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REYNOLDS v. GOORD

July 13, 2000

DENNIS REYNOLDS, PLAINTIFF,
V.
G. GOORD, COMMISSIONER, D.O.C.S.; CHRISTOPHER C. ARTUZ, SUPT., GREEN HAVEN CORRECTIONAL FACILITY; NORMAN SELWIN, MD, FACULTY HEALTH SERVICE DIRECTOR; LARRY ZWILLIGER, REGIONAL HEALTH SERVICE ADMINISTRATOR; CATHERINE METZLER, RN II; AND DON STEVENS, NURSE ADMINISTRATOR, DEFENDANTS.



The opinion of the court was delivered by: Cote, District Judge.

OPINION AND ORDER

This case addresses the rationality of a policy of the New York State Department of Correctional Services ("DOCS") which places inmates who refuse to submit to a Mantoux skin test — which is designed to detect whether the inmate is infected with the bacterium that causes tuberculosis ("TB") — into a restrictive confinement known as Tuberculin Hold ("TB Hold") for one year. Dennis Reynolds ("Reynolds"), the plaintiff in this case, is a Rastafarian inmate at Green Haven Correctional Facility ("Green Haven"). He refused to submit to the skin test on May 12, 2000, asserting his First Amendment right to exercise his religion, and has moved for a preliminary injunction barring his placement in TB Hold pending trial. Following a hearing held this week, the motion is granted.

PROCEDURAL HISTORY

Plaintiff filed the present action with a complaint dated June 3, 1998, to challenge the legitimacy of DOCS' use of TB Hold. Because Reynolds has decided on several occasions to submit to the skin test rather than remain in TB Hold, he has not yet spent any prolonged period in TB Hold. Following the completion of discovery, on February 28, 2000, this Court issued an Opinion and Order, granting in part defendants' motion for summary judgment and appointing plaintiff counsel for his remaining First Amendment claim. See Reynolds v. Goord, 98 Civ. 6722, 2000 WL 235278 (S.D.N.Y. Marl, 2000) (DLC). The law firm of Paul, Weiss, Rifkind, Wharton & Garrison entered an appearance on plaintiff's behalf on March 16, 2000. At an April 14 conference, on consent of the parties, the plaintiff's pending motion for injunctive relief was deemed moot since Reynolds was not in TB Hold or, to counsel's knowledge, scheduled to have the skin test. A schedule was set to allow for the full development of the issues at stake in this litigation: discovery was to be completed by the end of October 2000, and a summary judgment motion fully submitted by January 12, 2001.

Nevertheless, Green Haven scheduled Reynolds for the skin test, known as a PPD test, on May 12, 2000, and when he refused the test, placed him in TB Hold. On May 12, 2000, the Court ordered that Reynolds be removed from TB Hold until a hearing could be conducted on Monday, May 15, 2000. At the May 15 hearing, Dr. Lester Wright ("Dr.Wright"), the Deputy Commissioner/Chief Medical Officer of DOCS and the author of the TB Hold policy, testified and was cross-examined. On the evening of May 15, 2000, DOCS agreed to allow the plaintiff to remain in the prison's general population until July 14, so that the parties could prepare for and the Court could conduct a preliminary injunction hearing on July 10, 2000.

By Memorandum Opinion and Order dated June 22, 2000, the Court appointed Ronald Shansky, M.D. ("Dr. Shansky"), a leading expert in correctional medicine, to serve as its expert at the preliminary injunction hearing pursuant to Rule 706, Fed.R.Evid. See Reynolds v. Goord, 98 Civ. 6722, 2000 WL 825690 (S.D.N.Y. June 26, 2000). Shortly after such appointment, Dr. Shansky advised the Court of data he required to render an informed opinion. By Order dated June 26, the Court required DOCS to provide certain data regarding (1) each inmate who since 1994 has been diagnosed while a DOCS inmate as suffering from active TB, and (2) each inmate placed in TB Hold since May 1996. Communicable and Infectious Disease Coordinator Linda Klopf, who gathered the data, testified regarding the data on July 6, 2000.

At the hearing, which began on July 10, each of the witnesses who submitted an affidavit was cross-examined.*fn1 In addition, Dr. Shansky was examined by the parties and the Court. The hearing having now been held, the following constitute the Court's Findings of Fact and Conclusions of Law.

FINDINGS OF FACT

The Threat of TB

TB is a deadly disease caused by organisms of the mycobacterium tuberculosis complex, also known as tubercle bacilli. TB has plagued humanity since before recorded history and today is the leading infectious cause of death around the world. Globally, there are currently eight million cases of TB annually and two to three million deaths a year from the disease.

In the 1800s in the United States, TB (or "consumption" as it was called before the identification of the bacterium in 1882) accounted for as many as one-quarter of the deaths in urban areas. In the twentieth century, the development of medical treatment for the disease and the application of public health initiatives led to a steady decline in the incidence of the disease until the mid-1980s. At that point the incidence of TB began to increase. By 1992, there were 10.5 cases of TB identified per 100,000 persons, or 26, 673 cases, in the United States, compared to 9.3 cases per 100,000 in 1985. In New York City, the incidence of active TB increased even more dramatically: by 1992, there were 52 cases per 100,000, a significant rise from the 22.4 per 100,000 in 1981. Public health professionals believe that a major factor in the resurgence of TB was the high frequency of transmission of TB within institutions such as hospitals, shelters and correctional facilities. Other contributing factors are believed to have been an increasing rate of homelessness and of human immunodeficiency virus ("HIV"). With public health initiatives, the decline in the incidence of TB resumed again in 1993, reaching an all time low in the United States of 6.4 per 100,000 in 1999, or 18,361 cases.

The incidence of TB is not spread evenly across this country. There are several patterns relevant to this litigation that are discernible from public health data. Five states, including New York, have over half of the new cases. TB is frequently present among immigrants. In 1998, forty-one percent of all TB patients were foreign-born.*fn2 TB is relatively common among the homeless and those who reside in correctional institutions and other congregate facilities such as long-term care facilities. These high risk environments account for nearly fifteen percent of new cases. Substance abuse is yet another characteristic shared by many who suffer from TB.

TB can be present in any organ of the body, but most commonly exists in the lungs or respiratory tract. TB exists in two stages: latent and active. An individual has latent TB when the individual has been infected with the TB bacterium but does not have symptoms of the disease. Latent TB is not contagious, but without preventive therapy persons infected with latent TB may develop the active disease.

Active pulmonary TB, which is referred to as TB in this opinion, is in some circumstances highly contagious. In general, its symptoms are a prolonged cough, chest pain, coughing up blood, fatigue, anorexia, weight loss, and persistent low-grade fever. It is most commonly spread when a person with TB in the respiratory tract coughs, sneezes, laughs, yells, or sings, thereby generating airborne particles called "droplet nuclei." The largest of these particles quickly settle out of the air, but the smaller particles remain suspended, often for several hours. When inhaled, the smaller particles can reach the alveoli of the lungs and lead to infection. The TB bacilli may then multiply. If they are transported to regional lymph nodes, they can enter the bloodstream and establish sites of infection throughout the body. Their most common site, however, is the upper portions of the lungs. Indeed, eighty-five percent of those with tuberculosis have pulmonary TB.*fn3

The infectiousness of TB is directly related to the number of droplet nuclei containing tubercle bacilli that are expelled into the air. In general, persons suspected of having pulmonary TB are considered infectious if (1) they are coughing, or the laboratory analysis of their sputum smear results*fn4 are positive, and (2) they are not receiving drug therapy, have just started drug therapy, or are having a poor response to the drug therapy. In contrast, such persons are no longer considered to be infectious if they have (1) received adequate drug therapy for approximately three weeks, (2) a favorable clinical response to the therapy, and (3) three consecutive negative sputum smear results from sputum collected on different days.

Transmission of the disease usually requires close and prolonged exposure. Nonetheless, individuals who are malnourished, are generally in poor health, or whose immune systems are compromised — such as persons infected with HIV or suffering from Acquired Immune Deficiency Syndrome ("AIDS") — are at particular risk from any exposure. Persons with HIV are one hundred times more likely to develop active TB when infected than the average person; their risk of developing the disease after infection is estimated to be between eight to ten percent per year. HIV promotes the progression of latent TB to TB, and conversely, TB is the most common cause of death in persons infected with HIV.

On average, the investigation of a case of TB in the United States results in the identification of nine other individuals who are considered "close contacts." of that number, approximately twenty to thirty percent are found to be infected and one percent have developed the disease. Since the prevalence of TB among close contacts is many times greater than the incidence among the general population in the United States, the identification of those exposed to TB is an important public health issue.

Rates of Infection and the Development of the Disease

Within two to ten weeks of becoming infected, an individual usually develops a specific immunity that prevents further multiplication and spread of the TB bacilli. Individuals who have a successful immune response still harbor live TB bacilli in the parts of the body seeded by the early dissemination of the organism, however, and have what is called a latent tuberculosis infection. As already noted, a latent infection causes no symptoms and is not contagious.

Individuals with latent TB are capable of developing the disease at any time in their lives. The risk of disease is greatest, however, during the first two years after being infected. During this two year period, about five percent of infected persons develop TB. Although there is some variation in the statistics, it is generally understood that sixty percent of this risk falls into the first year after infection, and forty percent in the second. Another five percent of infected persons will develop TB at some later time in their lives. This risk is greatest among the elderly. It is believed that approximately ninety percent of individuals with latent TB will never develop the disease. As explained in a leading public health report on TB,

the screening of high-risk populations for latent tuberculosis infection and the provision of treatment of latent infection have been recognized for more than a decade as being central to the goal of tuberculosis elimination.

Institute of Medicine, Ending Neglect: The Elimination of Tuberculosis in the United States 34 (Lawrence Geiter ed., 2000) (advance copy) ("Ending Neglect").

Because TB exists in many strains, persons who previously have been infected with latent TB may be at risk of reinfection even after they have received a course of drug treatment for the infection. This risk — which at present is not quantifiable — is most pronounced among those with compromised immune systems.

Testing for TB

The standard test for discovering a latent infection is the Mantoux TB skin test or PPD test. The Mantoux test is performed by giving an intradermal injection of purified protein derivative ("PPD") tuberculin into the forearm. If a person is infected with the TB bacterium, a temporary swelling or "induration" occurs. This test has remained essentially unchanged for over 60 years.

The PPD test is not perfect though. Some infected people will not have a positive reaction. This phenomenon is referred to as false negatives. False negatives occur most frequently when the infection is very recent (since a positive skin test develops two to ten weeks after infection) or when the immune system is compromised as it is in individuals with HIV. The defendants' expert estimates that the rate of false negatives among those whose immune system is intact approaches five percent and that for those with HIV it approaches thirty percent. As significantly, persons who are not infected may test positive. This most frequently occurs with persons infected with a related bacterium and those recently vaccinated with "BCG," a vaccine against TB used in many foreign countries. Moreover, the PPD test is not a good method of screening for TB itself, since between ten to twenty-five percent of those with TB have a negative reaction to the test. Finally, once a person has been infected with TB, even if the latent infection or the disease has been successfully treated, the PPD test result will remain positive. There is, therefore, no test to determine if an individual has been reinfected with TB. Because of these deficiencies, the PPD test is not recommended where the prevalence of infection is sufficiently low, as it is in the United States generally.

Because the reliability of the PPD test is also dependent on the criterion used to define a positive test, however, the reliability can be improved by progressively increasing the reaction size that separates positive from negative reactors. In 1999, the American Thoracic Society ("ATS") and the Centers for Disease Control and Prevention ("CDC") jointly recommended three cut-off levels for defining a positive reaction: ≥5mm for persons who are at highest risk for developing TB disease if they become infected, including HIV-positive individuals, individuals recently in contact with TB patients, individuals with changes on chest x-rays consistent with prior TB, and patients with organ transplants and other immunosuppressed individuals; ≥10mm for persons with an increased probability of recent infection or with other clinical conditions that increase the risk for TB, including recent immigrants from countries where the prevalence of TB is high, injection drug users, and residents and employees of high-risk congregate settings, including prisons and jails; and ≥15mm for those persons with no risk factors for TB. Within high risk populations, annual PPD testing allows identification of test results that "convert" from negative to positive within one year, permitting treatment during the first year of infection when the risk of developing the disease is at its greatest.*fn5

There is an extremely high rate of error in reading the results of a PPD test. A recent study found that ninety-three percent of the medical professionals who examined an induration of ≥15mm misread it as less than 15mm, although only sixteen percent misread it to be less than 10mm.

As the defendants' expert readily admits, TB is easy to diagnose if one is looking for it. Pulmonary TB may almost always be found through a chest x-ray. Indeed, a chest x-ray has been described in a public health report prepared for correctional facilities as a "quick and effective way to identify" potentially infectious persons. U.S. Department of Health & Human Services, Controlling TB in Correctional Facilities 14 (1995) ("Guide"). While a chest x-ray may suggest that a person has TB, however, it is not sufficient to diagnose TB. On the other hand, it is often used to rule out the possibility of pulmonary TB.

TB may be diagnosed based on clinical signs and symptoms alone. The "gold standard" for the diagnosis of the disease, however, is isolation of the tubercle bacillus in a culture of a patient's sputum. In the United States, about eighty percent of reported cases of tuberculosis are confirmed by a positive sputum culture. Since this figure includes extrapulmonary tuberculosis, a culture is even more reliable in diagnosing pulmonary tuberculosis. A positive culture, however, generally takes at least two weeks.

In contrast, a microscopic examination of a "smear" of sputa is rapid and technically simple.*fn6 This examination, whose results can be read by a laboratory within twenty-four hours of receipt of a specimen, permits only a presumptive diagnosis of TB, however, since the reading also reflects mycobacteria other than tuberculosis*fn7 and since many TB patients, especially if recently infected, have negative readings. Since the smear test measures, in essence, the quantity of bacilli in the lungs, a positive result may be used to identify persons who are infectious. The microscopic analysis of a sputum smear is estimated to identify about thirty-five percent of the individuals with tuberculosis.

Treatment for Latent TB and TB

There are problems associated with the drugs used to treat latent TB. A nine month course of treatment with the most commonly used drug to treat the infection, isoniazid or "INH," is estimated to be about seventy-five percent effective in preventing the development of TB in persons with latent TB.*fn8 This figure accounts for those who cannot take the drug because of intolerance to the drug and for those who do not adhere to the regimen. When analysis is restricted to persons who are complaint with the medication, one study indicates ninety percent effectiveness. Since INH can have an adverse impact on the liver, particularly for those over thirty-five, persons taking INH must be monitored carefully for symptoms of hepatitis.*fn9

Generally, the drugs used to treat the disease itself are extremely effective. Treatment usually entails the administration of multiple drugs for a period of six to twenty-four months. An adverse reaction to the drugs used to treat TB is relatively rare, but may be severe.

Drug-Resistant TB

In the early 1990s, resistance to the drugs used to treat TB became a significant problem. By the mid-1990s, twelve percent of those within the United States newly diagnosed with TB and previously untreated were resistant to at least one of the drugs customarily used to treat TB. The number rose to twenty-three percent for those who had been previously treated for TB. The patients at an increased risk for drug resistance include those who have a history of treatment with TB medications, particularly with a history of nonadherence to a treatment regimen; those in contact with others known to have drug-resistant TB; aliens from areas where the prevalence of drug resistant TB is high, including parts of Asia, Africa, and Latin America; residents of those areas of this country where the prevalence of drug-resistant TB is four percent or higher; and those whose sputum smears or cultures remain positive after two months of therapy with customary TB medications. Since those with drug-resistant TB, even when treated appropriately, may remain infectious for several weeks or months, they require close monitoring and isolation until infectiousness is ruled out.

TB in Prisons

Prison populations are particularly vulnerable to TB. The majority of inmates of correctional facilities have the demographic characteristics that put them at a high risk of being infected with TB. In addition, TB can spread with ease within a prison unless adequate precautions are taken. Studies have shown a correlation between a positive PPD test result and the length of time a person spends in prison, suggesting that transmission of the infection may well have occurred within correctional facilities. Consequently, a draft report by the Institute of Medicine Committee on the Elimination of Tuberculosis in the United States entitled Ending Neglect*fn10 recommended this year that the PPD test be required of all inmates of correctional institutions and, when appropriate, that infected inmates be required to complete an appropriate course of treatment. Ending Neglect, supra, at 69. In the view of the Institute of Medicine,

without an effective vaccine for the prevention of pulmonary tuberculosis, the most effective means of preventing new cases is to take advantage of the relatively long period between infection and the development of active disease by treating individuals with latent infection to reduce the risk of disease.

Id. As this public health panel recognized, "no program of mandatory screening for latent infection could be justified unless it were linked to a program of treatment of latent infection." Id. at 74.

Health & Human Services Guide: Controlling TB in Correctional Facilities

In 1995, the United States Department of Health & Human Services published a comprehensive guide to assist correctional officials in controlling TB entitled "Controlling TB in Correctional Facilities." See Guide, supra.*fn11 The Guide's recommendations include adoption of measures to identify staff and long-term*fn12 inmates who are infected with TB, and to evaluate infected persons for preventive therapy. While it identifies the PPD test as the preferred method of screening for infection, it recommends exempting those who have a documented positive skin test result, who have a documented history of TB, or who report a history of a severe necrotic reaction to tuberculin. It recommends that persons exempted from the PPD test receive a chest x-ray unless there is proof that they have already completed a course of preventive TB therapy or treatment. See id. at 15.

For those who have a positive reaction to the PPD test and no symptoms of TB, the Guide recommends a chest x-ray. See id. If those with a positive reaction to the skin test are members of a high-risk group, then the Guide recommends that they start a course of preventive therapy unless it is medically contraindicated. High risk groups include those with HIV or at risk for HIV (including persons who have injected drugs), those in close contact with someone with TB, those with a positive chest x-ray but without a history of adequate treatment, and those whose reaction to the PPD test went from negative to positive within the past two years. In the absence of high risk factors, the Guide only recommends evaluation for preventive drug therapy if the inmate is younger than thirty-five. The demarcation by age is due to the increased risk to the liver from treatment with INH.

When a person who is likely to be infected refuses to take INH or is unable to do so, the Guide recommends that the person be counseled to seek prompt medical attention if TB symptoms develop. It recommends against routine chest x-rays, however, in the absence of symptoms. According to the Guide, chest x-rays should be given only if symptoms, particularly a persistent cough, develop. Id. at 44.

In addition, the Guide recommends that all those who test negative when given the PPD test be given a second test one to three weeks later. This recommendation is based on the observation that a person infected with TB many years earlier may not have a positive reaction to an initial PPD skin test, but that the PPD test may stimulate their ability to react to a later PPD test. This "boosted" reaction may be misinterpreted as a new infection. To avoid this misinterpretation, the Guide recommends that the second test be administered promptly. Id. at 16. If there is a positive reaction to the second test, it reflects an infection sometime in the past. If there is a negative reaction to the second test, then a positive reaction to any subsequent test likely represents a new infection. Id.

The Guide further recommends annual PPD testing of inmates and staff who have had negative skin tests. If a person has had a positive skin test result and has not completed a course of preventive therapy, then the Guide recommends that the person be screened each year for symptoms. It does not recommend annual chest x-rays for those without symptoms. Id. at 21-22.

When a person in the prison population appears to be infectious, the Guide recommends that "close contacts" be skin tested unless they have a documented history of a positive PPD test result. Close contacts are defined as "persons who sleep, live, or work with an infectious person or who share air with an infectious person through a common ventilation system." Id. at 35. Depending on the ventilation in a facility, contacts may include cell mates, inmates and staff on a tier or unit, or even all inmates and staff in a building if the person is very infectious. Id. at 35.

Federal Bureau of Prisons

On February 12, 1997, the Federal Bureau of Prisons issued a revised infectious disease management directive to update its procedures for screening for TB. It requires TB testing for all inmates.*fn13 Federal Bureau of Prisons, Directive PS 6190.02 Infectious Disease Management (February 12, 1997) ("Directive"). The Directive also requires all federal correctional facilities to comply with the CDC guidelines for control of TB in correctional facilities. Id. ¶ 18.

The Directive specifically requires TB screening for all newly admitted inmates, preferably through the PPD test, or in the alternative, through a chest x-ray. If the inmate refuses to submit to both procedures, mandatory testing is required and the inmate will be "subject to an incident report." The Directive states in relevant part:

All newly committed inmates shall receive TB screening by PPD (mantoux method) or chest x-ray. The PPD shall be the primary screening method unless this diagnostic test is contraindicated; then a chest x-ray shall be obtained. If an inmate refuses both the PPD test and a chest x-ray, then, the institution shall involuntarily test the inmate. . . . The [Clinical Director] shall educate and counsel any inmate prior to the involuntary use of any procedure. . . . Any inmate who refuses clinically indicated diagnostic procedures and evaluations for infectious and communicable diseases shall be subject to an incident report for failure to follow an order; involuntary testing subsequently may be performed in accordance [with this Directive].

Id. ¶ 10 (emphasis supplied). The Directive also provides for the isolation of any inmate believed to be infectious. According to the Directive,

Any inmate who refuses clinically indicated diagnostic procedures and evaluations for infectious and communicable diseases shall be subject to isolation or quarantine from the general population until such time as [the inmate] is assessed to be non-communicable or the attending physician determines the inmate poses no health threat if returned to the general population. . . . If isolation is not practicable, an inmate who refuses to comply with or adhere to the diagnostic process or evaluation shall be involuntarily evaluated or tested.

Id.

The Directive instructs facilities to treat any person with clinical indications of TB as if the person is infectious until it is confirmed that there is no active disease or the person is no longer infectious. Id. ¶ 18c(11). Only those inmates who are infectious, or are presumed to be, are restricted in either "duty or housing assignments." Id. ¶ 14b.

New York State's Prison System

Throughout the 1990s, approximately twenty-five percent of DOCS' incoming inmates have been infected with TB. The prevalence of HIV among inmates entering DOCS further compounds the problem of TB control. In 1996, for example, approximately eight percent of the adult males entering DOCS' facilities were infected with HIV. Today, there are an estimated 7,000 HIV-infected inmates in DOCS' custody, of whom about 2,000 are estimated to have latent TB. of ...


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