Medical Information Management in Diet Medication Litigation

Part I - Primary Pulmonary Hypertension

By:	Elizabeth B. Juliano
	James R. Fell

Copyright © 2002 Litigation Management, Inc. All Rights Reserved.

Amid mounting reports of serious medical conditions associated with intake of the weight reduction medications dexfenfluramine (Redux), fenfluramine (Pondimin), and phentermine (Adipex, Fastin, Ionamin), the legal profession has been tasked to fully comprehend claims of morbidity and mortality attributed to these products. Much of this challenge arises because many of the published clinical reports on these preparations originated as recently as 1997, and then consisted primarily of correlation studies. Scientific research has yet to prove a definitive causal relationship between these products and the alleged medical syndromes. Therefore, structuring medical analysis in diet medication litigation can be difficult.

A second challenge for attorneys litigating diet drug cases arises in understanding the clinical aspects of the various medical claims. The normal incidence of some of the named disorders is relatively rare, and consequently, medical professionals may have limited experience in their recognition and treatment. Furthermore, findings of in vivo studies on the possible negative effects of these preparations are just beginning to be published. Toxicological evidence on any harmful effects of these medications continues to be evaluated.

This manuscript is the first in a series that will outline cost-effective methods to manage medical record acquisition, review, and analysis in diet medication litigation. Because a mass tort often evolves from a series of individual lawsuits, the need for a medical information management program may not be totally apparent until cases are in discovery and trial dates have been set. Therefore, successful medical case management for such litigation depends upon proactive strategic planning versus a reactive approach.

Scope of the Review

In cases of emerging mass litigation involving medical issues, the prevailing practice has been to acquire and review in detail all plaintiff healthcare records. A sweeping record review in such litigation is justified on grounds that a complete analysis of all plaintiff medical records may yield evidence that would suggest alternate causation(s) for the allegations of injury, as well as additional valuable information.

Global record reviews are also required in developing medical class actions where an "alphabet soup" of allegations comes to involve all major body systems. In such litigation, costs associated with this intensive medical record analysis quickly mount because of management fees connected with record acquisition, duplication, and professional review of shear volumes of information.

Medical information management in diet medication litigation presents a somewhat different scenario as the allegations tend to be focused in specific areas. To date, epidemiologic investigations have focused on two principal concerns associated with the intake of selected diet medications primary pulmonary hypertension and cardiac valvular disorders. Further allegations have been related to the development of neurological disorders, psychiatric disturbances, and birth defects. Existing medical conditions, such as glaucoma, have been allegedly exacerbated by some of these products. Additionally, when consumed in combination with certain other medications, life-threatening reactions may occur as an outcome of diet medication intake.

Primary Pulmonary Hypertension

Primary pulmonary hypertension (PPH) is the pathological development of elevated blood pressure in the arterial blood vessels in the cardiopulmonary circulation loop. Under normal conditions, blood pressure in this loop is relatively low when compared to the pressures required to profuse blood in the larger systemic loop of the trunk and organs.

PPH manifests itself through injury to the endothelial cells lining the pulmonary blood vessels. This damage leads to an increased state of vasomotor tone (the muscles of the blood vessels contract more than is necessary) resulting in a decrease in the diameter of the blood vessel "pipeline." Blood vessel lumens further decrease as the tissues comprising the vessel walls overgrow, thicken, and scar. To compensate, the heart contracts harder leading to increased pulmonic blood pressure and eventual cardiac failure.

Normally, the incidence of PPH is extremely low, about 2 cases per million. Because PPH displays few specific early warning symptoms, diagnosis of the disease is often delayed. ¹ The mortality rate in any diagnosed PPH is quite high, with lung transplantation and a limited number of medications the only effective treatments.

The etiology of PPH is often unknown. It has been linked to chronic obstructive or interstitial fibrosing lung disease; collagen vascular disease, such as scleroderma; cirrhosis and portal hypertension; HIV infection; genetics; cocaine abuse; oral contraceptive intake; and recent pregnancy.^{2 3} Obstructive sleep apnea (itself a problem in obesity) has also been listed as a possible etiology.⁴

An alarming increase in the incidence of this disorder had been observed in the 1960's among individuals who consumed one diet medication, aminorex fumarate. In the early 1990's, development of PPH was associated with fenfluramine derivative intake. A 1996 study once again noted a possible connection between intake of certain appetite-suppressant medications and the onset of PPH.⁵ 

Medical Record Review

In diet medication litigation involving claims of injury linked to the development of primary pulmonary hypertension, the review should focus on the following medical documents:

Hospital Admission and Discharge Summaries. These reports provide concise overviews of the contents of the larger medical record and serve to structure and focus the analysis of the entire record. The medicolegal analyst should focus attention on all cardio-respiratory evaluations and findings.

Physical Examination Reports. In its initial stages, PPH is generally asymptomatic. Because of this, analysis of physical examinations may fail to reveal any documentation of emerging difficulties associated with this diagnosis. Gradually, shortness of breath will manifest itself and progressively limit the degree of functional activity for the patient. The appearance of fatigue, chest pain, peripheral edema (fluid accumulation and swelling in the extremities), peripheral cyanosis (dark blue discoloration of the extremities), and syncope (fainting) may be recorded. Auscultation of the heart may note alterations in cardiac sounds indicative of blood regurgitation through the tricuspid and pulmonic valves.⁶

Physician Progress Notes. To ascertain if adequate medical monitoring was implemented for plaintiffs undergoing diet medication therapy, all physician and physician extender (nurse practitioner, physician assistant) progress notes should be reviewed. Records should reveal that a plaintiff undergoing therapy was routinely evaluated for the onset of respiratory symptoms. However, in the case of PPH, the emergence of a classic warning sign - shortness of breath - can be a poor predictor of developing problems in an obese individual with poor physical conditioning,⁸ and accordingly, the patient may not have undergone extensive medical evaluation until subsequent symptomatology was manifested.

Nursing Notes. The typical hospital record contains voluminous quantities of nursing notes, whose acquisition and review can add considerably to the expense of medical analysis. Fortunately, in diet medication litigation initial attention need be only directed to a study of the nursing admission and discharge summaries, which should adequately document any pertinent physical assessment findings.

Laboratory Reports. Serum chemistries, blood cell, liver function, and coagulation studies should be evaluated as to their significance in the medical allegations. Arterial blood gas reports have importance in the assessment of hypoxemia, dyspnea, acid-base imbalances, and other pulmonary conditions.

Diagnostic Procedures. Findings and diagnoses from all the following evaluative studies should be reviewed into:

• Echocardiogram (ECHO). The transthoracic or transesophageal Doppler flow ECHO and Doppler ultrasound are indicated to assess the etiologies of PPH. ECHO can provide an estimation of actual pulmonary artery blood pressure, as well as detecting another PPH condition involving enlargement of the right ventricle of the heart. In this state, a corresponding decrease in the size of the chamber of the left ventricle can then produce a distorted interventricular septum (wall dividing the two ventricles) leading to heart failure.
• Electrocardiogram (EKG or ECG). This study of electrical activity of the heart can also reveal right ventricular hypertrophy that could possibly be symptomatic of PPH.⁹
• Cardiac Catherization (CC). CC involves insertion of a small tube directly into the heart via venous access and can document findings relative to blood pressures in the heart chambers and associated large blood vessels. In PPH elevated pulmonic blood pressure and increased pulmonary vascular resistance can be detected through this test.¹⁰
• Chest X-Ray (CXR). A chest x-ray may be the only pre-morbidity pulmonary diagnostic study on most plaintiffs. Prominence of the right ventricular outflow vessels has been observed in PPH on CXR,¹¹ although the lung fields themselves may actually be clear.¹²
• Pulmonary Function Test (PFT). The PFT is a lung volume study that measures the efficiency of air exchange into and out of the lungs. In PPH a mild restrictive pattern may be noted.¹³ However, in extreme obesity, findings from PFT testing can be compromised by the pressure of excessive adipose tissue that can significantly increase the effort of breathing.
• Ventilation-Perfusion Lung Scan. This test is mainly utilized to diagnose pulmonary embolism (a blood clot that is clogging an artery). While a published report describing findings of this scan in a case of PPH listed no abnormalities,¹⁴ situations may be encountered in medical record review where the patient was evaluated through application of this study.
• Chest Computed Axial Tomography (CT or CAT). A thoracic CT scan photographs "slices" of the chest region and can be useful to diagnose changes in vascular structures.

Autopsy Reports. Death and autopsy reports should be closely reviewed for findings on pulmonary examination. Autopsy reports should note which organs and tissue were selected for further pathologic study, and the disposition of these specimens. Records warranting examination include:

• Gross Pathology Reports. Examination of the respiratory system should note the presence of abnormalities in pulmonary vasculature and the air exchange structures of the lungs. Cardiac dissection should note the presence of ventricular enlargement and any septal displacement.
• Histopathology Records. Microscopic analysis of tissues removed from the deceased's respiratory system ideally will have been conducted by a pathology specialist, versus a generalist, in cases of PPH. If a specialist was not originally available to perform such a study at the actual time of death, slides and preserved tissue specimens should be acquired for further analysis by the attorney's own medical expert. One published autopsy report in a case of PPH noted the presence of alveolar edema (fluid accumulation in the minute air sacs in the lungs) and congestion. Plexiform arteriopathic lesions (pulmonary artery sclerosis) were widely observed, while the pulmonary veins were normal (as would be expected in a hypertensive state). ¹⁵

If the next of kin refused an autopsy request, this should also be documented in the medical record, along with any stated rationales.

Medicolegal Analysts

Primary pulmonary hypertension is rarely seen in a normal patient population, and most medical practitioners will have had limited experience with this disorder. Therefore, law firms should be highly selective in the retention of medical information management professionals to review these cases. In addition to possessing advanced education and specialization in pulmonary medicine, the medicolegal analyst should also evidence specific experience in the direct evaluation and treatment of PPH.

Foot Notes

¹Fauci AS, et al. (editors). Harrison's Principles of Internal Medicine. 14th ed. New York: McGraw-Hill; 1998: 1466.
²Mark EJ, Patalas ED, Chang HT, Evans RJ, Kessler SC. Fatal Pulmonary Hypertension Associated with Short-Term Use of Fenfluramine and Phentermine. N Engl J Med. 1997; 337: 602.
³Abenhaim L, Moride Y, Brenot F, Rich S, Benichou J, Kurz X, Higenbottam T, Oakley C, Wouters E, Aubier M, Simmonneau G, Begaud B. Appetite-Suppressant Drugs and the Risk of Primary Pulmonary Hypertension. N Engl J Med. 1996; 335: 609.
⁴Sobieraj J. (Letter) Appetite-Suppressant Drugs and Primary Pulmonary Hypertension. N Engl J Med. 1997; 336: 510.
⁵Abenhaim, et al. 609-610.
⁶Harrison's. 1466-1467.
⁷Fishman AP. (Letter). N Engl J Med. 1997; 336: 511.
⁸Ibid. 1313-1314, 1467.
⁹Ibid. 1313.
¹⁰Mark, et al. 602.
¹¹Ibid.
¹²Harrison's, 1467.
¹³Ibid.
¹⁴Mark, et al. 602.
¹⁵Ibid. 603.

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