Law and PH - Cards based on final class review Flashcards
ID structural factors in the US legal system that complicate responding to a PH emergency (natural or intentional causes)
- 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- Historical neglect of PH law – outdated communicable disease control laws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
Describe CT emergency PH response plan and the PH powers under a declaration of emergency
- 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
Implications of the gaps/barriers in the legal structure and the powers in CT PH preparedness plan to the current Ebola crisis
- 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…
Definitions and purpose of PH activities that impact privacy and confidentiality and examples
???
legal cases relevant to pH and privacy
Whalen v. Roe (1977)
US v. Westinghouse (1980)
How do PH ethics differ/similar from bioethics?
- 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.
What kinds of values/ethical principles should you refer to when evaluating the ethical justification or criticism of an actual or prposed PH program?
- 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
5 ethical criteria for evaluating government regulation
- Is the risk significant?
- Is the regulation effective?
- Is the regulation cost-effective?
- Is the regulation the least restrictive alternative?
- Is the regulation fair?
Definitions- PH research v. practice
- 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?
James Hodge, Jr.
how to distinguish research from practice
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)
ethical rules governing PH research
??
Lochner (everything about it)
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.
Current law on regulation of economic activities from a PH perspective
RUI v. Berkeley
- holding: the right to deal with wages/employment is part of police power
test:
- substantial interferene with contractual relationship?
- Significant and legitimate public purpose?
- reasonably related to achieving goal?
benefits of using torts to protect PH
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
burdens of using torts to protect PH
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
elements of negligence case and how to apply them
duty
breach
causation
harm
theories of tort liability beyond neglignce
- 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
Frye
general acceptance test – scientific evidence or theory must be sufficiently establishes to have general acceptance (consensus) in scientific community
Federal Rules of Evidence
– 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
Daubert
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
Joiner
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
Define commercial speech
- 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
3 ways government aims to control the info environment
Rules
Money
Changing Perceptions
marketplace of ideas
- 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
when can government compel speech? - legal test
Central Hudson Test
chemicals/nutrition labels/etc
when can government limit speech? - legal test
Central Hudson Test -
- Is the activity unlawful? Is the speech false, deceptive, or misleading? -
- Is the government interest substantial? -
- Does the regulation of commercial speech directly advance the state interest? -
- Is the regulation no more extensive than necessary to serve the government’s interests?
Goals of the ACA
- Increase access to health insurance
- Control rising cost of health care
- Ensure quality of care while achieving 1&2
- Change structure of health care system to promote access to primary care
- Promote population health
ACA Goal: Control costs of health care
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
ACA Goal: Increase access to health insurance
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
ACA Goal: Ensure quality of care
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
ACA Goal: Promote population health
community needs assessments as part of non profit status
Institutional responsibility for community health through integration of care
link reimbursements to outcomes
NFIB v. Sebelius (2012)
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
Burwell v. Hobby Lobby (2014)
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?
Halbig v. Burwell (2014) King v. Burwell (2014)
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
Takings doctrine and cases
- 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
Difference between public use and takings
- public use includes public purpose per Kelo
Possible alternatives to ACA
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
Lucas (1992)
- 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)
Palazzolo (2005)
- 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
Lingle v. Chevron (2005)
SCOTUS held “regulation has to be so dire to be functionally equivalent to the classic physical taking”
– more supporting of PH regulation
Kelo v. New London (2005)
- 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.
Penn. Central Transportation Company v. City of New York (SCOTUS, 1978)
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).
