Bioethics and Law Midterm 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

emergence of bioethics

* 1970
* 1. medicine can keep you alive even if you don’t want to
* 2. doctors eager to use all tools, patient death as failure
* left to state laws, safety of citizens includes public health

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

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

2. 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

3. 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

4. means-tested poverty care

* inexpensive healthcare insurance for poor populations, wealthiest citizens must seek private or pay
* often seen in poorer countries
* US: medicaid

5. 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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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?

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

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.

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

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

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
* \

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

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

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

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.

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

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

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

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