Litigation Management

PERSPECTIVES ON MEDICAL INFORMATION
MANAGEMENT IN DIET DRUG LITIGATION

Part III -- Medical Monitoring Claims

By:	Elizabeth B. Juliano
	James R. Fell

Litigation Management, Inc.'s series on medical information management (MIM) in diet drug litigation previously outlined practical approaches to primary pulmonary hypertension (PPH) and neuropsychiatric injury cases. Plaintiff demands in diet drug litigation are now calling for medical monitoring services to screen for the appearance of future disease. What MIM challenges do these newer claims present in diet drug class actions? Are MIM protocols different for this litigation? With potentially thousands of medical monitoring claimants, can MIM be cost-effectively implemented?

Claimant Characteristics

Manifestation of diet medication-associated mitral and/or aortic valve regurgitation (MR and AR, respectively) is a particular concern in diet drug litigation, with users fearing the onset of these disorders even after the use of diet medications has been discontinued. Although such cardiac valvulopathy may or may not develop, demands for medical screening and monitoring are predicated on the theory that early detection and treatment of diet drug-associated disorders will lessen their ultimate impact.

A number of pharmaceutical manufacturers are presently confronting diet medication lawsuits. At the time this article was authored, the actual number of medical monitoring claims to be filed in this litigation was yet unknown. However, some examples will illustrate the potential magnitude of these medical monitoring claims. In September 1999, the Manhattan Supreme Court certified a diet drug medical monitoring class action for some one million New York users¹ and a similar case in New Jersey involves about 94,000 plaintiffs.² On a national basis it is known that prior to September 1997 approximately six million individuals are reported to have consumed the American Home Products (AHP) brands of diet medications. At least 11,000 of these parties have already filed lawsuits against the company.³ ⁴

Monumental Awards

Cost projections for medical monitoring in diet drug claims are just as staggering. As one illustration, the Nationwide Class Action Settlement Agreement with American Home Products Corporation, (18 November 1999 version), allocated funding for medical screening and monitoring.⁵ The medical monitoring portion of this agreement is reported to amount to $1.2 billion.⁶

Large scale financing for class medical monitoring is partially driven by the increasing costs of health care. For example, a primary demand in diet drug medical monitoring calls for the administration and interpretation of one or more echocardiograms (ECHO). The cost of a routine ECHO ranges from approximately $200 (when administered in a doctor's office) to $800 (if performed in a hospital echocardiography laboratory).⁷ The implications for defendant corporations and shareholders, and their insurers, are obvious.

Opt-Outs and Other Situations

Further challenges arise in diet drug medical monitoring for those cases where individual plaintiffs "opt-out" and elect not to be a part of a larger settlement agreement. In these cases, would separately negotiated and individualized plans for medical monitoring be required? For example, some predictions have forecast that over 8,000 plaintiffs in diet drug litigation against AHP may choose legal redress apart from the Nationwide Settlement.⁸ Individualized medical monitoring can prove particularly expensive for a defendant because any administrative and economic benefits derived from mass litigation economies of scale can be lost.

More difficulties managing medical monitoring claims can occur at the state level. In the AHP litigation, at least one state, West Virginia, may not be covered in the Nationwide Settlement. Potential diet drug plaintiffs in this jurisdiction number 28,000.⁹

Medical Monitoring: Is It Needed?

Findings of three separate research studies, published in late November/early December of 1999, may influence the direction of medical monitoring in future diet drug litigation. Of note, this latest research begins to suggest that the demand for large scale medical monitoring in diet drug litigation should be carefully examined. Investigators report that valvulopathy associated with intake of certain diet medications may in some cases lessen over time. As has been the case with breast implants and electromagnetic field exposure, these reports characterize the issues which can arise when emerging toxic tort litigation progresses at a rate faster than medical and scientific understandings can support.

In the latest fen-phen research published by the Mayo Clinic (1999), progression of cardiac valvulopathy was tracked in fen-phen users who had evidenced ECHO-confirmed impairment during the initial Mayo study. Subsequent improvement in mild cases of valvular disease, as shown on ECHO, was noted in this group when examined six months after initial diagnosis, with three out of five patients no longer displaying the disorder.¹⁰ ¹¹ ¹²

A joint study by the Oregon Health Sciences University, University of New Mexico, University of Colorado Health Sciences Center, and Interneuron Pharmaceuticals (1999) followed the health status of 223 former dexfenfluramine users. Valvular regurgitation was again found to regress in some cases of suspected diet drug-induced pathology. Age and blood pressure were noted to be significant variables in development of valvulopathy.¹³

Progression of valvulopathy was also analyzed in former dexfenfluramine users by the Cardiovascular Research Foundation at Washington Hospital Center (1999). This article, published in a recent issue of the Journal of the American College of Cardiology, revealed that ECHO's performed three to five months post-cessation of dexfenfluramine intake indicated valvular regurgitation had regressed.¹⁴

Results from these three studies serve to emphasize the critical importance that product identification, duration of exposure, and physical examination findings all have in structuring medical information management in diet drug medical monitoring claims. In light of this research, as well as legal developments previously discussed, we suggest that review and analysis of claims in diet drug medical monitoring proceed as described in the following sections.

Operationalization of Medical Monitoring

Centralization

Medical monitoring in mass litigation is best administered through some type of centralized structure, and indeed this design has been incorporated into the Nationwide Class Action Settlement. We agree with such an approach in diet medication cases because historically, centralization has been found to offer the best solution to large-scale claims administration. For instance, centralized claims administration programs have been functioning for years to evaluate, settle, and dispense payments in mass product liability litigation in such diverse areas as asbestos and intrauterine devices (IUD). The important difference in the case of diet drug litigation is the introduction of the medical monitoring variable.

As outlined in our earlier publications on medical information management for litigation,¹⁵ ¹⁶ ¹⁷centralization in medical monitoring offers the following advantages:

Consistency in the approach to each medical review;
Cost Reductions realized as economies of scale come to be rendered by a centralized approach which yields increasing efficiencies in the record acquisition and review activities;
Cost Sharing in mass litigation involving multiple defendants who require a similar medical review and analysis. Class defendants build their cases using common work products and accordingly, equally share the expenditures;
Communication efficiencies which result when the central facility serves as a medical information "hub" for the defendant group;
Coordination among the defense group for case resolution strategies based upon a review of neutral data;
Continual Quality Assurance when the central facility implements a system of controls to ensure Total Quality for each of its medical evaluations.

The following sections present our perspectives on how a centralized facility could implement cost-effective document acquisition and review as integrated components of a medical information management strategy for diet drug medical monitoring.

Tiered Approach

Our experience suggests a tiered approach best focuses collection and analysis of medical monitoring information. Positive findings at one stage in the analysis of a claim would drive document acquisition and review for the succeeding tier. Likewise, negative findings at a given level would restrict progression to the next, and thereby eliminate unnecessary expenditures for further record acquisition and review.

Tier 1: Demographic Information

A diet drug medical monitoring claim would be initiated through the submission of a universal claimant form containing such demographic information as plaintiff name, address, Social Security Number, representative law firm, medical allegations, evaluating and treating physician information, and exposure data (medication name, dates of consumption, prescribing physician, dispensing pharmacy, etc.)

Record Acquisition: The centralized facility would mail a copy of the standardized claims form to a diet drug plaintiff or his/her representative law firm, upon receipt of a telephone, fax, or e-mail request. It would be completed by the plaintiff and plaintiff counsel, and returned to the centralized facility.

Record Review: Claim processing agents would review the designated demographic information for completeness and enter data into the central database. In cases where demographic information is incomplete, center representatives would follow-up with the law firm to obtain the required data.

Opportunities for Cost Reduction: Case preparation expenses can be markedly reduced if electronic submission of a universal claim form becomes the preferred option (much like electronic filing of an IRS return). Implementation of this more efficient processing mechanism would call for the centralized facility to maintain an Internet-based site from which the claims form file could be downloaded by the law firm, completed during a client interview, and immediately submitted to the Internet address. Upon receipt by the centralized facility, a claimant identification number could be electronically assigned with demographic information simultaneously transferred to the medical monitoring database. Incomplete sections of the claims form could be tagged by the central processor, with an electronic response automatically composed and referred back to the law firm specifying actions necessary to fulfill claim form requirements. Personnel costs associated with manual processing of demographic data could thus be substantially reduced.

Tier 2: Product Identification

Once a medical monitoring claim is activated, positive product identification must then be established.

Record Acquisition: In most cases only a small number of medical records need be acquired to support review in this tier; generally these would be pharmacy dispensing reports. Such medication records can be plaintiff-supplied, or more preferably, directly acquired from the dispensing pharmacy by the centralized facility using signed authorizations.

Record Review: Capture of relatively few data elements relating to the alleged diet drug exposure are necessary at this stage of the review-i.e. generic name, brand/trade name, manufacturer/distributor, prescribing physician. If diet drug intake cannot be verified, the claim is inactivated. In other cases diet drug exposure might be established, but for a different agent or manufacturer than defined in the medical monitoring lawsuit. This claim too could be inactivated. On the other hand, positive product identification for the specified brand(s) of medication and manufacturer(s) forwards the claim to the next stage of analysis.

Opportunities for Cost Reduction: Almost all drugstore and pharmacy prescription records are now maintained in computerized databases. In lieu of transmission of paper documents, relevant data pertaining to filled prescriptions can potentially be electronically transmitted directly from the pharmacy to the centralized review facility, incorporated into the computerized file of a given claimant, and electronically queried for specified medications and related information.

Tier 3: Exposure Duration

In evaluating toxic exposure incidents, duration and intensity of exposure are defining variables. As shown earlier, medical research relating to the significance of duration of diet drug consumption is only now coming forth. In the case of the Nationwide Class Action Settlement medical and screening benefits differ for those claimants who utilized specified brands of diet drugs for sixty (60) days or less versus those who consumed these medications for sixty-one or more days. One published report which discussed this particular settlement proposal noted an AHP estimate wherein approximately 3.8 million individuals consumed these drugs for sixty days or less, while two million used these for over sixty days.¹⁸

Record Acquisition: Pharmacy records acquired in Tier 2 should to be sufficient to also satisfy knowledge requirements of this tier.

Record Review: In this level of review, information pertaining to duration of diet drug exposure comprises only a limited number of data elements (dosage, dates for prescription and discontinuation of diet medications, number of prescription refills).

Opportunities for Cost Reduction: Cost reductions can also be derived if the central database is configured to perform functions which claims reviewers might otherwise have to execute manually. For instance, a computerized calculation of the number of months of diet drug consumption could be easily derived from the aforementioned prescription and discontinuation dates.

Tier 4: Verify Valvulopathy

Timely detection of cardiac valvulopathy is a primary issue in diet drug medical screening and monitoring. Because clinical symptoms may not appear until well after MR and AR have developed, diagnostic testing yields a more definitive appraisal of valvulopathy than physical examination alone. The most accurate study for these purposes is the ECHO, although the electrocardiogram (EKG) may also reveal useful supporting diagnostic insights.

At this stage of analysis, an interpretative evaluation by a qualified physician/cardiologist can complement the findings of the ECHO study. It should be noted however, that physical assessment findings alone may or may not reveal the presence of a heart murmur. To illustrate the seriousness of this problem, the 1997 Food and Drug Administration report on diet drug-associated valvulopathy noted that only 17% of patients meeting the study case definition actually evidenced an audible murmur. Factors such as claimant obesity may further impede detection of this symptom by the physician. For this reason, the Centers for Disease Control and Prevention advised that history and physical examinations alone are inadequate to accurately assess the appearance of MR and AR in diet medication-exposed persons.¹⁹

Record Acquisition: The ECHO report and medical interpretation of the specified examining physician will be acquired at this level.

Record Review: The Center for Disease Control has noted that minimal degrees of mitral regurgitation or trace aortic regurgitation are relatively common in the general population and are not considered abnormal. As a result, parameters which constitute "valvulopathy" should be defined before medical monitoring is initiated. Presently, it appears that the Food and Drug Administration's definition contains the most accepted criteria. In this definition, valvulopathy of concern is identified as AR of mild or greater severity and/or MR of moderate or greater severity subsequent to exposure to these pharmaceutical agents.²⁰ ²¹

Opportunities for Cost Reduction: Radiographic reports are typically now maintained in electronic format. Health information service (medical record) departments of clinics and hospitals should have the capacity to electronically forward ECHO reports to the claims processing site for direct transfer to the centralized database, thus further eliminating costs associated with manually manipulating paper reports and their associated photocopying and mailing expenses. Likewise, offices of cardiopulmonary specialists are sufficiently computerized that findings of interpretative evaluations could be sent to the claims facility via an Internet-based process. For instance, use of a standardized assessment form available through the centralized facility web site would enable physicians to complete their assessment and instantly e-mail their findings to the center where they would be electronically incorporated into the centralized database. Exception reports targeting those cases requiring additional medical monitoring could be automatically produced, thus reducing the amount of manual review by the center's medical professionals.

Tier 5: Additional Monitoring

Conclusions derived from ECHO testing and interpretative physician evaluations may ultimately transfer cases for more extensive valve-related medical studies. Depending on the case circumstances, these interventions could include further ECHO testing and added medical cardiovascular examinations.

Record Acquisition: Medical information management for this phase of monitoring and screening may consider acquiring the following records: evaluations by other medical specialists, additional ECHO testing; electrocardiograms, chest x-ray, and standard laboratory tests.

Record Review: Additional valve-related medical services may also incorporate "standard" laboratory testing. These studies may include, but are not limited to, serum chemistries and cell counts, coagulation rates, and blood cultures (in suspected bacterial endocarditis). In chronic cases of MR, chest x-rays may reveal an enlarged left atrium and ventricle. In AR, the apex of the heart may be observed on x-ray to be displaced downward and to the left. Enlargement of the left ventricle may also be present.²³ If available, EKG reports may also be reviewed in diet drug medical monitoring, but not to the exclusion of the ECHO report. In MR, the EKG may reveal the presence of left and right atrial enlargement. Atrial fibrillation (a rapid, irregular twitching of the upper heart chambers, abbreviated "AF") may be noted in cases of severe MR. In some cases, left ventricular hypertrophy (enlargement of the left, lower heart chamber, abbreviated "LVH") may be evidenced. EKG changes in AR may not be confirmed until the regurgitation is severe, at which time LVH is noted. ²³

Opportunities for Cost Reduction: Many of the same electronic efficiencies as noted for Tier 4 may be adopted for Tier 5, with similar reductions in expenditures for document accession and review.

Summary

Proactive planning for medical information management will ensure that claims processing requirements are adequately satisfied in cases of diet drug medical monitoring. This strategy will produce the highest quality case analysis while simultaneously achieving the lowest possible cost.

Until final settlements, opt-out decisions, and trial verdicts are reached in diet drug litigation, it is difficult to predict the duration for which MIM services will be necessary in medical monitoring. Emerging medical research also impacts planning for medical monitoring. However, despite the direction this litigation may take in the coming months, application of principles described above will facilitate timely implementation of medical information management protocols as characteristics and knowledge needs of the litigation continue to evolve.

Note: Complimentary copies of Parts I, II, & III of this series are available from Litigation Management, Inc. Please contact the newsletter Editor at 1-800-778-5424, or by e-mail at contactlmi@litigation-mgmt.com.

¹ Riccardi MA. Fen-Phen plaintiffs granted class status; diet drug users seek medical monitoring plan. NY Law J. September 17, 1999: 1.
² Ackermann M. Fen-Phen trial testimony: risks stop one year after use. NY Law J. September 13, 1999.
³ Ornstein C. Enormous fen-phen deal near: Texas state court cases not covered by accord. Dallas Morning News. Sept 16, 1999.
⁴ Federal judge gives preliminary approval to diet drug settlement. The Legal Intelligencer. November 29, 1999: 4.
⁵ In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation MDL No. 1203 and relating to Sheila Brown, et al v. American Home Products Corporation, Civil Action No. 99-20593. Nationwide Class Action Settlement Agreement with American Home Products Corporation, dated 18 November 1999, as noted at www.settlementdietdrugs.com.
⁶ Fen-Phen class action settlement is approved. Liability Week. 1999;46(14).
⁷ Sandrick KM. Phen-fen fallout financial side effects. Hosp & Health Networks. Feb 20, 1998: 90.
⁸ Bergstrom B. Judge orders diet drug attorneys to keep negotiating. Associated Press State & Local Wire. December 3, 1999.
⁹ Ibid
¹⁰ Hensrud DD, Connolly HM, Grogan M, Miller FA, Bailey KR, Jensen MD. Echocardiographic improvement over time after cessation of use of fenfluramine and phentermine. Mayo Clinic Proceedings. 74 (12) (1999).
¹¹ Reuters News. Dropping diet drug fen-phen eases heart ailment-study. December 1, 1999.
¹² Karnowski S. Hope for fen-phen takers seen. Associated Press Health Headlines. December 1, 1999.
¹³ Shively BK, Roldan CA, Gill EA, Najarian T. Loar SB. Prevalence and determinants of valvulopathy in patients treated with dexfenfluramine. Circulation. 100: 2161 (1999).
¹⁴ American College of Cardiology press release. Heart problems disappear once patients stop using diet pills. December 1, 1999.
¹⁵ Juliano EB. Medical information management for litigation. The Bureau of National Affairs, Inc. Toxics Law Reporter. 1997;12(15):436-438.
¹⁶ Juliano EB. Medical information management for litigation. The Bureau of National Affairs, Inc. Product Safety & Liability Reporter. 1997;25(34):814-816.
¹⁷ Juliano EB, Fell JR. Defense considerations in centralization of medical information management for litigation. MIM Reporter. 1998;1(3):1-4.
¹⁸ AHP agrees to settle heart valve cases for up to $3.75 billion; meetings under way as some attorneys question coverage, adequacy. Mealey's Litigation Report: Fen-Phen/Redux. October 12, 1999.
¹⁹ Centers for Disease Control and Prevention. Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: US Department of Health and Human Services interim public health recommendations, November 1997. JAMA. 278 (21): 1729-1731.
²⁰ Nationwide Class Action Settlement.
²¹ Singh JP, Evans JC, Levy D, Larson MG, Freed LA, Fuller DL, Lehman B, Benjamin EJ. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Card. 83: 897-902 (1999).
²² Fauci AS, et al. (editors). Harrison's Principles of Internal Medicine, 14th Edition. New York: McGraw-Hill, 1998. 1316, 1322.
²³ Ibid., 1316, 1321.
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