"Medical Information Management for Litigation" has been previously published in the Cleveland Bar Journal, Toxics Law Reporter, and Product Safety & Liability Reporter. It has been accepted for publication in the Trial Diplomacy Journal.

Medical Information Management for Litigation
By Elizabeth B. Juliano ¹, President, Litigation Management, Inc.
Copyright © 2002 Litigation Management, Inc. All Rights Reserved.

Abstract

Successful medical information management for toxic tort litigation is primarily dependent on the proactive development of a strategic plan for medical records acquisition, review, and analysis. Protocols can be formulated which integrate the competing agendas of quality record review and cost-effective information management.

Introduction

The term "mass tort " can refer to as few as 5 cases or as many as 15,000. In all instances, the common denominators are plaintiffs claiming a similar series of allegations due to a comparable series of alleged exposures/occurrences. Protocols can be established to promote efficient management of the medical aspects of these types of cases. The similarities allow for streamlined workflow management, while the methods of individual case analysis permit each plaintiff's unique medical status to be documented, understood, and evaluated. Although computer assistance can be utilized in all phases of medical information management processes, the use herein of the word "program" denotes the protocols and methods designed to efficiently manage and maximize use of medical information.

The success of a program for mass tort medical management depends, in large part, upon strategic planning before the project begins. Because a mass tort often evolves from a small series of individual lawsuits which escalate in number, the need for a comprehensive medical information management program may not be apparent until cases are in discovery and trial dates have been set. In reality, the majority of medical information management programs are implemented after litigation has begun. It may seem inconvenient to design a program when discovery is underway, but efficiencies and cost savings provide a worthy return on time invested.

Determine Your Objectives

Perhaps the primary objective of a medical information management program is to reduce or maintain the lowest possible litigation costs while ensuring the highest quality case preparation. Each medical information program must be designed with specific litigation in mind. For instance, in asbestos personal injury litigation, select medical information will provide the information necessary to confirm or refute a diagnosis of asbestos-related disease. The record gathering and analysis in asbestos personal injury litigation should follow criteria to avoid acquisition and handling of unnecessary information and the associated costs.

Because of inevitable changes in litigation, a medical information program must also be designed with the flexibility to accommodate changing schedules and information needs. Services are based upon "modules," which are steps, or phases, beginning with gathering medical records, progressing to basic categorization of case severity, and resulting, only when necessary, in development of a comprehensive medical records summary and analysis. Each successive phase incorporates the efforts of the previous phase, without duplication or redundancy. The information elicited during each phase is reported to the client, either on a case-by-case basis, or in a report which encompasses the entire litigation. Upon review of the information, a client can evaluate the medical aspects of the case and provide the directive for proceeding to the next step or phase.

During the initial categorization phase, the medical records for each plaintiff are assigned a Preliminary Summary Rating (PSR) which, in the event additional work is needed, provides an estimation of the hours and fees involved in production of the summary. In providing an estimation of the hours needed to produce the summary, the PSR also allows for the scheduling of the staff hours needed to complete a project to meet a deadline, even if the deadline is only 24 hours. Medical information management programs of this type provide a viable alternative to the non-focused manner in which some parties have traditionally operated.

In order to determine whether a medical information management program is achieving the desired objective of cost-effectiveness and high quality, methods of monitoring results are incorporated into the initial design. Not only are status reports generated at intervals requested by the client or for internal use, but cost figures and estimates are provided as well. The estimates and actual cost figures are accumulated and compared over time to provide necessary benchmarks upon which to project the cost of the entire litigation.

Develop A Checklist

What follows is a recommended procedure for development of an effective medical information management program for litigation. The review of these items, in the order in which they are presented, will guide a party through the thought processes necessary to develop an effective program. This list is not meant to be exhaustive, but displays the issues most often confronted during management of medical information in litigation.

1. Establish a medical information strategy as early as possible, knowing that the strategy will change over the course of litigation. Don't operate in a vacuum. Consider how aggressively one will defend/pursue each case.
   
2. Determine how and what quantity of information is required. Consider records to be obtained by local counsel or acquisition service. Does one want all plaintiff records? Determine when one will want records.
   
3. Determine how medical information will be used (discovery preparation, database information management, FDA reporting, setting reserves, settlement negotiations, trial strategy).
   
4. Identify "focus" issues within the medical information and watch them over the course of litigation. Consider what information the decision maker will need to prepare for trial or case resolution. Focus issues include:
   
   
   • What is the product exposure/product identification?
   • Latency?
   • Are there diagnostic criteria to support/refute allegations?
   • What are the symptoms/diseases which mitigate damage claim?
   • Life expectancy?
   • What is the health history pre-exposure?
   • What is the health history post-exposure?
   • Any lifestyle issues, i.e., substance abuse?
     
5. Utilize services which are provided in "modules" which build upon each other. Such services range from simple and inexpensive to complex and expensive, and might include:
   
   
   • Organization of records and assignment of case severity rating
   • Screening for product identification
   • Abstracting pertinent information from records for inclusion in database
   • Manipulating information to search for key phrases or words
   • Development of "key word" reports based upon specific diagnostic information
   • Development of a comprehensive medical record summary
   • Development of an analysis of the medical aspects of the case
     
6. Be certain one's technology is flexible - that the database can grow with changes in technology and litigation, and hardware can expand with litigation. Beware of proprietary hardware and software systems.
   
7. Determine how information will be delivered and accessed. Consider who will receive documents, and in which form (paper, diskette, etc.). Also determine what type of case management information will be needed, i.e., status reports, and decide whether anyone will require dial-in capability, etc.
   
8. Develop management reports and methods for determining if a program is working. These could include:
   
   • Benchmarks: How much did this cost the company before?
   • Milestones: When does one reassess the program?
   • Projections: How much does the company think this will cost per case, per month, per hour, etc.?
     
9. Focus the education of counsel and examine the possibility of developing a pretrial training program for counsel. Establish guidelines for medical literature research and education regarding medical issues. Consider development of a medical reference manual to avoid redundant education efforts by outside counsel.

Additional Successful Strategies

1. Centralize the collection and management of medical information. Centralization provides:
   
   
   • Inherent control over all medical information activities
   • Consistency of work product regardless of jurisdiction of case
   • No duplication of effort
   • Ability to project costs and workload
   • Planning and budgeting based upon projections
   • Efficient execution of client instructions and lowered communication costs.
     
     
2. Apply economies of scale to processing of medical information. Cost share with appropriate parties when possible. Establish review and analysis protocols which will result in building upon previous experience and eliminating the learning curve. Using the above strategies, attorney and paralegal time is utilized more efficiently.

Discussion

A medical information management program is most efficient when the criteria for diagnosing a plaintiff's alleged disease are well-established, because specific medical information can be sought. For example, in the majority of cases of alleged chemical-induced leukemia, the pivotal medical issue is not diagnosis, but causation. A plaintiff's medical records will reveal whether the diagnosis of leukemia has been made; the difficulty lies in determining whether epidemiologic studies have established an association between the chemical exposure and the disease. Therefore, when developing a medical information program for a case of alleged chemical-induced leukemia, a party may choose initially to limit the medical records acquisition and analysis to those documents which contain diagnostic and exposure information, and focus efforts upon the causation issue. The cost and time savings resulting from a narrowed approach can be significant, especially when the litigation involves hundreds of plaintiffs.

In many newly filed mass torts, either the diagnostic criteria are unclear, or answers concerning causation are not available. In those instances, the medical information management program will evolve as medicine and science fill in the gaps. Asbestos personal injury litigation provides an example of the way in which medical information management programs have evolved. In the late 1970's, the definitive criteria for diagnosing asbestos-related diseases were not established. Additionally, the results of few epidemiologic studies were available, and those were controversial; the role of asbestos in disease causation was unclear. Until the mid 1980's, the medical information strategy in asbestos personal injury litigation was to procure, summarize and analyze all of a plaintiff's medical records from childhood forward. During the 1980's, the American Thoracic Society and the American College of Pathologists published their criteria for diagnosing the various asbestos-related diseases. As a result, in current asbestos litigation, few parties conduct a comprehensive search and analysis of a plaintiff's medical records. Instead, the focus is upon treatment records and expert reports which provide specific pathologic, cardiopulmonary, and radiologic findings which are used to determine whether the published diagnostic criteria have been met.

Conclusion

A well-defined and flexible medical information management program can be designed to meet the needs of any particular litigation. This proactive management technique will ensure the highest quality case preparation at the lowest possible cost. Participation in such a program will permit a party to evaluate its cases in an efficient manner and provide the opportunity to implement its trial/settlement evaluation protocol. Under these circumstances, utilization of the medical information management program will result in counsel focusing their attention only on those cases which require judicial intervention.²

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¹ Elizabeth B. Juliano is the President of Litigation Management, Inc. (LMI), which she established in 1984. LMI assists corporations, insurance carriers, and defense counsel with management of the medical aspects of mass tort, product liability, personal injury, and complex litigation. Services include medical information acquisition, database development, summarization, and analysis, as well as medical literature reviews.

² For additional information regarding medical information management in litigation, or to be placed on a list to receive LMI's quarterly newsletter, please call the LMI Corporate Education Department at 1-800-778-5424, or e-mail LMI at jfell@litigation-mgmt.com.

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