Medical malpractice as reflected by the forensic evaluation of 4450

Medical malpractice as reflected by the forensic evaluation of 4450

Forensic Science International 190 (2009) 58–66
Contents lists available at ScienceDirect
Forensic Science International
journal homepage: www.elsevier.com/locate/forsciint
Medical malpractice as reflected by the forensic evaluation of 4450 autopsies§
Burkhard Madea *, Johanna Preuß
Institute of Forensic Medicine, University of Bonn, Stiftsplatz 12, 53111 Bonn, Germany
A R T I C L E I N F O
A B S T R A C T
Article history:
Received 10 February 2009
Received in revised form 12 May 2009
Accepted 15 May 2009
Available online 12 June 2009
A multicentre retrospective analysis of 4450 autopsies carried out due to suspicion of medical
malpractice in 17 German institutes of forensic medicine from 1990 to 2000 was performed for the
German Federal Ministry of Health. During the time period analysed an increase of cases could be
mentioned. The main results of the study are: in the cooperating institutes the total number of autopsies
due to suspected medical malpractice ranged from 1.4 to 20%. In more than 40% of the cases preliminary
proceedings were started because the manner of death was certified as non-natural or not clarified.
Hospital doctors were more affected by medical malpractice claims than doctors in private practice.
However, the number of confirmed cases of medical malpractice was higher for doctors in private
practice than for hospital doctors. Although surgery is still at the top of the disciplines involved in
medical malpractice claims the number of confirmed surgical cases was below the average. Mistakes in
care were confirmed to be above the average. Medico-legal autopsies are still a very sufficient method to
evaluate cases of medical malpractice: 2863 cases could already be clarified by autopsy. Up to now there
is no systematic registration of medical malpractice charges in Germany. A systematic registration
should be initiated to build up and/or improve error reporting systems and, thus, to improve patient
safety. Compared to other sources of medical malpractice claims (arbitration committees of the medical
chambers, reference material of health and insurance companies, files of civil courts) the data of the
present multicentre study are in so far unique as only lethal cases were evaluated and a complete
autopsy report was available as basis of an expert opinion in alleged medical malpractice cases.
ß 2009 Elsevier Ireland Ltd. All rights reserved.
Keywords:
Medical malpractice claims
Lethal outcome
Autopsies
Expert opinion
Forensic medicine
1. Introduction
Clear data on the epidemiology of medical malpractice are
missing, at least for Germany [12,21,22]. Furthermore data on the
frequency of medical malpractice claims – both in penal and in civil
law – are not available (Table 1).
For Germany it is estimated, that only 1500–2000 cases per year
are investigated by the public prosecutor, these are mainly cases
where death is thought to be due to medical malpractice and cause
and manner of death have to be cleared by a medico-legal autopsy.
In penal law it is estimated that one investigation by the public
prosecutor is performed on 60,000 inhabitants, one lawsuit filed on
90,000 inhabitants. Only eight cases per year are brought to a penal
court with four convictions and four stays of proceedings [47].
For civil law data on the frequency of medical malpractice
claims are also not available, estimations speak of about 15,000
claims per year [22,33].
Every doctor is obliged to have a liability insurance, data from
the liability insurance companies are, however, not available as
§
Supported by grants from the Federal Ministry of Health.
* Corresponding author.
E-mail address: [email protected] (B. Madea).
0379-0738/$ – see front matter ß 2009 Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.forsciint.2009.05.013
well [27,64,71,74–76]. One insurance company with 108,000
insured doctors reported about 4500 complaints a year with a
settlement of cases in 30%, 10% go to a civil court and in 4% medical
malpractice is confirmed at court.
In Germany most claims of medical malpractice are dealt with
at the arbitration committees of the medical councils (Table 2)
[2,16,17,46,53]. More than 30 years ago the medical councils
founded these arbitration committees to make medical malpractice claims possible without applying to the court. More than
10,000 cases per year are dealt with at the arbitration committees
and in 30% patient claims are confirmed. The data of the
arbitration committees of the medical councils are meanwhile
published once a year on a national basis (MERS: Medical Error
Reporting System) [2].
However, from epidemiological and health care research
important data on the frequency of adverse events (AE),
preventable adverse events (PAE) and negligent adverse events
(NAE) are available [6,25,56–59,66,67]. According to a systematic
review of the German Alliance of Patient Safety AE can be expected
in 5–10%, PAE in 2–4%, NAE in about 1% and lethal outcome in
about 0.1% of hospitalized patients. Thus, on a yearly basis of 17.5
million hospitalized patients in Germany 880,000–1,750,000 AE,
700,000 PAE, 175,000 NAE and 17,500 deaths could be expected.
This would mean that in Germany nearly as many people would
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
59
Table 1
Data on the epidemiology of medical malpractice claims in Germany (according to
[2,12,16,17,21,22,27,40,47,60,64,71,74–76]).
Penal law (estimations)
One investigation by the
prosecutor on 60,000 inhabitants
One complaint at a prosecutor on
90,000 inhabitants
Only eight cases per year going to
penal court: four convictions,
four acquittances
About 1500 cases a year
investigated by the
prosecutor
Civil law
No data available
Estimation: about 15,000
claims per year
Arbitration committees of the medical councils
Medical malpractice in
about 30% confirmed
About 10,000 cases a year
Liability insurance companies
Estimations based on the data of
one company with 108,000
insured doctors: about 4500
complaints a year
In 30% of cases settlement, 10%
go to ‘‘civil’’ court, in 4%
medical malpractice confirmed
Health insurance companies
Medical service of health
insurance companies
In 24% medical malpractice
confirmed
Fig. 1. UK annual accidental deaths (in thousands).
About 9700 cases (in 1999)
About 40,000 medical malpractice claims per year; about 12,000 confirmed.
die due to consequences of medical diagnoses or therapies than
due to colon cancer (20,200), breast cancer (18,000), pneumonia
(17,800) and traffic accidents (7700). Similar data have already
been published for the UK (Fig. 1).
However, the data from epidemiological research are not
compatible with figures from civil and penal law and they were
questioned after their publication [31,32,35,37,47,58,59]. Nevertheless they are in accordance with other international studies: e.g.
the Institute of Medicine stated that up to 98,000 patients die of
preventable medical errors in American hospitals each year [25].
Among 850,000 individuals dying in US hospitals per year a major
diagnosis remains clinically undetected in at least 8.4% (71,400
deaths). Furthermore 34,850 patients would have survived until
discharge had misdiagnoses not occurred [62,63]. One of the
Institute’s of Medicine recommendations called therefore for a
mandatory reporting system for deaths and serious injuries [25].
Medico-legal death investigation systems are one component of
this approach. These figures on the frequency of AE, NAE, PAE and
deaths – this has to be kept in mind – were calculated from
epidemiological- and health care research studies.
Data on malpractice cases are furthermore available from the
files of the institutes of forensic medicine [1,5,9,10,15,20,28,31–
33,36–41,44,50,52,54,60]. As the arbitration committees are
mainly dealing with living patients, lethal cases are found within
the material of the arbitration committees only in 2.7% of all cases.
The best available data source on lethal cases is in the files of the
institutes of forensic medicine. This subgroup is of special
importance since death is the most severe outcome of medical
malpractice and the reproach to have caused the death of a patient
by medical malpractice is the most severe malpractice claim.
2. Materials and methods
In Germany not only reliable data on medical malpractice charges in penal law are
missing but also data on lethal cases. A few studies of data from the files of the
institutes of forensic medicine were carried out in the past [1,9,10,28,29,38–40,43,44].
To obtain a broader data basis we carried out a standardized retrospective analysis on
medical malpractice claims in lethal cases for the German Federal Ministry of Health
[51,52]. This multicentre analysis was based on the data of 17 German institutes of
forensic medicine and covered the time period from 1990 to 2000. For the whole
period 101,358 autopsy reports were available; autopsies due to claims of medical
malpractice were carried out in 4450 cases (4.4%). The medico-legal autopsies are
ordered by the public prosecutor when a case of alleged medical malpractice comes to
his attention. The data were made completely anonymous (Table 3).
The material was analysed concerning the following variables.
How many cases are there per year? Is there a tendency? Rate of medical
malpractice autopsies on all autopsies? Are there regional differences (the public
prosecutor orders the autopsies and has a wide range of freedom for his decision)?
What disciplines are concerned? Who is more concerned with malpractice claims:
hospital doctors or doctors in private practice? What was the cause of the
proceeding? How came the cases to the attention of the public prosecutor? What
kinds of patients are involved? What mistakes were made, reproached? How often
was medical malpractice confirmed or negated and when? Is there a correlation
between medical disciplines, types of alleged mistake and outcome? Which
mistakes occur often? Are the epidemiological data on medication errors reflected
in the files of the institutes of forensic medicine? Is there a correlation between
cause of proceeding, medical disciplines and outcome?
Table 2
Institutions dealing with medical malpractice claims, kind of malpractice claims, legal area.
Institution
Kind of malpractice claim
Legal area
Institutes of
forensic medicine
Arbitration committees
of the medical councils
Medical malpractice claims in lethal cases
Expert opinion considering demands for evidence
in penal law
Expert opinion mostly from a medical point of view;
however, lawyers check the case if the demands of
evidence are taken into account
Medical service of health
insurance companies
Private expert opinion
In the majority of cases non-lethal cases,
malpractice claims by patients; mostly
two experts from the same discipline as
the doctor sued for medical malpractice
Malpractice claims by insured patients,
expert opinion ordered by the insurance
company, expert is usually a specialized
doctor of the same discipline
Expert opinion ordered by the patient
Expert opinion from the medical view; civil claim for
damages by the health insurance company against
the doctor remains separated
Medical view as basis for action for damages
60
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
Table 3
Retrospective analysis of medical malpractice claims.
Table 5
Autopsies due to medical malpractice claims in the 17 participating institutes.
Medical malpractice claims in lethal cases
Standardized retrospective analysis for the Ministry of Health
Multicentric analysis based on the data of 17 German institutes of forensic medicine
Period: 1990–2000
Total number of autopsy reports reviewed: 101,358
Autopsies due to claims of medical malpractice: 4450 (4.4%)
Data made completely anonymous
Institute
An advantage of the own investigations compared to epidemiological
investigations on adverse events, etc. is that the cause of death was qualified on
an objective basis (by autopsy). Furthermore forensic pathologists are familiar with
giving expert evidence in penal law, especially concerning a causal connection.
Forensic pathologists are not prejudiced against any field of medicine.
In most participating institutes forensic pathologists already had access to the
relevant clinical records before autopsy. When a comprehensive written report was
necessary all clinical data were of course available since they were necessary for
subsequent clinico-pathological correlations. The main task of a forensic pathologist is
to give an opinion on the cause, manner and causation of death. Based just on the
autopsy findings the forensic pathologist is often able to rule out medical negligence,
e.g. since a natural cause of death is evident. In blatant cases of res ipsa loquitur the
forensic pathologist can also give at least a first opinion on medical negligence. In all
other cases it is standard that reports of clinical experts in the appropriate speciality
are recommended. In some areas the forensic pathologist raises already the questions
which should be addressed by the clinicians, based on the autopsy findings. In rare
cases pathologist and clinician prepare a common final report.
Most clinical studies focus on adverse events during hospitalization. Relatively
little is known about adverse events outside hospitals concerning ambulant care.
The own analysis comprises both, hospitalized patients and patients in ambulant
care. A disadvantage is of course that the data are not representative since no figures
on the incidence can be given.
In 2863 cases only the autopsy reports were available, in 1587 further cases
beside the autopsy reports comprehensive written reports. The types of medical
malpractice were classified as follows:
group
group
group
group
group
1:
2:
3:
4:
5:
negligence, therapeutic omissions
complications at/and or after surgery, perioperative complications
wrong treatment, inappropriate management
mistakes in care, suboptimal care
medication errors.
Examples for the different types of medical malpractice are given in Table 4.
München
Hannover
Hamburg
Erlangen
Düsseldorf
Aachen
Frankfurt/M.
Köln
Berlin-Charité
Bonn
Lübeck
Rostock
Gießen
Leipzig
Göttingen
Würzburg
Greifswald
Total
Autopsies due
to medical
malpractice claims
Total number of
autopsies from
1990 to 2000
% of total
number
669
619
505
485
385
318
258
255
166
144
122
112
104
101
86
61
60
21,233
4,802
11,557
7,144
5,399
3,212
11,386
1,274
6,862
2,908
2,255
4,204
1,973
7,233
3,590
3,059
3,267
3.2
12.9
4.4
6.8
7.2
9.9
2.3
20
2.4
4.9
5.4
2.1
5.3
1.4
2.4
2
1.9
4450
101,358
4.4
3. Results
3.1. Frequency of autopsies due to medical malpractice claims
The autopsy rate in the participating institutes of forensic
medicine is differing widely. E.g. in Munich in the study period
more than 21,000 autopsies were carried out, in Cologne only
1274. While in Munich 669 autopsies were due to medical
malpractice claims, in Cologne nearly one quarter of all
autopsies were due to malpractice claims. The percentage of
autopsies due to malpractice claims on all autopsies is varying
widely between 1.9 and 20%. High rates of autopsies due to
medical malpractice can also be observed in Hanover and
Aachen (Table 5). However, the rate of medical malpractice
autopsies on all autopsies is not only varying between the
Table 4
Different types of medical malpractice.
Group 1—Negligence (omitting the necessary treatment),
therapeutic omissions
Insufficient diagnostics
For instance no CT after craniocerebral trauma,
no ECG in a cardiac emergency
Delayed reaction on postoperative complications
(e.g. postoperative peritonitis is not diagnosed)
Delayed admission to hospital, no admission to intensive care
Group 2—Complications at and/or after surgery,
perioperative complications
Intraoperative complications (e.g. injury of surrounding organs)
Exitus in tabula
Complications concerning endoscopic operations
Postoperative complications (postoperative bleeding,
suture insufficiency, postoperative peritonitis)
Anaesthetic mishaps
Group 3—Wrong treatment, inappropriate treatment
Transfusion reaction (control of ABO-compatibility omitted)
Telephone diagnostics (therapeutical recommendations via
telephone although the patient was not seen)
Further wrong treatment (corpus alienum)
Retained instruments
Group 4—Mistake in care, suboptimal care
Unsufficient prophylaxis of decubital ulcers
Unsufficient thrombosis prophylaxis
Wrong positioning during operation
Group 5—Adverse drug event, medication errors
Wrong drug
Wrong dose
Wrong application/administration
Wrong frequency
Disregarding drug allergy
Misinterpretation of order given
Illegible order
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
Table 6
Rate of medical malpractice autopsies on all autopsies.
All autopsies
101,358
Rate varying between different institutes from 1.4 to 20%
Rate varying over the years
Munich
Hanover
Hamburg
Aachen
Cologne
Bonn
Autopsies due to
medical malpractice
1.6–6.1%
8.1–19.7%
2.9–7%
7.2–14%
4.9–45.7%
0.4–9.8%
German institutes but also over the years within the institutes
(Table 6), for Munich between 1.6 and 6.1, for Hanover between
8.1 and 19.7 and for Cologne between 4.9 and 45.7%. An
increasing rate of autopsies due to medical malpractice in
Hanover may be due to the fact that special attention was given
to cases of decubital ulcers.
The number of analysed cases increased over the years
(Fig. 2) from 300 a year to 600 a year. After the German
reunification a similar increase of cases of alleged medical
malpractice could be observed in the New Laender. For the own
federal state North Rhine-Westphalia the cases increased from
about 40 a year to 150 a year (Fig. 3). An increase of cases could
also be observed for several medical disciplines, especially
surgery.
61
Table 7
Classification of malpractice claims according to
occupational groups.
Preliminary proceedings against
Cases
Hospital doctor
Emergency doctor
Doctor in private practice
Emergency service doctor
Resident
Practitioner with
cottage-hospital affiliation
Unknown
Nursing staff
Ambulance officer
Alternative practitioner
2811
103
901
224
7
14
183
172
23
12
(Table 7). Emergency doctors are part of the hospital, emergency
service doctors belong to doctors in private practice. At the top of
the medical disciplines concerned is of course surgery (Table 8)
since after an operation – using the terms of criminology – time
and location of crime and the name of the perpetrator are obvious.
Although surgical disciplines are at the top of accusations the cause
of accusation was mainly a conservative therapy (Table 9).
According to the classification of accusations most medical
malpractice claims were on account of negligence, complications
within surgical therapy, medication errors or mistakes in care
(Table 10).
3.2. Occupational groups and medical disciplines
The criminal proceedings were mainly against hospital doctors
but in nearly one third of cases against doctors in private practice
Fig. 2. Increasing number of malpractice claims over the study period from 300 in
1999 to 600 in 2000.
Table 8
Classification according to medical discipline.
Specialty
Number of cases
% age
Surgery (total number)
(with all subdisciplines)
Internal medicine
Unknown
General practitioner
Emergency service
doctor—various
specialties
Anesthesiology
Orthopedics
Emergency doctor
Gynaecology
Paediatrics
ENT
Psychiatry
Urology
Obstetrics
Radiology
Neurology
Emergency Department
General medicine
Dentistry
Naturophatic treatment
Ophthalmology
Radiotherapy
Dermatology
Chiropractic
Hygienics
Tropical medicine
1266
28.5
698
534
434
254
15.7
12.0
9.7
5.7
157
127
108
88
87
74
68
67
62
50
49
45
22
18
16
10
9
7
3
1
1
3.5
2.8
2.4
2.0
2.0
1.7
1.5
1.5
1.4
1.1
1.1
1.0
0.5
0.4
0.4
0.2
0.2
0.2
0.06
0.02
0.02
Table 9
Cause of accusation.
Fig. 3. Increase of cases in North Rhine-Westphalia in all participating institutes.
Conservative therapy
Surgical therapy
Endoscopy
Intensive care
Naturopathic treatment/
alternative medicine
2604
1737
232
88
18
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
62
Table 10
Classification of accusation (see also Table 4).
Type of accusation
Cases
%
Negligence, therapeutic omissions
Medication error, adverse event
due to drug therapy
Complications within surgical therapy,
perioperative complications
Wrong therapy, inappropriate treatment
Mistake in care, suboptimal care
Accusation not specified
2158
557
48.5
12.5
1472
33.1
766
320
153
17.2
7.2
3.4
3.3. Cause of preliminary proceeding/confirmation of medical
malpractice
Cause of the preliminary proceeding was in the majority of
cases (38.5%) the classification of the manner of death as unclear or
unnatural in the death certificate. Complaints by relatives or cotreating or post-treating physicians occurred in a lesser degree
(Table 11). The majority of patients were older than 50 years
(Fig. 4). While 10% of all cases (446 of 4550) were proven instances
of medical negligence in several occupational groups the
percentage of approved medical malpractice was higher
(Table 12). Especially doctors in private practice, nursing staff,
ambulance officers and practitioners with cottage hospital
affiliation are more often concerned with proven instances of
medical negligence.
The number of cases with proven instances of medical
negligence is of course higher than that of cases with additionally
Table 11
Causes of preliminary proceedings according to analysed documents.
Cause of preliminary proceedings
Number of
cases (%)
Manner of death ‘‘unclear’’ or ‘‘unnatural’’
in death certificate
Cause of proceedings is unknown
Complaint of the offence by relatives
(including friends and carers)
Complaint of a co-treating or
post-treating physician
Complaint of offence by relatives as well
as type of death unclear or unnatural
in death certificate
No formal preliminary proceeding by the
prosecutor, but proceeding to clear
cause and manner of death
Self-complaint of the physician(s)
Complaint by the patient himself before death
Complaint by staff (especially nursing staff)
Anonymous complaint of offence
Other
1715 (38.5)
Fig. 4. Age of patients concerned.
1303 (29.3)
831 (18.7)
271 (6.1)
190 (4.3)
Table 12
Occupational groups concerned by accusations of medical malpractice, number of
approved errors in treatment without considering of causality for death.
Occupational group
Accusations/
occupational
group
Medical
malpractice
without
consideration
of causality
Percentage of
proven instances
of medical negligence/
occupational group
Clinician
Doctor in private
practice
Nursing staff
Emergency service
doctor
A group of doctors
Ambulance officer
Practitioner with
cottage-hospital
affiliation
Alternative practitioner
First-year resident
Not to clarify
A single physician
Other
Student
Pharmacist
2809
877
220
129
7.8
14.7
172
253
35
30
20.3
11.9
50
23
14
6
5
3
12.0
21.7
21.4
12
6
58
57
8
1
2
3
2
1
1
1
0
0
25.0
33.3
1.7
1.8
12.5
0
0
Total
4450
446
confirmed causality between medical malpractice and death
(Table 13). Again, doctors in private practice, nursing staff and
emergency service doctors have a higher rate of approved cases
with confirmed causality than the average.
Table 13
Occupational group and number of proven instances of medical negligence with
approved causality for death (in brackets percentage of total number of cases of
each group).
Occupational group
Number of approved
medical malpractice
(absolute; %)
Total number
of cases of
each group
Clinicians
Doctor in private practice
Emergency service doctor
Nursing staff
Emergency physician
Resident
More than one doctor
98
46
12
16
5
2
2
2809
877
253
172
108
6
50
(3.5)
(5.2)
(4.7)
(9.3)
(4.6)
(33.3)
(4.0)
73 (1.6)
21
18
10
9
9
(0.5)
(0.4)
(0.2)
(0.2)
(0.2)
Table 14
Cause of proceeding and result of the expert opinion (in brackets: percentage of
total no. of cases of each category).
Cause of proceeding
Total
number
Medical
malpractice
approved
Doctor—manner of death ‘‘unclear’’
or ‘‘unnatural’’ in death certificate
Cause of the proceeding not apparent
from files
Relatives—complaint of offence
Complaint of a co-treating or
post-treating physician
Complaint of offence by relatives and
manner of death ‘‘unclear’’
or ‘‘unnatural’’ in death certificate
No formal preliminary proceedings,
just usual determination of death
Self-complaint of the physician
Complaint by the patient
Complaint by staff (excluding physicians)
Anonymous complaint
Other
1715
151 (8.8)
1303
124 (9.5)
831
271
90 (10.8)
38 (14.0)
190
30 (15.8)
73
3 (4.1)
21
18
10
9
9
6 (28.6)
3 (16.7)
0
1 (11.1)
0
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
63
Fig. 5. Flow chart how autopsy results contributed to solve a case.
Of special interest is the correlation between cause of the
proceeding and outcome of the case (Table 14). When the doctor
qualified the manner of death as unnatural in the death certificate
medical malpractice could be approved in 8.8% of cases. When a
complaint of a co- or post-treating physician was cause of the
proceeding medical malpractice was approved in 14%. In cases of
self-complaint of the physician medical malpractice could be
confirmed in 28.6%.
The efficiency of the medico-legal autopsy becomes evident
from the fact that most of the cases could already be cleared
immediately after autopsy (Fig. 5). In 2873 cases medical
malpractice was negated, in 1971 already after autopsy. In 189
cases medical malpractice was approved and causality for death
confirmed, in 27 cases already after autopsy.
Although surgery is at the top of all medical disciplines where
medical malpractice is claimed medical malpractice is confirmed
only in 6.8%, causality in 3.1%. Surgery is below the average of all
medical disciplines (Table 15). Of interest is also the correlation
between type of accusation and outcome. In cases where
negligence was claimed medical malpractice was confirmed in
13.5%, causality approved in 4.8%. Cases with complications within
Table 15
Results of expert opinions in the different occupational groups and clarification of
causality of the malpractice for death (in brackets percentage of total number of
cases of each group).
Occupational group
Number
of cases
Medical
malpractice
confirmed
Causality
negated
Causality
approved
Surgery
Internal medicine
Unknown
Family doctor/practitioner
Emergency service doctor
Other disciplines
Anesthesiology
Orthopaedics
Emergency doctor
Gynaecology
Paediatrics
ENT specialists
Psychiatry
Urology
1266
698
534
434
254
195
157
127
108
88
87
74
68
67
86
72
42
64
31
40
19
4
10
8
13
5
6
2
47
37
29
43
20
21
9
1
5
4
10
1
0
0
39
35
13
21
11
19
10
3
5
4
3
4
6
2
(6.8)
(10.3)
(7.9)
(14.8)
(12.2)
(20.5)
(12.1)
(3.2)
(9.3)
(9.1)
(14.9)
(6.7)
(8.8)
(3.0)
(3.7)
(5.3)
(5.3)
(9.9)
(7.9)
(10.8)
(5.7)
(0.8)
(4.6)
(4.5)
(11.5)
(1.4)
(3.1)
(5.0)
(2.4)
(4.8)
(4.3)
(9.7)
(6.4)
(2.4)
(4.6)
(4.5)
(3.4)
(5.4)
(8.8)
(3.0)
Table 16
Type of medical malpractice accusations and the result of expert opinion (in
brackets: percentage of total number of each accusation).
Type of accusation
No. of
cases
Medical
malpractice
confirmed
Causality
negated
Causality
approved
Negligence
Complications
within or after
surgical therapy
Wrong therapy
Adverse event due
to drug therapy
Mistake in care
Not specified
2158
1472
291 (13.5)
73 (5.0)
187 (8.7)
34 (2.3)
104 (4.8)
39 (2.6)
766
557
103 (13.4)
80 (14.4)
53 (6.9)
34 (6.1)
50 (6.5)
46 (8.3)
320
153
59 (18.4)
0
39 (12.2)
0
20 (6.3)
0
or after surgical therapy showed medical malpractice with
approved causality only in 2.6% (Table 16).
4. Discussion
Medical malpractice claims in penal law have increased over
the years from 300 to 600 cases in the cooperating institutes.
However, there is not an increase or boom of medical malpractice
claims like in civil law [40,72]. For Germany about 1000–1500
autopsies per year due to medical malpractice claims can be
expected today [32,47].
An interesting information is that the majority of cases comes to
the attention of the public prosecution by certifying the manner of
death as unnatural or undetermined. The old sentence that doctors
frequently make errors and normally do their best to hide them is
not true for our own data in this strict sense.
However, according to German legislation the doctor who has
made a mistake while treating a patient is allowed to perform the
external examination of the corpse and determine the cause and
certify the manner of death [30,34] himself. This situation is of
course problematic and it would probably be advantageous to have
an independent physician performing the external examination in
such cases to avoid conflicts of interest.
Most epidemiological studies on adverse events focus on
hospitalized patients for methodical reasons. Our own retrospective analysis covers also the ambulant sector of health care
with interesting results.
64
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
For doctors in private practice and nursing staff the rate of
approved medical malpractice is with 14.7 and 20.3% respectively
much higher than for clinicians although clinicians are more
frequently affected by malpractice claims. Therefore training and
supervision of these occupational groups must be improved.
Although surgery is the discipline with most accusations of
medical malpractice the rate of confirmed medical malpractice
with approved causality is with 3.1% low. However, in other
registers, e.g. of the arbitration committees of the medical councils,
surgeons are not only at the top of disciplines accused but also
concerning approved medical malpractice [2,16,17,33,46,53]. The
arbitration committees are dealing mainly with malpractice
complaints in living patients, rarely with lethal cases. This may
be a hint that the composition of cases in different registers varies
considerably and experiences from all registers are of importance
to get a realistic impression of the malpractice situation
[5,23,26,27].
The frequency of medico-legal autopsies due to medical
malpractice differs widely between the German institutes and
even for each institute over the years. Reasons are that the areas
served by the institutes are different concerning the number of
inhabitants, that the prosecutor is free in his decision to order an
autopsy and that the autopsy rate may be influenced by
information about cases in the media (high profile cases). For
instance in Hanover special attention is paid to cases of decubital
ulcers which are brought to the knowledge of the public
prosecutor.
In prospective clinical studies medication errors make up a
great part of adverse events [14,18,19,49,55], however, medication
errors are not represented in such a high rate in the own analysis.
Beside medication errors in epidemiological studies hospital
infections are frequently encountered adverse events which are
also hardly represented in our own retrospective analysis. Reasons
for this discrepancy may be that the treating physicians normally
do not realize adverse drug events themselves and therefore do not
report them [18,29,38,41,43] and that hospital infections may have
a mild course not leading to death. Also in other registers
medication errors or adverse drug events are underreported [27].
Another important reason for differences is the taxonomy and
the mode of measuring errors and adverse events in health care
[68]. In the discussion about adverse events in health care different
terms used in epidemiological and quality of care research on the
one hand and within a legal framework on the other hand have
strictly to be beard in mind. Among other organizations the Council
of Europe has just published a glossary of terms related to patient
and medication safety including more than 50 definitions
[8,69,70]. Useful definitions are:
An Adverse event is a noxious and unintended response.
Preventable adverse event is defined as a noxious and
unintended response that might have been prevented.
A negligent adverse event is a noxious and unintended response
due to a break of duty of care. A negligent adverse event is a
synonym of medical malpractice.
A medical error may be an error of execution or an error of
planning. An error of execution is defined as failure of a planned
action to be completed as intended while an error of planning is
defined as use of a wrong plan to achieve an aim.
Medical malpractice in penal law is defined as an adverse event
(injury, harm) caused by medical negligence. Negligence is a
preventable mistake due to a breach of duty of care. Of course there
must be a causal connection between mistake and injury and this
causal connection must be stated without reasonable doubt. In
civil law medical malpractice is defined as follows: The defendant
(doctor) owed duty of care to the plaintiff (patient). The doctor
breached this duty of care by failing to adhere to the standard of
care expected. The standard is the quality that would be expected
of a reasonable practitioner in similar circumstances. This breach
of duty caused an injury to the patient.
Of course methods like chart reviews, direct observation of
treatment, clinical surveillance are better indicators of active
errors or adverse events [68]. Therefore the rate of adverse events
is much higher in epidemiological studies in comparison to
malpractice claims where cases can only be evaluated retrospectively with the information available in documents. Due to
these reasons there is a great litigation gap between data from
epidemiological and quality of care research and data on legal
proceedings.
Autopsy is even nowadays a very efficient method of clarifying
medical malpractice claims [3,4,7,13,24,42,48,61–63]. 64.3% of all
cases were already clarified after autopsy. This is not only of special
interest to the prosecutor but for the accused doctors as well since
immediate clarification means that in two third of cases the
preliminary investigation can be terminated already after autopsy
[31,32]. The great value of autopsies for verifying medical
malpractice becomes also evident by a recent study from the UK
[65]. The National Confidential Enquiry into Peri-Operative Deaths
(NCEPOD) has been auditing data on deaths within 30 days of any
surgical operation or invasive diagnostic procedure under local or
general anaesthesia in England and Wales since 1987. Autopsy
often yields findings not suspected in live. For instance major
discrepancies between clinical diagnosis and postmortem findings
are encountered in 20.3% (81 of 346) of autopsies. Similar results
are known from other studies [39,45,61–63]. 21% of surgeons
receiving a copy of the autopsy report indicate that clinically
unexpected findings had emerged. Furthermore unexpected
findings continued to be provided by autopsy examination, there
was no decrease of unexpected findings over the years. This has
also been confirmed by other studies [62,63]. According to an US
American evaluation of autopsy reports in litigation cases doctors
sued for medical malpractice do not have to fear the autopsy [3,4].
A retrospective evaluation revealed that even in cases where the
autopsy report was in favour of the plaintiff the cases were often
settled. The authors conclude that their findings support the
proposition that autopsy information is generally not harmful for
defendants in law suits alleging medical malpractice. Fear of
autopsy findings is unbecoming to the medical profession and an
obstacle to the pursuit of excellence through uninhibited outcome
analysis [3,4].
This conclusion can be confirmed by our own retrospective
study: in the majority of cases, based on the autopsy report, the
case was settled even in cases with severe mistakes due to the fact
that the causal connection between mistake and death could not be
proved without reasonable doubt [50]. To perform an autopsy is
therefore always in the interest of doctors faced with malpractice
claims.
Based on the own studies no data on the incidence of medical
malpractice can be given since the autopsy rate and total number
of cases are to low to measure incidence and prevalence rates of
errors and adverse events and furthermore the data are not
representative since the correlation with a well defined reference
sample is missing. A recent systematic review of the German
Alliance for Patient Safety revealed that adverse events are found in
less than 5–10% of all cases, preventable adverse events in less than
2–4% of cases, negligent adverse events probably in about 1% of
cases and deaths in 0.1% [57,58]. The incidence of negligent
adverse events exceeds of course the incidence of medical
malpractice claims. A study from Utah and Colorado on negligent
care and medical malpractice claiming behaviour revealed
furthermore a negative correlation between medical negligence
and medical malpractice claims [67]. Paradoxically, when a
B. Madea, J. Preuß / Forensic Science International 190 (2009) 58–66
physician is sued, there is a high probability that it will be for
rendering non-negligent care. Nevertheless the autopsy data are of
special relevance for the identification, evaluation and prevention
of errors, autopsies are a valuable source of information for
improvement of patient safety. This has recently been underlined
by the Council of Europe which recommended in its recent
recommendation on management of patient safety and prevention
of adverse events in health care to review the role of other existing
data sources, such as patient complaints and compensation
systems, clinical data bases and monitoring systems as a
complimentary source of information on patient safety [8,37].
The World Alliance of Patient Safety recommends also as
alternative sources of information for patient safety medical
malpractice claims [77]. In their opinion analysis of claims has
identified the factors that increase the probability of a foreign body
being retained following surgery. The limitation of malpractice
claims is of course their non-representativeness. However, they do
provide data on events that are significant – serious injuries – as
well as data that are typically much more comprehensive than
provided to most reporting systems [77]. Lethal cases are certainly
the most dramatic events that can occur during medical care.
Without autopsies these cases cannot be properly clarified. To use
medical malpractice claims in lethal cases and their objective
clarification by autopsies as additional sources for the evaluation
and prevention of errors requires of course sampling of cases, but
sampling not only on a local but on a national or better
international level. The special value of objective data we have
in forensic pathology and toxicology becomes also evident from a
study on adverse drug events [14,18]: ‘‘Thus, without having
access to autopsy data and drug analysis data clinicians are
‘‘walking in the fog’’ as far as detecting fatal ADE’s is concerned.’’
[18].
The precise evaluation of autopsy reports in cases of medical
malpractice is also a task of forensic medicine as a contribution to
increase patient safety by the identification and reporting of errors.
Own published cases of intrathecal administration of vincristin in
cases of simultaneous administration of antineoplastic drugs were
the reason for the drug commission of the German Medical Council
to publish special recommendations to prevent wrong side
administration [11].
5. Conclusions
Autopsies are the essential basis for determining the cause of
death, medical negligence and causality of negligence for cause of
death. Without autopsy lethal cases cannot be judged in an
appropriate way. Autopsies are, however, not only the essential
basis for expert evidence in a practical case but also for preventing
similar cases. They provide data on events that are significant –
serious injuries – and that are much more comprehensive than
provided to most reporting systems. Autopsy reports are an
essential contribution to malpractice registers.
Compared to epidemiological data on the frequency of adverse
events or death as a consequence of negligent adverse events
malpractice proceedings are underreported; there is – obviously –
a great number of unreported cases. By comparison of cases which
come to our attention with the number in epidemiological studies,
areas with a high number of unreported cases can be identified:
medication errors, adverse drug reactions,
infections, especially hospital infections.
Rare but serious events detected at autopsy have to be reported
and evaluated, risk factors to be identified for preventive measures.
An often heard criticism of the malpractice system is that it fails
to prevent medical mistakes. However, it has to be acknowledged
65
one great success of malpractice deterrence: The reduction in
mortality after the adoption of monitoring guidelines in anesthesiology [36]. This was a step that was taken largely in response to
high malpractice charges. Also in Germany in agreement with this
the evaluation of malpractice claims and the decisions of the courts
are qualified as an element of risk management [73].
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ID
97230
Title
Medicalmalpracticeasreflectedbytheforensicevaluationof4450autopsies☆
http://fulltext.study/journal/56
http://FullText.Study
Pages
9