Difficulties in proving medical errors: Where do we stand?

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Strana 390 VOJNOSANITETSKI PREGLED Vojnosanit Pregl 2014; 71(4): 390–394.
Correspondence to: Nemanja Ranÿiý, Center for Clinical Pharmacology, Military Medical Academy, Belgrade, Serbia, University of De-
fence, Belgrade, Serbia. E-mail: nece84@hotmail.com
CURRENT TOPIC UDC: 174:61]:340.66
DOI: 10.2298/VSP1404390I
Difficulties in proving medical errors – Where do we stand?
Teškoüe u dokazivanju medicinskih grešaka – Gde smo trenutno?
Dragana Ignjatoviü Ristiü*, Svetlana Vasiljeviü†, Nemanja Ranþiü‡,
Branko Ristiü§
*Clinic for Psychiatry, §Clinic for Orthopedic Surgery and Traumatology, Clinical
Center Kragujevac, Faculty of Medical Sciences, University of Kragujevac, Kragujevac,
Serbia; †Basic Court in Kragujevac, Kragujevac, Serbia; ‡Center for Clinical
Pharmacology, Military Medical Academy, Belgrade, Serbia and Faculty of Medicine of
the Military Medical Academy, University of Defence, Belgrade, Serbia
Key words:
ethics, medical; physician-patient relations; medical
errors; jurisprudence; legislation; serbia.
Kljuÿne reÿi:
etika, medicinska; lekar-bolesnik odnosi; medicinske
greške; pravna nauka; zakonodavstvo; srbija.
Introduction
Developements in medicine, better informed patients
and more complicated medical procedures have increased
public interest in regard to errors in treatment. Heightened
public awareness is also reflected in the increased number of
judicial proceedings related to medical malpractice in many
countries worldwide
1. Approaching European standards
dealing with protection of patient’s rights further magnifies
the significance of this subject. Awareness of contemporary
medical achievements and developement of pharmaceutical
technology often leads patients to form unrealistic expecta-
tions of doctor’s and medicine’s capabilities, and the percep-
tion that all ills must be cured. The sensitivity of this subject
heightens the importance of health and the perceived impact
that actions or omissions on the part of medical practioners
may have on the lives of individuals. The constitutions of
many countries address this as well 2.
According to the report of Institute of Medicine, be-
tween 44,000 and 98,000 deaths per year were caused by er-
rors in treatment in the U.S. health system alone 3. One of the
report’s main conclusions was that the majority of medical
errors do not result from the recklessness of one individual.
More commonly such errors are caused by faulty systems,
processes, and conditions that lead people to make mistakes
or fail to prevent them. Ten years later, with little transpar-
ency and no public reporting (except in jurisdictions where
hard fought state laws now require public reporting of hos-
pital infections), scarce data does not paint a picture of real
progress 3.
Medical ethics on infallibility leads to an atmosphere in
which errors are seen as an individual problem of the one
who treats, for which the doctor punishes him and feels
ashamed, instead of seeking the root of the problem and
searching for a solution to improve the health system. On the
other hand, proving guilt often becomes a long process
which can be traumatic for patients, members of their family,
and also for the doctor who, even if acquitted, has no impres-
sion that they gained something, but only that they have lost
less.
Medical error – Error in treatment – Medical
malpractice
Error in treatment is not synonymous with neglect,
negligence and medical malpractice.
Medical error – error in treatment – medical malprac-
tice – these terms are not identical in their meaning or legal
and other consequences. Medical error and error in treatment
are terms derived from the medical profession with numer-
ous ethical and deontological implications. Medical mal-
practice is a term arising from the legal standard prescribed
by law as the basis of doctors’ liability.
According to The Joint Commission (TJC), a Sentinel
Event or “Never Event” is defined as an unforseen event in a
health system resulting in death of a patient or serious phisi-

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cal or mental health damage, non-related to natural course of
patient's illness 4–6.
The criminal offense of medical malpractice, as defined
in the Criminal Law of Republic of Serbia 7, occurs when a
doctor, in providing medical help, uses an obviously inade-
quate remedy or obviously inappropriate treatment or does
not apply appropriate hygiene measures at all, or obviously
acts unconscionably, thereby causing deterioration of a per-
son’s health.
In order to determine a crime of medical malpractice,
it is necessary to establish a causal relationship between a
doctor’s unconscionable action and a patient’s deterio-
rating health 2. That means that the aggrieved person can
be both healthy and sick. What is important is that their
health deteriorated due to medical malpractice. On the
other hand, if a doctor did act unconscionably but there
was no health deterioration, a criminal offence does not
exist. Serbia and neighboring former Yugoslav republics
have been and remain among the few countries whose
criminal justice specifically exculpates unconscionable
doctors 2, 8.
Penalties in the case of medical malpractice resulting in
a patient’s deteriorating health are different in different leg-
islatures – a fine or two years imprisonment (Penal Code of
Republic of Croatia) or imprisonment from three months to
three years (Penal Codes of Republic of Serbia, Republic of
Montenegro, Serb Republic, and Federation of Bosnia and
Herzegovina 2.
In all previously mentioned legislatures, more lenient
punishment is provided if it is proven that a doctor’s medical
malpractice occurred out of negligence – a fine or imprison-
ment up to one year may be imposed.
Every legal system mentioned above also provides for
more serious cases of this criminal offence, as determined by
more serious outcomes (such as severe injuries or death of a
patient). Therefore, the more serious case of this criminal of-
fence is a separate article of the Criminal Law in Serbian le-
gal system. Serious offenses against public health provide for
punishment from one to eight years of imprisonment (in case
of severe injury) or two to twelve years (in case of death of a
patient). For the same criminal offence, neighboring coun-
tries stipulate similar punishments 2.
Serbia statistics
The crime of medical malpractice is one of the rarest
offenses in Serbian judiciary for years 9. A disproportionately
small number of cases of medical malpractice was observed
and described in works dating from the mid-nineties 10.
From 2006 to 2010, in Serbia from 4,052 to 4,895
charges per year against adult persons for a crime against
public health were documented. This is an average of 4 to
5.5% of total charges for all crimes. Looking at individual
offenses in 2010, there are 4,052 charges with crimes against
public health. Of these, 47 cases were based on negligence in
providing medical care, and 4 cases on not providing medical
help. The total number of convictions in 2010 for crimes
against public health was 2,564, but of that number only 3
cases were based on negligence in providing medical aid,
while not a single person has been convicted of not providing
medical help. In all 3 cases there was a guilty verdict in
whom they received probation sentences.
In order to ilustrate the everyday practice in Serbia, we
analized twelve years data from the Municipal Court in Kra-
gujevac. According to the current organization of the courts,
the Municipal Court in Kragujevac covers the territory of
city of Kragujevac, municipalities Aranÿelovac, Batoþina,
Raþa and Topola. Data on the number of all initiated pro-
ceedings filed against doctors and other health workers, and
the number and gender of the accused persons for the period
from 2000 to 2011 were collected and processed (Table 1).
The total number of prosecutions and other prosecution
acts during this twelve years period was 18,732, an average
of (mean ± standard deviation) 1,561 ± 352.3 per year. In the
analyzed period there were six charges for the crime of
medical malpractice, which makes 1 crime per two years.
The situation is similar in Croatia. For the five-year pe-
riod (2005–2009) there were 10 reports for medical malprac-
tice, but were all rejected, so there were no convictions 11.
Difficulties in proving medical errors
Any medical procedure that was performed according
to the rules of medical profession, with the consent of an in-
formed patient and performed by a qualified person does not
Table 1
Number of cases of medical malpractice in Kragujevac Court
Year Total number of charges and other acts of
prosecution
Number of cases of medical
malpractice
2000 1,147 1
2001 1,170 0
2002 1,227 0
2003 1,382 0
2004 1,147 0
2005 1,674 0
2006 1,612 0
2007 1,478 1
2008 1,890 1
2009 2,064 0
2010 2,031 1
2011 1,910 2
Total 18,732 6

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come within the scope of criminal behavior even if a harmful
outcome for life and health of a patient does occur. On the
other hand, even if just one condition is not fulfilled, a medi-
cal procedure may result in criminal responsibility.
In order to even initiate a judicial proceeding, it is nec-
essary that the injured patient file a charge. Next, a prelimi-
nary proceeding will be conducted to determine whether
there are grounds for suspicion of a criminal offense. Of
course, charges may also be filed by any other party, espe-
cially by the doctors who are familiar with the questionable
medical treatment. The prerequisite is that a patient is in-
formed about his rights and the procedure.
To prove that a medical error does exist is problematic
per se. It is an imprecise standard that refers to the legal
standard “manifestly unconscionable (inappropriate),” cre-
ating the main problem of proving that such crimes were
committed. The next question is whether there is obvious in-
appropriateness in a general sense or just in the narrow pro-
fessional sense. If obvious, what defences may be raised by
the accused?
An obvious unconscionable/inappropriate act should be
seen as a striking fault, which is beyond the scope of medical
tolerance 9. The specificity of the medical profession allows
for a certain amount of tolerance, i.e. from the criminal jus-
tice/legal standpoint, all monetary losses that are not clearly
related and/or obviously ineligible are considered irrele-
vant 7.
Where does that dose of tolerance towards medical
profession come from?
The concept of a reasonable dose of tolerance primarily
comes from the fact that while medicine is a relatively exact
science, causes of illness and death are not nearly as clear as
their consequences 12. It cannot be predicted with absolute cer-
tainity how a person reacts to a disease. Therefore the selection
of a particular means of treatment is always relative. Another
reason is that medicine is not a complete and closed knowledge
system but, on the contrary, medical knowledge is enriched on
a daily basis, so questionable treatment will generally be re-
solved in the health sector within professional circles.
In every specific situation, a doctor’s ignorance mani-
fested during the treatment of a patient is a necessary (requi-
site), but not a sufficient condition for examination of the
doctor’s responsibility. Obviously using clearly inappropriate
means or methods of treatment constitute a more drastic and
serious deviation from the rules of science and the medical
profession, i.e. reflecting gross medical ignorance 7.
The question of knowledge, i.e. minimum standards of
knowledge, skill and expertise reasonably expected of a
qualified doctor to act in every circumstance, is the meas-
ure of that tolerance that recognizes the possibility of ac-
ceptable variations in treatment while on the other hand
does not create suspicion for alleged medical profession
privilege. From that comes the obligation for doctors to en-
gage in continuous vocational training and to adopt new
practices resulting from the rapid progress of medical sci-
ence and technology.
The law also recognizes other risk factors in medicine.
Every patient’s individual reaction to illness, their specific
response to therapy, even when applying known and trusted
treatment methods, may be variable. This requires that in
doctors’ everyday practice they must take into account that a
certain procedure or therapy may not be successful, i.e. may
have a negative effect on the patient 7. Factors that cannot be
predicted or avoided must be recognized as objective risks of
treatment that, with all the knowledge, skill, conscientious-
ness and technical equipment cannot be avoided. Objective
risk in medicine may be considered as the equivalent to force
majeure that excludes responsibility of a doctor in case of
unfavorable outcome of a treatment.
Subjective risk is one that could and should be avoided
if a doctor is more professional, careful, and conscientious.
In contrast, objective risk is a potential risk factor beyond the
control of the doctor which should be disclosed to each indi-
vidual patient with consent being obtained and understanding
confirmed. Subjective risk (insufficient knowledge and com-
petence of a doctor) directly leads to a doctor’s responsibility
in terms of medical malpractice if proved that it was crucial
to harmful effects to the patient’s health. Special and delicate
discussion is required if attempting to present subjective risk
as inevitable, that is, objective risk during treatment, in order
to avoid responsibility for the harm caused the patient.
Advantages and disadvantages of team work
One more aspect of the medical profession is teamwork.
This implies that several doctors of different specialities are
included in the treatment of a common patient. This ap-
proach provides the highest quality treatment for each pa-
tient, but in case of serious harm to health of a patient, the
question of responsibility is raised. There is no doubt that
even in a team, every individual is primarily responsible for
their own work, and teamwork is based on mutual trust
where team members complement and help each other in
knowledge and action. Thus there is the potential of causing
a mutual impact in which one’s error becomes an error in the
work of another team member (accumulation of errors), but
also the team concept can create the possibility of averting
error of one by corrective action of another team member. In
each individual case it is assessed whether and to what extent
there is a duty/obligation to remove an error of another team
member who had treated the patient. In this case also, these
issues are resolved by hiring forensic experts.
Expert selection
According to the rules of a proceeding, expertise is de-
termined in the investigation. Bearing in mind that the actions
involved in committing the offense may be debatable or un-
clear, expertise is crucial in determining whether the doctor
committed a crime or not. As judges do not have sufficient ex-
pertise in medical issues that would shed light on relevant cir-
cumstances of the offence, medical evaluation, implementa-
tion or lack of implementation of proper medical procedures
are entrusted to experts of medical profession by the judges.

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When determining the expertise required, all relevant
circumstances pertaining to the particular case should be
considered before delegating to an expert, an expert com-
mission, an expert institute or other institution. The main
objective is to provide appropriate and non-biased profes-
sional expertise. Proper selection of experts requires that
judges also have a broad enough education and knowledge
in those fields to assess which experts are required in each
particular case.
In any particular case of medical malpractice, it must be
taken into account that experts of the respective specialty are
present, or whether it is necessary that several specialists in
different fields be involved. The decision also depends on the
institution where the offender works.
After that assessment, the judge or president of the
panel decides the composition of the commission or institu-
tion to which the expertise will be delegated. Due to the very
few specialized institutions available to provide expertise
and the narrow scope of their work, the process of selection
may be unjustifiably long. This can be affected by the ad-
ministrative part of a proceeding – correspondence and pay-
ing the costs of expertise.
Practice has shown that judges often hire the same ex-
perts. This is usually a consequence of a judge’s trust and
confidence and the need for quick and competent expertise,
rather than, as sometimes negatively portrayed, that some
experts are privileged.
In the judicial process itself, of great importance is to
what extent the clinical environment in which a doctor or other
health care provider operated may have impacted the circum-
stances (i.e. conditions in the institution, equipment, number of
patients, level of training of other staff). Also relevant are the
problems of collecting valid documentation related to a par-
ticular patient. Proving guilt therefore often becomes a long
process which can be traumatic for patients, members of their
family, and also for the doctor who, even if acquitted, has no
impression that they gained something, but only that they have
lost less than would otherwise have been the case.
Final remarks
On behalf of patients
The prerequisite is that a patient is informed about his
rights and the procedure. Patient safety may be enhanced by
better information, which depends primarily on the doctor’s
competence, the conditions provided by the institution, the
time the doctor can devote to patient, and also on the interest
of the doctor to provide services and information to the pa-
tient.
On behalf of doctors
Doctor’s safety would be influenced by protocols used,
good teamwork, trained "support staff", better working con-
ditions, continuous education of doctors, financial satisfac-
tion, and anything else that could improve medical knowl-
edge and provide the basis for the provision of better medical
care. Regulating error reporting in medicine is also very im-
portant in reducing potentially fatal medical errors. In the
future, medical associations should be open to discussion of
these issues also.
On behalf of low
Bearing in mind that the actions involved in commit-
ting the offense may be debatable or unclear, expertise is
crucial in determining whether the doctor committed a
crime or not.
In any particular case of medical malpractice, it must be
taken into account that experts of the respective specialty are
present, or whether it is necessary that several specialists in
different fields be involved.
In each individual case it is assessed whether and to
what extent there is a duty/obligation to remove an error of
another team member who had treated the patient.
In the judicial process itself, of great importance is to
what extent the clinical environment in which a doctor or
other health care provider operated may have impacted the
circumstances (i.e. conditions in the institution, equipment,
number of patients, level of training of other staff).
Conclusion
Errors do happen. Like every human being, doctors and
other medical workers are not infallible. As the errors in the
course of treatment can be rightly expected, the system must
be adjusted so that it prevents errors and resolves them.
Acknowledgement
This work was partially supported by the Ministry of
Education, Science and Technological Development of the
Republic of Serbia (Grant N°175014 and 175007). The
authors expressed their gratitude to Frank J. Reichert, Master
Business Administration, Chicago, Illinois, for carefully
reading draft versions of this article as well as for helpful ad-
vices on English language.
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Received on November 2, 2012.
Revised on December 22, 2012.
Accepted on December 25, 2012.