Aids Vaccine Manufacturers V. Tort Regime:The Need For Alternatives

Vaccines have contributed more to public health in this country and around the world than any other medical product, device, or procedure.(1)Vaccines have effectively controlled or eradicated the once fatal and debilitating diseases of smallpox, diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio.(2) Yet, the imposition of strict product liability for adverse side-effects suffered by some vaccine users substantially deterred the development and manufacture of these vaccines and continues to hinder future access to them.(3) In the 1970s and early 1980s, twelve of the sixteen American vaccine manufacturers simply dropped out of the market, seriously threatening vaccine supply.(4) In response, Congress enacted legislation to address the detrimental effect the tort liability system was having on vaccine innovation and access.(5) In order to avoid repeating history, we must learn from these past vaccine scenarios and attempt to structure an effective method to deal with the problems conventional tort liability places in the path of finding an answer to the Acquired Immunodeficiency Syndrome (AIDS) epidemic.(6)AIDS is deemed the worst infectious disease in history.(7) The human immunodeficiency virus (HIV), responsible for transmitting AIDS, strikes all sectors of society, regardless of racial, economic, sexual, and age boundaries.(8) Fortunately, private industry has the ability to formulate, produce, and test an AIDS vaccine.(9) As of 1990, the National Institute of Allergic and Infectious Diseases reported at least thirty vaccines under development world-wide,(10) seven of which have already reached the human testing stage.(11) However, if the tort liability problems persist, these potential AIDS vaccines may never reach the market. Federal legislation is the necessary solution to the detrimental effect that imposition of traditional tort liability has on the development, marketing, and price of an AIDS vaccine.(12)I. GENERAL BACKGROUNDThe term "AIDS" designates the specific group of diseases and conditions that are indicative of the severe immunosuppression resulting from infection with HIV.(13) By August 1991 the total number of AIDS cases in the United States reached 186,895.(14) Some 1,500,000 United States citizens are infected with the HIV virus, and estimates predict that 365,000 Americans will develop AIDS by the end of 1992.(15) The world-wide picture is dimmer yet, with approximately eight to ten million people infected.(16) The most distressing statistic is the high mortality rate.(17) The average AIDS patient lives only eighteen months after diagnosis, and more than eighty-five percent die within three years.(18) AIDS is now the leading cause of death in New York City among young to middle-age men and women.(19) Currently there is no known cure for AIDS, and all scientific evidence indicates that individuals testing positive for the virus will eventually contract AIDS and die.(20) The above statistics indicate that AIDS is a frightening contagion that will challenge our medical, scientific, and legal communities for years to come.(21) Not surprisingly, health officials have propelled AIDS to the top of biomedical and public health agendas.(22)II. VACCINATION AS THE PREFERABLE MEDICAL APPROACHPractitioners can use various medical approaches, including drug therapy and vaccination, to combat AIDS.(23) In 1991 the Pharmaceutical Manufacturers Association identified fourteen approved drugs, as well as eighty-eight drugs and vaccines in development for AIDS and AIDS-related conditions.(24) The major goal of existing drug therapies is to increase the quantity and quality Of life: in other words, to delay mortality and to reduce morbidity.(25) While prolonging life and easing pain are important, a preventive or curative approach is clearly preferable and, thus, development of an AIDS vaccine is a highly desirable goal.(26)A "vaccine" is a biological agent derived from a living organism, as compared to chemically derived drugs, used for human immunization against a virus. …