Legal Issues in the Practice of Critical Care Medicine: a Practical Approach

Legal issues in the practice of critical care medicine: A practical approach

Critical Care Medicine, Volume 35(2) Suppl, February 2007, S44-S58

Szalados, James E. MD, JD, MBA, FCCM

HEALTH LAW MODULE

STUDY GUIDE

I. Medical Malpractice: The Law of Medical Negligence

A. Definition / Scope

·  Failure to adhere to accepted standards, resulting in injury

·  Negligence – tort

·  State-specific civil statutes govern

·  Certification of merit (some jurisdictions)

- Outside physician review determines case has merit/not frivolous

- Frivolous Lawsuit Reduction Act of 2004 – attorney sanctions for acting in bad faith

B. Proof / Elements

·  Plaintiff (patient) must prove, by a preponderance of the evidence (more probable than not) –

1. Duty existed

o  Created by physician-patient relationship

o  Reasonably prudent physician under similar circumstances

2. Breach of duty

o  Defendant (physician) did not act in accordance with standard of care

3. Cause

o  Close causal connection between negligent act/omission and resulting injury

o  Breach of duty was actual and proximate cause

a. Actual cause – causation in fact

- “But for” the act/failure to act, the injury would not have occurred

b. Proximate cause – legal causation

- Foreseeability – injury foreseeable result of defendant’s actions

4. Damages

o  Compensatory – “make the plaintiff whole”

a. Economic (special)

b. Noneconomic (general)

o  Punitive (exemplary) – “punish” behavior

·  Expert testimony required

C. Res Ipsa Loquitur

·  “The facts speak for themselves”

·  Creates prima facie case (valid on its face) of negligence

·  Elements –

1. Does not ordinarily occur in the absence of negligence

2. Caused by agency/instrumentality within the exclusive control of the defendant

3. Not due to any voluntary action/contribution on part of plaintiff

·  Example – retained instruments or fragments after procedures

II. Procedural Issues in the Defense of a Medical Malpractice Claim

A. Medical Malpractice Insurance

·  Types

1. Occurrence – covers incidents that occur during the policy period (even if claim is filed after the policy expires/is discontinued)

2. Claims-made – only covers claims that are filed during the life of the policy (while the policy is still in effect)

o  “Tail” (or “nose”) coverage – covers claims filed after the claims-made policy expires/is discontinued

B. Insurer / Insured Obligations

·  Insurer (Carrier)

1. Duty to defend

o  Retain defense counsel

- Attorney-client privilege – communication/documents prepared in anticipation/preparation for litigation are confidential

o  Pay legal fees

2. Duty to indemnify

o  Pay settlement/judgment on covered claim within policy limits

3. Report settlement/judgment to National Practitioner Data Bank (NPDB)

·  Insured (Physician)

1. Prompt notice of claim to insurer

2. Cooperation in defense of claim

C. Litigation Process

·  Letter of inquiry/notice – places physician on notice regarding potential claim

·  Complaint – filed with court by plaintiff’s attorney

o  Statute of limitations

- Complaint must be filed within state-specific time period

- Factors that may “toll” (extend) the statute of limitations –

a. Plaintiff under the age of majority

b. Plaintiff under continuous medical treatment

c. Delayed discovery of malpractice by plaintiff

·  Summons – issued by clerk of court to defendant (notification of lawsuit)

·  Discovery – opportunity for each party to obtain relevant information/documents from other parties

o  Interrogatories – written questions served on a party that must be answered

o  Production of evidence – e.g., medical records, policies/procedures, etc.

o  Depositions – formal oral testimony under oath

·  Settlement – Advantages

1. Juries unpredictable: may make an emotional decision

2. Negative consequences/publicity of negligence verdict lessened

3. Costs lower (defense attorney, expert witnesses, court costs)

4. Precedential effect of verdict to future similar cases is eliminated

·  Trial

o  Jury selection

- Voir dire – prospective jurors questioned regarding potential bias/prejudice

o  Opening statements – plaintiff’s (followed by defendant’s) counsel acquaint jury with general facts expected to be proved during trial

o  Witness testimony – plaintiff’s counsel begins

- Direct, cross, re-direct, and re-cross examination

- Expert testimony (offer opinions); all other testimony (only state facts)

- Counsel may object to testimony/evidence

o  Closing arguments – plaintiff’s (followed by defendant’s) counsel

o  Jury charge (instructions) – judge instructs jury regarding applicable law

o  Jury verdict

o  Judgment – final determination of the lawsuit entered by court clerk

o  Appeal – right to appeal judgment to at least one higher court

III. Defensive Medicine and CCM (Critical Care Medicine)

A. Practices

·  e.g., ordering tests/imaging studies, performing procedures, referring patients for consultation

·  However, defensive medical practices are not always in the patient’s best interest; for example, a delay in extubation may increase the risk of nosocomial pneumonia.

B. Strategy

·  Comprehensive/integrated documentation

o  Document basis for deviation from accepted guideline/protocol/pathway

C. Duty to Provide Care

·  Formal process for patient transfer – provide safe continuity of care

·  Abandonment – termination of physician-patient relationship at unreasonable time or without affording patient opportunity to obtain different physician

IV. Complications Associated with ICU Patient Care: Mitigation, Documentation, and Disclosure

A. Credentialing

·  Develop/maintain policies/procedures for credentialing/continued evaluation of provider team

B. Institutional Policies/Procedures

·  Under increased scrutiny by plaintiff’s attorneys because medical errors (and patient harm) are system-wide issue

C. Liability for Others’ Actions (Legal Doctrines)

·  Vicarious liability

o  e.g., hospital has nondelegable duty to provide nonnegligent physician care

o  Expands hospital’s independent duty of care to its patients

o  Physician liability imputed to hospital

·  Respondeat superior

o  e.g., physician (employer) liable for failure of nurse (employee) to follow accepted practices

o  Nurse liability imputed to physician

D. Culture of Safety – Disclosure

·  Medical error transparency – disclosure policies/procedures

o  Full disclosure may decrease litigation

·  Centers for Medicare & Medicaid Services (CMS), The Joint Commission [formerly known as Joint Commission on Accreditation of Healthcare Organizations (JCAHO)], state regulatory agencies’ philosophies

V. Emergency Medical Treatment and Active Labor Act (EMTALA): The Duty to Screen and Stabilize Before Transfer

A. Requirements –

·  Emergency department (ED) must conduct screening examination to determine whether emergency medical condition exists

o  Screening examination – within the capability of the hospital’s ED, including routinely available ancillary services

o  Emergency medical condition – medical condition manifested by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in:

a. placing health of individual in serious jeopardy,

b. serious impairment to bodily functions, or

c. serious dysfunction of any bodily organ/part

·  If emergency medical condition exists, ED must provide stabilizing treatment or transfer patient to another medical facility, in compliance with EMTALA, for treatment

o  Exception – patient who has not been stabilized may be transferred to another medical facility if:

a. Patient requests transfer in writing, or

b. Physician certifies that medical benefits reasonably expected from transfer outweigh increased risks to individual

·  Standard – hospitals must exercise skill/knowledge normally possessed by like institutions in similar communities

B. Enforcement

·  Centers for Medicare & Medicaid Services (CMS) and Office of Inspector General

·  Penalties –

o  Up to $50,000 per violation

o  Possible termination of hospital’s CMS provider agreement

C. Reverse-dumping (pwnt)

·  Hospital refuses to accept transfer of patient requiring its specialized capabilities

VI. Informed Consent

A. Type of contract

·  Requires disclosure (physician) and acceptance (patient) – imposes duties on both parties

·  Invalid if obtained inappropriately (e.g., fraudulent pretenses, under duress, from patient with impaired decision-making capacity)

·  Signed consent form – only rebuttable presumption of informed consent

B. Standards

·  Consent must be “informed” to be legally effective – physician must disclose risks, benefits, and alternatives of proposed intervention/treatment

·  Disclosure –

1. Physician-centered – what a reasonable physician would provide in the same/similar circumstances, or

2. Patient-centered (modern trend) – focuses on needs of a reasonable patient; what information (risks/benefits/alternatives) a reasonable patient in the same/similar circumstances would need to decide

C. Emergent Situations

·  Implied (vs. express) consent – physician could reasonably infer that patient would have consented to treatment (e.g., ICU patient – intubation for acute respiratory failure)

D. Decision-making Capacity vs. Competence

·  Capacity – contextual and situational

o  e.g., recent treatment with psychoactive substances (sedatives/analgesics), delusional states, acute injury, metabolic conditions (sodium/glucose disorders)

·  Competence – fixed characteristic of patient

o  e.g., age of minority without emancipation, long-term cognitive impairment

VII. Consent and Conflicts of Interest in Medical Research

A. Conflict of Interest

·  External relationship influences attitude/behavior toward particular research

·  Financial/personal relationship with third party may create bias

B. Common Rule (Federal Policy for the Protection of Human Subjects) Provisions

·  Informed Consent (Research)

o  Elements

a. Study involves research, purpose of research/expected duration, research procedures, identification of experimental procedures

b. Risks/discomforts

c. Benefits to subject/others

d. Alternative advantageous procedures/treatment

e. Confidentiality of records

f. Compensation/medical treatment available for injury (for research involving more than minimal risk)

g. Contact information: 1) for answers to questions about research and subjects’ rights; 2) whom to contact in the event of injury

h. Voluntary participation, refusal to participate involves no penalty/loss of benefits, subject may discontinue participation at any time without penalty/loss of benefits

·  Institutional Review Board Approval of Research (Without Informed Consent) in Emergency Care

o  Requirements

a. Life-threatening situation, available treatments unsatisfactory, and evidence must be collected to determine safety/efficacy of intervention

b. Informed consent cannot be obtained because of medical condition; to be effective, intervention must be provided before representative can consent

c. Particular subjects cannot be identified in advance

d. Intervention likely to benefit subject

e. Consultations with “representatives of the community”

f. Subject/subject’s representative informed about research as soon as possible; subject right to withdraw if research ongoing

VIII. Refusal to Consent: American Medical Association, DNR, Withdrawal of Life Support, and Assisted Suicide

A. Patient Rights

·  Refuse treatment

·  Right to die – right to refuse treatment even if refusal leads to death

o  Autonomy – individual’s right to decision-making regarding personal self-determination

- Physician must balance legal duty of care with legal/ethical respect for individual autonomy

B. State Interests

·  Preservation of life, prevention of suicide, protection of third parties, integrity of the medical profession

C. Advance Directives

·  Written requests by competent persons regarding future medical care; effective when person can no longer communicate

1. Living will – written directive that describes preferences under certain medical conditions

2. Durable power of attorney for healthcare (proxy / surrogate decision maker) – document in which person appoints an agent to make decisions

3. Do Not Resuscitate (DNR)

D. Treatment Refusal – Steps

1. Determine whether valid advance directive exists

2. Document clarifications/modifications/revocations of advance directive

3. Document determination of patient’s capacity/medical condition/prognosis/basis of no- treatment order

·  Withdrawal of life support – medical futility, brain death, or change in resuscitation status to “comfort measures only – DNR”

E. Decision-making capacity

·  Able to understand consequences of accepting/rejecting treatment, benefits/risks of treatment, alternatives to proposed treatment/refusal of treatment, and can communicate that decision

·  Presumption of capacity may be challenged – patient’s desire seems foolish, unwise, coerced, not in patient’s best interest

o  Situations –

1. Patient likely die without treatment and treatment highly likely to succeed

2. Patient seriously ill but mentally alert and treatment refusal almost certainly will lead to immediate death

3. Emergencies, when patient may be in shock

4. Patient under influence of psychotropic medications, sleep deprivation, undue coercion, depression, or suicidal ideation

F. Euthanasia / Assisted Suicide

·  Euthanasia – physician actively/intentionally ends patient life

·  Physician-Assisted Suicide – patient given access to means by which to end life

·  Laws

o  Most states – assisting/aiding/abetting suicide is felony

o  Oregon (Measure 16) – terminally ill can obtain prescriptions for drugs to end life

- Safeguards – 16-day waiting period, request twice orally and once in writing, second physician concurs, counseling if patient has mental disorder/impaired judgment/depression

IX. Peer-Review Process, Confidentiality, and the National Practitioner Data Bank

A. Peer Review

·  Continued evaluation/monitoring of qualifications/skills of physicians by colleagues

o  Facilitates candid/objective evaluation of physician’s professional conduct, competence, and ability to practice medicine

·  Legislatively mandated for

1. Provider credentialing – ensure minimum education/training/certification requirements met

2. Review of adverse clinical events/outcomes

B. Confidentiality

·  Peer-review committee proceedings = confidential

·  Immunity – limited immunity for peer-review participants in suits brought by disciplined physicians for money damages

o  Review action must be –

1. in reasonable belief that action was in furtherance of quality health care,

2. after a reasonable effort to obtain facts of the matter,

3. after adequate notice and hearing procedures afforded to physician involved, and

4. in reasonable belief that action was warranted by facts after a reasonable effort to obtain the facts.

·  Discovery of peer-review proceedings

o  Privilege = confidential and not subject to subpoena/discovery or introduced into evidence

o  Criminal conduct, fraud and abuse, antitrust actions

- Federal question cases – refuse to recognize privilege; need for evidence outweighs need for confidentiality of peer-review proceedings

- State laws – recognize qualified peer-review privilege in medical negligence cases (where state law is controlling)

- Exception – production hearings; after a hearing and for good cause arising from extraordinary circumstances being shown – may order disclosure

C. National Practitioner Data Bank

·  National clearinghouse for reports of