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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.
“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…
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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?
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
Ensure High Quality Practice
Maintaining clinical skills Avoiding procedures for which skill set is
inadequate Establishing mentorship - practice in isolation
is risky
Ensure High Quality Practice
Maintaining clinical skills Avoiding procedures for which skill set is
inadequate Establishing mentorship - practice in isolation
is risky
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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”
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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)
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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)
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
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
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
Once a lawsuit has been filed:
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…
Once a lawsuit has been filed:
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…
Avoiding Lawsuits in NeuromodulationAvoiding Lawsuits in Neuromodulation
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
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