Public Health and The Law Robert Kaman, JD, PhD The Summer Institute 2006

1. Public Health and The LawRobert Kaman, JD, PhDThe Summer Institute2006 Public Health and The Law The Constitutional Basis for Public Health Law Public Health Law and the Bill of Rights The Legal Framework for a Response to Bioterrorism Isolation and Quarantine

2. Public Health and the Law • Public Health is grounded in the law, and limited by it as well • Several basic functions in public health, all targeted to the maintenance of a healthy society: • Program development • Responding to technological advances • Public health enforcement • Sanctions for non-compliance

3. What is the “Law” • “A set of enforceable commands based on legislative authority and authorized to be carried out by the executive, including the administrative branches of government, such as health departments.” • Designed to prevent us all from intentionally or unintentionally hurting or killing each other. • Empower agencies to provide services • Services to people to advance their health • Well baby clinics, school health, immunization • Services to communities to prevent the spread of disease • Environmental programs, sanitation, waste disposal

4. The Constitution and Legal Sources of Public Health Powers and the Place of Public Health in Government

5. The Relationship Between Public Health and the Law • Transition of Public Health during the Twentieth Century: • Regulatory Orientation  Service Orientation • Reliance on legislative authorization • Public Health Sections of the US Code • State Public Health Law • Local Codes and Ordinances

6. Bases of Authority for Public Health Programs and Activities • Basis of Public Health Law has its origin in State and local levels • Federal government also has constitutionally-granted authority

7. Sources of State and Local Power • Two interpretations: • States granted power to regulate public health by “omission:” not mentioned in the US Constitution, and the Tenth Amendment says that “…all powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States….” • States have the sovereign “police power:” … the power to provide for the health, safety and welfare of the people. • State government, which preceded the federal government, has sovereign plenary powers • The police power is a sovereign power.

8. State and Local Power • The State has the police power, and in turn, delegates it to lower levels of government: county, municipal, city or village level • Many state and local regulatory programs rely on this police power to provide health and sanitary codes, hospital and nursing home codes, housing and plumbing codes, and health services such as municipal hospital systems and school health services.

9. Source of Federal Power • Federal government is not a government of plenary powers – it only has the powers that the states originally granted to it through the federal constitution. Hence it does not have the police power – to provide for the general health, safety and welfare of the people. • Federal powers in public health rest largely on two constitutionally-assigned authorities: • The Commerce Clause (Article I, Section 8, Clause 3) ”…the power of Congress to regulate commerce with foreign nations and among the several States,…” • The so-called taxing and spending power (Article 1, Section 8, Clause 1) “

10. The Commerce Clause Power • Allows Congress to regulate whatever passes in commerce between the states, as well as whatever “affects” interstate commerce. Usually in the form of federal statutes, such as • The Federal Food, Drug and Cosmetic Act • The Federal Meat Inspection Act • The Poultry Products Inspection Act • The Federal Insecticide, Fungicide, and Rodenticide Act • The Toxic Substances Control Act • The Consumer Products Safety Act • The Fair Labor Standards Act • The Occupational Safety and Health Act (health and safety work conditions)

11. The “Affect” on Interstate Commerce • Expands the reach of the Commerce Clause • Workers in a building in which interstate commerce is conducted • Products produced locally, since it is impossible to tell them from those produced in another state (e.g.: chickens)

12. The Taxing and Spending Power • Federal Grants-in-Aid (indirect regulation) • Grants federal money to state and local governments, which, if they accept the money, must adhere to federal standards (e.g.: Hill-Burton (1944) hospital construction, now replaced by US Code Subchapter IV, on Construction and Modernization of Hospitals and Other Medical Facilities) • Housing and urban renewal • Public waste-treatment plants • School Lunch • Health Planning • STD prevention • Primary Health Care Centers • Community Health Centers…. • Medicaid (Title XIX) provides money to the states to care for the medically indigent • Medicare (Title XVIII) is not a grant-in-aid, but is part of Social Security

13. Grants-in-Aid • Regulatory • Environmental Pollution (Resource Conservation and Recovery Act) • Categorical Grants now replaced by Block Grants • Federal government designates the general purpose of the grant, but allows state or local government to designate specific expenditures (e.g.: urban housing)

14. Government Departments and Agencies in Public Health • Federal Organization • Department of Health and Human Services (DHHS) • Public Health Service (PHS) • Surgeon General of the United States • NIH • CDC • Indian Health Service (HIS) • Social Security Administration/Health Services Administration • FDA • EPA • OSHA (Department of Labor) • Military Health (Department of Defense) • Department of Homeland Security (bioterrorism) • Department of Agriculture (plant diseases and epidemics)

15. State and Local Organization • Each of the fifty states has a state health agency authorized by specific state law. • State police power allows delegation of authority to both state and local agencies. • States differ in government organization: Texas has home rule and general law cities. • Basis is usually state health code, and local (county, city, town, village) public health ordinances, rules and regulations. • Centralized or decentralized:

16. Home Rule versus General Law Cities • Texas has both: The Texas system is legislative, not constitutional • Cities under 5,000 population are general law cities, and abide by state code • Cities over 5,000 are home rule cities, although their ordinances must not be in conflict with state law (courts usually rule in favor of state in disputes)

17. The Need for Intergovernmental Cooperation • Region-wide problems may cross several jurisdictional boundaries • Transportation • Air/water pollution/supply • Waste management • Texas has created several public health regional districts • Objective is to make standards uniform • Creates problems with the hierarchy of laws

18. Hierarchy of Laws • Federal law usually reigns – except if state laws are more stringent • Even if local law is in conflict with federal regulation, it is lawful until challenged. • Supremacy Clause of the US Constitution, Article VI, makes the “…Constitution, and the Laws of the United States, which shall be made in Pursuance thereof the supreme law of the Land.” • Concept of Preemption: the Court has ruled that if the federal government seeks to exercise exclusive authority in a field, state and local law is preempted, and must yield • Air emission standards for new cars • Noise emission standards • Nuclear power plant safety • Protection of Interstate Commerce • A local regulation will be invalidated if it places an undue burden on interstate commerce, unless it protects against the spread of disease, quarantine of diseased animals, or contaminated produce.

19. Recent Advances that Stimulate the Creation of New Public Health Law • Technology and changing economies require new laws: • Medicare and Medicaid (1965; 2005) • Reproductive Rights (Roe v. Wade, 1972) • Abortion, Cloning, Genetic Engineering • Environmental Laws • Physician Assisted Suicide • Human Genome Project • STD’s/HIV AIDS • Tobacco • Infectious Disease/Bioterrorism • Health Care Fraud/Compliance

20. Public Health Law Enforcement and the Bill of Rights

21. The Concepts of Equal Protection of the Laws and of Due Process • In our dual (federal and state) system of governance, individual rights are protected at both levels: • Federal Bill of Rights • Fourteenth Amendment: • All persons born or naturalized in the US, and subject to the jurisdiction thereof, are citizens of the US and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the US; nor shall any State deprive any person of life, liberty, or property without due process of law; nor deny to any person within its jurisdiction the equal protection of the laws. • Protects all rights that are fundamental to the concept of ordered liberty. • Have the right to seek the protection of the courts if those rights are violated.

22. Equal Protection • Concerned with the comparative treatment of individuals. • No governmental discrimination in the granting of privileges, or imposing burdens. • Allows differentiation between people or activities on reasonable grounds. • Classifications that are reasonably related to a legitimate government purpose are permitted. • Distribution of vaccine; licensing requirements, etc. • Classifications not based on reasonable grounds (e.g. race) are prohibited.

23. Supreme Court Deliberations regarding Equal Protection • Three approaches to examine equal protection: • Classifications rationally-related to the purpose of the statute (activities involving economic and liberty interest in the pursuit of a profession, occupation or trade) allowed • Classifications that burden a fundamental right (free speech, right to worship, right to vote, right to travel) are examined by strict scrutiny, and are prohibited. • Classifications based on gender and age are examined by an intermediate review.

24. Due Process • For the Public Health Officer, think “notice” and “hearing.” • “No person shall be deprived of those rights that are implicit in the concept of ordered liberty.” Every individual shall be treated with at lease a minimum of “decency and fairness.” • Fifth Amendment of the Bill of Rights • Fourteenth Amendment (added after the Civil War) extends due process to the States • From the First Amendment: the Establishment Clause (separation of church and state), freedom of religion, freedom of speech and press, and the right to assembly. • From the Fourth Amendment: freedom from unreasonable searches and seizures • From the Fifth Amendment: protection of the privileges against self-incrimination and double jeopardy • From the Sixth Amendment: the right to a speedy, public trial before an impartial jury, the right to confront witnesses and the right to counsel • From the Eighth Amendment: freedom from cruel and unusual punishment. • For the public health officer, the courts will usually uphold enforcement actions, as long as due process has been pursued.

25. Constitutional Protection Against Undue Interference with Personal Liberty • Right of Privacy • Supreme Court judicial construction, not mentioned in the Bill of Rights. Line of cases important to Public health: • Jacobson v. Massachusetts (1905) • Griswold v. Connecticut (1965) • Roe v. Wade (1973) • Series of cases on abortion • Bowers v. Hardwick (1986) • Lawrence v. Texas (2003)

26. Privacy • In Griswold, “Emanations…of…penumbras…” (J. Douglas) • First Amendment right of marital association • Third, Fourth and Fifth Amendments’ right of protection against police intrusion of the home • Ninth Amendment recognition of the existence of non-enumerated rights • A recognition of the right of privacy of sexual relations generally. • In Roe v. Wade: • “This right of privacy, whether it is founded in the Fourteenth Amendment’s concept of personal liberty and restrictions upon state action, as we feel it is, or, as the District Court determined, in the Ninth Amendment’s reservation of rights to the people, is broad enough to encompass a woman’s decision whether or not to terminate her pregnancy.” -J. Blackmun

27. Privacy • The Roe right of privacy is not absolute, but complements the State’s increasing level of government interest, as the term of pregnancy progresses: • First trimester primarily woman’s right • Second trimester intermediate • Third trimester primarily State’s compelling interest in the unborn child

28. Attacks on Roe • Line of cases (e.g.: Akron v. …Center for Reproductive Rights (1983) ; Doe v. Bolton (1973)…) requiring second trimester abortions to be performed in hospitals • Requirement for approval by committee or second physician (Doe v. Bolton, (1973)...) • Line of cases (e.g.: Bellotti v. Baird (1979)…); requiring approval by husband or parents • Texas legislature enacted parental consent law that has not yet been challenged • State not obligated to pay for non-therapeutic abortions (Maher v. Roe (1977)…) • Constitutional protections extended to “persons;” A fetus becomes a person only at birth. • Since a woman’s right to terminate a pregnancy is “constitutionally” determined, can only be abolished by constitutional amendment, or a reversal of opinion by the Supreme Court – Congress, to its immense relief, cannot.

29. Webster v. Reproductive Health Services (1989) • Constitutional challenge of a Missouri law that that sought to regulate the performance of abortions in that state. • The law’s preamble stated that the life of each human being begins at conception and that unborn children have protectable interests in life, health and well-being, equivalent to same rights enjoyed by other “persons.” (upheld) • Law required physician to ascertain viability of fetus. (upheld) • Law prohibited use of public resources to perform non-therapeutic abortion (upheld), or to provide pro-abortion counseling. (not addressed) • In a mixed decision, a plurality upheld the Missouri law in most instances, but did not overrule Roe; its significance is that it still leaves that key issue to the future.

30. Partial Birth AbortionStenberg v. Carhart (2003) • “…to make criminal the performance of a partial birth abortion violates the federal constitution as earlier interpreted in Roe, and in the Casey decision because the (Nebraska) law lacks any exception for the preservation of the health of the mother,and because it imposes an undue burden on the woman’s ability to choose a D&E abortion, thereby unduly burdening the right to choose abortion itself. -J. Dreyer

31. The Privacy Right in other Medical Treatment Decisions • A competent adult has the right to make decisions relating to medical treatment • A person is free to seek or refuse treatment for any illness, injury or defect. • A person is free to refuse treatment to sustain life (the right to die, but not a “right” to commit suicide). • Distinction between euthanasia and the withdrawal of life support. • Surrogate decisions for incompetent patients– best interest of the patient by the court • Balance state’s interest in protection of life against patient’s interest in a dignified death • Advanced directives • Physician-assisted suicide • Parents’ withholding of treatment for children – State intervention (In re Infant Doe (1982)…) led to the Child Abuse Prevention and Treatment Act

32. Informational Privacy • The right of privacy extends (from decisional privacy – abortion, treatment, sexual activity – to informational privacy - the right to limit and control other person’s knowledge of intimate facts about our state of health, our diseases, our genetic propensities, and our life expectancy. • This privacy right is best understood within the context of the patient health information sections of HIPAA – the Health Insurance Portability and Accountability Act

33. HIPAA: Guidance from the CDC and the US Department of HHS • Introduction and General Overview – transition from paper to electronic format • Impact on Public Health • Who is covered • Types of Health Information • De-identified Information • Limited Data Sets • Use or disclosure of PHI • Vested rights of individuals in their PHI • Required PHI disclosures • Permitted PHI disclosures • Other authorized disclosures

34. HIPAA 8. The Privacy Rule and Public Health 9. Disclosures for Public Health Purposes 10. Requirements for covered entities 11. Notice of Privacy Practices of covered entities 12. Minimum Necessary standard 13. Public Health Authorities performing covered functions 14. HIPAA and Public Health Research 15. HIPAA and other law, including pre-emption 16. Additional materials in the Guidance; Registries 17. Enforcement and Penalties 18. No private right of action – enforcement lies with DHHS – delegated to the OCR

35. Freedom of Religion and Separation of Church and State • Establishment clause protects religious beliefs, not religious practices • Does not exempt religion from the normal application of law to protect public health. • Churches must obey ordinances relating to health • Sectarian schools must obey as well • Some religious exemptions have been granted (immunizations) for both organized and individual beliefs • Faith-based services receiving government funds may present basis for establishment clause challenge • Supreme court ruling on the “Chastity Act:” not unconstitutional even though its effort to discourage abortion counseling agrees with the tenets of some religions

36. Freedom of Speech, Press and Assembly • Constitutional protection of freedom of speech: anti-littering laws can prohibit some commercial material, but may not prohibit the distribution of non-commercial messages bearing political, religious or other non-commercial messages. • Commercial advertising does not enjoy First Amendment protection. • Free speech extends to health professions advertising: pharmacies, physicians, etc. prohibited by traditional professional standards of “misconduct.” • Based on value to the consumer • Must not be misleading. • Free speech allows publication of unsubstantiated texts, but when associated with sale of un-efficacious drugs or devises, may be seized as mislabeled products. • Freedom of assembly may be disallowed in light of a genuine threat of naturally-occurring health emergencies, or instances of bioterrorism

37. Protection Against Unreasonable Searches and Seizures • Fourth Amendment right: • “The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures…” • Extended to include the privacy right, and to be free from unwarranted government interference. • May be countered by Public Health Law enforcement (administrative searches and inspections) which will be examined in detail in a later chapter. • “Reasonable” searches may be allowed without a warrant. Texas State Code may allow such searches by a duly authorized public health official.

38. Privilege Against Self-Incrimination • Fifth Amendment right of a defendant in a criminal trial to refuse to give testimony against himself may apply to the extent that a violation of public health law may be prosecuted as a criminal misdemeanor. • Highly regulated industries, and licensed activities, such as health care, pharmaceutical manufacture, nursing homes, etc. are not protected. Required report submissions may be subpoenaed, even if self-incriminatory. • Self-disclosures may be protected to encourage remediation.

39. Rights of Accused Persons • Misdemeanor prosecution of public health law violations must adhere to same constitutional protections as apply in other areas (speedy and public trial, right to know the details of the charge, right to confront witnesses, right of subpoena, jury trial, counsel representation, or court appointed counsel, reasonable bail, double jeopardy protections, and cruel and unusual punishment).

40. Writ of Habeas Corpus • Judicial order, commanding that the detained person be brought before a magistrate to assess the lawfulness of the detention. • Applied to patients in hospitals, sanitariums, and in cases of quarantine and isolation.

41. BIO-TERRORISM Robert Kaman, JD, PhD

42. KILL ONE, FRIGHTEN 10,000 -- Tom Clancy “The Sum of All Fears”

47. The Failure of the Public Health Response • Pearl Harbor all over again? Following 9-11 and the Afghanistan attacks, we were subjected to an anthrax attack. • Health officials did not realize that powder as fine as chalk dust might leak from an envelope • Postal workers were not tested and treated as quickly as congressional staffers • Public statements about the size and hazards of the spores were inconsistent and confusing • Still no guilty parties identified

48. What do we have now? • Ill-funded system • Fragmented • Highly respectful of personal choice • Founded on antiquated laws which actually thwart decisive public health action • They often prohibit data-sharing between public health, law enforcement and emergency management agencies; • They do not provide adequate powers for controlling property and persons in the event of bio-terrorism. • Unprepared for a nationally-coordinated response to crisis.

49. Biological Warfare The intentional use of microorganisms or toxins derived from living organisms to produce death or disease in humans, animals, or plants

50. Biological Warfare History ● 14th Century: plague at Kaffa ● 18th Century: smallpox blankets ● 1943: USA program established ● 1953: Defensive program established ● 1969: Offensive program disestablished ● 1979: Sverdlovsk Anthrax incident ● SE Asia: Yellow Rain ● London, Virginia: Ricin