Law and PH - Cards based on final class review

Question 1

ID structural factors in the US legal system that complicate responding to a PH emergency (natural or intentional causes)

Answer 1

• Fragmented legal system, with relevant powers divided at Federal, state, and local levels
• Emphasis on local responsibility for PH
• Historical neglect of PH law – outdated communicable disease control laws
• Neglect of PH infrastructure
• Emphasis on rights of individuals

Question 2

Describe CT emergency PH response plan and the PH powers under a declaration of emergency

Answer 2

• • Authorizes Comm. Of PH to order isolation or quarantine, under conditions prescribed, of those reasonably believed to have been infected or exposed to the virus.
• o Lasts for duration of the epidemic!
• o Screening patients for travel history and symptoms
• o Notification of potential cases
• o Adherence to CDC guidelines and recommendations for care, isolation, and transport of any suspected case

Question 3

Implications of the gaps/barriers in the legal structure and the powers in CT PH preparedness plan to the current Ebola crisis

Answer 3

• Fragmented Legal System – federalism sets us up so we have gaps in security/policy/regulations/training
• Local Responsibility – local PH departments not equipped to handle Ebola outbreak
• Historical Neglect of PH Law – having to start basically from scratch when the disease arrived here
• Neglect of Ph Infrastructure – lacking supplies,
• Emphasis on Right of Individuals – courts unlikely to uphold restrictions on liberties unless there is a compelling interest and the restriction is necessary and the least restrictive alternative. Especially if it stops you from bike riding…

Question 4

Definitions and purpose of PH activities that impact privacy and confidentiality and examples

Answer 4

???

Question 5

legal cases relevant to pH and privacy

Answer 5

Whalen v. Roe (1977)

US v. Westinghouse (1980)

Question 6

How do PH ethics differ/similar from bioethics?

Answer 6

• Bioethics - focus on doctor-patient or researcher-subject relationship 
  
  • Respect for persons 
  • Beneficence 
  • Non-malificence 
  • Justice
• PH Ethics - focus = protect and promote the health of populations rather than individuals.

Question 7

What kinds of values/ethical principles should you refer to when evaluating the ethical justification or criticism of an actual or prposed PH program?

Answer 7

• Communitarian – PH is founded on a sense of the social compact between all members of the community and between community and government
• Utilitarian – PH generally seeks the greatest benefit for the post people o Individuals can be expected to give up some rights for the benefit of all.
• Social justice – PH prioritize protecting and promoting the health of the most marginalized populations, often those who are not politically powerful •
• Paternalism – some people cannot take care of themselves

Question 8

5 ethical criteria for evaluating government regulation

Answer 8

1. Is the risk significant?
2. Is the regulation effective?
3. Is the regulation cost-effective?
4. Is the regulation the least restrictive alternative?
5. Is the regulation fair?

Question 9

Definitions- PH research v. practice

Answer 9

• Research definition: Systematic collection and analysis of identifiable health data by a PH authority for the purpose of generating knowledge that will primarily benefit those beyond the participating community who bear the risks of participation
• Practice (Not Research) – activities that facilitate situation specific public health activities (outbreak, investigations, contact tracing, monitoring of health and safety issues)

o The difference is the benefit – is it a present benefit or future benefit?

Question 10

James Hodge, Jr.

how to distinguish research from practice

Answer 10

Step 1 - sort out easy cases

Step 2 - use these guidelines for the rest:

• legal authority
• specific intent
• responsibility
• participant benefits
• experimentation
• subject selection v. population (for data collection)

Question 11

ethical rules governing PH research

Answer 11

??

Question 12

Lochner (everything about it)

Answer 12

Lochner v. New York (1905 - 1937?)

• Facts: Bakery law restricted bakers’ hours, and bakers wanted to work more. Justified on the basis of protecting the workers’ health, which is an important/legitimate interest.
• Holding: there is no reasonable ground here for interfering with the liberty of a person in the right of free contract; the act must have a direct reason as a means to an end and must be both appropriate and legitimate to be valid in interfering with the right to contract.
• Note: the Lochner era is… over. We do have restrictions on the ability to make contracts now.

o After this rule, over 200 laws were invalidated (ex: minimum pay, maximum hours, etc.)

• Importance:

o Allowed era of SC strike down important health and social legislation

o Unwarranted judicial interference with democratic control over the economy to safeguard the public’s health.

o Upheld the individual right to contract over the government’s ability to make laws for the public good.

Question 13

Current law on regulation of economic activities from a PH perspective

Answer 13

RUI v. Berkeley

• holding: the right to deal with wages/employment is part of police power

test:

1. substantial interferene with contractual relationship?
2. Significant and legitimate public purpose?
3. reasonably related to achieving goal?

Question 14

benefits of using torts to protect PH

Answer 14

private citizens and public agencies can address problems the legislatures have failed to address:

harms to environment,

exposure to toxic substances,

pharmaceuticals,

hazardous products and defective consumer goods

Question 15

burdens of using torts to protect PH

Answer 15

court and liability costs can deter business from entering or remaining in the market,

raise price of consumer goods,

limit consumer choices,

potential uneven impact,

stop research/growth

Question 16

elements of negligence case and how to apply them

Answer 16

duty

breach

causation

harm

Question 17

theories of tort liability beyond neglignce

Answer 17

• Private nuisance – unreasonable interference with a possessor’s use and enjoyment of land; requires: intention to interfere (knowledge of nuisance) and substantial interference
• Strict liability – liability without fault, based on abnormally hazardous activities or sale of defective products; requires: intention, proximate cause; includes limitation/defenses of public duty privilege, and sovereign immunity (SL only, not for negligence)

o Product liability – includes:  Manufacturing defects  Design defects  Failure to warn  Misrepresentation

Question 18

Frye

Answer 18

general acceptance test – scientific evidence or theory must be sufficiently establishes to have general acceptance (consensus) in scientific community

Question 19

Federal Rules of Evidence

Answer 19

– marked a shift allowed introduction of any scientific or technical evidence that will assist the trier of fact to understand… and a qualified expert may testify to it

 very broad! USE DAUBERT FOR THIS unless otherwise asked

Question 20

Daubert

Answer 20

held Federal Rules superseded Frye, BUT judges act as gatekeepers “must assure that scientific evidence is not only relevant, but reliable”  narrows the standard a little bit

o Reliable? 4 factors to consider (none determinative on its own, but court may consider all factors):

 Testing

 peer review

 error rate

 general acceptance

Question 21

Joiner

Answer 21

held TC can critically examine conclusions to determine if they are supported by studies cited.

Apply standards of relevance and reliability from Daubert

 looks more like court sitting to evaluate another layer of peer review

o Important because it still narrows the scope of evidence

Question 22

Define commercial speech

Answer 22

• Bolger v. Youngs Drug Products Corp (1983)

– 3 elements of commercial speech:

o Identifies a specific product

o Form of advertising

o Confers economic benefits – exchange for money v. goods

Question 23

3 ways government aims to control the info environment

Answer 23

Rules

Money

Changing Perceptions

Question 24

marketplace of ideas

Answer 24

1. Free marketplace of ideas – the idea that the truth will prevail if there are enough ideas around – similar to free market economics
   a. Problems – bad ideas win out when unhealthy ideas have more money, people put out wrong information, we might not have the right tools to evaluate that information, no guarantee that the right information will be accepted

Question 25

when can government compel speech? - legal test

Answer 25

Central Hudson Test

chemicals/nutrition labels/etc

Question 26

when can government limit speech? - legal test

Answer 26

Central Hudson Test -

1. Is the activity unlawful? Is the speech false, deceptive, or misleading? -
2. Is the government interest substantial? -
3. Does the regulation of commercial speech directly advance the state interest? -
4. Is the regulation no more extensive than necessary to serve the government’s interests?

Question 27

Goals of the ACA

Answer 27

1. Increase access to health insurance
2. Control rising cost of health care
3. Ensure quality of care while achieving 1&2
4. Change structure of health care system to promote access to primary care
5. Promote population health

Question 28

ACA Goal: Control costs of health care

Answer 28

limitations on admin costs

changing structure of health care system

link reimbursements to outcomes

subsidies and individual mandate decrease costs of individuals

promote integration of care across systems (systems sharing outcomes)

research to ID effective but lower cost treatments

Question 29

ACA Goal: Increase access to health insurance

Answer 29

Individual mandate - everyone must have insurance or pay tax health exchanges

cannot charge higher rates based on gender, health history, or status

stay on parents’ plan up to 26

tax incentives for small business imposes taxes on businesses not offering insurance

guaranteed coverage of all people

medicaid expansion

subsidies

preventative services covered

end lifetime/annual caps on benefits

Question 30

ACA Goal: Ensure quality of care

Answer 30

prevention services with no cost-sharing

essential services must be covered by almost all insurance

evidence-based standards built on clinical practice guidelines

link reimbursement to outcome

measures associated with health

Question 31

ACA Goal: Promote population health

Answer 31

community needs assessments as part of non profit status

Institutional responsibility for community health through integration of care

link reimbursements to outcomes

Question 32

NFIB v. Sebelius (2012)

Answer 32

Facts: ACA Imposed tax on people who did not follow the individual mandate for having insurance. Attorneys challenged it as soon as it was signed Issues:

• was individual mandate a valid exercise of Congressional power?
• was medicaid expansion?

Holding:

• Congress has the authority to enforce the individual mandate because it can be read as a tax, even though it was not constitutional under commerce power
• Struck down medicaid expansion as coercive Impact:
• use for tax powers may expand
• commerce clause legis may be overturned
• conditional spending provisions threatened

Question 33

Burwell v. Hobby Lobby (2014)

Answer 33

Issue: Can a corporation refuse to cover mandated service (contraception) because it would violate religious freedom?

Holding: Yes, corporations are “persons”, so their religious rights are protected

• possible alternatives for govt go cover contraception: directly cover it, extend “accomodation” already offered to religious non-profs Impact:
• contraceptive coverage challenges continue
• will religous objections extend to other types of corporations?

Question 34

Halbig v. Burwell (2014) King v. Burwell (2014)

Answer 34

Issue: Can federally run insurance exchanges provide tax credits (subsidies) to individuals purchasing insurance?

Problem: conflicting language in parts of statute, one section specifies - tax credits are available for individuals enrolled through an exchange established by the state

Holding (Halbig) - no, federal exchanges cannot

Holding (King) - yes, they can

Impact: - how will courts resolve conflict?

• absence of subsidies would reduce access in 34 states

Question 35

Takings doctrine and cases

Answer 35

• Traditional definition: when govt takes possession of property for public purpose, it must compensate owner (5th amdmt)
• regulatory takings
• per se takings

Lucas, Palazzolo, Lingle, Kelo, Penn Central

Question 36

Difference between public use and takings

Answer 36

• public use includes public purpose per Kelo

Question 37

Possible alternatives to ACA

Answer 37

Good ideas that died:

• • single payer -
• public option in the exchange -
• expansion of medicare for all -
• subsidized insurance

Not good ideas that have gone nowhere (Patient CARE Act): -

• eliminates free coverage of preventative services -
• changes ban on preexisting conditions -
• eliminated individual mandate -
• eliminates insurance exchanges -
• shrinks medicaid expansion -
• lowers income limit on subsidies -
• allows underwriting by age and gender

Question 38

Lucas (1992)

Answer 38

• Facts: Lucas bought two beachfront properties for 975k, and an Act later passed rendered the property useless. - Holding: the denial of all economically viable use is a taking  100% diminution in value. Note however that it is very hard to get land considered valueless. required compensation for regulation that “denies all economically beneficial uses of real property… unless activity/use was a common law nuisance” (key = expectations at time of purchase)

Question 39

Palazzolo (2005)

Answer 39

• Facts: plaintiff wanted to build a beach club.
• Holding: The entire property is the denominator, use Penn Central balancing test.

court extended taking to statutes and regulations that were in place when property acquired

Question 40

Lingle v. Chevron (2005)

Answer 40

SCOTUS held “regulation has to be so dire to be functionally equivalent to the classic physical taking”

– more supporting of PH regulation

Question 41

Kelo v. New London (2005)

Answer 41

• Facts: New London Development Corp planned and received state funds to exercise eminent domain to get properties in New London and then build a private waterfront development.
• Holding: Extends public use to include “public purpose”; the exercise of eminent domain does not have to actually be used by the public as long as it is intended to benefit the public.

o The government taking private property from one owner and giving it to another private owner for furtherance of economic development constitutes “public use” because it satisfies a public purpose.

• Dissent – There is an indirect harm in not benefitting the town, and the big risk for danger is forcing property owners to make the best use of their property, even if they don’t want to.

Question 42

Penn. Central Transportation Company v. City of New York (SCOTUS, 1978)

Answer 42

In deciding whether a particular government action has affected a taking, the court should focus on the character of the action and the extent of the interference with rights in the parcel as a whole

o 1. Economic impact of regulation on the claimant (who? How serious? Commercial v. residential?)

o 2. Interference with reasonable backed investment expectations – the greater the expectation of what the owner thought he could do with the property, the greater likelihood that the court will find a taking.

o 3. Character of the government action (regulatory v. physical occupation).