INDIANA LAW REVIEW [Vol

. Tort Liability for DPT Vaccine Injury and the Preemption Doctrine Infectious childhood diseases claimed thousands of lives annually in the United States before mass immunization brought the spread of communicable diseases under control. Today, vaccination of infants and young children is routine, and diseases such as pertussis, once a major cause of childhood mortality, are uncommon.' The development of vaccines to combat pertussis and other contagious diseases paralleled the growth of the administrative state during the 1930's and 1940's. The federal government, recognizing the national dimensions of disease control and the public health interest in safe and effective vaccines, implemented a regulatory scheme in 1944 which required licensure of all vaccine products and manufacturing facilities.^ Today, the Food and Drug Ad- ministration (FDA) is responsible for determining safety standards in the vaccine industry. The FDA licenses only one form of pertussis vaccine, which is administered routinely to young children as part of a three-in-one vaccination program. The FDA-approved DPT vaccine combines three dif- ferent antigens to provide protection against diphtheria ("D"), pertussis CT"), and tetanus C*T"). Despite consistent FDA approval, DPT vaccine has become the subject of controversy in recent years due to increased public awareness of the possibility of serious adverse reactions linked to the pertussis component. Although alternative types of pertussis vaccine currently are available in other countries, manufacturers are not permitted to distribute these vaccines in the United States because they do not satisfy federal standards for safety and efficacy. Even though the medical community continues to recommend routine vaccination to avoid the great public health risks of pertussis disease, some children inevitably will suffer severe brain damage or death as a result of the inoculation.^ When a vaccine-related injury occurs, a lawsuit against the manu- facturer often follows because many of these children are unable to pay for their medical and rehabilitative needs."^ Tort plaintiffs claim that 1 Cherry, The Epidemiology of Pertussis and Pertussis Immunization in the United Kingdom and the United States: A Comparative Study, 14 Current Problems in Pediatrics 7 (1984). 2. Public Health Service Act, Pub. L. No. 78-410, 58 Stat. 682 (1944) (codified as amended at 42 U.S.C. §§ 201-405 (1982)). 3. Peter, Vaccine Crisis: An Emerging Societal Problem, 151 J. of Infectious Disease 981 (1985). 4. H.R. Rep. No. 908, 99th Cong., 2d Sess. 4, reprinted in 1986 U.S. Code Cong. & Admin. News 6344, 6345. 655 656 INDIANA LAW REVIEW [Vol. 22:655 safer pertussis vaccines are feasible. Manufacturers, however, cannot distribute an alternative pertussis vaccine without violating current FDA regulations^ and, therefore, are confronted with skyrocketing litigation costs which threaten to render continued production of pertussis vaccine unprofitable. The withdrawal of this vaccine from the market could result in a substantial public health problem, and pertussis disease once again could reach epidemic proportions. Manufacturers, thus, are faced with a dilemma: should they stop producing the only approved vaccine to avoid huge tort judgments, or should they violate federal law by attempting to distribute an unlicensed vaccine which may be as effective but cause fewer or less severe reactions than the licensed variety. This dilemma stems from an inherent conflict between the federal regulatory system and state tort law in the area of vaccine regulation. Products liability law has developed in piecemeal fashion under state common law and state statutory reform, resulting in a system of litigation filled with uncertainties.^ Litigation costs and inconsistent results have led vaccine manufacturers to seek preclusion, or preemption, of tort liability for DPT-related injuries on the theory that damage awards are incompatible with the mandates and objectives of the federal regulatory scheme. They argue that there is an inherent conflict between federal regulations which mandate one vaccine design and state tort judgments holding manufacturers liable for producing that vaccine according to federal specifications. Under the Supremacy Clause of the United States Constitution,'' federal law can preclude concurrent state regulation in appropriate si- tuations. The preemption doctrine defines the boundaries of state power in relation to federal power. Its guiding principle is to promote the legitimate exercise of federal power without expanding that power at the expense of legitimate state interests. The scope of the federal law's preemptive effect, therefore, depends upon the subject regulated and the degree to which state and federal law conflict. 5. 21 U.S.C. §§ 331(d), 333(a), 355(a) (1982). See also Toner v. Lederle Labo- ratories, 779 F.2d 1429, 1431 (9th Cir. 1986). 6. Reed & Watkins, Product Liability Tort Reform: The Case for Federal Action, 63 Neb. L. Rev. 389, 394-95 (1984). See also Burke, DPT Vaccine Controversy: An Assessment of the Liabilities of Manufacturers and Administering Physicians Under Several Legal Theories, 17 Seton Hall 541 (1987). 7. The Supremacy Clause provides: This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding. U.S. Const, art. VI, cl. 2. 1989] DPT VACCINE INJURY 657 Recent shortages of DPT vaccine resulting from manufacturers' re- luctance to stay in the vaccine business^ have prompted the federal government to take action. In 1986, Congress enacted a program designed to limit manufacturers' liability, provide no-fault compensation to vaccine-injured persons, promote immunization, and encourage the development of safer vaccines. The two-fold purpose of the National Childhood Vaccine Injury Act of 1986^ (Vaccine Act) was to provide a new federal remedy and to ensure an uninterrupted supply of vaccines to meet federal immunization initiatives.'^ The provisions of the Vaccine Act were not immediately operative, however, because Congress failed to fund the compensation program at that time.'' With the national focus on reduced spending and a balanced federal budget. Congress was reluctant to appropriate the substantial amount necessary to fund no-fault compensation for vaccine-related injuries.'^ In addition, the Reagan administration opposed the compensation structure enacted by Congress and threatened to reject any funding measure until certain deficiencies in the program were corrected.'^ 8. Reitze, Federal Compensation for Vaccination Induced Injuries, 13 B.C. Envtl. Aff. L. Rev. 169, 194 (1986). 9. Pub. L. No. 99-660, 100 Stat. 3784 (codified as amended at 42 U.S.C. §§ 300aa-l to 300aa-33 (Supp. IV 1986)). 10. H.R. Rep. No. 908, 99th Cong., 2d Sess. 3-5, reprinted in 1986 U.S. Code Cong. & Admin. News 6344, 6344-46. See also Patten v. Lederle Laboratories, 655 F. Supp. 745, 749 (D. Utah 1987). 11. The Act provided that subtitle 2 (the vaccine compensation program) "shall take effect on the effective date of a tax enacted after the date of the enactment of this Act to provide funds for compensation paid under such subtitle 2." Pub. L. No. 99-660, tit. Ill, part B, § 323(a), 100 Stat. 3743, 3784 (1986). 12. It was estimated that an initial appropriation of $40 milUon would be required to establish the compensation fund which would be repayable to the federal treasury from excise taxes on future vaccine sales. H.R. Rep. No. 908, 99th Cong., 2d Sess. 33-34, reprinted in 1986 U.S. Code Cong. & Admin. Nevv^s 6344, 6374-75. Adequate tax rates, however, necessarily depend upon reasonably accurate predictions of the number and amount of claims. If future claims and operating costs are underestimated, additional annual appropriations would be necessary to offset resulting deficits in the fund. Funding Mechanisms for the National Childhood Vaccine Injury Program: Hearings Before the Subcomm. on Select Revenue Measures of the House Comm. on Ways and Means, 100th Cong., 1st Sess. 19-20 (1987) (statement of Dennis Ross, Tax Legislative Counsel, De- partment of Treasury). 13. The Vaccine Act was part of comprehensive public health legislation which President Reagan signed into law primarily because other parts of the legislation were deemed important to the national economy and also because the vaccine program would not take effect immediately. The President expressed his opposition to imposing any additional burdens on the American taxpayer and further objected to certain aspects of the structure and administration of the compensation program. 22 Weekly Comp. Pres. Doc. 1565-66 (Nov. 14, 1986). 658 INDIANA LAW REVIEW [Vol. 22:655 An apparent compromise was reached in the 1987 Vaccine Amend- ments which were passed as part of the Omnibus Budget ReconciHation Act of 1987. ^"^ Congress modified certain administrative aspects of the program and provided funding on a limited basis. Annual appropriations of $80 miUion from 1989 to 1992 are provided to compensate persons ^^ injured before October 1, 1988, the effective date of the program. Compensation for vaccine-related injuries or death on or after the effective date is to be paid from the new Vaccine Injury Compensation Trust Fund with revenues raised from an excise tax on vaccine sales between January 1, 1988 and December 31, 1992.^^ However, both funding mechanisms may be terminated before the end of 1992. If the annual appropriations from the general fund are insufficient, the only recourse for persons injured before the effective date is through civil actions for damages.'^ The Trust Fund program will terminate if the number of awards in a certain period of time exceeds the maximum number specified for that period.'^ The purpose of these limitations is to insure the solvency of the compensation program without creating an unfair excise tax burden.

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