LEGAL ISSUES IN THE CONTROL OF TB:

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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.
2
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.
3

• High-incidence groups include
• 1. Immigrants
• Prisoners
• 3. Others (undocumented immigrants, homeless
  persons, IV drug users)

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Would mandatory testing and treatment of latent
TB of individuals in these groups be lawful?
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Immigrants All 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.)
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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.
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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.
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• 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.
• 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.

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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.
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• 1. State police power to protect the public
  health is broad.
• 2. Case identification through screening is
  likely to be upheld.
• Mandatory treatment and isolation are more
  problematic.

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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?
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Just because its legal doesnt necessarily mean
that a public health intervention is a good idea.
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Prisoners

• Mandatory testing may be ineffective among jail
  inmates, whose short stays often last no more
  than 24 to 48 hours
• Effective treatment may be compromised by the
  exigencies of prison management, in which
  prisoners are frequently transferred among prison
  sites without regard to continuity of care
• The governments interest in mandatory treatment
  is less compelling for offenders who are released
  before completing TB treatment

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Other High Incidence Groups

• Mandatory testing may be ineffective among highly
  transient populations, such as homeless persons,
  who frequently cannot be located for follow-up
• Mandatory treatment, which may last for months,
  may be legally untenable if persons from high
  incidence groups are singled out for segregation
  without an individualized finding of both TB
  infectiousness and dangerousness to self or
  others

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The Role of Law In Public Health
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What is public health? Broad definition Any
measures that improve the health of the public.
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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
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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.
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• Why is it important to distinguish public health
  from population health?
• Only public health, with its mandatory government
  measures, raises the most serious and complex
  legal and ethical issues.
• Historically, public health has been the
  justification for numerous reprehensible
  policies, ranging from eugenics to Tuskegee.

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Public health must balance individual and group
interests, autonomy and paternalism, and
individual liberty and public well being.
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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.
22
Some examples Individual vs. group
interests Expanding human subject protections
may interfere with research and delay the
development of treatments and medications.
23
Autonomy vs. paternalism Prohibitions on
excluding from hazardous workplace exposures
individuals at genetically increased risk may
lead to more cases of occupational disease.
24
Individual liberty vs. public well being Greater
exemptions from immunization requirements may
lead to a resurgence of vaccine-preventable
diseases.
25
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.
26
Making the case for public health is not just a
matter of science. It includes social, political,
and legal considerations.
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What is public health law? What is public
health law research?
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Narrow View Public health law research
involves analyzing current and proposed laws to
determine whether they are or would be
constitutional or otherwise lawful.
29
Broader View Public health law research also
includes comparing laws in different
jurisdictions to see which laws have been most
effective.
30
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.
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Contrasting Public Health Research with Public
Health Law Research Methodology
32
Problem Evaluating the effectiveness of
directly observed therapy (DOT) in the control of
tuberculosis (TB).
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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
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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?
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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?
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• SUMMARY
• Public health (interventions)
• - narrow definition
• - government action based on legal authority
• Public health (discipline)
• - broad view
• - includes research and education on health of
  the population
• Public health (law)
• - broad view
• - includes interdisciplinary, qualitative
  research