LEGAL ISSUES IN THE CONTROL OF TB:

THE ROLE OF LAW IN PUBLIC HEALTH

Mark A. Rothstein

Herbert F. Boehl Chair of Law and Medicine and

Director, Institute for Bioethics, Health Policy and Law

University of Louisville School of Medicine

"The findings and conclusions in this presentation have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.”

Institute of Medicine, National Academy of Sciences:

Ending Neglect: The Elimination of Tuberculosis in the United States (May 2000)

The resurgence of TB is partly attributable to persons at high risk of contracting and spreading the disease.

High-incidence groups include:

1. Immigrants2. Prisoners

3. Others (undocumented immigrants, homeless persons, IV drug users)

Would mandatory testing and treatment of latent TB of individuals in these groups be lawful?

Immigrants

“[A]ll tuberculin-positive Class B immigrants

[should] be required to undergo an evaluation for

TB and, when indicated, complete an approved

course of treatment for latent infection before

receiving a permanent residency card (‘green

card’.)”

1. Congress has broad powers to regulate admission to the country.

2. The Public Health Service is authorized by statute to promulgate regulations governing medical examinations of aliens.

3. Because aliens are neither U.S. citizens nor on U.S. soil at the time entry is sought, they have few legal rights.

4. Therefore, mandatory TB skin testing and treatment as a prerequisite to permanent residency status is lawful.

Prisoners

“Tuberculin testing [should] be required of all inmates of correctional facilities and completion of an approved course of treatment, when indicated, [should] be required, with referral to the appropriate public health agency for all inmates released before completion of treatment.”

1. Mandatory TB testing is lawful to promote the compelling governmental interest in protecting inmates and correctional staff.

2. Segregation of prisoners who refuse testing has been upheld, even where the inmate charged that the testing violated his religion.

3. Failure to implement a mandatory TB testing program may lead to liability of prison officials.

4. Mandatory treatment of latent TB is a closer question because: (a) the inmate is not seriously ill, (b) the inmate does not pose a risk of serious harm to self or others, and (c) the treatment is intrusive and may have side effects.

Other High-Incidence Groups

“Programs to target tuberculin skin testing and treatment of latent infection [should] be increased for high-incidence groups, such as undocumented immigrants, homeless individuals, and IV drug users, as determined by local epidemiological circumstances.”

1. State police power to protect the public health is

broad.

2. Case identification through screening is likely to

be upheld.

3. Mandatory treatment and isolation are more

problematic.

LEGAL QUESTIONS REGARDING PUBLIC HEALTH ACTIVITY

1. Is the proposed public health action within the grant of authority (constitutional or statutory)?

2. Are distinctions drawn among individuals rationally related to promoting the public health?

3. Are the means used the least intrusive necessary to achieve public health objectives?

Just because it’s legal doesn’t necessarily mean that a public health intervention is a good

idea.

Prisoners Mandatory testing may be ineffective among Mandatory testing may be ineffective among

jail inmates, whose short stays often last no jail inmates, whose short stays often last no more than 24 to 48 hours more than 24 to 48 hours

Effective treatment may be compromised by Effective treatment may be compromised by the exigencies of prison management, in the exigencies of prison management, in which prisoners are frequently transferred which prisoners are frequently transferred among prison sites without regard to among prison sites without regard to continuity of carecontinuity of care

The government’s interest in mandatory The government’s interest in mandatory treatment is less compelling for offenders who treatment is less compelling for offenders who are released before completing TB treatmentare released before completing TB treatment

Other High Incidence Groups Mandatory testing may be ineffective Mandatory testing may be ineffective

among highly transient populations, such among highly transient populations, such as homeless persons, who frequently as homeless persons, who frequently cannot be located for follow-upcannot be located for follow-up

Mandatory treatment, which may last for Mandatory treatment, which may last for months, may be legally untenable if months, may be legally untenable if persons from high incidence groups are persons from high incidence groups are singled out for segregation without an singled out for segregation without an individualized finding of both TB individualized finding of both TB infectiousness infectiousness andand dangerousness to self dangerousness to self or othersor others

The Role of Law In Public Health

What is public health?

Broad definition:

Any measures that improve the health of the public.

Narrow definition:Public health is more limited and involves:

1. Public health officials

2. Acting pursuant to specific legal authority

3. After balancing private rights and public

interests, due process, and a range of social

considerations

4. Taking appropriate measures to protect the health of the public

5. Which involves government intervention and a range of coercive measures

Research and education are key roles of public health agencies even if they are not “public health interventions” in the narrow sense. I would term them “population health” activities.

Why is it important to distinguish public health from population health?

1. Only public health, with its mandatory government measures, raises the most serious and complex legal and ethical issues.

2. Historically, public health has been the justification for numerous reprehensible policies, ranging from eugenics to Tuskegee.

Public health must balance individual and group interests, autonomy and paternalism, and individual liberty and public well being.

These are common themes in contemporary bioethics and health policy.

Decisions about these issues are influenced by culture, both on a national level and on a population subgroup level.

Public views on these issues change over time.

Some examples:

Individual vs. group interests

Expanding human subject protections may interfere with research and delay the development of treatments and medications.

Autonomy vs. paternalism

Prohibitions on excluding from hazardous workplace exposures individuals at genetically increased risk may lead to more cases of occupational disease.

Individual liberty vs. public well being

Greater exemptions from immunization requirements may lead to a resurgence of vaccine-preventable diseases.

Because population attitudes regarding public health change over time, advocates for public health interventions must continually make the case for public health actions, even those measures of longstanding and proven efficacy.

Making the case for public health is not just a matter of science. It includes social, political, and legal considerations.

What is public health law?

What is public health law research?

Narrow View

Public health law research involves analyzing current and proposed laws to determine whether they are or would be constitutional or otherwise lawful.

Broader View

Public health law research also includes comparing laws in different jurisdictions to see which laws have been most effective.

Broadest View

Public health law research focuses on the role of law in promoting public health. It studies how legally-mandated public health interventions affect individuals, communities, and the nation.

Contrasting Public Health Research with

Public Health Law Research Methodology

Problem:

Evaluating the effectiveness of directly observed therapy (DOT) in the control of tuberculosis (TB).

“Scientific/Quantitative Analysis” Would Consider:

1. Number of TB cases

2. Compliance rate without DOT

3. Economic and health costs of each untreated case, including projections of new cases

4. Cost of hiring, training, and paying public health nurses or others to monitor therapy

5. Cost of medication

6. Other costs and benefits, alternatives

“Legal/Qualitative Analysis” Would Consider:

1. Is DOT within the statutory authority of the public health agency?

2. Is the proposal constitutional, considering due process, equal protection, invasion of privacy, and other principles?

3. What are the social costs of coercion?

4. What principles can be adopted to indicate when DOT is permissible? In other words, why not home monitoring for compliance with a PKU diet?

5. Suppose the public health nurse observes suspected child abuse (or some other unlawful activity) during a home visit, should there be a duty to report the conduct?

6. What other legal measures is the agency prepared to take if entry to a home is refused or if there is noncompliance?

7. Will the policy disproportionately affect certain subpopulations, and, if so, what can be done to lessen the adverse effects on the group?

SUMMARY

1. Public health (interventions)

- narrow definition

- government action based on legal authority

2. Public health (discipline)

- broad view

- includes research and education on health of the population

3. Public health (law)

- broad view

- includes interdisciplinary, qualitative research