Public Health 6335: Public Health Law

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What are the two different types of takings?

"Possessory" taking: Government confiscation or physical occupation of property "Regulatory" taking: Government regulation "reaches a certain magnitude" that in effect deprives the owner the enjoyment or economic benefit of his/her property.

What determines the reasonableness of a search and seizure?

"Reasonableness" is the point at which the government's interest in a particular search or seizure outweighs the loss of individual privacy or freedom that results from the government action. In criminal cases, typically need a judicial warrant issued upon probable cause, or "reasonable suspicion" if warrant is impracticable.

Text of the Congress' power to regulate interstate commerce

"The Congress shall have the power...to regulate Commerce with foreign Nations, and among the several states, and with the Indian Tribes"

Caviezel v. Great Neck Public Schools (E.D.N.Y, 2010) Case Summary

"The free exercise clause of the First Amendment does not provide a right for religious objectors to be exempt from New York's compulsory innoculation law." (Citing Jacobson, Zucht, Boone v. Boozman) There is no violation of liberty interests under SDP; Jacobson, Zucht, support state police powers to require compulsory vaccination.

In Mass Tort litigation, plaintiffs must show two types of causation:

1.) General Causation: Whether the substance (at the dosage at which Ps were exposed) is capable of the harm found at increased levels in the population. 2.) Specific Causation: Whether exposure to the substance in fact caused the plaintiff's harm

What is economic due process?Wh

1.) Government regulation that impairs economic interests must further a reasonable or important public interest. 2.) Rarely used to overturn state legislation; police power is usually sufficient justification if regulation is reasonable. a.) Exception is Lochner era (1905-1937) when courts prized economic freedoms and invalidated numerous laws designed to protect the public's health and safety (ex. minimum wage, licensing, etc.). b.) SCOTUS overturned Lochner in 1937— Great Depression and FDR's New Deal: People once again looked to government to ensure greater social and economic equity.

Under HIPAA, what are some permitted unauthorized disclosures for research?

1.) HIPAA covered entities may use/disclose identifiable health information for research w/o person's permission ONLY IF they obtain IRB approval and only in certain circumstances: a.) Disclosure involves more than minimal risk b.) Research could not practically be conduced otherwise c.) Privacy risks are reasonable in relation to anticipated benefits to individual or to the community d.) A plan to destroy the identifiers exists (unless there is a health or research reason for retaining them) e.) Written assurances that the data will not be reused or disclosed to others (except for research oversight or additional research)

Examples of challenges to agency regulations

1.) Industry being regulated argues that regs are too stringent/burdensome and agency is acting outside of power granted by legislature 2.) Public interest group argues that regs are too lax / not comprehensive enough to carry out statute, and agency is acting outside of power granted by legislature, or not carrying out mandate to regulate

What are the remedies for nuisances?

1.) Injunction to abate nuisances (order to clean up property, reduce noise, etc.) 2.) Damages (fines) 3.) Destruction of property

What are the three parts of the Lemon test (to determine whether or not a law is constitutional under the Establishment Clause?

1.) The law must have a secular (not religious) legislative purpose 2.) The law's principal or primary effect must be one that neither advances nor inhibits religion; and 3.) The law must not foster an excessive government entanglement with religion.

How does the Executive Branch interact with the Legislative Branch?

1.) The president can veto bills 2.) The Legislative Branch has the power to impeach, and can override vetoes with 2/3 vote

Pre-Civil Rights Era cases put three general limits on civil confinement:

1.) The subject must be infectious 2,) Safe and habitable conditions must be provided 3.) Confinement must be fair and just

Under HIPAA, what is linkable data?

Data is not immediately identifiable to the record holder, but a third party holds the "key" to the code

Under HIPAA, what is anonymous data?

Data with all identifiersstripped, no reasonable means to associate the information with a specific person

An agency must act within the scope of its ___ ___

Delegated authority

What is the issue/rule put forth in Lorillard Tobacco Co. v. Reilly?

Issue: Whether RI's tobacco advertising regulations violate the First Amendment? Rule: Government restrictions on commercial speech must meet the four prongs of Central Hudson; at issue here: 3) regulation must advance the government's interest to a material degree; and 4) must be no more extensive than necessary.

What is the issue/rule put forth in International Dairy Foods Association v. Amestoy?

Issue: Whether Vermont's law requiring milk labeling for products with rBST solely for the purpose of consumer curiosity violates the First Amendment speech rights. Rule: Government regulation compelling commercial speech solely to address consumer curiosity must pass the four-part Central Hudson test; at issue here, CH#2) the government's interest must be substantial.

What rules must agencies follow when issuing regulations?

Must act fairly, publicly, and within scope of legislative delegation of authority.

Does HIPAA preempt state laws for public health reporting, surveillance, investigation or intervention?

NO!

Constitution is written mostly in ____ terms - what the government ____ do.

Negative; Can't

Text of the Fourteenth Amendment

No State shall abridge the privileges or immunities of citizens of the United States; nor shall 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.

Text of the Fourteenth Amendment.

No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; 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.

What is the text of the Fourteenth Amendment?

No state shall "deprive any person of life, liberty, or property, without due process of law."

What are the key elements of procedural due process?

Notice, hearing, impartial decision-maker

What is express preemption?

Occurs when a law contains a preemption clause or other explicit preemptive language

What is the Penn Central balancing test for regulatory takings?

Use this test when the government's regulation is reducing some, but not all, use and enjoyment (or value) of the property: 1) The economic impact of the regulation on the property owner; 2) The extent to which the regulation has interfered with investment backed expectations; and 3) The character of the government action (e.g., government's interests in protecting public health and safety; interest in preserving historical landmarks, etc.).

What are the steps in a civil case?

Trial Court a.) File Pleadings (complaint/answer) b.) Pre-trial motions/discovery c.) Trial by jury/judge d.) Verdict Appellate Court a.) Appeal b.) Briefing/oral argument c.) Appeals decision (Repeat appeals process if appeal to higher level court)

Examples of criminal cases

US v. Smith (US government v. individual) Texas v. Brown (state government v. individual)

What is a private nuisance?

Unreasonable, unwarranted, or unlawful use of one's property in a manner that substantially interferes with the enjoyment or use of another private individual's property (Note: different from a public nuisance - an action that threaten the health, morals, safety, comfort, convenience, or welfare of a community)

Public health regulations are constitutionally permissible only if... (4 factors from Jacobson v. mass)

1.) They are necessary to prevent an avoidable harm 2.) They have a real or substantial relation to protection of public health 3.) Burdens imposed are not wholly disproportionate to the expected benefit 4.) They do not pose an undue health risk to the subjects of the regulation.

What are the components of Skidmore deference?

1.) Thoroughness 2.) Valid reasoning 3.) Consistency with agency position

What is the informal rulemaking process that agencies carry out?

1.) Vast majority of rulemaking goes through this process 2.) Must follow: prior notice, written comments, statement of basis and purpose of the rule 3.) Often several iterations of a rule before it is final 4.) Enabling statute may have different requirements

What are some other types of public health surveillance (besides mandatory reporting)?

1.) Voluntary, public reporting of behaviors, activities, health status (BRFSS) 2.) Biosurveillance/Syndromic Surveillance 3.) Environmental Public Health Tracking

What is the 'duty to inform'?

1.) An infected individual's duty exposed to infection 2.) Even if defendant lacks actual knowledge of his HIV status (he has not been tested), he still may have a duty to warn (John B v. Superior Court of LA County) 3.) State criminal laws

Rehnquist's Interpretation of the Due Process Clause

"Nothinginthelanguageofthe Due Process Clause itself requires the State to protect the life, liberty, and property of its citizens against invasion by private actors. The Clause is phrased as a limitation on the State's power to act, not as a guarantee of certain minimal levels of safety and security."

What are the 4 goals of tort law?

1) Assign responsibility to individuals or businesses that impose unreasonable risks of causing injury or disease 2) Compensate persons for loss caused by the conduct of individuals or businesses 3) Deter unreasonable hazards or conduct 4) Encourage innovation in product design

What are the four exceptions to the warrant requirement?

1) Legally valid consent (permission of authorized person) 2) In an emergency to avert immediate threat to health or safety 3) Areas open to the public ("open-fields") 4) "Closely regulated businesses" (see Burger test, next slide)

What is community containment?

1.) Additional tools to stem infectious diseases 2.) Not as intrusive as isolation & quarantine, but still raise critical social, political and economic considerations

Can agencies be compelled to take action?

1.) Agencies may decide not to act (or stall) even when Congress has clearly instructed an agency to do so. 2.) Interested persons (individuals, public interest groups, industry, etc.) may file a "citizen's petition" with the agency asking it to regulate. 3.) If petition is denied (agency chooses not to act), can appeal to federal court in some circumstances. 4.) Statute itself may provide a right to have a court review the agency's denial.

What are the three primary functions of the US Constitution?

1.) Allocate power between the federal and state governments 2.) Create and divide power between the three branches of the federal government 3.) Protect individual liberties from government overreaching

What is formal rulemaking?

1.) An agency employee or administrative law judge presides over 'on the record' hearing which typically includes: notice, right to present oral and written evidence, cross-examination of witnesses, agency findings of fact and law 2.) It is only required if it specifically called for in the enabling statute, or if an agency action results in deprivation of property or liberty

Explain freedom of contract.

1.) Applies only to state impairment of existing contracts a.) Challenges to federal regulations that impair private contracts must typically come under 5th Amendment Due Process 2.) Has not been a useful mechanism for overturning state public health regulations a.) Courts typically find reasonable regulation under police power sufficient to infringe on existing contracts

What kind of cases do federal courts hear?

1.) Cases involving federal questions (issues related to US Constitution/federal statutes, regulstions, etc.). Note case may involve a challenge to state law based on grounds that law violates rights under federal law/Constitution 2.) Cases related to a state law where parties have complete diversity (from different states) and relief sought exceeds $75,000

What kind of cases do state courts hear?

1.) Cases involving state laws and/or federal laws 2.) Sometimes parties to a case filed in state court may 'remove' case to federal court if it involves a federal question or the parties have complete diversity and relief sought exceeds $75,000 3.) May appeal to US Supreme Court after case decided by highest level state court if case involves federal question

What is a tort?

1.) Civil wrong that gives grounds for a lawsuit 2.) Mostly state level (few torts under federal law) 3.) Created by common law or, in some states, statute 4.) Involves an injured "plaintiff" who brings a suit against a "defendant"

Courts will NOT grant agencies deference under the following three circumstances:

1.) Congress has not granted the agency power to interpret the statute. a.) In such cases, the agency's interpretation is entitled to respect only to the extent it is persuasive (Skidmore deference—thoroughness, valid reasoning, consistency with agency position) b.) Gonzales v Oregon 2) Congress has directly spoken to the precise question at issue a.) FDA v Brown Williamson Tobacco 3) The agency's action raises significant Constitutional questions.

Examples of Civil cases

1.) David v. Burke (individuals) 2.) Liebeck v. McDonalds (individual v. business) 3.) Benning v. State (individual v. state government) 4.) Boone v. Boozman (individual v. state agency) 5.) Mass v. EPA (state v. federal agency)

To determine accountability for an alleged nuisance, a court will examine three factors:

1.) Defendant intends to interfere with the use and enjoyment of land; 2.) Interference by Defendant is substantial; and a.) Standard: ordinary member of the community with normal sensitivity and temperament 3.) Defendant's conduct is unreasonable. a.) Factors to weigh: Extent and duration of the disturbance; Nature of the harm; Social value of D's conduct / societal value of P's use of his or her property or other interest; Burden to the plaintiff in preventing the harm; Motivation of the defendant; Feasibility of the defendant's mitigating or preventing the harm; Locality and suitability of the uses of the land by both parties.

Freedom of contract, judicial review. What is the three part test (rational basis)?

1.) Does the government regulation substantially impair a contractual relationship? 2.) If so, does the regulation serve a significant and legitimate public purpose? 3.) Is the regulation reasonably related to achieving the government's purpose?

What are the constitutional protections related to economic liberty?

1.) Due Process (5th and 4th Amendments): "nor shall any state deprive any person [including corporations] of life, liberty, or property, without due process of law. . . ." 2.) "Freedom of contract" (Article I, Section 10): "No state shall enter into any. . .law impairing the obligation of contracts. . . ." 3.) Takings clause (5th): "nor shall private property be taken for public use, without just compensation."

In determining what procedures are constitutionally required under due process, the courts weigh three factors:

1.) Extent of the deprivation of liberty or property 2.) The risk of erroneous deprivation of liberty or property 3.) The burdens that additional procedures will entail

What are Bayer and Fairchild's Five Themes related to public acceptance of public health surveillance?

1.) Extent to which surveillance may lead to interventions, and the nature of those interventions 2.) Alarm caused by social stigma 3.) Special populations 4.) Awareness (or lack thereof) of the surveillance 5.) Changes in expectations regarding privacy

What are the key sections of a case briefing?

1.) Facts (what are the relevant facts) 2.) Procedural history (parties, court, lower-level (trial, appellate), court outcomes) 3.) Issue/Question (what is the legal controversy/question specific to this case?) 4.) Rule (what general legal standard will the court apply to the facts of this case to address the legal issue/answer the legal question?) 5.) Analysis (what reasoning/justification does the court use in applying the general legal rule to the specific facts of the case to resolve the legal issue?) 6.) Holding (what is the outcome? who won/lost?)

Explain the federal quarantine authority.

1.) Feds step in to prevent the spread of communicable diseases from foreign countries into the U.S. and between states a.) Authority derived from Commerce Clause b.) Public Health Service Act §§ 361-368 (enabling act) c.) 42 CFR Parts 70 and 71 (CDC regs for interstate and foreign arrivals quarantine) 2.) The Secretary of HHS (through CDC) may: a.) "Make and enforce regulations as are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the US or from one State or possession into another." PHSA § 361 b.) Apprehend, detain, medically examine, and conditionally release persons suspected of carrying certain communicable diseases (42 CFR Part 70)

Constitutional limits on public health powers, by Amendment

1.) First Amendment: Religion, Speech, Press, Assembly 2.) Second Amendment: Right to Keep and Bear Arms 3.) Fourth Amendment: Freedom from Unreasonable Search and Seizure 4.) Fifth Amendment: Due Process (federal government), Equal Protection (federal government), Takings 5.) Fourteenth Amendment: Due Process (states), Equal Protection (states)

Under HIPAA, what are permitted unauthorized disclosures for public health activities?

1.) For public health activities, including reporting, surveillance, investigations, interventions 2.) To FDA (reporting adverse events of drugs etc) 3.) For purposes of notifying individuals who are at risk of communicable disease 4.) To public health officials as otherwise required by law

In Tarasoff v. Reagents (Cal, 1976), a physician may have a duty to warn if...

1.) Forseeability 2.) A serious risk 3.) Identifiable victim/contact

What is the constitutional view point on isolation/quarantine?

1.) Isolation/Quarantine restrict individual liberty; deprive individuals of freedom to travel, associate (First Amendment). a.) Due Process: 5th Amendment (federal); 14th Amendment (states) b.) Balance state's public health interests with individual'sliberty interests 2.) Cannot violate Equal Protection (recall ; administration of quarantine order with "evil eye and unequal hand") 3.) Basic procedural due process requirements: a.) Right to notice, counsel, hearing (on request) b.) Reasonable belief for detention 4.) Federal and many state isolation/quarantine provisions do not provide any express due process provisions 5.) Additional state protections: a.) "Clear and convincing evidence" that isolation is necessary (TB cases) b.) Least restrictive alternative

How do the Judicial Branch and the Legislative Branch interact?

1.) Judicial branch can declare laws unconstitutional 2.) Legislature approves federal judges

What is strict scrutiny for equal protection/due process cases?

1.) Laws must be necessary to achieve a compelling government interest and must show that objectives could not be achieved by less restrictive or discriminatory alternative. 2.) Suspect classifications (race, national origin, alienage); fundamental rights 3.) Government has burden of proof

What is a rational basis level of scrutiny for equal protection/due process cases?

1.) Laws must be rationally related to a legitimate government objective/interest 2.) Standard used to review vast majority of public health regulations 3.) Challenger has burden of proof

What is intermediate scrutiny for equal protection/due process cases?

1.) Laws must be substantially related to an important government objective/interest. 2.) Standard used to review laws that discriminate based on sex or against illegitimate children (quasi-suspect classes) 3.) Government has burden of proof

If statutory language/terms/purpose is ambiguous, courts may look to:

1.) Legislative preamble 2.) Findings or purpose section 3.) Sense of Congress 4.) Or courts may assess the legislative history for background meaning, context, and meaning of specific terms/provisions

What is the nondelegtion doctrine?

1.) Legislatures may not delegate legislative policymaking functions to the executive branch. 2.) Legislature is politically accountable 3.) Legislatures must provide reasonably clear standards for agency rulemaking—cannot be so vague as to give the agency "unfettered discretion" to set policy; must provide "intelligible principle" from which agency can craft regulations 4.) Doctrine rarely used at the federal level to limit agency powers, but states use more frequently. 5.) However, where an enabling statute is vague, courts may use the nondelegation doctrine to interpret agency authority narrowly.

What are some examples of 'fundamental rights'.

1.) Liberties explicitly protected in the text of the Constitution (ex. religion, speech, assembly) 2.) Some liberties involving family and children (procreation, marriage, child rearing) 3)Rightsthatare"deeplyrootedintheNation'shistoryandtradition"

Three different types of product defects

1.) Manufacturing Defect: product does not conform to the manufacturer's design a.) Strict Liability b.) Consumer expectation test: Whether the product performed as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner 2.) Design Defect: even if manufactured properly, product is still not a safe/effective product a.) P must show product is (i) unreasonably dangerous and (ii) a reasonable alternative design could have reduced foreseeable risks b.) Strict liability except for: (i) Unavoidably unsafe products, including drugs and devices, and (ii) Inherently dangerous products in common use (e.g., guns) 3.) Informational Defect: failure to warn; misrepresentation

What kind of relief can you get from a tort?

1.) Monetary damages (compensatory, punitive) 2.) Injunction 3.) Both

What does an 'on the record' heading in formal rulemaking entail?

1.) Notice 2.) Right to present oral and written evidence 3.) Cross examination of witness 4.) Agency findings of fact and law

Name some examples of public health law tools.

1.) Police powers (states) 2.) Taxing and spending power/interstate commerce (federal government) 3.) Alter the informational environment 4.) Alter the built environment 5.) Direct regulation of persons, professionals, businesses 6.) Indirect regulation through the tort system

What are Congress' Enumerated Powers in the Constitution?

1.) Power to Tax 2.) Power to Spend 3.) Power to Regulate Interstate Commerce 4.) Power to Promote the Progress of Science and Useful Arts 5.) Power to Make Treaties 6.) "Necessary and Proper" Clause

What is included in Congress' power to tax and spend?

1.) Power to raise revenue for public health services 2.) Power to allocate resources for the common good 3.) Power to regulate risky behaviors and promotion of healthy activities via incentives (spending power) and penalties (taxes) 4.) By setting conditions on the granting of funds, power to induce states to adopt federal regulatory standard

What is the Congress' power to tax and spend?

1.) Power to regulate, both directly and indirectly, private activities that endanger the public's health 2.) Regulate channels of interstate commerce 3.) Regulate"instrumentalities"of interstate commerce 4.) Regulate something that "substantially affects" interstate commerce

What three requirements must agencies generally follow when issuing regulations (in accordance with the Administrative Procedures Act)?

1.) Prior notice (publication in Federal Register) a.) Time, place, nature b.) Legal authority c.) Description of subject or issue (often a draft rule) 2.) Written comments by interested persons 3.) Statement of basis and purpose of the rule a.) Provided in the regulation preamble b.) Addresses comments

Overview of Product Liability Law

1.) Products liability - STRICT LIABILTY for "defective products" a.) Injured party (plaintiff) must show that the product that caused injury was defective and that the defect made the product unreasonably dangerous. 2.) Theory: substantial settlements and verdicts against a manufacturer of an unnecessary defect, dangerous product will ultimately cause the manufacturer to invest in prevention (through additional research and development) rather than keep paying penalties to consumers and paying high insurance premiums

Licenses and permits in public health

1.) Provides formal permission from the government for a person to hold a certain status or perform certain activities that would otherwise be unlawful: a.) Practice profession (medicine, law, hairdresser, electrician) b.) Conducting a business (restaurant, tattoo parlor) c.) Operating an institution (hospital, nursing home) d.) Keep certain "property" (firearm, dog) 2.) Licensing regimes must strike a balance between quality and access 3.) Standard setting must avoid cultural and social discrimination 4.) License may be valuable property interest: Triggers right to PDP for denials, revocation 5.) May infringe on constitutional rights (expression, assembly) a.) License must be neutral; free from unbridled discretion and arbitrary decision making.

Explain state quarantine authority.

1.) Quarantine is mostly a state and local power 2.) Considered part of police powers 3.) Municipal and state quarantine laws have existed since the colonial period in the U.S. 4.) Modern state laws vary

What is the Per Se test (Lucas) for regulatory takings?

1.) Regulation results in a permanent physical invasion of the property; or 2) Regulation deprives the owner of all economically beneficial or productive use of the property. a.) In either "per se" case, just compensation is required 2.) "Per se" takings claims are limited to these two narrow circumstances and apply only to takings resulting from statutes/regs not in place at time property was acquired or where owner's use of property would not result in common law nuisance (public or private nuisance). a.) Later case (Palazzolo): Can have takings claim requiring just compensation from statutes/regs existing at time of purchase/acquisition.

Explain Mandatory Reporting in public health

1.) Reporting is a form of surveillance - PH Depts have few resources to conduct surveillance, so they rely on clinical reports of disease and injury 2.) Statutes or agencies detail list of "reportable" diseases or events that must be reported to local or state public health agencies 3.) Reporters are usually healthcare providers and labs 4.) CDC has national reporting system, including standardized definitions - but it's voluntary for states to report to CDC

What is substantive due process?

1.) Requires government to sufficiently justify any deprivation of life, liberty or property 2.) For public health purposes, mainly used for protection of unenumerated rights (those not expressly provided in the Constitution) 3.) For liberty protection under SDP, Court typically requires that the interest be "deeply rooted in the Nation's history and traditions" and requires "careful description" of the liberty interest at stake. 4.) Gives the Court leeway to determine what types of "rights" fall within liberty and property due process protections

Mass Torts: Scientific Evidence to Show Causation Pre-Daubert

1.) Restrictive: Frye v US (1923) Court sets a standard that only scientific evidence that is "generally accepted" can be allowed in court 2.) Permissive: Federal Rules of Evidence (1975): Any relevant testimony is allowed - judge as gatekeeper and jury process should sort out weak evidence

What is the search and seizure standard for testing and screening?

1.) SCOTUS has held that the collection and analysis of biological samples are "searches." 2.) "Special needs" exception: a.) If screening is for public health (or other non-law enforcement purposes), the warrant and probable cause requirements may not be applicable. b.) Courts balance governmental interest in public health with privacy interests of the individual to determine the reasonableness of the search.

For mandatory treatment of competent adults for public health purposes, the state must demonstrate:

1.) Significant risk of transmission; and 2,) Medical appropriateness of treatment Note: There is also a common law right to refuse medical treatment grounded in the doctrine of informed consent. In absence of statute giving power to impose treatment, physicians must abide by patient wishes.

Is there a duty to warn (partners of infectious diseases)?

1.) Some states impose duty on healthcare providers to warn third parties of physical harm or infection 2.) Other states permit disclosure physician has discretion whether to disclose, physician cannot face liability

What are some reasons for judicial review of agency decisions?

1.) Statutory language is often inherently broad or ambiguous 2.) Crucial terms are purposefully undefined 3.) Statute may not plan for all contingencies or new circumstances

What is strict liability?

1.) Strict liability = liability without regard to fault a.) Actions for which a defendant can be held liable for damages without plaintiff having to demonstrate defendant's negligence 2.) "Inherently dangerous" activities or substances/wild animals a.) High degree of risk, seriousness of resulting harm, inability to eliminate risk by the exercise of due care, activity's danger compared to value to community, activity is not common 3.) Intention (to engage in the activity); and 4.) Proximate cause 5.) Exceptions: a.) Public Duty Privilege b.) Sovereign Immunity

The Constitution grants certain enumerated powers, such as...

1.) Tax and spend 2.) Regulate interstate commerce 3.) Implied powers through the necessary and proper clause

The Legislature acts within Constitutional powers such as...

1.) Taxing power 2.) Spending power 3.) Commerce clause 4.) Implied powers

What are the key components of the Legislative Branch?

1.) The House of Representatives 2.) The Senate

What are the key components of the Executive Branch?

1.) The President 2.) Executive and Cabinet Departments 3.) Independent Government agencies

How do the Executive Branch and the Judicial Branch interact?

1.) The President can appoint judges and has the power to pardon individuals. 2.) The Judicial Branch can declare presidential acts unconstitutional.

What are the key components of the Judicial Branch?

1.) The Supreme Court 2.) Courts of Appeal 3.) District Courts

Even when a court decides to give deference to an agency decision under Chevron, the amount of deference given varies based on:

1.) The degree of care the agency took in arriving at its interpretations; 2.) It's consistency, formality of the proceedings, and relative expertise; and 3.) The persuasiveness of the agency's position. NOTE: Grant of deference does not automatically mean the agency wins; court will weigh based on the facts of the case.

Businesses and Administrative Searches and Inspections

1.) Warrants are not required for inspections of "closely regulated businesses" a.) Have a reduced expectation of privacy b.) Must meet three criteria: Burger test 1) Substantial government interest for the regulatory scheme under which the warrantless inspection is conducted; 2) Warrantless inspection must be necessary to further the regulatory scheme; and 3) Inspections must be regular and certain under the regulatory scheme such that the owner "cannot help but be aware" that the property will be subject to inspections.

What are some questions asked during judicial review of agency decisions?

1.) What authority did legislature delegate to an agency? Is agency action (or non-action) within scope of its delegated authority? 2.) Did the legislature appropriately delegate power to an agency within Constitutional limits? 3.) Does agency's action raise other Constitutional questions?

When a statute is ambiguous, courts usually defer to agency action (Chevron deference):

1.) When Congress explicitly left a gap in a program to fill, the agency's regulations are given controlling weight unless arbitrary, capricious, or manifestly contrary to statute. 2.) When such a gap is implicitly left by Congress, the court will not substitute its own construction of the statute - court will generally defer as long as the agency's interpretation of the statute is reasonable.

The ___th Amendment applies to state and local governments. The ___th Amendment applies to the federal government.

14th, 5th

Implementing IHRs (2005)

2005 Adopted by 194 states parties 2007 Entered into force 2009 States assess core capacities Plan/implement capacity building 2012 States report meeting all core capacity requirements or request extension 2014 States report meeting all core capacity requirements or request 2nd extension

What is an intentional tort?

A deliberate act that causes harm, including Private Nuisance (other examples: assault, battery, trespass, defamation, intentional infliction of emotional distress)

What is an ALJ?

Administrative law judge

Where do public health emergencies appear?

Africa, 288 Western Pacific, 108 Eastern Mediterranean, 89 South East Asia, 81 Europe, 78 Americas, 41

Why do we trust executive agencies with legislative, executive, and judicial powers?

Agencies have advantages—specialization and expertise; ongoing commitment to particular issues; flexibility; shielded from political pressures

What is commercial speech, and it's three criteria?

An expression related solely to the economic interests of the speaker and its audience that does no more than propose a commercial transaction. Three criteria: 1.) Identifies a specific product 2.) Is a form of advertising; and 3.) Confers economic benefits

What is a public nuisance?

An unreasonable interference with the community's use and enjoyment of a public place or harm to common interests in health, safety, and welfare. Interest must be common to the public as a class; small group or individual interest alone will not suffice.

Explain equal protection (facially neutral)

Applies one standard to all people or groups, but disproportionately affects particular persons or groups as applied. For an equal protection claim to exist, the person/group must show that the government's actual purpose was to discriminate against that group.

What is the Supremacy Clause?

Article VI, Paragraph 2 "The laws of the United States shall be the supreme law of the land; anthing in the laws of any State to the contrary notwithstanding."

How is civil tort law used for advancing public health goals?

As indirect public health regulation - attorneys general and private citizens use tort law to hold individuals and businesses accountable for pollution, toxic substances, unsafe pharmaceuticals, unsafe vaccines, defective/hazardous consumer products

What are two defenses to a negligence claim?

Assumption of Risk: If P is aware of the risk, but nonetheless engages in the activity, then P may not be able to recover from D Contributory/Comparative Negligence: Damage award can be wiped out or reduced if Ps own negligence contributed to a portion of the injury/disease she suffered

RJ Reynolds v. FDA (DC Circuit) and Discount Tobacco and Lottery v. US (6th Circuit) Case Summaries

Both cases challenged whether graphic cigarette warning labels violate the First Amendment: a.) 6th Cir: Challenged graphic warning requirements in the Tobacco Control Act. Using Zauderer (rational basis), found that purpose of warning labels was to inform consumers of the risks of smoking (factual and uncontroversial message); warning labels were rationally related to government's interest in informing consumers of the health risks of smoking. Tobacco companies filed writ of cert on Nov 6, 2012 asking SCOTUS to hear case; SCOTUS denied cert. on April 22, 2013. b.) DC Cir: Challenged FDA final rule under Tobacco Control Act and the nine graphic warnings FDA developed under the Act's authority. Held Zauderer did not apply because FDA's purpose was not to correct deceptive advertising, and graphic labels were not purely factual and uncontroversial. Therefore, court held that Central Hudson was appropriate test. Found graphic warnings violated First Amendment b/c they did not advance the government's primary interest in reducing smoking rates to a material degree [Central Hudson #3]. RJ Reynolds asked for full DC Cir review (en banc) on Oct. 9, 2012; request denied; in March 2013 FDA announced decision not to appeal to SCOTUS and will issue new rule and graphic warning labels.

What is negotiated rulemaking?

Brings stakeholders together to negotiate the text of a proposed rule

What falls under liberty interests?

Broadly defined through court precedent Examples: Imprisonment,contract,work,study,marry, raise children, worship, bodily integrity, travel/movement, other "privacy" rights (abortion, private sexual activity)

Quote from Washington v. Glucksburg on Substantive Due Process

But we "have always been reluctant to expand the concept of substantive due process because guideposts for responsible decision-making in this unchartered area are scarce and open- ended." By extending constitutional protection to an asserted right or liberty interest, we, to a great extent, place the matter outside the arena of public debate and legislative action. We must therefore "exercise the utmost care whenever we are asked to break new ground in this field," lest the liberty protected by the Due Process Clause be subtly transformed into the policy preferences of the members of this Court. - Washington v. Glucksburg, 521 U.S. 702 (1997)

In negligence cases, what are the two types of causation?

Cause-in-fact ("but for" causation) Proximate causation (foreseeability of injury)

The ACA's individual mandate is NOT valid under the ____

Commerce Clause Commerce Clause can only regulate activity not inactivity (i.e. refusal to purchase health insurance) Individual mandate is an attempt to exercise police power - Congress is acting in an area traditionally reserved to the states under the 10th Amendment

Public health regulation entails trade offs between public goods and private interest...

Conflicts between the collective benefits of population health on the other hand, and personal interests on the other Designed to monitor health threats and intervene to reduce risk or ameliorate harm Public health powers encroach on fundamental civil liberties Privacy, bodily integrity, and freedom of movement, association, religion

Crimes v. Torts

Crimes: a.) Government is always the party that initiates prosecution b.) Defendant may face fines or incarceration c.) Government must prove guilt "beyond a reasonable doubt" Torts: a.) Both parties may be private actors b.) Defendant may face fines or be forced to change behavior, no incarceration c.) Plaintiff must prove liability based on "the preponderance of the evidence"

Text of Congress' power to tax and spend

Congress shall have Power To lay and collect Taxes, Duties, Imposts and Excises to pay the Debts and provide for the common Defense and general Welfare of the United States

Text of the First Amendment

Congress shall make no law respecting an establishment of religion [Establishment Clause], or prohibiting the free exercise thereof [Free Exercise Clause]

Text of the First Amendment.

Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.

What is the text of the First Amendment, pertaining to freedom of speech?

Congress shall make no law...abridging the freedom of speech, or of the press...

Name some sources of law.

Constitution, statutes, regulations, judicial decisions.

Explain administrative searches and inspections, and their role in public health law.

Constitutional considerations: Fourth Amendment a.) Protection against unreasonable search and seizure b.) Typically requires a warrant based on probable cause Warrants for health and safety inspections (if not subject to exceptions below), require: a.) Specific evidence of an existing violation of a health and safety standard; or b.) Reasonable plan supported by a valid public interest

What are the primary arguments against Economic Due Process?

Courts should not substitute their view for that of the elected legislature as to what is in the best interests of society and the economy.

Under HIPAA, what is a patient authorized disclosure?

Disclosure for "routine" uses (e.g. treatment, payment or healthcare operations): covered entities required to obtain patient's written consent

Under HIPAA, what is an unauthorized disclosure?

Disclosures of PHI w/o patient consent) allowed only in certain circumstances: a.) To law enforcement under certain conditions b.) As necessary to prevent or lessen a serious/imminent threat to health and safety of a person or the public c.) For certain types of public health practice activities d.) For certain types of research activities

Economic interest v. public health interests

Economic interests: a.) Freedom to enter into legally binding agreements b.) Own and use property c.) Engage in business and professions Public health interests: a.) Protect health and safety of workers, patrons, consumers, community b.) Property use for community benefit

Federal and state legislatures delegate broad powers to agencies through ___ ___

Enabling statutes

Whalen v. Roe Case Briefing

Facts: A NYS statute targeting prescription drug abuse classified drugs and required physicians to file prescription forms for them with the State DOH. It required that all Schedule II (high potential for abuse and dependence; has a currently accepted medical use) prescriptions be written in triplicate (except in emergencies). The form includes the doctor, pharmacy, drug dosage, and name, address and age of the patient. One copy was retained, one went to the pharmacy, and one to the DOH. Forms are entered into a secured computer system and retained for five years before destruction. Public disclosure of identity of patient prohibited by statute and a DOH reg. Issue: May a State retain the names and address of all people who have obtained prescriptions for Schedule II drugs without violating the due process clause of the 14th Amendment? Rule: There is a narrow right to privacy under 14th amendment, but a statutorily-required disclosure of health information does not constitute a violation of this constitutional right to privacy if the state has in place adequate safeguards Analysis: The Court recognizes two types of "privacy" -informational (avoiding disclosure of personal matters) and decisional. The NYS system doesn't, on its face, sufficiently threaten either. There's no support in the record for assuming that the security system won't work. Also, NYS had already required physicians to provide the info upon request, so the only new element was the computer system. Holding: State wins. The "remote possibility" of potential abuses of disclosure are not sufficient to establish an invasion of any rights or liberties protected by the Fourteenth Amendment.

Boone v. Boozman Case Briefing

Facts: Ashley Boone not permitted to attend high school b/c she didn't have Hep B vaccine as required under state law for admittance to school; religious exemption not applicable because Mom didn't belong to a recognized church or denomination Procedure: Mom sues in federal civil court to challenge constitutionality of the state law. Issue: 1) Are Mom's religious beliefs entitled to protection under the First Amendment? 2) Does exemption violate Est. Clause? 3) Does exemption violate Free Exercise Clause? 4) Does compulsory vaccination requirement [minus exemption] violate the Free Exercise Clause? 5) Does the compulsory vaccination requirement violate liberty interests under the Due Process Clause of the Fourteenth Amendment? Rule: 1) First Amendment provides protection for sincerely held religious beliefs; 2) Law violates Est. Clause when it has the purpose or effect of advancing or inhibiting religion and results in unnecessary government entanglement with religion [ Test]; 3) Law violates Free Exercise Clause when protects free exercise rights of some individuals and inhibits FE rights of others on an arbitrary basis; 4) Laws of neutral and general applicability do not violate the Free Exercise clause; 5) A state may enact reasonable regulations to protect the public's health pursuant to its police power, even if such rights infringe on the right to Free Exercise or liberty interests under Due Process. Analysis: Mom's beliefs re immunization are protected under First Amendment b/c rooted in religion and sincere. However, statute's exemption is unconstitutional under Est. Clause b/c it violates ; unconstitutional under FE b/c it arbitrarily accommodates FE rights of some religions but not others. Compulsory vaccination law w/o exemption is "neutral law of general applicability"—need only show rational basis for law. Ct. finds reasonable and substantial relation of Hep B vaccination requirements to public health and safety even though not emergency—reasonable exercise of police power. State's interest overrides "parental rights" and liberty interests related to the refusal of unwanted medical treatment. Holding: Court strikes down religious exemption but upholds compulsory vaccination requirements.

Gonzalez v. Raich Case Briefing (545 U.S. 1 [2005])

Facts: CA's "Compassionate Use Act of 1996," permitted use of medical marijuana for people with serious medical conditions. The law created an exemption from prosecution for physicians, patients, and primary caregivers. Federal DEA agents seized and destroyed Respondent's cannabis plants under the Controlled Substance Act (CSA). Respondents brought action against U.S. Attorney General arguing that the CSA as applied to medical marijuana pursuant to CA law exceeds Congress' constitutional authority. Issue: Does "Congress's power to regulate interstate markets for medicinal substances encompass[] the portions of those markets that are supplied with drugs produced and consumed locally"? Rule: Congress may regulate intrastate activity if Congress has a rational basis for believing the activity substantially affects interstate commerce (hint: think about the aggregate effects of the state law—intrastate activity may substantially affect interstate commerce if, in the aggregate, the law undercuts efforts to regulate interstate markets). Analysis: Primary purpose of the CSA is to control the supply and demand of controlled substances in both lawful and unlawful drug markets. Congress has a rational basis for concluding that leaving home-consumed marijuana outside federal control would affect prices and market conditions. Holding: Valid exercise of Congress's power to regulate interstate commerce. Respondents lose.

Camara v. Municipal Court of the City and County of San Francisco (U.S. Supreme Court 1967) Case Briefing

Facts: Camara was arrested for not allowing a warrantless inspection of his private residence under the SF Housing Code. Procedure: While awaiting his criminal trial, Camara sued SF in state civil court to challenge the SF inspection ordinance as violating the Fourth and Fourteenth Amendments. Issue: Does the SF ordinance allowing for warrantless inspections of private residences violate the Fourth Amendment (Fourteenth not discussed)? Rule: The Fourth Amendment requires that the government obtain a warrant based on probable cause to conduct routine public health and safety inspections of private residences; in such cases the government may justify the probable cause and reasonableness of an inspection based on a valid public interest in protecting the public's health and safety. Analysis: Under the SF inspection scheme, individuals who wish to challenge a warrantless inspection must subject themselves to criminal penalties by first refusing the search, leaving the resident subject to the discretion of the government official. Broad statutory safeguards are not sufficient to protect individuals from unreasonable and warrantless inspections; individualized review is necessary. The burden of obtaining a warrant for a public health/safety inspection is unlikely to frustrate the government's purpose for the search. A warrant ensures that the search is justified by a reasonable government interest, which may be the protection of public health and safety. Holding: Camara wins; ordinance is unconstitutional.

Brown v. Stone Case Briefing

Facts: Chad Brown denied religious exemption to mandatory school vaccination requirements under state law because his father's religion didn't meet exemption requirements (bone fide member of a recognized denomination whose teachings require reliance on prayer or spiritual means of healing). Procedure: Dad sued to compel school to admit Chad without vaccination. Issue: 1) Does Miss. mandatory school vaccination law violate the Free Exercise Clause? 2) Does Miss. religious exemption violate the EPC? Rule: 1) The Free Exercise clause is not violated where the state has an overriding and compelling interest in protecting the public's safety, morals, and health; 2) A law violates the EPC where it treats people of a certain religious denomination differently and does not serve a compelling government interest Analysis: The Miss. mandatory vaccination requirement serves an overriding and compelling public interest in protecting children and the school community from disease. The law is a reasonable exercise of the state's police power and the government interests in protecting children prevail over the religious beliefs of parents. The exemption would discriminate against kids whose parents' religious beliefs do not meet standards for exemption; therefore exemption violates EPC and is void. Holding: Brown loses; child must be vaccinated to attend school.

Kirk v. Wyman (65 S.E. 387 (S.C. 1909)) Case Briefing

Facts: City found Mary Kirk had contagious leprosy from her missionary days. They required her to be isolated in the hospital for infectious diseases. She complained that it was a "pesthouse" used for "incarcerating negros having small-pox and other dangerous infectious diseases." Issue: Was Kirk's detention constitutional? Was isolating Ms. Kirk a "necessary" to protect the public? Rule: (1) Isolation is not unconstitutional if it's necessary to protect others. (2) States giving this power to local boards of health is reasonable exercise of police power. (3) Power can't be arbitrary - must be reasonably necessary, and include notice. (4) Must be subject to judicial review. (5) Court must see if there is a "real relation" between public health and the action Analysis: There is "hardly any danger of contagion," and she has lived in the community for years without infecting anyone. Her house was quarantined effectively, and the board has agreed to build her a cottage outside town. The pesthouse was small and near the trash burning facility. Isolation of Ms. Kirk in the pesthouse was not a "necessity": "Miss Kirk is not only a lady of refinement, highly esteemed in the community, but she is quite advanced in years....we are forced to the conclusion that even temporary isolation in such a place would be a serious affliction and peril to an elderly lady, enfeebled by disease, and accustomed to the comforts of life." Holding: Miss Kirk wins. Isolation violates principles of constitutional law (violates her 14th Am rights to due process).

City of Cleburne v. Cleburne Living Center Case Briefing (U.S. Supreme Court, 1985)

Facts: City of Cleburne denied a special use permit for the operation of a group home for the mentally disabled. Home sued to challenge this decision under the 14th Amendment's Equal Protection Clause. Issue: Was the City's denial of the group home permit a violation of the Equal Protection Clause of the 14th Amendment? Rule: A law/government action that distinguishes among similarly situated groups that are not suspect or quasi-suspect classes (mentally disabled and others), must be rationally related to achieve a legitimate government objective. Analysis: Mentally disabled are not a quasi-suspect class, so the court will apply rational basis review. Under rational basis standard, the denial of the zoning permit was not rational; "the state may not rely on a classification whose relationship to an asserted goal is so attenuated as to render the distinction arbitrary or irrational. Holding: Denial of zoning permit is unconstitutional; violates Equal Protection Clause of 14th Amendment.

Ferguson v. City of Charleston Case Briefing

Facts: City/hospital has policy to test pregnant patients for drug use without consent; policy includes police procedures and criteria for arresting patients who tested positive. Ferguson and (other OB patients) were arrested for drug use while OB patients at the hospital pursuant to the policy. Procedure: Ferguson and other OB patients sued the City in state civil court to challenge the policy's validity. SCOTUS granted cert. Issue: Does the City's policy fall within the "special needs" doctrine such that the hospital can test pregnant patients for drug use without a warrant and probable cause, and without the patient's consent? Rule: Where the gov't has special needs beyond law enforcement in conducting biological screening/testing, the gov't does not need to obtain a warrant and have probable cause under the Fourth Amendment so long as the government's interest outweighs the individual's privacy interests. Analysis: A "close review" of the policy shows that it does not fall within the special needs doctrine because the primary purpose of the policy is to obtain evidence for law enforcement and coerce patients into substance abuse treatment by threatening arrest. Holding: Patients win; policy is not valid.

Massachusetts v. EPA Case Briefing

Facts: Clean Air Act (CAA) requires EPA to set standards for vehicle emissions that contribute to "air pollution" and threaten public health. Private organizations filed rulemaking petition with EPA asking it to regulate greenhouse gas emissions from new motor vehicles under the CAA EPA says: (1) We have no authority to regulate greenhouse gases b/c these are not "air pollutants" under CAA; and (2) Even if we have authority, it would be unwise to issue regs at this time. Procedure: EPA denied rulemaking petition; State and local governments and private organizations sued in federal (civil) court. Issue: Whether EPA acted arbitrarily and capriciously (i.e., without reason) in deciding not to regulate greenhouse gas emissions from new motor vehicles under the CAA. Rule: A court may reverse an agency's decision not to issue a rulemaking where the action was arbitrary and capricious (rule comes from the CAA itself) Analysis: 1) EPA has statutory authority to regulate emissions because carbon dioxide is an "air pollutant" under the CAA—EPA must regulate if it makes judgment that gases contribute to climate change (endanger public health or welfare); 2) EPA failed to provide "reasoned justification" for failing to make endangerment finding—action arbitrary & capricious. Holding: EPA failure to regulate is arbitrary and capricious; Mass wins

South Dakota v. Dole Case Briefing (483 U.S. 203 [1987])

Facts: Congress enacted legislation ordering the Secretary of Transportation to withhold 5% of federal highway funds from states that do not adopt a 21- year-old minimum drinking age. South Dakota, a state that permitted persons 19 years of age to purchase alcohol, challenged the law. Issue: Did Congress exceed its spending powers by conditioning the award of federal highway funds on the states' adoption of a minimum drinking age? Rule: Congress may attach conditions to federal spending so long as the exercise of the spending power is: (1) in pursuit of the general welfare; (2) unambiguous; (3) related to the federal interest at issue; and (4) not unduly coercive. Analysis: (1) Addressing problem of youth crossing state lines to drink was in pursuit of the general welfare; (2) The conditions were clearly stated; (3) Drinking age is related to the federal interest in safe interstate travel; and (4) Financial inducement of 5% of highway funding is not unduly coercive. Holding: Statute is a valid exercise of Congress's tax-and-spend power. SD loses.

Dent v. West Virginia (U.S. Supreme Court, 1889) Case Briefing

Facts: Dent was indicted for practicing medicine without a certificate (license) as required by WV statute. Dent did not meet any of the statutory requirements for obtaining a medical license. Procedure: Dent appealed his conviction (criminal/state) claiming that the WV law deprives him of his liberty to pursue a medical career without due process of law Issue: Does the WV statute requiring a license to practice medicine based on one of three criteria measuring the applicant's qualifications deprive Dent of his liberty to engage in a profession of his choice without due process under the Fourteenth Amendment? Rule: 1) States may use their police power to require licenses to practice medicine, and may condition licensing on meeting certain criteria that the state deems necessary to demonstrate the individual's qualifications so long as the criteria are related to the profession and are reasonably attainable; 2) State licensing statutes do not violate due process if they are of general applicability, impose readily obtainable conditions, and are enforceable through usual modes of administrative action. Analysis: WV statute was a reasonable use of the state's police power to ensure that physicians are qualified for the protection of society, since individuals may not be able to judge a physician's qualifications (states may also require continuing medical education as a condition of licensure renewal). The statute is not arbitrary—applies to all docs, conditions may be readily met, and is enforceable through usual administrative proceedings adapted to the case. Holding: Dent loses; need a license based on statutory criteria to practice medicine in WV

FDA v. B&W Tobacco Corp Case Briefing

Facts: FDA claimed it had the power to regulate tobacco under the FDCA and issued regulations relating to the sale of tobacco products to minors. Procedure: B&W sued FDA in federal (civil) court claiming FDA did not have the power to regulate tobacco Issue: Whether Congress intended to give the FDA the authority to regulate tobacco products. Rule: Where Congress has directly spoken to an issue, an agency cannot form a different judgment and a court will not give deference to the agency's contradictory actions. (Chevron Step 1/Chevron Exception #2) Analysis: Congress clearly intended to exclude tobacco from the FDA's jurisdiction, and therefore FDA has no power to regulate tobacco (FDA's interpretation of the statute is not entitled to deference). First: if FDA has power to regulate tobacco, the FDCA would require FDA to ban tobacco products as not "safe," and Congress has said no ban. Second: Tobacco- specific regulation has precluded any role for FDA. Because congress has regulated tobacco otherwise, any "ambiguity" in FDCA by itself is understood as unambiguous in the context of the rest of the statutory scheme Holding: FDA's regulation is invalid; B&W wins

Castle Rock v. Gonzales Case Briefing (545 U.S. 748 [2005])

Facts: Gonzales had restraining order against estranged husband. He violated it by kidnapping their three daughters. Gonzales repeatedly requested enforcement of restraining order, but no response. 8 hours later, husband opened fire in police station. Bodies of daughters found in truck. Gonzales brought suit claiming a federally- protected property interest in enforcement under the 14th Amendment. Issue: Does the state law regarding protection from private actors create a property interest for purposes of the due process clause of the 14th Amendment? Holding: To have a 14th amendment-protected "property interest," an individual must have a legitimate claim of entitlement to that property interest. Even if a law grants a specific entitlement, it is not necessarily a "property interest" triggering 14th amendment protection. Analysis: olorado law has not created a personal entitlement to enforcement of restraining orders. Since the arrest of any person that violates a restraining order is discretionary, there is no "entitlement" to police enforcement. Even if the statute had created entitlement, it would not be a "property interest" protected under the DP clause. Holding: Gonzales did not, for Due Process Clause purposes, have a property interest in police enforcement of the restraining order against her husband. Dissent: CO law required police to enforce the restraining order.

Greene v. Edwards (263 S.E. 2d 661 (W. VA 1980) Case Briefing

Facts: Greene was involuntarily confined in a hospital pursuant to the WV TB Control Act. He alleges that he was not provided with counsel until immediately before the hearing. He sues, claiming his confinement violates his procedural due process rights under the 14th Amendment. Issue: Whether Greene's confinement for TB under the WV law violates his procedural due process rights where he did not have access to counsel until immediately before the hearing. Rule: Due process for involuntary commitment requires 1) adequate written notice with grounds and facts for commitment; 2) right to counsel; 3) right to be present, cross-examine, confront and present witnesses; 4) clear and convincing standard of proof; and 5) right to transcript. Analysis: Because Mr. Greene was not provided with counsel until immediately before the hearing, counsel could not have been properly prepared to defend him. Holding: Violation of Greene's right to counsel, violates 5th Amendment (and WV Constitution)

Greene v. Edwards Case Briefing (Sup. Ct. App. West Virginia, 1980)

Facts: Greene was involuntarily confined in a hospital pursuant to the WV TB Control Act. He alleges that he was not provided with counsel until immediately before the hearing. He sues, claiming his confinement violates his procedural due process rights under the 5th Amendment. Issue: Whether Greene's confinement for TB under the WV law violates his procedural due process rights where he did not have access to counsel until immediately before the hearing. Rule: Due process for involuntary commitment requires 1) adequate written notice with grounds and facts for commitment; 2) right to counsel; 3) right to be present, cross-examine, confront and present witnesses; 4) clear and convincing standard of proof; and 5) right to transcript. Analysis: Because Mr. Greene was not provided with counsel until immediately before the hearing, counsel could not have been properly prepared to defend him. Holding: Violation of Greene's right to counsel, violates 5th Amendment (and WV Constitution)

US v. Lopez Case Briefing (514 U.S. 549 [1995])

Facts: Gun-Free School Zones Act of 1990 made it a federal crime for anyone to have a firearm within a school zone. Lopez carried gun into a school. He argues against his federal charges that the Act is in violation of the Commerce Clause. Issue: Does the Gun Free School Zones Act exceed Congress' power under the Commerce Clause? Does a federal law prohibiting gun possession within a school zone regulate an activity that substantially affects interstate commerce? Rule: To be a valid exercise of Congress's commerce power, the statute must regulate either (1) the channels of interstate commerce; (2) the instrumentalities of interstate commerce; or (3) activities that have a substantial relationship to interstate commerce Analysis: - Congress exceeded its commerce authority by making gun possession within a school zone a federal offense. Possessing a gun within a school zone does not "substantially affect" interstate commerce. Congress does not have power to regulate here and the law is unconstitutional. - Gov't argument that possession of gun in a school zone can lead to violent crime and threats to the learning process would result in unlimited federal power to regulate in areas of criminal law or education, "where States have historically been sovereign." Holding: Act exceeds Congress's authority because the relation to interstate commerce is too tenuous. Lopez wins.

City of New York v. Antoinette R. (630 N.Y.S. 2d 1008 [NY Sup. Ct. 1995]) Case Briefing

Facts: In 1993 because of a TB resurgence, NYC revised its health code to allow detention of people with TB who have shown an inability to comply with treatment. The Commissioner could seek an order to remove or detain someone for treatment in a hospital or other appropriate facility. The health code includes several due process safeguards. NYC Health Commissioner sought enforcement of an order to detain Antoinette R. in a hospital to complete treatment for active, infectious TB. Issue: Whether confinement of a patient for TB treatment under the NYC statute violates due process. Rule: Involuntary detention of an individual is permissible: (1) where state officials can show "clear and convincing" evidence that the individual poses a health risk if they remain in less a restrictive environment; and (2) procedural due process safeguards are observed. Analysis: (1) The Commissioner has offered "clear and convincing evidence" that Antoinette R. is unable to comply; her repeated refusal to complete therapy creates the risk of resistant strains and therefore is a threat to public health. (2) The health code has several DP safeguards, and all have been observed in this case. Holding: Antoinette R. loses. Detention is permitted and is not in violation of due process.

Jacobson v. Massachusetts Case Briefing (U.S. Supreme Court, 1905)

Facts: Jacobson refuses to comply with Cambridge, Mass. ordinance requiring a smallpox vaccination (pursuant to state statute) for all those over age 21, and thus gets arrested, prosecuted, and fined $5. Issue: Did the Cambridge mandatory vaccination laws/Mass. statute violate Jacobson's constitutional rights of due process, equal protection, [and privileges or immunities] clauses of the 14th Amendment? Rule: Public health regulations are constitutionally permissible only if 1) they are necessary to prevent an avoidable harm; 2) they have a real or substantial relation to protection of public health; 3) burdens imposed are not wholly disproportionate to the expected benefit; and 4) they do not pose an undue health risk to the subjects of the regulation. Analysis: Vaccination of entire population is necessary to prevent spread of smallpox; vaccination is commonly understood to be best means for protecting against infectious disease; vaccination will benefit population as a whole; assume there are medical exceptions. Court recognizes police power and legislative deference. Holding: Cambridge ordinance/Mass statute are constitutional

Daubert v. Merrell Dow Chemical (509 US 579 [1993]) Case Briefing

Facts: Jason Daubert & Eric Schuller were born with limb reduction birth defects, allegedly caused by their mothers' ingestion of Bendectin, an antinausea drug taken during pregnancy. Some reports in medical literature of possible links between the ingestion of Bendectin and birth defects, and Plaintiffs wanted to have experts testify as to causation. Trial and appeals courts applied Frye test and excluded expert testimony. Issue: What is the standard of evidence for admitting expert scientific testimony in a federal trial? How should judges determine if scientific evidence is admissible and sufficient to show causation? Rule: Federal Rules of Evidence supersede Frye test in federal court. All scientific testimony/evidence admitted in court must be (1) Reliable, and (2) Relevant. Reliability: 4 factors to assess reliability of scientific evidence: (i) testing; (ii) peer review; (iii) error rate; (iv) general acceptance. Relevance: If scientific, technical or other specialized knowledge will assist judge/jury to understand the evidence or to determine a fact in issue, a qualified expert may testify Analysis: N/A Holding: Judgment vacated and remanded to lower court

DeShaney v. Winnebago County Department of Social Services Case Briefing (489 US 189 [1989])

Facts: Joshua was physically abused by father for years and wound up with severe brain damage. The Department of Social Services was aware of the case and involved. Joshua and mother filed federal action in US District Court claiming a 14th amendment due process violation (deprivation of liberty). Issue: Does substantive due process place an affirmative obligation on states to protect their citizens from private actors? Does a duty arise if a special relationship exists? Rule: Constitution does not place an affirmative obligation on states to protect their citizens from private actors. No duty arises unless state:(1)takes person into its custody; or (2) state action created/increased the harm. Analysis: State agencies did not inflict the harm themselves. Joshua injured while in father's custody; father not state actor. Even though state aware of situation, they did not create the harm or render Joshua more vulnerable. Holding: No due process violation. Dept of Social Services wins. Blackmun dissent: Too formalistic to distinguish inaction from action.

Kelo v. City of New London Case Briefing

Facts: Kelo's home (and 14 others) were to be condemned (destroyed through gov't taking) through City's eminent domain power with just compensation so that City could move forward with economic revitalization plan—new businesses, park, waterfront area; Pfizer was to build plant right outside city limits. City was a "distressed municipality" with high unemployment, run-down areas, etc. Procedure: City brought civil condemnation proceeding against Kelo's property in state court; state supreme court upheld takings; Kelo appealed to SCOTUS Issue: Whether the City's condemnation of Kelo's property with just compensation for purposes of economic revitalization, where some land would be used for private purposes, constitutes a permissible "public use" under the Fifth Amendment takings clause. Rule: A state may transfer property from one private party to another if the purpose of the taking is for future "use by the public" and serves a "public purpose." Analysis: Economic revitalization plan will benefit the public by bringing jobs, income, new public spaces, recreation, etc.; courts defer to elected legislature to decide whether a taking of private property under eminent domain is for a "public use." Moreover, courts look to the taking's purpose, not its mechanics, in determining public use. Holding: Kelo loses, property is condemned for economic revitalization plan. Dissent: Majority significantly expands meaning of public use; essentially any government taking could be considered for public use now; seriously jeopardizes security of private property ownership and will disproportionately affect disadvantaged populations.

Lucas v. South Carolina Coastal Council (U.S. Supreme Court, 1992) Case Briefing

Facts: Lucas purchased residential lots for ~1M on beachfront with intention of building two single-family homes; two years later SC enacted law which would bar Lucas from building the homes (or any other permanent habitable structures). Procedure: Lucas sued in state civil court to challenge the law; trial court found that law rendered property "valueless" and entitled to just compensation under takings clause. Gov't appealed; SC supreme court ruled in favor of SC; Lucas appeals to SCOTUS Issue: Does a government regulation the renders property valueless constitute a taking requiring just compensation? Rule: Just compensation is required under the takings clause when a government regulation deprives a property owner of all economically beneficial or productive use of the property; a case specific inquiry into the government's interest is not required [per se categorical taking]. Analysis: Where all economic or productive value of property is foreclosed by government action not in place at the time the property was acquired and where owner's use of property does not constitute a public or private nuisance under common law, action should be treated similarly as a physical taking and requires just compensation no matter how substantial the government interest. Holding: Case remanded to SC court to determine if owner's plan to build homes on the beachfront would constitute a common law nuisance or violate other common law property interests.

Lorillard Tobacco Co. v. Reilly (SCOTUS 2001) Case Briefing

Facts: Mass regulations prohibited 1) outdoor advertising of tobacco products within 1000 feet of a public playground or school; and 2) required that retailers within 1000 feet of a school or playground place advertisements for tobacco products at least 5 feet from the floor; 3) bar use of self-service displays and require tobacco products be placed out of reach of all consumers in a location only accessible to salespersons. Issue: Whether RI's tobacco advertising regulations violate the First Amendment? Rule: Government restrictions on commercial speech must meet the four prongs of Central Hudson; at issue here: 3) regulation must advance the government's interest to a material degree; and 4) must be no more extensive than necessary. Analysis: Mass has shown sufficient evidence that tobacco use among youth is a problem [satisfies CH#3], but is not narrowly tailored; would prevent advising in 87-91 percent of major Mass cities; includes advertisements inside that can be seen from street—overbroad and disregards security needs in some stores for visible front; not limited to signs of specific size, etc. Holding: Mass regulations violate First Amendment

New York State Restaurant Association v. NYC Board of Health Case Briefing

Facts: NY City passed a law requiring chain restaurants of a certain size to post calorie counts on their menu boards (like ACA menu labeling law). NYS Restaurant Association sued claiming that law violated First Amendment free speech Issue: Whether a government regulation requiring compelled menu labeling violates the First Amendment Rule: Regulations that require disclosure of factual and uncontroversial commercial information are subject to more lenient review than prohibitions or restrictions on commercial speech, and need only be reasonably related to the State's interest in preventing deception of consumers (Zauderer/Sorrell rule). Analysis: Menu labeling regulation compels disclosure of purely factual and uncontroversial commercial information—the calorie count of menu items. Reg attempts to address a state policy interest in combatting obesity by making complete and accurate information available to consumers; Int'l Dairy's use of Central Hudson not applicable here because that case was expressly limited to case where state disclosure requirement is supported by no interest other than consumer curiosity. ***Zauderer/Sorrell demonstrate that the state's interest in preventing consumer confusion and deception is not limited to an interest in correcting affirmatively misleading statements and may include an interest in remedying consumers' ignorance or misinformation regarding the products they purchase [Compare with RJ Reynolds v. FDA] City is attempting to combat obesity by addressing information gap—provide consumers information about potential health impact of foods they purchase. For rational basis standard, court doesn't require conclusive proof that posting calorie counts will help reduce obesity—reasonable to expect based on evidence presented and common sense that this will impact how some consumers choose restaurant foods. Holding: Menu labeling regulations are upheld

Lochner v. New York (U.S. Supreme Court, 1905) Case Briefing

Facts: NY law prohibited bakery employees from working more than 10 hours per day or 60 hours per week. Lochner (both owner and employee of the bakery) was criminally charged [misdemeanor], convicted, and fined for working over the state's legal time limits. Procedure: Lochner challenged his conviction on grounds that NY law was unconstitutional; state criminal proceeding/SCOTUS. Issue: Is the NY law an unreasonable, unnecessary, and arbitrary interference with Lochner's "right to labor" (liberty) or the "right to contract" under 14th Amendment due process or the Article I contracts clause? Rule: Public health regulation pursuant to a state's police powers may not interfere with individual liberty or contract rights unless it is directly related to an appropriate and legitimate state interest. Analysis: Almost all occupations affect health to some degree; must be more than a "mere fact of possible existence" that worker will experience negative health effects to the extent to warrant government intrusion on the right to labor and contract. Such laws might impair a worker's ability to support himself and family; workers should be able to labor and contract as they think best. Holding: Lochner wins; NY law invalidated

New York v. New St. Mark's Baths (Supreme Court of New York, 1986) Case Briefing

Facts: NYC sought to close bathhouse as a public nuisance to help prevent spread of AIDS Procedure: NYC sued in state civil court [for injunctive relief] to close the bathhouse; New St. Marks and its patrons seek to dismiss based on violation of rights to privacy and association Issue: Whether NYC's closing of the bathhouse as a public nuisance violates bathhouse patrons' right to privacy of sexual activity and freedom of association. Rule: A state may act through its police power to abate a public nuisance, where such abatement would infringe on one's freedom of association, if it has a compelling interest in acting to protect the public's health and the remedy and abatement is the least intrusive measure reasonably available [strict scrutiny]. Analysis: Issue: Whether NYC's closing of the bathhouse as a public nuisance violates bathhouse patrons' right to privacy of sexual activity and freedom of association. Rule: A state may act through its police power to abate a public nuisance, where such abatement would infringe on one's freedom of association, if it has a compelling interest in acting to protect the public's health and the remedy and abatement is the least intrusive measure reasonably available [strict scrutiny]. Holding: City wins, New St. Marks must close

Ex Parte Company (139 N.E. 204 [Ohio 1922]) Case Briefing

Facts: Ohio sanitary code lists certain diseases, including syphilis and gonorrhea, as dangerous to the public health, and empowered city health commissioners to examine and quarantine people "reasonably suspected" of having VD. Prostitutes and people "associating with them" are reasonably suspected. Company and Irvin were both arrested for prostitution and related crimes. They were both found to have syphilis and gonorrhea. The Akron Commissioner of Health detained them home for a 2-month quarantine. They filed writs of habeas corpus, stating that this violated their right to due process under the Fourteenth Amendment Issue: Is testing and quarantine of people "reasonably suspected" of VD constitutional? Rule: States have police power authority to restrain persons and property to secure the public's health and safety without violating due process; quarantine [isolation] of persons infected with contagious STDs is a permissible use of the state's police power to protect the public's health. Analysis: State/city has police power authority to quarantine Company under state statute and regs because she engaged in prostitution and has infectious STDs, and is thus a "menace to the health and morals of the community." No conflict between regs and statute (does not matter that the statute uses the word "charged"). Holding: Company and Irvin lose. The testing and quarantine does not violate due process

Geier v. American Honda Company Case Briefing (529 U.S. 861 [2000])

Facts: Plaintiff Geier suffered severe injuries when her 1987 Honda Accord collided with with a tree. The car was equipped with manual shoulder and lap belts, but not with airbags or other passive restraints. Plaintiff sued Honda, claiming car was negligently designed because it was not equipped with an airbag. DC law required driver-side airbags, but regulations under the National Traffic and Motor Vehicle Safety Act required auto manufacturers to equip some, but not all of the 1987 vehicles with passive restraints, such as airbags. Issues: Whether the National Traffic and Motor Vehicle Safety Act, and the standard for passive restraints that is imposed on car manufacturers, can preempt a state common law tort action, even though Congress did not specify its intent of preemption when passing the Act? Rule: If a state law stands as an obstacle to the accomplishment and execution of the important objectives of a federal statute, it is pre-empted Analysis: The Act provided car manufacturers with a range of choices. It does not require Honda to equip all cars made in 1987 with airbags. Rather, the Act rejected an all airbag standard (concerns about airbags trumping use of seatbelts). The Act also sought a gradual phase-in of passive restraints. To impose a duty upon Honda to equip all cars with airbags would be in direct conflict with the objectives and purpose of the federal statute. Holding: Defendant wins. The Act does not expressly preempt state law, but this state law stands as an obstacle to the accomplishment of important federal objectives; the law is preempted. Dissent: Society generally is in agreement that to be safe, a car must have an airbag. The majority decision holds that an interim regulation motivated by the desire to foster gradual development of a variety of passive restraint devices deprives state courts jurisdiction to decide if Defendant has a duty to equip all cars with airbags.

Players, Inc. v. City of New York (US District Court for the Southern District of NY 2005) Case Briefing

Facts: Private social club with food service challenged NYC smoking ban law on grounds that it violated the Fourth Amendment by allowing warrantless inspections of food service establishments to monitor compliance with the ban. Procedure: Players sued in federal court /civil proceeding to challenge NYC law. Issue: Whether NYC's smoking ban law violates the Fourth Amendment by allowing warrantless inspections of a private social club that provides food service to monitor compliance with the ban Rule: Warrantless inspections of "closely regulated businesses" such as food service establishments do not violate the Fourth Amendment if 1) there is a substantial government interest that informs the regulatory scheme pursuant to which the inspection is made; 2) the inspection is necessary to further the regulatory scheme; and 3) the certainty and regularity of inspections adequately put the property owner on notice that the property will be subject to inspection. [Burger test] Analysis: NYC satisfies Burger. City has interest in safety of food quality and restaurant patrons from secondhand smoke; advance knowledge of inspections would allow temporary remedial measures; and law explicitly puts food service establishments on notice that they will be subject to inspections to monitor for compliance with smoking ban. Holding: Players loses; NYC inspections do not violate Fourth Amendment

44 Liquormart, Inc. v. Rhode Island (SCOTUS 1996) Case Briefing

Facts: RI legislature enacted two prohibitions against advertising the retail price of alcoholic beverages. The first prohibits vendors from advertising in any manner whatsoever the price offered for sale (except for price tags or signs displayed with merchandise within licensed premises and not visible from the street); the second prohibits publication or broadcast of any advertisements—even those referring to sales in other states—that make reference to the price of alcoholic beverages. Issue: Whether RI's ban on advertising prices of alcoholic beverages violates the First Amendment protections for commercial speech. Rule: A state regulation banning truthful, non-misleading commercial information must meet the four prongs of Central Hudson and Court will review with "special care"; at issue here, #3) state must show that regulation will advance its interest to a material degree; and # 4) restriction must be no more extensive than necessary. Analysis: RI provided no factual/evidentiary support to show that restrictions would significantly reduce alcohol consumption (e.g., would not reduce alcohol consumption to a material degree) [failed CH#3] and there were less restrictive alternatives available to achieve these means [failed CH #4]. Holding: RI restrictions violate First Amendment

What is preemption?

Federal law does not allow state to regulate in a certain area

What is HIPAA?

Federal law governing the handing of protected health information

What is federal preemption?

Federal laws/regulations can invalidate state and local laws, regulations, rules and lawsuits, even if state is acting squarely within its police powers.

Zucht v. King Case Briefing

Facts: Rosalyn Zucht excluded from school b/c she did not have a certificate of vaccination as required for admittance to school under local ordinance and refused to be vaccinated. Procedure: Zucht sued public officials in state civil court to stop enforcement of the ordinance and to compel officials to admit her to school without vaccination. Issue: 1) Does the mandatory vaccination requirements deprive Zucht of her liberty without due process? 2) Does the law delegate improper authority to the local board of health? 3) Does the law violate the EPC? Rule: : 1) States may require compulsory vaccination under their police powers; 2) States may delegate enforcement of public health laws to local health officials; 3) States may make reasonable classifications in the exercise of their police power without violating the EPC. Analysis: States may use police power to require vaccinations for school admittance under and may delegate authority to carry out such laws to local government officials. The ordinance did not confer arbitrary power on gov't but gives broad discretion to carry out laws for public's health. Law does not violate EPC—permissible for states to make reasonable classifications (here, school children/age) that embrace only a segment of the population under police powers. Holding: Zucht loses, compulsory vaccination requirements are upheld.

In Re Washington (Sup. Ct. Wisc. 2007) Case Briefing

Facts: Ruby Washington, a homeless woman with TB, was put in jail (civil confinement) because she failed to comply with TB therapy. Court found she was a "huge health risk" and refused to place Washington in a hospital under guard instead of jail. Issue: Does the Wisconsin Court have authority under the state TB statute to confine TB patients to jail for failure to adhere to treatment? Rule: Where no less restrictive alternative exists, jail is a permissible placement option for persons with TB who are noncompliant with treatment, provided the jail provides proper care and medical treatment and prevents the spread of disease. [rule comes from state statute] Analysis: "No less restrictive alternative" applies to both the fact and place of confinement. Washington was at risk of developing more dangerous, drug-resistant TB; testimony that if she were to escape custody she would be infectious within a week to a month; has history of disappearing. Medical facility would not be equipped to handle Washington; added security of jail necessary to ensure she completes treatment. Holding: Washington must stay in jail; civil confinement for TB is permissible under statute.

In Re Washington Case Briefing

Facts: Ruby Washington, a homeless woman with TB, was put in jail (civil confinement) because she failed to comply with TB therapy. Court found she was a "huge health risk" and refused to place Washington in a hospital under guard instead of jail. Procedure: Washington appeals civil confinement in state court. Issue: Does the Wisconsin Court have authority under the state TB statute to confine TB patients to jail for failure to adhere to treatment? Rule: Where no less restrictive alternative exists, jail is a permissible placement option for persons with TB who are noncompliant with treatment, provided the jail provides proper care and medical treatment and prevents the spread of disease. [rule comes from state statute] Analysis: "No less restrictive alternative" applies to both the fact and place of confinement. Washington was at risk of developing more dangerous, drug-resistant TB; testimony that if she were to escape custody she would be infectious within a week to a month; has history of disappearing. Medical facility would not be equipped to handle Washington; added security of jail necessary to ensure she completes treatment. Holding: Washington must stay in jail; civil confinement for TB is permissible under statute.

Jew Ho v. Williamson (Circuit Court, N.D. Cal., 1900) Case Briefing

Facts: San Francisco Board of Health adopted a resolution authorizing quarantine of 12 city blocks known as Chinatown after nine people in the area die of bubonic plague. Resident of the area sued, claiming the regulation was being enforced only against the Chinese and not other races. Issue: Did the city's enactment of the quarantine exceed its police powers and thus violate the 14th Amendment rights (SDP and EPC) of the inhabitants of Chinatown? Rule: Regulations must be reasonable to accomplishes the purposes sought and must not be administered in a discriminatory manner ("with an evil eye and an unequal hand"). Analysis: States may enact reasonable regulations through their police powers to protect people from infectious disease. However, this 12-block quarantine is clearly an ineffective method at preventing spread of disease because people can move freely within boundaries; also discriminatory because applied only to Chinese residents. Holding: San Francisco law struck down as violating the 14th Amendment.

Jew Ho v. Williamson Case Briefing (Circuit Court, N.D., Cal., 1900)

Facts: San Francisco Board of Health adopted a resolution authorizing quarantine of 12 city blocks known as Chinatown after nine people in the area die of bubonic plague. Resident of the area sued, claiming the regulation was being enforced only against the Chinese and not other races. Issue: Did the city's enactment of the quarantine exceed its police powers and thus violate the 14th Amendment rights (SDP and EPC) of the inhabitants of Chinatown? Rule: Regulations must be reasonable to accomplish the purposes sought and must not be administered in a discriminatory manner ("with an evil eye and an unequal hand"). Analysis: States may enact reasonable regulations through their police powers to protect people from infectious disease. However, this 12-block quarantine is clearly an ineffective method at preventing spread of disease because people can move freely within boundaries; also discriminatory because applied only to Chinese residents. Holding: San Francisco law struck down as violating the 14th Amendment.

Coreali v. Axelrod Case Briefing

Facts: Sec 225(5)(a) of the Public Health Law authorizes NY Public Health Council (PHC) to "deal with any matters affecting the...public health". NY PHC issued regulations prohibiting smoking in certain public spaces after NY legislature failed to pass similar legislation. Procedure: Restaurant owner (Boreali) sued State Health Commissioner (Axelrod) and the PHC in state (civil) court. Issue: 1) Whether NY legislature can grant the PHC broad authority over public health in the first instance; 2) Whether the PHC had authority to issue smoking regulations under its broad enabling statute when legislature failed to pass similar legislation. Rule: Agencies do not have authority under broad enabling statutes to issue regs making legislative policy choices. However facially broad a grant of authority, it must be construed so that it is no broader than what Nondelegation Doctrine would permit. Analysis: NY's broad grant of authority to the PHC is not itself unconstitutional. But, PHC improperly assumed a legislative policy function in issuing regs; 3 factors demonstrate this: 1) agency engaged in weighing social cost vs. public health in determining exemptions for certain entities; 2) acted without legislative guidance and "wrote on a clean slate," and 3) acted on issue where legislature had tried and failed. Holding: PHC did not have authority to issue regs; Boreali wins.

New York v. United States Case Briefing (505 U.S. 144 [1992])

Facts: The Low-Level Radioactive Waste Management Act Amendments of 1985 required states to dispose of radioactive waste within their borders. Act offered series of three incentives for states to comply with the Act, including a "take title" provision (requiring states to assume liability for waste generated within their borders if they failed to arrange for disposal of waste). NY filed suit against the federal government, questioning the authority of Congress to direct states to regulate radioactive waste management. Issue: Can Congress require states to enact and enforce a federal regulatory program? Rule: Congress has the power to regulate individuals, not states. Congress cannot commandeer state legislatures to act according to federal standards. Analysis: Although regulating radioactive waste is generally within Congress' Commerce Clause authority and giving states incentives to encourage them to dispose of waste is generally within Congress' spending power, the "take title" clause violates 10th Amendment principles by commandeering the States' legislative processes and directly compelling states to enact and enforce a federal regulatory program. Holding: The take title provision exceeds Congress' authority in violation of the 10th Amendment.

Aakjer v. City of Myrtle Beach Case Briefing

Facts: The city of Myrtle Beach enacted a number of ordinances in response to various concerns stemming from motorcycle rallies (e.g. rowdy behavior, burden on local police. Ordinance 2008-64 required motorcycle riders to wear a protective helmet and eyewear (the Helmet Ordinance). Petitioners were each cited for violating the Helmet Ordinance by failing to wear the requisite helmet and eyewear. Petitioners seek declaratory judgment that motorcycle ordinances are invalid in light of state motorcycle helmet and eyewear requirements. Issue: Whether state law preempts the City's Helmet Ordinance. Rule: A local ordinance is preempted by state law under implied field preemption when the state regulatory scheme so thoroughly covers the subject area so as to occupy the field or when the subject mandates statewide uniformity. Analysis: The state law requires all riders under age 21 to wear a protective goggles/face shield. Myrtle Beach's ordinance, in contrast, requires ALL riders to wear protective gear regardless of age. In matters of regulating motorcyclists, there is a need for uniformity. Local motorists cannot be expected to familiarize themselves and comply with various local ordinances. "Such burdens would unduly limit a citizen's freedom of movement throughout the State. " Holding: Petitioners (motorcyclists) win. The City Ordinance is invalid because it is preempted by state laws governing a subject area that requires statewide uniformity.

International Dairy Foods Assoc. v. Amestoy (2nd Circuit Federal Cirtcuit, 1996) Case Briefing

Facts: Vermont passed law requiring retailers to label milk products indicating whether cows were treated with rBST. FDA had previously declined to require labeling, finding that dairy products from herds treated with rBST are indistinguishable from products from untreated herds. Issue: Whether Vermont's law requiring milk labeling for products with rBST solely for the purpose of consumer curiosity violates the First Amendment speech rights. Rule: Government regulation compelling commercial speech solely to address consumer curiosity must pass the four-part Central Hudson test; at issue here, CH#2) the government's interest must be substantial. Analysis: Vermont states that it's purpose behind the law is to provide consumers with information; it does not argue that it would protect the public's health, as there is no evidence to support this point. The demand for consumer information is inadequate to compel commercial speech. "Were consumer interest alone sufficient, there is no end to the information that states could require manufacturers to disclose about their production methods." Holding: Vermont law is struck down; does not meet Central Hudson #2 Dissent: Policy of First Amendment re commercial speech is the flow of accurate, relevant information; this is exactly what VT was trying to do and what Ct decided was unconstitutional.

Washington v. Glucksburg Case Briefing (U.S. Supreme Court, 1996)

Facts: Washington physicians and terminally ill patients brought suit challenging Washington's ban on physician-assisted suicide, which imposed criminal penalties for doctors; claimed they had a 14th Amendment liberty interest in choosing to die. Issue: 1) Whether the right to die is a fundamental right subject to heightened scrutiny; and 2) Whether Washington's ban on physician assisted-suicide violates the Fourteenth Amendment's Due Process Clause by denying competent terminally ill adults the liberty to choose death over life. Rule: 1) In determining whether an asserted liberty interest is a fundamental right subject to heightened scrutiny, the court will require a careful description of the asserted right, and whether that asserted right is deeply rooted in the nation's history and traditions. 2) Where a law does not impinge of fundamental rights, the law must be rationally related to a legitimate government interest. Analysis: The right asserted is not "the right to die" but rather the right to assisted suicide; this is not a fundamental liberty interest protected by the Due Process Clause since its practice has been, and continues to be, offensive to our national traditions and practices. Moreover, employing a rationality test, Washington's ban was rationally related to the state's legitimate interest in protecting medical ethics, shielding disabled and terminally ill people from prejudice which might encourage them to end their lives, and the preservation of human life. Holding: Washington ban upheld.

Gonzalez v. Oregon Case Briefing

Facts: •OR legalized assisted suicide (1994), allowing docs to prescribe lethal doses of drugs for terminally-ill patients without facing criminal or civil liability. 1971 U.S. AG rule under the CSA says all prescriptions for controlled substances must be for "legitimate medical purpose." 2001 U.S. AG interpretive rule says using controlled substances to assist suicide is not a "LMP" and prescriptions for this purpose are unlawful. Procedural History: Oregon and few state residents sued U.S. AG in federal (civil) court Issue: Whether the AG acted within the scope of his authority in promulgating the rule; whether rule is valid under CSA. Is an interpretive rule entitled to Chevron deference? Rule: Courts will not defer to agency interpretation of ambiguous regs or statute where Congress has not given agency power to do so (Chevron Exception #1). Agency may be entitled to deference, but only to the extent that the Agency's action is "persuasive". Analysis: The CSA does not grant the AG authority to make an interpretive rule of meaning of "legitimate medical purpose" so no Chevron deference; AG's rule is not persuasive under Skidmore test b/c AG lacks expertise in this area and did not consult with anyone outside DOJ to form a reasoned judgment. Holding: AG had no authority to make statutory interpretation and rule is not valid; Oregon wins.

What is a negligent tort?

Failure to exercise the care toward others that a reasonable person would use in the same circumstances, or taking action that such a reasonable person would not, resulting in unintentional harm to another

What is the Takings Clause?

Fifth Amendment: Limits scope of eminent domain power: "...nor shall private property be taken for public use, without just compensation." "Public use" constraint: Ensures that government does not abuse eminent domain power by confiscating property solely for the benefit a private party. "Just compensation" constraint: Ensures that individuals do not have to bear public burdens that the community should share as a whole.

What is compelled commercial speech?

First Amendment constrains the government both from restricting speech, and from requiring individuals/businesses to speak at all! When can the government require a business to disclose information about a service or product offered?

What are strict liability torts/strict product liability?

For some extremely risky/dangerous behaviors and many products, defendant can be held liable for damages without plaintiff having to demonstrate culpability/fault

What is implied preemption?

Happens when a court finds that a law is preemptive even in the absence of an express preemption clause (field preemption and conflict preemption)

Under HIPAA, who are covered entities?

Health plans, healthcare providers, health clearinghouses (and business associates of cov. entities)

What is the issue/rule put forth in New York v. United States?

Issue: Can Congress require states to enact and enforce a federal regulatory program? Rule: Congress has the power to regulate individuals, not states. Congress cannot commandeer state legislatures to act according to federal standards.

Summary of the Workman v. Mingo Board of Education (4th Circuit, 2011) Case

Held that W.V. mandatory vaccination law which provides no religious exemptions for school children: 1) Did not violate First Amendment Free Exercise rights b/c preventing spread of communicable disease is a compelling state interest (citing , Jacobson, Boone v. Boozman) 2) Did not violate EPC by not providing a religious exemption; states may make reasonable classifications in the exercise of their police powers (citing Zucht v. King) 3) Did not violate SDP right to do what's best for her child because the law was rationally related to a legitimate gov't objective. Strict scrutiny not used here--"a parent's right to refuse to have her child immunized before attending public or private school where immunization is a precondition to attending school is not a fundamental right [entitled to strict scrutiny review]" (citing Boone v. Boozman).

What is contact tracing?

Identification and diagnosis of persons who may have come into contact with an infected person. 1.) For sexually transmitted diseases, generally limited to sexual partners 2.) For highly virulent diseases such as Ebola and tuberculosis, a thorough contact tracing would require information regarding casual contacts. 3.) Statutes may authorize state or local public health agencies to locate sexual or other contacts who may have been exposed to infection/disease

The use of health information for surveillance must be balanced against _____ _____

Individual privacy Pub Health agencies cannot avert health threats w/o a system of early detection and continuous monitoring... Yet infringing too much on privacy could reduce the public's willingness to seek medical care or cooperate with public health authorities

Under HIPAA, what is protected health information (PHI)

Individually identifiable health data that is transmitted or maintained in electronic form

Public and private rights of action for nuisance abatement.

Individuals in private actions must demonstrate injury different from the harm suffered by the public in general.

What is self-regulation?

Industry chooses to adopt voluntary standards

What is self-policing?

Industry itself is responsible for ensuring regulatory compliance

What are the two primary types of rulemaking?

Informal rulemaking (notice and comment) Formal rulemaking (rulemaking on the record)

What are the three major categories of tort law?

Intentional Torts Negligent Torts Strict Liability Torts/Strict Product Liability

How do we examine Free Exercise Clause challenges?

Is the law at issue a valid and neutral law of general applicability? a.) Yes: The right of free exercise does not relieve an individual of the obligation to comply with a "valid and neutral law of general applicability." Individual must comply with the law if it is reasonably related to a legitimate government interest. b.) No: Government must justify any substantial burden on religiously motivated conduct by a compelling government interest and by means narrowly tailored to achieve that interest (strict scrutiny).

How do we examine Establishment Clause challenges?

Is the law discriminatory (treats different religious denominations differently)? a.) If yes, apply strict scrutiny b.) If no: apply the 3-part Lemon Test to determine whether the law is constitutional under the Establishment Clause: 1.) The law must have a secular (not religious) legislative purpose; 2.) The law's principal or primary effect must be one that neither advances nor inhibits religion; and 3.) The law must not foster an excessive government entanglement with religion.

What is the issue/rule put forth in Boone v. Boozman?

Issue: 1) Are Mom's religious beliefs entitled to protection under the First Amendment? 2) Does exemption violate Est. Clause? 3) Does exemption violate Free Exercise Clause? 4) Does compulsory vaccination requirement [minus exemption] violate the Free Exercise Clause? 5) Does the compulsory vaccination requirement violate liberty interests under the Due Process Clause of the Fourteenth Amendment? Rule: 1) First Amendment provides protection for sincerely held religious beliefs; 2) Law violates Est. Clause when it has the purpose or effect of advancing or inhibiting religion and results in unnecessary government entanglement with religion [ Test]; 3) Law violates Free Exercise Clause when protects free exercise rights of some individuals and inhibits FE rights of others on an arbitrary basis; 4) Laws of neutral and general applicability do not violate the Free Exercise clause; 5) A state may enact reasonable regulations to protect the public's health pursuant to its police power, even if such rights infringe on the right to Free Exercise or liberty interests under Due Process.

What is the issue/rule put forth in Brown v. Stone?

Issue: 1) Does Miss. mandatory school vaccination law violate the Free Exercise Clause? 2) Does Miss. religious exemption violate the EPC? Rule: 1) The Free Exercise clause is not violated where the state has an overriding and compelling interest in protecting the public's safety, morals, and health; 2) A law violates the EPC where it treats people of a certain religious denomination differently and does not serve a compelling government interest

What is the issue/rule put forth in Zucht v. King?

Issue: 1) Does the mandatory vaccination requirements deprive Zucht of her liberty without due process? 2) Does the law delegate improper authority to the local board of health? 3) Does the law violate the EPC? Rule: : 1) States may require compulsory vaccination under their police powers; 2) States may delegate enforcement of public health laws to local health officials; 3) States may make reasonable classifications in the exercise of their police power without violating the EPC.

What is the issue/rule put forth in Boreali v. Axelrod?

Issue: 1) Whether NY legislature can grant the PHC broad authority over public health in the first instance; 2) Whether the PHC had authority to issue smoking regulations under its broad enabling statute when legislature failed to pass similar legislation. Rule: Agencies do not have authority under broad enabling statutes to issue regs making legislative policy choices. However facially broad a grant of authority, it must be construed so that it is no broader than what Nondelegation Doctrine would permit.

What is the issue/rule put forth in Washington v. Glucksburg

Issue: 1) Whether the right to die is a fundamental right subject to heightened scrutiny; and 2) Whether Washington's ban on physician assisted-suicide violates the Fourteenth Amendment's Due Process Clause by denying competent terminally ill adults the liberty to choose death over life. Rule: 1) In determining whether an asserted liberty interest is a fundamental right subject to heightened scrutiny, the court will require a careful description of the asserted right, and whether that asserted right is deeply rooted in the nation's history and traditions. 2) Where a law does not impinge of fundamental rights, the law must be rationally related to a legitimate government interest.

What is procedural due process?

Requires government to provide a fair process before depriving persons of life, liberty or property

What is the issue/rule put forth in South Dakota v. Dole?

Issue: Did Congress exceed its spending powers by conditioning the award of federal highway funds on the states' adoption of a minimum drinking age? Rule: Congress may attach conditions to federal spending so long as the exercise of the spending power is: (1) in pursuit of the general welfare; (2) unambiguous; (3) related to the federal interest at issue; and (4) not unduly coercive.

What is the issue/rule put forward in Jacobson v. Massachusetts?

Issue: Did the Cambridge mandatory vaccination laws/Mass. statute violate Jacobson's constitutional rights of due process, equal protection, [and privileges or immunities] clauses of the 14th Amendment? Rule: Public health regulations are constitutionally permissible only if 1) they are necessary to prevent an avoidable harm; 2) they have a real or substantial relation to protection of public health; 3) burdens imposed are not wholly disproportionate to the expected benefit; and 4) they do not pose an undue health risk to the subjects of the regulation.

What is the issue/rule put forth in Jew Ho v. Williamson

Issue: Did the city's enactment of the quarantine exceed its police powers and thus violate the 14th Amendment rights (SDP and EPC) of the inhabitants of Chinatown? Rule: Regulations must be reasonable to accomplishes the purposes sought and must not be administered in a discriminatory manner ("with an evil eye and an unequal hand").

What is the issue/rule put forth in Jew Ho v. Williamson?

Issue: Did the city's enactment of the quarantine exceed its police powers and thus violate the 14th Amendment rights (SDP and EPC) of the inhabitants of Chinatown? Rule: Regulations must be reasonable to accomplish the purposes sought and must not be administered in a discriminatory manner ("with an evil eye and an unequal hand").

What is the issue/rule put forth in Gonzalez v. Raich?

Issue: Does "Congress's power to regulate interstate markets for medicinal substances encompass[] the portions of those markets that are supplied with drugs produced and consumed locally"? Rule: Congress may regulate intrastate activity if Congress has a rational basis for believing the activity substantially affects interstate commerce (hint: think about the aggregate effects of the state law—intrastate activity may substantially affect interstate commerce if, in the aggregate, the law undercuts efforts to regulate interstate markets).

What issue/rule was put forth in Lucas v. South Carolina Coastal Council?

Issue: Does a government regulation the renders property valueless constitute a taking requiring just compensation? Rule: Just compensation is required under the takings clause when a government regulation deprives a property owner of all economically beneficial or productive use of the property; a case specific inquiry into the government's interest is not required [per se categorical taking].

What is the issue and holding put forth in DeShaney v. Winnebago?

Issue: Does substantive due process place an affirmative obligation on states to protect their citizens from private actors? Does a duty arise if a special relationship exists? Rule: Constitution does not place an affirmative obligation on states to protect their citizens from private actors. No duty arises unless state:(1)takes person into its custody; or (2) state action created/increased the harm.

What is the issue/rule put forth in Ferguson v. City of Charleston?

Issue: Does the City's policy fall within the "special needs" doctrine such that the hospital can test pregnant patients for drug use without a warrant and probable cause, and without the patient's consent? Rule: Where the gov't has special needs beyond law enforcement in conducting biological screening/testing, the gov't does not need to obtain a warrant and have probable cause under the Fourth Amendment so long as the government's interest outweighs the individual's privacy interests.

What is the issue/rule put forth in US v. Lopez?

Issue: Does the Gun Free School Zones Act exceed Congress' power under the Commerce Clause? Does a federal law prohibiting gun possession within a school zone regulate an activity that substantially affects interstate commerce? Rule: To be a valid exercise of Congress's commerce power, the statute must regulate either (1) the channels of interstate commerce; (2) the instrumentalities of interstate commerce; or (3) activities that have a substantial relationship to interstate commerce

What is the issue/rule put forth in Camara v. Municipal Court of the City and County of San Francisco?

Issue: Does the SF ordinance allowing for warrantless inspections of private residences violate the Fourth Amendment (Fourteenth not discussed)? Rule: The Fourth Amendment requires that the government obtain a warrant based on probable cause to conduct routine public health and safety inspections of private residences; in such cases the government may justify the probable cause and reasonableness of an inspection based on a valid public interest in protecting the public's health and safety.

What is the issue/rule put forth in Dent v. West Virginia?

Issue: Does the WV statute requiring a license to practice medicine based on one of three criteria measuring the applicant's qualifications deprive Dent of his liberty to engage in a profession of his choice without due process under the Fourteenth Amendment? Rule: 1) States may use their police power to require licenses to practice medicine, and may condition licensing on meeting certain criteria that the state deems necessary to demonstrate the individual's qualifications so long as the criteria are related to the profession and are reasonably attainable; 2) State licensing statutes do not violate due process if they are of general applicability, impose readily obtainable conditions, and are enforceable through usual modes of administrative action.

What is the issue/rule put forth in In Re Washington?

Issue: Does the Wisconsin Court have authority under the state TB statute to confine TB patients to jail for failure to adhere to treatment? Rule: Where no less restrictive alternative exists, jail is a permissible placement option for persons with TB who are noncompliant with treatment, provided the jail provides proper care and medical treatment and prevents the spread of disease. [rule comes from state statute]

What is the issue/rule put forth in Castle Rock v. Gonzalez?

Issue: Does the state law regarding protection from private actors create a property interest for purposes of the due process clause of the 14th Amendment? Holding: To have a 14th amendment-protected "property interest," an individual must have a legitimate claim of entitlement to that property interest. Even if a law grants a specific entitlement, it is not necessarily a "property interest" triggering 14th amendment protection.

What is the issue/rule put forth in Ex Parte Company?

Issue: Is testing and quarantine of people "reasonably suspected" of VD constitutional? Rule: States have police power authority to restrain persons and property to secure the public's health and safety without violating due process; quarantine [isolation] of persons infected with contagious STDs is a permissible use of the state's police power to protect the public's health.

What is the issue/rule put forth in Lochner v. New York?

Issue: Is the NY law an unreasonable, unnecessary, and arbitrary interference with Lochner's "right to labor" (liberty) or the "right to contract" under 14th Amendment due process or the Article I contracts clause? Rule: Public health regulation pursuant to a state's police powers may not interfere with individual liberty or contract rights unless it is directly related to an appropriate and legitimate state interest.

What is the issue/rule put forth in Whalen v. Roe?

Issue: May a State retain the names and address of all people who have obtained prescriptions for Schedule II drugs without violating the due process clause of the 14th Amendment? Rule: There is a narrow right to privacy under 14th amendment, but a statutorily-required disclosure of health information does not constitute a violation of this constitutional right to privacy if the state has in place adequate safeguards

What is the issue/rule put forth in Kirk v. Wyman?

Issue: Was Kirk's detention constitutional? Was isolating Ms. Kirk a "necessary" to protect the public? Rule: (1) Isolation is not unconstitutional if it's necessary to protect others. (2) States giving this power to local boards of health is reasonable exercise of police power. (3) Power can't be arbitrary - must be reasonably necessary, and include notice. (4) Must be subject to judicial review. (5) Court must see if there is a "real relation" between public health and the action

What was the issue/rule put forth in City of Cleburne v. Cleburne Living Center?

Issue: Was the City's denial of the group home permit a violation of the Equal Protection Clause of the 14th Amendment? Rule: A law/government action that distinguishes among similarly situated groups that are not suspect or quasi-suspect classes (mentally disabled and others), must be rationally related to achieve a legitimate government objective.

What is the issue/rule put forth in Daubert v. Merrell Dow Chemical?

Issue: What is the standard of evidence for admitting expert scientific testimony in a federal trial? How should judges determine if scientific evidence is admissible and sufficient to show causation? Rule: Federal Rules of Evidence supersede Frye test in federal court. All scientific testimony/evidence admitted in court must be (1) Reliable, and (2) Relevant. Reliability: 4 factors to assess reliability of scientific evidence: (i) testing; (ii) peer review; (iii) error rate; (iv) general acceptance. Relevance: If scientific, technical or other specialized knowledge will assist judge/jury to understand the evidence or to determine a fact in issue, a qualified expert may testify

What is the issue/rule put forth in FDA v. B&W Tobacco Corp?

Issue: Whether Congress intended to give the FDA the authority to regulate tobacco products. Rule: Where Congress has directly spoken to an issue, an agency cannot form a different judgment and a court will not give deference to the agency's contradictory actions. (Chevron Step 1/Chevron Exception #2)

What is the issue/rule put forth in Massachusetts v. EPA?

Issue: Whether EPA acted arbitrarily and capriciously (i.e., without reason) in deciding not to regulate greenhouse gas emissions from new motor vehicles under the CAA. Rule: A court may reverse an agency's decision not to issue a rulemaking where the action was arbitrary and capricious (rule comes from the CAA itself)

What is the issue/rule put forth in Greene v. Edwards?

Issue: Whether Greene's confinement for TB under the WV law violates his procedural due process rights where he did not have access to counsel until immediately before the hearing. Rule: Due process for involuntary commitment requires 1) adequate written notice with grounds and facts for commitment; 2) right to counsel; 3) right to be present, cross-examine, confront and present witnesses; 4) clear and convincing standard of proof; and 5) right to transcript.

What is the issue/rule put forth in Greene v. Edwards?

Issue: Whether Greene's confinement for TB under the WV law violates his procedural due process rights where he did not have access to counsel until immediately before the hearing. Rule: Due process for involuntary commitment requires 1) adequate written notice with grounds and facts for commitment; 2) right to counsel; 3) right to be present, cross-examine, confront and present witnesses; 4) clear and convincing standard of proof; and 5) right to transcript.

What is the issue/rule put forth in New York v. New St. Mark's Bath?

Issue: Whether NYC's closing of the bathhouse as a public nuisance violates bathhouse patrons' right to privacy of sexual activity and freedom of association. Rule: A state may act through its police power to abate a public nuisance, where such abatement would infringe on one's freedom of association, if it has a compelling interest in acting to protect the public's health and the remedy and abatement is the least intrusive measure reasonably available [strict scrutiny].

What is the issue/rule put forth in Players, Inc. v. City of New York?

Issue: Whether NYC's smoking ban law violates the Fourth Amendment by allowing warrantless inspections of a private social club that provides food service to monitor compliance with the ban Rule: Warrantless inspections of "closely regulated businesses" such as food service establishments do not violate the Fourth Amendment if 1) there is a substantial government interest that informs the regulatory scheme pursuant to which the inspection is made; 2) the inspection is necessary to further the regulatory scheme; and 3) the certainty and regularity of inspections adequately put the property owner on notice that the property will be subject to inspection. [Burger test]

What is the issue/rule put forth in 44 Liquormart, Inc. v. Rhode Island

Issue: Whether RI's ban on advertising prices of alcoholic beverages violates the First Amendment protections for commercial speech. Rule: A state regulation banning truthful, non-misleading commercial information must meet the four prongs of Central Hudson and Court will review with "special care"; at issue here, #3) state must show that regulation will advance its interest to a material degree; and # 4) restriction must be no more extensive than necessary.

What is the issue/rule put forth in New York State Restaurant Association v. NYC Board of Health?

Issue: Whether a government regulation requiring compelled menu labeling violates the First Amendment Rule: Regulations that require disclosure of factual and uncontroversial commercial information are subject to more lenient review than prohibitions or restrictions on commercial speech, and need only be reasonably related to the State's interest in preventing deception of consumers (Zauderer/Sorrell rule).

What is the issue/rule put forth in City of New York v. Antoinette R.?

Issue: Whether confinement of a patient for TB treatment under the NYC statute violates due process. Rule: Involuntary detention of an individual is permissible: (1) where state officials can show "clear and convincing" evidence that the individual poses a health risk if they remain in less a restrictive environment; and (2) procedural due process safeguards are observed.

What is the issue and rule put forth in Aakjer v. City of Myrtle Beach?

Issue: Whether state law preempts the City's Helmet Ordinance. Rule: A local ordinance is preempted by state law under implied field preemption when the state regulatory scheme so thoroughly covers the subject area so as to occupy the field or when the subject mandates statewide uniformity.

What are the issue/rule put forth in Gonzalez v. Oregon?

Issue: Whether the AG acted within the scope of his authority in promulgating the rule; whether rule is valid under CSA. Is an interpretive rule entitled to Chevron deference? Rule: Courts will not defer to agency interpretation of ambiguous regs or statute where Congress has not given agency power to do so (Chevron Exception #1). Agency may be entitled to deference, but only to the extent that the Agency's action is "persuasive".

What is the issue/rule put forth in Kelo v. City of New London?

Issue: Whether the City's condemnation of Kelo's property with just compensation for purposes of economic revitalization, where some land would be used for private purposes, constitutes a permissible "public use" under the Fifth Amendment takings clause. Rule: A state may transfer property from one private party to another if the purpose of the taking is for future "use by the public" and serves a "public purpose."

What is the issue/rule put forth in Geier v. American Honda Company (2000)

Issue: Whether the National Traffic and Motor Vehicle Safety Act, and the standard for passive restraints that is imposed on car manufacturers, can preempt a state common law tort action, even though Congress did not specify its intent of preemption when passing the Act? Rule: If a state law stands as an obstacle to the accomplishment and execution of the important objectives of a federal statute, it is pre-empted

Explain equal protection (facial classification)

Law expressly makes a distinction among persons or groups

What are the four elements of a negligence case? Plaintiff must prove each element by preponderance of the evidence to succeed on negligence claim

Legal duty of care, breach of duty, causation, damages (actual loss/harm to plaintiff)

The federal government is a government of...

Limited power

What are the two different types of tests for regulatory takings?

Per se (Lucas) Penn Central balancing test

Under HIPAA, what is individually identifiable information?

Person can be identified either by information contained in the record or by other information available t o record holder

What is the 10th Amendment?

Plenary power reserved by sovereign states. "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

What is Eminent Domain?

Power of government to confiscate private property for government purpose.

Frameworks for Global Health Security

Pre-1851 o Evolving Trade o Rise of State Sovereignty o Poor understanding of disease 1851-1948 o Expanded trade and migration o Rise of conference diplomacy o New understanding of disease spread 1948-2005 o Rapid trade and travel o Intense multilateralism o Effective public health interventions 2005 o Interdependent economies o Proliferation of actors and institutions o Diffusion of advanced technologies

What falls under property interests?

Property: Examples: Real property (land, house, building), business and professional property (i.e., licenses, permits), welfare benefits; certain benefits where person has "legitimate claim of entitlement" Entitlement is measured by the importance of the interest to the person's life, usually has monetary value

What is parens patriae power?

Protecting the interests of minors and incompetent persons.

What is Procedural Due Process?

Protects individuals from coercive power of government by ensuring that adjudication processes/procedures are fair and impartial (e.g., the right to sufficient notice, the right to an impartial arbiter, the right to give testimony and admit relevant evidence at hearings, etc.). Not examining whether the underlying law is Constitutional; looking at whether the processes by which that law is enforced are Constitutional under the 14th amendment.

What is Substantive Due Process?

Protects individuals from state laws/actions/policies that exceed the limits of governmental authority under the Constitution. Regardless of how fair the process of enforcing government action/policy is, gov't cannot act in a way that limits life/liberty/property in violation of the 14th Am. (we'll spend much of the semester thinking about what gov't can and cannot do under the 14th Amendment!)

What is equal protection?

Provides protection from government action that discriminates among different persons or groups Requires that government treat like cases alike, but permits government to treat unlike cases differently: Do public health authorities have a valid reason for distinguishing among people, and if so, how substantial is that reason?

What is public health?

Public health is what we, as a society, do collectively to assure the conditions for people to be healthy.

Examples of public health practice v. human subjects research

Public health practice: 1.) High schools reporting viral meningitis incidence to local public health department for surveillance purposes 2.) Childhood immunization study using birth certificates to determine immunization rates in community to direct program planning and education Human subjects research: 1.) Study of high school students with viral meningitis and several unaffected classmates to identify associated risk factors 2.) Double-blind randomized control study on new childhood vaccine to determine effectiveness of one dose of vaccine vs. two doses

What is the difference between public health practice v. human subjects research?

Public health practice: a.) Surveillance, epidemiology, reporting, monitoring b.) Historic and constitutionally recognized exercise of state c.) Specific legal authorization d.) Direct performance, oversight by PH officials and accountability to the public e.) May involve persons who did not volunteer (no informed consent required) f.) PH practitioner intends primarily to prevent or control disease, not intended to contribute to general knowledge g.) Supported by principles of pub health ethics that focus on populations while respecting dignity of individuals Human subjects research: a.) Research on living individuals b.) Researcher obtains data on a human subject (1) through intervention or interaction; or (2) individually-identifiable health information (e.g. from a chart review) c.) Fed/state/local laws governing research can require extensive procedures and burdens (IRB review, consent etc) - Common rule d.) Research subjects volunteer to participate and give their informed consent e.) PH researcher intends to generate new info with relevance beyond her particular study/program f.) Supported by principles of research ethics that focus on interests of individuals while balancing the communal value of research

What are the three levels of review for due process/equal protection cases?

Rational Basis, Intermediate Scrutiny, Strict Scrutiny

For compelled commercial speech: which test do we use?

Recent tobacco cases demonstrate uncertainty over appropriate standard 1.) But for now... a.) When the purpose of the compelled commercial disclosure is to provide purely factual and uncontroversial commercial information (e.g., calorie counts on menus, text warnings on cigarette packages re proven health effects of smoking), use Zauderer rational basis standard (Sorrell/NYSRA v. NYC BOH): i.) The government's disclosure requirement must bear a rational connection to its purpose. ii.) ***But note: DC Cir. (RJ Reynolds v. FDA) would limit Zauderer only to those situations where the government regulation is requiring business to correct for previous deceptive advertising. 2.) When the purpose of the compelled commercial disclosure is solely for the purpose of satisfying consumer curiosity, or requires commercial disclosures that may not be purely factual and uncontroversial, apply Central Hudson (Int'l Dairy v. Amestoy)

What is the nonaggregative understanding of public goods?

Recognizes that everyone benefits from living in a society that regulates the risks shared by all Law designed to promote the common good may sometimes constrain individual actions People may have to forgo some self interest in exchange for the protection and satisfaction gained from sustaining healthier and safer communities

Federal agencies establish...

Regulations/rules and oversight/enforcement

Is there a right to refuse medical treatment?

Right is not absolute: Court uses a balancing test that weighs personal liberty against state interests. Treatment usually upheld if "reasonably necessary to safeguard the population." State interest must be "essential" or "overriding" to overcome individual liberty interest.

What are the three powers of executive agencies?

Rulemaking (legislative): power to issue regulations Enforcemement (executive): power to enforce regulations through inspections, monitoring compliance, and sanctioning offenders Adjudication (judicial): power to adjudicate disputes over agency-related issues; may be formal (hearing) or informal (decision based on documents submitted to the agency)

What is SCOTUS' view on compulsory treatment?

SCOTUS has recognized constitutionally protected liberty interest/right to bodily integrity (due process) in refusing unwanted medical treatment. Leading case is Cruzan v. Director, Missouri Department of Health (U.S. 1990). BUT Cruzan " left many questions unresolved.... did not articulate a level of scrutiny to be used in evaluating government regulation of personal decisions concerning refusal of medical treatment. Although the majority opinion recognized such a right to exist, it did not use the label "fundamental" or imply that strict scrutiny was appropriate. But nor did it suggest that a lower level of scrutiny was to be used; the Court just did not say." - Erwin Chemerinsky, Constitutional Law: Principles and Policies (2011)

The First Amendment provides constitutional protection for ___ ___ religious beliefs

Sincerely held

Medicaid expansion is unconstitutional under the _____ to authorize termination of all existing funds to Medicaid Program

Spending Clause SD v Dole: risk of loss = 5% of highway funds ACA: risk of loss = 100% of Medicaid funds At some point, the financial inducement offered by Congress is "so coercive to pass the point at which pressure turns into compulsion" (SD v Dole) 1st case SCOTUS has found that Congress' exercise of Spending Clause rises to level of impermissible coercion

In negligence cases, what are the elements of breach of duty?

Standard of Care: Did the defendant fail to conform to the legally recognized standard of care? Would a reasonable person have acted the same way as the defendant in similar circumstances? Foreseeability: Was the harm caused to P reasonably foreseeable from D's actions?

What is agency incapacity?

Starve agency for funds

The ACA's individual mandate is a valid exercise of Congress' ________ power

Taxing Power (taxes may seek to affect conduct [example: cigarette taxes])

How does the Executive Branch influence public health law?

The Executive Branch enforces public health statutes, develops regulations, and collects public input through notice and comment

What is the Central Hudson Test (and it's four parts)?

The Government may place restrictions on commercial speech if the following four criteria are met: 1) The commercial speech to be regulated must concern a lawful activity and not be false, deceptive, or misleading; 2) The government's asserted interest in regulating the speech must be substantial; 3) The government's regulation/action to restrict speech must directly advance the asserted governmental interest; and 4) The regulation must be no more extensive than necessary to serve the government's interest.

How does the Judicial Branch influence public health law?

The Judicial Branch interprets laws and resolves legal disputes, determines the boundaries of government power to act in the interest of Public Health, determines constitutionality of statutes, and determines whether agency actions are authorized by legislation

How does the Legislative branch influence public health law?

The Legislature creates health policies, allocates necessary resources, and has influence over federal dollars

US Federalism Reservation - IHRs

The government of the US reserves the right to assume obligations under these regulations in a manner consistent with its fundamental principles of federalism. With respect to obligations concerning the development, strengthening and maintenance of the core capacity requirements... these regulations shall be implemented to the extent that the implementation of these obligations comes under the legal jurisdiction of the Federal Government. To the extent that such obligations come under the legal jurisdiction of the state governments, the Federal government shall bring such obligations with a favorable recommendation to the notice of the appropriate state authorities

Public health law is the study of...

The legal powers and duties of the state, in collaboration with its partners, to ensure the conditions for people to be health, and the limitations of the power of the state to constrain for the common good the autonomy, privacy, liberty, proprietary, and other legally-protected interests of individuals.

What is the text of the Fourth Amendment?

The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized.

Text of the Fourth Amendment

The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, or the persons or things to be seized

What is quarantine?

The separation and restriction of movement of persons who, while not yet ill, have been exposed to an infectious agent and therefore may become infectious. a.) Home (shelter in place); institutional (school, dorm, hotel); work; travel; geographic

What is isolation?

The separation of persons who have a specific infectious illness from those who are healthy and the restriction of their movement to stop the spread of that illness. a.) Jail, Medical Isolation

What are police powers?

The state and local power to ensure the conditions for the public's health. The inherent authority of the state to enact laws and promulgate regulations to protect, preserve, and promote the health, safety, morals, and general welfare of the community.

What is an enabling statute? Give an example.

The statute, passed by the legislature, that gives the agency power to act. FDAgivenauthoritytoregulatemenulabelingforchainrestaurants under the Patient Protection and Affordable Care Act (health reform). FDCA previously excluded restaurants from FDA authority over food labeling requirements.

How do judges formate law?

Through the interpretation of laws and through the formation of common law through judicial opinions.

What is the key responsibility of the Legislative Branch?

To create laws

What is the key responsibility of the Executive Branch?

To enforce the law

Explain the CDC Do Not Board List

To include someone on the list, CDC must determine that the person: 1.) Likely is contagious with a communicable disease that would constitute a serious public health threat should the person be permitted to board a flight 2.) Is unaware of or likely to be nonadherent with public health recommendations, including treatment; and 3.) Likely will attempt to board a commercial aircraft.

What is the key responsibility of the Judicial Branch?

To interpret the laws

IHR Revision Process (1995-2000)

To prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks and which avoid unnecessary interference with international traffic and trade

What is the prime objective of public health law?

To pursue the highest possible level of physical and mental health in the population, consistent with the values of social justice

Examples of state quarantine authority (Virginia and Washington, Florida State Codes)

Virginia Code: The State Health Commissioner shall have the authority to require quarantine, isolation, immunization, decontamination, or treatment of any individual or group of individuals when he determines any such measure to be necessary to control the spread of any disease of public health importance and the authority to issue orders of isolation pursuant to Article 3.01 (§ 32.1-48.01 et seq.) of this chapter and orders of quarantine and orders of isolation under exceptional circumstances involving any communicable disease of public health threat pursuant to Article 3.02 (§ 32.1-48.05 et seq.) of this chapter. Washington Code: Each health officer is hereby directed to use every available means to ascertain the existence of, and immediately to investigate, all reported or suspected cases of tuberculosis in the infectious stages within his or her jurisdiction and to ascertain the sources of such infections. In carrying out such investigations, each health officer is hereby invested with full powers of inspection, examination, treatment, and quarantine or isolation of all persons known to be infected with tuberculosis in an infectious stage or persons who have been previously diagnosed as having tuberculosis and who are under medical orders for treatment or periodic follow-up examinations. Florida State Code: It is the duty of the Department of Health to: Declare, enforce, modify, and abolish quarantine of persons, animals, and premises as the circumstances indicate for controlling communicable diseases or providing protection from unsafe conditions that pose a threat to public health, except as provided in ss. 384.28 and 392.545-392.60. The State Health Officer, upon declaration of a public health emergency, may take actions that are necessary to protect the public health. Such actions include, but are not limited to ordering an individual to be examined, tested, vaccinated, treated, or quarantined for communicable diseases that have significant morbidity or mortality and present a severe danger to public health. Individuals who are unable or unwilling to be examined, tested, vaccinated, or treated for reasons of health, religion, or conscience may be subjected to quarantine. (a.) Examination, testing, vaccination, or treatment may be performed by any qualified person authorized by the State Health Officer. (b.) If the individual poses a danger to the public health, the State Health Officer may subject the individual to quarantine. If there is no practical method to quarantine the individual, the State Health Officer may use any means necessary to vaccinate or treat the individual.

Standard of judicial review for nuisance abatement.

Whether the nuisance abatement is reasonably necessary to avert a health threat, even if it interferes with private property rights [rational basis review, unless abatement affects a constitutionally protected right (e.g. freedom of assembly)—then strict scrutiny]


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