Bioethics and Law Midterm 1

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Baby K

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Law

41 Terms

1

Baby K

  • anencephalic baby, hospital rescues for respiratory problems, seeks court opinion about declining to reat

  • trial court: disability discrimination under ADA 2 statutes (refusing to treat bc disability, disability doesn’t interfere w treatment), EMTALA, Roe v. Wade parental medical choices for children

  • appellate court: narrow stance of EMTALA based on wording

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2

emergence of bioethics

  • 1970

    1. medicine can keep you alive even if you don’t want to

    1. doctors eager to use all tools, patient death as failure

  • left to state laws, safety of citizens includes public health

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3

state vs federal healthcare law

  • bioethics as mostly a matter of state law

  • “laboratory of states” mean better approaches often come to dominant, but not always the case; states express moral character

  • human subjects research as exception

  • congress can frame health issues federally, but policy freeze and election cycles

  • uniform law commission: group of attorneys drafting uniform laws and lobbying states to adopt

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  1. national health service

  • government owned healthcare, doctors employed by country, free service via taxpayers

  • older people use more healthcare, intergenerational service comes around

  • UK

  • US: gov. owned hospitals include veterans administration, native reservations, military hospitals

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  1. national health insurance

  • private doctors and hospitals compete for patients but paid by government run insurance company funded by taxes

  • Canada

  • US: Medicare for everyone over 65, doesn’t cover long term nurisng care

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  1. corporate insurance

  • insurance supplied by corporate entities e.g. employers, regional suppliers. often gov. mandated

  • Germany, Japan, many wealthy countries

  • private insurance entities are heavily regulated and subsidized to ensure access

  • more expensive to seek independent insurance than provide; cheaper as group

  • US: companies, unions, covers majority of Americans, tax codes allow insurance as deductible business expense

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  1. means-tested poverty care

  • inexpensive healthcare insurance for poor populations, wealthiest citizens must seek private or pay

  • often seen in poorer countries

  • US: medicaid

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  1. nothing

  • insufficient resources to subsidize healthcare access

  • US: undocumented immigrants, people above medicaid threshold that gamble not to pay

  • working for small companies → no corporatist insurance, rates go up for small groups

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9

cost of American healthcare

  • even with insurance, drugs and procedures not necessarily free

  • copayments uninsured, deductibles mean insurance only kicks in with sufficient spending

  • healthcare costs account for 1/4 of personal bankruptcies

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10

Obamacare

  • corporatist insurance: tax penalty for larger uninsured firms

  • Medicaid

    • previously; state determined % of poverty threshold where medicaid applies, red states less generous

    • original prop: cover 125% of state poverty line, or take away federal subsidy for existing Medicaid

    • SCOTUS ruled taking away federal assistance is unconstitutional

  • subsidized private insurance

    • large subsidies for people just above 125%, diminishing up to 140%

    • would have been continuous coverage if not for SCOTUS holding, gap between state threshold

  • state exchanges

    • accessible page for minimal health insurance packages at clear price, all on one page

  • individual mandate

    • controversial; uninsured people pay a relatively unthreatening tax, much less than health insurance

    • SCOTUS upheld, incentivized many to purchase

  • most popular provision; stay on parents health insurance till 26

  • 1/2 states didn’t adopt at first, but many folded due to pressure from doctors/hospitals lobbying

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insurance death spiral

  • healthy people dropping out of insurance plan leaves sick people in the pool, causing insurance company to raise rates

  • implication: making healthy people buy insurance is good even though they get little return

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America healthcare system

  • spending per capita highest in the world, double OECD average of 38 wealthiest countries

  • procedural problems

    • see doctors less often

    • birth and pregnancy related illness/death on par w sub-saharan African countries

    • lower life expectancy and disease outcomes

    • good medical education and tertiary care

  • social factors

    • lack of vacation, family leave, exercise, obesity

  • healthcare costs

    • American doctors paid more, higher % of specialists, insurance never pays full medical charges

    • bureaucratic/administrative overload from many systems

    • cost of prescriptions; pharma lobbies for high prices to fund R&D, funding comes disproportionately from US

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entering patient-physician relationship

  • voluntary relationships and contract, doctors generally have no duty to treat the sick unless agreed

    • Hurley v. Eddingfield, doctor refused to treat and patient died at home

    • Obstetrician that only delivered children of poor patients if sterilized

  • commercial relationships can be stopped for any reason except for legally prohibited reasons (race, sexuality, religion)

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14

duties and agency

  • an agent acts on behalf of a principle, e.g. yale professor, doctor, lawyer, therapist

  • owes particular duties and acts on their behalf/best interests

  • duty of competence:

    • standard of care varies regionally, medical malpractice cases define precedent

    • different from whether patient is harmed

  • duty of obedience:

    • patients must give informed consent

  • duty of confidentiality:

    • not divulging things learned during course of agency

    • illegal behaviors, sexual, violence/abuse

    • exception: money if patient isn’t paying enough

    • mandatory reporting: child abuse, elderly unfit to drive, intent to harm/self harm

  • duty of loyalty:

    • avoiding conflicts of interest

    • e.g. lending patients money, treating family members

  • unique constraints for doctors:

    • no sexual regard for patients, no moral judgements that would affect care

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exceptions to voluntarily entering doctor patient relationship

  • “common carrier”

    • someone having something available e.g. innkeeper has limited ability to deny entrance to relationships

    • hospital ER

    • ER doctor cannot deny patients, recognized specialty with hospitals contracting ER docs

  • EMTALA

    • Burditt v US Dept of Health

  • specialists contract hospitals to oversee patients, e.g. anesthesiologists, radiologists

  • hospitalist specialty cares for wards full time, instead of physicians dropping by

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hospital doctor relationship

  • most US hospitals are non-profit, no shareholders take home profit

  • money reinvested into mission; lowering prices, improving facilities

  • doctors generally not employed but have admitting privileges; hospital as workshop for procedures

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17

Good Samaritan laws

  • if you have given level of healthcare training and help someone w/ emergency, relieved of legal liability from care

  • encourages people to help by removing threat of lawsuit

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18

prohibited reasons for turning away patient

  • federal anti discrimination laws: race, religion, sexuality, disability

  • Bragdon v. Abbott

    • dentist afraid to treat HIV+ patient; cultural climate of HIV fear, homophobia

    • courts held HIV+ as disability, disability discrimination, no appreciable risk given standard procedures

    • doctors can refuse patient care if legitimate risk of contracting

  • Glanz v. Vernick

    • established you can’t discriminate against someone otherwise qualified for treatment, applied in Bragdon case

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19

informed consent

  • duty of obedience entails giving patient what they want; notably different than patient dictating treatment

  • general information

    • diagnosis, prognosis

    • risks and benefits of procedure

    • alternative interventions

    • consequences of doing nothing

  • surveys indicate patients aren’t interested in many of these details, but still required by law

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informed consent state law

  1. standard of care approach

    • IC as part of medical practice in same manner as intervention

    • what does the typical doctor tell patients about the treatment?

    • problem: what if the standard is bad

  2. patient-centered standard

    • what would a reasonable patient want to know?

    • extraordinary concerns for patients e.g. prior conditions, fear of needles, occupation, etc.

  • doesn’t have to be disclosed: health status, experience level, malpractice history

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informed consent for children

  • assent doesn’t require actual understanding

  • sliding scale of informed consent based on procedure, age, maturity

  • standard of care is best interest for the child, doctors can override parent in many states e.g. vaccines

  • Jehova’s witnesses; religion loses in court until child old enough to claim religion as their own

  • age of maturity; circumstances for minors to make adult decisions; homeless/independent of parents, teen parents, abortion/STDs without parental

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22

Beriberi disease study

  • Berberi linked to diet in chickens, British physician conducted human experiment using Malaysian mental asylum patients

  • published in Lancet in 1905 w tremendous reception, none attacked Dr. Fletcher for killing his patients

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23

Nazi human experimentation and Nuremberg

  • mostly Jewish subjects, gratuitous “experiments”

  • some useful data e.g. physiological response to cold and revival process

    • debate over whether data could be published, eventually used to resuscitate people

  • Nuremberg; Nazi doctors jailed and executed

    • declaration of Nuremberg; no human research without “voluntary knowing consent”

    • human experimentation continued in America though; US military, intentional infection

  • Henry Beecher

    • gathered info on 50 ongoing studies without patient consent, included from each leading medical institution

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Tuskegee experiment 1930-1970

  • study of untreated syphilis in black men, belief in racialized differences in pathology

  • physicians told to avoid treating subjects, even after advent pf penicillin as permanent cure

  • study not secret; publications, conferences, US health service recruits participate in annual roundup

  • sudden whistleblowing in post civil rights era climate, Kennedy hearings

  • concurrent study of intentionally infected Guatemalan prisoners

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Belmont administration/report

  • commission of scientists, philosophers

  • articulating ethical principles as part of public report without higher ethical framework using “mid level principles”

    • beneficence/non-maleficence

    • justice: draw members from community that benefits

    • respect for autonomy

  • expanded to encompass all biomedical ethics

  • bioethics regarded as low class by phil departments since no meta-ethics or theory

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Common Rule

  • adopted by most agencies within federal government that conduct or fund human research (except US military)

  • reaches three categories of research

    • federally funded

    • data presented for FDA approval

    • major research universities contractually agree

  • exceptions: food, cosmetic, electronic devices, quality improvement initiatives

  • applies to all human subjects; any living person that had data gathered, whether drug trials or questionaries

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institutional review boards

  • common rule decentralizes obligations onto people/fields performing the research

  • members: researchers, lawyers, non-scientists, community

  • occasional review by gov. to ensure proper functioning

  • factors considered

    • quality of science/experimental design

    • benefits to research

    • risks to patient

  • payment allowed, but not considered benefit

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vulnerable populations for human research

  • prisoners as ideal subjects due to controlled environment

    • problematic power dynamic when giving consent

    • new regulations; no research on prisoners unless it regards being imprisoned

  • children

    • need adult to consent

    • below minimal risk faced in ordinary life or wellness visit

    • above that, only studies where children may directly benefit

    • Kennedy Krieger Institute v. Grimes; lead paint

  • socioeconomically disadvantaged

    • payment to participants clouds judgement? permissible risk prerequisite for improvement

  • race missing?

  • “minimal risk” for who’s everyday life? who benefits from the research?

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court cases

  • Burditt v. US Dept of Health (EMTALA)

  • Bragdon v. Abbott

    • Glanz v. Vernick

  • Baby K

  • Hurley v. Eddingfield

  • Kennedy-Krieger Institute v. Grimes

  • Strunk v. Strunk

  • Lausier v. Perscinski

  • McFall v. Shimp

  • Moore v. Regents of the UC

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actors in organ transplantation law

  1. state law

    • determines organ recruitment; type, consent, sign up, death

  2. organ procurement organizations (OPOs)

    • state licensed, send reps to obtain/confirm permission harvest organs at the bedside

    • match donor organ to recipient

  3. organ transplant clinics

    • freestanding or within hospitals

    • decide candidates for organ transplant and urgency/line

  4. UNOS

    • private nonprofit NGO contracted w/ gov

    • determines ethical standards for allocating organs within geographical regions and prioritizing waitlists based on age, need, success, etc.

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living organ donation

  • donating live kidneys, liver lobe, uterus

  • informed consent rules apply, but balancing benefits to recipient

  • parents can consent to their children donating organs if best interest (Strunk v. Strunk)

  • renewable tissues/cells (blood, eggs/sperm, bone marrow) done through different procedures than organ transplant

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Strunk v. Strunk

  • man with mental disability have parents consent to donating his kidney for brother

  • court ruling: donating to save his brother is in his best interest; trauma if brother died

  • dissenting: gov did not have the authority to remove a healthy organ from incompetent ward of the state

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Lausier v. Pescinski

  • sibling match, but the potential donor was in a catatonic schizophrenic state

  • court ruling: the court cannot order the incompetent person to make an organ donation without any benefit to themself, not in best interest

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McFall v. Shimp

  • McFall needed bone-marrow transplant from cousin, but Shimp did not agree

  • plaintiff: infringing on bodily security to save another’s life

  • ruling: a person could not be legally compelled to participate in medical treatment to save another person's life

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savior siblings

  • parents that anticipate their child will need a future organ transplant have another child to match the first

  • MA court case of whether clinic can perform IVF to ensure match; ruled that nothing was illegal about savior sibling, donation was a later question

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rights to donated organs

  • Moore v. Regents of the UC

    • while treated for hairy cell leukemia, doctors harvested Moore’s cells for research without his knowledge

    • intentional misleading into additional appointments and screenings, e.g. spinal tap

    • developed a drug and made millions

  • ruling: Moore to be compensated for harms from informed consent violation (missing work, pain from procedures)

  • no property interest in tissues outside the body

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kidney transplants

  • shortage of kidneys due to poor matches, even when considering family members

  • immunosuppressant drugs reduce rejection, but downsides

  • circuit of donors coordinating to incentivize donation

  • paying people; ethical concerns, poor people, etc.

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defining death

  • urgency of getting organs to avoid organ hypoxia

  • Harvard group brain death standard; if brain stops functioning, other organs will naturally fail

  • verify brain death through tests, then keep organs oxygenated via ventilator

  • “dead donor rule” as policy

  • objections to donation after cardiopulmonary death (DAC), arteries to brain clamped off to keep dead while organs revived

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brain death standard

  • uniform law adopted across states; “complete irreversible cessation of all function in the whole brain”

  • occasional neuron sparks, glandular activity, anencephaly don’t indicate consciousness but violate definition

  • DNR example; new technology for reversing brain death, legal perspective

  • T.A.C.P. case; anencephalic babies cannot be donors

  • bodies can persist on life support for a while even after brain death

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40

cadaveric organ donation

  • consent in advance: online sites, organizations, drivers license

  • State v. Powell and Brotherton v. Cleveland establish quasi-property right to body of loved one

    • can’t take tissues/organs without hearing, common law to handle body for purposes of burial

  • US soft opt-in: family members can still object post-mortem

  • soft opt-out: sweden, brazil, spain, UK

    • UK recently shifted, though previously expert group determined cheaper to run publicity than convert whole system

    • opt-out requires good medical records available all the time to ensure the donor didn’t opt-out

  • hard opt-out: austria

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determining organ queue

  • UNOS

    • expert committees for different organs, varied criteria

    • life years saved, likelihood of success, urgency of rescue, compensatory justice

  • organ transplant clinics

    • decides patient eligibility at own discretion

    • Steve Jobs preferentially received liver transplant

    • incentive to get best possible survival %s even though partial liver or one lung transplants could save more people

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