medico-legal issues in neuromodulation 2012 robert m. levy, m.d., ph.d. professor and chairman,...

Medico-Legal Issues in Neuromodulation 2012Medico-Legal Issues in Neuromodulation 2012

Robert M. Levy, M.D., Ph.D.Professor and Chairman, Department of

NeurosurgeryCo-Director, Shands Jacksonville

Neuroscience InstituteUniversity of Florida College of Medicine

Jacksonville, FL

Robert M. Levy, M.D., Ph.D.Professor and Chairman, Department of

NeurosurgeryCo-Director, Shands Jacksonville

Neuroscience InstituteUniversity of Florida College of Medicine

Jacksonville, FL

Editor-in-ChiefRobert Levy, MD, PhD

Editor-in-ChiefRobert Levy, MD, PhD

www.neuromodulationjournal.com www.neuromodulationjournal.com

North American Neuromodulation Society Annual

Meeting

North American Neuromodulation Society Annual

Meeting

Wynn Hotel

Las Vegas, NV

December 8, 2012

Wynn Hotel

Las Vegas, NV

December 8, 2012

DisclosuresDisclosures Consultant/Research/Stock Options

Alfred Mann Foundation Bioness Mainstay Medical Medtronic Nevro Spinal Modulation St. Jude Medical Vertos

Consultant/Research/Stock Options Alfred Mann Foundation Bioness Mainstay Medical Medtronic Nevro Spinal Modulation St. Jude Medical Vertos

Critical Teaching PointsCritical Teaching Points

Inevitability of Errors Increasing complexity of dynamic specialty Importance of Continuing Education:

Guidelines, risk averse practices Patient behavior and relationship

management

Inevitability of Errors Increasing complexity of dynamic specialty Importance of Continuing Education:

Guidelines, risk averse practices Patient behavior and relationship

management

Medical Error ReductionMedical Error Reduction

Pay attention to the case report literature: “birth pains”

Go to meetings, especially those discussing pertinent clinical management of controversial topics

Adopt consensus standards and practice guidelines in your practice, e.g. AANS/CNS guidelines

Pay attention to the case report literature: “birth pains”

Go to meetings, especially those discussing pertinent clinical management of controversial topics

Adopt consensus standards and practice guidelines in your practice, e.g. AANS/CNS guidelines

Three Types of Errors: LitigationThree Types of Errors: Litigation

1) Process errors: During the conduct of procedures, system problems (personnel, equipment, monitoring)

2) Knowledge errors: A drug interaction is not known or identified; Medications are not reconciled; Drugs are mal-prescribed

3) Documentation: Informed Consent

1) Process errors: During the conduct of procedures, system problems (personnel, equipment, monitoring)

2) Knowledge errors: A drug interaction is not known or identified; Medications are not reconciled; Drugs are mal-prescribed

3) Documentation: Informed Consent

“Nevers”“Nevers”

Surgery on wrong body part: Left sided selective root block on patient with right side radicular pain

Surgery on wrong patient Retained foreign body: e.g. shunt fragment Death of healthy patient from procedure or

medication error

Surgery on wrong body part: Left sided selective root block on patient with right side radicular pain

Surgery on wrong patient Retained foreign body: e.g. shunt fragment Death of healthy patient from procedure or

medication error

Are Medical Errors Inevitable?Are Medical Errors Inevitable?

Factors under physicians control

1. Medical knowledge

2. Technical skills

3. Risk practices; Documentation

• Factors not under physician control

1. Personnel ( other doctors, RN’s, AHP)

2. Equipment, systems, demanding hours

Factors under physicians control

1. Medical knowledge

2. Technical skills

3. Risk practices; Documentation

• Factors not under physician control

1. Personnel ( other doctors, RN’s, AHP)

2. Equipment, systems, demanding hours

Are Medical Errors Inevitable?Are Medical Errors Inevitable?

Complex interaction of multiple dynamic personnel and systems = a statistical inevitability for error

Human failing of seeking someone to blame confounds efforts to find and remediate factors that cause error

Complex interaction of multiple dynamic personnel and systems = a statistical inevitability for error

Human failing of seeking someone to blame confounds efforts to find and remediate factors that cause error

Runciman WB, Merry AF, Tito F. Error blame and the law in health care:An antipodean perspectiveAnn Intern Med 2003;138:974-9

Blaming PhysiciansBlaming Physicians

Patients hold physicians accountable, and do not see errors as inevitable

Survey of large health plan: 39% felt that physician should be punished when errors led to morbidity

Patients:Licensure suspension, dismissal from health plan, etc.

Patients hold physicians accountable, and do not see errors as inevitable

Survey of large health plan: 39% felt that physician should be punished when errors led to morbidity

Patients:Licensure suspension, dismissal from health plan, etc.

Mazor KM, Simon SR, Yood RA, et al. Ann Intern med 2004;140:409-18

“Frivolous Lawsuits”“Frivolous Lawsuits” 1452 closed claims: Expert evaluation 3%: no evidence of injury 80% of claims were for serious injury/death 27% discordant (10% payment, no error;

16% no payment, but true error)

1452 closed claims: Expert evaluation 3%: no evidence of injury 80% of claims were for serious injury/death 27% discordant (10% payment, no error;

16% no payment, but true error)

Studdert DM, Mello MM, Gawande AA, et al.NEJM 2006;354:2024-33.

Standard of CareStandard of Care

“Standard of Care” has moved from a regional to national benchmark

Definition: Physician activity that a

“ Reasonably prudent and competent physician with the same or similar training would do in the same or similar circumstances”

“Standard of Care” has moved from a regional to national benchmark

Definition: Physician activity that a

“ Reasonably prudent and competent physician with the same or similar training would do in the same or similar circumstances”Rich BA. Medico-legal commentary.Pain Medicine 2003;4:202-5

Patient Relationships

American Academy on Physician and Patient

Patient Relationships

American Academy on Physician and Patient

1. Partnership2. Empathy3. Apology

1. Partnership2. Empathy3. Apology

Lazare A, Putnam SM, Lipkin M Jr. The Three functions of the medical interview. In Lipkin M Jr,Putnam SM, Lazare A, eds. The Medical Interview:Clinical Care Education and Research. New York:Springer-Verlag, 1995:3-19

4. Respect

5. Legitimization

6. Support

4. Respect

5. Legitimization

6. Support

TrustTrust Patients at 20 family practices asked to

take the “Trust in Physician Scale” Being comforting and caring Demonstrating competency Encouraging and answering questions and

explaining were all predictive of trust

Patients at 20 family practices asked to take the “Trust in Physician Scale”

Being comforting and caring Demonstrating competency Encouraging and answering questions and

explaining were all predictive of trust

Thom DH, Stanford Trust Study Physicians. Physician behaviors that predict patient trust. J Family Practice 2001;50:323-8.

Disclosure of ErrorsDisclosure of Errors Patients want full disclosure of errors Encouraged statement:

a. an error has occurred;

b. the nature of the error;

c. why the error occurred;

d. how future recurrence will be avoided

e. an apology

Patients want full disclosure of errors Encouraged statement:

a. an error has occurred;

b. the nature of the error;

c. why the error occurred;

d. how future recurrence will be avoided

e. an apology

Gallagher TH, Levinson W. Arch Intern Med2006;165:1819-24.

Saying “I’m Sorry”Saying “I’m Sorry”

“Authentic apology”:

1. A standard was broken

2. Admission of fault

3. Genuine remorse/regret

4. Offer restitution/promise reform

“Authentic apology”:

1. A standard was broken

2. Admission of fault

3. Genuine remorse/regret

4. Offer restitution/promise reform

Berlin L. Will saying “I’m sorry” prevent a lawsuit.AJR 2006;187:10-15.

Saying “I’m Sorry”Saying “I’m Sorry”

There is evidence that a sincere apology can reduce risk of litigation.

However, a “botched apology” might engender even more hostility and anger

There is evidence that a sincere apology can reduce risk of litigation.

However, a “botched apology” might engender even more hostility and anger

Taft L. Apology and medical mistake: Opportunity or foil?Ann Health Law 2005;14:55-94.

When to apologize??When to apologize??

“It’s easier to eat crow while it’s still warm”

“Saying I’m Sorry”“Saying I’m Sorry”

Know the policies that are pertinent to your state!

Know the policies of your malpractice carrier!

Know the policies of your hospital and/or institution!

Know the policies that are pertinent to your state!

Know the policies of your malpractice carrier!

Know the policies of your hospital and/or institution!

10 Ways to Get Sued10 Ways to Get Sued

• Poor records• No informed consent• “Fixing” the record• Trusting the patient to

follow up• Not tracking test

results

• Poor records• No informed consent• “Fixing” the record• Trusting the patient to

follow up• Not tracking test

results

Not reconciling meds/allergies

Diagnosis by phone Poor physician patient

relationship Inadequate time “Mum” after error

Not reconciling meds/allergies

Diagnosis by phone Poor physician patient

relationship Inadequate time “Mum” after error

Rice, Medical Economics 2005

Conclusions from the LiteratureConclusions from the Literature

Strong Relationships Culture of Safety: procedural processes,

safeguards, after-action reviews Knowledge: Case report literature, practice

guidelines, expert reviews Awareness: Print/television media

Strong Relationships Culture of Safety: procedural processes,

safeguards, after-action reviews Knowledge: Case report literature, practice

guidelines, expert reviews Awareness: Print/television media

Conclusions from the LiteratureConclusions from the Literature

Full Disclosure of the error to patient/family Thorough Evaluation and active follow-up

of all injured patients

*Documentation: particularly of informed consent, aftercare actions

Full Disclosure of the error to patient/family Thorough Evaluation and active follow-up

of all injured patients

*Documentation: particularly of informed consent, aftercare actions

Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation

With significant assistance from Dr. Marc Huntoon, Part I discussed the extensive medical literature on this topic…

Let’s take it to everyday clinical practice…

With significant assistance from Dr. Marc Huntoon, Part I discussed the extensive medical literature on this topic…

Let’s take it to everyday clinical practice…


Caveat: Despite best medical practice and exemplary behavior, you cannot be guaranteed that you will not be sued

Some patients are motivated by anger, greed and the desire for retribution

All plaintiff’s malpractice lawyers are motivated by anger, greed and the desire for remuneration

Caveat: Despite best medical practice and exemplary behavior, you cannot be guaranteed that you will not be sued

Some patients are motivated by anger, greed and the desire for retribution

All plaintiff’s malpractice lawyers are motivated by anger, greed and the desire for remuneration


Tort reform is critical for maintaining high quality medical care in the US

Tort reform is difficult due to the high prevalence of lawyers in government and the power of trial lawyers and their lobbyists

Tort reform is critical for maintaining high quality medical care in the US

Tort reform is difficult due to the high prevalence of lawyers in government and the power of trial lawyers and their lobbyists


We must increase our political and educational efforts to survive - if we don’t work for change then how can we complain?

We must increase our political and educational efforts to survive - if we don’t work for change then how can we complain?


Short of eliminating plaintiff’s attorneys with extreme prejudice (the CHICAGO approach to problem solving), there ARE strategies that you can use to avoid lawsuits

These strategies are the same as those used to maintain a high quality medical practice

Short of eliminating plaintiff’s attorneys with extreme prejudice (the CHICAGO approach to problem solving), there ARE strategies that you can use to avoid lawsuits

These strategies are the same as those used to maintain a high quality medical practice


Ensure High Quality Practice

Best medical care (NOT standard of care - this is a legal term that describes the minimum acceptable care)

Up to date education (MOC, MOP) CME, Professional Meetings, Courses, Reading


Best medical care (NOT standard of care - this is a legal term that describes the minimum acceptable care)

Up to date education (MOC, MOP) CME, Professional Meetings, Courses, Reading



Maintaining clinical skills Avoiding procedures for which skill set is

inadequate Establishing mentorship - practice in isolation

is risky


Maintaining clinical skills Avoiding procedures for which skill set is

inadequate Establishing mentorship - practice in isolation

is risky


Patient Communication Perform a TRUE history and physical

examination on all patients Take the time to establish a diagnosis and

treatment plan Communicate this plan effectively with the

patient and their caregivers Maintain communication Let the patient know that you care

Patient Communication Perform a TRUE history and physical

examination on all patients Take the time to establish a diagnosis and

treatment plan Communicate this plan effectively with the

patient and their caregivers Maintain communication Let the patient know that you care


Patient Communication - Pitfalls “I have too many patients to see to spend that

much time with each patient” “I am too busy to return patient phone calls” “I already explained that” “I’ll do it tomorrow”

Patient Communication - Pitfalls “I have too many patients to see to spend that

much time with each patient” “I am too busy to return patient phone calls” “I already explained that” “I’ll do it tomorrow”


Accurate and Timely Documentation Document informed consent discussion

immediately after it occurs IN ADDITION to standard informed consent

form Dictate operative dictations in a timely manner

Accurate and Timely Documentation Document informed consent discussion

immediately after it occurs IN ADDITION to standard informed consent

form Dictate operative dictations in a timely manner


Informed Consent Always discuss risks, benefits and alternatives

in detail with the patient Identify the frequency of risk that you are

discussing (ie., every complication reported to occur 1% of the time or greater)

Informed Consent Always discuss risks, benefits and alternatives

in detail with the patient Identify the frequency of risk that you are

discussing (ie., every complication reported to occur 1% of the time or greater)


Immediate Recognition, Evaluation and Treatment of Complications

Neuroimaging studies immediately upon demonstration of new complaints or neurologic deficits (even in PARR)

Early neurosurgical consultation and reoperation for decompression or device removal

Immediate Recognition, Evaluation and Treatment of Complications

Neuroimaging studies immediately upon demonstration of new complaints or neurologic deficits (even in PARR)

Early neurosurgical consultation and reoperation for decompression or device removal


Timely communication with the patient and family about: the nature of complications the plan for their management their potential outcomes

Timely communication with the patient and family about: the nature of complications the plan for their management their potential outcomes


Do not hesitate to request backup or additional opinions

Follow the recommendations of your expert consultants (or at least document that

you have read and considered them)

Do not hesitate to request backup or additional opinions

Follow the recommendations of your expert consultants (or at least document that

you have read and considered them)


Do not withdraw in the face of complications or bad outcomes

This may be the MOST common reason patients resort to litigation

Do not withdraw in the face of complications or bad outcomes

This may be the MOST common reason patients resort to litigation


Before a lawsuit is filed: Contact risk management Involve hospital and clinic resources to provide

appropriate attention and support Follow the recommendations of health care

administration risk management experts

Before a lawsuit is filed: Contact risk management Involve hospital and clinic resources to provide

appropriate attention and support Follow the recommendations of health care

administration risk management experts


Once a lawsuit has been filed:

NEVER alter the medical record NEVER destroy or hide notes or records Even if you are completely in the right, this will

suggest culpability and the plaintiff’s attorneys will capitalize on this


NEVER alter the medical record NEVER destroy or hide notes or records Even if you are completely in the right, this will

suggest culpability and the plaintiff’s attorneys will capitalize on this



ALWAYS be fully disclosing with your attorneys and experts

ALWAYS be willing to accept education and training for depositions and trials

They are the experts and they cannot help if they don’t know…


ALWAYS be fully disclosing with your attorneys and experts

ALWAYS be willing to accept education and training for depositions and trials

They are the experts and they cannot help if they don’t know…


In a Deposition or in the Courtroom:

Answer only the questions that are asked NEVER volunteer information or explanations that

are not specifically requested NEVER present yourself as haughty, patrician,

unconcerned or superior

In a Deposition or in the Courtroom:

Answer only the questions that are asked NEVER volunteer information or explanations that

are not specifically requested NEVER present yourself as haughty, patrician,

unconcerned or superior

email: [email protected]: [email protected]

Telephone: 904 244 9451Telephone: 904 244 9451

email: [email protected]: [email protected]

Telephone: 904 244 9451Telephone: 904 244 9451

medico-legal issues in neuromodulation 2012 robert m. levy, m.d., ph.d. professor and chairman,...

Documents

wrong patient

fl slide

knowledge errors

medical errors inevitable

jude medical vertos

relationship management

medical knowledge

practice guidelines