Medical errors, negligence, and litigation

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? (Modified from Leape) Dangerous (>1/1000) Regulated Ultra-Safe (<1/100K) HealthCare Bungee Jumping Mountain Climbing Driving Chemical Manufacturing Chartered Flights Scheduled Airlines European Railroads Nuclear Power Numbers of encounter for each fatality Total lives lost per year

Medical Errors, Negligence, and Litigation
Medical Errors
Relationship of Medical Errors to Negligence
Why do People Sue their Doctors?
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 AE Preventable AEs

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 Source – Brennan, 1991 13,451 (13.6%) Death 2,550 (2.6%) Permanent impairment, > 50% disability 3,807 (3.9%) Permanent impairment, < 50% disability 2,762 (2.8%) Moderate impairment, recovery > 6 mo 13,521 (13.7%) Moderate impairment, recovery >1 to 6 mo 56,042 (56.8%) Minimal impairment, recovery 1 mo Adverse Events (%) Category of Disability

Harvard Medical Practice Study Source – Leape, 1991 36 System and other 35.4 Therapeutic mishap 25.3 All 28.8 Procedure-related 47.0 Diagnostic mishap 14.1 Drug-related Non-operative 24 All 17.5 Surgical failure 43.8 Nontechnical complication 35.7 Late complication 12 Technical complication 17.9 Wound infection Operative Proportion of Events with Serious Disability Type of Event

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 5 th 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 Source- Blendon, 2002 <0.001 62 14 Made public <0.001 34 86 Confidential Hospital reports of serious medical errors should be: <0.001 23 1 Increasing lawsuits for malpractice Possible solutions to the problem of medical errors <0.001 30 31 Health professional told respondent an error had been made <0.001 81 70 Parties who had “a lot” of responsibility for the error: (Doctors) Respondents reporting an error <0.001 24 18 Health consequences: (Serious) <0.001 42 35 Error made in own or family member’s care percent All Respondents P Value Public (N = 1207) Physicians (N = 831) Response

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

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 Sources- Mills et al. (1977), Brennan et al. (1991), IOM (1999). All Hospitalizations Negligent Injuries (1-2%)

Percent of Injuries due to Negligence California Medical Insurance Feasibility Study Harvard Medical Practice Study 17% 28% AE’s AE’s

Proportion of Adverse Events Involving Negligence Source – Leape, 1991 35.9 System and other 76.8 Therapeutic mishap 37.2 All 15.1 Procedure-related 75.2 Diagnostic mishap 17.7 Drug-related Non-operative 17.0 All 36.4 Surgical failure 20.1 Non-technical complication 13.6 Late complication 17.6 Technical complication 12.5 Wound infection Operative Proportion of Events Due to Negligence Type of Event

Rates of Adverse Events and Negligence by Specialty Source – Leape, 1991 0.64 <0.0001 P value 19.7 3.0 Other 30.9 3.6 General medicine 28.0 7.0 General surgery 25.8 0.6 Neonatology 38.3 1.5 Obstetrics 18.0 16.1 Vascular surgery 23.0 10.8 Thoracic and cardiac surgery 35.6 9.9 Neurosurgery 19.4 4.9 Urology 22.4 4.1 Orthopedics Rate of Negligence (%) Rate of Adverse Events (%) Specialty

Percent of Negligent Injuries that File a Claim California Medical Insurance Feasibility Study Harvard Medical Practice Study 10% 13% All Negligent Injuries All Negligent Injuries

1000 280 36 All Injuries All Negligent Injuries Files a Claim 13% of Negligent Injuries Results in 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 Source – Brennan, 1996 55,853 21 (46) 46 All claims 201,250 7 (88) 8 Permanent 38,857 4 (29) 14 Temporary 28,760 10 (42) 24 None Disability 66,944 5 (56) 9 Negligent adverse event 98,192 6 (46) 13 Adverse event 28,760 10 (42) 24 No adverse event Type of injury $ no (%) Mean Settlement Settled for Plaintiff No. of Closed Cases Rating

Logistic-Regression Analysis of Predictors That A Claim Would Be Settled in Favor of the Plaintiff Source – Brennan, 1996 0.61 1.8 (0.2-17.5) > 59 yr 0.73 0.6 (0.0-10.6) < 21 yr Age 0.10 0.1 (0.0-1.5) Low income 0.79 0.7 (0.1-7.1) Adverse event 0.32 0.2 (0.01-4.1) Negligent adverse event 0.003 29.7 (1.41-621.4) Permanent Disability P Value Odds Ratio (95% confidence interval) Predictor

1000 280 6 All Injuries All Negligent Injuries Files a Claim 30 2% of Negligent Injuries Results in 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

Reasons Why People Sue Their Doctors
Advised to sue by influential other 32
Needed money 24
Believed there was a cover-up 24
Child would have no future 23
Needed information 20
Wanted revenge, license 19
Percent Expressing Concern Source - Hickson, 1992

Malpractice Risk
Malpractice activity is disproportionate among physicians
75% - 85% of awards, settlement costs over a 5-year 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 Source – Hickson, 2002 4.6 2 or more lawsuits (N = 8) 9.2 1 lawsuit (N = 57) 4.7 No lawsuits (N = 361) Non-surgeons (N = 426) 35.1 2 or more lawsuits (N = 35) 16.7 1 lawsuit (N = 82) 6.1 No lawsuits (N = 102) Surgeons (N = 219) Mean Number of Complaints Physician Characteristic Total Physicians (N = 645)

Nine Percent of Physicians Account for Fifty Percent of the Complaints % of Complaints % of Physicians Source – Hickson, 2002

Communication and Malpractice Claims Source – Levinson, 1997 Affect < 0.05 3.4 4.8 Laughs (Physician) No. of utterances per 15-min visit: NS 7.5 7.8 Laughs (Patients) < 0.05 11.2 14.5 Orientation (Physician) < 0.05 11.9 19.4 Facilitation (Physician) Process: NS 26.3 28.5 Gives information – medical NS 16.9 18.3 Asks questions- medical Content < 0.05 15.0 18.3 Visit length, min P- Value Claims (n = 30) No Claims (n = 29) Variable Primary Care Physicians (n = 59)

Communication and Malpractice Claims Source – Hickson, 1994 0.01 8.7 1.4 No concern for me as a person 0.15 9.2 4.8 Yelled 0.01 17.4 4.8 Humanity of a physician 0.01 7.1 1.9 Did not listen 0.01 23.5 6.7 Would not talk 0.01 27.6 8.2 Physician-patient communication P - value High Frequency No Claims Category of complaint, % Prior Malpractice Claims Group

Medical Errors

Malpractice Litigation

Relationship between Malpractice Claims History and Subsequent Obstetric Care Source – Entman, 1994 2 0 17 High Frequency 7 8 42 No Claims No. of Cases of Subjective Substandard Care Total No. of Relevant Errors No. of Charts with Adverse Outcomes Physician Group

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”

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