The Future of Cardiovascular Medicine: Selected Legal Issues

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.

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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.”

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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.

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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