1. Chapter I
Introduction
This research compiled and summarized existing case law, reports, and evidence on
the aspects of medical malpractice as it related to tort law, proximate cause, and
education in the hospital system. Risk associated from the emerged problem was focused
in the medical setting when the physician or clinician performed a negligent medical
treatment which caused harm to the patient. Medical errors caused up to 98,000 people
to die in the United States yearly and fifty eight percent (58%) of these deaths from errors
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2. may had been preventable. They were the fifth leading cause of death and cost the
United States $29 billion dollars annually (Kohn,1999). An estimated 15 million
incidents of medical harm occurred in the US each year at a rate of over 40,000 people
per day (IHI, 2006). This was a burden larger than most patients, medical professionals,
and even healthcare researchers realized. The healthcare system focused on
improvements in systems but many of the strategies and technology recommended had
not been fully implemented.
The National Patient Safety Foundation (2002), a multidisciplinary group was founded
in 1998, for the purpose of identifying approaches, which when implemented would
improve healthcare practice. They intended to improve patient safety through identified
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3. approaches which were imperative to the healthcare industry to promote safe healthcare.
The Foundation included increased awareness on patient safety issues through research,
publication, and advocacy. Medical schools needed more emphasis on the educated
efforts in handling errors that occurred in the hospital system . Medical students needed
to learn how to develop rapport with patients and family members when errors occurred.
This was a skill in which many practicing physicians had never dealt with in medical
school. Thus, the lack of experience and training in coping with affected family members
hindered important communication between the patient and physician (Meyer,2001).
Physicians were less likely to be sued if they had established a relationship with the
patient (Levinson, 1997).
The “Leap Frog Group,” an advocacy group founded in 2000, recognized a
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4. dysfunction in healthcare. They consolidated from a group of large employers to work
together to influence quality and affordability when they purchased healthcare.
Employers were spending billions on healthcare for their employees but had no way to
assess the quality of service rendered. They also had identified strategies that decreased
medical errors and improved patient care and safety. Computerized prescriptions in
hospitals emerged from this, decreasing errors caused by incorrectly reading hand-written
material. Patients who had complex conditions or needed specialized procedures were
sent to hospitals with documented proven outcomes experienced in handling those
procedures or conditions. Properly staffed intensive care units were recognized in
hospitals (ICU’s) with physicians, such as Intensivists, well-trained to care for this
population. These measures were based on credible data that supported these
implemented steps (Leapfrog Group, 2000).
A sentinel event was defined according to The Joint Commission on Accreditation
(JACHO) as an unexpected occurrence that involved death or serious physical or
psychological injury, or the risk thereof. The defined term a risk thereof, included any
process variation for which a recurrence would carry a significant chance of a serious
adverse outcome (ISPM Medication Safety Alert, 2006).
Recent cases that were examined indicated that there was sufficient evidence in the
lack of understanding and education which contributed to the long term consequences
which had impacted staff and the hospital institution. Criminal investigations and felony
indictments were levied against some or all of the practitioners involved in errors under
the theory of respondent superior. Tragic loss of life and these events had adverse effects
on the healthcare system. Critical process improvements and education were propelled to
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5. the forefront as initiatives for improved safety outcomes for the patient population
(Wisconsin Nurses Association, 2006).
Safety experts and the criminal justice system seemed to be at odds over the proper
course of action of a fatal event. Licensing boards took exception to human errors and
tended to limit or revoke licenses for reckless or incompetent healthcare practice. The
hospital employee could be held responsible for negligence. To avoid acting negligently,
healthcare workers needed to minimize risk through the identification of their internal
policies and the empowerment of education. By implementing standard protocols in the
hospital system, errors were diminished (Diamond 200). Most errors were not due to a
reckless or incompetent employee, but to faulty, complicated structures (Olsen, 2002).
The Institute for Healthcare Improvement (IHI) a not-for-profit organization led the
improvement of health care throughout the world by making needed changes. Founded
in 1991 and based in Cambridge Massachusetts, IHI worked to accelerate change by
cultivating concepts for improved patient care and turning those ideas into actions. The
IHI’s proposed solutions to the problem of sub-standard quality care had included
upgrading quality through process improvement, reporting of system errors, performance
standards, new education, cultural change, and new technology. The IHI initiative for
reduced mortality was the ultimate health care improvement goal as a result of these
proposals. Thousands of hospitals reached new thresholds of safety, and new standards of
care were established as a result (IHI, 2006).
Medical errors were grouped into four categories that affected the patient:
diagnostic, treatment, preventative, and other. Diagnostic errors included errors or a
delay in the actual diagnosis. This type of error would delay proper treatment that the
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6. patient needed to prevent further complication or even spread of the illness. Studies
comparing diagnoses to postmortem necropsy results indicated that forty percent ( 40%)
to sixty percent (60%) of diagnoses listed in the patients’ charts were incorrect. The
same study indicated that the errors had a significant impact on the patients’ outcomes in
ten percent (10%) of the cases reviewed (Goldberg, 2002).
The effects of medical malpractice suits had far reaching consequences webbed into
the societal structure of the United States. The published information included the
patient, physicians’ practice, the organization or the hospital, and society. This crisis had
negative consequences which impacted care received and the availability of quality of
care. A few reasons were identified why this crisis had impacted so many in the
United States. Physicians had left states associated with high cost insurance premiums
and had left high risk specialty areas such as obstetrics and neurosurgery. Physicians
sometimes withheld their services or refused services, which left other physicians
covering their specialties. Economic cost increased as the cost of medical malpractice
rose. The premiums in a few states rose thirty three percent (33%) which could equate to
$150,000 a year for medical malpractice insurance. Physicians had demanded the right
not to carry insurance coverage and refused to provide after hour services which
placed them in direct violation with state by-laws (Darr, 2004).
Defensive medicine was a consequence of medical malpractice. The term came from
the practice of physicians ordering expensive procedures used to defend physicians
against liability. The unnecessary tests were evident in delays of diagnosis and led to
often more expensive tests that were not necessary. This created an environment that
often carried risk from delays and increased financial costs. Defensive medicine added
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7. about $50 billion annually to the cost of healthcare in the United States between 2005
and 2006 ( Joyce, 2007).
The American public had been associated to the risk with medical care provided in
the hospitals in the United States. The consumer had become aware through publicized
accounts of errors and medical malpractice in the media. This information emphasized
quality in the hospital system. A poll revealed that 56 percent (56%) of Americans
believed that the healthcare system needed change (Louis Harris and Associates, 2002).
A few U.S Hospitals adopted and implemented various total quality management
(TQM) programs as a result. A quality movement incorporated plan that offered to
accelerate change in the hospital was Six-Sigma, a methodology an extension of the
Failure Mode and Effects Analysis that was required by JACHO. The methodology had
taken TQM to the next level with reduced medical errors and increased
profitability in the hospital system through employee training and a quality philosophy.
The available evidence supported the recommendations that healthcare systems
needed to initiate education to modify or mitigate the risk (Cook, 2004). The lack of
education focused on tort law and the elements, or prima facie case requirements, were
unknown or not fully understood by the medical staff. Risk information provided in case
studies had given examples of consequences that occurred from a particular
medical procedure, and the duty to disclose a risk, which represented the proxy of
court outcomes associated with these events. Negligence occurred in many instances,
such as errors while delivering care to the patient in the hospital system. There were
documented proximate causes associated with errors such as lack of knowledge about a
drug, condition or procedure. Rule violation was also identified as a proximate cause
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8. which led to negligence such as, not following hospital protocols or standard of care
during procedures. Several other documented causes that satisfied the link in proximate
cause were: faulty interaction, communication and documentation for provided
continuum of care, followed by slips in memory, and staffing ( Al-Assaf,2003).
Negligence contained four elements, or prima facie case requirements, which needed to
be established for liability purposes. The four were: 1.) A duty by the physician which
met the standard of care 2.) Failure to perform that duty 3.) Proximate cause between
defendants’ failure and plaintiffs’ injury, and 4.) The injury in which compensation was
adequate for relief of the injury (Madden, 2000).
Another case for the plaintiff arose when there was an injury caused by the outcome
or procedure and there was no medical consent for that procedure. The error did not
occur in the care given by the physician but in the physician not obtaining medical
consent. Consent had to be given by a patient that had the capacity under the mental
health act to make rational decisions. Age was another factor that contributed when
consent was obtained; adults were classified as eighteen years old and over unless the
patient had been legally emancipated. Consent is a legal defense against assault and
battery cases (Campbell-Tiech, 2003). The prima facie case requirements for this type of
case were as follows: The physician had a duty to disclose particular information to the
patient and the disclosure did not occur. This lack of information about the significant
risk affected the outcome, and the patient would likely have refused the procedure if he
had been apprised of that information. Lastly, the procedure caused the plaintiffs’ injury
which courts treated as a matter of negligence (Madden,2000).
In “failure to warn” cases, juries were empowered to dissect the case presented and
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9. determine if all the prima facie case requirements were satisfied and determine if the
warning was adequate. Medical Informed Consent law required the disclosure of the
risks and the alternative suggested medical procedures to provide patients with
knowledgeable decisions about their care ( Madden, 2000).
Both the legal system and healthcare system were complex, and the purpose of the legal
system was to ensure the healthcare system functioned in accordance to laws. The
courts primarily ensured that contracts were followed, by resolving disputes, by judging
whether reasonable expectations of performance were met, and by meting out awards and
penalties based on legal decisions (Eddy, 2001).
Legal settlements in medical malpractice did not mandate system changes or root
causes which prevented future errors (Eddy, 2001). Deming (1986) a renowned
philosophy leader in total quality organization systems, identified measures to improve
processes which had been adopted in some hospital organizations. Deming stated that 94
percent (94%) of all errors were related to the system and not an individual employee
(Deming 1986).
Statement of the Problem
This study addressed the following questions and examined the related problems of
malpractice and errors in the hospital system. The questions stemmed from interests and
concerns in the area of patient safety, education, and proximate cause which accelerated
in the last decade. The questions in this study were formatted: 1.) Was there a casual
connection between errors and lack of education? 2.) Were there quantitative
strategies to analyze root causes in order to understand the source of the medical
error? Research identified and emphasized the complexity of the errors stemmed from
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10. several variables rather than one cause (Plsek, 2005). 3.) Was there a lack of support
through quality of education provided to the healthcare worker in the university setting
and also in their working environment?. 4.) Would education improve healthcare
workers ability to provide quality of care and mitigate the risk associated with negligent
medical treatment?
With regard to pedagogy, observers noted and criticized that during the first few years
memorization skills overcame critical thinking skills (Carraccio, 2002). The emerged
medical malpractice insurance cost and the cost associated with litigation had impacted
financial consequences for both the physician and the hospital organization (Darr, 2004).
The cost associated with medical malpractice impacted health–insurance programs and
society from defensive medical practice. Taxpayer funds for supporting this practice
were reported to be between $28.6 and $47.5 billion per year ( Joyce, 2007).
The healthcare industry had always sought ways to provide improvements in
healthcare design and re-engineering. Increased complexities emerged out of tort
law formed the basis for physician liability. The lack of understanding and education by
healthcare workers was a focal point of interest for this research study. Hospitals and
medical organizations needed focused management approaches to identify and reduce
risk. Policies and procedures needed to be developed to promote best practice standards
to set a clear vision for provided quality healthcare to the community. Healthcare
workers needed an understanding of the legal elements through formal programs
established in universities and hospital based risk management programs.
The null hypotheses for the quantitative analysis were as follows:
1. There was no significant difference in casual connection between hospital errors
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11. and lack of provided education to the healthcare worker.
2. There was no significant difference in the quantitative strategies utilized in the
healthcare system and the number of errors that occurred in the hospital.
The Purpose of the Study
The Healthcare and medical professionals faced malpractice issues and liability
problems. This study investigated the lack of education and understanding in the area of
tort law and liability. Education was introduced through instruction within defined areas
of tort law which improved the understanding of negligence and, more specifically, the
reduction of medical errors in the hospital system. Constant improvement measures in
risk discipline and education in the university settings needed to be delivered in a subject
format. The education formulated awareness and the understanding of the prima facie
case requirements for the intentional torts and how the laws were applied in the medical
setting.
A change in education was yet another solution with a developed six-sigma model that
was highly rated by individuals which introduced learning by instructional video. This
provided a culture of safety and education quality when new technology for patient care
was initiated in the hospital system (Cook, 2004).
Significance of the Problem
The study produced evidence that there was a correlation of increased medical liability
and the healthcare workers’ lack of education. There was a significant amount of
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12. documented accounts of liability and the determent errors had on the medical community
and patients. Medical errors accounted for more than 98,000 deaths in the United States
yearly, and approximately 58 percent (58%) of those deaths had been preventable (Kohn,
2001). Millions of dollars related to damages contributed to increased medical
malpractice insurance premiums that compromised care in specialty areas in some states
(McElhatton, 2004). Even with tort reform in most of the states, the medical malpractice
economic solutions had not identified the root cause of errors to prevent further potential
fatal errors in the future (Darr,2004).
Education in this area was not mandated or even presented as a course or possible
solution in the universities where the medical community were trained. Continued
education and training programs which involved risk management not only established
patient safety, but also reduced malpractice lawsuits. Interdisciplinary training had
proven to strengthen teams and reduce errors (Cook, 2004).
The contribution of the study provided a greater depth of knowledge about this
previously studied phenomenon, changed prevailing beliefs and education requirements,
and extended a research methodology for reducing errors.
Delimitations
This study was limited to the demographic area of the medical community in the
Midwestern states from the surrounding hospitals and medical universities. Finally, the
observation phase of the study was not expanded to all the geographical area, due to the
time and monetary constraint of the study.
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13. Limitations
The study was limited to a small geographical region in the Midwest. Subjects in the
study were not culturally diverse. The study pool was small limiting needed experience
with errors that occurred in the hospital system. Most university education in this area
did not emphasize hospital law or tort law in its content to prepare students. In addition,
the data collected from the surveys was not independent to state law which varies from
state to state and was noted in the context of answers. Graduates of medical and nursing
schools obtained their education from a variety of universities, including trade schools as
well as teaching universities. Another factor, which could impact the study was the
reported case studies were not independent only to the demographic area studied in the
Midwest states, but also included Florida and California.
Assumptions
The assumption was made that the available data from the case studies provided a vast
array of topic information on medical errors. Another assumption was that the research
could be easily replicated and justified by another researcher. It was assumed there was a
direct correlation between education of medical personnel and medical liability. Finally,
it was assumed that costs of medical malpractice insurance increased due to increasing
costs associated with medical malpractice claims affected by the civil penalties opposed
by the proxy of the court
Definition of Terms
1. Assault, according to Madden was an intentional tort. The defendant must desire or
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14. be substantially certain that the actions caused the apprehension of immediate
harmful or offensive contact.
2. Battery, according to Madden was an intentional tort. The defendant acted
Intentionally to cause harmful or offensive contact with a victim’s person.
3. Consent, was a legal condition whereby a person could be said to have given consent
based upon an appreciation and understanding of the facts, implication and future
consequences of an action. In order to give consent, the individual concerned had
adequate reasoning faculties and be in possession of all relevant facts at the
time consent was given. Impairments to reasoning and judgment which would make it
impossible for someone to give informed consent included such factors as severe
mental retardation, severe mental illness, intoxication, severe sleep deprivation,
Alzheimer’s disease, or being in a coma.
4. False Imprisonment, according to Madden, was an intentional tort. The defendant
unlawfully acted to intentionally cause confinement or restraint of the victim within a
bounded area.
5. Emancipation, according to Gifis, was the freeing of someone from the control of
another, such as a parent.
6. Intensivists, were physicians who had training in critical care medicine. The specialty
required additional fellowship training in critical care medicine after their
primary training in internal medicine, anesthesiology, or surgery was completed.
7. Malpractice was a type of negligence in which the misfeasance, malfeasance or
nonfeasance of a professional, under a duty to act, failed to follow generally accepted
professional standards, and that breach of duty was the proximate cause of injury to a
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15. plaintiff who suffered damages.
8. Proxy, according to Gifis, was an individual or court who was the recipient of a grant
of authority to act or speak for another.
9. Negligence was a duty of defendant the physician to meet the standard of care, failure
to perform that duty, casual connection between defendants’ failure and plaintiffs’
injury, and the injury in fact, one in which compensation was adequate for relief.
10. Policy, referred to the process and achieve rational outcomes.
11. Prima facie was used in modern legal English to signify that on first examination,
a matter appeared to be self-evident from the facts. In common law jurisdictions,
prima facie denoted evidence that, unless rebutted, would be sufficient to prove a
particular proposition or fact. Most legal proceedings required a prima facie case to
exist, following which proceedings then commenced to test it, and created a ruling.
12. Process improvement, was a series of actions taken to identify, analyze and improve
existing processes within a organization to meet new goals and objectives. These
actions often followed a specific methodology or strategy to create successful results.
13. Protocols were medical guidelines for medical treatment. It usually included a
treatment plan and summarized consensus statements and addressed practical issues.
14. Proximate cause was a primary or moving cause of continuous sequence which
produced the injury.
15. Respondent superior was a legal doctrine which stated that, in many circumstances,
an employer was responsible for the actions of employees performed within the course
of their employment. This rule was also called the “Master-Servant Rule”.
16. Six-Sigma was a business management strategy, originally developed by Motorola,
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16. that today enjoyed wide-spread application in many sectors of industry. It sought to
identify and remove the cause of defects and errors in manufacturing and
business practices. It used a set of quality management methods, including statistical
methods, and created a special infrastructure of people within the organization who
were experts in the method. Each Six-Sigma project carried out within the
organization followed a defined sequence of steps and had quantified financial targets
(cost reduction or profit increase).
17. Tort Law was the name given to a body of law that created, and provided remedies
for civil wrongs that did not arise out of contractual duties. Torts covered intentional
acts and accidents.
18. Vicarious Liability, was a form of strict, secondary liability that fell under common
law doctrine of agency- respondent superior-the responsibility of the superior for the
acts of their subordinate or in a broader sense, the responsibility of any third party that
had the right, ability, or duty to control the activities of a violator.
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