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
medicine can keep you alive even if you don’t want to
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
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
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
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
means-tested poverty care
inexpensive healthcare insurance for poor populations, wealthiest citizens must seek private or pay
often seen in poorer countries
US: medicaid
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
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
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
state law
determines organ recruitment; type, consent, sign up, death
organ procurement organizations (OPOs)
state licensed, send reps to obtain/confirm permission harvest organs at the bedside
match donor organ to recipient
organ transplant clinics
freestanding or within hospitals
decide candidates for organ transplant and urgency/line
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