Litigation Management

Strategic Determinants Of Medical Information Management In Toxic Torts

By:	Elizabeth Juliano
	Carey J. Marousek
	James R. Fell

Decision Triad

The interplay of three critical variables defines the nature of information management in mass toxic tort litigation containing some medical element. Two of these factors-toxicology and epidemiology-constitute the foundation for the medical information management (MIM) process. The scientific community must first peer-review and validate published toxicologic and epidemiologic research before concluding that an association exists between a named agent and a given medical condition. However, once this consensus is achieved, the third variable-diagnostic criteria-assumes a prominent role in the toxic tort.

The dynamic interaction of these three variables evolves across the lifespan of the toxic tort. The relative importance of each of these parameters will vary depending both on the developmental stage of the litigation and the concomitant medical knowledge requirements of the legal department. This relationship defines the MIM approach that is appropriate for the toxic tort at a given point in time. Furthermore, an understanding of this changing relationship can be translated into significant reductions in case preparation costs in that the most cost-effective MIM strategies can be implemented while continuing to optimize the production of medical knowledge to address attorney needs.

Defining Elements

Several mass torts are presented in the accompanying table. Developmentally, each is at a different phase in maturity. For instance, although asbestos litigation continues to generate thousands of cases annually, these torts have been around since the 1970's and are very "mature." Conversely, diet drug litigation erupted relatively recently and is at a more "junior" stage of development. Current affirmation of toxicologic, epidemiologic, and medical evidence for each of these mass torts differs, and is compared and contrasted within the table.

Toxicology :

Toxicological information is derived from research studies on the effects of controlled exposure to a named agent employing either human subjects, or animals which to some degree replicate human physiological functioning. Despite the fact that animal studies can pose particularly difficult admissibility issues, published toxicological data will continue to be introduced in toxic torts to support or refute causation. As a toxic tort grows and matures, the value of toxicological information increases because additional scientific research clarifies the extent of a causal association between an agent and alleged medical effects.

Epidemiology :

Epidemiological information is produced from studies which seek to identify a correlation between exposure to a given agent and certain observed conditions in a sample population. Such research attempts to establish a statistically significant link between the agent and these disorders, while attempting to exclude other variables which could have impinged on the suspected relationship. This latter activity can prove quite confounding in itself. Continued epidemiological research generates additional information which either strengthens or weakens the suggested association between an agent and the alleged medical outcomes.

Diagnostic Criteria :

The derivation of medical diagnostic criteria also represents a changing scenario. In the very early stages of a new type of toxic tort, injuries attributed to an implicated agent(s) tend to be nonspecific. At times, no matching disorder state can be identified within the context of the World Health Organization's International Classification of Diseases (ICD). Recent mass tort examples of this have included "human adjuvant disease" (silicone breast implants) and "sick building syndrome" (school and office building environments). However, as medical science advances, diagnostic parameters may be identified to better define the disorder. In some cases, such a degree of diagnostic specificity can be established so as to create a new disease name and entity, as has occurred with "asbestosis" and "silicosis."

From Theory to Practice

For practical purposes, how does this abstract perspective on MIM translate into real world applications? To address this question, Litigation Management, Inc. (LMI) simultaneously engaged in two activities. First, LMI conducted a retrospective analysis of high profile toxic torts from the 1970's to the present date. Characteristics of evolving MIM requirements were noted as each mass tort emerged, gained prominence, matured, and eventually stabilized or declined. Second, LMI undertook an internal review to ascertain how its own MIM applications had changed across the company's fifteen years of operation, during which time major developments in toxic tort litigation occurred. The outcome of these investigations was the formulation of dynamic models, or paradigms, for structuring MIM. These models will be subsequently presented in several upcoming issues of The M.I.M. Reporter.

Determinant Factors In Cases Of Selected Toxic Tort Litigation (1999 Status)

Litigation Focus	Status Of Toxicological Evidence	Status Of Epidemiological Evidence	Status Of Medical Diagnostic Criteria
ENVIRONMENTAL ILLNESS	Some medical professionals have criticized the field of "clinical ecology". Animal studies can often be challenged on the basis of research methodology and transferability of findings. Difficulty in extrapolating findings from studies of high-exposure populations (i.e. occupational exposures) to bystander, low-level exposure populations.	While the presence of a cluster may be identified in a given mass tort, potential competing variables which offer alternative causation can be difficult to rule out.	No established ICD codes exist for most of these conditions. For example, "Sick Building Syndrome," "Environmental Illness," and "Multiple Chemical Sensitivity" are more conceptual than diagnostic in their applications. Issues arise as to which diagnostic studies and immunologic tests offer the best means to both diagnose these disorders and establish causation.
POWERLINE & LOW LEVEL ELECTROMAGNETIC FIELD RADIATION	Physicists dispute possible effects of low-level EMF exposures typically encountered in the non-industrial setting. Problems designing comparable animal exposure studies make extrapolation of findings to human subjects difficult.	Driving force in EMF cases has been epidemiological studies. However, it is difficult to accurately reconstruct exposure history to low-level EMF's. Populations are exposed to a wide variety of sources of EMF's and other potentially toxic agents in home/work environment resulting in the argument for competing causation.	While clear diagnostic criteria exist for general medical conditions such as cancer and leukemia, no condition, such as an "EMF cancer," has been classified in ICD coding.
DIET MEDICATIONS	Animal studies on the nature of potential pathological side effects of these drugs continue. In some cases, i.e. neurologic effects, procedural issues can impact transfer of findings from these animal tests to human populations.	Number of published epidemiologic studies has been growing since original medical reports released. Exposure correlation to cardiac valvulopathy and primary pulmonary hypertension regarded as sufficiently strong by medical and regulatory communities to limit use of some preparations.	Clear diagnostic criteria for specific conditions, such as primary pulmonary hypertension and cardiac valvular disorders, exist. Neurologic disorders have proven more difficult to qualify in these exposure cases due to variety of, and difficulty in, evaluating alleged symptoms.
SILICONE BREAST IMPLANTS	Procedural issues have arisen in animal testing, i.e. direct silicone injections into subject animals versus insertion of silicone encapsulated inside implant. Controversy also exists regarding the form of the chemical tested-are studies on the effects of "silica," "silicon," and "silicone" comparable?	While original epidemiological studies may have indicated the possibility of silicone-related diseases, subsequent analyses by independent investigators and government groups have typically revealed negative or weak correlations.	Clear diagnostic criteria exist for many autoimmune and connective tissue diseases, but not for nonclassic disorders such as "Atypical Connective Tissue Disease" and "Human Adjuvant Disease." Questions arise as to how causation can be identified for these non-classical disease states.
ASBESTOS	Toxicological evidence generally accepted by medical and scientific community for specific conditions, such as mesothelioma.	Correlation studies linking occupational asbestos exposure to development of certain asbestos-related diseases is also accepted. However, smoking histories and other impacting variables in study populations can confound these findings.	"Asbestosis" and "mesothelioma" are coded diseases in International Classification of Diseases (ICD) manual. Standardized diagnostic criteria have been developed by professional organizations for certain of the asbestos-related disorders.

Return back to articles page.