The Future of CV Medicine: Selected Legal Issues Marshall B. Kapp, JD, MPH Director, FSU Center for Innovative Collaboration in Medicine & Law
Agenda Patient safety/Error reduction/Quality Improvement, through Clinical Practice Guidelines (aka Parameters, Pathways, Decision supports) End of life medical decision making, particularly CIED deactivation FSU COLLEGE OF MEDICINE
Patient safety/Error reduction/ Quality Improvement CV-related litigation: – Most CV litigation relates to Workers’ Compensation or Disability claims, not medical malpractice. Implication: Documentation
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CV physicians and malpractice claims* – Most common medical misadventures: Diagnostic error Improper performance Failure to supervise case (Vicarious liability) Medication errors Failure to recognize complication Delay in performance, referral, consultation Oetgen et al., Characteristics of Medical Professional Liability Claims in Patients With Cardiovascular Diseases, AM. J. CARDIOL. 2010;105:745-752 FSU COLLEGE OF MEDICINE
Most Prevalent Diagnoses in CV Claims – – – – – – – –
Artherosclerosis Acute M.I. Chest pain not further defined Dysrhythmia Heart disease not further defined Heart failure Atrial fibrillation and flutter Aortic aneurysm* (rare but severe) FSU COLLEGE OF MEDICINE
Most Prevalent Problems in CV Cases – Informed consent (usually combined with other problems) – Communication among providers – Equipment malfunction – Premature discharge – Problem with history or exam – Medical records [Implications of EMRs?] – Abandonment – Unnecessary treatment
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Clinical Practice Guidelines – Strengths Prospective guidance Evidence-based (when they are) Set by medical peers – Challenges Timeliness Lack of an evidence base Inconsistencies Physician knowledge Physician inertia, resistance
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Movement from “Cookbook Medicine” to medical school curriculum (Informatics)
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CPGs include CVD risk assessment, lifestyle modification strategies, and treatment modalities to achieve specific therapeutic goals regarding BP and cholesterol reductions. – – – –
J. Am. Coll. Cardiol. 2006;47:2130-39 JAMA 2003;289:2560-72 J. Am. Coll. Cardiol. 2004;44:720-32 Crit. Pathways Cardiol. 2008;7:122-25 FSU COLLEGE OF MEDICINE
Legal (judicial) uses of CPGs Institute of Medicine. 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press, at 174.
– “[C]ourts continue to use guidelines only occasionally and largely conservatively…Overall, the application of CPGs to medical malpractice has had varying practical influence.” FSU COLLEGE OF MEDICINE
Real value of CPGs – Discourage the filing of lawsuits – Improved patient care=fewer injuries=fewer lawsuits
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Deactivation of Cardiac Implantable Electrical Devices Permanent Heart Rhythm(Resyncranization) Devices
– Pacemakers (PMs) – Implantable cardioverter-defibrillators (ICDs)
2 million+ Americans FSU COLLEGE OF MEDICINE
Ethical and Legal Principles – Heart Rhythm Society Expert Consensus Statement on the Management of Cardiovascular Implantable Electronic Devices (CIEDs) in Patients Nearing the End of Life or Requesting Withdrawal of Therapy, HEART RHYTHM 210;7:1008-1026 – European Heart Rhythm Association/HRS, Expert Consensus Statement, EUROSPACE 2010;12:1480-89 FSU COLLEGE OF MEDICINE
ďƒ˜ A patient with decision-making capacity has the right to refuse or request withdrawal of any medical intervention, regardless of medical condition, and regardless of whether death will result. ďƒ˜ For a patient without capacity, this right may be exercised by a surrogate decision maker. FSU COLLEGE OF MEDICINE
Presumption of adult decision making capacity No difference between refusing CIED intervention and requesting withdrawal of CIED intervention Advance directives may deal with CIEDs FSU COLLEGE OF MEDICINE
CIED deactivation ≠ physician-assisted death or euthanasia The right to refuse or request withdrawal of treatment does not depend on the characteristics of the particular treatment. But see: – Kramer et al., Ethical and Legal Views of Physicians Regarding Deactivation of Cardiac Implantable Electrical Devices: A Quantitative Assessment, HEART RHYTHM 2010;7:1537-42 – Kapa et al., Perspectives on Withdrawing Pacemaker and Implantable Cardioverter-Debrillator Therapies at End of Life, MAYO CLIN. PROC. 2010;85:981-90 FSU COLLEGE OF MEDICINE
Clinician cannot be compelled to carry out an ethically and legally permissible act that violates the clinician’s own values. – Duty of non-abandonment/Referral
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Putting principles into practice – Communication Benefits, burdens, consequences Options, alternatives
– Role of family – Role of other health care team members – Logistics – Documentation FSU COLLEGE OF MEDICINE