An Economic Analysis of Liability for Aids-contaminated Blood Products
| Publication year | 1988 |
| Citation | Vol. 12 No. 01 |
The occurrence of acquired immunodeficiency syndrome (AIDS) in America has raised difficult new questions in the fields of medicine, religion, and ethics. AIDS has invaded the bedroom, the boardroom, and the hospital room-in the latter case in the form of contaminated blood products. The law has dealt with this challenge by relying on liability doctrines developed to deal with the threat of other blood-borne diseases such as hepatitis. But because AIDS and hepatitis differ markedly in their communicability, preventability, duration, and severity, reliance on those doctrines is ill-advised.
The purpose of this Comment is to develop an economic analysis of possible blood products liability rules in order to determine what the effects of such rules are on blood users and providers. To the extent that current liability rules fail to promote an efficient allocation of risks and resources, this Comment will propose changes designed to correct such deficiencies.
The economic analysis of liability rules relating to blood products contamination requires an understanding of the nature of the risks posed by AIDS and of the precautions that blood providers and blood users may take to avoid those risks.
AIDS(fn1) destroys the body's ability to fight infections, and thus leaves its victim vulnerable to a host of opportunistic diseases.(fn2) AIDS is nearly always fatal. As of May, 1984, nearly half of all persons diagnosed as having AIDS had died from the disease.(fn3)
A wealth of information has been developed about the methods of transmission of the disease since it was first reported in the United States in June, 1981.(fn4) Although not conclusively proved, AIDS is thought to be transmitted by a virus known as human t-cell leukemia virus III.(fn5) The most common means of transmission of the virus are blood-to-blood contact through the use of contaminated hypodermic needles, and homosexual or heterosexual intercourse.(fn6) AIDS can also be communicated to hemophiliacs through the injection of contaminated clotting agents made from blood(fn7) and by the transfusion of other AIDS-contaminated blood and blood products.(fn8)
It is not known how many of those persons infected with HIV will develop the AIDS complex, although the conversion rate is now thought to be much higher than the twenty percent rate originally estimated.(fn9) The minimum dose of the virus needed to cause infection is also unknown.(fn10)
The long incubation period of HIV has hampered efforts to calculate the extent of the spread of AIDS. The median incubation period of HIV is estimated to be 4.5 years.(fn11) During the incubation period, an AIDS victim may have no apparent symptoms.(fn12) It also appears that HIV antibodies, the presence or absence of which is used as a test for AIDS, may not appear for some time after infection has occurred.(fn13)
The spread of AIDS has been geographically concentrated. Although AIDS cases have been reported in forty-seven states, Washington D.C., Puerto Rico, and thirty-six foreign countries, eighty percent of all cases reported as of June, 1985 had occurred in six metropolitan areas, principally New York City.(fn14) Seventeen percent of AIDS cases occurred among intravenous drug users. Eighty-two percent of these cases occurred in New York City.(fn15)
Much progress has been made in developing precautionary medical procedures to safeguard the general population from accidental AIDS infection by the transfusion or use of blood and blood products.
Currently, transfusion-related AIDS is prevented by heat-treating blood products, by deferring donations of blood by members of high-risk groups, and by testing(fn16) donated blood for the presence of HIV antibodies.(fn17) These measures have been credited with reducing the risk of transfusion-related AIDS infection to an extremely low level, currently estimated to be between 1 in 100,000 and 1 in 1,000,000.(fn18) In 1986, the present value of direct and indirect losses caused by AIDS was $275,890/individual/year, and is expected to increase to $384,629/individual/year by 1991.(fn19) For the purposes of this Comment, these rough probability and loss estimates will be multiplied to produce an approximation of the present expected value of the risk of receiving HIV-contaminated blood equal to $1.82 per unit of transfused blood.(fn20)
It is estimated that 600 persons were infected with HIV by transfusion during a period in which 60,000,000 units of blood were transfused. Of this infected group, all but one or two received transfusions before widespread blood testing was commenced in early 1985.(fn21)
The current test for HIV antibodies is not fail-safe;(fn22) it does not detect those persons who, though infected with HIV, have not yet developed HIV antibodies. These antibodies may not develop until after one is infectious.(fn23) At least one case of HIV infection has been traced to donated blood that tested negative for HIV.(fn24) The virtual cessation of transfusion-related AIDS since the commencement of testing suggests, however, that such cases are exceedingly rare.(fn25)
I. Who Are the Victims?
The victims of blood-related AIDS infection can be roughly divided into three groups. The first group of victims is comprised of hemophiliacs. Hemophilia is a hereditary disease that causes its victims to bleed excessively.(fn26) Hemostatic integrity of the blood may be achieved for several hours by the injection of potent concentrates of antihemophilic factor VIII (factor VIII), which is made from the blood plasma of donors.(fn27) This injection is usually accomplished by the patient himself, with factor VIII being provided by prescription on an outpatient basis.(fn28)
Factor VIII is made in two ways.(fn29) The method most commonly employed by commercial plasmapheresis centers, which produce eighty percent of the clotting agent used,(fn30) involves the pooling of the blood of between 5,000 and 50,000 paid donors.(fn31) This pooling method creates a high risk of contamination, since the entire batch may be contaminated by one infected donor. Each batch of clotting factor is then distributed to 100 hemophiliacs.(fn32) Risk of exposure is further heightened by the fact that a hemophiliac may be exposed to several batches of factor VIII over the course of a few years.(fn33)
The second method of production is the cryoprecipitate process. In this process, only one donor's blood is used to create a particular batch of factor VIII.(fn34) Thus, the risk of infection from a particular batch of cryoprecipitated factor VIII is several hundred times lower than the risk presented by pooled factor VIII. The cryoprecipitate method is primarily used by blood banks and hospitals.(fn35)
The second group of victims is comprised of elective donees. As defined in this Comment, elective donees are those who receive whole blood or blood components as part of elective medical treatment, usually surgery. Elective donees differ from other transfusion-related AIDS victims in that their exposure to blood products is, by definition, completely voluntary.
The third group of victims of transfusion-related AIDS is comprised of emergency donees. As defined in this Comment, emergency donees are those persons who need blood transfusions on an emergency basis but who, because of the emergent nature of their need, are unsuitable candidates for autologous transfusions. Emergency donees are likely to use the same type of whole blood products as elective donees, since both are administered to replace blood lost either through surgery or trauma.
Hemophiliacs, elective donees, and emergency donees differ markedly in their ability to avoid the risk of AIDS-contam-inated blood products. A significant percentage of hemophiliacs can successfully substitute cryoprecipitated factor VIII for factor VIII mass-produced by the pooling method,(fn36) reducing their exposure to HIV infection. However, cryoprecipitated factor VIII has several drawbacks. It is not as convenient as mass-produced factor VIII, which is freeze dried and requires no special refrigeration to store.(fn37) Cryoprecipitated factor VIII is also not as effective as freeze dried concentrate in treating severe hemophilia. Further, because pooling allows factor VIII to be mass-produced, it is likely to be less costly than cryoprecipitated factor VIII, which is produced in single lots.
Furthermore, substituting cryoprecipitated factor VIII for freeze dried factor VIII may no longer be cost effective as a preventive measure. As stated above, the heat disinfection of blood products has reduced the risk of AIDS infection to virtually zero. Although there is a .02 percent chance of contracting HIV through the use of heat treated factor VIII made from the blood of unscreened donors, there have been no documented cases of infection from factor VIII when both screening tests and heat treatment are used.(fn38) Because blood screening tests and heat disinfection are both used by all U.S. producers,(fn39) the risk of HIV infection and the need for substitutes are negligible.
Elective donees may take a number of precautionary measures to avoid exposure to HIV. They can abstain from surgery, they can use blood donated by persons known to them, or they can use their own blood during surgery...
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