The Future of CV Medicine: Selected Legal Issues

Marshall B. Kapp, JD, MPH

Director, FSU Center for Innovative Collaboration in

Medicine & Law

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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

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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

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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)

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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

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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

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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

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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.

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

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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

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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