safety first: avoiding medico- legal pitfalls paramedical

6/2/2015

1

Safety first: Avoiding medico-

legal pitfalls

Paramedical aspects (medico-

legal situation in the USA)

G. Willy Davila, MD

Chairman, Department of Gynecology

Section of Urogynecology/Reconstructive Pelvic Surgery

Cleveland Clinic Florida

Weston/Ft. Lauderdale, Florida, USA

Past-President, International Urogynecological Association (IUGA)

Medicolegal aspects in

Urogynecology: Medico-legal

situation in the USA

Lessons to be learnt

G. Willy Davila, MD

Chairman, Department of Gynecology

Section of Urogynecology/Reconstructive Pelvic Surgery

Cleveland Clinic Florida

Weston/Ft. Lauderdale, Florida, USA

Past-President, International Urogynecological Association (IUGA)

6/2/2015

2

The numbers: how many

OBGYN’s sued

77.3%

6/2/2015

3

The numbers: how many

included care during

residency

41.9%

Claims experience (OBGYN)

New York (%) Florida (%)

One claim 12 24.7

Two claims 17.3 21.3

Three claims 15.7 19.5

Four claims 49.9 34.5

NY 2009, Florida 2012

6/2/2015

4

Claims experience (OBGYN)

New York (%) Florida (%)

One claim 12 24.7

Two claims 17.3 21.3

Three claims 15.7 19.5

Four claims 49.9 34.5

NY 2009, Florida 2012

Mean: 2.6 claims/career

Most are mal-occurrences

6/2/2015

5

Liability insurance premiums

State 2003 2006 2010 Change

(%)

California 60,259 63,272 49,804 -17.3

Texas 92,236 73,342 62,168 -32.6

New York 123,853 156,032 186,772 50.8

OBGYN premiums. Med Liability Monitor

in USD

Scope of practice premiums

OBGYN GYN/surgery Low risk O/G GYN only

Long Island 186,772 102,961 61,220 43,181

Bronx 176,573 97,339 57,877 40,181

2010-2011 Med Liability Mutual Ins Co.

in USD

6/2/2015

6

Types of Claims: ACOG Survey

11

Top Gynecologic Claims* ACOG-Florida Surveys

1. Major patient injury (29-35.1%)

2. Delay in/failure to diagnose (22%)

3. Minor patient injury (21%)

4. Foreign object (8.1%)

12

6/2/2015

7

Gynecologic Claims ACOG Survey

Primary factors contributing:

• Surgical complications (44%)

• Hysterectomy-related complications (29%)

• Laparoscopic procedures (15%)

13

Laparoscopy & Robotic Surgery

• Laparoscopy: A factor in 15% of gynecologic

claims

• Robotic surgery: No advantage over existing,

minimally invasive techniques for routine

procedures

14

6/2/2015

8

Outcome of Claims ACOG Survey

• 44% dropped or settled without payment on

behalf of the ob-gyn (dropped by plaintiff,

dismissed by court, or settled without

payment)

• 39% settled with payment to plaintiff

15

The process

16

6/2/2015

9

Four Elements Plaintiff Must Prove

―Preponderance of the evidence‖

(at least 51% likelihood)

not

―Beyond a reasonable doubt‖

(as in criminal cases)

17


• Duty of care

• Breach of duty

• Causation

• Damages

18

6/2/2015

10


1. Duty of Care

• Existence of patient–physician relationship

• Appointment scheduled/HMO enrollee

• Appointment scheduled/life-threatening condition

• Advice given by phone, e-mail, or online

• Emergency patient (EMTALA violation could be

used in liability case)

19


2. Breach of duty: Failure to meet standard of

care

• Act of commission

• Act of omission

20

6/2/2015

11


2. Breach of duty established by:

• Doctrine of res ipsa loquitur

• Common knowledge

• Expert witness testimony (most common method)

• National guidelines (NIH, ACOG, etc.)

• Hospital protocols

21


3. Causation

• Causal connection between breach of standard of

care and patient’s injury

• Requires only ―reasonable degree of medical

probability‖ that physician’s negligence caused the

injury

22

6/2/2015

12


4. Damages: Compensatory

Special damages (economic)

• Medical expenses, Rehab costs, Lost wages

General damages (noneconomic)

• Pain and suffering

• Disfigurement

• Loss of consortium

Loss of enjoyment of life

23


4. Damages: Punitive (exemplary)

• Intended to punish, not compensate

• Usually excluded by insurance policy

• Not commonly awarded

24

6/2/2015

13



Examples:

• Willful and wanton disregard for patient well-being

• Sexual misconduct

• Criminal behavior such as assault, battery

25



Examples:

• Willful and wanton disregard for patient well-being

• Sexual misconduct

• Criminal behavior such as assault, battery

26

6/2/2015

14

Expanding Scope of Injury

• Loss of chance for better outcome, recovery, or

survival

• Damages for emotional distress not

accompanied by physical injury

27


Loss of chance (3 categories)

1. Relaxed causation standard

• Was patient’s chance of recovery reduced by (even if not

caused by) doctor’s negligence?

Example:

Improper breast cancer screening reduced chance

from 40% to 15%.

28

6/2/2015

15



2. Increased risk of harm

• Patient must prove:

• Negligence increased her risk of harm

• Increased risk was major factor in injury

29



3. Separate cause of action

• No proof needed that negligence caused injury,

only that negligence reduced patient’s chance

• Damages calculated as % of chance lost, applied to

total value of damages

30

6/2/2015

16


Emotional Distress as a Standalone Injury

• Emerging legal theory in some states

• Physician responsible for overall well-being

• Be aware of potential emotional consequences

of action/inaction

31

Joint and Several Liability (“Deep Pocket” Rule)

• Each defendant liable for 100% of damages

• If one defendant has no $ or insurance, other

defendant pays all

• Several states have minimum liability

thresholds to protect defendants who played a

small role

32

6/2/2015

17

Proportional Liability

• Allocates portion of blame to each defendant

(eg, defendant X pays 25% of damages if found

to be 25% liable)

• Considered fairer than joint and several

liability

• Is a goal of tort reform

33

Expert Witness

• Role = Helps lay jury interpret scientific

evidence

• Judge determines if qualified in most states

• Defendant usually should not serve as expert

34

6/2/2015

18

Expert Witness: Key Criteria

• Current unrestricted license

• Board-certified

• Demonstrated competence, relevant training, and clinical

experience

• Clinically active in relevant specialty in previous 5 years

• Has had CME relevant to case

• Disclosure of fees/time as expert witness

35

Expert Witness Affirmation

• Truthful

• Impartial and fair

• Relevant experience

• Use standards current

with case

• Objective and scientific

• Distinguish between

adverse outcome and

substandard care

• Clarify causality

• Allow peer review of

testimony

• Fee ≠ Outcome

36

6/2/2015

19

What can you do to reduce your risk?

37

OFFICE RISK MANAGEMENT

38

6/2/2015

20

Administrative and Office Areas

• Private area for confidential conversations

• Secure records system

• Neat and orderly desks, files

39

Personnel

• Clear job descriptions

• Duties within abilities/credentials of staff

• Licensure, continuing education maintained

• Training in emergency procedures

• Regular staff training/orientation

40

6/2/2015

21

Staff Training and Orientation

• Expectations for patient interactions

• Risk management/liability issues

• HIPAA compliance

• Office policies

41

New Patients

Give information about practice

• How to contact you

• Coverage arrangements

• Who may provide care

• Hospital affiliations

• What to do in emergency

• Billing procedures, administrative practices

• Scope of services

42

6/2/2015

22

Telephone Policy/Procedures

• Put policies in writing

• Have periodic training sessions

• Limit number of rings allowed

• Limit length of time on hold

• Monitor and add phone lines/staff if needed

• Consider e-mail for non-urgent questions

43

E-mail Use

Pros

• No phone tag

• Fewer unnecessary visits

• Ready-made documentation

• Patient has information for future reference

Cons

• Confidentiality risk

• Added complexity: more policies, tracking, filing

• Potential for violating HIPAA, state licensing laws

44

6/2/2015

23

Digital Communication/New Media

E-mail, text messages, social media—same approach

as telephone:

• Ensure patient understands advice, instructions

• Don’t give advice to patients you don’t know

• Know your state’s laws on electronic Rx

HIPAA privacy and confidentiality rules apply.

45

HOSPITAL RISK MANAGEMENT Most ob-gyn lawsuits arise in hospital settings

46

6/2/2015

24

The Hospital Team

• Communicate, communicate, communicate!

• Know capabilities of team members

• Speak up if you have concerns

47

Working With Residents

• Introduce resident to patient, explain resident’s

role

• Know resident’s skill/training level

• Give clear, specific direction

• Notify resident of all orders, keep resident

informed

48

6/2/2015

25

Transfer of Care

• Discuss reasons with patient

• Obtain patient consent document

• Communicate with other doctor to keep

informed

• If patient is in your hospital, visit or follow up

by phone

49

Follow-up: Discharge Instructions

• Oral and written

• Self-care

• Activity restrictions

• Possible complications

• When to see you again

50

6/2/2015

26

RESPONSIBILITY FOR FOLLOW-UP Duty of care = Reasonable efforts to ensure patient receives care you recommended

51

Lab Tests

• Give patient written instructions

• What, where

• Why ordered

• Pretest instructions (fasting, etc.)

• How she will learn results

• Document above communication

52

6/2/2015

27

Tracking Systems

• Tracking system in place

• Test results within X days

• Staff assigned to check every X days (backup for

vacation/sick days)

• Follow up on abnormal results

• Patient is informed

53

Disclosing Error/Adverse Outcome

• Patient has right to know

• Many lawsuits result from lack of

communication about errors/reasons for poor

outcome

• Disclosure could prevent lengthy lawsuit

54

6/2/2015

28

Disclosing Error/Adverse Outcome

• Don’t avoid the patient or family

• Stick to the facts

• Tell what you know

• Express sympathy and regret for what

happened without an admission of fault

55

INFORMED CONSENT

56

6/2/2015

29

Principles

Premise:

Patient must understand treatment she is

agreeing to receive

57

Principles

Informed consent = Process

Informed consent ≠ Form to sign

58

6/2/2015

30

7 Things the patient needs to know:

1. Diagnosis/medical condition

2. Recommended treatment and purpose

3. Likely benefits of treatment

4. Probability of success

59

7 Things the patient needs to know (continued):

5. Potential risks/complications

6. Alternatives and their risks/benefits

7. Possible consequences of no treatment

60

6/2/2015

31

safety first: avoiding medico- legal pitfalls paramedical

Documents