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Transcript of Medical Errors, Negligence, and Litigation Harvey Murff, M.D.,M.P.H. Center for Improving Patient...
Medical Errors, Negligence, Medical Errors, Negligence, and Litigationand Litigation
Harvey Murff, M.D.,M.P.H.Harvey Murff, M.D.,M.P.H.
Center for Improving Patient SafetyCenter for Improving Patient Safety
Vanderbilt University Vanderbilt University
Estimated Deaths Due to Medical Estimated Deaths Due to Medical ErrorError
Source – The Philadelphia Inquirer
How Hazardous Is Health Care?How Hazardous Is Health Care?(Modified from Leape)(Modified from Leape)
1
10
100
1000
10000
100000
1 10 100 1000 10000 100000 1000000 10000000
DangerousDangerous
(>1/1000)(>1/1000)RegulatedRegulated
Ultra-SafeUltra-Safe
(<1/100K)(<1/100K)HealthCare
Bungee Jumping
Mountain Climbing
Driving
Chemical Manufacturing
Chartered Flights
Scheduled Airlines
European Railroads
Nuclear Power
Numbers of encounter for each fatalityNumbers of encounter for each fatality
Tot
al li
ves
lost
per
yea
rT
otal
live
s lo
st p
er y
ear
Medical Errors, Negligence, Medical Errors, Negligence, and Litigationand Litigation
I.I. Medical ErrorsMedical Errors
II.II. Relationship of Medical Errors to Relationship of Medical Errors to NegligenceNegligence
III.III. Why do People Sue their Doctors?Why do People Sue their Doctors?
IV.IV. Potential Solutions to the Problem of Potential Solutions to the Problem of Medical ErrorsMedical Errors
Medical Errors, Negligence, Medical Errors, Negligence, and Litigationand Litigation
I.I. Medical ErrorsMedical Errors
II.II. Relationship of Medical Errors to Relationship of Medical Errors to NegligenceNegligence
III.III. Why do People Sue their Doctors?Why do People Sue their Doctors?
IV.IV. Potential Solutions to the Problem of Potential Solutions to the Problem of Medical ErrorsMedical Errors
DefinitionsDefinitions
• 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 Relationship of Medical Errors to Adverse EventsAdverse Events
Medical ErrorsMedical Errors
AEAE
Preventable AEs
Epidemiology of Medical ErrorsEpidemiology 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 StudyHarvard Medical Practice Study
Category of DisabilityCategory of Disability Adverse Events Adverse Events (%)(%)
Minimal impairment, recovery 1 moMinimal impairment, recovery 1 mo 56,042 (56.8%)56,042 (56.8%)
Moderate impairment,Moderate impairment,
recovery >1 to 6 morecovery >1 to 6 mo
13,521 (13.7%)13,521 (13.7%)
Moderate impairment, recovery > 6 moModerate impairment, recovery > 6 mo 2,762 (2.8%)2,762 (2.8%)
Permanent impairment, < 50% disabilityPermanent impairment, < 50% disability 3,807 (3.9%)3,807 (3.9%)
Permanent impairment, > 50% disabilityPermanent impairment, > 50% disability 2,550 (2.6%)2,550 (2.6%)
DeathDeath 13,451 (13.6%)13,451 (13.6%)
Source – Brennan, 1991
Harvard Medical Practice StudyHarvard Medical Practice StudyType of EventType of Event Proportion of Events with Proportion of Events with
Serious DisabilitySerious Disability
OperativeOperative
Wound infectionWound infection 17.9
Technical complicationTechnical complication 12
Late complicationLate complication 35.7
Nontechnical complicationNontechnical complication 43.8
Surgical failureSurgical failure 17.5
AllAll 24
Non-operativeNon-operative
Drug-relatedDrug-related 14.1
Diagnostic mishapDiagnostic mishap 47.0
Therapeutic mishapTherapeutic mishap 35.4
Procedure-relatedProcedure-related 28.8
System and otherSystem and other 36
AllAll 25.3
Source – Leape, 1991
Quality in Australian Health Care Quality in Australian Health Care StudyStudy
• Reviewed 14,179 admissions in 1995Reviewed 14,179 admissions in 1995
• 16.6% of admissions had an AE’s16.6% of admissions had an AE’s– Permanent disability 13.7%Permanent disability 13.7%– Death 4.9%Death 4.9%
• 51% of events preventable51% of events preventable
Source – Wilson, 1995
To Err is HumanTo Err is Human
• IOM releases report IOM releases report To Err is Human To Err is Human (2000)(2000)– Estimates 44,000 to 98,000 unnecessary deaths Estimates 44,000 to 98,000 unnecessary deaths
each year due to medical erroreach year due to medical error– Estimated 1,000,000 excess injuries due to Estimated 1,000,000 excess injuries due to
medical errormedical error– Numbers based on the MPS and extrapolated to Numbers based on the MPS and extrapolated to
the general populationthe general population
Deaths due to Medical ErrorDeaths due to Medical Error
• 44,000 to 98,000 unnecessary deaths each 44,000 to 98,000 unnecessary deaths each yearyear– 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 5Are medical errors the 5thth leading leading cause of death in the U.S.?cause of death in the U.S.?
Some important caveats about these Some important caveats about these numbersnumbers
Where do these numbers come from and Where do these numbers come from and why might they be overestimatedwhy 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 Other investigators have suggested with a better suggested with a better
methodology the number of methodology the number of deaths per year from medical deaths per year from medical
errors is closer to 5000errors is closer to 5000
Source – Hayward, 2001Source – Hayward, 2001
Views of the Public on Medical Views of the Public on Medical ErrorsErrors
• Percentage of adults experiencing an errorPercentage of adults experiencing an error– Medication or medical errorMedication or medical error
22%22%
– Mistake at the physician’s office or hospitalMistake at the physician’s office or hospital10%10%
– Wrong medication or doseWrong medication or dose16%16%
Source- The Commonwealth Source- The Commonwealth Fund, 2001Fund, 2001
Views of Practicing Physicians and Views of Practicing Physicians and the Public on Medical Errorsthe Public on Medical Errors
Response Physicians
(N = 831)
Public
(N = 1207)
P Value
All Respondents percent
Error made in own or family member’s care 35 42 <0.001
Health consequences: (Serious) 18 24 <0.001
Respondents reporting an error
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
Possible solutions to the problem of medical errors
Increasing lawsuits for malpractice 1 23 <0.001
Hospital reports of serious medical errors should be:
Confidential 86 34 <0.001
Made public 14 62 <0.001
Source- Blendon, 2002
Why Do So Many Mistakes Why Do So Many Mistakes Occur?Occur?
Human ErrorHuman Error
• Extensively studied in other industriesExtensively studied in other industries
• Cognitive psychologists divide errors into:Cognitive psychologists divide errors into:– Errors occurring in “automatic mode”Errors occurring in “automatic mode”
• SlipsSlips– Occur during fatigue, interruptions, anxietyOccur during fatigue, interruptions, anxiety
– Errors occurring in “problem solving mode”Errors occurring in “problem solving mode”• MistakesMistakes
– Occur due to incomplete knowledge and the tendency to Occur due to incomplete knowledge and the tendency to apply rules to simplify problem solvingapply rules to simplify problem solving
Why is medicine so susceptible?Why is medicine so susceptible?
• Lack of awareness to the problemLack of awareness to the problem• ““Culture of Silence”Culture of Silence”
– Blame and shame mentalityBlame and shame mentality
• System constraintsSystem constraints– Staffing problemsStaffing problems– FatigueFatigue– Knowledge requirementsKnowledge requirements– Communication and continuity of careCommunication and continuity of care
Medical Errors, Negligence, Medical Errors, Negligence, and Litigationand Litigation
I.I. Medical ErrorsMedical Errors
II.II. Relationship of Medical Errors to Relationship of Medical Errors to NegligenceNegligence
III.III. Why do People Sue their Doctors?Why do People Sue their Doctors?
IV.IV. Potential Solutions to the Problem of Potential Solutions to the Problem of Medical ErrorsMedical Errors
All Errors are not NegligentAll 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 Negligent Medical Injuries
Sources- Mills et al. (1977), Brennan et al. (1991), IOM (1999).
All All HospitalizationsHospitalizations
Negligent Injuries (1-2%)
Percent of Injuries due to Percent of Injuries due to NegligenceNegligence
California Medical Insurance Feasibility
Study
Harvard Medical Practice Study
17% 28%
AE’s AE’s
Proportion of Adverse Events Involving Proportion of Adverse Events Involving NegligenceNegligence
Type of EventType of Event Proportion of Events Due to Proportion of Events Due to NegligenceNegligence
OperativeOperative
Wound infectionWound infection 12.5
Technical complicationTechnical complication 17.6
Late complicationLate complication 13.6
Non-technical complicationNon-technical complication 20.1
Surgical failureSurgical failure 36.4
AllAll 17.0
Non-operativeNon-operative
Drug-relatedDrug-related 17.7
Diagnostic mishapDiagnostic mishap 75.2
Therapeutic mishapTherapeutic mishap 76.8
Procedure-relatedProcedure-related 15.1
System and otherSystem and other 35.9
AllAll 37.2
Source – Leape, 1991
Rates of Adverse Events and Negligence by Rates of Adverse Events and Negligence by SpecialtySpecialty
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
P value <0.0001 0.64
Source – Leape, 1991
Percent of Negligent Injuries that Percent of Negligent Injuries that File a ClaimFile a Claim
California Medical Insurance Feasibility
Study
Harvard Medical Practice Study
10% 13%
All Negligent Injuries
All Negligent Injuries
10001000
280280
3636
All InjuriesAll Injuries
All Negligent All Negligent InjuriesInjuries
Files a ClaimFiles a Claim
13% of Negligent Injuries Results in a Claim
• 42% of public report a medical 42% of public report a medical errorerror
• 66% reported serious consequences 66% reported serious consequences such as severe pain, substantial such as severe pain, substantial loss of time at work or school, loss of time at work or school, disability or even deathdisability or even death
• Only 6% had suedOnly 6% had sued
Disposition of Claims According to the Disposition of Claims According to the Rating of the Plaintiff's Injury and Degree of Rating of the Plaintiff's Injury and Degree of
DisabilityDisabilityRating 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
Disability
None 24 10 (42) 28,760
Temporary 14 4 (29) 38,857
Permanent 8 7 (88) 201,250
All claims 46 21 (46) 55,853
Source – Brennan, 1996
Logistic-Regression Analysis of Predictors Logistic-Regression Analysis of Predictors That A Claim Would Be Settled in Favor of That A Claim Would Be Settled in Favor of
the Plaintiffthe PlaintiffPredictor Odds Ratio (95%
confidence interval)P Value
Permanent Disability 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
Age
< 21 yr 0.6 (0.0-10.6) 0.73
> 59 yr 1.8 (0.2-17.5) 0.61
Source – Brennan, 1996
10001000
280280
66
All InjuriesAll Injuries
All Negligent All Negligent InjuriesInjuries
Files a ClaimFiles a Claim30
2% of Negligent Injuries Results in a Claim
Negligent Injuries that Did Not Negligent Injuries that Did Not Result in a ClaimResult 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 Medical-malpractice litigation infrequently compensates patients infrequently compensates patients
injured by medical negligence injured by medical negligence and rarely identifies, and holds and rarely identifies, and holds
providers accountable for, providers accountable for, substandard care”substandard care”
Source – Localio, 1991
Medical Errors, Negligence, Medical Errors, Negligence, and Litigationand Litigation
I.I. Medical ErrorsMedical Errors
II.II. Relationship of Medical Errors to Relationship of Medical Errors to NegligenceNegligence
III.III. Why do People Sue their Doctors?Why do People Sue their Doctors?
IV.IV. Potential Solutions to the Problem of Potential Solutions to the Problem of Medical ErrorsMedical Errors
Reasons Why People Sue Their Reasons Why People Sue Their DoctorsDoctors
• Advised to sue by influential otherAdvised to sue by influential other 3232• Needed moneyNeeded money 2424• Believed there was a cover-upBelieved there was a cover-up 2424• Child would have no futureChild would have no future 2323• Needed informationNeeded information 2020• Wanted revenge, licenseWanted revenge, license 1919
Percent Expressing Percent Expressing ConcernConcern
Source - Hickson, 1992
Malpractice RiskMalpractice Risk
• Malpractice activity is disproportionate among Malpractice activity is disproportionate among physiciansphysicians
• 75% - 85% of awards, settlement costs over a 5-75% - 85% of awards, settlement costs over a 5-year period made on behalf ofyear period made on behalf of
1.8% of internists1.8% of internists
6.0% of obstetricians6.0% of obstetricians
8.0% of surgeons8.0% of surgeons
Source- Sloan, 1989, Bovbjerg, 1994
Malpractice Activity and Malpractice Activity and Patient ComplaintsPatient Complaints
Physician CharacteristicPhysician Characteristic
Total Physicians (N = 645)Total Physicians (N = 645)
Mean Number of Mean Number of ComplaintsComplaints
Surgeons (N = 219)Surgeons (N = 219)
No lawsuits (N = 102)No lawsuits (N = 102) 6.16.1
1 lawsuit (N = 82)1 lawsuit (N = 82) 16.716.7
2 or more lawsuits (N = 35)2 or more lawsuits (N = 35) 35.135.1
Non-surgeons (N = 426)Non-surgeons (N = 426)
No lawsuits (N = 361)No lawsuits (N = 361) 4.74.7
1 lawsuit (N = 57)1 lawsuit (N = 57) 9.29.2
2 or more lawsuits (N = 8)2 or more lawsuits (N = 8) 4.64.6
Source – Hickson, 2002
Nine Percent of Physicians Account Nine Percent of Physicians Account for Fifty Percent of the Complaintsfor Fifty Percent of the Complaints
0
20
40
60
80
100
30 40 50 60 70 80 90 100
% of Complaints
% of PhysiciansSource – Hickson, 2002
Communication and Malpractice ClaimsCommunication and Malpractice ClaimsPrimary Care Physicians (n = 59)
Variable No Claims (n = 29) Claims (n = 30) P- Value
Visit length, min 18.3 15.0 < 0.05
No. of utterances per 15-min visit:
Content
Asks questions- medical 18.3 16.9 NS
Gives information – medical 28.5 26.3 NS
Process:
Facilitation (Physician) 19.4 11.9 < 0.05
Orientation (Physician) 14.5 11.2 < 0.05
Affect
Laughs (Physician) 4.8 3.4 < 0.05
Laughs (Patients) 7.8 7.5 NS
Source – Levinson, 1997
Communication and Malpractice ClaimsCommunication and Malpractice Claims
Prior Malpractice Claims Group
Category of complaint, % No Claims High Frequency P - value
Physician-patient communication 8.2 27.6 0.01
Would not talk 6.7 23.5 0.01
Did not listen 1.9 7.1 0.01
Humanity of a physician 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
Source – Hickson, 1994
Medical Errors, Negligence, Medical Errors, Negligence, and Litigationand Litigation
I.I. Medical ErrorsMedical Errors
II.II. Relationship of Medical Errors to Relationship of Medical Errors to NegligenceNegligence
III.III. Why do People Sue their Doctors?Why do People Sue their Doctors?
IV.IV. Potential Solutions to the Problem of Potential Solutions to the Problem of Medical ErrorsMedical Errors
Malpractice LitigationMalpractice Litigation
Relationship between Malpractice Relationship between Malpractice Claims History and Subsequent Obstetric Claims History and Subsequent Obstetric
CareCarePhysician GroupPhysician Group No. of Charts No. of Charts
with Adverse with Adverse OutcomesOutcomes
Total No. Total No. of Relevant of Relevant
ErrorsErrors
No. of Cases No. of Cases of Subjective of Subjective Substandard Substandard
CareCare
No ClaimsNo Claims 4242 88 77
High FrequencyHigh Frequency 1717 00 22
Source – Entman, 1994
Malpractice as a Barrier to SafetyMalpractice as a Barrier to Safety
• Physicians overestimate the risk of being Physicians overestimate the risk of being suedsued
• Less likely to report errors as a resultLess likely to report errors as a result
Malpractice ReformMalpractice Reform
• Reforms include– No-fault – Enterprise liability
• No-fault system used in other countries
Increased RegulationsIncreased Regulations
• IndustryIndustry– Leapfrog ConsortiumLeapfrog Consortium
• Private OrganizationsPrivate Organizations– National Patient Safety Foundation– Joint Commission on the Accreditation of
Healthcare Organizations
• Federal LegislationFederal Legislation
Other Potential SolutionsOther Potential Solutions
• Learn lessons from other industriesLearn lessons from other industries– Aviation, Military, Nuclear PowerAviation, Military, Nuclear Power
• Development of IT infrastructuresDevelopment of IT infrastructures– POE, CommunicationPOE, Communication– Less reliance on memoryLess reliance on memory
• Restriction on working hoursRestriction on working hours– AAMC proposed guidelines (80 hour week)AAMC proposed guidelines (80 hour week)
• Greater staffing to patient ratiosGreater staffing to patient ratios– Improved nursing jobsImproved nursing jobs
• Organizational CultureOrganizational Culture
““Physicians and nurses need to Physicians and nurses need to accept the notion that error is an accept the notion that error is an inevitable accompaniment of the inevitable accompaniment of the human condition, even among human condition, even among
conscientious professionals with conscientious professionals with high standards. Errors must be high standards. Errors must be
accepted as evidence of system flaws accepted as evidence of system flaws not character flaws.”not character flaws.”
Leape, 1994
Litigation in Human Subjects Litigation in Human Subjects ResearchResearch
Litigation and Clinical ResearchLitigation 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 Why Suits Related to Research will Probable Continue to RiseProbable 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 Impact of Rising Litigation on Clinical ResearchResearch
• Improved human subjects protection• System for compensation• Increased cost of research• Less people for IRBs• Research oversight takes a legalistic
approach– “defensive research”