Medical Errors, Negligence,
and Litigation
Harvey Murff, M.D.,M.P.H.
Center for Improving Patient Safety
Vanderbilt University
Estimated Deaths Due to Medical
Error
Source – The Philadelphia Inquirer
How Hazardous Is Health Care?
Dangerous
(Modified from Leape)
(>1/1000)
Total lives lost per year
100000
Ultra-Safe
Regulated
(<1/100K)
HealthCare
Driving
10000
1000
Scheduled
Airlines
100
Mountain
Climbing
Bungee
Jumping
10
European
Railroads
Nuclear
Power
Chemical
Manufacturing
Chartered
Flights
1
1
10
100
1000
10000
100000
1000000
Numbers of encounter for each fatality
10000000
Medical Errors, Negligence,
and Litigation
I.
II.
Medical Errors
Relationship of Medical Errors to
Negligence
III. Why do People Sue their Doctors?
IV. Potential Solutions to the Problem of
Medical Errors
Medical Errors, Negligence,
and Litigation
I.
II.
Medical Errors
Relationship of Medical Errors to
Negligence
III. Why do People Sue their Doctors?
IV. Potential Solutions to the Problem of
Medical Errors
Definitions
• Error
– Failure of a planned action to be completed as intended
(i.e., error of execution) or the use of a wrong plan to
achieve an aim (i.e. error of planning)
• Adverse Event (AE)
– An injury caused by medical management rather than
the underlying condition of the patient
• Preventable Adverse Event
– An adverse event attributable to an error
Source – IOM, 2000
Relationship of Medical Errors to
Adverse Events
Medical Errors
Preventable AEs
AE
Epidemiology of Medical Errors
• California Medical Insurance Feasibility
Study (1974)
– 20,864 hospital admissions
– 4.65 injuries per 100 hospitalizations
• Harvard Medical Practice Study (1984)
– 30,121 hospital admissions in NY state
– Reported adverse events (AE’s)
– 3.7% of admissions had an AE
Harvard Medical Practice Study
Category of Disability
Adverse Events
(%)
Minimal impairment, recovery 1 mo
56,042 (56.8%)
Moderate impairment,
recovery >1 to 6 mo
13,521 (13.7%)
Moderate impairment, recovery > 6 mo
2,762 (2.8%)
Permanent impairment, < 50% disability
3,807 (3.9%)
Permanent impairment, > 50% disability
2,550 (2.6%)
Death
13,451 (13.6%)
Source – Brennan, 1991
Harvard Medical Practice Study
Type of Event
Proportion of Events with
Serious Disability
Operative
Wound infection
Technical complication
17.9
12
Late complication
35.7
Nontechnical complication
43.8
Surgical failure
17.5
All
24
Non-operative
Drug-related
14.1
Diagnostic mishap
47.0
Therapeutic mishap
35.4
Procedure-related
28.8
System and other
36
All
25.3
Source – Leape, 1991
Quality in Australian Health Care
Study
• Reviewed 14,179 admissions in 1995
• 16.6% of admissions had an AE’s
– Permanent disability 13.7%
– Death 4.9%
• 51% of events preventable
Source – Wilson, 1995
To Err is Human
• IOM releases report To Err is Human
(2000)
– Estimates 44,000 to 98,000 unnecessary deaths
each year due to medical error
– Estimated 1,000,000 excess injuries due to
medical error
– Numbers based on the MPS and extrapolated to
the general population
Deaths due to Medical Error
• 44,000 to 98,000 unnecessary deaths each
year
– More Americans are killed in US hospitals
every 6 months than died in the entire Vietnam
War
– Death rate equivalent to three “jumbo” jet
crashed every two days
Are medical errors the 5th leading
cause of death in the U.S.?
Some important caveats about these
numbers
Where do these numbers come from and
why might they be overestimated
• Methods of the MPS
– Physician implicit judgment
– Causality of death difficult
– Kappa statistics low
• Overcoming these shortcomings
– Utilizing more reviewers
– Requiring greater agreement
– Requiring assessment of overall prognosis
Other investigators have
suggested with a better
methodology the number of
deaths per year from medical
errors is closer to 5000
Source – Hayward, 2001
Views of the Public on Medical
Errors
• Percentage of adults experiencing an error
– Medication or medical error
22%
– Mistake at the physician’s office or hospital
10%
– Wrong medication or dose
16%
Source- The Commonwealth Fund, 2001
Views of Practicing Physicians and
the Public on Medical Errors
Response
Physicians
(N = 831)
All Respondents
Public
(N = 1207)
P Value
percent
Error made in own or family member’s care
35
42
<0.001
Health consequences: (Serious)
18
24
<0.001
Parties who had “a lot” of responsibility for the error:
(Doctors)
70
81
<0.001
Health professional told respondent an error had been
made
31
30
<0.001
1
23
<0.001
Confidential
86
34
<0.001
Made public
14
62
<0.001
Respondents reporting an error
Possible solutions to the problem of medical errors
Increasing lawsuits for malpractice
Hospital reports of serious medical errors should be:
Source- Blendon, 2002
Why Do So Many Mistakes
Occur?
Human Error
• Extensively studied in other industries
• Cognitive psychologists divide errors into:
– Errors occurring in “automatic mode”
• Slips
– Occur during fatigue, interruptions, anxiety
– Errors occurring in “problem solving mode”
• Mistakes
– Occur due to incomplete knowledge and the tendency to
apply rules to simplify problem solving
Why is medicine so susceptible?
• Lack of awareness to the problem
• “Culture of Silence”
– Blame and shame mentality
• System constraints
–
–
–
–
Staffing problems
Fatigue
Knowledge requirements
Communication and continuity of care
Medical Errors, Negligence,
and Litigation
I.
II.
Medical Errors
Relationship of Medical Errors to
Negligence
III. Why do People Sue their Doctors?
IV. Potential Solutions to the Problem of
Medical Errors
All Errors are not Negligent
• Medical negligence
– Failure to meet the standard of practice of an
average qualified physician practicing in the
specialty in question
Occurs not merely when there is an error, but
when the degree of error exceeds the accepted
norm
Negligent Medical Injuries
All
Hospitalizations
Negligent Injuries
(1-2%)
Sources- Mills et al. (1977), Brennan et al. (1991), IOM (1999).
Percent of Injuries due to
Negligence
California Medical
Insurance Feasibility
Study
17%
AE’s
Harvard Medical
Practice Study
28%
AE’s
Proportion of Adverse Events Involving
Negligence
Type of Event
Proportion of Events Due to
Negligence
Operative
Wound infection
12.5
Technical complication
17.6
Late complication
13.6
Non-technical complication
20.1
Surgical failure
36.4
All
17.0
Non-operative
Drug-related
17.7
Diagnostic mishap
75.2
Therapeutic mishap
76.8
Procedure-related
15.1
System and other
35.9
All
37.2
Source – Leape, 1991
Rates of Adverse Events and Negligence by
Specialty
Specialty
Rate of Adverse
Events (%)
Rate of
Negligence (%)
Orthopedics
4.1
22.4
Urology
4.9
19.4
Neurosurgery
9.9
35.6
Thoracic and cardiac surgery
10.8
23.0
Vascular surgery
16.1
18.0
Obstetrics
1.5
38.3
Neonatology
0.6
25.8
General surgery
7.0
28.0
General medicine
3.6
30.9
Other
3.0
19.7
<0.0001
0.64
P value
Source – Leape, 1991
Percent of Negligent Injuries that
File a Claim
California Medical
Insurance Feasibility
Study
10%
All
Negligent
Injuries
Harvard Medical
Practice Study
13%
All
Negligent
Injuries
1000
280
36
13% of Negligent Injuries Results
in a Claim
All Injuries
All Negligent
Injuries
Files a Claim
• 42% of public report a medical
error
• 66% reported serious consequences
such as severe pain, substantial
loss of time at work or school,
disability or even death
• Only 6% had sued
Disposition of Claims According to the Rating
of the Plaintiff's Injury and Degree of
Disability
Rating
No. of
Closed
Cases
Settled
for
Plaintiff
Mean
Settlement
no (%)
$
Type of injury
No adverse event
24
10 (42)
28,760
Adverse event
13
6 (46)
98,192
Negligent adverse event
9
5 (56)
66,944
None
24
10 (42)
28,760
Temporary
14
4 (29)
38,857
Permanent
8
7 (88)
201,250
46
21 (46)
55,853
Disability
All claims
Source – Brennan, 1996
Logistic-Regression Analysis of Predictors
That A Claim Would Be Settled in Favor of
the Plaintiff
Predictor
Odds Ratio (95%
confidence interval)
P Value
29.7 (1.41-621.4)
0.003
Negligent adverse event
0.2 (0.01-4.1)
0.32
Adverse event
0.7 (0.1-7.1)
0.79
Low income
0.1 (0.0-1.5)
0.10
< 21 yr
0.6 (0.0-10.6)
0.73
> 59 yr
1.8 (0.2-17.5)
0.61
Permanent Disability
Age
Source – Brennan, 1996
1000
All Injuries
All Negligent
Injuries
280
6
30
2% of Negligent Injuries Results
in a Claim
Files a Claim
Negligent Injuries that Did Not
Result in a Claim
27,179 adverse events
due to negligence
26,764 with no
malpractice claim (98%)
415 malpractice claims
(2%)
14,180 with strong
evidence of negligence
12,858 with disability
7462 with disability < 6
mo (58%)
5396 with disability ≥ 6
mo (42%)
Source – Localio, 1991
“Medical-malpractice litigation
infrequently compensates
patients injured by medical
negligence and rarely identifies,
and holds providers accountable
for, substandard care”
Source – Localio, 1991
Medical Errors, Negligence,
and Litigation
I.
II.
Medical Errors
Relationship of Medical Errors to
Negligence
III. Why do People Sue their Doctors?
IV. Potential Solutions to the Problem of
Medical Errors
Reasons Why People Sue Their
Doctors
Percent Expressing
Concern
•
•
•
•
•
•
Advised to sue by influential other
Needed money
Believed there was a cover-up
Child would have no future
Needed information
Wanted revenge, license
32
24
24
23
20
19
Source - Hickson, 1992
Malpractice Risk
• Malpractice activity is disproportionate among
physicians
• 75% - 85% of awards, settlement costs over a 5year period made on behalf of
1.8% of internists
6.0% of obstetricians
8.0% of surgeons
Source- Sloan, 1989, Bovbjerg, 1994
Malpractice Activity and
Patient Complaints
Physician Characteristic
Total Physicians (N = 645)
Mean Number of
Complaints
Surgeons (N = 219)
No lawsuits (N = 102)
6.1
1 lawsuit (N = 82)
16.7
2 or more lawsuits (N = 35)
35.1
Non-surgeons (N = 426)
No lawsuits (N = 361)
4.7
1 lawsuit (N = 57)
9.2
2 or more lawsuits (N = 8)
4.6
Source – Hickson, 2002
Nine Percent of Physicians Account
for Fifty Percent of the Complaints
% of Complaints
100
80
60
40
20
0
30
40
50
60
70
80
90
100
% of Physicians
Source – Hickson, 2002
Communication and Malpractice Claims
Primary Care Physicians (n = 59)
Variable
Visit length, min
No Claims (n = 29)
Claims
(n = 30)
P- Value
18.3
15.0
< 0.05
Asks questions- medical
18.3
16.9
NS
Gives information – medical
28.5
26.3
NS
Facilitation (Physician)
19.4
11.9
< 0.05
Orientation (Physician)
14.5
11.2
< 0.05
Laughs (Physician)
4.8
3.4
< 0.05
Laughs (Patients)
7.8
7.5
NS
No. of utterances per 15-min visit:
Content
Process:
Affect
Source – Levinson, 1997
Communication and Malpractice Claims
Prior Malpractice Claims Group
Category of complaint, %
No Claims
High Frequency
P - value
8.2
27.6
0.01
Would not talk
6.7
23.5
0.01
Did not listen
1.9
7.1
0.01
4.8
17.4
0.01
Yelled
4.8
9.2
0.15
No concern for me as a person
1.4
8.7
0.01
Physician-patient communication
Humanity of a physician
Source – Hickson, 1994
Medical Errors, Negligence,
and Litigation
I.
II.
Medical Errors
Relationship of Medical Errors to
Negligence
III. Why do People Sue their Doctors?
IV. Potential Solutions to the Problem of
Medical Errors
Malpractice Litigation
Relationship between Malpractice
Claims History and Subsequent Obstetric
Care
Physician Group
No. of Charts Total No. of No. of Cases
with Adverse
Relevant
of Subjective
Outcomes
Errors
Substandard
Care
No Claims
42
8
7
High Frequency
17
0
2
Source – Entman, 1994
Malpractice as a Barrier to Safety
• Physicians overestimate the risk of being
sued
• Less likely to report errors as a result
Malpractice Reform
• Reforms include
– No-fault
– Enterprise liability
• No-fault system used in other countries
Increased Regulations
• Industry
– Leapfrog Consortium
• Private Organizations
– National Patient Safety Foundation
– Joint Commission on the Accreditation of
Healthcare Organizations
• Federal Legislation
Other Potential Solutions
• Learn lessons from other industries
– Aviation, Military, Nuclear Power
• Development of IT infrastructures
– POE, Communication
– Less reliance on memory
• Restriction on working hours
– AAMC proposed guidelines (80 hour week)
• Greater staffing to patient ratios
– Improved nursing jobs
• Organizational Culture
“Physicians and nurses need to
accept the notion that error is an
inevitable accompaniment of the
human condition, even among
conscientious professionals with
high standards. Errors must be
accepted as evidence of system flaws
not character flaws.”
Leape, 1994
Litigation in Human Subjects
Research
Litigation and Clinical Research
• Traditional Claims
– Lack of appropriate “informed consent”
• Clinical model already exists
• New Claims
– New Arguments
• Defective products, negligence, fraud
– Larger number of defendants
• IRB’s, Investigators, ethicists
– Class action suits
Why Suits Related to Research will
Probable Continue to Rise
• Research has historically been noncompliant with
regulations
• Fraud claims produce more punitive damages
• Conflicts of interest and investigators “motives”
• Regulations of research versus “customary
practice”
• Institutions are inclined to settle quickly
Impact of Rising Litigation on Clinical
Research
•
•
•
•
•
Improved human subjects protection
System for compensation
Increased cost of research
Less people for IRBs
Research oversight takes a legalistic
approach
– “defensive research”