Confidentiality:
I.
History
A. Hippocrates to World Medical Association’s Declaration of Geneva
II.
Definitions
A. Confidentiality vs. Privacy
1. Violation of Confidentiality
a. Occurs only if the person/institution to whom the information
was disclosed in confidence fails to protect the information or
deliberately discloses it to someone without 1st party consent.
2. Violation of Privacy
a. Example – A person without authorization who breaks into a
hospital record room or computer data bank
3. To clarify, only the person/institution who receives info in a
confidential relationship can be charged with violating rights of
confidentiality
III.
The Reality of Medical Confidentiality
A. Mark Siegler argues that confidentiality in medicine is a decrepit concept
1. “Confidentiality is compromised systematically in the course of
routine medical care”
B. Case Study
1. Man was aggravated that his confidentiality was being compromised
– figure out how many people look at a given patient chart
a. Approx. 75 people had “needs and responsibilities” to look at
the patient’s chart
C. Doctor’s can’t Even Protect Themselves!
1. William Behringer, Doctor found to be HIV positive
a. He lost surgical privileges and medical practice was ruined
b. Despite his expectation and request for confidentiality, the
medical center did not take any precautions to protect his
medical records
D. Survey of patient expectations reveals patients expect a higher standard of
confidentiality than is being given
1. Patients do not expect their situation to be discussed at parties, with
friends, or spouses.
E. Health Insurance Portability and Accountability Act (HIPAA)
1. Allow disclosure of Protected Health Information (PHI) for:
a. Treatment
b. Payment
c. Operations
Why is it important?
A. Consequence Based Arguments
1. If patients cannot trust a physician to keep medical information in
confidence, they may be more reluctant to share fully
IV.
V.
VI.
2. This consequence could hinder a physician’s ability to test,
diagnosis, and treat
B. Autonomy and Privacy Arguments
1. The values of autonomy and privacy themselves support stringent
confidentiality
C. Fidelity Based Arguments
1. Fidelity = The physician’s obligation to live up to the patient’s
reasonable expectations of privacy and confidentiality.
2. Physician’s take a professional’s public oath
Values Underlying Confidentiality (restated from IV. to reinforce)
A. Trust
B. Privacy
C. Autonomy
Exceptions to Confidentiality
A. Mandated Reporting (by law)
1. Gunshot Wounds
a. Reported to law enforcement
2. Specified STDs and other Infectious Diseases
a. Reported to Health Department
3. Suspected child abuse
a. Reported to Child Protective Services
B. Disclosure of Information in a particular context
1. Company physicians
a. Not bound by obligations of confidentiality in the same way as
a private physician
b. Physician is not free to disclose everything to the company
a. Limited disclosures are legitimate as long as the patient
is aware of the provisions in their contract
2. Military physicians
a. Duel responsibility to soldier patient and military
C. Disclosure of HIV Status to positive patient’s spouse/lover
1. American Psychiatric Association says disclosure is appropriate if:
a. HIV test is positive
b. There is a good reason to believe that patient’s actions will
place others at an ongoing risk
c. Disclosure is a last resort
2. American Medical Association says the following steps should be
taken:
a. Try to get the patient to disclose on their own/cease
endangering
b. If this fails, alert the authorities
c. If this fails, alert the 3rd party
3. Dilemma #1 – Can a doctor take the patient’s word that they will
disclose/cease endangering others? How far should a doctor go to
determine compliance?
4. Dilemma #2 – Which saves more lives: Confidentiality or
Disclosure?
a. Confidentiality is important so that people feel comfortable
getting the test and treatment
b. Disclosure is important so that 3rd party is not harmed
D. Disclosure of Genetic Information to 3rd party
1. This type of information could help a 3rd party with risk reduction,
family planning, or treatment options
2. Confidentiality can be breached when:
a. There is a failure to elicit voluntary disclosure
b. There is a high probability of irreversible/fatal harm to 3rd party
c. Disclosure of information will prevent harm
d. Disclosure is limited to the information essential for
diagnosis/treatment of 3rd party
e. There are no alternatives to prevent harm to 3rd party
E. Determining whether to breach confidentiality – Questions to ask.
1. What is the magnitude of the expected harm?
2. What is the probability of the harm?
3. Will breaching confidentiality prevent the harm?
4. Are there alternatives?
5. Is the breach of confidentiality proportionate?
a. Meaning – How bad could the outcomes be if confidentiality is
breached vs. not breached
Medical Errors
Concept One:
Lawsuits against surgeons are most commonly associated with the relationship
between patient and surgeon.
Concept Two:
Errors are the result of systems that fail to account for human error, i.e., are not
redundant.
Concept Three:
Hippocrates tells us that doctors should pick and choose when to be truthful, based on
the situation.
Concept Four:
Talking with families about medical errors has actually been shown to reduce costs to
hospital and physician.
Concept Five:
Medical residents often find making mistakes to be emotionally disturbing, and use
different methods to escape their guilt: denying the severity of the incident/pretending
it didn’t happen, distancing themselves emotionally from patients, blaming other
members of the hospital staff for the error, etc.
Concept Six:
Medical Errors account for an enormous number of deaths every year, more than
motor vehicle accidents, AIDS, or breast cancer.
Session 7: Actively Hastening Death
Learning Objectives:
1) To understand the relationship between actively hastening death and passively
hastening death.
2) To understand the traditionally voiced objects of legalization of actively hastening
death
3) To understand how actively hastening death has been practiced in Oregon and the
consequence of legalization
1) Active euthanasia is often described as “killing” by giving a lethal injection while
passive euthanasia is “letting die” by prescribing a lethal drug, but the line between
actively hastening death and passively hastening death is not as “bright” as the courts
claim.
2) There were three examples given in class describing the traditionally voiced
objections of legalization of actively hastening death. The first voiced object is that
people will be pressured to accept euthanasia, but this objection doesn’t take into
account the fact that patients are already susceptible to pressure by physicians
whether it is subtle or heavy-handedly in deciding to forgo life-sustaining treatments.
The second voiced object is that actively hastening death will undermine patients’
trust in doctors. This objection doesn’t taken into account that fact that the failure of
physicians to provide patients with assistance in actively hastening their death
undermines patient’s trust that doctors will help them in their greatest moment of
need. The last object is that “permitting assisted suicide may start us down the path
to voluntary and perhaps even involuntary euthanasia”. This objection fails to
recognize that any right creates the possibility of abuse. Individuals against abortion
used this same claim stating that,” legalizing abortion would lead to its widespread
use as a substitute for other forms of birth control or as a means of racial genocide.”
3) In 1994, Oregon passed the Death with Dignity Act, which legalized physicianassisted suicide. There were multiple threshold requirements established as well as
eligibility requirements.
Threshold requirements:
 An adult(18 yrs or older)
 A resident of Oregon
 Capable(defined as able to make and communicate health care decisions)
 Diagnosed with a terminal illness that will lead to death within six months
Eligibility Requirements to Receive Prescription
 Two oral requests to physician, separated by at least 15 days.
 Written request to physician, signed in presence of two witnesses.
 Prescribing physician and consulting physician confirm diagnosis and
prognosis.
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Prescribing physician and consulting physician determine whether patient is
capable.
If either physician believes patient’s judgment impaired by psychiatric or
psychological disorder, patient must be referred for psychological
examination.
Prescribing physician must inform patient of feasible alternatives to assisted
suicide including comfort care, hospice care, and pain control.
Presenting physician must request, but may not require, patient to notify nextof-kin of the prescription request
Additional Info:
1. Physicians must report to Oregon Dept. of Human Services all prescriptions unless
the pt never actually receives it.
2. Pharmacists must be informed of the medication’s ultimate use
3. Physician’s and pts who adhere to the rules of DWD (death w/ dignity) Act are
protected from criminal prosecution.
4. Choosing PAS cannot affect life / health insurance policies.
5. No one is obligated to participate in DWD-act
Session 5: Caring for Minors
1. Understand the ethical and legal framework guiding the treatment of minors
a. Minors are constitutionally protected
i. In re Gault – 1967
1. “neither the Fourteenth Amendment nor the Bill of Rights is for
adults alone”
b. Considered “legally disabled”
i. Bellotti v. Baird; Parham v. J.R. – 1979
1. “Most children, even in adolescence, simply are not able to make
sound judgments concerning many decisions, including their need
for medical care or treatment”
ii. Need for parents or state to make decisions
1. Parents are protected by the Fourteenth Amendment – freedom of
decision making in raising and rearing children
a. Parental decision making limited by harm caused to minor
when parents exercise religious beliefs, or there is abuse,
neglect, or abandonment
i. Prince v. Massachusetts – 1944
ii. Nixon v. Pennsylvania - 2001
2. Parens Patriae – “parent of the country”
a. “the power of the state to act in loco parentis for the
purpose of protecting the child”
c. Adolescent Patients (14-17)
i. Assumed legally incompetent, with conditional exceptions
1. Social circumstances
a. No capacity assessment required
b. Homelessness, marriage, pregnancy, parenthood, high
school graduation, military enlistment, imprisonment,
independent lifestyle
2. Medical situations
a. Variable by state; may include age restrictions
b. Treatment for STDs, substance abuse, mental health, or
sexual assault
3. Minors can assent to treatment, but still cannot refuse life-saving
treatment
ii. Mature Minor Doctrine
1. Judge-determined capability of adolescent to decide on health care
based on age, experience, maturity, condition of long-term or lifethreatening illness
2. Many physicians believe physicians should make this
determination; many assessments of adolescent capability
performed by pediatricians
2. Explore the framework in specific contexts, including:
a. Religious beliefs for refusing life-saving treatments
i. Rena’s case
1. Jehovah’s Witness requiring religiously-forbidden blood
transfusion, refused by both Rena (16) and her parents
2. Hospital sought authority to give transfusion if necessary
3. Trial judge authorized transfusion if condition should become life
threatening
4. Overturned by appellate court, reasoning that judge erred in
considering Rena’s maturity to make informed decisions
ii. Must consider parents’, state’s, and minor’s best interest, minor’s
maturity, religious conviction, and incapacity
b. Mental health treatment
i. Involuntary civil commitment
1. Requires parental consent
2. Parham v. J.R. – 1979
a. Parental consent and psychiatric exam as safeguards
ii. Voluntary, out-patient treatment
1. Variable by state
2. Age restrictions (e.g. PA – 14 or older)
c. Reproductive rights
i. Pediatric patient confidentiality for reproductive services supersedes state
parent consent requirements
ii. Contraception & pregnancy decision making
iii. Sterilization
1. Due process and procedural safeguards required (e.g. clear and
convincing evidence, best interest determination)
iv. Technological conception – regulation virtually nonexistent
v. Abortion decision making
1. Required parental notification and consent
d. HIV/AIDS
i. Rare explicit inclusion of HIV/AIDS in STD statutes
ii. Of those inclusions, ~12 mention minors
iii. Considerable variation among provisions concerning testing and
treatment, privacy, decisional ability, and protocol development
e. Confidentiality
i. Physicians’ legal responsibilities
1. Maintain confidentiality
2. Report harm
a. Mandatory reporting requirements for abuse, neglect,
abandonment, or injury as a result of crime
ii. Attorney Ad Litem for D.K. v. Parents of D.K. – 2001
1. Motion to protect D.K.’s privilege to confidential information after
court ordered psychological counseling
2. Court denied motion; reversed by appellate court, reasoning that
not all decisions are removed from minor, D.K. (17) had capacity
and maturity not present in minors under 14
3. Underscored tension between rights, roles, and responsibilities of
parents and adolescents, possibility of parents inhibiting seeking
and success of treatment
f. End-of-life care
i. Deference to physician for determining decision-making capacity
ii. Some recognition of adolescent autonomous wishes and advanced
directives; possibility of authorizing parental wishes, referral to ethics
committee, institution of guardians ad litem
g. Research participation
i. No distinction among minors
ii. Parental consent/minor assent
1. Therapeutic – consent from one parent
2. Non-therapeutic – consent of both parents; minimal risk as
determined by IRB
iii. Grimes v. Kennedy-Krieger Institute, Inc. – 2001
1. Government-funded research; incentives
2. Highlighted issues of competing interests of parental authority and
researchers’ aims, systemic problems of medical research; critical
of IRB
3. “Not legally acceptable” to expose children to long-term adverse
health effects
iv. Adolescent experimentation: issues meriting exploration
1. Capacity for autonomous choice
2. Scope of decision making
3. Maturation, experience, altruistic motivation
4. Revision or creation of adolescent-specific regulations
5. Pediatric IRB
6. Role of parens patriae in research
* This entire lecture pretty much boils down to this: some minors can make their own
decisions and some can’t, but you have to approach it case-by-case and this determination is
made by a variety of people including judges and physicians. If they can make a decision,
great; if not, the parents may be allowed to, although sometimes the state will step in to
protect the minor’s best interest.
Session 3 (September 13)
Informed Consent
1) Learning Objectives:
a) To understand the concept of informed consent
b) To identify and explain the components of informed consent
c) To identify a physician’s roles and responsibilities in relation to informed decisionmaking
2) Reading: Informed Consent : Legal Theory and Clinical Practice
a) Introduction:
i) Informed consent (IC): autonomy and concern for the individual well-being
ii) IC is critical to contemporary health care and medical research
(1) 1960s and 1970s: new technological developments provided patients with
treatments that could possibly conflict with patient’s values or culture:
possible conflicting ideas as to what is best for the patient
(2) Bioethics in 1990s solidified IC importance
iii) Patient perspective: IC is a right
iv) Physician perspective: IC is a duty or obligation
b) What is Informed Consent?
i) 3 interpretations:
(1) Policy-Oriented
(a) “Legally or institutionally effective authorization from a patient or subject.
Such authorization is effective because it has been obtained through
procedures that satisfy the rules and requirements defining a specific
institutional practice in health care or in research”
(b) These rules came to be for a reason… trying to adhere to philosophical
idea of IC
(2) Philosophical Concept
(a) Autonomous authorization
(b) “In authorizing, one both assumes responsibility for what one has
authorized and transfers to another one’s authority to implemented”
(c) Non-medical example: Person A hires person B to paint his house because
he does not have the skills; this gives authority to person B to paint the
house based on industry standards, while still being responsible for the
decision he(A) made (i.e. if A does not like the color he picked out for his
house, A is responsible, not B)
(d) IC is different, however, from everyday examples, such as described
above, due to the fact that patients and subjects often rely upon physicians
or researchers to inform them adequately, so that they can then
autonomously authorize a course of action this leads to the 3rd
interpretation of IC
(3) Shared decision making
(a) This idea goes beyond the physician educating the patient and then the
patient consenting to the treatment; shared decision making is where the
physician educates the patient and the patient expresses their values to the
physicians and together they come to a decision to best treat the entire
patient (physically, mentally, spiritually….)
(4) The three interpretations are intertwined and strict adherence to one
interpretation over the other can pose a problem depending on the
circumstances and personality of the patient
(a) Ex: placing too much emphasis on sharing the decision might undermine
the decisional authority of some patients if they overvalue maintaining a
good relationship with the physician (pg. 17)
c) Goals of Informed Consent:
i) Protection of the patient/subject welfare and promotion of autonomy
(1) Conflict: how define welfare and by who?
(2) Welfare protection/ autonomy promotion is an example of the conflict
between medical paternalism and patient autonomy
(3) Giving patients autonomy has good benefits in treatment:
(a) Increases patient compliance
(b) Reduces anxiety
(c) Enhances patient satisfaction
(d) Facilitates monitoring of symptoms
(4) IC allows patients to exercise their autonomy and protect their well-being as
they themselves define it
(5) IC is not a matter of informing patients, when doing so will conveniently
promote treatment plan; it requires that patients recognize that they may
disagree with a recommendation and retain the authority to do so without fear
of withdrawal of treatment overall or any negative impacts from the treating
team
d) Autonomy and Well-Being
i) Key Idea: Need to view IC from the perspective that the patient’s values might
conflict with the physician’s desire to preserve life at all costs when sharing the
decision making, need to look at patient as person too
(1) Ex: patients who do not want to be put on ventilators or go through dialysis
(also an example of how increased technology has made IC much more
important to medical practice)
e) Ethical Justification of Informed Consent
i) Philosophy behind autonomy:
(1) Persons can exercise their wills, their self-ruling capacities, their autonomy.
This feature makes them inherently valuable.
(2) Kant argues that persons must act with respect for other persons as
intrinsically valuable, self-legislating beings
ii) Autonomy is the freedom from constraints and the capacity for self-determination
that permits individuals to pursue their own good in their own way: when they
have adequate information and opportunity they tend to promote their own wellbeing.
(1) Typically, respect for individual’s autonomy coincides with promotion their
well-being
(2) Patients must have the right to decide in light of adequate information, and
choose freely, to act in a way that will permite their well-being, as they define
it.
(3) This (2) act of autonomy promotes thier values and thus their overall wellbeing, even though another person might view this decision as contrary to
their well-being (from a strictly objective, or health provider perspective)
f) Constraints on Autonomy
i) Influencing patient’s decision:
(1) Can give opinion, but avoid overwhelming pressure on the patient, pressures
of time, dictatorial presentations of the information and options, and
suggestions that choice of “wrong” option will be dealt with punitively
ii) Ignorance
(1) The physician must provide substantial education and understanding to the
patient
(2) Ignorance is a remediable impediment to autonomous decision-making
(3) When patients are provided with information relevant to their treatment
decisions, in terms they can comprehend(!!!), then they are able to authorize
implementation of the treatment plan
iii) Intent
(1) Patient must intend to authorize the course of action consented to, or
alternatively, intent to refuse such authorization
(2) In intending, the patient assumes responsibility for the decision made!
g) Diversity of Decision-Making Preferences
i) Not all patients want to make decisions about health care
(1) Even if patients do want to make the final decision, they empirically want to
be well informed
ii) Patient views on IC: empowering to burdensome
(1) Important for physician to talk to patient to determine what role the patient
wants to play in deciding the course of treatment
(2) Many examples of views of patients (pg. 29- look at syllabus only if you don’t
understand, purely hypothetical examples given)
iii) One ideal model of IC is the shared decision making where the physician supplies
information on diagnosis and different treatment options, the patient supplies their
values and concerns and then the decision is made based on patient’s preferences
as to how they want to make decision (from signing a waiver of right to informed
consent because they feel to burdened, to involving family members and/or
friends, to an equal partnership between physician and patient)
h) Informed Consent: Right or Obligation & Reconceptualizing Autonomy
i) These were sections heavy in philosophy that, I think, go way beyond the scope of
the course… don’t waste your time here
3) Current Opinions of the AMA: see syllabus (three bullet-points)
4) Informed Consent Lecture: see syllabus (lecture in outline form, pay attention to LO
when reviewing because they are addressed specifically and also look out for decisionmaking capacities since it was not really covered in the reading)
5) GOOD LUCK!
Session 4: Treatment Refusal
Reading 1: Canterbury v. Spence 1969-1972
I. Facts of the case:
 19-yr-old Jerry Canterbury had back pain
o went to the doctor, medication did not alleviate pain
o was referred to Dr. Spence, a neurosurgeon
o told, after x-ray (normal) and myelogram (“filling defect” in T4 vertebra) that
he required surgery (laminectomy) to correct presumed ruptured disc
 Patient did not raise objections or ask about nature of surgery
o Mother poor and lives in W.V.
 Dr. Spence spoke with mother and when she asked if the operation
was serious he replied, “not anymore [sic] than any other operation.”
 Told her that her presence in Washington not necessary
 Testimony contradictory as to whether or not mother expressed
consent to operation
 Laminectomy performed
o Several anomalies
 Spinal cord swollen and unable to pulsate
 Accumulation of large tortuous and dilated veins
 Complete absence of epidural fat which normally surrounds spine
o Dr. Spence attempted to relieve pressure on spinal cord by enlarging dura at
area of swelling
 Patient recuperated normally until suffered a fall while attempting to void unattended
o Suffered immediate setback
o Several hours after fall could not move his legs and had trouble breathing
o Dr. Spence rushed to hospital and operated again
 Control over muscles returned but still could not void properly
o Has been under the care of several specialists, a urologist, and has had several
surgeries since
o At time of trial 10 years later, required crutches to walk, suffered from urinal
incontinence and paralysis of the bowels, and wore a penile clamp (ha!)
o Has had trouble finding work because of constant need to sit and be near a
bathroom
II. The Case Against Dr. Spence
 The testimony of Canterbury and his mother indicate that Dr. Spence did not reveal
the risk of paralysis from laminectomy
o Violation of physician duty to disclose
 Also claim that Dr. Spence performed the laminectomy negligently (which I think is
irrelevant to this topic and probably bogus anyway)
III. Duty to Disclose
 “Every human being of adult years has a right to determine what shall be done with
his own body…”
 True consent is informed, and allows a patient to evaluate the options available and
the risks of each option
 Physician under an obligation to communicate specific info to the patient when
reasonable care (due care) calls for it
o Includes warning the patient of any risks to his well-being involved with the
recommended course of action
 Course of action may seen obvious to the physician, but it is up to the patient to
decide for himself in which direction his interests lie
 Patients are nearly wholly dependent upon their physicians for medical information
and decisions, and an earlier case had found that in the patient-physician relationship,
the physician had a duty to reveal to the patient “that which in his best interests it is
important that he should know.”
o This case extends this duty to reasonable disclosure of choices with respect to
a proposed therapy and the dangers inherently and potentially involved
When/What is a Physician Obligated to Disclose?
 Traditionally, what a physician was obligated to disclose was dictated by the
standards and customs of the physicians practicing in a certain community
o Could be held liable for an unreasonable and injurious failure to divulge, but if
the omission did not forsake a practice prevalent in the profession, there could
be no recovery of damages by the patient
o This standard no longer holds
 No true discernible custom
 Must look at each case individually
 Gives the decision to the physician alone
 Patient’s right of self-decision can be effectively exercised only if patient possesses
enough info to be able to make an intelligent choice
o Test for determining whether a particular danger must be told is its relevance
to the patient’s decision
 How do we know what is relevant to the patient? We don’t.
 Don’t need to tell EVERYTHING, but need to approach from a view
of reasonable adequacy
 “Risk is this material when a reasonable person, in what the physician knows or
should know to be the patient’s position, would be likely to attach significance to the
risk or cluster of risks in deciding whether or not to forego the proposed therapy.”
 Need to disclose:
o Inherent and potential hazards of proposed treatment
o Alternatives to the treatment
o Results likely if patient remains untreated
 No bright line separating significant from insignificant, must use reason
o No need to disclose dangers inherent in any operation (e.g. infection)
o No need to disclose that which has no bearing on decision
Reading 2: State of Georgia v. McAfee 1989
Facts of the Case:
 Larry McAfee suffered severe spinal cord injury in motorcycle accident
 Quadriplegic and needs ventilator
 No hope his condition will improve
 Filed a petition with the Superior Court to be allowed to turn off ventilator, which
will result in death
o Requested a sedative to alleviate pain
 Competent adult who has been counseled and has talked to his family
o Family supports decision
 Petition granted
o Rights to privacy, liberty, and to refuse medical treatment outweigh state
interest in preserving life
o Could not order medical professional to remove, but will not prosecute anyone
who does
o “no basis in this case upon which the State may intervene and oppose the
exercise of Mr. McAfee’s right to refuse treatment.”
o Also granted the sedative to alleviate pain
 4 interests of the state balanced against right to refuse treatment:
o interest in preserving life
o interest in preventing suicide
o preservation of integrity of medical profession
o protection of innocent third parties
Powerpoint slides
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Purpose of consent
o Promote individual autonomy
 “Every human being of adult years and sound mind has a right to
determine what shall be done with his body”
Origins and current status of informed consent
o Originates from battery law – treatment WITHOUT consent
o Today: hybrid of battery and negligence – 2 duties
 Duty to obtain consent (battery)
 Duty to disclose info to patient to obtain consent “worthy of the name”
(negligence)
What to disclose?
o Risks, benefits, alternatives
How much to disclose?
o A “standard of care” issue – 2 standards
 “Materiality” standard: what a reasonable patient would find material
to making a decision
 “Customary” standard: what a reasonable physician would disclose
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o Exceptions
 Emergency
 Obtain consent if possible
 In “act now” situations, treat w/o consent or disclosure
 Incompetency
 Patient lacks capacity to make decisions – informed consent
not needed
 Need informed consent of someone with legal authority to
consent
 Waiver
 No need to disclose if patient doesn’t want it
 Patient may give right to decide to someone else
 Has right to decide/info before waiver is valid
 Therapeutic priviledge
 Physician may withhold certain info if providing info would
cause patient to be so upset they could not make rational
decision
 Cannot withhold info if providing info would cause patient to
refuse treatment
Origins of right to refuse treatment
o Battery to treat w/o consent
 Therefore there is a right to refuse treatment
Extent of right to refuse treatment
o Treatment refusal is permitted even when result is patient’s death, if patient is
competent
 Incurable (McAfee)
 Curable (blood transfusion refusal)
Incompetent patients
o Also have right to refusal, but someone else must make that decision –
surrogate
o Surrogate should be guided by patient’s actual or presumed wishes, and if not
known, by patient’s best interest
Dax’s Case
o Dax Cowart critically injured in an explosion which killed his father
o Underwent painful treatment for over a year in acute burn wards and surgical
suites of hospitals
o Wanted to die ever since he came to hospital
o Declared competent by his psychiatrist but pleas rejected
o Made “Please Let Me Die” video and “Dax’s Case” video
Reproductive Technology
Article I - Sex selection and preimplantation genetic diagnosis
 In 1994 the Ethics Committee of the American society of Reproductive Medicine
concluded that sex selection is not acceptable for when used for nonmedical reasons.
 Three methods are available for prepregnancy/prebirth sex selection:
o Prefertilization separation of X-bearing from Y-bearing sperm
o Pre-implantation genetic diagnosis (PGD) w/sex-selection
o Prenatal genetic diagnosis followed by sex-selective abortion
 PGD is main focus and used with IVF to identify genetic disorders.
 Sex selection motivations: culturally preferred gender, balance in a family, birth order
 Two primary arguments for PGD:
o The right to reproductive choice; sex selection is a logical extension of this
right
o The medical benefits of preventing sex-linked genetic disorders
o Further arguments include: gender balance in society, lesser evil compared to
sex-selection by abortion, population control (parents no longer would have to
keep having children to get one of the desired sex), arguments same as
motivations above
 Arguments against include: potential for gender discrimination, control over
nonessential characteristics in children, unnecessary cost/burden on parents, use of
limited medical resources on selection rather than more genuine needs.
 Four cases where embryo sex identification by PGD for nonmedical (no sex-linked
disease risk) reasons each requiring distinct ethical assessment:
o Patient learns sex of embryo as a by-product of undergoing PGD for other
medical reasons.
o Patient requests sex identification added to PGD being done for other medical
reasons
o Patient undergoing IVF, PGD not necessary but patient requests for sole
purpose of sex identification
o Patient requests both IVF and PGD for sex identification
 For sex-related disorders, selection is justified, it is less easy to eliminate concerns
regarding sex selection thru PGD when descending the above list.
 Such selections has the potential to contribute to a society’s gender stereotyping and
discrimination, giving gender as a reason to value one person over another
 Furthermore, many would judge it unreasonable for individuals who otherwise do not
need IVF to undertake its burdens solely for the purpose of sex selection.
 The article suggests the “slippery slope” argument of choosing nonessential
characteristics is overdrawn in the case of sex-selection
 In US healthcare system, questions of misallocation of resources difficult to sustain; it
is hard to judge if an individual is willing to pay for services how that takes away
from the basic care of others.

Recommendations from committee:
o Preimplantation genetic diagnosis in prevention of serious genetic disease is
ethically acceptable
o In patients undergoing IVF, PGD used for sex selection for nonmedical
reasons holds some risk of gender bias, harm to society, etc. Such use of PGD
should not be encouraged.
o Use of IVF and PGD solely for sex selection has an even greater risk and
should be discouraged.
o Ethical caution regarding PGD for sex selection calls for the continued study
of the consequences of this practice.
Article 2 – Reproduction and Responsibility, The Regulation of New Biotechnologies
A Report of the President’s Council on Bioethics, March 2004
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Primary goal of report is to describe and assess the various oversight and regulatory
measures that govern the biotechnologies and practices associated with assisted
reproduction, human genetics, and human embryo research.
Reasons the Council took up the subject:
o Health/Well-being of humans directly affected by the technologies
o Relief of those affected by infertility
o Compassion for children with serious genetic diseases
o Intrinsic value of knowledge of human development/genetics for new
treatments.
o Privacy of genetic information
o Foundational value of human life and respect owed at its various stages
o Aspects of human freedom in regard to these issues (parents making own
reproductive decisions, scientists to conduct research, protect children from
improper control of their genetic-make up)
o Promotion of justice and equality (access, prevent discrimination for genetic
inferiority, etc.)
o Protection of human dignity, relationships, humanity of procreation
Report aims to improve nation’s capacity for future diagnosis of the state of this field.
Council feels that the starting point is related to assisted reproduction because all
future technologies presuppose this ability.
Council’s Findings:
o Fields of assisted reproduction, genetics, and embryo research increasing
converging
o There is no uniform system of oversight for reproduction biotechnologies
o Minimal direct governmental regulation of assisted reproduction or access to
it
o Extensive professional self-regulation that is purely voluntary
o No oversight of how new biotechnologies affect the well-being of children,
donors, gestational mothers
o Novel technologies/practices move from experimental to clinical contexts
with little oversight/deliberation
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o No uniform system for public review regarding larger social significance of
reproductive biotechnologies
o PGD is unregulated
o Gene transfer research highly regulated
o No uniform oversight regarding use and disposition of in vitro human
embryos, nor is there a mechanism for regulation of commerce is gametes,
embryos, and assisted reproductive technology services
o Patenting of embryonic or fetal human organisms prohibited as of 2004
Policy Options and Recommendations are difficult to make due to a simple lack of
data. The Council was not prepared to recommend any sweeping institutional reform.
Modest measures and recommendations to clear and significant present problems
were made in three general categories: studies/data collection, oversight and self
regulation by professional societies, targeted legislative measures:
Studies/Data collection:
o Federally funded longitudinal study of impact of these biotechnologies on
children born with their aid, and the health and well-being of women who use
them
o Strengthen and augment the Fertility Clinic Success Rate and Certification
Act:
 More user-friendly reporting of data, report all adverse health effects,
average price of procedures, info on new/experimental procedures,
specific reporting of specialized techniques (like PGD), provide model
forms for decision making, provide stronger penalties to enforce act,
increase funding
Oversight by Professional Societies
o Strengthen informed patient decision-making
o Treat child born by assisted reproduction as patient
o Improve enforcement of existing guidelines
o Improve movement of procedures from experimental to clinical
o Minimum standards for protection of subjects
o Develop additional self-imposed ethical boundaries
Legislative Measures
o Prohibit transfer of human embryo into any non-human species
o Prohibit hybrid human-animal embryo
o Prohibit transfer of human embryo into a women for any purpose other than
attempt to produce a live-born child
o Prohibit attempts to conceive by any means other than union of egg and sperm
o Prohibit conception by using gametes obtained from human fetus or human
embryonic stem cells
o Prohibit attempts to conceive by fusing blastomeres from two or more
embryos
o Prohibit use of human embryos in research beyond designated state in their
development (10-14 days post fertilization).
Article 3 – Preembryo Research
 The purpose of this article is to present the relevant considerations from the findings
of contemporary embryology and to propose ethical guidelines for research
 Historical Perspective: Restrictions and Policies
o In 1974 national Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research was established by Congress
o In 1975 all IVF related projects had to be approved by a national Ethics
Advisory Board {EAB}
o In 1979 EAB agreed embryo entitled to respect but not necessarily full
legal/moral rights attributed to persons and recommended use of gametes of
consenting donors to study IVF
o As of 1994 recommendations still not approved by Secretary of Health and
Human Services, no federal support of IVF permitted
o Research has only occurred in private and university-based in context of
infertility treatment.
 American Fertility Society recognized ethical difficulties and
recommended specific guidelines, noting preembryonic state is
considered to last until 14 days after fertilization
 Therefore, human preembryos are not to be maintained past 14 days
o In 1991 National Advisory Board on Ethics in Reproduction established in
private sector
 The Benefits and Risks of Human Preembryo Research
 Benefits:
o Knowledge of embryogenesis and embryopathy
o Understanding of human implantation and causes of spontaneous abortion
o More effective/simpler forms of contraception
o Improving IVF treatment for both male/female infertility
o Develop preembyro techniques for PGD
o Improving technique of microinjection of spermatozoa into eggs
 Risks:
o Some research only validated and clinically beneficial if there is a subsequent
transfer of preembryo in attempt at creating a pregnancy. Such research may
enhance success, others may hinder
o Preembryo research may be performed in a way that risks infringement of the
rights of sperm and oocyte donors
o Great potential to harm or destroy the preembryo itself
o Raises concern that this will diminish respect for human life in general
o This turns discussion to degree of moral weight to be given to a preembryo
 Fertilization and Preembryonic Development Stages
 Preembryo refers to entity in development that begins with fertilization and ends
approx 14 days later with appearance of primitive streak
 Check out graph on page 94
 Fertilization:
o Takes approx 24 hrs after penetration of oocyte, typically occurring in
fallopian tube at the end near the ovary
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o Completed when pronuclei of sperm & oocyte fuse to form zygote
 Genetic contributions separate at this point and can be removed
o Last stage called syngamy when haploid chromosome sets finally fuse
Early Preembryonic Development
o Zygote undergoes mitotic division, moves towards uterus
 First divisions takes approx 20 hrs
o Series of divisions leads to development of preembryo with newly divided
cells called blastomeres
o From 1-3 days division into 2 then 4 cells, at 3 days reach 8 cell, and from 4-5
days reach 16 cell stage
o Blastomeres remain undifferentiated (totipotent) until after 8-cell to 16-cell
stages at which point they from the morula
o First 3, maybe 4 divisions occur with no fusion b/w cells, they are instead held
loosely by the zona pellucida
o mRNA, organelles of oocyte provide everything for early cells, paternal
genome does not occur until approx 8-cell stage
o Blastomeres grow progressively smaller during early division, with group
retaining the size of the original oocyte
o From 4-5 days after syngamy, morula develops into a blastocyst, which
remains unattached in uterine cavity for about 2 days
Implantation
o As blastocyst attaches, cells organize into 2 layers, with the outer layers
(trophectoderm) eroding uterine wall
o Implantation completed when blastocyst fully embedded in endometrium
o Outer cell layer continues to establish complex interaction with uterine tissues
and give rise to placenta and membranes
o Inner cell is progenitor of all cells of future embryo, still undifferentiated
o Embryo stage begins after about 16 days when all cells are either part of the
placenta or part of the embryo
Ethical Relevance of Scientific Information – 2 factors of embryonic development
vital to identify the 14 day limit:
o Lack of individuation of developing entity
o Natural failure of a high percentage of zygotes to develop into embryos
Individuation of Singleness
o From what is known, final individuation only accomplished with development
of primitive streak (approx 14 days after fertilization)
o Fertilization, however, is a 2 day process
o Once completed, there is an entity with a new genotype, but it is not capable
of expression of new genotype and is regulated by oocyte
o It has been demonstrated that up to 8-cell stage, 1 or more blastomeres can be
removed and still produce a complete adult individual
o Also 2 preembryos can aggregate into one individual (chimera)
o Up until formation of primitive streak preembryo capable of dividing into
more than 1 entity
o Researchers thus suggest that up to 14 days after fertilization, the preembryo
does not possess the biologic individuality necessary for a concrete
potentiality to become a human person, despite unique genotype
 Spontaneous Early Preembryo Loss
o There is evidence of a naturally high percentage of loss of preembryos
o Generally 10-15% clinically recognized pregnancies terminate spontaneously
o Up to 60% of fertilizations do not survive long enough to result in a missed
menstrual period
o May be caused by error in gametogenesis, defects in fertilization process,
developmental abnormalities, delay in implantation, etc
o According to available data, loss is highest in first 14 days
o Investigators have not sustained viable in vitro human preembryo beyond 6-9
days after fertilization
o This high rate of loss further suggest the moral status of preembryos be
differentiated from that of embryos
 Ethical Considerations – the guidelines discussed here are in context of embryos
created for a prospective couple to have a child, and “spare” embryos are left over,
NOT for the case of preembryos created for the purpose of research
1. Guidelines:
1.1. Research conducted only by qualified individuals in appropriate settings with
adequate resources and protections
1.2. Questions explored are scientifically valid
1.3. Information sough offers potential scientific and clinical benefit
1.4. Research objective cannot be met thru research on animals or unfertilized gametes
1.5. Design of research clearly formulated in protocol submitted to special independent
committee (such as IRB)
1.6. Research concluded at earliest possible developmental stage
1.7. Preembryo that has undergone research only transferred to uterus if related to
preparation for placement, reasonable confidence in normal development
1.8. No sale of purchase of preembryos
1.9. Donors adequately informed of goals, methods, hazards/benefits
1.10.
Donors provide opportunity to determine disposition of preembryos
 Ethical Commentary on Guidelines(only the unclear ones):
o 1.4 – human research only engaged when alternative means inadequate,
however, direct extrapolation of results from in vitro animal studies to human
can be misleading, also unfertilized oocytes do not offor knowledge of growth
processes
o 1.6-1.8 – Based on position that preembryo is human, but not a human person
with a determinate potential to become an individual, risks of harm to
preembryo in research can be justified, but not without limits
o 1.9-1.10 – Issues of what to do with extra preembryos is a major issues here.
One possibility - cryopreservation for future use, or donation to recipient
unable to produce. Individuals who donate are responsible for proper decision
making. Each IVF program must develop policies regarding disposition of
preembryos, and must fully and completely inform all participants
Power Point Points
Objectives: Review infertility/assisted reproduction, use of analogous cases in ethical issues
Infertility
 15% reproductive age women had infertility-related medical visit in the past, 2% in
the last year
 Main Causes: Semen Abnormality, Tubal Defect, Endometriosis, Ovulation Defect,
Unknown
 Assisted Reproduction includes all fertility treatments in which both eggs and sperm
are handled
 Costs: IVF procedure – 6000, IVF drugs – 4000, Special fertilization – 1000, Egg
Donor – 6000, PGD – 5000, Cryopreservation – 1000
Ethical Issues in Assisted Reproductive Technology (ART)
 Patients are healthy, therapy not risk free, justify risk of procedures?
 Successful therapy creates another person
o Moral status of embryo, cannot advocate for itself
o Embryo creation/disposal/adoption, selection of characteristics
o Are patients fit to be parents?
 Poor evidence base for clinical practice - uncertainty for practitioners
o Difficulty with informed consent
o No treatment algorithms, large amnt of discretion
 Rapid Pace of innovation turning into available therapy
o No time to evaluate long term outcomes
o Therapy causes unexpected medical harm? Impact on individual or family?
 Is infertility a disease?
o Disorder may be present, therapy does not treat however
o Therapy treats childlessness
o Is problem significant enough to warrant insurance coverage, no coverage for
most Americans
 Financial pressure for successful therapy, treatment decisions focus on
cost
 “Cost Sharing” for ART
o Lump sum payment for successful outcome (Baby w/in 3 cycles or money
back)
o Parents who succeed on 1st cycle subsidize those that get mondy back
o Ethical issues of this policy?
The idea of analogous cases is mentioned as a bullet point at the end of each slide, but she
didn’t actually include any, it was something that was discussed in class as something that
can shed light on ethical dilemmas in ART.
Law at the End of Life
Blue page 14 in syllabus
Learning objectives:
1. To understand the relationship between the right to refuse treatment and end-of-life
decision making
2. To understand that the legal basis for end-of-life decision making is based not only on law
but also on a societal consensus composed in part of public opinion and professional ethics
3. To understand the procedures and standards governing end-of-life decision making for
both competent patients and incompetent patients
I. Lecture material
*rrt = right to refuse treatment
A. The consensus for end of life decisions
 Brought to forefront by Quinlan case in 1976 (recognize the name Quinlan)
 Involves law (judicial decisions, legislation), ethics (commentaries of
experts), public policy (e.g. commissions and panels for such matters), and
currently accepted medical practice
1. Competent Patients’ RRT
- virtually absolute right from common law, constitution and principle of
autonomy
2. Incompetent Patients’ RRT
- still have same RRT, but must be exercised differently
3. Traditional moral distinctions *note all have been discredited
a. acts vs. omissions
- traditional: acts leading to death = unacceptable
Omissions are acceptable
- discredited: omissions can be immoral if there is a duty to act
b. withholding vs. withdrawing
- traditional: withholding = OK, withdrawing = unacceptable
- discredited: slippery slope because doctors might not try some options
like a stomach tube
c. Ordinary vs. extraordinary treatment
- traditional: patients morally obligated to accept ordinary treatment
Not obligated to accept extraordinary treatment
- discredited: impossible to define extraordinary & goes against RRT
4. RRT procedure for Incompetent
- should be done in clinical setting by the close family members IF the
patient no longer has capacity AND lacks an advanced directive
- only go to court if there’s an intractable argument or conflict of interest
5. RRT standards for incompetent patient
- must use “substituted judgment” standard (what the person would want if
competent)
6. Role of advanced directives
- Living Will – indicates persons wishes for certain types of treatment
- durable power of attorney – give someone else authority to act for you on
your behalf for all health care decisions if incompetent
7. Artificial hydration and nutrition
- IS a form of medical treatment that can be withheld or withdrawn
8. Actively hastening death
- forgoing life sustaining treatment is not active euthanasia nor murder
II. Readings
A. Brophy v. New England Sinai Hospital
In this case, Brophy’s husband was in a persistent vegetative state (PVS) with no
chance of recovery. Prior to injury, he had clearly and repeatedly said he never wanted to live
in a PVS. No one objected to the removal of his G-tube. Hospital refused to remove it; courts
backed hospital. Judge said he considered: 1. Brophy’s expressed preferences 2. his religious
convictions 3. impact on his family 4. probability of adverse effects 5. prognosis with and
without treatment.
“The right to refuse medical treatment in life threatening situations is not absolute.
We have recognized at least four countervailing State interests: 1. the preservations of life 2.
the protection of interests of innocent third parties 3. the prevention of suicide 4. the
maintenance of the ethical integrity of the medical profession.”
#4 is why hospitals can refuse to remove life sustaining treatment.
B. Schiavo Autopsy Shows Massive Brain Damage
Terry Schiavo had been in a PVS for 15 years. Husband wanted to remove feeding
tube as per her wishes; parents wanted to keep her alive and try therapy. Legislature and
executive branch both had some intervention on her behalf, but courts would not intervene.
G-tube eventually removed and she died. Autopsy shows was indeed brain dead with no
chance of recovery. Case highlights importance of having clear wishes and system to express
those wishes should one become incapacitated.
Ethics, Law & Professionalism – Final Exam Review
IMPAIRED PHYSICIANS – Lecture by Dr. Melissa McNeil
Learning Objectives:
1. Understand the definition of impaired physicians
2. Know the prevalence and characteristics of physician substance abuse
3. Understand the consequences of substance abuse to the individual physician
4. Appreciate the appropriate course of action if one suspects a colleague of
substance abuse
Reading:
Knight, J. “A 35-year-old physician with opioid dependence.” Journal of the American
Medical Association, 2004. 292: 1351-1357.
[No summary is provided here as Dr. Pacella indicated at the 11/29 lecture that test questions
are NOT derived from assigned readings]
Lecture:
Definitions:
o Impaired physician – any physician who is unable to practice medicine with
reasonable skill and safety.
o Substance abuse – a cluster of cognitive, behavioral, and physiological symptoms
indicating that the individual continues use despite significant problems; these
symptoms may or may not be present in the workplace
o Substance dependence – multi-faceted; includes: tolerance, withdrawal
symptoms, ineffective attempts to cut down usage, increased proportion of time
devoted to using and recovery
Key Points of Impairment
o Impairment can result from many things, including mental illness, physical injury,
substance abuse, or even HIV infection (according to some)
o Impairment related to substance abuse can result from actual use as well as
withdrawal symptoms, including “hangovers”
o Professional work is commonly one of the last components of a physician’s life to
suffer when addiction develops, in large part because physicians will go to great
lengths to prevent the loss of their medical licenses or their good reputation within
the medical profession
o Ironically, some drug-dependent MDs may be less impaired when actively using
than when withdrawing
Key Points of Self-Prescribing
o A somewhat common, but also illegal practice
o Can be a sign of undiagnosed disorders related to stress or pain – an attempt to
treat quickly and get on with work (very common for MDs who self-prescribe to
cite “improved work performance” as a reason for doing so)
o Use typically accelerates over a period of months or years into the domain of
abuse
Risk Statistics:
o Substance Abuse rates NOT statistically different than general population; 8%
faced an addiction at some point; 2% faced an addiction within last year
o Alcohol use rates are HIGHER than general population
 Men – physicians 88%; general pop: 79%
 Women – physicians 85%; general pop: 70%
o Physicians LESS likely to use illicit drugs, but MORE likely to use prescription
analgesics (i.e. – self-prescribe) than general population
o Drug abuse most common among emergency medicine physicians (increased
odds ratio for marijuana use), psychiatrists (increased OR for benzodiazepines),
and anesthesiologists (increased OR for opioids); least common among surgeons
and pediatricians
o Behavior as a premedical and medical student may predict future risk of substance
abuse
Signs of Impairment -Early:
- alcoholic family
- drinking while studying
- frequent intoxication
- blackouts
- no religious affiliation
- likable personality
- good grades/patient care
Late:
- family dysfunction
- drinking “on call”
- auto accidents
- public intoxication
- memory impairment
- missed work
- poor patient care
Where to Get Help
o Every state has a programs designed to assist physicians with substance abuse
problems (PA has Physician’s Health Program)
o Most hospitals have a confidential physician health/wellness committee
o The goals of the referral programs are to provide assistance BEFORE patient care
is adversely affected – these programs provide rehabilitation, and are not punitive
(i.e. – do not result in loss of medical privileges)
o Physicians who break the law (practice while under the influence, get caught selfprescribing narcotics, etc.) are subject to review by the state board of medical
licensing. Additionally, they may lose their admitting privileges at the hospital
with which they were affiliated whether or not they lose their license
o Society invests a lot of resources in physicians – they are expensive to train and
difficult to replace; therefore, the optimal outcome is to rehabilitate every
physician and not let addiction progress to the point where the only safe, viable
option is to revoke license/privileges
o PittMed – SHARP offers peer counseling and referral services
Responsibilities when one suspects a colleague of substance abuse
o You are obligated to report a reasonable suspicion to the state board
o Many states (including PA) allow for initial attempt to help via referral to a
confidential physician health program (no punitive measure from state board)
o If a colleague refuses help, it is your professional obligation to report him or
her to the state board
o Alcohol is especially tricky because it is NOT illegal to be alcohol-dependent; it
is, however, illegal to be intoxicated or in withdrawal while working as a
physician
o Reporting requirements do not change whether work impairment becomes selfevident (i.e. – you are no more or less obligated to report a colleague after s/he
screws up on the job than you were when you initially developed your suspicion
of abuse)
Treatment & Return to Practice
o Usually begins with acute detoxification under medical supervision
o Follow-up always includes therapy (individual and group); support of family and
peer groups (e.g. – Alcoholics Anonymous) is crucial to obtaining a positive
outcome
o Reports indicate 75-90% of substance-dependent physicians are able to
rehabilitate and stay sober; a clear majority are able to return to practice
eventually
o Long term monitoring (usually by Physician Health Program) is important and
frequently a mandatory stipulation in order to return to practice
o Returning to practice is an individual decision. As long as no law was broken
which resulted in suspension of the medical license, recovering physicians are
usually able to obtain work again
Medical Student Impairment
o Common; and commonly explained away as “study hard, party hard”
o SHARP is ready to act as advocate and assist in obtaining help for any medical
student at Pitt
o “Easier to get help BEFORE you are licensed and have a patient population than
afterwards” (Dr. McNeil’s words of wisdom)
Conclusions:
o Physician substance abuse is common
o Drugs of abuse are often prescription and alcohol rather than street drugs
o Work performance is often the last facet of the physician’s life to be affected
o Treatment has an excellent prognosis
o “You don’t do anyone any favors by not reporting” [another of Dr. McNeil’s
words of wisdom]
Session 9: Abortion
Notes: abortion = AB. I attempted not to include statistics since we were told those would not
be tested. However I did include a few to illustrate important points.
Learning Objectives:
1. To acquire a basic understanding of the Constitutional and legal framework
established in Roe v. Wade and the reasons for the Supreme Court’s decision in
that case
2. To acquire a basic understanding of how the Supreme court’s decision in
Planned Parenthood v Casey modified Roe’s constitutional framework and the
reasons for the court’s decision in that case
3. To gain an introductory understanding of some of the current legal and ethical
issues likely to affect access to abortion in the future and the legal environment
for abortion providers and women seeking access to abortion
History of abortion Prior to Roe v Wade:
• Until mid 1800’s abortion legal up to “quickening” (feeling fetus move)
• By 1900s illegal across country
Exceptions: -Mother’s life in danger
-1967-73 some states had exceptions for rape, incest, mental health in
jeopardy
• Illegal abortions: despite being illegal they were common (and dangerous)
1930 abortion accounted for 18% maternal deaths that year
1960 hospital admissions: 1 abortion for every 42 deliveries
• Disproportionately affected poor women and women of color
• Video: Motherless Four people telling personal stories of how their mothers died from
illegal abortions. Addressed medical issues leading to their deaths, social/political context
that drove these women to seek illegal abortions, and broke down stereotypes of the kinds
of women who sought illegal abortions.
Beginning of Change:
• 1967: England liberalized AB law-any woman could have AB with consent of 2 doctors.
Sparked trend of US women traveling abroad to receive ABs (in other words, women
with money could travel to have legal abortions, poor women could not)
• 1970: Four states (AK, HA, NY, WA) repealed abortion laws
Physicians allowed to perform ABs on request before viability
AK, HA, WA required 30 day residency period
NY did not have residency, thus became haven for women seeking abortion
Roe V Wade (1973):
• Jane Roe: anonymous woman in Texas. At the time claimed she was a rape victim.
Roe claimed Texas’ strict abortion law had violated her right to terminate her pregnancy and
that this was a violation of the 14th amendment: 14th amendment 1868- protection of life,
liberty, property without due process of law
• Court notes “sensitive and emotional nature of abortion controversy”
• Reference to separation of church and state
• Acknowledged vintage of relatively recent implementation of modern, strict, abortion
bans and the effect they have had.
• When a constitutional question comes forward, court tries to weigh state’s interest in
intervening (in this case, what is state’s interest in banning abortion?)
o Points:
• Morality of 1850’s was different than morality of 1970’s “an anachronism”
• Concern about medical safety: in the hands of experienced physician 1st
trimester abortion is very safe (actually safer than carrying pregnancy to term)
while backroom abortions were extremely dangerous
• Protection of fetal life: legitimate interest but fetus not protected by constitution
• Woman’s right to privacy: No established, constitutional right to privacy, but it is
implicitly protected under 1st,4th,5th,9th,14th amendments
• Fight for abortion rights grounded in “liberty”: Being forced to continue unplanned
pregnancy represented bodily harm to women
Right to decisional autonomy, bodily integrity
Decision was not based on women’s equality, or equal protection
 Scope of rights:
Did not assert right to abortion, rejected abortion on demand
Only rejected state intervention. They are not mandated to provide service.
• Adopted trimester framework:
i.
1st trimester: women’s right prevails, may elect for abortion free of
interference
ii.
2nd trimester: state’s interest in maternal health is stronger because procedure
has more risks. State may restrict access to this service as long as maternal
health is preserved
iii. 3rd trimester: fetus has reached viability, states interest in protecting fetal life
plays large part. State may prohibit procedure but *must have exception for
health of mother*
Post Roe v Wade:
• Abortion funding: shortly after Roe, decision made that federal funds cannot be used to
fund abortions except for cases where mother’s life is at risk, rape, or incest. Abortion is
right to freedom from government interference, not an entitlement to government help.
• Roe did not end abortion debate
• Many states have passed restrictions to test limits of Roe
• 1980’s during Reagan administration saw huge push to overrule Roe- it didn’t happen
Planned Parenthood v Casey (1992)
• Planned Parenthood challenges PA law:
• Three tenets of PA law:
i.
Parental consent for minors
ii.
Husband notification for married women
iii. “informed consent” and mandatory waiting period: 24 hrs prior to procedure
woman must meet with Dr who will perform procedure to receive state
mandated literature and consultation.
• PA welcomed challenge in hopes court would use opportunity to overturn Roe
• Outcome: Court upheld Roe, but with revisions:
 Before viability state cannot restrict abortion if it imposes an undue burden- vague
about what constitutes undue burden
 Interest in protecting fetal life from onset, even in 1st trimester
 Viability became marker for when state can ban AB entirely as long as there is a
maternal life/health exception- how broad is this exception? Who decides? Not
specific.
 24 hr waiting period with informed consent upheld
 Parental consent upheld. Consent of one parent or guardian required. Required a
judicial bypass option.
 Spousal notification not upheld: found to provide undue burden
 Restrictions on abortion only violate Roe if they provide undue burden. However it is
unclear what defines an undue burden.
 Life/health exception is key to upholding modifications of Roe. However there is no clear
line for where these exceptions lie, as we saw with our case study.
Partial birth abortion controversy:
• Stenberg V Carhart (2000)
• Nebraska had attempted to pass law banning method known as “dilation and extraction”
or (D&X) aka “partial birth abortion” without an exception for maternal health. They
claimed there was no circumstance in which D&X would be only option to protect a
woman’s health. Made it a felony for any Dr to perform this procedure.
• Court struck down this law because it had no exception for health of mother, also because
law was vague and poorly written.
• Remains ongoing, hot topic of controversy.
• Current federal “Partial Abortion Ban” being challenged in federal court. It too, lacks
adequate exception for maternal life/health risks.
Lecture 1
Reading 1: Oath of Hippocrates
 Doctor must protect confidentiality, show respect to mentor, give money to
teachers in need, avoid intentional injustice, not to give a deadly drug to
anybody if asked for it.
Reading 2: Principles of Medical Ethics-AMA
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Physician must recognize responsibility to patients (primarily), society, other
health professionals, and to self.
Physicians must:
o Provide competent care with compassion for human dignity and rights
o Uphold the standards of professionalism
o Respect the law and seek changes when law is contrary to the best
interests of the patient
o Respect patient confidentiality
o Continue to study, apply, and advance scientific knowledge, medical
education
o Be free to choose whom to serve and with whom to associate
o Improve the community and public health
o Responsibility to the patient is paramount
o Support access to medical care for all people
Reading 3: Declaration of Professional Responsibility-AMA
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
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Medical profession must reaffirm its historical commitment to combat natural
and man-made assaults on the health and well being of humankind
“Humanity is our patient.”
Physicians must commit themselves to:
o Respect human life and dignity of every individual, refrain from
supporting or committing crimes against humanity, treat the sick and
injured with competence and compassion and without prejudice, apply
knowledge and skills as needed, though doing so may put us at risk,
protect the privacy of patients, work freely with colleagues to develop
advances in medicine, educate the public, advocate for social,
economic, etc changes that ameliorate suffering, and teach and mentor
those who follow.
Guidelines for Analyzing Ethics Cases
Identify:
1) Ethical problem
2) Relevant ethical standards and values and the clinical and social facts
-respect for autonomy, patient well being, honesty, etc.
-mental status, patient actions and motives, etc.
3) Alternative resolutions of the ethical problem
4) Best resolution of the ethical problem
5) Justify the conclusion-requires:
a) Assessing each alternative from the perspective of the relevant ethical
standards
b) Presenting the reasons for concluding that the favored alternative is the best.
[Will draw on analysis in a)]
Reading 4: Can Ethics Provide Answers?
Ethics and Ethical Theory
 Two schools of thought:
1) Ethics is a subject-provides answers to questions of conduct.
2) Ethics is not a subject-there are important questions, but they do not
have definite answers.
 Ethics-the subject that attempts to provide directions for conduct
 Ethical theory-concerns itself with questions about ethics-2 categories:
1) The relations between various principles that are used in justifying
particular moral judgments
2) The status of ethics
 Philosophers in the past turned away from studying ethics ( for lack of
definite answers), but rather focused on the study of the language of
ethics, the ethical theory
 Modern times have shown a reuniting of ethical theory with ethics.
The Case Against Ethics
 Social sciences’ understanding of human nature has seemed to many
people incompatible with a belief in the objectivity of ethics (a belief in
objective standards of right and wrong).
 Moral standards differ from culture to culture according to sociologists.
Psychologists argue that moral beliefs are formed in nonrational ways in
the individual. Thus, many people believe that these subjects explain
ethics away.
 Philosophers believe that differences in ethics among cultures does not
entail that ethical truths do not exist. Also, psychology tells one only about
how beliefs are formed and nothing about the nature of those beliefs.
 Emotivism-the most influential theory of ethics in the 20th century.
-moral judgments are not really judgments at all, but disguised imperatives
Ex.- Moral judgment: It is wrong to make someone the subject of an
experiment without his permission.
Translates to…
Don’t make someone the subject of an experiment without his permission.
Problem with emotivism: Failure to account for the place of reason in
ethics
Ethics and Rationality
 The case against ethics can be answered only by demonstrating how moral
problems are amenable to solution by rational methods.
 One must be sure to correctly represent the facts. Reason sets out the facts.
 Consistency is the prime requirement of rationality. An ethical view must
pass the test of consistency.
 Consistency requires that if there are exactly the same reasons in support of
one course of conduct as there are supporting another, those actions are
equally right or equally wrong.
 One must be sure to be clear about the definitions of the concepts that are
employed in moral arguments.
The Limits of Rationality
 The fact that rationality has limits does not subvert the objectivity of ethics,
but it does suggest a certain modesty in what can be claimed for it. Ethics
provides answers about what we ought to do, given that we are the kinds of
creatures we are, caring about the things we will care about when we are as
reasonable as we can be.
Introduction to Ethics-Power Point Summary
Standards of Right and Wrong
1) Ethical standards
2) Clinical norms
3) Legal standards
4) Professional codes and guidelines
Clinical norms
-effectiveness in diagnosing disease, restoring health, or preventing death
-standard of care
Legal standards
-avoiding civil or criminal liability
Legal and ethical standards-a necessary connection?
No. (think about example of physician assisted suicide)
Professional codes and guidelines
-oath of Hippocrates, AMA medical ethics, declaration of professional
responsibility.
Two standards and obligations in professional codes and guidelines:
1) Special professional standards (apply specially to doctors)
2) General ethical standards (apply to everyone)
Special professional standards (shown in Oath of Hippo, AMA Med Ethics, DPR)
-see above notes
Possible bases of special professional standards and obligations:
1) Tradition
2) Job description
3) Goals of medicine
4) Social contract
5) Justice
6) General ethical standards
General ethical standards (shown in Oath of Hippo, AMA Med Ethics, DPR)
-see above notes
Possible bases of general ethical standards and obligations:
1) Good based ethical theories
2) Universalizability based ethical theories-good moral rules apply to all human
beings
3) Respect based ethical theories
4) Agreement based ethical theories-all rational people should be able to agree on
5) Rights based ethical theories-rights should underlie the ethical principles
6) Ideal observer theories-think of all knowing spectator who views things and then
makes a decision
Realistic goal for ethical questions: Produce well-reasoned answers where all clinical issues,
relevant values, and social facts are considered.
Lecture 13 - Interactions with Pharmaceutical Companies
Reading One
 The issues regarding doctor/drug rep relationship:
o Surge in prescription drug spending ($162.4 bil in 2002)
o Publicity surrounding several prominent legal cases against drug companies
o Increased recognition of embarrassing relationships between physicians and
drug reps
 Drug companies serve two purposes:
o Make available helpful medications to physicians and general public
o Generate money to keep their company viable
 Profit generation usually takes precedence
 Physicians meet w/ drug reps approximately 4 times per month
 Marketing expenditures are b/w $12 and $15 billion / year, or $8000-15000 per
physician, and are widely diverse
o Gifts to physicians, including free pens/pads, honoraria or consulting fees,
entertainment/travel gifts, etc.
 Older, company-loyal physicians generally receive the more lavish
treatment
o Funding of continued medical education
 Drug companies fund 90% ($900mil) of continuing medical education
efforts
 “Not for profit” entities funding these medical education bodies
actually are branches of drug companies
o Funding of national meetings/conferences of several bodies within the
medical profession (ie. AMA)
o Fund discounts to managed care organizations to promote usage of their
products
 Most doctors believe they are immune to the influence of drug reps
o Medical training has taught them to focus on patient health
o Relationship only problematic when gifts become expensive and lavish
 Studies actually show small gifts, especially those vital to humans
(food, friendship, etc.), appear to be the most influential
o Most doctors believe while they are immune, their colleagues are not
 Guidelines have been formulated to regulate the doctor/rep interactions
o Only suitable gifts must deal with the practice of medicine (ie. No more
recreational gifts)
o Many are skeptical that this system is viable, no means of enforcing the rules
or detecting violations
o The positive effects that this relationship gives in many instances will prevent
its complete abolishment
Reading Two
 Drug reps often don’t provide accurate information (11% of statements are false) but
doctors don’t recognize these errors (only 26% recognized these errors)
Reading Three
 High US drug prices due to need for research and development
o Marketing is funded two times more than R&D
o Research jobs have remained the same, Marketing has increased by more than
60%
o In 2002, only 17 of 78 new drugs brought to FDA had new active ingredients
 FDA only classified 7 of 78 new drugs as improvements
Introduction to Law, Torts, & Professional Liability
Readings Summaries:
- “Local malpractice insurance costs are lowest in state.”
 ~$3 of every $100 spent on patient care in PA hospitals goes toward the cost of
malpractice insurance
 Pittsburgh is the lowest cost region in PA for malpractice insurance
- “PA healthcare cost containment council reports hospital malpractice expenses.”
 Hospital malpractice expenses represent only a portion of the malpractice expenses
incurred by the healthcare industry
 Commercial malpractice insurance becoming increasingly difficult for hospitals to
obtain, so more than 2/3 of hospital malpractice expenditures were incurred through
some self-insurance arrangement
 Significant regional variations in hospital malpractice costs across PA
- “Tort reform & the patient safety movement: seeking common ground.”
 Extraordinary extent to which physicians report going against their own clinical
judgment in the hope of minimizing malpractice exposure
 “Defensive medicine” may reduce or improve quality, depending on the
circumstances
 Despite the profession’s inherent orientation toward doing only what is necessary for
patients, medicine’s self-regulatory controls appear to permit many physicians to
deviate readily from accepted medical practice
 Number of physicians in “high-risk” specialties increased in states that enacted
legislation to “directly” limit malpractice awards through “caps”
 However, malpractice climate has a “relatively modest impact” on physician supply
 Piecemeal tort reform over the past 30 years – some results, but not all consequences
positive & medical care quality has not been ameliorated
 Systematic incorporation of evidence-based medical guidelines could reconcile the
legal & medical standards & provide some tort relief
 Unlikely improvement if patient safety movement & tort reform continue to proceed
along separate tracks
- “Hospital-acquired infections in Pennsylvania.”
 PHC4 = Pennsylvania Healthcare Cost Containment Council
 2004 – 7.5 hospital-acquired infections per 1000 patients admitted to PA’s general
acute care hospitals (15.4% died); $2 billion in additional hospital charges & 205,000
additional hospital days associated
 Urinary tract infections – greatest percentage
 Hospital-acquired infections are life-threatening, costly, & a grave concern to the
purchasers of healthcare

Hospital-acquired infections were likely underreported in 2004 (discrepancy btw.
those reported and those billed for by hospitals)
- “Hospitals move to cut dangerous lab errors.”
 3-5% of billions of specimens taken each year are defective, with the error rate even
higher
 9 major medical centers in a lab-safety collaborative to redesign the error-prone
systems for collecting, labeling, handling, and interpreting blood & tissue samples;
quality-control methods such as checklists & automated specimen processing
 Lab errors – not only patient safety issue, but all incurs huge costs (repeats tests &
more expensive procedures)
 Double-reading of pathology reports can reduce errors (second opinions)
- “Anesthesiologists not offer model of how to improve safety, lower premiums.”
 Anesth. pay less for malpractice insurance today, in constant dollars, than they did 20
years ago
 Focused on improving patient safety
 Advocated use of devices that alert doctors to potentially fatal problems in the
operating room
 Computerized mannequins that stimulate real-life surgical crises (training)
 Over past 20 years, patient death from anesthesia down from 1/5000 cases to
1/200,000-300,000 cases
 Anesth. putting more emphasis on patient safety than malpractice reform versus other
specialties
 1985 – Anesthesia Patient Safety Foundation (solely for patient safety)
 2 Innovations that all but eliminate “intubation errors”
o Pulse oximetry (oxygen in patient’s blood)
o Capnography (carbon dioxide in patient’s expelled breath)
 Extra care to keep patients warm during surgery (prevent tissue death)
 Much better prevention of patient exposure to carbon monoxide
 Focus on machines with alarm bells when certain thresholds are crossed
Lecture Slides Summary:
- How Law is Made
- Legislative – statutes
- Executive – regulations
- Judicial – cases (case law/common law); interpretation of statutes & regulations
- Types of Law – Civil (tort, contract), Criminal (state prosecutes), & Administrative
(issuing regulations, prosecuting violations)
- How Case/Common Law is Made
- Accident, Informal efforts, Civil lawsuit filed, Settlement efforts, Trial (settlement
or verdict), Appeal (settlement or oral argument; written, published decision = LAW)
- Appeal to State/US Supreme Court possible (discretionary – will only accept if
NEW question of law OR area of law which needs to be re-examined)
- Settlements – MOST cases not tried in court, but are settled, B/C both sides’ fear of losing
and/or high costs of litigation even if one prevails; role of liability insurance companies
(payment of settlement/judgment, costs of defense)
- Precedent – Decided, published decisions of appeals courts are LAW (binding on lower
courts in the same state); decisions in other states are NOT binding outside the state of
decision (may be followed or rejected)
- Tort Law – largely JUDGE-MADE law
- Functions of Tort Law
- Deterrence (incentive to safety)
- Compensation (for loss caused by someone else’s wrongdoing)
- Retribution (promotes civilized society)
- Loss spreading (cost of loss spread throughout everyone who buys insurance)
- Tort VS. Crime
- Tort = wrong against and individual, must be remedied by the individual
- Crime = wrong against the state, prosecuted by the state
- Tort VS. Contract
- Contract is a PROMISE; breach of contract, recover damages
- Lesson – do NOT make explicit promises (then no assurances about likely
outcomes)
- Tort Players – Plaintiff, Defendant, Liability insurance company
- Tort Lawyers – plaintiff’s lawyer not paid if lost (contingent fees), liability insurance
supplies & pays defendant’s lawyer & plaintiff’s compensatory (non-punitive) damages
- Tort Types – (1) Negligence (harm caused to another by accident)
(2) Intentional (harm “intentionally” caused to another; BATTERY)
- Negligence = if one causes harm to another as a result of failure to use reasonable care
- Elements of Negligence (ALL must be proved)
(1) Defendant owed plaintiff a duty to use reasonable care
(2) The breach of such reasonable care
(3) Caused
(4) Harm to plaintiff’s person or property
- Professional negligence = negligence law applied to professionals
- Medical Malpractice
- Bad results alone DO NOT equal malpractice
- Liability imposed on MD ONLY IF did not perform in compliance with “standard
of care” (usually established by professional “custom” or standard)
- Negligence must be proved by – testimony of other physicians, policy statements of
medical organizations, “learned treatises” and journal articles
- Accident would not happen UNLESS there was negligence
- Damages
- Compensatory – can be economic OR non-economic (pain & suffering)
- Punitive
- Battery – an “intentional tort”; also a crime (criminal & civil cases are separate)
- Elements of Battery (ALL must be proved)
(1) Defendant must do an act
(2) With an intent to cause harmful or offensive contact with another person
(3) Act does in fact cause
(4) Nonconsensual contact with the plaintiff, which is harmful or offensive
- “Intent” – 2 Kinds = Purpose & Knowledge
- Purpose – actor’s purpose is to cause nonconsensual, harmful/offensive “touching”
of another person
- Knowledge – actor does NOT have purpose to cause harmful/offensive contact,
BUT actor knows with substantial certainty that his/her conduct will cause
harmful/offensive contact with another person
- Battery VS. Assault
- Battery = an unwanted (nonconsensual) harmful or offensive touching of another
- Assault = an “apprehension” of an unwanted harmful or offensive contact; an
“incomplete” battery
- Ex. Battery in Medical Context
- Nonconsensual sexual contact with patient
- Performing surgery without consent (still battery even if good outcome)
- Extending surgery outside “scope of consent”
- Misrepresentation of seriousness of procedure
- Treatment of person who gives permission but LACKS capacity to consent
- Drunk; sedated; child