RELEVANCE OF R A D I A T I O N C O M P E N S A T I O N LITIGATION TO C O M P E N S A T I O N FOR T O X I C E X P O S U R E S

G L E N N E . SCHWEITZER Science Policy Studies, Environmental Research Center, University of Nevada at Las Vegas, U.S.A.

(Received October 10, 1985) Abstract. Several recent court decisions add to the growing body of law concerning the responsibility of Government in radiation matters and the quantum of proof needed to show causation between radiation exposures and certain types of cancer and leukemia. The courts have also been addressing a wide range of compensation claims for exposures to toxic chemicals with demonstration of causation being a particularly difficult task. Meanwhile, the Congress has been attempting to legislate a far reaching administrative and judicial framework for compensating toxic victims, including an easing of burden-of-proof requirements for demonstrating causation and a broadening of the basis for admissibility of scientific evidence. Drawing parallels between radiation and toxic exposure problems can be both instructive and misleading. Some of the technical issues are quite similar, including the importance of person-specific exposure estimates and of epidemiological studies. However, the uncertainties associated with toxic exposures are usually far greater, and the scientific data base for relating exposures and effects is much more uncertain.

1. Recent Developments in Radiation Compensation

Since World War 11 the U.S. Government has supported extensive scientific investigations of the relationships between radiation exposures and adverse health effects. The results of these investigations are reflected in documents prepared by the National Academy of Sciences (e.g. the BEIR reports), a variety of consensus reports of international scientific bodies, and 'many textbooks. Still, many uncertainties remain concerning the effects of low level exposures which are increasingly becoming the subject of law suits. Several recent judicial decisions add to the growing body of law concerning the responsibilities of the U.S. Government in the field of radiation exposure and the quantum of proof needed to establish causation between exposures to radiation and development of certain types of cancer and leukemia. The broad discretion of the Government in engaging in radiation-producing activities is repeatedly acknowledged while the Government's responsibility for prudently exercising this discretion is forcefully underscored. The credibility of scientific witnesses and the authoritativeness of scientific documentation are central issues in recent cases. Finally, the weight given to exposure standards set by national and international scientific bodies of experts varies among the cases. In 'Irene Allen et al. vs. United States of America' (1984) [I], Judge Bruce S. Jenkins of the Utah District Court addressed 24 bellwether cases from 1192 pending claims concerning alleged radiation injuries. The injuries were attributed to exposure to radiation from nuclear weapons tests conducted in the atmosphere over the Environmental Monitoring and Assessment 8 (1987) 1-10. @ 1987 by D. Reidel Publishing Company.

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Southern Nevada desert during the 1950s and early 1960s. The plaintiffs claimed that the victims lived in radiation fallout areas in Nevada and Utah, that they suffered radiation-induced cancer or leukemia, and that the injuries resulted from negligence of the Government. With regard to negligence the Court ruled that while atmospheric testing was a discretionary function of the Government, such testing must be bounded by due care for the safety of nearby residents. Specifically, the Court determined that the Government had failed (1) to inform the residents adequately of the biological consequences of fallout, (2) to measure radiation levels sufficiently during and following cloud passage, and (3) to inform communities on a timely basis of steps to minimize the consequences of fallout. In concluding that in 9 of the 24 cases causation could be adequately demonstrated, the Court gave weight to the following factors: time and extent of exposure to fallout age and organ sensitivities retrospective dose assessment studies - consistency of latency period and radiation etiology - statistical evidence of increased incidence of disease among local populations. Judge Jenkins was not impressed by arguments that de minimis radiation levels, i.e. levels well below guideline levels established by expert bodies, should not be considered to cause the alleged injuries. He documented in great detail scientific arguments to support his opinion that any level of radiation above background increased the probability of injury, and he repeatedly cited expert witnesses of the plaintiffs whose calculations suggested probabilities of causation ranging from 10~ to 90070. In 'Dorothy Roberts et al. vs. United States of America and Louise Nunamaker vs. United States of America' (1984) [2], Judge Roger D. Foley of the Nevada District Court considered the claims of workers at the Nevada Test Site. They had been exposed to fallout on the Test Site as the result of the accidental radiation venting through a crack in the ground following an underground nuclear weapons test in 1970. Despite the venting, they would not have been exposed to the radiation plume had not the wind shifted unexpectedly bringing some fallout into a populated work area. This Court was equally adamant on the responsibility of the Government to use the utmost care in carrying out nuclear weapons tests. Specifically, the Court found the Government negligent in the manner of evacuating persons from the fallout area and in the procedures that were used for decontaminating persons exposed to radiation. However, with regard to causation, the Nevada Court parted company with the Utah Court. Judge Foley gave great weight to the radiation safety guidelines developed by expert bodies over the years, noting that the exposures from the venting were well below the guideline levels. He also noted that exposures from the venting were substantially lower than exposures from other sources such as x-rays and environmental background. He delved into the specific medical symptoms of the -

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plaintiffs, rejecting radiation from venting as the cause of these symptoms. He also accepted statistical arguments of the defendants that the leukemias in question were not caused by the venting, rejecting as methodologically flawed the epidemiological studies presented by the plaintiffs designed to show causation. Judge Patrick F. Kelly of the Kansas District Court considered claims that workers in an aircraft instrument facility in Wichita, Kansas, developed cancers because they worked with luminous dials supplied by the Government. His opinion is set forth in 'Ada G. Johnston vs. United States of America, Barbara J. Womack and Loyd B. Womack vs. United States of America, Estella I. Vessels vs. United States of America, and Lila M. Mewhinney and Richard M. Mewhinney vs. United States of America (1984)' [3]. The workers contended that over the years the Government had been negligent in not warning employees of the biological consequences of working with aircraft parts which could emit radium, radon, and other radioactive materials, and as a result of this negligence the materials were improperly handled and indiscriminately stored, thereby causing excessive radiation levels at the facility. With regard to the obligation of the Government to adequately warn employees concerning the handling of luminous dials, a key issue was whether each dial should have been individually labelled. Noting that the Government had taken a number of steps to alert the industry of the radiation aspects in general terms, the Court rejected the contention that individual labels were required for such minute sources of radiation. Judge Kelly, however, considered causation to be the overriding issue. Much o f his opinion was a scathing condemnation of the lack of objectivity of the key scientific witnesses for the plaintiffs. Their lengthy testimony on all aspects of the case was almost totally rejected. The Court gave great credence to the judgements of expert scientific panels, and particularly to the significance of established radiation safety standards. In each of the three cases, the Courts presented considerable discussion of the technical aspects of the health physics considerations, presumably to inform interested parties of the extent of the Court's understanding of the scientific bases for the decisions. In any event these dissertations will certainly provide targets for controversy, both within the legal system and among scientific groups. There was unanimity as to the importance of determining good retrospective estimates of radiation dosages. In two cases this seemed to be a hopeless task. While Judge Jenkins nevertheless gave weight to plaintiff estimates based on very uncertain data, Judge Kelly totally rejected plaintiff estimates that were based on equally uncertain data and assumptions. One of the most significant differences among the opinions was the credence given by Judge Jenkins to two scientific witnesses for the plaintiffs who during subsequent court appearances were discredited by Judge Kelly. It may be that the scientific witnesses supporting the Government's case were more effective in Kansas City in debating technical issues, but the contrast in treatment of the expert testimony is striking indeed.

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These three cases and several recent workmen's compensation decisions demonstrate that there is no consensus in an approach to the probability of causation issue in the radiation field. The difficulty that the courts and other agencies have in attempting to decide claims of radiation injury has often led them to give considerable weight to expert witnesses who put forward simple and unequivocal opinions on causation even if they deviate markedly from the consensus of nationally and internationaIly recognized scientific bodies. As one step in providing better guidance for future cases, Congress has requested the Department of Health and Human Services to develop probability of causation tables for use in claims of radiation injury [4]. Since such tables will be helpful only when radiation exposure levels are known, the documentation of ongoing exposures and development of sound methods for estimating previous exposures take on high priority. Meanwhile, consideration of possible legislative remedies for victims of radiation exposures will probably continue [5].

2. The Framework for Compensation for Exposures to Toxic Chemicals As noted above much of the recent debate over compensation for radiation exposures has taken place in the courtrooms. However, given the potentially broader impact of exposures to toxic substances on large segments of the population, the Congress has taken a very active role in providing a major forum for considering the issues surrounding victims of toxic exposures. A number of existing Federal laws address different aspects of compensating victims of both public and private actions. Usually cited as the most relevant to the issue of toxic exposures, although not necessarily a model to be emulated, is existing legislation which provides an administrative system for compensating coal miners who suffer from black lung disease. Beginning in 1976 with efforts to include compensation provisions within the Toxic Substances Control Act and continuing into the 1980s with proposed amendments to the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), Congressional delegations have been actively responding to constituents who have alleged injury from uncontrolled toxic chemical discharges. Constituent concerns with particularly high public visibility have related to kepone exposures in Virginia in 1976, leakage from Love Canal since 1978, and dioxin contamination uncovered in Missouri during the early 1980s. The focal point for much of the Congressional deliberations has been the Congressionally mandated report of an intensive study by a blue-ribbon panel of legal scholars and practitioners on the entire range of victims compensation issues. The report was delivered to Congress in September 1982 [6]. With the report in hand a number of Representatives and Senators introduced a variety of compensation bills in Congress during 1983-4 (HR 2330, HR 2482, HR 2585, HR 4303, HR 4813, $917, $945, $946). These bills generally covered the principal issues discussed in the report,

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although frequently diverging from the recommendations of the study. These issues included the extent of compensation that should be considered, an administrative system for handling claims for medical expenses and property damage, and judicial remedies for other types of injury [7]. In calling for a two tier system of administrative and judicial remedies, the bills generally followed the definition of harmful agents set forth in CERCLA. However, there would be no exemptions for discharges that are allowed under Federal permits. Remedies could be sought under this legislation as well as under other existing laws when applicable, although duplicative claims could not be pursued. The administrative system envisaged in the bills would be the responsibility of a Federal agency, but delegation of administrative authority to the States would be encouraged. When possible, initial claims would be presented by plaintiffs to the responsible parties for redress, and only if unresolved, would they be presented to the agency. Statute of limitation restrictions would be eased in light of latency periods associated with chronic effects and of the time often required to clarify scientific uncertainties. Also, burden of proof requirements for plaintiffs would be eased through provisions for rebuttable presumptions which place a greater burden on the defendants. Finally, administrative hearings would follow the procedures set forth in CERCLA with appeals to be directed to the District Courts. In providing a framework for judicial remedies, the bills would establish a Federal cause of action which would enable private parties to sue for damages in Federal courts, and the bills would reinforce the concepts of strict, joint, and several liability. The ground rules for admissibility of scientific and medical evidence would be expanded. There was no consensus among the bills on whether special presumptions would be appropriate. Finally, the statute of limitations from time of discovery of the injury and identification of the responsible party would be from three to six years. Meanwhile, a number of toxic compensation cases have been resolved in state courts, highlighting many of the generic issues and perhaps establishing precedents in important areas [8-12]. Several years ago the Congressional Research Service commissioned studies of cases in six states (Alabama, California, Minnesota, Missouri, New Jersey, and Texas) [13]. These studies addressed many key concerns including: constitutional and statutory causes of action; negligence, nuisance, and trespass aspects; strict liability for abnormally dangerous activities; and strict product liability. The studies concluded that there were significant barriers to recovery in state courts. The following concerns were highlighted: statutes of limitation difficulties in proving causation costs of scientific tests and expert testimony lack of awareness among plaintiffs of scientific considerations difficulties in recovering economic losses - bias in law toward compensating for property but not for health - difficulties in resolving joint liability -

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Reflecting this increased activity in state courts, legal scholars have exhibited considerable interest in toxic torts. For example, they have addressed misleading assertions of scientific precision in risk estimates, difficulties in identifying appropriate defendants when a harmful agent is traced to multiple sources, uncertainties in discriminating victims of a disease that can be traced to a defendant's action when

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C Monitoring / / ~ ~ / MedicalExams Predictive ModelsI" [ ~ I'~ Animal Experiments Body Burden | ~Exl~osure~ / / Epidemiology Studies Measurements| ~ | Fig. 1. Classical Approach to Risk Assessment.

Fig. 2. Risk Assessment in Compensation Cases.

General population Current Future Distant future

Known populations Unknown populations

Acute effects

Single exposure Continuous exposure Fig. 3. Types of Risk.

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the disease is common within the population, and the significance o f a showing of causation [14-16].

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prima facie

3. Risk Assessment and Toxics Compensation Figure 1 sets forth the traditional approach to chemical risk assessments that generally provide the basis for regulations at the national level and for remedial actions in site-specific situations. Figure 2 emphasizes those aspects of risk assessment that are particularly important in compensation cases, namely the source of the toxicant attributable to the defendant and the specific health effects which are the basis for the legal action. The possible exposure of individuals who are not parties to the suit and the possible health effects of the toxicant which are not manifested in the victim are not o f particular interest. Obviously sources of the toxicant not attributable to the defendant and other causes o f the alleged health effects complicate the proceedings. Figure 3 sets forth the types of risks that are of concern in comprehensive risk assessments. With regard to the more difficult compensation cases, however, the interests are usually more restricted. Specifically, of primary concern are past exposures, exposures of known individuals, intermittent exposures, and chronic effects. Unfortunately, the results of risk assessments, whether to support regulatory actions or to support compensation claims, are often reported with a degree of numerical precision that belies the uncertainties inherent in the assessments. For example, assessments frequently conclude that human exposure to a certain quantity o f an environmental chemical presents a risk of cancer equivalent to one additional cancer in a population of one million persons. It is not uncommon for the uncertainties in such assessments to be so large that the estimated risk could be 100 times greater or smaller. However, seldom are these ranges o f uncertainty set forth or even acknowledged in the conclusions that are reported. The sources o f uncertainty are manyfold. They include (1) the difficulty in estimating the amount o f the chemical that comes into contact with individuals which depends on the variable activity patterns of the individuals; (2) inadequate understanding of the mechanisms that determine the amount of the chemical that is taken into the body; and (3) the need to rely on data from animal experiments for estimating the effects of the vast majority o f chemicals on organs of the human body. In all o f these areas there must be reliance on scientific judgements which may vary significantly among experts.

4. Comparing Approaches to Radiation and Toxics Compensation There are some similarities but also substantial differences in addressing the problems associated with radiation compensation and toxics compensation. Clearly the

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most striking similarity is the centrality of the issue of causation and the many uncertainties in attempting to establish causation. One of the most obvious differences is the different institutions that have been historically involved in assessing radiation risks and those involved in assessing toxic risks. This institutional gap has resulted in significant differences in perceptions of the issues and in methodological approaches. With regard to the exposure aspects of causation, recent litigation in both the toxics and radiation fields underscores the importance of estimating exposures on a person-specific basis. Much of our past monitoring efforts has been directed to determining pollutant levels on a geographic basis with little attention to individual dosimetry outside the workplace. While technologies are gradually providing the capability for personal monitoring devices to detect a range of pollutants, large scale deployment of personal monitors seems unrealistic. In considering air pollutants, monitoring of micro environments - both indoors and outdoors - may be an alternative to simply monitoring ambient conditions, provided the activity patterns of exposed individuals can be reconstructed, a task that has proved difficult in the past. Turning to the health effects component of causation, studies of the effects of radiation or toxic chemicals on human populations almost always carry far more weight than studies using experimental animals. Of special interest have been epidemiological studies of the populations which have been exposed to the pollutants of concern in the geographical area under consideration, even if the designs of these studies leave much to be desired. Also with regard to similarities in the approach in the radiation and toxics fields, there will continue to be heavy reliance on the testimony of expert scientific witnesses, particularly concerning the relationships between exposures and effects, in almost all compensation cases. The selected experts will inevitably disagree on key issues, and separation of facts from opinions will be difficult if not impossible. Turning to significant differences in addressing toxics and radiation compensation cases, the following characteristics of radiation exposure problems tend to set them apart from toxics problems which in general are more difficult to resolve. - The Government has been involved since World War II in almost all aspects of radiation and therefore is a central party in almost all radiation cases. - There are a limited number of experts in the field of radiation health, with the scientific credentials of the experts usually well documented in the scientific literature. Radiation sources, and particularly man-made sources, are usually easily identifiable. Background radiation levels outside the workplace are well established, and workplace levels are usually well known; uncertainties in this area are generally easy to resolve. Accurate radiation monitoring technologies have been used for many years and are widely available. -

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Radiation exposure guidelines based on detailed health investigations since World War II have been in place for many years, they are generally accepted throughout the scientific community, and they are being uniformly enforced at facilities throughout the country. Given the many uncertainties involved even in radiation cases, the satisfactory resolution of toxics cases will usually remain beyond our scientific capabilities. Occasionally in the consideration of claims, well studied disease-exposure relationships exist such as lead poisoning, or unique health indicators of chemical effects are identifiable such as angiosarcoma of the liver following exposure to vinyl chloride. However, in most cases adverse health effects cannot be uniquely attributed to specific chemicals, and the victim's lifestyle adds confounding factors when trying to demonstrate cause and effect. Therefore, the development of an adequate scientific data base concerning the behavior and effects of the many toxic chemicals that could cause injury must remain a priority activity of the nation's research establishment. Meanwhile, in many toxics cases several areas of uncertain policy and uncertain science will continue to be of key importance. Classical methodologies for chemical risk assessment are usually of limited help in attempting to demonstrate the required threshold of 'significant' likelihood of cause and effect. The necessity to estimate exposure levels that cause harm in the absence of reliable dose-response curves has become commonplace as the increase in the number of chemicals of concern rapidly outpaces the expansion of the supporting scientific data base. Finally, negative findings concerning impacts of specific chemicals on human populations are increasingly introduced to counter claims of injury, and a satisfactory approach to weighing such negative findings with positive toxicological evidence related to the chemicals has yet to be developed.

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References

[1] Jenkins, Bruce, S., 'Irene Allen et al., Plaintiffs, vs United States of America, Defendant', United States District Court for the District of Utah, Civil No. C 79-0515-J, May 9, 1984. 489 pp. [2] Foley, Roger, D., 'Dorothy Roberts et al., Plaintiffs, vs United States of America, Defendant; and Louise Nunamaker, Plaintiff, vs United States of America, Defendant', United States District Court, District of Nevada, Civil LV 1766 RDF and Civil LV 76--259 RDF, June 14, 1984. 118 pp. [3] Kelly, Patrick, F., 'Ada G. Johnston, Individually, and as Administratrix of the Estate of Earl E. Johnston. Deceased, Plaintiff, vs The United States of America et al., Defendants: Barbara J. Womack, and Loyd B. Womack, Plaintiffs, vs The United States of America et al., Defendants, Estella I. Vessels, Individually, and as Executrix of the Estate of Don C. Vessels, Deceased, Plaintiff, vs The United States of America et al., Defendants, Lila M. Mewhinney and Richard M. Mewhenney, Plaintiffs, vs The United States of America et al., Defendants', United States District Court for the District of Kansas, No. 81-1060; No. 81-1061, 82-1537; No. 81-1100, 82-1539; No. 81-1101, 82-1538, November 15, 1984. 150 pp. [4] Orphan Drug Act, Public Law 97-414, January 4, 1983. [5] See, for example, S. 921, Radiogenic Cancer Compensation Act of 1983 (proposed), March 24, 1983. [6] Injuries and Damages f r o m Hazardous Wastes - Analysis and Improvement o f Legal Remedies, A Report to Congress on Compliance with Section 301(c) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (P.L. 96-510) by the Superfund Section 301(e)

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[7]

[8] [9]

[10] [11] [12] [13]

[14] [15] [16]

GLENN E. SCHWEITZER Study Group. Senate Committee on Environment and Public Works, 97th Congress, 2d Session. September 1982. 755 pp. Hazardous Substance Victims Compensation Legislation. Hearing before the Subcommittee on Commerce, Transportation, and Tourism of the Committee on Energy and Commerce on H.R. 2582, Serial No. 98-45, June 29, 1983. 'Borel v. Fibreboard Paper Producs', Hazardous Waste and Toxic Torts: Regulation. Enforcement, Liability. Law Journal Seminars-Press, Inc. (1983) p. 328. Pacht, Jerry and Robert I. Well, 'Judith Sindell, Plaintiff and Appellant, v. Abbott Laboratories et al., Defendants and Respondents; Maureen Rogers, Plaintiff and Appellant, v. Rexall Drug Company et al., Defendants and Respondents', Supreme Court of California, 26 C.3d 588, March 20, 1980; Rehg. den. May 7, 1980. 'Keene Corp. v. Insurance Co. of North America', Hazardous Waste and Toxic Torts: Regulation, Enforcement, Liability, Law Journal Seminars-Press, Inc. (1983) p. 232. 'Branch v. Western Petroleum', Hazardous Waste and Toxic Torts: Regulation, Enforcement, Liability, Law Journal Seminars-Press, Inc. (1983) pp. 269-278. 'Beshada v. Johns-Mansville Products Corp.', Hazardous Waste and Toxic Torts: Regulation, Enforcement, Liability, Law Journal Seminars-Press, Inc. (1983) pp. 232. Six Case Studies of Compensation for Toxic Substances Pollution: Alabama, California, Michigan, Missouri, New Jersey, and Texas, A Report for the Committee on Environment and Public Works, U.S. Senate. June 1980. Serial No. 96-13. 521 pp. Tribe, Laurence H., 'Trial by Mathematics: Precision and Ritual in Legal Process', Harvard Law Review 84(6), 1329-1393, April 1971. Delgado, Richard, 'Beyond Sindell: Relaxation of Cause-In-Fact Rules for Indeterminate Plaintiffs', California Law Review 70(4), 881-908, July 1982. Strand, Palma J., 'The Inapplicability of Traditional Tort Analysis to Environmental Risks: The Example of Toxic Waste Pollution Victim Compensation', Stanford Law Review 35, 575-619, February 1983.

Relevance of radiation compensation litigation to compensation for toxic exposures.

Several recent court decisions add to the growing body of law concerning the responsibility of Government in radiation matters and the quantum of proo...
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