Chapter 1:

Cost, Quality, Access, and Choice

I. Introduction
- Cost, quality, access, and choice are the chief concerns of the health care
system and the central themes of these materials.

II. Regulation or Competition?

- Legal system structure is complex with federal and state law. 50
different sets of state law. Healthcare including insurance and equality
is highly different.
- Top down strategy to fix problems occurring (foreign)
- In our system (unless talking about medicare) it is not a gov run
regulated system, really hard to make a top down fix to a pervasive
problem throughout the system. Obamacare makes amendments to
the medicare system, is the largest government payor, in order to try
and improve quality and reduce cost. Trying to improve quality by
evaluating outcomes of doctors. Not a course about insurance.

Class Notes:
All adverse medial events

Unavoidable adverse events Avoidable adverse events

Known but unavoidable side effects of Deviations from standard of care
medically necessary treatment also resulting in injury: why?:
known as iatrogenic harm from Physician lack of knowledge
treatments or tests and procedures Physician poor exercise of judgment
- You can have a doctor who
provides the appropriate
treatment based on the SOC
who provides it well and non-
negligently, but unfortunately it
doesn't work

Not all bad health outcomes are the result of medical negligence

Distributive justice

Cost of care is the care priced in a way that is sustained

Quality of care is it delivered properly?
Access to care can they get access in their communities? Clinic or doctor
available? Also based on insurance
Choice about care in our system there is a strong emphasis on individual
autonomy and choice. Different people have different values and goals with
respect to getting well and what type of care to use. Bioethics is relevant to
this course.
 - Autonomy
o Right of bodily integrity
o Right to make decisions about healthcare based on their
individual values, preferences, and beliefs important because
some medical conditions where there is only one treatment, but
other medical conditions that have multiple treatments (informed
consent patients and physicians should be having
conversations for treating medical condition)

Cost of care has limited access or choice of care with respect to some
patients?
High cost and limits access or choice?
- HIV drugs
- Cancer therapies
- Epi-Pens
- Immunotherapy for cancer
- Hep C treatment

What is a physician to do if he believes patient needs very high cost drug or

therapy in order to treat their cancer and patient doesn't have money or
insurance?

Ex: surgery in basement, had license, but was doing cash payments
meant to be prevented by regulatory system
Compliance with customary practice is a defense

Medicine is an imperfect science. Not all bad health outcomes are the result
of medical negligence. Need to think about which of the orbit of negative
health outcomes are the source of scenarios where we are thinking as
attorneys that a lawsuit would be appropriate.

Affordable Care Act:

Medicare entitlement program for everyone over age 65 federal program

Medicaid federally funded, but doesn't cover everyone. For medically needy
and low income.
Veterans Health federal program
Private Insurance - Everyone else is getting insurance through a private
system either individually purchased or provided thru employer.

What is lacking at the moment is coordination amongst these insurers.

Enthoven note on page 5 uncertainty about whether treatment will work

Clinical uncertainty: below is all under the umbrella of clinical uncertainty
Prognosis, diagnosis, about which treatment option is best for the patient
Best treatment = necessary treatment, comes up in context of different
kinds of cancer

Scenarios where physician decision and care that he or she provides is

actually going to be considered by legal system to be negligent as opposed
to bad luck?

January 17, 2017

III. What is Illness?

- i. Main issue under this section is what constitutes an illness...most
people consider themselves ill if they have a broken leg or migraine,
but are you ill when you have arteries that are in the process of
becoming clogged?
- ii. World Health Organization definition - a state of complete physical,
mental and social well-being and not merely the absence of disease or
infirmity.
- iii. Illness requires something more than a mere biological abnormality
is needed.
 o 1. To be ill is to have deviant characteristics for which the sick
role is appropriate. The sick role exempts one from normal social
responsibilities and removes individual responsibility.

Katskee v. Blue Cross/Blue Shield of Nebraska (1994) (Page 10)

- 1. Issue: what is considered an illness regarding the insurance policy.
o Breach of k, claiming failed pursuant to insurance k to reimburse
her for surgery that she has already had
o Insurance co is saying she doesn't have a diagnosis of an illness,
but court held this was under diagnosis in illness in the insurance
k and rejected insurers argument.
- 2. Womans family had a history of breast cancer and it was
determined that she had the gene that would cause her to likely
develop breast cancer as well. Her and her doctor decided to have her
breasts taken. Her insurance would not cover the cost of the surgery.
The policy only broadly described illness as a bodily disorder or
disease.
- 3. Defined disease as - any deviation from or interruption of the normal
structure or function of any part, organ, or system of the body that is
manifested by a characteristic set of symptoms and signs and whose
etiology [theory of origin or cause], pathology [origin or cause], and
prognosis may be known or unknown.
- 4. Illness - deviation from what is considered a normal, healthy physical
state or structure.
- Case is in the book b/c it raises interesting q about logical
consequences of defining disease so broadly. If you define disease so
broadly then it has serious implications.

- Difference b/w disease and illness

o Disease is a biological malfunction (8) dont rise to the level of
daily illness
Maybe a mild cold
Chronic and long term autoimmune disorder
Fibromyalgia
High blood pressure, high cholesterol
Diabetes
Aging process? Is that a disease? Being frail and not able to
move very quicklyis that a disease. Its certainly not an
illness.
o Illness (8)
- WHO definition on page 8
o Kelsey raised her hand for being completely physically and
mentally well
- Conditions of the body that might cause people to disagree about
whether or not they are an illness?
 o Example: addiction. Is being addicted to something an illness or
disease? More of a physiological process. Used to cause quite a
bit of debate about whether medical conditions that require
treatment. Once something moves from being a character flaw
into the realm of a medical condition for which treatment is
required to restore the persons health. It changes things.
o So there are implications of defining medical conditions
- Note 4, page 17: gender identity disorder, wasn't covered by
insurance, but deducted all of the money paid out of pocket from taxes
and tax court didn't see it as medically necessary. Court concluded that
it was and should have been deducted. It was medically necessary.
There were real life implications to treating something as a disease or
as something a person has to deal with on their own.
- What are the purposes of medical care? Is it meant to be only to treat a
disease or illness that has manifested itself in the body? Or is it to
reduce morbidity and mortality?
o Doctor will do preventative care. Asking questions about lifestyle
habits. It is broadly understood that purposes of medical care are
reactive not proactive. Matters for course b/c a lot of what we
see in reaction to medical negligence are examples to our
system being reaction to an event instead of being proactive to
an event in the first place.

Problem: The Couples Illness (19)

- couple is trying to conceive and each has their own infertility problems
- have intervention type treatment and go thru protocol that paid for out
of pocket in advance and submit bill to insurance and insurance wont
pay.
- Insurance says neither are injured or ill and together their medical
consequences made them unable to conceive. Some may say it was a
disease.
- A # of states have passed laws to provide for half of infertility
treatment

Quality of care: what is good medical care? List on screenshot.

R - technology
R - interpersonal are healthcare providers appropriately trained? Is
communication good?
R - medical necessity v. risk of iatrogenic harm situations where
patients absolutely have to have medical treatment to make them well
again. Question becomes whether inherent risk of medical treatment
itself is worth the benefit.

Medical Practice Variation

a. Three categories of care (23)
 i. Effective Care - interventions that are viewed as medically
necessary on the basis of clinical outcomes evidence and for which the
benefits so outweigh the risks that virtually all patients with medical need
should receive them.
ii. Preference-sensitive Care - treatments for which there are two or
more valid treatment alternatives and the choice of treatment involves
tradeoffs that should be based on patients preferences.
iii. Supply-sensitive Care - services such as physician visits and stays
in intensive care units involved in the medical management of diseases.

B. Evidence-Based Medicine (EBM) and Comparative Effectiveness

Research (CER)
- EBM - the conscientious, explicit, and judicious use of current best
evidence in making
- decisions about the care of individual patients.
o a. incorporates clinical expertise and patient values as well, but
the emphasis is on the use of current best evidence.
o b. assumes that the physician will keep up with and incorporate
the best evidence into his practice in advance of the
development of a clinical practice guideline.
- 2. CER - natural outgrowth of EBM. It is a major component of current
health care policy. This effective initiative is based on three
premises:
o a. Many current medical practices either are ineffective or could
be replaced with less expensive substitutes.
o b. Physicians often select more expensive treatments because of
bias, fear of litigation, or financial incentives.
o c. Patients would often choose different options from those
recommended by their physicians if they had better information
about treatment risks, benefits, and costs.
- 3. Goal for the two is to narrow variation in medical practice by
developing guidelines and best practices for clinicians.
- 4. The ACA places a strong emphasis in federal health care policy on
comparative effectiveness research. (p.37-38)
o a. ACA defines comparative clinical effectiveness research to
mean research evaluating and comparing health outcomes and
the clinical effectiveness, risks and benefits of two or more
medical treatments, services and items.
- trying to use payment models to deal with the fact that it is a fee for
service system. When a dr performs test or procedure, each one of those
items, the dr receives a fee from Medicare.
- unnecessary procedures that don't cause harm? Still a financial harm.
Not all errors cause injuries and not all injuries that occur in the hospital are
resulting from errors. Some are not preventable. Not all bad outcomes are
malpractice or error.
- institutions as well as individuals can be responsible for medical
malpractice.
- Obvious examples of malpractice that don't need expert testimony: case
where man went into hospital to have one leg amputated due to poor
circulation (FLA) and the hospital amputated wrong leg and he ended up with
a double amputation.surgery to remove hematoma in brain, same
hematoma on wrong side of head, drilled thru patients skull and realized CT
film was backwards on the screen, hospitals response to accept the
resignation of the surgeon and not renew staff privileges of the other and the
state fined them $14k

C. The Problem of Medical Error

1. Adverse Events: Definition and Scope
- Adverse Events: Definition and Scope
o a. Adverse event - an injury caused by medical management
rather than the underlying condition of the patient.
o b. Medical error - the failure of a planned action to be completed
as intendedor the use of a wrong plan to achieve an aim.
o c. Scope:
i. the law has historically focused on physician error. The
narrow focus on individual error defined bad medicine as
what doctors did.
ii. However, the larger problem of quality in medical care
must also address systemic failure, poor administrative
design for review of health care, inadequacies in training
of physicians, and the nature of practice incentives.

2. The Extent of Medical Misadventures

- This section dealt with a study of medical adverse events and the
percentages in which they occurred. Didnt seem all that important. If
it comes up on the exam, the percentages can be found on these
pages. (32-35)
- 10% of the time the wrong medication is dispensed.

Patients, Doctors, and Lawyers: Medical Injury, Malpractice

Litigation, and Patient Compensation in New York (1990)

To Err Is Human: Building A Safer Health System (2000)

Problem: Why Operate? (48)

- Surgeon does surgery. She deteriorates rapidly and has heart failure
and dies a few days afterward. Anesthesia was viewed as COD.
- Proactive: maybe physical therapy to mitigate symptoms instead of
surgery. Look at some other way to fix elbow problem without surgery.
 - From hospital perspective: hospital should not have allowed this and
needed to have communicated risks with her. He did the surgery for
money. Every surgery that surgeon performs results in compensation.
Cynical layer of this course.
- Preventive measures by hospital: should have screened surgeons
decisions and required approval from a surgical committee, maybe
insurance company should have, seek clearance from other physicians
taking care of her and decide as a group if it is appropriate. On the
reverse, she could shop around for a surgeon who will do it.
- Talk to risk manager? If that is something they do
- Should not be a unilateral decision.
- Anybody going under general anesthesia, meets with general
anesestiologist
- As long as patient has decisional capacity, family cant overrule her
decision. Family should have been consulted. Broader point is that
there are a variety of different ways to prevent this from happening.
Anste could have stood up, family members could have, etc.
- Hospitals ill have bi-weekly morbidity and mortality conferences. This
is reactive not proactive.

Dennis Quaid talks about his twins and medical negligence video
- One of leading causes of death in America is preventative medical
error.
o Causes range from misdiagnosis, dosage errors, etc.
- Twins given an adult dose of blood thinner instead of child dosage.
(Heparin is commonly used in hospital and always in top ten for
medical error and death, labeling easily leads to mistakes)
o Lidocaine (mouth pain), lithium (depression) another confused
drug
o Baxter manuf who is responsible for Heparin was aware of
problems with labeling. It didnt recall old stock sitting in
hospitals over the country. So Quaids kids were given old stock
with old packaging.
o They recall toasters, trucks, dog food, but not medicine that can
kill people in the wrong dosage.

January 24, 2017

 - Page 23 categories
- Effective care slam dunk
- Preference-Sensitive Care
- Supply-sensitive Care
Chapter 2:
Quality Control Regulation:
Licensing Health Care Professionals
I. Introduction
- i. Structure of the Licensure System
o 1. Controlled by State law under the states police power.
o 2. Statutes govern entry into the professions, regulate what
services that the professionals may provide, and prohibit
unlicensed persons from providing services reserved for the
licensed professionals.
o 3. Penalizes or removes incompetent practitioners from practice.
o 4. Boards
a. A form of self-regulation (membership usually from
within the profession)
b. Operate as state administrative agencies
c. Governed by state licensing statutes and administrative
procedures act
d. Subject to judicial review.
 o 5. Federal overlap onto state law
a. Licensure is subject for Federal and state Constitutional
requirements for due process and equal protection.
i. Ex: Americans with Disabilities Act.

- Licensure to proactively or reactively improve quality of care?

o OSHA? By setting regulations that need to be met so forms a
standard of care. Designed to prevent spread of diseases to both
patients and workers.
o Granting and removing of staff privileges
o Joint Commission on Accreditation (JCAHO)
o Morbidity and mortality conferences
- Quality medical care should not allow the following things? Legislation
o Drive by delivery laws
- Every state has a board of medicine and they license the healthcare
field

- ii. Quality, Access, Cost, and Choice

o 1. Do the prohibitions and restrictions imposed by licensure and
discipline serve the public good or established professional
interests.
o 2. Are state health professions boards the best tool for achieving
patient safety and accessible care
- iii. Pressures for Change in Licensure and Discipline
o 1. Professional Domination of Boards
a. Reliance on participation by licensees brings expertise
to the evaluation of competency and behavior.
b. However, this can result in anticompetitive conduct
facilitated by the board.
c. As healthcare data becomes more readily available, will
there be less need for boards or more?
d. ACA pushes for more reliance on scientific evidence of
effectiveness and outcomes.
e. ACA also brings about expanded roles for nurses and
physicians assistants...will this result in boards not being
able to restrict their work?
II. Discipline

In Re Williams (1991) (Page 68)

- 1. Doc prescribed weight loss medicine for long term. Majority view
was to not use it very long, minority view was that you could use it
long term.
- 2. Board said he did not use reasonable care because he departed
from accepted standards. Board examiner suggested a light
punishment and board made it more harsh.
 - 3. Courts all agreed that board cannot convert its own disagreement
with an experts opinion into affirmative evidentiary evidence where
the issue is one in which medical experts are divided. (Unless a statute
exists).
- FDA or DEA to find out what use as drugs
- Felt with careful monitoring that it was reasonable to prescribe drugs
more than FDA thought should be done.

Hoover v. The Agency for Health Care Administration (1996) (Page 71)
- 1. Doc in trouble for excessively and inappropriately prescribing
controlled substances and providing substandard care.
- 2. Agency expert witnesses, despite not having the patients medical
records, said doc was wrong. Doc said she was not and the hearing
officer agreed. However, the agency filed exceptions and the board
agreed with agency, punishing doc. Board said that hearing officer was
wrong.
- 3. Court said hearing officer was correct and had sound reasoning, and
that the board cannot overzealously put their opinions over the valid
findings of the hearing officer.

- She mentioned admin lawwe all cringed. No thanks.

- Does a particular form of regulation improve quality of care?
- Does a particular regulatory intervention diminish access to care?
Either by diminishing cost or personal choice?
- If a doctor prescribes a drug and prescribes it in a way that is not
expressly permitted on FDA labeling of drug? Might not be malpractice
or a deviation from standard of care. Have to differentiate when
looking at facts like this. Ex: dennis quaids babies
o Discretionary approach?
o off-label prescribing
o as long as not unreasonable and dangerous
- minority view of medical treatment:
- expert opinion wont excuse violation if rule exists?
o Should still have a valid reason for the course of treatment for
each individual patient and not just take a minority approach
that would put a certain patient in danger since its not
necessarily a standard of course/approved course of treatment.
o Minority view should only be taken when it makes sense on an
individualized basis for a particular patient.
- Barbiturates for sleep insomniaI just wanted to type barbiturates
- Hoover varies state to state that hospitals need Boards to back up
their decisions and take disciplinary actions
- Issue regarding use of experts in Hoover is different. None of them
practice chronic pain, they practiced internal medicine.
 January 24, 2017

Note: State and Federal Regulation of Prescribing Practices

- iii. Regulation of the practice of medicine is with the states through the
police power.
o 1. But, the FDA and DEA also have influences, especially over
prescribing.
o 2. Congress did not intend for these agencies to regulate the
legitimate practice of medicine, but the boundary of where they
must stop is blurry.
a. FDA approves the drug, but once approved, cannot
restrict how physicians prescribe it for particular purposes.
i. Thus, docs and prescribe it for purposes that it was
not approved for. Off-Label prescribing.
ii. Off-Label prescribing is necessary and common.
May even become the standard of care in certain
circumstances.
b. DEA more directly regulates prescribing practices
through the Controlled Substances Act.
i. CSA governs production and distribution of drugs
that have potential to be abused or cause addiction.
(Schedule V through Schedule I)
o 1. Docs cannot prescribe I (Heroin, coke, weed,
etc.).
o 2. Docs must have DEA permit to prescribe II -
V.
o 3. DEA can take away permit and bring criminal
action if prescribing or distribution falls below
DEAs view of legit medical practice.
c. DEA policies conflict with state law and policy.
i. Medical Marijuana
o 1. Some states legalizing, but Feds dont like it.
ii. Prescribing controlled substances for pain
treatment.
o 1. Intractable pain treatment acts
a. Limit disciplinary action in certain
situations.
b. Model Act recognizing that opioids are
essential for pain treatment.
o 2. But, DEA continues to take aggressive
stance against controlled substances for pain.
a. Doctors agree its needed, but DEA
and other agencies are against it. How do
docs know what to do.
 o 3. ACA established committee to research the
issue of pain treatment.
- iv. Should Medical Boards require physicians to meet the majority
standard or should they recognize both majority and minority
approaches?
o 1. Should doctors have to tell patients that the approach they are
using is the minority approach?
o 2. With controlled substances being a major issue in the US, who
should be responsible for the public well being?
- v. Board discipline can have effects on other physicians. Removing the
bad apple is good for other docs.
o 1. However, this can also result in avoiding legit treatment for
fear of legal sanction.
o 2. Doctors will avoid techniques that might bring on an
investigation, even if it might be an effective technique.
a. Should the standard for initiating an investigation be
higher to avoid this?
b. Some statutes are being put in place as a sort of safe
harbor for doctors to be able to prescribe in certain
situations.
o 3. With state boards, what number of sanctions is too much, just
enough, or too little?
- vi. Impaired professionals
o 1. Most states have programs that provide rehabilitative, non-
punitive interventions.
a. Punitive disciplinary action can push impaired
professionals to hide their issues.
b. Due process requires that discipline for behavior must
show a nexus between the behavior and the ability to
practice medicine.
o 2. If professionals seek help voluntarily, should it be confidential
or must they notify the board?
- vii. Telemedicine
o 1. Must the physician be licensed in the state where the patient
is?
a. State statutes on this issue range from very restrictive to
very open.
o 2. Issues of online prescriptions are also arising, especially with
controlled substances.

Note: The National Practitioner Data Bank

- 1. Established by Congress to help track doctor discipline.
o a. Now one doctor cant move from one state where he/she had
disciplinary history to another state without being detected.
o b. State boards are required to report certain disciplinary actions.
 o c. Public cannot access individual practitioner info.
o d. But, many states have established publicly accessible
websites where they post physician profiles.

Problem: Three Strikes and Youre Out

- Some states are beginning to integrate malpractice actions into
disciplinary processes.
o 1. Some states are going to a three strikes and youre out
statute.
a. Commit three or more incidents of medical malpractice
and you cannot be licensed.
b. Some states also say that the final judgement of medical
malpractice must be by clear and convincing evidence.
What level is appropriate?

III. Complementary and Alternative Medicine (CAM)

- rapidly growing in certain ways. Some expanded recognition of CAM
providers who are not MDs. MD v. DO DO is doctor of osteopathy,
MD is medical doctor. Medical schools grant either one or the other. DO
tend to then go into general practioner or preventative care. If you
want to be a specialist, have to be MD.

In Re Guess (1990) (Page 84)

- Facts: Dr. George Albert Guess (D) was a licensed physician who
practiced family medicine and regularly treated his patients using
homeopathic medical practices. Behind homeopathy is the theory that
large doses of a certain drug given to a healthy person will produce
certain conditions which, when they are a spontaneous symptom of a
disease, are relieved by small doses of the same drug. The State Board
of Medicine (Plaintiff) charged Defendant on the basis that homeopathy
was not an acceptable and prevailing system of medical practice and
was therefore prohibited by statute. Defendant argued that
homeopathy is a recognized system of practice in three or more other
states and many foreign countries as well. No evidence was shown that
Defendants homeopathic treatment harmed even one patient, and
there was anecdotal evidence that several patients experienced relief
from Defendants homeopathic remedies when they had been unable
to experience relief from allopathic medicine. Plaintiff stayed the
revocation of Defendants license to practice medicine on the condition
that he not practice homeopathy, which Defendant appealed to the
relevant trial court which reversed and vacated the decision of the
Plaintiff. Upon appeal by the Plaintiff, the intermediate appellate court
rejected the reasoning of the trial court but affirmed the Plaintiffs
decision, which was then subject to another appeal.
 o Primary issue: whether the board can discipline the physician for
engaging in the practice when there is no evidence that patient
has been injured
o One goal of life insurers is to prevent injury to patient
o Homeopathy:
o Why was state board of medicine worried about this guy doing
homeopathy?
Which treatment is more effective or accomplishing the
medical goal if you are doing both?
o Other risk of injury that forgoing standard treatment in favor of
homeopathic one
o Board decided dont need proof of injury. Standard doesn't leave
a lot for minority view.
o Courts are really reluctant to get involved in actual substance of
medical practice or procedure. Especially in licensing and
medical malpractice.
o Balancing act encouraging physicians to stick with status quo to
avoid malpractice and moving practice forward.
o Standard of review is highly deferential in Guess case. Court
treats it as different from Williams and Hoover case. Williams and
Hoover were engaging in normal actions.
o Example: fairly widespread use of homeopathy doctors
prescribed glucosinine
- Rule: Actual harm to a patient is not required to be shown in order to
revoke the privilege to practice medicine.
- No. Actual harm to a patient is not required to be shown in order to
revoke the privilege to practice medicine. The statute central to this
cases resolution provides in relevant part: (a) The Board shall have the
power to deny, annul, suspend or revoke a license . . . issued by the
Board to any person who has been found by the Board to have
committed any of the following acts or conduct, or for any of the
following reasons: . . . (6) Unprofessional conduct, including, but not
limited to, any departure from, or the failure to conform to, the
standards of acceptable and prevailing medical practice, or the ethics
of the medical profession, regardless of whether or not a patient is
injured thereby . . . .
o The intermediate appellate court concluded that the legislature
may properly act only to protect the public from harm in
exercising the police power. Therefore, in order to be a valid
exercise of the police power, the intermediate appellate court
reasoned that the statute must be interpreted as giving the
Plaintiff authority to prohibit or punish a doctors action only
when there is evidence that the action in question poses a
danger of harm to the patient or the public.
 o The intermediate appellate court erred in construing the statute
to add a requirement that each specific practice prohibited by
the statute must pose an actual threat of harm. A basic
constitutional principal introduces the analysis: the General
Assembly, in exercising the states police power, may legislate to
protect the public health, safety and general welfare. A statute
will be upheld when challenged as being beyond the scope of the
police power, as long as there is a rational relationship to such a
legitimate public purpose.
- Protecting the health and safety of the public by regulation of the
medical profession is obviously a legitimate public purpose. It has been
long recognized that state regulation of the medical profession is a
legitimate exercise of the police power.
o In the case of Dent v. West Virginia, 129 U.S. 114 (1889), "Few
professions require more careful preparation by one who seeks to
enter it than that of medicine . . . . Reliance must be placed upon
the assurance given by his license, issued by an authority
competent to judge in that respect, that he possesses the
required qualifications . . . . The same reasons that control in
imposing conditions, upon compliance with which the physician
is allowed to practice in the first instance, may call for further
conditions as new modes of treating disease are discovered, or a
more thorough understanding is obtained of the remedial
properties of vegetable and mineral substances, or a more
accurate knowledge is acquired of the human system and of the
agencies by which it is affected."
- The provision of the statute in this case is reasonably relevant to the
public health. The legislature reasonably believed standards of
"acceptable and prevailing" medical practice that are not conformed to
by any practice inherently pose a general risk of endangerment to the
public. The statute is a valid exercise of the police power. The statute
in this case is a valid regulation which in general works to secure the
public health, safety, and general welfare. With permission, the
legislature delegated to the Plaintiff certain regulatory functions
related to the valid exercise of the police power. However, there is no
requirement that every action taken by the Plaintiff must specifically
identify or address a particular injury or danger to any person or to the
public. As long as the Plaintiffs action complies with the statute, it is
enough that the statute is a valid exercise of the police power for the
public health and general welfare. Therefore, the intermediate
appellate court erred by requiring a show of potential harm from
certain practices of Defendant prior to action by the Board.
o The Plaintiffs findings that lead to its decision were based on
competent, material, and substantial evidence regarding what
the state considers "acceptable and prevailing" standards of
medical practice. Nothing more was required. Defendants
 evidence regarding the efficacy of homeopathy and its use
outside the state was simply not relevant to the issue before the
Plaintiff. The Plaintiff properly complied with its statutory notice
and hearing requirements, and its decision was sufficiently
supported by evidence that was proven, competent, material and
substantial.
- Some physicians value the homeopathic system of practice and others
seem to consider homeopathy an outdated and ineffective system of
practice. While this conflict may be interesting, it simply is not relevant
in this case due to the proven evidence and the Plaintiffs findings and
conclusion that homeopathy is not currently an "acceptable and
prevailing" system of medical practice in the state. Reversed and
remanded.
- The state medical boards decision to offer licensing and regulate its
practice is a reasonable exercise of state power. The trial courts focus
was misplaced as the statute did not require a finding on whether or
not any of Defendants patients suffered an actual harm. The
Defendant was not likely to win a battle regarding the controversy over
the effectiveness of homeopathic treatments while continuing to
engage in the practice. Indeed, further appeals were unsuccessful.

Problem: The Doctor andCAM?

- Skipped
- Based on an actual case. chelation therapy heavy metal poisoning
treatment

January 24, 2017

IV. Unlicensed Providers

Problem: Making Room for Alternative Practitioners (2052, 2053.5,

2053.6) (91-92)
- does a nutritionist apply?
- Tattoo artist? Do they have to be licensed? Depends on the state
- Not holding themselves out to be physicians so wouldn't apply.

State Board of Nursing and State Board of Healing Arts v. Ruebke

(1996) (Page 93)
Facts: Ruebke (Defendant) worked as a lay midwife, helping pregnant
women at length starting with prenatal care, and continuing through
delivery and post-partum care. She consulted with doctors regularly
and followed a complete set of standards to ensure safe practice. The
State Board of Healing Arts (Plaintiff) and the State Board of Nursing
(Plaintiff) sought a temporary injunction to stop Defendants alleged
practice of medicine and nursing. There was testimony from a
gynecologist that many of Defendants assessments were obstetrical
diagnoses, and there was testimony from a nurse that Defendant
practiced nursing functions during deliveries. The trial court found that
 the two acts the Plaintiffs cited were unconstitutionally vague. Further,
even if the acts were constitutional, Defendants acts fell within
exceptions to them. The injunction was denied by the trial court. The
Plaintiffs appealed.
o Accused of practice of medicine without a license. Think about
tradeoffs b/w forcing unlicensed practice of medicine against a
lay midwife.
o All state boards would have statutes that cover unauthorized
practice of medicine and scope of medicine.
o Testimony from experts. She was instructing patients to go to
physicians and get a prescription to produce contractions.
o Diagram of all medical practice, then obstetrics, midwifery.
o Shes doing things that obstetricians do and therefore she is
engaging in medicine.
Rule: For the purpose of professional regulation by statute, the
practice of lay midwifery is not equal to the practice of nursing and
medicine.
Holding: No. For the purpose of professional regulation by statute, the
practice of lay midwifery is not equal to the practice of nursing and
medicine. It is always preferable to interpret a statute as constitutional
where possible without undermining the intent of the legislature. Here,
it is unclear whether the state regulations are intended to cover
midwifery. The act defines the healing arts in terms of pathologies and
abnormal conditions. As long as there are no major complications,
pregnancy and delivery are simply a continuation of normal human
conditions. It appears consistent with legislative intent to reason that
midwifery was not prohibited by the regulation of the healing arts. This
interpretation does not make the acts unconstitutionally vague, or
apply to restrict lay midwifery. Affirmed in part and reversed in part.
o Nave of court to say pregnancy is natural and lay midwives can
perform birth.
Reasoning: There is wide disagreement among the states regarding
how to treat midwifery. Nursing boards tried to carve out the field of
midwifery from medicine by certifying nurses as nurse-
midwives. Various courts have separated the act of assisting during a
delivery with the act of delivering a baby, a very minor
distinction. Nevertheless, for low-risk births, there will likely be
increased favor for midwives as the trend toward low-cost alternatives
in medicine grows.
o Midwives are for comfort versus nursing.
o Recommended doc called business of being born
o This is case is almost like a turf dispute between obstetricians
and midwives
 o I think it might set a standard for which is better and in turn it
would be the court's holding as oppose to the medical field
court starting examining safety data.

V. Scope of Practice Regulation

Change in health care has resulted in expanded roles for advanced
nurse practitioners and physician assistants.
o ACA supports these expanded roles. However, ACA still defers to
state law on the scope of practice for ANPs (advanced nurse
practitioners) and PAs.

Sermchief v. Gonzales (1983) (Page 103) Missouri tends to be quite

strict on unauthorized practice of medicine. Lay midwifery is completely
illegal there.
Nurses performed acts as assigned by physicians that the state board
says was beyond their scope and thus the unlicensed practice of
medicine by the nurses.
Court said that new statutes are more open ended on what nurses can
do and are not meant to restrain the evolution of the way healthcare is
administered.
Must fall within the nurses specialized education.
Nurse must know the limits of their professional knowledge, and make
the appropriate judgement on when to refer the patient to a physician.
Facts: Medical services were provided by the Missouri Action Agency
at several locations, mainly to low-income individuals. Nurses were
allowed by protocols of the Agency to perform procedures such as
taking histories, conducting examinations, performing lab tests,
dispensing certain medications, and providing family planning
information. The Missouri State Board of Registration for the Healing
Arts (Defendant) threatened to cite the nurses for the unauthorized
practice of medicine and the physicians at the clinic for aiding and
abetting. An action was filed by several of these nurses and doctors
seeking a declaratory judgment that they were not in violation of the
law. Plaintiffs also sought an injunction against the Defendant
prohibiting Defendant from prosecuting a case against them. The trial
court denied relief and held that the clinic allowed the unauthorized
practice of medicine. An appeal was taken.
Rule: Certain medical procedures may be performed by a nurse
without the nurse having engaged in the unauthorized practice of
medicine.
Holding: Yes. Certain medical procedures may be performed by a
nurse without the nurse having engaged in the unauthorized practice
of medicine. Missouris revised statutes 334.010 prohibit unauthorized
medical practice. 334.155 exempts nurses who are performing their
professional duties lawfully. Where nursing ends and medical practice
 begins has never been clear. However, in 1975 the Missouri legislature
revised 335.016.8, which defines the scope of legitimate nursing
duties. It is consistently agreed that these revisions broadened the
scope of what a nurse can do. The requirement that all nursing must
be done under the direct supervision of a physician was gone. Also, the
statute uses the language "including, but not limited to" when
examples are provided of what a nurse may do. In light of this legal
framework, it is clear that actions of the Plaintiffs in their clinic were
well within the tolerable limits of nursing. Reversed and Remanded.
Reasoning: It was a rather narrow decision by the court in this
case. The decision did not try to define the outer scope of what a nurse
may do; it only held that the tasks performed by the nurses in this case
were acceptable. The court felt that it was inappropriate in this case to
try to make rigid rules regarding exactly what constitutes the practice
of medicine.

This results in an open ended definition of the practice of nursing.

If the legislature or state board enacts specific boundaries, then that is
clearly the scope of how far a nurse can go in that specific set of
circumstances.
Statutes provide that nurses must act within a defined relationship with
a licensed physician.
o This includes physician supervision at a certain level or formal
collaboration with a licensed physician.
PAs view themselves at physician delegates.
o Some states require PAs and physicians to submit particular
details about the position and its specifics. (What specifically that
particular PA will do).
o Some states limit the number of PAs a physician can supervise.
o States also have varying levels of what supervision entails.
Authority to prescribe medicine.
o Many states allow for a certain amount of prescribing by nurse
practitioners and PAs.
o There is debate about the prescribing authority of certain
licensed health care professionals, such as doctorally trained
psychologists.
The Federal Trade Commission monitors anticompetitive scope of
practice regulations by boards. FTC also monitors agencies and
legislatures acting to expand or limit scope of practice.
o They look to provide what is best for patients. Ex: Advanced
Nurse Practitioner staffed clinics can provide weekend and night
hours and thus more flexibility for patients.
Sometimes federal standards require physician supervision for
Medicare reimbursement.
 Ex: Nurse anesthetists must be supervised as a condition of Medicare
reimbursement for their services.

Problem: Physicians, Physician Assistants, and Nurses (110)

Basically considering the balance between having more flexibility and
access for patients and making sure the patients get proper care from
licensed physicians.
ANPs and PAs can provide many services, but must understand their
scope and pass patient along to a physician when the situation calls for
it.
Will also result in balancing the ACAs push and support for a broader
scope of what APNs and PAs can practice and the right for states to
regulate this field.

Problem: Retail Clinics (113)

January 26, 2017

- Article by American Medical News

Chapter 5: Liability of Health Care Professionals (277)

1. The Standard of Care

A. Establishing the Standard of Care

Hall v. Hilbun (1985) (Page 277)

- Facts: Dr. Glyn Hilbun (defendant), a general surgeon, examined Terry
Hall (plaintiff) who was complaining of abdominal pain. Hilbun
concluded that there was likely an obstruction in Halls small bowel and
recommended an exploratory surgical procedure, which was performed
with Halls consent. After the procedure, Hilbun accompanied Hall back
to her private room. At that time, Halls vital signs were stable and she
was alert and communicating with Hilbun. Shortly thereafter, Hilbun
left the hospital for the evening. That night, Hall repeatedly
complained of abdominal pain to her nurses and her husband.
Throughout the evening and night, Hilbun did not follow-up on Halls
condition and the nursing staff did not call him. Early the next morning
Hilbun was called to the hospital when Halls condition rapidly
deteriorated. By the time Hilbun arrived, Hall had died. At autopsy
revealed that a sponge had been left in Halls abdominal cavity, but
had not contributed to her death. Halls husband filed a
malpractice/wrongful death action against Hilbun alleging that he
failed to inquire about Halls post-operation recovery and failed to give
appropriate post-operation instructions to the hospital nursing staff. At
trial, Halls husband called Dr. Hoerr as an expert witness to establish a
national standard of care applicable to all surgeons including the duty
to follow the patient through the first several hours after surgery to
monitor for complications. The trial court disqualified Hoerr as an
expert witness because he was not familiar with the local standard of
care. Hilbun was granted a directed verdict and Halls husband
appealed.
- Issue: Does a physician have a non-delegable duty to treat each
patient with skill and competence comparable to physicians in the
same field throughout the nation?
o Good discussion about standard of care in a malpractice case.
o Open exploratory surgery of her abdomen which went fine, went
into recovery room and a number of hours later she began to
have difficulties with breathing and nurses were aware, she died
This was entirely preventable.
o Wrongful death action that Hilbun failed to advise post op
appropriately and had not checked with the nurses to see how
his patient was. Standing orders are described in the case. Basic
rules that provide outer limit on when the nurses should be
exercising their own judgment opposed to asking for assistance.
 (ex: call me if patient temp goes over 100 degrees indicating
infection, if respiration goes above a certain rate etc.)
o Sponge had been left in her abdomen which had nothing to do
with her death but if she had survived this could have been
problematic. Doctor malpractice, also nursing malpractice.
o Is surgeon held liable vicariously for nurses negligence?
o Nurses are hospital employees, not doctors. Dr here was an
independent contractor with staff privileges so liability may be
imputed to him through delegable duty.
o Once trial judge decided Hoerrs testimony was not included was
that saying that P has no case. Why did judge do this? It is the
old style argument that experts have to come from somewhere
local so that they have first hand knowledge of custom and
traditions.
o Central issue: locality rule in 2 different dimensions: whether the
doctor shold be judged by standards of those in the same
community or highly similar community? And evidentiary
question.
- Rule: A physician has a non-delegable duty to treat each
patient with skill and competence comparable to other
physicians in the same field throughout the nation, not simply
within the locality.
- Holding: Yes. For years, courts reviewed medical malpractice cases
under a locality rule. However, medical education and training is now
fundamentally national by nature. Nationally uniform standards are
enforced in the certification of specialists and physicians are more
mobile than ever. Each physician may reasonably be expected to
possess or have access to medical knowledge commonly held by
physicians in other states within the same general field or specialty.
However, the duty of care must also be objectively determined by
examining the availability and quality of facilities, equipment, and
other resources. Consequently, the standard of care for a general
surgeon in a very rural part of the country may differ from a general
surgeon in an urban setting simply because resources may be more
plentiful in urban environments. Here, Hoerrs testimony should not
have been excluded. Where an expert witness lives or where he
practices medicine has no relevance per se with respect to whether he
is qualified and an acceptable expert witness. A qualified medical
expert witness may, without more, express an opinion regarding the
meaning and import of the duty of care, given the circumstances of the
case. In those instances, the witness should visit the specific hospital
or practice setting in an effort to become familiar with the facilities,
equipment, and other resources that were available to the physician in
question. Once the expert has familiarized himself with such resources,
he should be allowed to express his opinion. The trial courts granting
of a directed verdict in favor of Hilbun is reversed and the matter is
 remanded for a new trial on the grounds that Hoerrs testimony was
improperly excluded.

- Medical Malpractice - is legal fault by a physician or surgeon, arising

from the
- failure of a physician to provide the quality of care required by law
(282)
o When a physician undertakes to treat a patient, he takes on an
obligation enforceable at law to use minimally sound medical
judgment and render minimally competent care in the course of
the services he provides
o If a patient sustains injury because of the physicians failure to
perform the duty he has assumed under [the] law, the physician
may be liable for damages.
o A competent physician is not liable per se for a mere error of
judgment, mistaken diagnosis or the occurrence of an
undesirable result
o The twin principles undergirding our stewardship of the law
regulating professional liability of physicians have always been
REASON and FAIRNESS
o Handling a patient with a fever is the same in Pascagoula as they
do in Boston. There is a baseline standard of care in the US.
o When talking about proof of reliance on standard or care etc?
have to go through several steps
Prove what SOC is
Prove deviation from SOC
- Was it fair to hold dr. Hilbun liable given that this is a small rural
hospital with staffing deficiencies given the comparison to the
Cleveland clinic?
o Yes, the Doctor should be held liable. Following the national
standard, it shouldn't matter whether this was a rural clinic or a
city clinic, it has no effect on the Doctor leaving instructions for
the nurses and responding to the nurses calls
o Post Op care is not resource dependent. Don't need special
technology for standing orders, etc. can be reach by telephone.
Rural v. urban is not a good argument for post op care.
o He should have at least called about his patient.
o Regarding expert testimony:
Easier. It widens the pools of experts and also decreases
the likelihood that the expert has a bias for or against that
physician
gives them more of an opportunity and not restricted just
to their location--broadens their choices of available expert
- The Competence-Based National Standard of Care (285)
o Each physician may with reason and fairness be expected to
possess or have:
1. reasonable access to such medical knowledge as is
commonly possessed or reasonably available to minimally
competent physicians in the same specialty or general field
of practice throughout the United States
2. to have a realistic understanding of the limitations on his
or her knowledge or competence, and,
3. in general, to exercise minimally adequate medical
judgment
o Each physician has a duty to have:
1. a practical working knowledge of the facilities,
2. equipment,
3. resources (including personnel in health-related fields
and their general level of knowledge and competence), and
4. options (including what specialized services or facilities
may be available in larger communities) reasonably
available to him or her as well as the practical limitation on
same.
o In the care and treatment of each patient, each physician has a
non-delegable duty to render professional services consistent
with that objectively ascertained minimally acceptable level of
competence he may be expected to apply given the
qualifications and level of expertise he holds himself out as
possessing and given the circumstances of the particular case.
1. The professional services contemplated within this duty
concern the entire caring process, including but not limited
to:
a. examination
b. history
c. testing
d. diagnosis
e. course of treatment
f. medication
g. surgery
h. follow-up
i. after-care and the like
o The content of the duty of care must be objectively determined
by reference to the availability of medical and practical
knowledge which would be brought to bear in the treatment of
like or similar patients under like or similar circumstances by
minimally competent physicians in the same field, given the
facilities, resources and options available
 1. the content of the duty of care may be informed by local
medical custom but never subsumed by it
- The Resources-Based Caveat to the National Standard of Care
o The duty of care, as it thus emerges from considerations of
reason and fairness, when applied to the facts of the world of
medical science and practice, takes two forms:
1. a duty to render a quality of care consonant with the
level of medical and practical knowledge the physician
may reasonably be expected to possess and the medical
judgment he may be expected to exercise, and
2. a duty based upon the adept use of such medical
facilities, services, equipment and options as are
reasonably available
o As a result of its resources-based component, the physicians
non-delegable duty of care is this:
1. Given the circumstances of each patient each physician
has a duty to use his or her knowledge and therewith treat
through maximum reasonable recovery each patient with
such reasonable diligence skill competence and prudence
as are practiced by minimally competent physicians in the
same specialty or general field of practice throughout the
United States who have available to them the same
general facilities services equipment and options.
- Who may qualify as expert medical witness in malpractice cases
o A qualified medical expert witness may without more express an
opinion regarding the meaning and import of the duty of care,
given the peculiar circumstances of the case.
1. The witness must be familiarized with the facilities,
resources, services and options available
2. Once he has become informed of the facilities, etc.
available to the defendant physician, the qualified medical
expert witness may express an opinion what the care duty
of the defendant physician was and whether the acts or
omissions of the defendant physician were in compliance
with, or fell substantially short of compliance with, that
duty.
- Notes
o The customary or accepted practice standard measures
physicians against the standard of their profession, not merely
the standard of a reasonable and prudent person.
o Physicians who hold themselves out as having specialized
knowledge will be held to the standard of specialists with those
enhanced qualifications.

Note: Expert Testimony in Professional Liability Cases

- The standard of practice in the defendant doctors specialty or area of
practice is normally established through the testimony of medical
experts.
- In any jurisdiction, plaintiffs, to withstand a motion for directed verdict,
must
o qualify their medical witnesses as experts;
o satisfy the court that the experts testimony will assist the trier of
fact; and
o have the witnesses testify based upon facts that support their
expert opinions.
- The requirement that the expert be of the same specialty as the
defendant typically governs the qualifying of the expert for testifying at
trial.
- The standard of care may be based upon the experts own practice and
education.
- Plaintiffs experts normally must be in the same specialty as the
defendant.
o Under some circumstances, however, courts have allowed
physicians in other specialties to testify, so long as the alleged
negligence involved matters within the knowledge of every
physician.
e.g. A general surgeon can testify as to the standard of
care of a plastic surgeon performing elective surgery, as to
general surgical issues
- An expert need not be board certified in the subject of the suit, so long
as he has the appropriate education and experience.
- Expert testimony is often based upon clinical literature, FDA
statements, and other evidence of the standard of practice and of side-
effects of treatments and drugs.
- Practice guidelines or parameters
o Statements by medical societies as to good practice will provide
a ready-made particularized standard that an expert can use as a
benchmark against which to test a defendants conduct
- Pharmaceutical package insert instructions and warnings
o Package inserts may be used to establish the standard of care of
the particular drug.
- Physicians Desk Reference (PDR)
o The PDR is allowed by most courts as some evidence of the
standard of care, if an expert witness relies on it.
o Other courts allow the PDR as prima facie evidence of the
standard of care under some circumstances.
1. In a medical malpractice case alleging improper
administration, dosage, and monitoring of the drug, they
are admissible as both prima facie evidence of the
standard of care and physicians notice of their contents.
 - Judicial Notice
o When the defendant physicians clinical decisions violate a
clearly articulated practice within the specialty, courts are
sometimes willing in rare cases to make a finding of per se
negligence.
- Substantive use of a learned treatise
o The Federal Rules of Evidence (FRE 803(18)) allow a learned
treatise to be used for substantive purposes so long as the
treatise is accepted as reliable.
o An expert must be on the stand to explain and assist in the
application of the treatise.
o The treatise must be declared reliable by the trial court after a
motion by the moving lawyer to use the treatise substantively
under FRE 803(18).
- Expert reliance on research findings
o Experts in malpractice cases may rely on outside studies in the
research literature in addition to their knowledge, education, and
experience.
o On rare occasions, courts have allowed such research material
into evidence in a malpractice suit.

- Doctors have to be minimally confident

- Only 2% of malpractice lawsuits actually result in payouts
- Compliance with custom means compliance with standard of care
January 31, 2017

Discussant with Corryn

B. Practice Guidelines as Standards of Care
1. P has to establish what the relevant standard of care is with regard to the
P
Most involve expert testimony
2. establish that the Ds position deviated from the SOC
3. Tot claims, have to establish that the deviation actually caused harm to
the P

Conn v. United States (2012) (Page 292)

- Facts: John Conn (plaintiff) suffered a heart attack and was admitted
to a Veterans Affairs (VA) hospital (defendant) in Jackson, Mississippi.
The VA kept John overnight for observation but discharged him the
following morning. Unbeknownst to John or the VA, Conn had a 90
percent blockage in a left artery of his heart. Two days later John
suffered a second, massive heart attack and nearly died. After John
recovered, he and his wife, Patricia, filed a medical malpractice suit
against the federal government. The Conns engaged Mark Strong,
M.D., to serve as their medical expert. Dr. Strong reviewed Johns
medical records and issued a report which stated that John had
 suffered an acute heart attack immediately preceding his admission to
the VA hospital and that the VAs course of treatment was not
appropriate and contrary to the course of action recommended by the
American Heart Association (AHA) and the America College of
Cardiology (ACC). Additionally, Dr. Strong noted that his personal
recommendation would have been for John to undergo several
coronary tests at the time of admission to the VA. The federal
government filed a motion for summary judgment.
- Rule: In a Mississippi medical malpractice action, a plaintiffs
medical expert must articulate an objective standard of care
that was breached by the defendant and resulted in injuries or
damages.
- Issue: In a Mississippi medical malpractice action, must a plaintiffs
medical expert articulate an objective standard of care that was
breached by the defendant and resulted in injuries or damages?
- Holding: Yes. In its motion for summary judgment, the federal
government argues that Dr. Strongs medical report (1) failed to offer
an objective standard of care; (2) failed to show that the VA breached a
standard of care owed to John; and (3) did not establish that the breach
of a duty owed to John caused his injuries.
- In Mississippi, the success of a plaintiffs medical malpractice case
frequently hinges upon his medical expert who must articulate a
specific and objective standard of care. If the medical expert fails to do
so, then summary judgment should be granted in favor of the
defendant. Here, the federal government argues that Dr. Strong failed
to state such a standard of care in his report.
- The Conns disagree and claim that Dr. Strongs reference to standards
and practices recommended by the AHA and ACC, in addition to
delineating a specific course of treatment for the treatment of a heart
attack, sufficiently establishes a specific standard of care that was not
adhered to by the VA.
- However, there is a lack of consensus in the federal courts as to
whether AMA or ACC guidelines can establish an appropriate standard
of care in medical malpractice actions. Moreover, Dr. Strong failed to
affirmatively state in his report that the VA physicians were, or were
not, minimally competent to treat a patient suffering a heart attack.
- Regardless, Dr. Strong failed to state with specificity an objective
standard of care applicable to, and breached by, the VA physicians.
Summary judgment is awarded in favor of the federal government.
o Case is suboptimal in the sense that it doesn't get into a whole
lot of discussion as CPG and their use as proof.
o More broadly, case is a good example of the facts that cts in
different jx struggle with what to do with CPG, should they be
evidence of customary practice or should they be supplement
information.
o CPGs as the definitive statement of SOC:
- Suit against the VA for malpractice
o Negligence suits against the federal government are
controlled by the Federal Tort Claims Act, and they are
evaluated in accordance with the law of the place where
the act or omission occurred.
Mississippi in this case
o In Mississippi, a plaintiff in a medical malpractice case
must prove, among other things, that a standard of care
governed his physicians actions.
The standard of care must be specific, and at its
core, it is a requirement that a physician be
minimally competent in his practice.
- Issue:
o Whether the ACCF/AHA (American College of Cardiology
Foundation/American Heart Association) Guidelines, or any other
set of published clinical practice guidelines, can establish a
national standard of care in a medical malpractice lawsuit.
No consensus on the issue
o Several courts have considered clinical practice guidelines in
favorable lights, and not solely for the purpose of establishing a
standard of care.
o Other courts view these publications as just guidelines and
have held that they do not establish a standard of care.
- Holding:
o Expert witnesses are permitted to rely on clinical practice
guidelines if the conduct prescribed by those guidelines does
indeed describe the specific actions that would be taken by a
minimally competent physician.
- Notes
o The Institute of Medicine has defined clinical guidelines as
systematically developed statements to assist practitioner and
patient decisions about appropriate health care for specific
clinical circumstances.
They are standardized specifications for using a procedure
or managing a particular clinical problem.
Such guidelines may be quality oriented, reducing
variations in practice with improving patient care;
They may also be cost-reducing, promoting a lower cost to
health care
o Clinical guidelines raise difficult legal questions because they
potentially offer an authoritative and settled statement of what
the standard of care should be for a given treatment or illness.
Courts have several choices when such guidelines are
offered in evidence (every patient has different medical
 history and what might be good for one patient might not
be right for another by following one standard guideline,
it may not fit that patient. There isnt a one size fits all
treatment even for something like a heart attack cost is
also an issue. It could end up costing the patient an
excessive amount that they might not have wanted to
spend)
First, such a guideline might be evidence of the
customary practice in the medical profession.
o A doctor practicing in conformity with a
guideline would be shielded from liability to the
same extent as one who can establish he
followed professional custom.
o The guideline acts as an authoritative expert
witness or a well-accepted review article.
Second, clinical practice guidelines can be used to
impeach the opinion of an expert witness.
Third, such guidelines might be used as an
affirmative defense by physicians in a malpractice
suit to show compliance with accepted practice.
o Professional societies often attach disclaimers to their guidelines,
thereby undercutting their defensive use in litigation
The American Medical Association calls its guidelines
parameters instead of protocols to indicate a large
sphere of physician discretion, and further suggests that all
guidelines contain disclaimers stating that they are not
intended to displace physician discretion.
o The Role of the National Clearinghouse
The National Guideline Clearinghouse offers free access by
physicians and others to the current clinical practice
guidelines, with instantaneous searches of the database.
These guidelines must pass certain criteria to be included:
they must be current,
contain systematically developed statements to
guide physician decisions,
have been produced by a medical or other
professional group, government agency, health care
organization or other private or public organization;
and
they must show that they were developed through
systematic search of peer-reviewed scientific
evidence.

Note: Outcomes, Practice Guidelines, Best Practices, and the

Affordable Care Act
- The ACA has several sections that affect the potential tort liability of
physicians, even though nothing in the Act deals explicitly with tort
issues except the tort demonstration project section.
- ACA creates four streams of pressure that converge toward measurable
and specific standards of care in practice.
o First, outcome measures will be researched, developed, and
disseminated.
Section 10303 of the ACA instructs the Secretary of HHS to
develop provider-level outcome measures for both
hospitals and physicians, as well as other providers.
Such measures will include at least ten outcome
measurements for acute and chronic diseases.
o Second, best practices will be researched and disseminated.
Section 10303 inserts a new Subpart II - Health Care
Quality Improvement Programs.
It mandates the Director to identify, develop, evaluate,
disseminate, and provide training in innovative
methodologies and strategies for quality improvement
practices in the delivery of health care services that
represent best practices in health care quality, safety, and
value in collaboration with other Federal agencies.
o Third, clinical practice guidelines will be developed in light of the
research on outcome measures and best practices.
o Fourth, outcomes, best practices and guidelines will be
disseminated rapidly to practice settings.
The Center for Quality Improvement and Patient Safety will
support research on system improvements and the
development of tools to facilitate adoption of best
practices that improve quality, safety, and efficiency of
health care delivery services. Such support may include
establishing a Quality Improvement Network Research
Program for the purpose of testing, scaling, and
disseminating of interventions to improve quality and
efficiency in health care.
- A Patient-Centered Outcomes Research Institute (PCORI) is created by
Section 6301, Patient-Centered Outcomes Research.
o This institute is to assist patients, clinicians, purchasers, and
policy-makers in making informed health decisions by advancing
the quality and relevance of evidence concerning the manner in
which diseases, disorders, and other health conditions can
effectively and appropriately be prevented, diagnosed, treated,
monitored, and managed through research and evidence
synthesis.

- Notes
 o The effect of the cumulative ACA requirements - with money
allocated for research on practice guidelines, best practices and
outcome measures - will be to accelerate the diffusion of these
new standards for best practice.
First, federal research dollars under the American Recovery
and Reinvestment Act of 2009 are supporting research to
analyze what the practice-outcome linkage and what best
practices should be.
Second, the ACA mandates dissemination in a variety of
ways, including websites, pay-for-performance reforms,
and models of integrated practice.
Best practices, grounded in research and made
accessible and transparent to providers, patients,
and payers, will start to squeeze out medical practice
variation in clinical practice.
o The tort effect of such narrowing of practice is
clear
Defenses under liability rules will rapidly
narrow as practice choices also narrow.

Problem: The Battle of Standards II

Case in note 3 page 298

Debribrilators
Court isnt going to solely rely on the guidelines,
What would you want Ps expert to add about the applicability of these
guidelines to try to prove malpractice? Maybe situation in which the
implantation of the ICD would be appropriate to despite those circumstances
to show there was oversight on the part of the physician and not an actual
reason for doing it

C. Other Methods of Proving Physician Negligence

- Examination of defendants expert witness
o The plaintiff may establish the standard of care through defense
witnesses, leaving the issue of breach within the province of the
fact finder, not the trial court on summary disposition
- An admission by the defendant that he was negligent
o An implicit admission of culpability can be found through
evidence of intimidation by defendant of plaintiffs expert
witness, which a jury is allowed to consider as defendants
consciousness of the weakness of his case.
o An extrajudicial statement by a physician that he would not
provide necessary treatment because of financial constraints has
been held by one court to be an implicit admission of liability,
 sufficient to relieve the plaintiff of the need for expert testimony
on the standard of care.
- Common knowledge in situations where a layperson could understand
the negligence without the assistance of expert
o e.g. plastic cap from a surgical instrument left in plaintiffs hip
socket after a hip joint replacement.
- Use of res ipsa loquitur
o In most states, res ipsa loquitur operates as an inference of
negligence
That is, the jury may infer that the defendant was in some
way negligent, but it is not compelled to conclude
negligence. It can reject the inference as well as accepting
it.
o The doctrine has three conditions
the accident must be of a kind which ordinarily does not
occur in the absence of someones negligence;
it must be caused by an agency or instrumentality within
the exclusive control of the defendant;
it must not have been due to any voluntary action or
contribution on the part of the plaintiff
o The doctrine continues to be applied in medical malpractice
cases where the injury is to a part of the body outside the scope
of an operation.
o Many states have eliminated the availability of res ipsa loquitur
by statute as part of malpractice reform packages
- Vicarious Liability
o Physicians who offer services directly to patients in outpatient
settings, such as gastroenterologists, typically use nurses and
anesthesiologists to assist when performing certain procedures.
o If the physician uses independent contractors, not full-time
employees, this risks expanding physician liability for mistakes of
these independent contractors.
o the Captain of the Ship doctrine is an older doctrine that imposes
liability on the surgeon who manages a medical procedure in the
hospital using a variety of medical professionals, including
nurses.

Problem: Evidentiary Hearings

In the deposition, the doctor said that based on the symptoms that a doctor
should be put on notice of this condition, but he doesn't do this with Diane
Scott, instead he says it is common in first pregnancies and basically ignores
it. So, he didn't follow the standard of care and was negligent
- ignoring the pre-existing conditions and ignored multiple symptoms
- not ordering the urine sample
Have to establish that one or more of these failures are a departure of the
standard of care
P has to prove in order to win case:
- direct cause of the death
- departure of standard of care resulting in the injury
how do we get review article before the court FRE 803(18). New England
journal of medicine is a well regarded journal
End
February 2, 2017
310-314, 314-337 (none of this is in the outline)

II. Judicial Standard Setting

Helling v. Carey (1974) (Page 310)

- Facts: Helling (plaintiff) suffered from primary open angle glaucoma, a
condition where fluids are unable to flow out of the eye. As a result,
pressure gradually rises to a point where optic nerve damage results,
as well as loss of vision. The condition comes with very few symptoms
and is primarily detected through a pressure test performed on the
eye. Helling saw her ophthalmologists, Drs. Thomas Carey and Robert
Laughlin (defendants) for a number of years, including for regular
appointments and the fitting of glasses and contact lenses. After years
of seeing Carey and Laughlin for what she believed were issues and
irritation caused by her contact lenses, Carey tested her eye pressure
and field of vision. It was determined that Helling, then 32-years-old,
 had glaucoma resulting in some loss of vision. Helling filed suit against
Carey and Laughlin alleging, among other things, that defendants
negligence proximately caused the permanent damage to her eyes. At
trial, expert witnesses from both sides testified that the standards of
the profession did not require a pressure test to be given to patients
under the age of 40 to determine the presence of glaucoma because
the disease rarely occurs in individuals in that age group. The jury
found in favor of Carey and Laughlin. The court of appeals affirmed the
judgment and Helling petitioned to the states supreme court.
o Court said no reason not to give her the test earlier.
o Bottom of page 311, underlined in orange, judgment factor
involved, test is harmless,
o TJ Hooper case quoted on 312
o The holding in this cases establishes a standard of care.
o Can you think of any potential downsides to the courts decision
in this particular case?
Physicians and insurance companies bill it as a separate
test which raises aggregate cost
Maybe doctors are wasting their time administering this
test, when they could take another route.
Court has made it so that everyone who has an eye exam
has a glaucoma test.
o Is one of the small number of cases rejecting a customary
medical practice.
o Judicial willingness to second guess medical standards, but its
tricky when judges try to develop customs and standards
themselves. Judges are obvi not medical doctors and lack the
expertise.
o Doctors are highly sensitive to judicial announcement it's a
complicated topic.
o Not 5, page 314 a # of jx are making a shift to the reasonable
practice standard opening door to allow juries to consider
whether in fact the custom is suboptimal or reasonable under the
circumstance.
- Rule: A reasonable prudence standard should be followed in
medical diagnosis and treatment even when there is no
requirement under generally accepted professional standards.
- Issue: Should defendants compliance with the standards of the
medical specialty insulate them from liability?
- Holding: No. Although the incidence of glaucoma in individuals under
the age of 40 is one out of 25,000 persons, that one person who suffers
deserves the same protection as the others. The eye pressure test is
simple and relatively inexpensive. Failure to administer it can result in
severe and permanent injury and loss of vision. There is no doubt that
the administration of this easy test to detect a potentially life-changing
 condition should, in fact, be undertaken. There are precautions so
imperative that even their universal disregard will not excuse their
omission. The decision of the lower courts is reversed.

- Bystander type of emotional distress if they meet following conditions:

physically present when a terrible thing happens to a close person and
ultimate injury to close relative is severe,

III. Other Theories

A. Negligent Infliction of Emotional Distress

Strasel v. Seven Hills OB-GYN Associates, Inc. (2007) (Page 314)

- Facts: Christina Strasel (plaintiff) went to Seven Hills OB-GYN
Associates, Inc. (Seven Hills) (defendant) for an initial pregnancy
appointment. A sonogram revealed a sac in her uterus, but did not
detect a fetal heartbeat. The sonographers report stated that she
believed Strasel had a blighted ovum, a condition where an empty
placental sac developed in the uterus without a fetus. The report
recommended an additional sonogram and a blood test to confirm the
pregnancy. Seven Hills physician, Dr. Xavier Ortiz, reviewed Strasels
file including the sonographers report. Without personally examining
Strasel or ordering an additional sonogram or blood test, Ortiz
scheduled a dilatation and curettage (D & C) for the following morning.
A D&C is essentially an abortion procedure. Ortiz told Strasel and her
husband that he was confident in his diagnosis of a blighted ovum and
informed Strasel that putting off the D&C might endanger her health.
Four weeks after the D&C procedure, Strasel experienced bleeding,
discomfort, pain, camping and nausea. Strasel also believed she was
still pregnant. Strasel returned to Seven Hills where a blood test
confirmed her pregnancy and a sonogram indicated that she had a 13-
week-old fetus. Ortiz told Strasel that he misdiagnosed her viable
pregnancy as a blighted ovum and informed her that the baby might
have suffered significant and unknowable problems as a result of the
D&C procedure. Strasel suffered from panic attacks and nightmares
related to her fear of the harm the D&C may have caused to the child,
separated from her husband, and suffered from major depressive
disorder and post-traumatic stress disorder. Strasel delivered a healthy
baby girl, but continued to worry about possible long-term neurological
issues that may affect the child. Strasel filed suit against Seven Hills
and Ortiz for malpractice and negligent infliction of emotional distress,
and requested punitive damages. Arbitration awarded Strasel
$210,000. Seven Hills and Ortiz appealed the arbitration award. A jury
found in favor of Strasel and awarded damages of $372,000. The trial
court denied motions by Ortiz and Seven Hills for a new trial and
judgment notwithstanding the verdict. Strasel filed for a motion for
 prejudgment interest, which the court denied. Seven Hills appealed the
jurys verdict and Strasel appealed the trial courts denial of
prejudgment interest.
o Strasel satisfied the requirements, sought psychiatric treatment
and met all of the standards. Only weird thing is that the whole
idea of being a bystander witness to D and C, at the time she
had the D and C, she did not believe she was pregnant. She
thought she was having a normal medical procedure.
o This doctor did not perform a D and C properly because he
wouldve terminated the pregnancy
o I think he might've been over-confident in what he saw given her
medical history and thought there was no need for it
o i think he just went with what the sonographer said and ordered
the procedure that she was not able to sign off on without him. I
really dont understand as an outsider why he would not have
examined her himself or ordered the blood tests
o negligence was conceded with the doctors order in this case, I
think.
o Court is satisfied the Strasels stress is real and she suffered
here.
o Note 2, page 318 courts have allowed emotional distress
without physical injury or expert testimony. Campbell v.
Delbridge Jehovahs witness case about blood with express
denial. Dont need testimony to prove breach.
o Note 2, Oswald case. Large jury verdict to husband and wife in
this case because of how she was treated. Don't need an expert
to prove that doctors were negligent, rude, and uncaring and
deviated from the standard of care.
o With emotional distress, don't need expert testimony to prove it,
and even if patient sustained only emotional injury and has not
suffered a physical injury, then this will not bar Ps recovery. P
has sought some sort of treatment, I think.
- Rule: A cause of action for negligent infliction of emotional
distress may be stated where a mother reasonably believes
that the unborn child is in peril, regardless of whether the
child suffers actual physical harm, and as a result of the fear,
the mother suffers serious emotional distress.
- Issue: Does a cause of action for negligent infliction of emotional
distress exist when a mother reasonably believes that the unborn child
is in peril, regardless of whether the child suffers actual physical harm,
and as a result of the fear, the mother suffers serious emotional
distress?
- Holding: Yes. Generally, an individual in Ohio may not recover
damages when a defendants negligence produces no actual threat of
physical harm to the individual. Seven Hills and Ortiz rely on this
 principle in arguing that the trial court erred in allowing Strasel to
present evidence of, and recovery for, emotional injuries for a non-
existent peril, when she delivered a healthy baby. The principle cited
by Seven Hills and Ortiz, however, applies when the individual herself
goes unharmed. Ohio courts have recognized a cause of action for the
negligent infliction of emotional distress when a mother reasonably
appreciates the peril placed on a family member, whether or not the
family member suffers actual physical harm. Here, Strasel was clearly
present when the D&C was performed and her unborn child was
subjected to real physical peril by the procedure. Even though no harm
to the child actually resulted, Strasel suffered real emotional distress.
Evidence of how Strasels fear and distress manifested itself was
provided by Strasels expert psychologist. The judgment of the trial
court denying Strasels motion for prejudgment interest is reversed,
and the cause is remanded for a determination of the amount of
prejudgment interest to be awarded to Strasel. The trial courts
judgment is affirmed in all other respects.

B. Physician Duties to Contest Reimbursement Limits

- Managed care organizations
- A physician may have an obligation to assist patients in obtaining
payment for health care. At a minimum, this means that the doctor
must be aware of reimbursement constraints.

- Implications of switching from fee for service to pre-authorization.

Wickline v. State (1986) (Page 320)

- Facts: Wickline (plaintiff) suffered from a clot in her right leg due to
her arteriosclerosis condition. Dr. Daniels informed Wickline that
surgery was necessary and she was eligible for Medi-Cal, Californias
financial medical assistance program. Daniels submitted a request for
financial assistance to Medi-Cal which approved surgery and ten days
hospitalization. Dr. Polonsky performed the operation to remove the
clot, but complications arose, which required a second operation.
Wicklines authorized hospitalization ended on January 17, but Polonsky
requested an additional eight days from Medi-Cal on January 16.
Polonsky had concerns about Wickline developing a possible infection
and wanted to monitor her in case her condition deteriorated. The on-
site Medi-Cal nurse consultant did not believe that an additional eight
days was necessary and she telephoned Dr. Glassman, the Medi-Cal
physician consultant, to review the request. Glassman rejected the
request for an additional eight days, but approved an additional four
days of hospitalization beyond the original discharge date of January
17. Polonsky and Daniels did not question Glassmans decision.
Wickline was discharged in stable condition, but began experiencing
pain in her right leg within a few days. Nine days later, Wicklines leg
 required amputation. Wickline brought suit against the State of
California (defendant), which managed the Medi-Cal program, for
damages resulting from the loss of her leg. At trial, Polonsky testified
that had Wickline remained in the hospital, he would have been able to
save her leg. The state argued that the decision to discharge Wickline
was made by her physicians and that Medi-Cal played no part in the
discharge decision. The jury found for Wickline and the State appealed.
o Trying to assign blame to Medi-Cal
o Dicta that says 3rd party payors can be held accountable for the
ill effects of wrongfully withholding
o The physician who complies without protest
o note 3 and 4 have examples of Wilson about utilixation review
and
- Rule: It is the patients treating physician who must determine
when the patient should be discharged from a hospital based
on his best medical judgment, not third-party payors of health
care services.
- Issue: May third-party payors of health care services be held liable
when a patients treating physician makes a medical determination to
discharge a patient from a hospital?
- Holding: No. Cost-containment programs have been a mechanism to
promote the public interest in controlling health care costs by reducing
the number of unnecessary medical services. These programs use two
utilization review processes: retrospective and prospective.
Retrospective utilization review occurs when a third-party payor
reviews the patients medical chart after the fact to determine whether
treatment provided was medically necessary before paying for the
services. Prospective utilization review requires payment authorization
prior to medical services being rendered. A wrong conclusion under the
retrospective analysis may result in the withholding of payment. A
wrong conclusion under the prospective analysis may result in the
withholding of necessary medical care. If Dr. Polonsky believed it was in
his patients best interest to remain in the hospital for an additional
four days beyond the four granted by Dr. Glassman, he should have
made some effort to keep Wickline there. Polonsky or Daniels could
have directly challenged Glassmans conclusion that four days was all
that was needed, but neither physician did. Polonsky admitted that he
was responsible for the care provided to Wickline. A patient who is
harmed when necessary treatment is not provided is entitled to
recover from all those responsible for the withholding of such care,
including third-party health care payors. However, Medi-Cal was not a
party to the medical decision to discharge Wickline and thus cannot be
held to share in the resulting harm. The judgment of the jury is
reversed.
 - Reimbursement constraints may involve not only expensive
hospitalization, but also expensive modern drug therapies. High-cost
drugs may strand physicians between a patients clinical needs and the
limits of possible reimbursement.

Murray v. UNMC Physicians (2011) (Page 328)

- Facts: Mary Murray suffered from pulmonary arterial hypertension, a
chronic medical condition in which the blood vessels in the lungs
constrict causing heart failure. The condition could be treated using
Flolan therapy, a medication administered by a pump that relaxed the
blood vessels. However, the therapy cost approximately $100,000 per
year and was required to be administered constantly. It was life
threatening for the patient if treatment was interrupted, but extremely
expensive to administer for the remainder of an individuals life. Marys
physician, Austin Thompson, M.D., had prepared to treat her with
Flolan therapy pending results of several tests and insurance approval,
but Mary died before treatment could begin. Marys husband, Robert
(plaintiff), individually and as executor of Marys estate, filed suit
against Nebraska Medical Center, the Board of Regents of the
University of Nebraska, UNMC Physicians (UNMC), Dr. Thompson and
others (defendants) claiming the defendants caused Marys death by
negligently failing to administer the Flolan therapy. However, UNMC
was the only defendant remaining at the time of trial. At trial, the
parties disputed whether UNMC had breached the requisite standard of
care. At the close of his case, Robert moved for a directed verdict on
the standard of care. He argued that an insurance company cannot
dictate what doctors may do. UNMC claimed that an ongoing financial
source is something a physician must consider in determining a course
of treatment for a patient. Roberts motion was overruled. The jury
found for UNMC. Robert filed a motion for a new trial, which the trial
court granted. UNMC appealed.
o Patient needs high priced drug and company is balking at paying
for it.
o This case does a good job of explaining the switch in health care.
o Customary practice in a cost contained era?
o Ave to divide into 2 scenarios: drug is medically necessary or
physician is in a bind because insurance couldn't pay for it.
Generally a personalized grievance.
o If we had universal coverage of all of our citizens in the US
through single payor system
no because the physicians still had discretionary on what
was medically appropriate in that given case. What
seemed like a payment issue as stated was more of a
concern of stopping the treatment prematurely
 from a funding perspective: even if everyone has coverage
the problem is there will still be outer limits to what
insurance companies can afford and the physician will still
have to make a decision on whether to start the treatment
and I it is appropriate.
- Rule: In Nebraska, a physician does not deviate from the legal
standard of care by considering the risks and effects of
interrupting a patients particular course of treatment.
- Issue: In Nebraska, does a physician deviate from the legal standard
of care by considering the risks and effects of interrupting a patients
particular course of treatment?
- Holding: No. In granting Roberts motion for a new trial, the trial court
erroneously held that, as a matter of law, a medical standard of care
cannot be tied to, or controlled by, an insurance company or the need
for payment. In Nebraska, the standard of reasonable and ordinary
care is found in the customary practices prevailing among reasonable
and prudent physicians without concern over whether has the ability to
pay. Today, however, there is a rising lack of available health care
resources versus dramatically increasing health care costs.
Consequently, physicians freedom to practice medicine as they see fit
has been limited. Physicians are often caught in a bind between legal
expectations related to the provision of medical care and economic
realities. Contrary to the opinion of the trial court however, the case is
not about a physicians medical judgment being clouded by an
insurance company. Rather, UNMCs expert testimony evidence
showed that the physicians decision to wait to begin Flolan treatment
was based on the potential dire health consequences to Mary if
treatment had to be interrupted later. The core issue is whether
UNMCs actions were consistent with the applicable legal standard of
care in the state. UNMCs expert testimony clearly established that the
applicable standard of care in Nebraska requires a physician to (1)
make sure that a basic payment source is in place before beginning
Flolan treatment due to the risks associated with interruption of the
treatment; (2) ensure that the treatment practices employed by the
physician are similar to those utilized in the surrounding community;
and (3) not allow economic considerations to enter into the decision-
making process regarding the welfare of the patient. Each of the
foregoing considerations was met by UNMC and its physicians. Roberts
witnesses were free to disagree with UNMCs witnesses. In the end,
however, it was the jurys decision to determine whether UNMCs
particular course of action deviated from the standard of care. The jury
decided in favor of UNMC. The trial court erred in granting Roberts
motion for a new trial based on the judges opinion that the jury should
have reached a different conclusion. The trial courts order granting
Roberts motion for a new trial is reversed.
-
 End
February 7, 2017

f
338-355 (not on outline)

IV. Defenses to Malpractice

A. Standard of Care Exceptions

Problem: To Monitor or Not?

Based on an actual controversy based on the best way to monitor
fetuses during the process of labor and delivery.
Does question of capacity come u if woman is in labor?
o Not really, woman have decisional capacity in labor
Asking Mrs. Rudd to know the risks and if anything happens I promise
not to sue? Is that going to be an effective strategy?
o Probably not, might not fully comprehend the risk/benefit
tradeoff.
o Duty of care to fetus
o Doctors preference for EFM shows that they feel safer with that
and sounds like it's a risk management oriented preference

B. Clinical Innovation
1. Procedure Innovations

Brook v. St. Johns Hickey Memorial Hospital (1978) (Page 341)

Facts: At approximately two years of age, Terry Lynn Brook (plaintiff)
was diagnosed as having a possible urological disorder that would
need to be confirmed by injecting her with a contrast medium and then
taking x-rays. Dr. Fischer (defendant), a radiologist, injected the
contrast medium into the calves of Terrys legs despite the instruction
on the package label that it should be injected into the buttocks. About
four months later, Terrys right leg became stiff and her heel began to
lift off of the ground. It was later determined that a shortening of her
Achilles tendon was the cause of her leg problem which was
subsequently corrected via two surgical operations. Tracys father,
Arthur, brought suit against Fischer, St. Johns Hickey Memorial
Hospital, and two other physicians, alleging that Fischer went beyond
common medical practice by negligently choosing an improper site on
Terrys body to inject the contrast medium and that his decision
amounted to a medical experiment. At trial, the court refused to give
the Brooks jury instruction number 4 which stated that any new
medical procedure should pass through an experimental stage and that
a radiologist is not authorized in trying untested experiments on
patients. Brook appealed. The court of appeals found that Fischers
choice of injection site may have been a medical experiment since
other physicians did not use the calf muscles as injection sites for the
contrast medium.
o Parents are saying they experimented on their child and are
unhappy and want to know why the doctor was doing this
o Clinical innovation is ok but experimentation is bad. there are
some limited circumstances for doctors to try experimental
procedures. Note 4, page 344
o If it was the first patient it would be harder for the family to win
yes. because we discussed how the doctor has to look at
each patient on a case by case basis and make judgment
calls. and his experience and research showed that this
patient might have adverse affects if he did inject where
they suggest the injections should go

Issue: Whether a physicians peculiar choice for an injection site

amounts to a medical experiment.
Rule: Physicians have the knowledge and skill necessary to use
therapeutic innovation when making judgments regarding a
particular course of medical treatment for patients and such
decisions do not amount to medical experiments.
Holding: No. Fischer read several medical journals which cautioned
against the injection of contrast medium into the buttocks and thighs
 of infants and small children; previously used the same injection site
successfully on other children; and had not heard or read anything that
cautioned against the use of the calf muscles as an injection site.
Evidence of a medical experiment has not been introduced at trial.
Thus, it is improper to give an instruction covering medical
experiments. The judgment of the trial court is affirmed.

2. Drug Therapy Innovations Off-Label Uses

Richardson v. Miller (2000) (Page 345)

Facts: Cynthia Richardson became pregnant and sought prenatal care
from Dr. James Miller (defendant). Thereafter, Richardson complained
of rapid heartbeats, palpitations, and shortness of breath. Miller
referred Richardson to Dr. James Ward, Jr., a cardiologist who placed
Richardson on a heart monitor for 24 hours to monitor her heart
rhythms. Nothing significant was found by Ward who reported to Miller
that Richardsons prenatal care did not need to be modified. When
Richardson was 35-weeks pregnant, she went into labor and was
admitted to the hospital. Miller ordered bed rest and administered
drugs to stop the labor. When one particular medication failed to stop
Richardsons labor, Miller ordered the administration of terbutaline, a
drug that had only been approved by the U.S. Food and Drug
Administration (FDA) to treat asthma. After taking two doses of the
drug, Richardson experienced chest pain and refused to take any
further dose. Miller examined Richardson, noted that her labor had not
stopped, and then recommended the use of an infusion pump to
administer the terbutaline subcutaneously. Miller had little experience
in the use of terbutaline infusion pumps. Tokos Medical Corporation
(Tokos), the supplier of the infusion pump, sent a nurse to instruct
Richardson and hospital nursing staff concerning the use of the pump.
Over the next 48 hours, Richardson received regular subcutaneous
doses of terbutaline, but the drug did not stop Richardsons
contractions initially. By the time Richardsons labor had stopped, she
complained of having a rapid heartbeat. Shortly thereafter, Richardson
had a heart attack and then delivered a healthy baby. She required
cardiac bypass surgery to alleviate heart damage. Richardson and her
husband (plaintiffs) filed suit against the infusion pump supplier, Tokos
and Miller (defendants) for his alleged negligence in using the
terbutaline infusion pump as a treatment to stop premature labor. Prior
to trial, Miller moved to prevent Richardson from introducing into
evidence any information from terbutalines package insert and the
Physicians Desk Reference (PDR) indicating that the drug had not
been approved by the FDA for use in stopping premature labor. The
PDR is an encyclopedia of medications written from product inserts and
published annually and provided to all practicing physicians. The trial
 court granted Millers motion and the jury subsequently found for Miller
and Tokos. Richardson appealed.
She was already having heart palpitations and trouble breathing

Issue: Is a prescription drugs labeling or its PDR reference, when

introduced along with other expert evidence on the standard of care,
admissible to assist the trier of fact to determine whether the drug
presented an unacceptable risk to the patient?
Rule: A prescription drugs labeling or its PDR reference, when
introduced along with other expert evidence on the standard
of care, is admissible to assist the trier of fact to determine
whether the drug presented an unacceptable risk to the
patient.
Holding: Yes. A patient who is prescribed a drug or medical device in a
manner that has not been approved by the FDA is called an off label
use. Under the federal Food, Drug, and Cosmetic Act, a prescription
drugs label must include information necessary for the safe and
effective use of the drug, such as dosage, warnings, precautions, and
other details. Drug manufacturers are not required to submit labeling
reflecting all potential uses for the drug. The same drug label
information is also contained in the PDR. Currently, physicians routinely
use approved drugs and devices in ways not explicitly approved by the
FDA. If a physician decides to prescribe and administer an off label
use of a drug, he has a responsibility to have up-to-date knowledge on
the drug including discussions with colleagues, continuing medical
education seminars on the drug, and recent case studies and reports.
Most jurisdictions conclude that a drugs labeling and PDR reference
are relevant to the standard of care issue, but are usually not the sole
determinant. Thus, a prescription drugs labeling or its PDR reference,
when introduced along with other expert evidence on the standard of
care, is admissible to assist the trier of fact to determine whether the
drug, used in an off-label manner, presented an unacceptable risk to
the patient. Here, Richardson intended to call expert witnesses to
provide testimony in addition to the PDR and labeling evidence. This
expert testimony would have been that terbutaline should not have
been administered after Richardson experienced chest pain which
would have been sufficient for Miller to explain why he continued to
use it, as well as questioning the basis for his decision to use an
infusion pump and how the proper dosage was determined. The trial
court is thus in error for excluding the package insert, PDR information
and expert testimony to the triers of fact. The trial courts judgment is
reversed and the matter is remanded for a new trial.

End
Class on February 9, 2017 Cancelled - Snow
 February 14, 2017

355-379

C. Affirmative Defenses

1. Statute of Limitations
Malpractice litigation is subject in most states to its own statute of
limitations, often shorter than the other civil litigation.
Complication is often how and when the P becomes aware that her
injury was caused by her physician.

Arroyo v. U.S. (2011) (Page 356)

Facts: At birth, Christian Arroyo contracted a bacterial infection known
as Group B Streptococcus (GBS) from his mother, Maria. Because the
treating physicians failed to diagnose and treat the infection, Christian
suffered severe brain damage as a result. The physicians involved were
affiliated with Erie Family Health Center, Inc. (defendant), a health
clinic that received federal funds for the purpose of treating low
income individuals. Shortly after his birth, Christian exhibited several
symptoms indicating he had GBS. Upon her discharge, Maria was not
 informed by hospital staff that, had Christian been properly diagnosed
and treated, his resulting injuries could have been prevented. During
the birth of their second son, the Arroyos (plaintiffs) learned that
Christians injuries could have been treated and prevented. The
Arroyos filed a medical malpractice suit pursuant to the Federal Tort
Claims Act (FTCA) in state court against the federal government (as the
funding agency for Erie). The Federal Tort Claims Act (FTCA) would
shield the Erie physicians from liability while acting within the scope of
their duties with the federal government assuming liability for any
negligent acts they commit. 42 U.S.C. 233(g)(1). The suit was later
removed to federal court. After a bench trial, the district court found
that the physicians had committed negligence and awarded the
Arroyos $29 million in damages. The federal government appealed.
o Solutions on 364-365
o Suggestions by judge posner:
Do we really think a doctor who is negligent is going to turn
themselves in?
I dont think it's a great idea in the sense that it would bar
a suite after two years then because I am thinking about
injuries that occur after those two years due to the
negligence at birth or whatever it may be. some injuries
arent apparent right away especially with infants. things
could develop later on in their development

Issue: Under the Federal Tort Claims Act, does the two-year statute of
limitations begin to run when either (A) the plaintiff discovers
information that the government may have caused the injury or (B)
that a reasonable person in plaintiffs position would have acquired
sufficient knowledge to make a deeper inquiry into a potential
government cause of the injury?
Rule: Under the Federal Tort Claims Act, the two-year statute
of limitations begins to run when either (A) the plaintiff
discovers information that the government may have caused
the injury or (B) that a reasonable person in plaintiffs position
would have acquired sufficient knowledge to make a deeper
inquiry into a potential government cause of the injury.
Holding: Yes. The federal government argues that the district court
erred by rejecting its claim that the Arroyos suit was barred by the two-
year statute of limitations. Under the FTCA, a plaintiffs claim accrues,
and the statute of limitations begins to run, when either the plaintiff
discovers that the federal governments actions could have caused the
injuries in question or when a reasonably diligent person standing in
the shoes of the plaintiff could have discovered that the federal
government might have been at fault. Thus, there are objective and
subjective components to the two-prong test. The statute of limitations
 begins to run, not when a plaintiff obtains complete knowledge of the
cause of the injury, but rather when the plaintiff acquires knowledge
that would prompt a reasonable person to make a deeper inquiry into a
potential government cause. Here, the district court carefully
considered what information the Arroyos knew and when and
subsequently applied the proper accrual test. Upon her discharge,
Maria was not informed by the hospital that the physicians may have
committed negligence in causing the injuries sustained by Christian. In
fact, the Arroyos had no way of knowing that the physicians could have
done anything wrong until the following year when they learned
information pertaining to the bacterial infection. Moreover, the federal
government failed to provide any evidence to suggest that the Arroyos
knew more than they did. Additionally, there was nothing to lead the
Arroyos to inquire deeper into the possibility that the physicians could
have caused Christians injuries. The judgment of the district court is
affirmed.
Concurrence: While the majority came to the correct conclusion, a
larger philosophical issue is present. The Arroyos were low-income and
not-well-educated individuals. As a result, they are more likely to be
deferential to medical personnel than more educated persons, such as
other physicians. There should be an exception to the average
person test to include an examination of the plaintiffs personal
circumstances and use the same circumstances when utilizing the
average person test.

2. Good Samaritan Acts

- focused on just healthcare providers and then one for those who help
anybody etc.
-

D. Contributory Fault of the Patient

Very few tort cases have raised a patients lifestyle as a defense to a
malpractice claim.

Ostrowski v. Azzara (1988) (Page 369)

Facts: Ostrowski (plaintiff) consulted Dr. Azzara (defendant), a
podiatrist, for a sore left big toe. Ostrowski was heavy smoker, an
insulin-dependent diabetic, and obese. Azzara diagnosed Ostrowski
with a fungal disease of the toenail requiring its removal. Tests
conducted by Azzara also revealed that Ostrowski had very high blood
sugar levels and some peripheral vascular disease. Azzara explained to
Ostrowski that she could loose a limb if she did not better monitor her
blood sugar levels and her weight. After the procedure was performed,
Ostrowski continued to smoke against Azzaras medical advice. Also,
her toe became painful, discolored, and pre-gangrenous due to a lack
of blood circulating to the toe to aid in the healing process. As a result
of her poor circulation from the diabetes and her smoking habits,
Ostrowski required two operations and a vein transplant procedure in
an attempt to save her foot and leg from amputation. Ostrowski filed
suit against Azzara for malpractice and at trial, Azzara was permitted
to present evidence that Ostrowski significantly contributed to her
injuries because she continued to smoke against medical advice and
failed to maintain her weight, diet, and blood sugar at acceptable
levels. No medical expert for either side testified that Ostrowskis post-
treatment health habits could have caused her need for surgery six
weeks after Azzaras toenail removal. The jury found Azzara acted
negligently by removing Ostrowskis toenail without adequate
consideration of her vascular condition, but denied Ostrowski any
damages because she was more at fault for continuing to smoke and
failing to properly take care of herself after the procedure. The court of
appeals affirmed the jurys verdict in favor of Azzara and Ostrowski
appealed.
o In what sense could a jury conclude that the D had acted
negligently?
o Nature of malpractice that Dr. Azzara might have committed?
What is the likely negligence by Dr. Azzara? Failure to
obtain tests/monitor healing process closely
Believed Ps representations about seeing internist, Dr.
shouldve looked into it.
Would the doctor be able to bring in that fact that she
signed a consent from after reviewing the risks?
Something to fight out at trial to find out what
exactly she consented to at trial. Some jx do treat a
signed consent form as a defense but other jx are not
happy about doing that since patient is a lay person.
It would be something to try, but not going to get
doctor off the hook because of doctrine of being
particularly susceptible.
Modified comparative fault in NJ case. Jury found 61% at
fault and 49%.
Mention of the bar and pure comparative negligence.
Doctrine of avoidable consequences: post surgery conduct,
port tort and it is an appropriate way to approach Ps
conduct after (372)
Are Ps pre-treatment health habits not relevant? They are
relevant but only as to the doctrine of the particularly
susceptible victim.
Ps post treatment health habits? Doesnt have to do with
contributory negligence?
 Court remands the case for a new trial for better jury
instructions. D still bears the burden.
How would D win this lawsuit? If going back now with
better jury instructions that saw doctrine of particular
susceptibility and talking about avoidable consequences:
what is going to be the challenge for relying on these
facts?
Ps contribution to injuries post tort could be hard to
measure and to prove.
Avoidable consequences and comparative negligence of Ps
behavior is sort of opening the door to let the jury make
social judgments about Ps behavior in a particular case. If
they had barred this Ps claim,
Is it fair to blame doctor for the patients failing doctors
orders? Would it be fair or useful as a means of lowering
the Ds damages?
Patient should be liable to some degree. The doctor
is giving orders to achieve the best outcome.
Yes, in situations like that where the doc gives you
clear instructions and you completely ignore it I don't
think the doc should be held liable or negligent so
long as the instrcutions were based on the patient's
medical history and the doc's reasonable judgment

Issue: May a patients poor post-procedure health habits act as a bar

to recovering damages in a medical malpractice action when the
patients actions did not cause the injuries?
Rule: A patients poor post-procedure health habits are not a
bar to recovering damages in a medical malpractice action
except to the extent that the patients fault caused the
injuries.
Holding: No. Negligence law generally calls for a reduction of
damages to a plaintiff when her negligence is found to be a substantial
contributing factor in increasing the resulting harm. To determine the
extent of Ostrowskis contribution, if any, to her injuries from her post-
treatment habits, several relevant doctrines must be examined
including avoidable consequences, the particularly susceptible victim,
aggravation of a preexisting condition, comparative negligence, and
proximate cause. Under the doctrine of avoidable consequences, a
plaintiff who suffers an injury may not recover damages for any portion
of the resulting harm that could have reasonably been avoided. This
doctrine often comes into play when the injured partys carelessness
occurs after the defendants negligence as opposed to the doctrine of
contributory negligence which comes into play before the defendants
negligence occurs. Under the theory of the particularly susceptible
 victim, a defendant takes a plaintiff as he finds him. The doctrine of
aggravation of preexisting condition is very similar to avoidable
consequences, except that the injured persons conduct is irrelevant. A
defendant whose acts aggravate a plaintiffs preexisting condition is
liable only for the amount of harm actually caused by the defendants
negligence. Comparative negligence is intended to leave the door open
to those plaintiffs whose fault was not greater than the defendants
and will qualify the doctrine of contributory negligence when that
doctrine is applicable as a limitation on a plaintiffs recovery. Finally,
proximate cause binds it all together. Each of these doctrines has some
application in this case. Ostrowski failed to minimize her damages that
she might have otherwise sustained due to mistreatment. Such
mistreatment may or may not have been the proximate cause of her
ultimate condition. Ostrowski is not responsible for her initial injury, i.e.
the complications arising from the toenail removal. However, Ostrowski
is more susceptible to experience complications than other patients
due to her underlying health conditions, but that is the condition in
which her physician found her. Although Azzara must take Ostrowski as
he finds her, Azzara cannot reverse Ostrowskis poor health condition.
Azzara is not responsible to the extent that Ostrowskis condition would
have deteriorated absent Azzaras negligence. Also, Ostrowskis
recovery should be reduced to the extent that she could have avoided
her complications by not smoking and taking better care of herself in
accordance with medical advice. Taking these doctrines and applying
them to the facts in this case is undoubtedly a difficult task and there
may not be easy answers. However, the judgment of the trial court is
reversed and the matter is remanded for a new trial for the jury to
consider each partys conduct in light of the theories and doctrines
mentioned.

Problem: The Difficult Patient

February 16, 2017

379-381, 381-391, 391-394

V. Causation Problems
- a question of causation is a jury question, its a question of face, not one for
judge to rule one.
- most states have adopted a comparative fault
- more and more states are adding the Ps contribution to their injuries
- joint tortfeasor where multiple parties have come together to split the
injury since the negligence of multiple defendants produced a non-
defeasible injury. Burden shifts to each individual D to prove they arent
responsible or for a portion of the damages. (definition on page 379)
- P can go after any and all damages under several liability in the old
common law.
- Ybarra case mentioned on page 380
- something about an Egghell Plaintiff

VI. Damage Innovations

A. The Loss of a Chance Doctrine

Herskovits v. Group Health Cooperative of Puget Sound (1983) (Page
381)
Facts: Herskovits consulted Group Health Hospital (GHH) (defendant),
operated by Group Health Cooperative of Puget Sound (defendant),
complaining of chest pain and coughing. Treating physicians at the
GHH took a chest X-ray but did not perform any other tests. GHH
treated Herskovitss condition with a cough suppressant. Herskovitss
chest pain and coughing persisted, and he consulted Dr. Jonathan
Ostrow for a second medical opinion. Ostrow diagnosed Herskovits with
an advanced form of lung cancer. Herskovits underwent an operation
to remove the cancerous lung but died 20 months later. Herskovitss
wife, as administratrix of his estate (the Estate) (plaintiff), filed a
wrongful death suit against GHH. Ostrow testified for the Estate that
had GHHs physicians detected the cancer, Herskovitss possibility of a
five-year survival would have been 39 percent. Due to GHHs failure to
detect the cancer, Herskovitss chance of survival was reduced to 25
percent. The Estate argued that the reduction in the chance of survival
from 39 percent to 25 percent was sufficient evidence to allow a jury to
consider the proximate cause issue. GHH argued that the Estate was
unable to produce expert testimony that the delay in Herskovitss
diagnosis probably or more likely than not caused his death. The
trial court granted GHHs motion for summary judgment, and the
Estate appealed.
o 39% chance to 25% is a 14% difference. Doesnt sound good.
o Full life expectancy calculated by loss of wages for death, loss of
support etc. then discount that number by the original
percentage change that they had for survival if their illness had
been diagnoses and treated in a timely fashion.
o Dissent: proximate cause is a more likely than not standard
according to the dissent
o Cancer: the staging process and early diagnosis does not
necessarily alter the outcome, what it does alter is how long you
live knowing you have cancer. At least with respect to certain
cancers
o I think the proximate cause burden that the dissent talks about is
also a high burden because it's hard for one to show that they
would have survived even considering things like tumor size, etc.
because so many other factors can be at play such as response
to medication. But then again loss of a chance is also difficult to
deal with because like you said most time it just lets the patient
know about their illness earlier. But I think that matters a lot
because then it allows them to know what's next in their life and
it also builds trust in the medical field
 o Benefit to knowing your diagnosis earlier is that can get affairs in
order, have a conscious understanding that their time is limited,
etc. Some people prefer not to know unless they have to.
Issue: In a wrongful death action, is expert medical testimony of a
reduction of chance of survival sufficient evidence to allow the
proximate cause issue to go to a jury?
Rule: In a wrongful death action, proof that the defendants
conduct increased the risk by decreasing the chances of
survival of a plaintiff is sufficient as to the issue of proximate
cause.
Holding: Yes. The core issue presented is one of first impression. Does
a patient with less than a 50 percent chance of survival have a cause
of action against a hospital and its physicians if they are negligent in
diagnosing a deadly form of lung cancer that reduces the patient's
chances for survival for five years by 14 percent? Under 323(a) of the
Restatement (Second) of Torts [1965], proof that the defendants
conduct increased the risk of death by decreasing the chances of
survival is sufficient to take the issue of proximate cause to the jury.
Some jurisdictions have accepted this as proximate cause in cases
where a defendants conduct deprived a plaintiff of a significant
chance to survive. Other jurisdictions have flatly rejected this
approach, generally holding that a plaintiff is required to show that it
was more likely than not that the harm sustained was caused by the
defendants negligence. Such an approach is too strict and would send
the message that physicians and hospitals would not be liable any time
there was less than a 50 percent chance of survival, regardless of how
flagrantly negligent the act is. Here, once the Estate is able to
demonstrate that GHHs acts or omissions increased the risk of harm to
Herskovits (by decreasing the chance of survival), such evidence is a
basis for the cause of action to go to a fact finder. It is not required that
the Estate introduce evidence to establish that GHHs alleged
negligence resulted in the death of Herskovits, but simply that the
negligence increased Herskovitss risk of death. The trial courts award
of summary judgment to GHH is reversed, and the matter is remanded
to reinstate the cause of action.
Concurrence: The all-or-nothing approach utilized by some
jurisdictions is arbitrary and denies recovery for the effects of negligent
conduct that cause statistically demonstrable losses. Under such an
approach, a plaintiff who establishes that but for the defendants
negligence, the decedent had a 49 percent chance of survival recovers
nothing. The best resolution here is to recognize an action for the loss
of chance of survival.
Dissent: The evidence in this case does not rise above speculation
and conjecture. The use of statistical data can be manipulated to serve
either partys interest. Statistical evidence should only be admissible if
 it has a tendency to make the existence of any fact more or less
probable than without the statistical evidence. Here, while the
statistical reduction in chance of survival is relevant, it is not sufficient
to show proximate cause.

Problem: Missing the Diagnosis

- Against Dr. James: no claim because he told the whole family to get
checked out. He doesn't have a direct doctor-patient relationship with her to
examine her so no claim based on this.
- Against Dr. Gillespie: negligent failure to diagnose, loss of chance,
- Against Jane: for continuing to lifeguard and having sun exposure? She is
aware of the risk of sun exposure but she might not have continued if her
diagnosis had been right. She was given all clear by Dr. Gillespie so cant
really blame her.
- Against Dr. Wunch:
- Doctors are now very hesitate to do what Dr. Wunch did. Even in a casual
encounter/party a doctor giving a diagnosis and giving contact info is
sufficient to form a doctor/patient relationship. Doctors have now been told
not to diagnose people in a casual setting.

B. Punitive Damages

Marsh v. Arnot Ogden Medical Center (2012) (Page 391)

Facts: Leslie Marshall was a patient in a hospital owned and operated
by Arnot Ogden Medical Center (AOMC) (defendant). Jane Doe
(defendant), a registered nurse, wrongfully injected Marshall with an
insulin-reducing medication that had not be prescribed or ordered by a
treating physician. After learning of the mistake, Doe contacted the
attending physician, Renee Abderhalden-Friend, M.D., at home.
Abderhalden-Friend instructed Doe to monitor Marshalls glucose level
every two hours. Early the following morning, Abderhalden-Friend
instructed AOMC staff by phone to discontinue the monitoring.
However, Dr. Abderhalden-Friend did not personally examine Marshall
at the hospital. Marshall died shortly thereafter. An autopsy revealed
that Marshalls cause of death was attributed to the administration of
the medication. Debra Marsh (plaintiff), as executor of the estate of
Marshall, filed a negligence and medical malpractice suit against
AOMC, Doe, and Dr. Abderhalden-Friend, among others. Included in her
complaint was a claim to be awarded punitive damages. Dr.
Abderhalden-Friend moved to dismiss the punitive damages claim
against her pursuant to state law while AOMC and Doe filed a motion
for partial summary judgment to dismiss the punitive damages claims
against them. The Supreme Court granted defendants motions. Marsh
appealed.
o To receive punitive damages (page 392)
 o The nurse messes up and gives huge dose of insulin, doctor said
to monitor the patient and call him
o Any theory as to why doctor on call said patient was all good to
go and nothing else needed to be done: it was an oversight or
obvious mistake.
o Normal fasting blood glucose level is between 98-103, his was
107 so it wasn't too drastic, but it was high.
o An explanation could be that he thought the blood glucose level
was going to fall, but it probably isnt enough to get rid of a
negligence claim.
Issue: In New York, will a punitive damages claim in a medical
malpractice and negligence action survive dismissal and partial
summary judgment if there is a question as to whether a defendant
acted with reckless indifference equivalent to willful or intentional
misdoing or a wanton and reckless disregard for the plaintiffs rights?
Rule: In New York, a punitive damages claim in a medical
malpractice and negligence action will survive dismissal and
partial summary judgment if there is a question as to whether
a defendant acted with reckless indifference equivalent to
willful or intentional misdoing or a wanton and reckless
disregard for the plaintiffs rights.
Holding: Yes. In a New York medical malpractice action, punitive
damages may be recovered when a defendants conduct can be shown
to have risen to the level of reckless indifference, willful or intention
misdoing, or a wanton and reckless disregard for the plaintiffs rights. A
showing of malice or wrongful intent is not required. In her complaint,
Marsh alleges that despite Dr. Abderhalden-Friends knowledge of the
medication error and Marshalls resulting, serious medical condition,
she failed to come to the hospital to personally examine Marshall.
Instead, Dr. Abderhalden-Friend directed AOMC staff by telephone to
discontinue monitoring of Marshalls glucose level until the following
morning without ordering any other actions to monitor his condition in
the interim. If proven by Marsh, it is possible that such conduct by Dr.
Abderhalden-Friend could be found to have been grossly inappropriate,
warranting imposition of punitive damages. Additionally, Marsh must
sufficiently show there are factual issues present that require
deliberation by a jury in order to overcome partial summary judgment
being awarded to AOMC and Doe on the punitive damages claim. Here,
Marsh claims that just before Doe administered the medication
Marshalls daughter specifically warned that he was not diabetic and
did not use insulin. Doe nonetheless gave the medication to Marshall
without confirmation that a physician had ordered it or that his medical
condition warranted it. It is undisputed that Does administration of the
medication to Marshall caused his death. Thus, there are factual issues
present regarding whether Does conduct demonstrated the requisite
 reckless indifference to Marshalls medical care to justify a punitive
damages award. Additionally, Does mistake was not immediately
documented in Marshalls medical chart. Instead, it was entered four
months after Marshalls death. There has been no explanation from
Doe or AOMC for this oversight. Willful failure to disclose pertinent
medical information may be sufficient to support punitive damages
when undertaken to evade a malpractice claim. A medical facilitys
failure to provide appropriate safety precautions and training may
constitute a basis for punitive damages if it can be shown to constitute
a conscious disregard for patient safety. The judgment of the Supreme
Court is reversed.

February 23, 2017

155-168, 168-174

Chapter 4: The Professional-Patient Relationship

I. Introduction
Introduction -- this chapter considers the formation of the physician-
patient relationship and a range of other obligations that the law
imposes on physicians and other health care professionals.
Physician-Patient Relationship:
o Contract approach usually applied k, not express
o Fiduciary obligations
o Limits/ severity of doctor-patient relationship
Limited specialty
Scope of practice
Hours/conditions
Scope of agreement to TX
Transfer of patient care
Scheduling appointment is usually not enough
Advice via email/take medicine may suffice
Dont need to actually meet patient
Concept of abandonment
Uncooperative patient

Esquivel v. Watters (2007) (Page 155)

Facts: After receiving obstetric counseling at Ark City Clinic
(defendant), a pregnant Michelle Esquivel (plaintiff) went to the South
Central Kansas Regional Medical Center (SCKRMC) (defendant) for a
free sonogram to determine the sex of the baby. Prior to the procedure,
Michelle signed a consent and waiver of liability form stating that there
was no guarantee that a gender could conclusively be determined and
that the sole purpose of the test was to determine the babys gender
not to determine any fetal abnormalities or other complications. A
 technician at the SCKRMC performed the sonogram and, while taking
pictures, noticed that the babys bowel was outside of his body, a
condition known as gastroschisis. The technician was unable to
determine the gender due to the presence of this condition. The
technician did not inform Michelle of the condition because he was not
qualified to make a medical diagnosis. He sent the sonogram pictures
to a radiologist at Ark City Clinic who refused to view them because the
procedure was solely to determine the sex of the baby. The technician
also orally informed Michelles obstetrician, Dr. Aaron Watters,
(defendant) of the condition. No written report was made by either the
technician or Watters regarding the conversation. Shortly thereafter,
Watters asked a nurse to follow up with Michelle. She was
unsuccessful. During subsequent prenatal visits, Watters forgot to
inform Michelle of the babys medical condition. Michelle gave birth to
Jadon about one month later when she, her husband Jesse, and the
medical staff became aware of his condition. Jadon was transferred to
another hospital the same day and a physician performed surgery on
Jadon, but informed the Esquivels that there was no hope for his
survival. Jadon died approximately one month later. Michelle and Jesse
Esquivel (plaintiffs) brought suit against the Ark City Clinic, Watters and
the SCKRMC for the wrongful death of Jadon. The district court granted
summary judgment to all of the defendants. The Esquivels appealed
the summary judgments of Watters and the SCKRMC.
o Why would hospital offer free sonograms?
To get patients
o Why bring a lawsuit?
If she had known earlier she could have been prepared
Duty of reasonable care as part of the contractual
agreement with letting them know something was wrong
o Baby could have survived if diagnosed beforehand.
o What is technically legally required is not what is ethically right.
o Say not enforceable in law, but seems ridiculous that this didnt
end up in her chart. Why did her obstetrician not also perform a
sonogram? Why was it never brought back up?
o There is a whole other layer of malpractice here that isnt
discussed and not sure why.
o If already doctor-patient relationship formed, then it lasts and
includes fiduciary duty. Cant have fiduciary duty without doctor-
patient relationship.
o Some could have said that marketing by a hospital to lure a
patient there is not always sufficient for a doctor-patient
relationship.
Issue: Does a hospital owe a duty of care to an individual when no
hospital-patient relationship exists beyond a specific purpose?
 Rule: In the absence of a hospital-patient relationship, a
hospital owes no duty to an individual to provide treatment for
a disease, illness, or medical condition.
Holding: No. No hospital-patient relationship existed between the
SCKRMC and Michelle triggering a duty of the facility to provide
medical treatment or diagnosis beyond its limited duty of performing a
sonogram to determine the gender of her baby, which it performed in a
non-negligent manner. The facility did not offer to advise or treat
Michelle for any medical condition. The courts award of summary
judgment in favor of Watters and the SCKRMC is affirmed.

o 1. Duty to Notify -- a patient of illness

o 2. Doctor - Patient relationship is fiduciary in nature -- hospital
patient is not fiduciary
o 3. Patient -- healthcare provider gives rise to a duty to treat a
patient
a. no such relationship arises when provided service is
limited by waiver to do certain procedure only (sonogram
only for purpose of determining sex)
o b. treatment -- medical application of remedies so as to affect
a cure
ii. Duty on Physicians retained by 3rd Parties to Independent Medical
Examinations:
o 1. to exercise ordinary care to discover those conditions which
impose an imminent danger to the examinees physical or
mental well-being and take reasonable steps to communicate the
examinee the presence of any such condition;
o 2. to exercise ordinary care to assure that when he or she
advises an examinee about her condition following an
independent examination, the advice comports with the standard
of care for the health care providers profession
iii. Fiduciary Duty in Medicine
o 1. physician focuses exclusively on the patients health;
o 2. patient assumes the doctors single-minded devotion to him;
and
o 3. doctor-patient relationship is expected to be free of conflict

II. The Contract Between Patient and Physician

White v. Harris (2011) (Page 160)

Facts: Fourteen-year-old Krystine White committed suicide after a
suffering from a mental illness for a long period of time. During the
course of her mental health treatment, Krystine enrolled in a
telepsychiatry research study conducted by Mark Harris, M.D.
(defendant), an employee of Fletcher Allen Health Care, Inc. (FAHC)
 (defendant). As part of the study, Krystine participated in a one-time,
90-minute video-conference session with Harris. Afterwards, Krystine
completed a questionnaire about her experience. Thereafter, Harris
completed a consultation evaluation that described Krystines illness,
provided his diagnostic impression, and set forth a treatment plan.
However, Harris did not provide any further follow-up clinical services
to Krystine and no medications were prescribed. Additionally, Harris
provided his recommended treatment plan to Krystines regular group
of treating physicians. After her death, Krystines father, Terrence
White (plaintiff) filed a wrongful death action against Harris and FAHC.
White argued that Harriss treatment of Krystine fell below the required
standard of care of a skillful physician. Harris and FAHC claimed that
Harris did not have a doctor-patient relationship with Krystine. The trial
court granted summary judgment to Harris and FAHC. White appealed.
o This court thinks SJ wasn't appropriate.
o EMTALA any hospital that receives funds and Medicare are
required to treat anyone who comes into their hospital if it is a
emergency.
Issue: In Vermont, are a 90-minute video-conference consultation
between physician and individual along with a subsequent written
consultation assessment and treatment plan sufficient to create a
doctor-patient relationship?
Rule: In Vermont, a 90-minute video-conference consultation
between physician and individual along with a subsequent
written consultation assessment and treatment plan are
sufficient to create a doctor-patient relationship.
Holding: Yes. On appeal, Harris and FAHC argue they owed no medical
duty to Krystine and thus no doctor-patient relationship was present. In
assessing whether a duty exists, [t]he question is whether the
relationship of the parties was such that the defendant was under an
obligation to use some care to avoid or prevent injury to
plaintiff. Markowitz v. Arizona Parks Bd., 706 P.2d 364, 368
(Ariz.1985). Some of the factors considered by a court to determine
whether a duty exists include (1) whether the doctor was in a unique
position to prevent harm; (2) the burden of preventing harm; (3)
whether the individual relied upon the doctors diagnosis; (4) the
connection between the doctors conduct and the harm caused to the
plaintiff; and (5) the skill or special reputation of the actors, and public
policy. Stanley v. McCarver, 92 P.3d 849, 853 (Ariz.2004).
Here, while the interaction between Harris and Krystine was limited to
a 90-minute video conference, Harris completed a post-session
psychiatric assessment and worked with Krystines treating physicians
on a proposed treatment plan. Such actions are sufficient to support
the existence of a duty. FAHC argues that Harris submission of his
consultation evaluation and treatment plan to Krystines treating
 physicians effectively terminated any relationship he may have had
with her. Under Vermont law, however, whether a doctor has ceased
treating a patient is irrelevant to whether he may be held liable for
injuries resulting from failure to exercise due care while treating the
patient. Here, the trial court did not address whether Harriss actions
fell below the applicable standard of care of a treating physician. The
judgment of the trial court is reversed and the matter is remanded for
additional proceedings.

o Duty Exists - when the relationship of the parties was such that
the defendant was under an obligation to use some care to avoid
or prevent injury to the Plaintiff
a. Factors: (see case for application of factors)
i. Dr. was in a unique position to prevent harm
ii. burden of preventing harm
iii. did plaintiff rely upon doctors diagnosis or
interpretation
iv. closeness of connection between the defendants
conduct and the injury suffered
v. degree of certainty that the plaintiff has or will
suffer harm
vi. skill or special reputation of the actors
vii. public policy
ii. Telephone - courts reluctant to find a doctor patient relationship
created by a conversation/consultation over the phone with a patient
or other physician
o a. video conferencing - more likely to find a relationship and duty
iii. Physician - patient relationship as a contract: can be limited and
define scope of treatment
o 1. once relationship is created physicians are subject to an
obligation of continuing attention
a. refusal to continue to treat a patient is abandonment
and may be malpractice
Hand v. Tavera (167) have to treat patients

A. Physician Contracts with Third Parties

1. Doctor is part of managed care network, Dr. responsible for
admission at a hospital send a patient with a headache home, patient
dies, Dr. cant defend suit by arguing no relationship existed b/c his
contract between Dr.s employer and patients insurance company
obligated doctor to treat.
2. Physicians who practice in organizations must provide health care
within the limits of the health plan coverage or their employment
contracts with the institution
 3. A physician with staff privileges at a hospital agrees to abide by
hospital by-laws and policies

B. Specific Contract Promises

Kaplan v. Mayo Clinic (2011) (Page 168)

Facts: Elliot Kaplan (plaintiff) was taken from his home to a nearby
hospital in Kansas City, Missouri, after complaining of severe
abdominal pain. During the hospital visit, Kaplans long-time physician
performed a CT scan on him which showed an enlarged pancreas.
Kaplan was then referred to Mayo Clinic Rochester, Inc. (Mayo)
(defendant) for further treatment. After consulting with two Mayo
pathologists, Lawrence Burgart, M.D. and Thomas Smyrk, M.D., Mayo
surgeon, David Nagorney, M.D. (defendant), recommended Kaplan
undergo surgery to remove a portion of his pancreas and stomach
believed to be cancerous. After the surgery, Mayo pathologists
examined tissue taken from Kaplans pancreas and stomach and found
no cancerous cells. Kaplan and his wife, Jeanne, (plaintiffs) filed suit
against Mayo and the physicians for breach of contract and negligent
failure to diagnose. The district court granted Nagorneys motion for
summary judgment and proceeded to trial on the other defendants. At
the close of Kaplans case, the district court granted judgment as a
matter of law (JAML) in favor of Mayo and Burgart on the breach of
contract claim. Thereafter, a jury returned a verdict in favor of Mayo
and Burgart on the negligent failure to diagnose claim. The Kaplans
appealed.
o Whipple procedure recovery from this is very difficult, never
going to eat or digest food again.
o 2 biopsies done beforehand where multiple people said yes this
is cancer, but turned out not to be cancer.
o Did not need an expert witness when lay person can understand
the terms in the contract.
Issue: Is summary judgment warranted in a breach of contract claim if
a plaintiff can sufficiently show the formation of a contract, the
defendants breach of the contract, and resulting damages?
Rule: Summary judgment is not warranted in a breach of
contract claim if a plaintiff can sufficiently show the formation
of a contract, the defendants breach of the contract, and
resulting damages.
Holding: No. The Kaplans argue that the district court erred in
granting summary judgment in favor of Dr. Nagorney, Mayo and Dr.
Burgart on their breach of contract claim. To successfully make a claim
for breach of contract the Kaplans must show the formation of a
contract, the defendants breach of the contract, and resulting
damages. Here, the district court concluded that the Kaplans breach of
 contract claim was merely a medical negligence claim in disguise and
disposed of the matter. However, the evidence shows that Kaplan had
expressed concerns and doubts to Dr. Nagorney regarding the cancer
diagnosis. As a result, Kaplan and Dr. Nagorney had a definitive
agreement that Dr. Nagorney and his pathology colleagues would
insure that the pancreatic cancer diagnosis was precise before Kaplan
underwent the surgical procedure and even during the procedure. Dr.
Nagorney indicated to the Kaplans that, during the surgery, he could
perform an intraoperative biopsy of the affected tissue and a
pathologist would examine it to definitively determine whether cancer
was present. Dr. Nagorney breached that agreement by not only failing
to discuss with his pathology colleagues prior to the surgery Kaplans
concerns regarding the diagnosis, but also for failing to perform the
intraoperative biopsy during the surgical procedure. Dr. Nagorney
denies making such an agreement with Kaplan. Nevertheless, the
evidence suggests that Dr. Nagorney has performed intraoperative
biopsy procedures during surgeries similar to the one that Kaplan
underwent. Thus, it is clear that evidence suggests the formation of a
contract and a breach of the agreement. To prove damages, Kaplan
must offer evidence to support a finding that the intraoperative biopsy
results would have been negative for cancer. It is indisputable that
Kaplan did not have cancer when tissue was examined by pathologists
after the surgery was performed. Further, the evidence supports a
finding that Dr. Nagorney would not have continued the surgical
procedure if an intraoperative biopsy showed no cancer. Therefore,
Kaplan could sufficiently show that he suffered damages due to Dr.
Nagorneys breach of their agreement. Dr. Nagorney argues that the
Kaplans failed to provide expert testimony regarding certain aspects of
their breach of contract claim. However, there is no need for expert
testimony when a lay person can understand the simple claim that a
physician promised to perform a certain procedure and failed to do so.
The district courts judgment on the negligent failure to diagnose claim
is affirmed. The district courts judgment in favor of Mayo and Dr.
Nagorney on the breach of contract claim is vacated and the matter is
remanded to the district court for further proceedings consistent with
the opinion.

February 28, 2017

In class, 2 essay exam. Open note, open book.

174-184
C. Exculpatory Clauses

Tunkl v. Regents of Univ. of California (1963) (Page 174)

- Facts: Hugo Tunkl (plaintiff) was selected to participate in a research
project conducted by the University of California at Los Angeles
Medical Center (Medical Center), a charitable hospital operated and
maintained by the Regents of the University of California (Regents)
(defendant). Upon admission, Tunkl signed a conditions of admission
document including an exculpatory clause stating that he would
release the Regents from any liability resulting from the negligent or
wrongful acts or omissions of its employees if the Medical Center had
used due care in hiring the employees. At the time of signing the
document, Tunkl was in great pain, under sedation, and likely unable to
read the document. Tunkl brought suit to recover damages for personal
injuries he sustained from the negligence of two physicians employed
at the Medical Center. Prior to trial, Tunkl died and his wife, as executrix
of his estate, was substituted as plaintiff. Tunkl stipulated that the
physician employees of the Medical Center had been selected with due
care. The trial court submitted the issue regarding the validity of the
exculpatory clause to the jury. If the jury found that the clause did not
bar Tunkls suit from proceeding, a second jury would try the issue of
the alleged malpractice. The first jury returned a verdict sustaining the
validity of the executed release and the court entered judgment in
favor of the Regents. Tunkl appealed the courts judgment.
- Issue: May a hospital use an exculpatory clause to bar a patients
medical malpractice action if it provides services in the public interest
and possesses superior bargaining strength?
- Rule: A hospital that provides medical services to the public, is
subject to public regulation, and possesses superior
bargaining strength over its patients and may not use an
exculpatory clause barring a patients malpractice action.
o A release waiving any malpractice liability of a nonprofit
hospital is unenforceable
- Holding: No. Only an exculpatory provision that does not involve the
public interest may be upheld. The public interest concerns any
business that is subject to public regulation and performs necessary
services to a great number of people. Due to the essential nature to
patients of receiving needed medical treatment, a hospital possesses
an advantage of bargaining strength that it relies on when placing
documents in front of a patient that must be signed. The Medical
Centers exculpatory provision clearly meets the public interest
requirement. Although the Medical Center selects patients suitable for
the research and training it specializes in, such selectivity does not
negate its public interest status.
o A k will such interest if the party seeking exculpations engaged in
performing a service of great public importance. Refer below
o Stretch for civil code to apply, not a perfect fit, but court was
willing to say they are expanding the reach
o Court concludes this is unenforceable
o P puts himself in control of hospital employees so court says not
going to have someone be off hook for med neg because patient
has signed waiver
o Not discussed is that P came to hospital and signed contract
under great pain and sedation.
o Tunkl factors and public policy (175-176)
Public policy argument: because people who are in need of
medical attention would sign the waiver regardless
because they have no other option
Enforcing this waiver gives a free pass to providing
negligent care and courts are saying that these waivers of
liability are particularly offensive because they waive
lawsuits for unavoidable bad outcomes, but waive
possibility for suing for negligent care. Courts are saying
that is unacceptable. No matter who you are and your
income you have a right to receive non negligent care.
Waiver only kicks in if care that was delivered was
negligently delivered. Doesn't guarantee a good result.
Backdoor method of achieving charitable immunity that
hospitals used to have. Charitable immunity for hospitals
used to be immune by court and lawsuits used to be barred
by law. Not the case anymore.
 Could a hospital turn someone away for refusing to sign
one of these waivers?
Hospitals know that these waivers are not favorable
by courts, but hospitals really cant refuse treatment,
EMTALA tied to Medicare funding. Any hospital that
receives funding from fed gov for medical treatment
from Medicare, must provide emergency medical
care.
Hospitals don't have same freedoms to refuse patients that
some doctors have.
Pt scheduled for minor elective surgery and said I
absolutely must have general anesthesia, and surgery is
normally done with local anesthesia, can surgeon turn
them away? Yes, surgeon can say that is not the standard
of care to perform the surgery under general anesthesia.
What if surgeon says ok? But now you need to waive
liability. Kind of like next case. Waiver would be
limited to consequences directly related to giving of
anesthesia.
- Once the patient signs the adhesion contract, he is at the mercy of
potential recklessness or negligence from physicians. The Regents
argues that it should be excused from negligence suits where the
treatment is provided to non-paying patients. A potential consequence,
the Regents argues, is that the focus of the facility would shift from one
of research and treatment to one focused on the payment of claims
and processing. However, negligence is not inferred. The patient would
still be required to prove all of the essential elements of a malpractice
action. The removal of the exculpatory clause simply aids the patient in
his ability to pursue a malpractice action. The judgment of the trial
court is reversed.
- Notes: In general, courts have been rather hostile to efforts by health
care providers to limit their malpractice liability. Rarely are general
releases honored and arbitration provisions have been only somewhat
successful. Liability limitations that do exist, do so by virtue of action
by the legislature.
-
Shorter v. Drury (1985) (Page 178)
- Facts: Doreen and Elmer Shorter (plaintiffs) were Jehovahs Witness, a
faith prohibiting its followers from receiving blood transfusions. When
Doreen was pregnant, she consulted with Dr. Robert Drury (defendant),
a family practitioner who diagnosed her as having a missed abortion,
a condition in which a fetus dies and the uterus fails to discharge it. To
guard against infection, a dilation and curettage (D and C) was
recommended. Of the three commonly-used methods to perform the
procedure, Drury chose the method that posed the highest risk of
bleeding due to possible puncture from the instrument used. Drury
explained the procedure to Doreen, including the risk of bleeding, but
failed to advise her of the two alternate methods. A second opinion
obtained by Doreen confirmed the procedure as appropriate and
warned her of the risk of significant blood loss. At the hospital, the
Shorters signed a document releasing the hospital, physicians, and
 staff from all liability stemming from her refusal to accept blood if
needed. During the procedure, Drury lacerated Doreens uterus
causing her to bleed profusely. Physicians repeated attempts to have
Doreen, as well as Elmer, consent to a blood transfusion were rejected.
Doreen bled to death. Mr. Shorter filed a wrongful death action alleging
Drurys negligence proximately caused Doreens death. At trial, the
release document was entered into evidence and the jury was
instructed on assumption of the risk. The jury found Drury proximately
caused Doreens death and awarded $412,000 in damages. That
amount was reduced by 75 percent because the jury also found that
the Shorters knowingly and voluntarily assumed the risk that
refusing blood transfusions would result in Doreens death. Motions for
a judgment notwithstanding the verdict were filed by both parties, and
denied by the court. Shorter appealed and Drury cross-appealed, but
did not appeal the issue of his negligence.
o Mention of failure to mitigate damages as long as procedure is
not considered to be invasive. In this case it was post tort, but
combo of assuming the risk of undergoing surgery with bleeding
is reasonable under the circumstances and unavoidable so
damages reduced.
o P not denied all recovery probably.
o Enforceability of waiver: valid but not as a complete excuse for
wrongful death
o Did not accept consequences of Dr. Drurys negligence, she did
accept the consequences of not receiving blood.
o You do assume the risk up front
- Issue: May a contract releasing a physician from liability resulting from
negligent acts be upheld as valid?
- Rule: A contract against liability for negligence will be held
valid except in cases where the public interest is involved.
o When a patient refuses advised medical treatment, a
document releasing medical providers from liability
resulting from such refusal is valid.
- Holding: Yes. Doctors for both parties agreed that a blood transfusion
would likely have saved Doreens life. However, the Shorters knowingly
and voluntarily signed a document stating that all blood or blood
derivatives were refused, even if needed during the procedure. The
execution of this document protected the hospital, the physician, and
the Shorters from accepting blood, which is against their faith. The
refusal is valid and not against public policy. However, the document
does not release Drury from liability for his negligence. The jury
correctly found that Drurys negligence was the proximate cause of
Doreens death. The Shorters specifically accepted the risk that Doreen
could have bled during the operation and that the refusal of blood or
 blood derivatives could lead to her death. The judgment of the trial
court is affirmed.
- Notes: Various religious denominations accept only some or no
medical treatment. What to do in such a situation has long been a
difficult issue in health law, especially when the situation involves a
minor. A competent adult refusing treatment is not the same as a
parent denying treatment to a child. The implications of this type of
situation go beyond health law and spill over into constitutional and
criminal law.
Problem: Arbitrating Disaster
- Negligence in providing medication, but signed waiver
- Might be some inherent bias if D is paying for arbitration and arbitrator
but cap is pretty low for something as serious as a stroke in a young
woman
- Not an emergency procedure
- More like Shorter case then Tunkl
- Easier to defeat binding arbitration clause if pt had come to clinic for
emergency treatment, than in this case.

Problem: Mediating Disaster

March 2, 2017
184-201

- So, he has about a year to live, so we want to make sure that the
quality of life during that year is the best that it can be. Given that, I
would not choose the first option because it will not solve the pain
issue. I think the second option is the least extreme of the two
 remaining and he would have the highest chance of retaining some
ability to be independent despite the fact that the procedure would
take longer.
- as a patient I would choose option #2. If you are looking at it purely
from a risk standpoint option 1 requires the loss of your leg which
severely inhibits your mobility. Option 3 has an 80% chance of bladder
and bowel incontinence which will put a large strain on your daily life
and probably financial life if you need a full time nurse or caretaker.
Although option 2 may seem as the "least effective" and will take the
longest to actually show result, in my eyes is the best option.
- The doctor should be as open as possible with the patient. He or she
should discuss, in depth, the options with the patient and maybe even
give his opinion based on the circumstances. I think the patient should
choose the second option. It provides the most amount of time at
home, with a decent chance of pain management. Compared to option
1, it seems like the benefits are low. He maybe has a year left to live,
and a long recovery away from his family doesn't seem worth it. The
third has too high of a risk compared to the 2nd option.
- I would go with the choice that incorporates as many of the things that
are important to the patient such as pain management, time with their
family and effects on them (such as additional care they would need to
provide), money, and so on. As far as the doctor's perspective, I think
this is a situation where the choices are all so difficult that they need
to discuss the most medically beneficial procedure and incorporate the
patient's needs more than their own medical preference especially
given that he is terminally ill and has a relatively short life expectancy

- 2 strikes the balance between adequate long term control and

maintenance. But from a physical risk benefit balancing approach it
seems like the one that maximizes the benefit and minimizes the risk.

2 steps in informed analysis:

- step one: what jurisdiction are you in?
o professional what a reasonable doctor would disclose
o patient what a reasonable patient would want to know
- step 2: is would a reasonable patient in this patients position have
made a different decision if they had had the undisclosed information

III. Informed Consent: The Physicians Obligation

A. Origins of the Informed Consent Doctrine

B. The Legal Framework of Informed Consent

1. Negligence as a Basis for Recovery

Canterbury v. Spence (1972) (Page 187)
Facts: At the age of 19, Canterbury (plaintiff) experienced severe
upper back pain and was examined by Dr. Spence (defendant), a
neurosurgeon. After undergoing a diagnostic procedure to determine
the cause of the pain, Spence recommended that Canterbury undergo
a laminectomy, an operation to repair a suspected ruptured disc.
Canterbury did not object to nor did he ask any questions about the
procedure. Spence spoke to Canterburys mother by telephone and
informed her that she did not need to come to the hospital and the
operation was no more serious than any other operation.
Canterburys mother signed a consent form after the procedure was
performed. Post-operation, Canterbury began recuperating normally
until he fell from his hospital bed while attempting to use the restroom.
Thereafter, Canterbury became paralyzed from the waist down
requiring additional surgery. After a second operation, Canterbury
regained some limited control over his muscles, but suffered long-term
incontinence and bladder paralysis. Canterbury brought a medical
malpractice action against Spence and the hospital in federal district
court. Spence and the hospital moved for directed verdicts, which the
court granted on the basis that Canterbury had failed to produce any
medical evidence of negligence. Canterbury appealed to the court of
appeals.
Issue: Is a physician, prior to a medical procedure, under a duty to
disclose all risks that a reasonable person would find significant in
making an informed decision whether to undergo the specific
procedure?
Rule: Prior to a medical procedure, a physician is under a duty
to disclose all risks that a reasonable person would find
significant in making an informed decision whether to undergo
the specific procedure.
Holding: Yes. It is the right of the patient, not the physician, to decide
for himself whether to pursue a proposed therapy or operation
recommended by the physician. However, the average patient does
not possess the skill or medical knowledge to make an informed
decision about proposed medical care. That is the responsibility of the
physician to explain. It is only when the patient has received sufficient
information from the physician regarding all aspects of the proposed
treatment that he can provide the necessary informed consent. A
physicians noncompliance with a professional custom to reveal
necessary information may give rise to liability. However, we do not
agree that a uniform standard can be applied across the entire medical
profession regarding the degree of information that must be supplied
to a particular patient. Respect for the patients right of self-
determination demands a legal standard for physicians to follow, not a
 self-regulating standard. Thus, a physicians duty to disclose is
governed by conduct that is reasonable under the circumstances. Once
that duty arises, the next question is the scope of the required
disclosure by the physician. The appropriate scope is any information
that is sufficient and material for the patient to make an informed
decision regarding a proposed course of treatment. The scope is
objective, providing due regard for the patients informational needs
with leeway for the physician if he is unable, through discussions with
the patient, to determine the patients questions and concerns. A
material risk that should be disclosed to a patient is one that the
physician knows or should know that a reasonable person would find
significant in determining whether to undergo the proposed treatment.
A fact-finder should only impose liability upon a physician if it
determines that the physicians communication to a patient regarding
the risks was unreasonable or inadequate. Here, the testimony of
Canterbury and his mother was sufficient to allow a jury to determine
whether Spence failed to reveal the risk of paralysis from the operation
in violation of his duty to disclose material information. The judgment
of the district court is reversed and the case is remanded for a new
trial.

2. Decision Aids and Informed Consent

1. Decision Aids - DAs - decision support tools that:
o a. provide patients with detailed and specific information on
options and outcomes
o b. help them clarify their values, and
o c. guide them through the decision making process
2. Brochures, DVDs, online tools
3. Shared Medical Decision Making - process by which DAs are used by
the provider and the patient
4. Goal of DAs - establish where the standard of care should be
5. Could replace informed consent doctrine completely - Prof. Fox
6. ACA - adopts DAs for preference-sensitive care - clinical evidence
does not clearly support on treatment option over another

Problem: Establishing the Centers

Problem: State Legislation

March 7, 2017
201-222
Affordable care act is helping physician aids and make better choices.
3. Disclosure of Physician-Specific Risk Information
1. ACA adopts a model of disclosure of provider performance
information to consumers
(physician compare website) website will include:
o a. measures collected under the physician quality reporting
initiative
o b. an assessment of patient health outcomes and the functional
stats of patients
o c. an assessment of the continuity and coordination of care and
care transitions, including episodes of are and risk-adjusted
resource use
o d. an assessment of efficiency
o e. an assessment of patient experience and patient, caregiver,
and family engagement
o f. an assessment of the safety, effectiveness, and timeliness of
care, and
o g. other information as determined appropriate by the Secretary
of HHS
2. Should Secretary of HHS require the website to include:
o a. disciplinary information provided by the state medical boards?
 o b. complaints and investigations as well as final disciplinary
actions
o c. information on denial, limitation, or revocation of staff
privileges
o d. malpractice filing, settlements, or judgments
proposals to provide information on physician competency and their
practice information
unintended consequences of making this information available on a
website?
o It might put out some physicians from business or drive up costs
for the physicians that have a poor record and or are just starting
out or inexperienced.
o Could create unfair conclusions by physicians competency.

Problem: Content for Physician Compare

Johnson v. Kokemoor (1996) (Page 204)

Facts: Donna Johnson (plaintiff) suffered from persistent headaches
and had a CT scan performed to determine the cause. Afterwards,
Johnsons family physician referred her to neurologist Dr. Richard
Kokemoor (defendant) who diagnosed Johnson as having an enlarging
aneurysm in the rear of her brain. Although the aneurysm was not
causing Johnsons headaches, Kokemoor recommended surgery to clip
the aneurysm. Known as basilar bifurcation aneurysm surgery, the
operation was one of the most difficult to perform in neurosurgery.
Prior to the operation, Kokemoor spoke to Johnson and informed her
that he had performed the procedure dozens of times, and compared
the seriousness of it to a tonsillectomy or gall bladder surgery.
Kokemoor also told Johnson that there was a 2 percent risk of death
when in reality it was closer to a 30 percent chance when performed by
inexperienced physicians. Kokemoor did not mention that she had the
option of having the procedure performed by more experienced
surgeons. Johnson agreed to the operation. Due to the operation,
Kokemoor became a wheelchair-dependent quadriplegic with impaired
vision, speech, and other impairments. Johnson brought suit against
Kokemoor for failing to properly obtain her informed consent to the
operation. After a trial, a jury found in favor of Johnson. Kokemoor
appealed arguing that the trial court erred in admitting physician-
specific evidence including Kokemoors failure to inform Johnson of his
lack of experience in performing the operation, Kokemoors failure to
properly compare morbidity and mortality rates among experienced
and inexperienced surgeons, and Kokemoors failure to refer Johnson to
more experienced surgeons. The court of appeals reversed and
Johnson appealed.
 o You don't get to lie to patients and say you are a hotshot at a
surgery when youve only done it a few times. Has to be a way to
bridge the gap between the patient without letting them out.
Way to do that is to do doctors surgery by having experienced
neurosurgery in the room and basically guiding less experienced
surgeon.
o Patient needs to ask questions material under the circumstances.
Physicians experience with this type of aneurysm is material
under the circumstances.
o Citing Canterbury
o Court allowed statistics which is highly controversial.
o In what sense could the Kokemoor jury have decided what the
harm was to the patient?
If she was informed then she wouldve one to another
doctor who wouldve been able to perform the surgery with
less risk of paralysis
ticking time bomb in your head would you rather walk
around thinking of it blowing up or would you rather
undergone surgery with a surgeon who has a 11% chance
of morbidity and mortality?
Issue: May trial courts admit specific evidence of a physicians
statements and conduct to determine whether a patient had sufficient,
material information to make an informed and intelligent decision to
consent to suggested medical treatment?
Rule: A trial court may admit specific evidence of a physicians
statements and conduct to determine whether a patient had
sufficient, material information to make an informed and
intelligent decision to consent to suggested medical
treatment.
Holding: Yes. A patient cannot make an informed, intelligent decision
to consent to a physicians suggested treatment unless the physician
discloses what is material to the patients decision, i.e., all of the viable
alternatives and risks of the treatment proposed. A physicians
experience in performing a procedure is certainly relevant. When
Johnson asked Kokemoor how many times he had performed the
specific type of operation he replied that he had performed the
procedure dozens of times. In actuality, Kokemoor had very little
experience performing the specific operation. Johnson introduced
ample evidence that had a reasonable person in her position been
aware of Kokemoors lack of experience in performing the aneurysm
operation, the person would not have undergone the operation.
Additionally, Johnsons use of risk statistics to compare the morbidity
and mortality rates without explaining the difference between an
inexperienced physician, such as Kokemoor, and more experienced
surgeons was inappropriate. Had a reasonable person in Johnsons
 position been made aware that the risk of death was closer to 30
percent, he or she would not have had it performed. When different
physicians have substantially different success rates with the same
procedure and a reasonable person in the patients position would
consider such information material, the trial court may admit the
statistical evidence. Finally, Kokemoor argues that the trial court erred
in allowing evidence that he should have advised Johnson of the option
to seek a second medical opinion from a more experienced surgeon.
Although it is not directly an informed consent issue and is more
closely linked to a negligence action, the inquiry is whether the
information would have assisted Johnson in making an intelligent and
informed decision to undergo the operation. Here, the trial court
properly allowed Johnsons evidence because it demonstrates that
Johnson chose not to go to another, more experienced surgeon
because she relied on statements made by Kokemoor that the surgery
was routine, he was capable of performing it, and that there was a low
risk of permanent harm or death. The trial court did not erroneously
exercise its discretion in admitting the evidence under the facts of this
case. The decision of the court of appeals is reversed and the case is
remanded to the trial court.

o Johnson v. Kokemoor- We therefore conclude that when different

physicians have substantially different success rates with the
same procedure and a reasonable person in the patients
position would consider such information material, the circuit
court may admit this statistical evidence.
4. Most courts resist requirements that specific percentages of risks be
disclosed, arguing that medicine is an inexact science
5. Most courts do not Mandate Physician Disclosure of Experience and
Qualification
o a. if patient asks specific questions and Dr. equivocates, may risk
liability
6. Hypothetical Problems on Page 233

what are limits of required disclosure?

Holding in Kokemoor is fact specific to this case. Very good idea to ask
doctors questions and to not be brushed off with a general answer.
Risk making surgeon uncomfortable but oh well.

Problem: Disclosing Physician Risks

- case a lot like Kokemoor but unclear here what experience would have on
patient mortality in this case. Without additional info it is hard to say how it
would turn out.
- could be that 9 times is sufficient to have experience doing the surgery,
might be data isnt available in patient mortality.
- why should a patient protective rule be only applicable to the patient who is
brave enough or knowledgeable enough to ask these questions.

- I think as long as there is no emerging pattern of serious error and his

performance continues to be excellent, there is no duty to disclose that. But,
I think the Dr. should consider looking at retirement options for the future.
Something about iatrogenic harm.
- Given the physical effects of alcohol withdrawal, yeah I would want to
know. Even if the alcohol isn't impairing him at the moment, the tremors
might.
- i think i reasonable patient would not want an alcoholic performing the
surgery. I would hope the staff/hospital would be aware of this section on
peer review, preemptive disclosure some courts have said yes which leads to
a substantial reduction in their patient caseload, other courts said no and it's
a condition that doesn't effect performance unless under the influence while
performing the surgery.
- hospitals can restrict the scope of practice dr is allowed in the hospital, or
proctoring the surgeon while performing surgery.

4. Disclosure of Statistical Mortality Information

Arato v. Avedon (1993) (Page 212)

Facts: Arato completed a routine questionnaire that asked, among
other things, whether he wanted to be told the truth about his
pancreatic cancer condition. Arato answered yes. The oncologists,
including Dr. Melvin Avedon (defendant), recommended a course of
chemotherapy medication and radiation treatment. Arato and his wife
were never told the statistical probability of his survival. Arato nor his
wife ever asked for life expectancy information and Aratos operating
surgeon did not disclose statistical life expectancy data because Arato
was extremely anxious about his condition. Avedon also did not
disclose the specific statistics because the direct disclosure of
extremely high mortality rates for pancreatic cancer would negatively
impact Aratos hope for a possible cure. About eight months after his
surgery, Aratos cancer returned and quickly spread. He died shortly
thereafter. Aratos wife (plaintiff) filed suit against Avedon, his surgeon,
and the other physicians alleging that they had not adequately
disclosed statistical mortality information of the cancer and thus failed
to obtain his informed consent to undergo the treatment. His wife
claimed that had he known the bleak truth regarding his chance for
survival he would not have sought treatment and, instead would have
chosen to die peacefully at home. At trial, all of the physicians testified
that statistical life expectancy data obtained from large groups had
little predictive value when applied to a particular patient with
individual symptoms, history, etc. The jury found in favor of Avedon. A
 divided court of appeals reversed and ordered a new trial. Avedon
petitioned the California Supreme Court to review the decision.
o What has the patient lost? He has lost the ability to select a
different course of treatment, have no treatment, and get his
affairs in order.
o More than 70 medical appointments over the year, he never
asked about pancreatic cancer and if he was going to die, only
asked little things about symptoms. Not saying it to excuse
doctors, but showing doctors navigate fine line with hitting
patient with bad news. Can give info with caveats: cancer
discovered in relatively early stage, removed with clean margins
and no cancer cells, no metastasis, he couldve been the lucky 1
in 100 who survives.
o Injury is that reasonable patient in this situation might have
chosen not to undergo this toxic chemo and radiation treatment
if they had known that it was extremely statistically unlikely to
save them.
o Kind of a catch 22 for doctors
Issue: In order to effectively obtain informed consent, must a
physician disclose all material information to a patient that the
physician knows or should know would be regarded as significant by a
reasonable person in the patients position when the patient is
deciding to accept or reject medical treatment?
Rule: To obtain sufficient informed consent, a physician is
under a legal duty to disclose to a patient all material
information that the physician knows or should know would be
regarded as significant by a reasonable person in the patients
position when deciding to accept or reject medical treatment.
Holding: Yes. However, a physician is not under a legal duty to
disclose every contingency that might affect the patients nonmedical
rights and interests. This includes the disclosure of statistical mortality
information. The testimony of every physician-witness at trial
confirmed that statistical morbidity values obtained from various
population groups are unreliable and provide little assurance regarding
the potential survival possibility of a specific patient. Here, the
evidence at trial was more than sufficient to support the jurys finding
that Avedon and the other physicians adequately disclosed material
information to Arato and his wife regarding his specific condition to
allow him to make an informed decision regarding the proposed
treatment. Aratos wife claims that the physicians should have
disclosed the statistical mortality information because it was material
to his nonmedical interests, i.e., his business affairs. A physician has a
legal obligation to the patients medical affairs not the patients
financial affairs. Aratos wish to be told the truth regarding his medical
condition, as expressed on the office questionnaire, does not by itself
 heighten a physicians duty to disclose information to a patient. A
physician is already held to a legal duty to obtain a patients informed
consent to any proposed treatment, regardless of what is written on an
office form. The judgment of the court of appeals is reversed and
remanded with directions to affirm the judgment of the trial court.

Arato v. Avedon- says whether statistical mortality information should

be disclosed is a question of materiality for the jury. (gave jury general
definition of Informed Consent)
Dispute about requested jury instructions
o They said that they inclined to intrude further on the scope of
the physician-patient relationship
o Non-disclosed material being material. Dr-patient relationship is
fiduciary but a therapeutic one
o The professional standard is not to disclose information that is
stressing to the patient, like the high mortality rates of someone
with pancreatic cancer
222, 4 categories of tests, how to sort them into different catgeories?
o A couple of different considerations that could be considered in
providing guidance.
o Invasive or noninvasive? Invasive are more likely to carry
physical risks. Amnicentisis has a risk of miscarriage.
o Carrier status?

Problem: Information Overload

March 9, 2017
223-233
- the immortal self of henrietta lacks? HeLa cell line
5. Disclosure of Financial Conflicts of Interest
Rule:
o a. Physicians must disclose personal interests unrelated to the
patients health, whether research or economic,
o b. that may affect the physicians professional judgment; and
o c. a physician failure to disclose such interests may give rise to a
cause of action for performing medical procedure without
informed consent

Moore v. Regents of the University of California (1990) (Page 223)

Facts: John Moore (plaintiff) underwent treatment for leukemia at the
University of California, Los Angeles (UCLA) Medical Center. There, Dr.
David Golde (defendant) recommended removal of Moores spleen.
Golde then used Moores cells for research without Moores permission.
Golde established a patented cell line, which he licensed for
commercial development. The patent was held by the Regents of the
University of California (Regents) (defendant), and listed as inventors
Golde and UCLA researcher Shirley Quan (defendant). The defendants
made a significant amount of money from the cell line. Moore filed a
thirteen-count lawsuit. Specifically, Moore sued for lack of informed
consent and breach of fiduciary duty, due to the defendants omission
of their financial interests in Moores cells. Moore also sued for
conversion. The defendants moved for summary judgment, which was
granted on the conversion count. The trial court dismissed the rest of
the complaint. Moore appealed, and the California Court of Appeal
reversed, ordering the trial court to reinstate the conversion claim,
allow Moore to amend his inadequate informed consent claim, and rule
on the remaining claims. The defendants appealed.
o Conversion is an intentional tort meaning a deliberate attempt to
steal something
o Nothing to say that spleen surgery was tainted
o Decision causation: I dont think so, b/c the spleen still needed to
be removed. A reasonable patient would not have made a
different choice if the undisclosed info was disclosed
o Was there a valid or sincere medical reason for having Mr. Moore
return several times?
They couldve been checking for purposes of the cancer,
but being cynical says that they had a different motive
More in Goldes interest than Moores because Golde also
insisted that Moore only see him
o What are the damages to Mr. Moore?
Unnecessary testing, potential for increased risk with those
additional tests, taking away Moores decision making
rights, and invasion into Moores body and privacy.
If anyone can prove these tests werent medically
necessary, then damages.
o If a doctor makes and inappropriate recommendation either from
inherent bias or something elseWhy isnt medical mal claim
enough? Neades case in note 4, page 229.
o Could a doctor refuse to do this type of surgery if the patient said
they did not want their cells to be used for research? Sure
because dr-patient relationship is voluntary. But should at least
take care of his patient despite that. Technically it is very
unprofessional and kind of like extortion, but doctor would have
to transfer care to someone equally as skilled and capable.
o How does something become a standard of care without
experimentation then?
o Estrada: shot in the leg, signed a consent form and surgery did
not end up well and had an amputation. He basically said
surgeons never told him it was an experimental way. Court said
he has a right to know and doctors have a duty to tell patients
they are being used as a guinea pig. Risks and benefits of this
way of treating a patient are highly uncertain and drs might have
other reasons for trying this approach, like fame and glory. Why
doesn't basic med mal claim cover? Respective minority rule or
 privilege might cover it. Informed consent claim is more designed
and focused to what has happened.
o If doctor has never tried it before is it automatically an
experiment? Usually yes. Patient should want to know why a dr
wants to try it on them and what is the usual way. Why wont
usual way work? Etc.
o Could a patient get a cut into the doctors financial gain from
their cells and other bodily substance? Courts have said once a
body part is removed from you its not yours anymore.
Maybe pre-treatment contract? Who knows? Probably not
much precedent for this to happen. Courts have said we
have autonomous control over bodies while alive, but after
something is removed or dead, no longer have
autonomous control.
Issue: (1) Will a patients consent to a medical procedure be effective
if the physician failed to disclose her personal research and economic
interests beforehand? (2) Does a patient continue to have ownership
rights in his cells after they leave his body?
Rule: (1) A physician has a fiduciary duty to disclose all
material personal interests that may influence her professional
judgment before securing a patients informed consent to
medical treatment. (2) Once cells leave a patients body, they
are no longer that patients property.
Holding: (1) No. A physician must disclose all personal interests in a
medical procedure that may influence her professional judgment
before securing the patients informed consent. A competent adult has
the right to decide whether or not to receive medical treatment. A
physician must secure the patients informed consent to treatment,
and the physician is under a fiduciary duty to give the patient all
information material to that decision. Thus, it is necessary that a
physician disclose any personal interests in the treatment that may
influence her professional judgment. A reasonable patient would want
to know that her doctor has an unrelated research or financial interest
in her treatment. Consent is thus ineffective if the physician fails to
make these disclosures, and the physician may be subject to liability
for providing medical treatment without consent or breach of duty.
Physicians are free to conduct research, but the goals of research may
conflict with patient care. Here, Golde argues that research on a
patients cells after removal has no impact on her medical interests.
That is true if the doctor has no intent to use the cells for research
when recommending the procedure, but not if the physician has a
preexisting research interest. Unfortunately, a patient may refuse a
treatment in reaction to disclosure of research and economic interests,
rather than her own health interests. This does not justify physicians
having unlimited discretion to withhold material information. Of course,
 just as there is no duty to disclose remote medical risks, there is no
duty to disclose insignificant research interests. Moore stated a valid
cause of action for lack of informed consent for his spleen removal and
subsequent tissue samples, because Golde failed to disclose his
financial interests. Further, the remaining defendants may be
vicariously liable. (2) No. Once cells leave a patients body after
surgery, she no longer has sufficient ownership rights to uphold a
conversion claim. Conversion occurs when a party interferes with
anothers property ownership or right to possession. To date, no court
has allowed a conversion action for use of a patients cells in medical
research. Further, permitting a patient to recover in such a case
implicates serious public policy considerations related to medical
research. Generally, excised cells are treated as medical waste under
statute, and patients have no ongoing property interest. Under existing
law, Moore has no conversion claim. Moore did not expect to retain
possession of his cells after surgery. Moores analogy to privacy rights
is unpersuasive. The lymphokines that Golde and Quan produced from
Moores cells have the same molecular structure in every human; they
are not unique to Moore. The patent was for a cell line that is distinct
from Moores cells. Further, patents are unavailable for an individuals
cells; there must be some form of human ingenuity added. The cell
line Golde developed is unique and patentable, unlike Moores cells
themselves. Moore can claim no interest in the patent. Accordingly,
because Moore has no property interest in his cells or the patent, he is
unable to state a cause of action for conversion. The California Court of
Appeal is affirmed in part and reversed in part.
Concurrence: Although what Golde and Quan did was morally wrong,
the human body cannot be treated as a commodity unless the
legislature decides to do so.
Concurrence/Dissent: Moore claims that Golde and Quan
intentionally withheld information from him regarding the use of his
cells and that they were under an obligation to disclose this
information. If this claim is taken as true, it would be sufficient to
uphold a finding of conversion. Therefore, Moore has adequately stated
a cause of action for conversion, and summary judgment should have
been denied.
Dissent: Humans have a property interest in their bodies and its
products. Moore had the right to do with his cells what Golde and Quan
did to them. This exploitation of Moores body for the benefit of
another is akin to slavery and should not be tolerated. Additionally, in
terms of the patent, although the Regents are the rightful patent
holders, Moore had a critical contribution to the invention, as without
his cells there would have been no invention. Moore should be
compensated accordingly.
Note: Physician Payment Sunshine Act
Patients wont even know database is there and even if they did, would
they search it or behave differently once they have the information
they want? Probably will not make a difference to most patients.

C. Causation Complexities
Causation - Requires a link between failure of a doctor to
disclose and the patients injury
o 1. Two Causation Tests
a. Objective Reasonable Patient Test - what a
reasonable patient would have done?
i. what a prudent person in the patients
position would have decided if suitably
informed of all peril bearing significance
ii. if adequate disclosure could reasonably be
expected to have caused that person to decline
the treatment because of the revelation of the
kind of risk or danger that resulted in charm,
causation is shown, but otherwise not.
b. Subjective Particular Patient Test - What a
particular patient would have done?
o 2. Causation is an objective standard:

Canterbury v. Spence (again) (1972) (Page 232)

Facts:
Issue:
Rule:
Holding:
March 21, 2017
233-245, 245-256
IV. Confidentiality and Disclosure in the Physician-Patient
Relationship
Protection of confidences revealed by the patient to the professional is
one of the most important obligations owed by a pro to a patient

A. Breaches of Confidentiality

Humphers v. First Interstate Bank of Oregon (1985) (Page 233)

Facts: Ramona Humphers (plaintiff) gave her newborn up for adoption.
Medical records of the childs birth and the adoption documents were
sealed from the public. Only Humphers, her mother, and the physician
treating Humphers at the time, Dr. Mackey (defendant), knew about
the daughter she gave up for adoption. Twenty-one years later, the
adopted daughter, Dawn Kastning, sought out Mackey in her quest to
find her biological mother. Mackey provided Kastning with information,
some of which was false, to help her successfully locate Humphers.
Humphers became distressed over the contact. Humphers filed suit
against Mackeys estate, which was managed by First Interstate Bank
 of Oregon (the Bank) (defendant). Humphers five-theory complaint
alleged that (1) Mackeys outrageous conduct should result in
liability; (2) that Mackeys disclosure of a professional secret fell below
the applicable standard of care; (3) that his disclosure was a breach of
a confidential relationship; (4) that his disclosure was an invasion of
Humphers privacy; and (5) that his disclosures to Kastning breached a
contractual obligation of secrecy. The trial court granted the Banks
motion for summary judgment on all of Humphers theories and
Humphers appealed. The court of appeals affirmed the trial courts
judgment except for the third and fourth theories. The Bank then
appealed to the states supreme court.
o Theory of privacy of invasion doesnt fit this case. The doctor
didnt pry into anything. He didnt invade her privacy. It had the
effect that her privacy was invaded, but it wasnt the tort of
invasion of privacy. Tort covers the circumstance where if anyone
else had done the same thing without privilege they would be
liable for invading privacy.
o Disclosure of info by someone else didnt have obligation to keep
it secret.
o Professional discipline is sufficient here, but other cases where
actual harm occurs, maybe damages are necessary
o There would still be a breach of the duty of confidentiality
o It might be considered an overriding interest since she would
need that in order to seek her own medical treatment/opinion
Issue: May a physician be held liable for damages if he reveals
confidential information learned in the context of a physician-patient
relationship without consent?
Rule: A physician may be liable for damages if he reveals
confidential information learned in the context of a physician-
patient relationship without consent.
Holding: Yes. Although Humphers breach of confidential relationship
and invasion of privacy theories appear to be very similar, each has
different burdens of proof and other requirements. The most important
distinction between the two is that only the individual who holds
confidential information can be charged with a breach of confidence,
unlike an invasion of privacy tort which could apply to anyone who
informed Kastning the particular facts of her birth. Simply knowing
facts about an individuals location does not give rise to an invasion of
privacy claim. In this case, Mackey did not pry into a confidence but
instead, failed to keep one. Consequently, Humphers invasion of
privacy theory fails. However, Humphers breach of confidential
relationship theory is valid. State law requires physicians to keep
medical and related information about a patient in confidence or
otherwise be disciplined. A physician is exempted from the confidence
requirement in events where the needed information is necessary to
 protect the health of another. However, that was not the case here.
Additionally, other state statutes mandate the secrecy of adoption
records. The judgment of the court of appeals is reversed with respect
to Humphers invasion of privacy claim and affirmed with respect to
her breach of confidential relationship claim and is remanded for
further proceedings consistent with this opinion.

Physician/Medical Professional owe a duty to keep medical and related

information about a patient in confidence
o i. Consent Assumed - to have been given to other medical
professionals/staff/3rd party payer systems, for treatment
purposes

Problem: The Hunt for Patient Records

- Based on Bittle v. Warren general in Ohio
- The hospital is releasing confidential info to a party that has no existing
relationship with the patients for purposes that do not fall under the
four circumstances discussed.
- Seek patient approval through something like a letter to be signed and
returned.

Doe v. Medlantic Health Care Group, Inc. (2003) (Page 241)

Facts: John Doe (plaintiff) had not told his employer that he was HIV
positive. Doe worked as a janitor for a company that provided cleaning
services to the U.S. Department of State. A State Department co-
worker, Tijuana Goldring, was also a temporary receptionist at the
Washington Health Center (WHC), a facility owned by Medlantic Health
Care Group (defendant). Doe went to the emergency room at WHC
complaining of severe headaches, nausea, and high fever. Doe retuned
to WHC for a follow-up appointment and stopped by Goldrings desk to
say hello. Goldring asked for the spelling of Does last name so that
she could send him a get-well card, which she never sent. Goldring
informed other workers at the State Department that she learned from
the hospital that Doe was HIV-positive. When Doe returned to work, he
was teased, ridiculed, and shunned by his co-workers and others
throughout the State Department. Once Doe learned that Goldring was
the source of the disclosed information, he filed a complaint against
Medlantic and Goldring alleging tort claims of invasion of privacy based
on Goldrings disclosure of Does HIV-positive status and breach of
confidential relationship based on WHCs negligence in permitting
Goldring access to confidential patient information. After a trial, the
jury found Medlantic liable for breach of confidential relationship and
awarded Doe $250,000 in damages. The jury found against Doe on his
invasion of privacy claim against Goldring because the disclosure was
not within the scope of Goldrings employment with WHC. Medlantic
filed a motion for judgment arguing that Does claims were barred by
 the statute of limitations. The trial court granted Medlantics motion
and Doe appealed.
o Invasion of privacy doesn't work because Goldring was going
outside the scope of her employment
o Jury would be able to figure it out that the protocols were poor,
did not require technical expertise.
o Similar to a negligence case, court wont require an expert when
the issue isnt too technical
Issue: Does the special hospital-patient relationship create a stricter
duty on a hospital than that of a reasonable person to protect the
confidentiality of a patients medical information?
Rule: Due to the special hospital-patient relationship, the tort
of breach of confidential relationship imposes upon a hospital
a stricter duty than a reasonable person to protect the
confidentiality of a patients medical information and to honor
the patients trust and confidence.
Holding: Yes. The tort of breach of confidential relationship is one
where the unwanted disclosure of nonpublic information to a third
party occurs within the confines of a special, confidential relationship.
Medlantic argues that Doe failed to produce any expert testimony or
evidence that WHC specifically disclosed Does medical information.
While that is true, there is sufficient evidence to conclude that the
hospitals protocols regarding the protection of patient information
were not followed. WHC employees testified that there were no
safeguards protecting patient information from unjustified hospital
employee requests. Expert testimony is not required in this case to
establish the appropriate standard of care because the jury could
reasonably conclude that WHCs lackluster protocols contributed to the
eventual disclosure of Does medical information. The trial court
properly instructed the jury that it could consider whether WHCs
protocol was properly followed in practice and whether it was
successful in preventing the unauthorized disclosure of confidential
medical information. Goldring was identified as the one who disclosed
Does HIV-positive status to employees at the State Department and
she had access to Does records at WHC. Thus, the trial court properly
allowed the jury to find that WHC breached its duty to observe the
utmost caution in protecting the confidentiality of Does medical
records. The trial courts entry of judgment in favor of Medlantic is
reversed and the case is remanded so that the jurys verdict in favor of
Doe can be reinstated.

Hospitals can be found negligently liable for breach of confidence

where an employee breaches the confidence, and there is evidence
that the hospitals protocol for protecting confidential information are
not strong enough or are not followed enough.
B. Federal Medical Privacy Standards

Know what the federal standards are for HIPAA that provided
federal medical records and was amended in 2009, 2013.

Standards for Privacy of Individually Identifiable Health Information

a. 3 main purposes
o i. protect and enhance the rights of consumers by providing
them access to their health information and controlling the
inappropriate use of that information;
o ii. improve the quality of health care in the U.S. by restoring trust
in the multitude of organizations and individual committed to the
delivery of care; and
o iii. to improve the efficiency and effectiveness of health care
delivery by creating a national framework for health privacy
protection that builds on efforts by states, health systems, and
individual organizations and individuals.
b. HIPAA - sets a floor of ground rules for health care providers, health
plans, and health care clearinghouses to follow, in order to protect
patients and encourage them to seek needed care.

Office of Civil Rights, Summary of the HIPAA Privacy Rule

a. Who is covered by the Privacy Rule?
o i. health plans, health care clearinghouses, and to any health
care provider who transmits health information in electronic form
in connection with transactions for which the Sec. of HHS has
adopted under HIPAA
b. What information is Protected - all individually identifiable health
information held or transmitted by a covered entity or its business
associate, in any form or media, electronic, paper, or oral. PHI
o i. individuals past, present or future physical or mental health or
condition
o ii. the provision of health care to the individual, or
o iii. the past, present, or future payment for the provision of
health care to the individual
1. De-Identified Health Information - no restriction on use
or disclosure
c. General Principle for Uses and Disclosures
o i. basic principle - to define and limit the circumstances in which
an individuals protected health information may be used or
disclosed by covered entities
1. can not use or disclose info except:
a. as the Privacy Rule permits or requires; or
 b. as the individual who is the subject of the info
authorizes in writing
o ii. required disclosures
1. to individuals specifically when they request access to,
or an accounting of disclosures of their protected health
info; and
2. to HHS when it is undertaking a compliance
investigation or review or enforcement action
d. permitted uses and disclosures
o i. Permitted uses and disclose covered entity permitted by not
required to use/disclose info for the following purposes or
situation:
a. to the individual
b. treatment, payment, and health care operation
opportunity to agree or object
c. incident to an otherwise permitted use and disclosure
d. public interest and benefit activities; and
e. limited data set for the purpose of research, public
health or health care options
o ii. treatment, payment, health care operations - a covered entity
may use and disclose protected health info for treatment,
payment, and health care operations activities
1. treatment - is the provision, coordination, or
management of health care and related services ...
2. payment - encompasses activities of health plan to
obtain premiums, determine or fulfill responsibilities for
coverage and provision of benefits, reimbursement for
health care
3. health care operations - include a lot of different
activities see pg 271
o iii. uses and disclosures with opportunity to agree or object - may
be obtained by asking individual outright, or by circumstances
that clearly give the individual opportunity to agree, when
incapacitated, emergency, or unavailable covered entities
generally may sue professional judgment to disclose or use
health care information
o iv. incidental use and disclosure - every risk of an incidental use
or disclosure of protected health information is not required to be
eliminated
o v. public interest and benefit activities - permitted use and
disclosure of health info for 12 national priority purposes
1. required by law - health can be used/released when
required by law
2. public health activities - may disclose info to
 a. public health authorities
b. entities subject to FDA regulation for products or
activities for adverse event reporting, recalls
c. individual who may have been exposed to
communicable diseases
d. employers, regarding employees, when requested
by employers, for information concerning work-
related illness/injury so employer can comply with
OSHA
e. authorized uses and disclosures
o i. authorization - must be written and in specific terms
o ii. psychotherapy notes - authorization required
o iii. marketing - communication about a product or service that
encourages recipients to purchase or use is allowed when:
1. the product or service is being marketed by the covered
entity and that entity provides or includes that
product/service in their plan
2. communications about participating providers in a
provider or health plan network, replacement of or
enhancements to a health plan, and health related
products or services available only to a health plans
enrollees that add value to, but are not part of, the benefits
plan
3. communications for treatment of the individual; and
4. communications for case management or care
coordination for the individual, or tot direct or recommend
alternative treatments, therapies, health care providers, or
care setting to the individual
f. limiting uses and disclosures to the minimum necessary
o i. minimum necessary - covered entity must make reasonable
efforts to use, disclose, and request only the minimum amount of
protected health information needed to accomplish the intended
purpose of the use, disclosure, or request
1. for exceptions see page 273 (a) - (f)
o ii. Access and Uses - for internal uses, a covered entity must
develop and implement policies and procedures that restrict
access and uses of protected health information based on the
specific roles of the members of their workforce
o iii. disclosures and requests for disclosure - covered entities must
have policies and procedures for routine, recurring disclosures or
request for disclosures that limit amount of health information
disclosed
g. notice and other individual rights
 o i. privacy practices notice - covered entity, with certain
exception, must provide a notice of its privacy practices
o ii. access - except in certain circumstances and individual has the
right to review and obtain a copy of their own protected health
information
h. administrative requirements
o i. privacy policies and procedures - covered entity must have
written privacy policies and procedures consistent with the
Privacy Rule
o i. privacy personnel - covered entity must designate a privacy
official
o iii. workforce training and management - in privacy is required
o iv. mitigation - required of effect of harmful disclosure it learns of
o v. data safeguards - reasonable data safeguard is required
i. enforcement and penalties for noncompliance
o i. civil money penalties
o ii. criminal penalties - fines and imprisonment
j. Notes and Questions

March 23, 2017

257-268
Note: 2013 Amendments to HIPAA Privacy, Security, Breach
Notification, and Enforcement Rules
- the more robust and demanding the rules are the more trouble there
is.
- Commitment that healthcare institutes have to make to HIPAA is
substantial.
- Notification must be undertaken by the covered entity. If you have
something like a hospital and they have a private medical billing
company who handles that and if they inadvertently disclose PHI, the
notification of the breach has to come from the hospital itself rather
than the billing company. Have to notify any individual affected.

Yath v. Fairview Clinics, N.P. (2009) (Page 260)

Facts: Candace Yath (plaintiff) visited Fairview Clinics, N.P., doing
business as Fairview Cedar Ridge Clinic (the Clinic) (defendant), to be
treated for a sexually transmitted disease. Navy Tek (defendant), a
medical assistant at the Clinic who was related to Yaths ex-husband,
recognized Yath and accessed her medical file without authorization.
Tek learned of Yaths medical diagnosis as well as information related
 to Yaths new sex partner and relayed the information to another Clinic
employee, Net Phat (defendant), who in turn, disclosed it to others,
including Yaths ex-husband. Subsequently, the Clinic investigated the
unauthorized access to Yaths medical file and eventually fired Tek.
Shortly thereafter, a MySpace.com webpage emerged showing Yaths
photo, name, and stating that she had a sexually transmitted disease
and had cheated on her spouse. The webpage was created at a
business where Teks sister, Molyka Mao (defendant), was employed.
Yath sued Tek, Mao, Phat, and the Clinic for invasion of privacy, breach
of a confidential relationship, intentional infliction of emotional distress,
negligent infliction of emotional distress, and for violating Minnesota
law related to unauthorized disclosure of a persons medical
information. Yath subsequently dismissed the claims against Mao and
Tek. The trial court granted summary judgment in favor of the Clinic
and Phat. Yath appealed.
o Interplay between rights under HIPAA and Minnesota state law.
HIPAA is not operated by a private right of action, its all about
compliance and right to report PHI breach to relevant
governmental entity but cant sue based on HIPAA
o Court said no preemption issue.
o Problem was that the court said she made a case, but relevant
defendant had been dismissed from the case so the claim failed
Issue: May a state law prohibiting the unauthorized disclosure of an
individuals private medical information be preempted by the federal
Health Information Portability and Accountability Act (HIPAA) if the
state law is contrary to the purposes of the federal law?
Rule: A state law prohibiting the unauthorized disclosure of an
individuals private medical information may be preempted by
the federal Health Information Portability and Accountability
Act (HIPAA) if the state law is contrary to the purposes of the
federal law.
Holding: Yes. Yath first argues that the trial court erred in granting
summary judgment in favor of the Clinic and Phat on her invasion of
privacy claim. Yaths claim is based on publication of private facts and
should survive a motion for summary judgment if there is evidence to
support that (1) a defendant gave publicity to a matter concerning
Yaths private life; (2) the publicity of the private information would be
highly offensive to a reasonable person; and (3) the matter is not of
legitimate concern to the public. The trial court concluded that Yaths
private information was not given publicity within the meaning of the
statute because Yath failed to substantiate the number of people that
had seen the MySpace.com webpage. However, the publicity element
is satisfied when private information is posted on an unrestricted,
publicly-accessible website. That was the case here. Nevertheless, the
individual most likely liable for the webpage creation and posting,
 Molyka Mao, is no longer a party to the action. Yath dismissed all
claims against Mao. Yath next argues that the trial court erred in
granting summary judgment in favor of the Clinic and Phat on her state
law claim related to the unauthorized disclosure of a persons medical
information. The Clinic counters that the Minnesota law is preempted
by the federal Health Information Portability and Accountability Act
(HIPAA). Specifically, the Clinic argues that HIPAA does not provide for
a private cause of action for the wrongful disclosure of an individuals
medical information while Minnesota law does. Therefore, the Clinic
argues, the state law contrary to the federal law. A state law is
contrary to HIPAA if a health care provider would find it impossible
to comply with both the State and federal requirements or if the state
law is an obstacle to the accomplishment and execution of the full
purposes of HIPAA. 45 C.F.R. 160.202. The only difference between
the two laws is that a HIPAA violation subjects a person to criminal
penalties while the Minnesota statute provides for compensatory
damages in a civil action. The state law is not contrary to the aims of
HIPAA. Similarly, the Minnesota law is not an obstacle to the
accomplishment to the execution of the full purposes of HIPAA. The
purpose of HIPAA is to improve the federal Medicare and Medicaid
programs as well as the efficiency and effectiveness of the health
information system through the establishment of standards and
requirements. The Minnesota law supports that federal effort by
establishing another disincentive for wrongfully disclosing health
information. The Minnesota law is not preempted by HIPAA. The
judgment of the trial court is affirmed in part, reversed in part, and
remanded for further proceedings consistent with the opinion.

a. HIPPA preempts state medical privacy statutes

b. HIPPA creates standard of care for handling confidential patient info,
but no private right of action for individuals, only criminal remedies
c. Reliance on computer record keeping creates a major liability risk

iii. Privacy, Confidentiality, and Security in Health Information

Exchanges
o 1. Govt. provided funding for health information exchanges
o 2. Goal was to magnify gains in quality and efficiency that are
expected from electronic medical records
o 3. HIE consolidates patient health info from the patients many
health care providers into one virtual record
o 4. An HIEs consent, privacy, and confidentiality standards must
inspire trust on the part of patients that the information will not
be misused or distributed inappropriately. That concern extends
to providers as well.
Problem: Leaking Patient Information
1. Dr. jasmine appears to be exempt from HIPAA rule and theoretically
impossible to avoid HIPAA by taking only cash. He is governed by the
relevant state privacy law but he seems to be exempt under HIPAA due to
the lack of any transmissions in electronic form in PHI.
2. privacy rule protects all individually identifiable health information which
includes name, address, social security, etc. office could have an assistant
take the papers instead. Just change the procedure so that it isnt visible and
then it is all good.
3. Doesnt seem like the PHI was actually viewed, by paging someone gives
them your number so not breach unless person is showing up with name
beside number it is a de minimum breach.
4. possibly a breach of confidentiality on the part of the lab tech. law is
unclear on this issue. Dont have same fiduciary relationship as doctor and
patient but some jx might interpret it as ne.
5. marketing rule on 257, limited marketing to consumers, so it says patient
authorization is required. So wouldn't it turn on whether or not the patient
consented to the mailing or not. Can it be argued that flyer is related to
treatment? No, shes already getting another drug. Would have to contact
her first and ask if they can send marketing materials.
6. they clearly violated medical privacy rules by disclosing medical health
info very broadly. Date of that case predated HIPAA but rule now is that it
was a violation, which creates a serious deterrent effect to hospitals, the
would have to pay a big fine.
7. gave name, address, and number to law firm for them to find out if they
could get SSI reimbursement, clearly this would violate HIPAA and would
qualify. Any info would be imputed back to the hospital and the hospital
would have to notify everyone whose records had been sent.

Problem: Hitech and HIPAA

Hypothetical problem from class:

- this guy is going to freak out and have a hard time enjoying vacation
and this is the first time he is back on his feet after his wifes death.
- You can tell doctor would like to hold off on telling him, but he asked a
direct question.
- Arielle gave some dumbass answer
- Doctor is in a tough spot because patient asked a specific question.
Doctor couldve said there is nothing immediate to be concerned about
but since he asked about cancer, probably has to answer. Doctor cant
lie and say no you don't have cancer because that would be bad.
- Therapeutic privilege in informed consent sometimes doctor can
withhold info if it is menacing in Canterbury.
- There is an ethical duty to tell the truth to patients, but strong sense
that there is no obligation to hit patient over the head with bad news
- Problem also is that this guy is very anxious and nervous, anything
short of a complete reassurance is probably not going to do the job.

March 28, 2017