not be subject to review by another official of the United States or by a court by mandamus or otherwise.

The medical benefit is limited. It is second dollar coverage, paying only what is left after other insurance plans , including worker's compensation, or any other payer (including tort awards or settlements) has contributed. There are no payments at all for persons who are eligible for Medicare, despite the many expenses left to patients by the Medicare system.

The lost wages benefit is paid at 2/3 of the monthly wage, with no payments for the first 5 days of lost wages, and a cap on all payments of $50,000. As with the medical benefit, this is second dollar coverage and payment from any other sources will be deducted.

S15 provides a death benefit and a benefit for total and permanent disability equal to the benefits paid under the Public Safety Officers' Benefits Program, which, according to an announcement by the Secretary of HHS, are $262,100. This appears to be in addition to any other benefits that the individual receives, except for benefits from the Public Safety Officers' Benefits Program. It appears that there can also be benefits for partial disability, but this is unclear from the Act.


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