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					    THE ETHICS OF PANDEMIC
INFLUENZA PLANNING IN INDIANA:
     LEGAL PERSPECTIVES


          Eleanor D. Kinney, JD, MPH
   Hall Render Professor of Law & Co-Director
         Hall Center for Law and Health
 Indiana University School of Law -- Indianapolis
    Are we prepared as
a legal matter in Indiana?
          THE CHALLENGE
• An influenza pandemic will pose
  tremendous challenges to health care
  providers, third party payers and state
  public health authorities.
• It will be difficult for providers to meet the
  customary legal standards of care
  imposed by state and federal regulatory
  authorities as well as the common law
  tort system.
    The Eventuality of Adverse
Conditions Making Compliance with
Standards of Care Impossible Proble




               →

                           YIKES!
   IUCB Recommendations for Altered
Standards of Care and Pandemic Influenza
              Preparedness
1. The State of Indiana should develop a protocol
   for altered standards of care, which would take
   effect for all healthcare institutions upon the
   declaration of a statewide pandemic influenza
   emergency by the Governor. Triggers for this
   declaration should be identified prior to their
   occurrence. This protocol should specify
   those healthcare professionals affected by the
   protocol and should include legal protections
   for healthcare providers and institutions.
   IUCB Recommendations for Altered
Standards of Care and Pandemic Influenza
              Preparedness
2. The State should begin immediately to
  engage owners/administrators of all
  healthcare facilities in discussions about the
  impact of a statewide protocol for altered
  standards of care, including the selection of
  alternate care sites. All efforts should be
  made to agree to these site acquisitions by
  consensus and partnership.
1. Can the state convene a group
of stakeholders to develop
protocols with legal authority to
establish an altered standard of
care for flu pandemic?
2. Will state immunity statutes
keep health care providers out of
court?
         Four Hot Topics
Altered Standards of Patient Care – Three
Challenges
Patient Triage in a Surge.
Vaccination and antiviral medication
  distribution.
Workforce Management.
The Standard of Care
   The Concept of “Standard of Care”
• In medicine, public health and the other health
  professions, the standard of care refers to
  accepted standards acknowledged by the
  profession as defining acceptable and
  appropriate practice.
   Increasingly, standards of care are developed
     by professional organizations, accrediting
     bodies and government agencies in
     processes that vary greatly in their democratic
     characteristics.
The Concept of “Standard of Care”

In law, standard of care is the legal standard
that must be followed to avoid liability,
sanctions or other legal consequences.
 The law does not generally establish the
   content of the standard of care and relies
   on experts to do so.
 The law simply designates an expertly
   established standard of care as the legal
   standard of care.
The Concept of “Standard of Care”
What criteria does the law use to designate a
standard as the legal standard of care?

 The reputation of the expert authors of the
  standard.
 The process by which the standard was
  adopted.
     Legal Standards of Care
There are three primary sources of legal
standards of care that will be most relevant
during pandemic influenza, particularly during
the time of the surge. These are:
(1) regulatory standards for both health care
facilities and health professionals;
(2) tort standards pertaining to nonconsensual
conduct, and
(3) criminal standards.
         Basis of Tort Liability
(1) liability for intentional conduct;

        In between there is willful and
        wanton conduct, reckless conduct,
        grossly negligent conduct – all of
        which have a distinct legal meaning)


(2) liability for negligent conduct, and
(3) strict liability pertaining to certain activities.
     The Restatement (3rd) Torts
       Definition of Negligence
A person acts with negligence if the person does not
exercise reasonable care under all the circumstances.
Primary factors to consider in ascertaining whether the
person's conduct lacks reasonable care are the
foreseeable likelihood that it will result in harm, the
foreseeable severity of the harm that may ensue, and
the burden that would be borne by the person and
others if the person takes precautions that eliminate or
reduce the possibility of harm.
Provisions of our Statute
    Indiana Public Health Emergency Act
 regarding Immunity for Health Care Services
              HEA 1235 (2006)
 IC 16-41-9, Communicable Disease: Imposition
  of Restrictions on Individuals With Certain
  Communicable or Dangerous Communicable
  Diseases
 IC 10-14-3, Emergency Management and
  Disaster Law
 IC 34-30-13.5, Health Care: Immunity for
  Persons Providing Services in a Disaster
Communicable Disease: Imposition of Restrictions on
Individuals With Certain Communicable or Dangerous
        Communicable Diseases (IC 16-41-9)

 • IC 16-41-9-1.5, Isolation; quarantine; notice;
   hearing; orders; renewal; crime; rules
 • IC 16-41-9-1.6, Actions of public health authority
   in event of quarantine
 • IC 16-41-9-1.7, Immunization programs
 • IC 16-41-9-3 – 10, Treatment of special groups,
   e.g., infected students, mentally ill persons,
   carriers, prisoners, etc.
 • IC 16-41-9-12, Refusal of admission to facilities;
   actions against persons and licensed facilities
           IC 16-41-9-1.7
       Immunization Programs
     Sec. 1.7. (a) An immunization program
established by a public health authority to combat a
public health emergency involving a dangerous
communicable disease must comply with the following:
      (1) The state department must develop and
distribute or post information concerning the risks and
benefits of immunization.
      (2) No person may be required to receive an
immunization without that person's consent. No child
may be required to receive an immunization without
the consent of the child's parent, guardian, or
custodian. . . .
    IC 16-41-9-1.7
Immunization Programs
           Sec. 1.7. (a) * * *
    (b) The state department shall
    adopt rules to implement this
    section. The absence of rules
    adopted under this subsection
    does not preclude the public
    health authority from
    implementing any provision of
    this section.
  Emergency Management and
   Disaster Law (IC 10-14-3)
IC 10-14-3-1, "Disaster"
    Sec. 1. (a) As used in this chapter, "disaster"
means an occurrence or imminent threat of
widespread or severe damage, injury, or loss of life
or property resulting from any natural phenomenon
or human act.
   (b) The term includes any of the following: . . .
     (22) Epidemic.
     (23) Public health emergency. . . .
       IC 10-14-3-7, Declaration of purposes
• to provide for emergency management under the department
  of homeland security;
• to create local emergency management departments and to
  authorize and direct disaster and emergency management
  functions in the political subdivisions of the state;
• to confer upon the governor and upon the executive heads or
  governing bodies of the political subdivisions of the state the
  emergency powers provided in this chapter;
• to provide for the rendering of mutual aid among the political
  subdivisions of the state, with other states, and with the federal
  government to carry out emergency, disaster, or emergency
  management functions; and
• to authorize the establishment of organizations and the
  implementation of steps that are necessary and appropriate to
  carry out this chapter.
        IC 10-14-3-11, Governor; duties

   Sec. 11. (a) The governor has general direction and control
of the agency and is responsible for carrying out this chapter.
In the event of disaster or emergency beyond local control, the
governor may assume direct operational control over all or
any part of the emergency management functions within
Indiana.
   (b) In performing the governor's duties under this chapter,
the governor may do the following:
     (1) Make, amend, and rescind the necessary orders, rules,
and regulations to carry out this chapter with due
consideration of the plans of the federal government.
             IC 10-14-3-15
Governmental functions; liability;
               management this chapter
emergency Any function under workers and any
  Sec. 15. (a)
 other activity relating to emergency management is a
 governmental function. The state, any political
 subdivision, any other agencies of the state or
 political subdivision of the state, or, except in cases of
 willful misconduct, gross negligence, or bad faith, any
 emergency management worker complying with or
 reasonably attempting to comply with this chapter or
 any order or rule adopted under this chapter, or under
 any ordinance relating to blackout or other
 precautionary measures enacted by any political
 subdivision of the state, is not liable for the death of
 or injury to persons or for damage to property as a
 result of any such activity. . . .
                            * * *
            IC 10-14-3-22
Orders, rules, and regulations;
                    and subdivisions and
 amendment politicalrescission agencies
   Sec. 22. (a) The
designated or appointed by the governor may make, amend,
and rescind orders, rules, and regulations as necessary for
emergency management purposes and to supplement the
carrying out of this chapter that are not inconsistent with:
      (1) orders, rules, or regulations adopted by the
governor or by a state agency exercising a power delegated
to it by the governor; and
      (2) [OTHER AUTHORITIES] * * *

   (b) Orders, rules, and regulations have the full force and
effect of law when:
      (1) adopted by the governor or any state agency and a
copy is filed in the office of the secretary of state and mailed
to all members of the county emergency management
advisory council at their last known addresses; or
      (2) filed in the office of the clerk of the adopting or
promulgating political subdivision or agency of the state if
adopted by a political subdivision or agency authorized by
this chapter to make orders, rules, and regulations.
Health Care: Immunity for Persons Providing
     Services in a Disaster IC 34-30-13.5

Sec. 1. Except as provided in section 2 of this chapter, a person who
meets the following criteria may not be held civilly liable for an act or
omission relating to the provision of health care services in response
to an event that is declared a disaster emergency under IC 10-14-3-
12, regardless of whether the provision of health care services
occurred before or after the declaration of a disaster emergency:
     (1) Has a license to provide health care services under Indiana
law or the law of another state.
     (2) Provides a health care service:
        (A) within the scope of the person's license to another person;
and
        (B) at a location where health care services are provided
during an event that is declared as a disaster. IC 34-30-13.5-1
          IC 34-30-13.5-2
Liability for gross negligence or
        willful misconduct
   Sec. 2. A person described in this chapter is
 not immune from civil liability if the damages
 resulting from the act or omission relating to the
 provision of the health care services resulted
 from the person's gross negligence or willful
 misconduct.
       IC 34-30-13.5-3
     Immunity of facility
   Sec. 3. A facility or other location that is providing
health care services in response to an event that is
declared as a disaster emergency may not be held
civilly liable for an act or omission relating to the
provision of health care services in response to that
event by a health professional licensed to provide the
health care service under Indiana law or the law of
another state if the person is acting during an event
that is declared as a disaster emergency, regardless
of whether the provision of health care services
occurred before or after the declaration of a disaster
emergency.
Conclusions?
 1.    Can the state convene a group of
 stakeholders to develop protocols with
 legal authority to establish an altered
 standard of care for flu pandemic?

• Yes and probably should.
• But that does not guarantee that a court in a
  lawsuit will conclude that the protocol is the
  legal standard of care.
• But again, it is better than no protocol
  American Health Lawyers
Association Pan Flu Check List

            An excellent resource in
            the development of such
            protocols available on the
            AHLA website.
         2. Will state immunity
         statutes keep health care
         providers out of court?

• Statutory immunities apply only to negligent conduct.
• They do not apply to grossly negligence conduct,
  willful misconduct, criminal conduct or conduct in
  “bad faith.”
    Are we prepared as
a legal matter in Indiana?

				
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