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Medico-Legal Issues in Neuromodulation 2012 Robert M. Levy, M.D., Ph.D. Professor and Chairman, Department of Neurosurgery Co-Director, Shands Jacksonville.

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Presentation on theme: "Medico-Legal Issues in Neuromodulation 2012 Robert M. Levy, M.D., Ph.D. Professor and Chairman, Department of Neurosurgery Co-Director, Shands Jacksonville."— Presentation transcript:

1 Medico-Legal Issues in Neuromodulation 2012 Robert M. Levy, M.D., Ph.D. Professor and Chairman, Department of Neurosurgery Co-Director, Shands Jacksonville Neuroscience Institute University of Florida College of Medicine Jacksonville, FL Robert M. Levy, M.D., Ph.D. Professor and Chairman, Department of Neurosurgery Co-Director, Shands Jacksonville Neuroscience Institute University of Florida College of Medicine Jacksonville, FL

2 Editor-in-Chief Robert Levy, MD, PhD 

3 North American Neuromodulation Society Annual Meeting Wynn Hotel Las Vegas, NV December 8, 2012 Wynn Hotel Las Vegas, NV December 8, 2012

4 Disclosures  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

5 Critical 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

6 Medical 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

7 Three 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

8 “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

9 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

10 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 perspective Ann Intern Med 2003;138:974-9

11 Blaming 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

12 “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:

13 Standard 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

14 Patient Relationships American Academy on Physician and Patient 1. Partnership 2. Empathy 3. Apology 1. Partnership 2. Empathy 3. 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: Respect 5. Legitimization 6. Support

15 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  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.

16 Disclosure 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 Med 2006;165:

17 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.

18 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.

19 When to apologize?? “It’s easier to eat crow while it’s still warm”

20 “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!

21 10 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 Rice, Medical Economics 2005

22 Conclusions 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

23 Conclusions 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

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25 Avoiding 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…

26 Avoiding 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

27 Avoiding 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

28 Avoiding 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?

29 Avoiding 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

30 Avoiding 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

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39 Avoiding 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

40 Avoiding 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

41 Avoiding 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”

42 Avoiding 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

43 Avoiding 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)

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46 Avoiding 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

47 Avoiding 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

48 Avoiding 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)

49 Avoiding 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

50 Avoiding 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

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52 Avoiding 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

53 Avoiding 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…

54 Avoiding 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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56 Telephone:


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