1. 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

2. Are we prepared as a legal matter in Indiana?

3. 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.

4. The Eventuality of Adverse Conditions Making Compliance with Standards of Care Impossible Proble → YIKES!

5. 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.

6. 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.

7. 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?

8. 2.Will state immunity statutes keep health care providers out of court?

9. Four Hot Topics Altered Standards of Patient Care – Three Challenges  Patient Triage in a Surge.  Vaccination and antiviral medication distribution.  Workforce Management.

10. The Standard of Care

11. 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.

12. 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.

13. 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.

14. 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.

15. Basis of Tort Liability (1) liability for intentional conduct; (2) liability for negligent conduct, and (3) strict liability pertaining to certain activities. In between there is willful and wanton conduct, reckless conduct, grossly negligent conduct – all of which have a distinct legal meaning)

16. 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.

17. Provisions of our Statute

18. 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

19. 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

20. 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....

21. 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.

22. 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....

23. 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.

24. 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.

25. IC 10-14-3-15 Governmental functions; liability; emergency management workers Sec. 15. (a) Any function under this chapter and any 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.... * * *

26. IC 10-14-3-22 Orders, rules, and regulations; amendment and rescission Sec. 22. (a) The political subdivisions and agencies 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.

27. 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

28. 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.

29. 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.

30. Conclusions?

31. 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

32. American Health Lawyers Association Pan Flu Check List An excellent resource in the development of such protocols available on the AHLA website.

33. 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.”

34. Are we prepared as a legal matter in Indiana?