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Health Law
University of Minnesota Law School
Wolf, Susan M.

I. Intro to Healthcare
o Defining Sickness / Health:
o WHO
· state of complete physical, mental, and social well-being; others say it is a reasonably serious diseases that make its effects undesirable.
· 2 parts – theoretical notion – the opposite of disease, as well as ethical notion, the opposite of illness
o 3 Criteria that makes up healthcare
· Service – to fix or lessen the burden of disease
· Subject to Quality standards – Want to know when it is acceptable quality and when it is not
· With Accountability for error – Does not necessary judge where accountability will lie
o Katskee v. Blue Cross/Blue Shield, 1994
· Facts: P diagnosed with cancer-likelihood syndrome, wants preventative treatment under HMO, gets it but Blue Cross won’t pay because doesn’t “have cancer”
· Rules:
§ Health Contract: When terms of a contract are clear, no rules of construction
§ Insurance: ambiguous terms construed in favor of insured
§ Disease: an impairment of the normal state of living, deviation from healthy state affecting functions or tissue in body, or a morbid physical or mental state
§ Likelihood of Illness (dormant diseases): When a condition is such that in its probable and natural progression it may be expected to be a source of mischief, it may reasonably be described as a disease or an illness. On the other hand, if the condition is abnormal when tested by a standrd of perfection, but so remote in its potential mischief that common speech would not label it a disease, such a condition is at most a predisposing tendency.
· Hereditary Dispositions Counts
II. Quality in HealthCare
o Definition of Quality:
· the management by a physician of clearly definable episode of illness
· Made of technical and interpersonal process
· Def1: Extent to which the care provided is expected to achieve the more favorable balance of risks and benefits
· Def2: degree of quality in the management of interpersonal relationship measured by the extent of conformity to the values.

o Quality as 3 parts:
· Structure – institutional aspects of medicine, includes human, physical, and financial resources that are needed to provide medical care. Nurse to patient ratios, etc.
· The better the numbers, the higher the probability of good quality, but nothing directly, just a numbers game
· Process – set of activities that go on between doctors and patients, made by direct observation or by review of recorded information.
· Drawbacks: weakness in scientific basis perpetuates error, emphases on technical interventions lead to high cost, interpersonal process slighted.
· Advantages: Can perform peer based assessment early on – can analyze range of responsible process early on
· Outcome – Mortality and morbidity rates, basically rates of success, “a change in a patient’s current and future health status that can be attributed to antecedent health care.”
· Morbidity: Disability or illness short of death resulting from treatment.
· Mortality: people dying
· Advantages: over both process and structure
o Improving Quality:
· Who responsible?: Large health care is dominating delivery of such services
· How? Revolution in information processing has accompanied the reorganization of the health care industry
· Competition: Enable consumers to comparatively evaluate quality in health care markets

o Medical Error: Iatrogenesis
· Law historically focuses on physician error
· Iatrogenesis: disease or illness induced by medical treatment or diagnosis
§ Categories
§ Willful or reckless acts – ex. Knowingly recommending unnecessary surgery
§ Negligence
a. Result of inattentiveness
b. Bad training
c. Impairment
· The standard is : deviation from the standard of one’s peers
§ Error due to patient variation
· Ex. 10% of patients are allergic to this drug, and patient turns out to be so
§ Injuries of ignorance (didn’t know X could do Y – limits of medical knowledge today)
§ Iatroepidemics – erroneous embrace of a bad medical technique by the whole industry
· Liability: Can have culpability for willful or negligent acts, sometimes for error/variation, and very hard for willful ignorance because the standards for the peers makes it very hard for iatroepidemics
· Extent of Medical Error: Harvard malpractice study, 3.7% in NY

o Systemic Quality problems for medical profession:
· Failure to admit: Trained to function at high level of proficiency, but it is not possible to be infallible, thus Medical profession does not admit its mistakes (perfectibility model)
§ Methods used to achieve this include: training and punishment
· Low Systemic Resolution: Seldom are underlying problems explored
§ Usually, blame is put on the individual.
· Near misses rarely if ever examined
· Resistance to TQM
– Solutions:
· Systemic solutions are most likely to be effective
· Goal: make it difficult for individuals to err
· Reduced reliance on memory – short term memory and vigilance unreliable
· Improved info access – computerization of medical record
· Error proofing – critical tasks should be structured so that errors cannot be made.
· Standardization – several devices can help develop standards
· Training – include greater emphasis on possible errors
· Establishing a national focus to create leadership, research, tools and protocols to enhance the knowledge base about safety
§ Create a system that voluntarily allows error reporting for medical field – deal with it as a “systems error”
§ Create a mandatory reporting system when death and serious harm results
· Although: can be a lot of tricky questions here – who decides what “caused” harm, etc.

o JCAHO
– Def: – private accrediting body given power by government to accredit medical institutions.
· Sentinel Event Policy – It requires reporting on two levels when “an unexpected occurrence involving death or severe physical or psychological injury, or risk thereof” happens:
1. Serious events to report to JCAHO
2. Requires reporting to patients
· JCAHO can pull accreditation if their standards are not met, but they rarely do.
o Centers for Medicare and Medicaid Services (CMS)
· Quality Monitoring: Have their own mechanisms for performance improvement (QAPI), the threat is that if they do not meet requirements they can get dropped from Medicaid or Medicare.

III. Public Health
o “What is public health: Lots of different definitions:
· “What we, as a society do collectively to assure the conditions in which people can be healthy”
· Includes: environmental health, governmental regulations, disease and injury control, laws pertaining to vital statistics, contract tracing, involuntary testing, immunizaitons, personal restrictions
o Johnson v. Massachusetts
· Facts: Man challeneged mandatory vaccination law (had been injured as a child by it). Ruling for State based on right to control public health.
· Rules:
§ State’s Interest: While individuals do a have a sphere of control of his own will, under the pressures of great dangers, the state can at times enforce reasonable regulations, as the safety of the general public may demand.
· Notes: this is the first major recognition that there is a state power to compel vaccination.

ii. Wong Wai v. Williamson, 1900
· Facts: Apparently a lot of history of racism associated with vaccination. Prevented chinese people from moving around without being innoculated.

o Bioterrorism and Public health Model State Emergency Health Act
· State can pretty much do what it wants in medical emergencies

IV. Licensure and Regulation
o Statutes are implemented by boards:
· that operate as state agencies but which are generally dominated by members of the licensed profession.
· Ironic because doctors are saying “what are the set of practices that you need an MD in able to be able to do?” – conflict of interest
o In Re Williams, 1991
· Facts: Doc prescribed diet drug for an extended period of use, was punished by medical board for his departur

VIII. Doctor-Patient Relationship
· Doctor patient relationship is a tort-contract hybrid.
o Duties once formed:
· continuing care, exercise ordinary care, freedom from malpractice
o Offer/Acceptance
· if you go to the doctor it is an offer for treatment, and the doctor’s subsequent treatment is acceptance.
o Doctors examining on behalf of 3rd parties:
· Courts have disagreed whether there is then a duty to treat or disclose problems, but in times of immediate danger they must do more

o Doctor patient Contract Theory

contract, possibly an implied contract between patient and the physician.

· Advantages: Don’t have to establish standard of care, even if standard of peers for doctors is different, can change it through the magic of contract.
· Courts vary in how happy they are to allow contract claims and find breach.
§ May impose higher burdens of proof, may require writings
i. Dingle v. Belin, 2000
· Facts: P went to get gallblader removed by D-doc, resident did it instead and screwed up, sues for breach of contract. Court says a doctor may be liable for traditional professional negligence, lack of informed consent, and breach of contract, depending in part on the nature of the consequences that flow from the abandonment. However, here the jury already didn’t believe the woman.
· Rules:
§ Recovery for Malpractice Requires Doc-Pat. Relationship: Except in those unusual circumstances when a doctor acts gratuitously or in an emergency situation, recovery for malpractice is only available when there is a doctor patient relationship, express or implied.
§ Breach: Physician who agrees to a specific allocation of responsibility or a specific limitation on his discretion, absent some emergency, proceeds to contravention of that allocation has not obtained informed consent of the patient.
ii. Hand v. Tavera, 1993
· Facts: P goes to ER, one doc says to admit, but health-plan doc refuses to admit him (thinks he’s drunk), P goes home and dies, wants to sue refusing supervisory Doc. Court finds Doc-Patient relationship between doc and insured.
· Rules:
§ Relationship Formed – When the patient shows up at a participating hospital emergency room, and the plan’s doctor on call is consulted about treatment or admission, there is a physician-patient relationship between the doctor and the insured.

IX. Warranties/Specific Promises
o Contract claim benefits for patients:
I. longer statute of limitations, may be viable even when doctor made proper risk disclosure, need not establish standard of care

i. Tunkl v. Regents of Univ. of California
· Facts: Concerns the validity of an exculpatory clause for contract, P died after surgery, hospital claims clause exculpates them. Court finds clause does not exculpate.
· Rules:
§ Exculpation Clauses – Cal. Statute: All contracts which have their object, directly or indirectly, to exempt anyone from responsibility for his own fraud, or willful injury to the person or property of another, or violation of law, whether willful or negligent, are against the policy of law, but if they do not affect public interest, they will be upheld.