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61 Def. Counsel J. 28 (1994)
Role of Toxicology in Toxic Tort Litigation: Establishing Causation

handle is hein.journals/defcon61 and id is 38 raw text is: ROLE OF TOXICOLOGY IN TOXIC TORT LITIGATION: ESTABLISHING CAUSATION Conservative regulatory risk assessments can predict what doesn't cause disease but not what does in a particular case By ROBERT C. JAMES TOXICOLOGISTS research the nature of any adverse health effects produced by a chemical and assess the probability of occurrence of these adverse effects. In applying their science to toxic torts, toxicologists establish the known effects of the chemical in human beings and determine whether the alleged dose experi- enced by plaintiffs was sufficient to have caused any of their alleged diseases. Called causation analysis, this process utilizes a spe- cific methodology to establish to a scientific degree of certainty whether plaintiffs' claims are valid. Possibly the first effort to formalize this ob- jective methodology occurred more than a century ago with the development of the Henle-Koch postulates for establishing the causes of infectious diseases. Sir Bradford Hill later defined a similar methodology for deter- mining whether a particular chemical found in the workplace should be considered a human carcinogen. Now there are at least 10 criteria proposed as the basis of the scientific method for determining whether a chemical in fact does cause a specific disease in human be- ings.' These criteria include: 1. The strength of the human association, 1. A. B. Hill, The Environment and Disease: Associa- tion or Causation? Proceedings of the Royal Society of Medicine, Section of Occupational Medicine 295 (1965); A. Evans, Causation and Disease: The Henle-Koch Postu- lates Revisited, 49 YALE J. MED. 175 (1976); J. D. Hackney & W. S. Linn, Koch's Postulates Updated: A Potentially Useful Application to Laboratory Research and Policy Analysis in Environmental Toxicology, 119 AM. REV. REspi- RATORY Dis. 849 (1979); R. Doll, Occupational Cancer: Problems in Interpreting Human Evidence, 28 ANN. OCC. HYG. 291 ((1984); T. Guidotti & D Goldsmith, Occupa- tional Cancer, 34 AFP 146 (1986). 2. Office of Research and Development, EPA, Working Paper for Considering Draft Revisions to the U.S. EPA Guidelines for Cancer Risk. EPA/600/AP-92/003 (1992). 3. K. T. ROTHMAN, MODERN EPIDEMIOLOGY (Boston: Little, Brown & Co., 1986). Robert C. James is founder and president of Terra Inc., a toxicology consulting firm ac- tive in the environmental contamination field. He holds a bachelor degree in chemistry (1972) and a doctoral degree in pharmacol- ogy (1977) from the University of Utah and completed post-doctoral training in toxicol- ogy at the Vanderbilt Medical Center in 1979. In addition to consulting, he has taught and published. 2. The consistency of the human associa- tion, 3. The specificity of the human association, 4. Temporal relationships, 5. Dose-response relationships, 6. Biological plausibility, 7. Experimental evidence in animals, 8. Structure activity analogy, 9. Confounding disease or risk factors, and 10. The coherence and weight of the evi- dence. Regulatory agencies are recognizing the im- portance of adhering to an established scien- tific methodology to determine risks. In its 1992 draft guidelines for carcinogen risk as- sessment, the Environmental Protection Agency cites seven criteria2 adapted from Rothman3 as those it recognizes as the scien- tific method that should be used to determine whether a chemical is a human carcinogen. These are: 1. Temporal relationship. This is the single absolute requirement. It does not prove causality itself, but it must be present if cau- sality is to be considered. The disease must occur within a biologically reasonable time frame after the initial exposure. The initial period of exposure to the agent is the accepted starting point in most epidemiologic studies. 2. Consistency. Associations are observed in several independent studies of a similar ex- posure in different populations. This criterion

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