medical errors, negligence, and litigation

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


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

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


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


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


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


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

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

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”

medical errors, negligence, and litigation

Documents

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medical error22

medical management

medical errorestimated

medical error44

medical errornumbers

daysare medical errors

medical errorssource