Medicolegal Aspects in Intensive Care

Quick Answer

Medicolegal aspects in intensive care encompass the legal framework governing consent, capacity, substitute decision-making, and professional liability in the care of critically ill patients. Informed consent requires disclosure, comprehension, voluntariness, and capacity; in emergencies, treatment may proceed under implied consent (doctrine of necessity) when delay would cause serious harm or death. Capacity assessment follows the Grisso-Appelbaum framework: understanding, appreciation, reasoning, and communication of choice. When patients lack capacity, substitute decision-makers (SDMs) provide consent according to a legally defined hierarchy that varies by Australian state/territory. Advance care directives (ACDs) and advance health directives (AHDs) take precedence when valid and applicable. Clinicians owe a duty of care to patients, with negligence requiring breach of duty causing harm (Bolam-Bolitho test). Open disclosure is mandatory for adverse events under ACSQHC standards. Coroner notification is required for reportable deaths including unexpected deaths, deaths during/after procedures, and deaths in custody. Documentation standards require contemporaneous, objective, legible entries with clear authorship. Intensivists may be called as expert witnesses or to give evidence, requiring objectivity, avoidance of hindsight bias, and adherence to court duties. Australian legislation varies significantly between states, requiring familiarity with local Guardianship Acts and Coroners Acts.

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CICM Exam Focus

Written Exam High-Yield Topics:

• Informed consent: elements, implied consent in emergencies, therapeutic privilege limitations
• Capacity assessment: four domains (Grisso-Appelbaum), decision-specific nature, fluctuating capacity
• Substitute decision-maker hierarchy: state-by-state variations (NSW, VIC, QLD, WA, SA, TAS, ACT, NT)
• Advance care directives: validity requirements, interpretation, limitations
• Duty of care: establishment, Bolam-Bolitho test, breach, causation
• Medical negligence: elements, documentation as defense, reasonable intensivist standard
• Open disclosure: ACSQHC framework, legal protections, apology legislation
• Coroner notification: reportable death categories, state legislation, physician obligations
• Documentation standards: CICM IC-7, contemporaneous entries, corrections, electronic records
• Expert witness role: duties to court, opinion evidence, avoiding hindsight bias

Viva Voce Themes:

• Capacity assessment in the critically ill patient (sedation, delirium, fluctuating capacity)
• Emergency treatment without consent: doctrine of necessity, two-physician rule
• Conflict between family wishes and clinical judgment
• Advance directive interpretation when circumstances differ from anticipated
• Coroner notification: when to report, what happens after
• Medical error disclosure: balancing honesty with medicolegal risk
• Giving evidence: subpoena, court procedure, expert witness preparation
• Indigenous health considerations in consent and decision-making

Hot Case Scenarios:

• Patient lacking capacity with no available family: emergency surgery decision
• Family disagreement with withdrawal of life-sustaining therapy
• Patient with advance directive declining ICU admission now requiring resuscitation
• Death following a procedure: determining reportability to Coroner

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Key Points

• Informed consent requires: disclosure (adequate information), comprehension (patient understanding), voluntariness (no coercion), and capacity (decision-making ability) (PMID: 30273748)
• Capacity assessment (Grisso-Appelbaum): understanding, appreciation, reasoning, communication; is decision-specific and time-specific (PMID: 15520660)
• MacArthur Competence Assessment Tool (MacCAT-T) is the gold standard for structured capacity assessment in ICU (PMID: 25324330)
• Implied consent applies in emergencies when treatment is necessary to prevent death or serious harm, and consent cannot be obtained (doctrine of necessity) (PMID: 15174070)
• 70-95% of ICU patients lack decision-making capacity, requiring surrogate consent for most decisions (PMID: 29106240)
• Substitute decision-maker hierarchy varies by Australian state: appointed guardian > spouse/partner > unpaid carer > close friend/relative
• Advance health directives take precedence over SDM decisions when valid and applicable to the clinical situation (PMID: 30139145)
• Duty of care established upon patient admission or consultation request; standard of care = "reasonably competent intensivist" (Bolam-Bolitho test)
• Negligence requires: duty of care, breach of duty, causation (but for test), and damage/harm
• Open disclosure is mandatory in Australia for adverse events under ACSQHC National Safety and Quality Health Service Standards (PMID: 24947776)
• Reportable deaths must be notified to Coroner; includes unexpected deaths, deaths during/after procedures, deaths in custody (state Coroners Acts)
• Documentation must be contemporaneous, legible, objective, signed, dated, and timed; alterations must preserve original entry
• Expert witnesses owe their primary duty to the court, not the instructing party; must avoid hindsight bias in evaluating clinical decisions
• State-by-state legislation differences are substantial; clinicians must know their jurisdiction's Guardianship Act and Coroners Act

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Clinical Overview

Consent in Intensive Care

Consent is a fundamental ethical and legal requirement for medical treatment. In ICU, the challenge is that most patients lack decision-making capacity due to critical illness, sedation, delirium, or metabolic derangement.

Types of Consent:

Elements of Valid Informed Consent (PMID: 21213215):

1. Disclosure: Provision of adequate information

   • Nature and purpose of the proposed intervention
   • Material risks (common risks, rare but serious risks)
   • Benefits and expected outcomes
   • Alternatives (including no treatment)
   • Clinician's recommendation
   • Rogers v Whitaker (1992): Australian High Court established the "reasonable patient" standard - disclose what a reasonable person in the patient's position would want to know

2. Comprehension: Patient understands the information

   • Use plain language, avoid jargon
   • Teach-back technique: patient explains back in own words
   • Consider health literacy, language barriers, cognitive impairment
   • Use interpreters for non-English speakers (professional, not family)

3. Voluntariness: Decision is free from coercion

   • No undue pressure from clinicians, family, or institutions
   • Time to consider options (where clinically appropriate)
   • Capacity to refuse treatment even if refusal seems unwise

4. Capacity: Decision-making ability present

   • Must be assessed before obtaining consent
   • Presumption of capacity unless demonstrated otherwise
   • Capacity is decision-specific and time-specific

Emergency Exception (Doctrine of Necessity) (PMID: 15174070):

When a patient lacks capacity and delay in treatment would cause death or serious harm, treatment may proceed without explicit consent under the doctrine of necessity (implied consent):

• Requirements:

  • Patient lacks capacity (cannot provide consent)
  • Emergency exists (delay would cause death or serious harm)
  • No available substitute decision-maker
  • Treatment is in patient's best interests
  • Treatment is what a reasonable person would consent to

• Documentation: Record the emergency circumstances, attempts to contact SDM, clinical necessity, and rationale

• Two-physician rule: In some jurisdictions and policies, having two physicians agree on necessity strengthens medicolegal protection

Therapeutic Privilege:

Historically, clinicians could withhold information if disclosure would cause serious harm to the patient. This is now very narrowly applied:

• Not applicable simply because information is distressing
• Rarely justified in modern practice
• Does not apply to substitute decision-makers
• May be appropriate in rare psychiatric emergencies

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Capacity Assessment

Definition: Capacity (clinical) refers to a patient's ability to make a specific healthcare decision at a specific time. Competence (legal) is a court determination. In practice, clinical capacity assessments are accepted as the standard.

Grisso-Appelbaum Framework (Four Domains) (PMID: 15520660):

Key Principles:

1. Presumption of capacity: All adults are presumed to have capacity until demonstrated otherwise
2. Decision-specific: A patient may have capacity for simple decisions but not complex ones
3. Time-specific: Capacity may fluctuate (delirium, sedation, hypoxia)
4. Unwise decisions ≠ incapacity: Patients may make decisions clinicians disagree with
5. Threshold varies with risk: Higher-risk decisions require more rigorous assessment

MacArthur Competence Assessment Tool for Treatment (MacCAT-T) (PMID: 25324330):

• Structured semi-standardized interview
• Gold standard for capacity assessment
• Assesses all four Grisso-Appelbaum domains
• Takes 15-20 minutes to administer
• Provides scoring for each domain
• Does not give a binary "capacity" result - clinical judgment still required

Capacity Assessment in ICU - Special Considerations:

Documentation of Capacity Assessment:

A robust medicolegal record should document:

• Date and time of assessment
• Clinical context and decision being assessed
• Assessment of each of the four domains
• Specific questions asked and patient responses
• Presence of any capacity-impairing factors
• Conclusion regarding capacity for this specific decision
• Plan if capacity is lacking (SDM identification, reassessment timing)

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Substitute Decision-Makers

When a patient lacks capacity, a substitute decision-maker (SDM) provides consent on the patient's behalf. The hierarchy of SDMs is defined by legislation that varies significantly between Australian states and territories.

Australian State-by-State Substitute Decision-Maker Hierarchy:

(PMID: 28434316)

Principles of Substitute Decision-Making:

1. Substituted Judgment Standard: SDM should decide what the patient would have wanted (based on known values, beliefs, prior statements)

   • Primary standard when patient's wishes are known
   • "What would the patient have decided if they could?"

2. Best Interests Standard: When patient's wishes are unknown, SDM decides based on patient's best interests

   • Secondary standard when wishes are unknown
   • Considers benefits, burdens, quality of life

3. SDM authority is limited to:

   • Decisions the patient would have been entitled to make
   • Decisions not covered by a valid advance directive
   • Does not extend to demanding futile or harmful treatment

4. SDM responsibilities:

   • Gather information about patient's values and prior wishes
   • Consider patient's best interests
   • Make decision patient would have made
   • Not impose their own values on the decision

When SDM is Unavailable or Cannot Be Identified:

• Document attempts to identify and contact SDM
• Apply doctrine of necessity for emergency treatment
• Consider Public Guardian/Public Advocate involvement
• Two-physician agreement for non-emergency decisions
• QCAT/NCAT/VCAT emergency application (urgent guardian appointment)

Conflict Resolution (PMID: 26509317):

When SDM decision conflicts with clinical recommendation:

1. Ensure SDM understands the clinical situation (PMID: 30855665)
2. Explore SDM's understanding of patient's values
3. Involve other family members (if SDM agrees)
4. Ethics consultation
5. Consider second medical opinion
6. If unresolved: seek Guardianship Tribunal review

Surrogate Decision-Maker Burden (PMID: 21357911):

Making treatment decisions for others causes significant psychological burden. Support SDMs by:

• Providing clear, consistent information
• Emphasizing they are honoring patient's wishes, not "choosing death"
• Allowing time for family discussion
• Offering pastoral and psychological support
• Acknowledging the difficulty of their role

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Advance Care Directives

Advance care directives (ACDs) allow competent adults to document their future healthcare preferences in case they lose capacity. They may also appoint a substitute decision-maker.

Types of Advance Directives in Australia:

(PMID: 30139145)

Requirements for Valid Advance Health Directive:

Limitations of Advance Directives:

1. Applicability: Must apply to the current clinical situation

   • "No ventilation" for terminal cancer may not apply to reversible pneumonia
   • Interpret in context of overall goals

2. Contemporaneous statements may take precedence:

   • Recent verbal statements by a capacitous patient override older written directives

3. Cannot demand inappropriate treatment:

   • Directive cannot compel futile or harmful treatment
   • Cannot override professional judgment on clinical appropriateness

4. Emergency treatment exception:

   • In life-threatening emergency, may treat while clarifying directive applicability
   • Document rationale

Interpreting Advance Directives in ICU (PMID: 31256331):

• Consider the intent behind the directive
• Consult SDM and family for context
• Was this situation anticipated when directive was made?
• Would the person have the same preference given current circumstances?
• Ethics consultation if uncertainty exists
• Document interpretation and rationale

Futility and Inappropriate Treatment (PMID: 25978438):

Advance directives cannot compel treatment that is:

• Physiologically futile (will not achieve intended effect)
• Medically inappropriate (burdens outweigh benefits)
• Outside standard of care

The ATS/AACN/ACCP/ESICM/SCCM Policy Statement provides guidance on responding to requests for potentially inappropriate treatments.

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Duty of Care and Negligence

Duty of Care:

A duty of care is established when a doctor-patient relationship exists. In ICU, this occurs upon:

• Patient admission to ICU
• Consultation request accepted
• Telephone advice provided
• Involvement in emergency response

Elements of Medical Negligence (PMID: 27573341):

To establish negligence, the plaintiff (patient/family) must prove all four elements:

Standard of Care - Bolam and Bolitho Tests:

• if practice is supported by a responsible body of peers, it is not negligent | | Bolitho Modification (1998) | Bolitho v City & Hackney Health Authority | The practice must have a "logical basis"
• court can reject even a widely held opinion if illogical | | Australian Position | Rogers v Whitaker (1992) | Bolam applies to treatment decisions; for disclosure/consent, the "reasonable patient" standard applies |

Common Areas of ICU Litigation (PMID: 28835461):

1. Diagnostic errors: Failure to diagnose sepsis, PE, MI, meningitis
2. Procedural complications: Central line insertion, intubation, tracheostomy
3. Monitoring failures: Failure to respond to deterioration, alarm fatigue
4. Communication failures: Handover errors, failure to escalate, miscommunication (PMID: 10966293)
5. End-of-life decisions: Withdrawal without consent, failure to discuss prognosis (PMID: 20194817)
6. Falls and pressure injuries: Preventable complications
7. Medication errors: Wrong drug, wrong dose, drug interactions

Defenses in Medical Negligence:

1. Met standard of care: Practice was in accordance with responsible medical opinion
2. No breach: Followed accepted protocols and guidelines
3. No causation: Outcome would have occurred regardless of alleged breach
4. Contributory negligence: Patient contributed to their own harm
5. Volenti non fit injuria: Patient consented to the risk

Risk Mitigation Strategies:

• Follow evidence-based guidelines (ANZICS-CORE, CICM, SSC)
• Document decision-making rationale
• Communicate with patients/families
• Escalate concerns appropriately
• Participate in morbidity and mortality reviews
• Maintain competence through continuing education

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Medical Error Disclosure and Open Disclosure

Open Disclosure Framework (ACSQHC) (PMID: 24947776):

Open disclosure is the process of providing an open, consistent approach to communicating with patients/families following adverse events. It is mandatory under the National Safety and Quality Health Service Standards (Standard 1: Clinical Governance).

Elements of Open Disclosure:

Apology Legislation in Australia:

All Australian jurisdictions have enacted "apology legislation" that protects expressions of regret from being used as admissions of liability:

What an Apology May Include (Protected):

• Expression of sympathy or regret
• Statement that the person is sorry
• Expression of compassion for suffering

What May NOT Be Protected:

• Admission of fault or liability
• Statement of specific causation
• Acknowledgment of substandard care

SAC (Severity Assessment Code) Rating:

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Coroner Notification Requirements

In Australia, certain deaths must be reported to the Coroner. Legislation varies by state, but categories of reportable deaths are broadly similar.

Categories of Reportable Deaths (PMID: 26490036):

State Coroner Legislation:

Procedural/Healthcare-Related Deaths - Key Points:

• Anaesthetic deaths: Death during, or attributable to, administration of anaesthetic
• Surgical deaths: Death during or following surgery where surgery contributed
• Procedural deaths: Death during or following a diagnostic or therapeutic procedure
• The "unexpected" criterion: Death that was not an expected outcome of the patient's condition or treatment
• No time limit: Previous "24-hour" rules largely replaced by "unexpected outcome" approach

Physician Obligations:

Coronial Process (PMID: 27059793):

1. Notification: Death reported to Coroner
2. Investigation: Coroner orders investigation (may include autopsy)
3. Determination: Coroner determines identity, cause, and circumstances of death
4. Inquest: Formal hearing (not in all cases) if death is complex or public interest
5. Findings and recommendations: Coroner may make recommendations to prevent similar deaths

The Coroner Cannot:

• Make findings of civil liability
• Make findings of criminal guilt (but may refer to DPP)
• Order compensation

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Documentation Standards

Clinical documentation is the primary medicolegal record of patient care. In negligence litigation, "if it wasn't documented, it didn't happen."

CICM Professional Document IC-7: Administrative Services (PMID: 26944524):

Medicolegal Documentation Principles:

Corrections to Medical Records:

Essential ICU Documentation:

1. Admission note:

   • Presenting problem and history
   • Examination findings
   • Investigations and results
   • Diagnosis (or differential)
   • Management plan
   • Code status/goals of care

2. Daily progress note (systems-based):

   • Neurological: GCS, sedation (RASS), delirium (CAM-ICU)
   • Respiratory: Ventilator settings, ABG, weaning plan
   • Cardiovascular: Vasopressors, rhythm, fluid balance
   • Renal: UO, CRRT settings, electrolytes
   • Infectious Disease: Antibiotics (day X), cultures, procalcitonin
   • GI/Nutrition: Feeding, motility, liver function
   • Haematology: Coagulation, transfusions
   • Endocrine: Glucose, cortisol status
   • Lines/drains: Location, day of insertion, plan

3. Procedure notes:

   • Indication
   • Consent obtained (and from whom)
   • Technique (including US guidance, sterile precautions)
   • Findings
   • Complications (or "nil immediate complications")
   • Post-procedure plan

4. Family meeting notes:

   • Attendees (names and relationships)
   • Key information conveyed
   • Questions asked
   • Decisions made
   • Outstanding concerns
   • Follow-up plan

5. End-of-life decisions:

   • Decision-making capacity assessment
   • SDM consultation
   • Goals of care discussion
   • Treatment limitation orders (specific)
   • Comfort measures ordered
   • Family support plan

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Giving Evidence and Expert Witness Role

Intensivists may be called to give evidence as a treating physician (fact witness) or as an expert witness (opinion evidence).

Treating Physician as Witness:

Expert Witness Role (PMID: 27158543):

An expert witness provides independent opinion evidence to assist the court in understanding clinical matters.

Duties of Expert Witness:

Expert Witness Report Requirements:

1. Expert's qualifications and experience
2. Statement of facts assumed
3. Documents/materials reviewed
4. Questions posed and answers
5. Reasoning process
6. Opinion on standard of care
7. Opinion on causation (if asked)
8. Statement acknowledging duties to court
9. Declaration that opinion is genuinely held

Avoiding Hindsight Bias:

The expert must evaluate the clinician's decisions based on information available at the time, not with the benefit of knowing the outcome:

• What was known when the decision was made?
• What would a reasonably competent intensivist have done with that information?
• Was the clinical reasoning sound given the available data?
• Outcome does not determine whether care was appropriate

Bolam-Bolitho Applied by Expert:

• Was the treatment supported by a "responsible body of medical opinion"?
• Did the practice have a "logical basis"?
• Guidelines are evidence of standard but not determinative
• Variations from guidelines may be justified by clinical circumstances

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State-by-State Australian Legislation Summary

Key Legislation by State:

(PMID: 28434316; PMID: 30139145)

Key Differences to Know:

1. Victoria (VIC): Medical Treatment Planning and Decisions Act 2016 introduced the Medical Treatment Decision Maker (MTDM) as a specific role, separate from general guardianship

2. Queensland (QLD): Statutory Health Attorney concept - automatic default hierarchy if no appointed attorney

3. South Australia (SA): Advance Care Directives Act 2013 most comprehensive advance directive legislation with binding effect and requirement for doctor witness

4. New Zealand: Differs from all Australian states - governed by Code of Health and Disability Services Consumers' Rights

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Indigenous Health Considerations

Aboriginal and Torres Strait Islander Peoples:

Medicolegal considerations must account for cultural factors affecting consent and decision-making (PMID: 31063040):

Religious and Cultural Considerations in End-of-Life (PMID: 17541555):

The ETHICUS study demonstrated significant variation in end-of-life practices based on religious affiliation and geographic region. Clinicians must:

• Inquire about religious and cultural beliefs early
• Involve chaplaincy and cultural liaison services
• Respect cultural practices around death and dying
• Document cultural considerations in care planning

Best Practice:

• Involve Aboriginal Health Workers (AHWs) and Aboriginal Liaison Officers (ALOs) early
• Ask patient/family about cultural protocols for decision-making
• Allow time for family consultation
• Document cultural considerations in care planning
• Consider cultural protocols around death and dying

Māori Health Considerations (New Zealand):

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Applied Basic Sciences

Legal Frameworks

Common Law vs Statutory Law:

Key Australian Cases in Medical Law:

Hierarchy of Decision-Making Authority:

1. Competent patient - highest authority; can refuse any treatment
2. Valid advance health directive - binding if applicable to situation
3. Appointed guardian/enduring guardian - if appointed with health decisions authority
4. Tribunal-appointed guardian - NCAT/VCAT/QCAT appointed
5. Statutory hierarchy - default "person responsible"
6. Clinician determination - only when no SDM available and emergency/necessity applies
7. Public Guardian/Advocate - may consent if no other SDM available

Ethical Frameworks Applied to Medicolegal Situations

Principlism in Medicolegal Context:

Conflicts Between Ethical and Legal Frameworks:

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Investigations

Capacity Assessment Tools

Documentation Review for Medicolegal Purposes

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Management Approach

Consent Pathway in ICU

┌─────────────────────────────────────────┐
│         DOES PATIENT HAVE CAPACITY?      │
└──────────────────┬──────────────────────┘
                   │
          ┌────────┴────────┐
          │                 │
         YES                NO
          │                 │
          ▼                 ▼
┌─────────────────┐  ┌─────────────────────────┐
│ Obtain informed │  │ IS THIS AN EMERGENCY?    │
│ consent from    │  └──────────┬──────────────┘
│ patient         │             │
└─────────────────┘    ┌────────┴────────┐
                       │                 │
                      YES                NO
                       │                 │
                       ▼                 ▼
         ┌─────────────────────┐  ┌─────────────────────┐
         │ Proceed under       │  │ IDENTIFY SDM        │
         │ DOCTRINE OF         │  │ (hierarchy by state)│
         │ NECESSITY           │  └──────────┬──────────┘
         │ Document rationale  │             │
         └─────────────────────┘             ▼
                                 ┌─────────────────────┐
                                 │ IS THERE A VALID    │
                                 │ ADVANCE DIRECTIVE?  │
                                 └──────────┬──────────┘
                                            │
                                   ┌────────┴────────┐
                                   │                 │
                                  YES                NO
                                   │                 │
                                   ▼                 ▼
                     ┌─────────────────────┐  ┌─────────────────────┐
                     │ Follow directive    │  │ Obtain SDM consent  │
                     │ if applicable       │  │ (substituted        │
                     │ to situation        │  │ judgment)           │
                     └─────────────────────┘  └─────────────────────┘

Capacity Assessment Pathway

1. Identify the decision - What specific decision requires consent?
2. Presume capacity - Start with assumption patient has capacity
3. Assess each domain:
   • Understanding: Does patient comprehend the information?
   • Appreciation: Does patient recognize how it applies to them?
   • Reasoning: Can patient weigh options?
   • Communication: Can patient express a consistent choice?
4. Document assessment - Record questions asked, answers given, conclusion
5. If lacking capacity:
   • Is this reversible? (Treat delirium, reduce sedation)
   • When should capacity be reassessed?
   • Identify SDM
6. If borderline capacity:
   • Second opinion
   • Consider formal MacCAT-T
   • Ethics consultation

Coroner Notification Pathway

┌─────────────────────────────────────────┐
│         DEATH HAS OCCURRED               │
└──────────────────┬──────────────────────┘
                   │
                   ▼
┌─────────────────────────────────────────┐
│   IS THE CAUSE OF DEATH KNOWN?           │
└──────────────────┬──────────────────────┘
                   │
          ┌────────┴────────┐
          │                 │
         YES                NO ──────────────────► REPORT TO CORONER
          │
          ▼
┌─────────────────────────────────────────┐
│   WAS THE DEATH EXPECTED?                │
└──────────────────┬──────────────────────┘
                   │
          ┌────────┴────────┐
          │                 │
         YES                NO ──────────────────► REPORT TO CORONER
          │
          ▼
┌─────────────────────────────────────────┐
│   WAS THERE A PROCEDURE/ANAESTHETIC?     │
│   (that may have contributed)            │
└──────────────────┬──────────────────────┘
                   │
          ┌────────┴────────┐
          │                 │
          NO               YES ─────────────────► REPORT TO CORONER
          │
          ▼
┌─────────────────────────────────────────┐
│   WAS THE PERSON IN CUSTODY/CARE?        │
└──────────────────┬──────────────────────┘
                   │
          ┌────────┴────────┐
          │                 │
          NO               YES ─────────────────► REPORT TO CORONER
          │
          ▼
┌─────────────────────────────────────────┐
│   CAN A DEATH CERTIFICATE BE ISSUED?     │
│   (Doctor has seen patient, known        │
│    natural cause of death)               │
└──────────────────┬──────────────────────┘
                   │
          ┌────────┴────────┐
          │                 │
         YES                NO ─────────────────► REPORT TO CORONER
          │
          ▼
    Issue Medical Certificate
    of Cause of Death (MCCD)

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Prognosis and Outcome Measures

Medicolegal Outcomes

Documentation Quality Metrics

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Monitoring and Complications

Warning Signs of Medicolegal Risk

Preventing Medicolegal Issues

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SAQ Practice

SAQ 1: Consent and Capacity in ICU (20 marks)

Stem: A 72-year-old woman is admitted to ICU with severe community-acquired pneumonia requiring mechanical ventilation. She is sedated and has delirium. Her husband of 45 years is at the bedside. She has no advance health directive. The surgical team requests consent for an emergency tracheostomy due to failed extubation.

Questions:

a) Describe how you would assess this patient's decision-making capacity if sedation were reduced. (4 marks)

b) Outline the elements required for valid informed consent and explain why each is important. (4 marks)

c) The patient lacks capacity. Describe the substitute decision-maker hierarchy in your state/territory and identify who can provide consent in this case. (4 marks)

d) The husband states "she would never want a tracheostomy - she told me that." How would you approach this situation? (4 marks)

e) If the husband cannot be contacted and the tracheostomy is urgently required, under what legal doctrine may you proceed? What documentation is required? (4 marks)

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Model Answer:

a) Capacity Assessment (4 marks)

Capacity assessment follows the Grisso-Appelbaum framework with four domains (1 mark each):

1. Understanding: Assess comprehension of relevant information

   • "Can you tell me why you are in hospital?"
   • "What is a tracheostomy and why is it being recommended?"

2. Appreciation: Recognition of how information applies to self

   • "How do you think this breathing problem affects you?"
   • "Do you believe you need this procedure?"

3. Reasoning: Ability to weigh options and consequences

   • "What do you see as the benefits and risks of having the tracheostomy?"
   • "What would happen if we don't do it?"

4. Communication: Expression of a clear, consistent choice

   • "What is your decision about this procedure?"
   • Assess stability of choice over time

Prerequisites: Minimize sedation, treat delirium, optimize metabolic state, use communication aids if needed. Document the assessment in detail.

b) Elements of Valid Informed Consent (4 marks)

c) Substitute Decision-Maker Hierarchy (4 marks)

Example for NSW (adapt to relevant state):

Under the Guardianship Act 1987 (NSW), the hierarchy of "Person Responsible" is (1 mark):

1. Guardian (if appointed with health authority)
2. Spouse or de facto partner (including same-sex)
3. Person who has unpaid care of the patient
4. Close friend or relative

In this case, the husband is the spouse and would be the appropriate SDM (1 mark).

The SDM must make decisions using:

• Substituted judgment standard (what the patient would have decided) if patient's wishes are known (1 mark)
• Best interests standard if patient's wishes are unknown (1 mark)

d) Approach to Husband's Statement (4 marks)

1. Clarify the context (1 mark):

   • When did she say this? In what circumstances?
   • Was she discussing a reversible illness or terminal condition?
   • Did she have capacity when she made this statement?

2. Explore applicability (1 mark):

   • Was she anticipating this specific situation?
   • Would she feel the same about a potentially reversible condition?

3. Multidisciplinary discussion (1 mark):

   • Clarify medical prognosis and likelihood of recovery
   • Discuss temporary vs permanent tracheostomy
   • Consider trial of treatment with later review

4. If conflict persists (1 mark):

   • Ethics consultation
   • Second medical opinion
   • If family insists on non-treatment and team believes treatment beneficial, consider Guardianship Tribunal application

e) Doctrine of Necessity (4 marks)

Legal doctrine: Doctrine of necessity / implied consent (1 mark)

Requirements (1 mark):

• Patient lacks capacity
• Emergency exists (delay would cause death or serious harm)
• No SDM available despite reasonable attempts
• Treatment is in patient's best interests
• Treatment is what a reasonable person would consent to

Documentation required (2 marks):

• Attempts to contact husband (times, phone numbers, messages left)
• Clinical urgency (airway compromise, risk of cardiac arrest)
• Assessment that patient lacks capacity
• Agreement of treating team (consider two-physician documentation)
• Rationale: treatment is life-saving and reasonable person would consent
• Plan for communication with husband as soon as possible

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SAQ 2: Coroner Notification and Open Disclosure (20 marks)

Stem: A 58-year-old man underwent elective coronary artery bypass surgery 3 days ago. Post-operatively he developed respiratory failure requiring ICU admission and mechanical ventilation. Despite maximal therapy, he died this morning from multiorgan failure. The surgical team asks you to sign the death certificate.

Questions:

a) List the categories of deaths that are reportable to the Coroner in Australian jurisdictions. (4 marks)

b) Is this death reportable to the Coroner? Justify your answer with reference to the relevant criteria. (4 marks)

c) If you determine the death is reportable, outline your obligations as the treating intensivist. (4 marks)

d) The family states they were not informed of the risk of death during consent for surgery. Outline the framework for open disclosure in this situation. (4 marks)

e) Describe the apology legislation that exists in Australia and its implications for open disclosure conversations. (4 marks)

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Model Answer:

a) Categories of Reportable Deaths (4 marks)

Reportable deaths include (0.5 marks each, max 4):

1. Cause unknown: Death where cause cannot be determined
2. Violent or unnatural: Accidents, suicides, homicides, suspicious circumstances
3. During or as a result of procedure: Death during/following medical/surgical procedure or anaesthetic where procedure may have contributed
4. In custody or detention: Prisoners, police custody, immigration detention
5. In care: Persons in residential care facilities (some jurisdictions)
6. Healthcare-related death: Unexpected outcome of healthcare
7. Mental Health Act: Involuntary psychiatric patients
8. No recent medical attendance: Doctor has not seen patient recently (varies by state)

b) Reportability Assessment (4 marks)

This death IS reportable (1 mark).

Justification (3 marks):

• Procedure-related death: Patient died following elective CABG surgery (1 mark)
• Unexpected outcome: Elective surgery with expectation of recovery, not anticipated fatal outcome (1 mark)
• Healthcare-related: Question of whether intra- or post-operative care may have contributed to death (1 mark)

Even though multiorgan failure has a proximate "natural" cause, the fact that death followed an elective procedure and was not an expected outcome makes it reportable under most state Coroners Acts.

c) Intensivist Obligations (4 marks)

1. Do NOT sign the death certificate - if reportable, MCCD must not be issued (1 mark)

2. Notify the Coroner (1 mark):

   • Via hospital coronial liaison officer or directly
   • Provide patient details and brief clinical summary
   • Answer Coroner's questions

3. Preserve evidence (1 mark):

   • Do not remove lines, tubes, drains (Coroner may request)
   • Secure medications and equipment
   • Preserve all medical records

4. Inform and support family (1 mark):

   • Explain that death is being reported to Coroner
   • Explain coronial process (may involve autopsy)
   • Maintain compassionate communication
   • Arrange pastoral/social work support

d) Open Disclosure Framework (4 marks)

Open disclosure is mandatory under ACSQHC National Safety and Quality Health Service Standards (1 mark).

Elements of open disclosure (3 marks):

Timing: Initial conversation within 24 hours, with follow-up meetings as investigation proceeds.

e) Apology Legislation (4 marks)

Legislation exists in all Australian jurisdictions to protect expressions of regret from being used as admissions of liability (1 mark).

What IS protected (1.5 marks):

• Expression of sympathy or regret
• Statement that the person is sorry
• Expression of compassion for the suffering experienced
• General acknowledgment of an adverse outcome

What is NOT protected (1.5 marks):

• Admission of fault or specific liability
• Statement accepting causation
• Acknowledgment that care was substandard
• Statement admitting breach of duty

Implications for open disclosure: Clinicians can (and should) express genuine empathy and regret without fear that this will be used against them in litigation. Avoid making specific admissions of fault or causation during open disclosure conversations, but do not withhold compassion.

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Viva Voce Scenarios

Viva 1: Capacity Assessment and Emergency Consent

Examiner Introduction: "A 45-year-old man is brought to your ICU from the emergency department with severe community-acquired pneumonia and septic shock. He is hypotensive despite fluid resuscitation and requires urgent central venous access. He is confused and agitated but intermittently responds to questions. His wife is en route but will take 2 hours to arrive. Tell me about your approach to consent for central line insertion."

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Candidate Response (Expected Framework):

"This is a clinical scenario requiring urgent intervention in a patient with potentially impaired capacity and no immediately available substitute decision-maker. My approach would address capacity assessment, the emergency consent framework, and documentation."

Examiner: "How would you assess his capacity?"

"I would use the Grisso-Appelbaum framework to assess the four domains of capacity:

1. Understanding: Can he comprehend information about the central line procedure, its purpose, and risks?
2. Appreciation: Does he recognize how this applies to his own situation?
3. Reasoning: Can he weigh the benefits against risks?
4. Communication: Can he express a clear and stable choice?

Given his confusion and agitation, which suggest delirium in the context of sepsis, I would anticipate he lacks capacity for this decision. I would document my assessment of each domain and my conclusion."

Examiner: "He is unable to understand the procedure due to delirium. His wife cannot be reached. Can you proceed?"

"Yes, I can proceed under the doctrine of necessity (implied consent). This legal doctrine permits emergency treatment when:

• The patient lacks capacity
• There is a genuine emergency where delay would cause serious harm
• No substitute decision-maker is available
• Treatment is in the patient's best interests
• A reasonable person would consent

Central venous access for resuscitation in septic shock meets these criteria. I would document:

• My capacity assessment findings
• The clinical emergency (hypotension, need for vasopressors)
• Attempts to contact wife (phone calls, times)
• Rationale for proceeding
• Ideally, agreement from a second senior physician

I would also ensure the wife is informed as soon as she arrives."

Examiner: "The procedure is performed. An hour later, the wife arrives and says her husband has a document at home stating he does not want invasive procedures. What do you do?"

"This raises the question of a potential advance health directive. I would:

1. Obtain the document to determine if it is a valid advance directive
2. Assess validity: Was it made when he had capacity? Is it witnessed appropriately? Is it revoked?
3. Assess applicability: Does 'invasive procedures' include central lines? Was he contemplating a reversible illness like pneumonia, or terminal illness?
4. Contextual interpretation: The purpose of the directive matters. If refusing futile treatment at end of life, it may not apply to a reversible condition

If the directive clearly and specifically refuses central lines in this context, I would need to consider withdrawal. However, given the treatment has already been provided in an emergency and the patient is currently unable to participate in decision-making, I would:

• Continue current treatment
• Arrange ethics consultation
• Have a detailed discussion with the wife about his values and wishes
• Reassess if and when he regains capacity"

Examiner: "Good. What are the key differences in advance directive legislation between Australian states?"

"There are significant differences:

All require the directive to have been made with capacity, be applicable to the current situation, and not be revoked. The key is to interpret the directive in light of the patient's overall values and goals, not just the literal text."

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Viva 2: Medical Negligence and Expert Witness

Examiner Introduction: "You have been asked to provide an expert opinion in a medical negligence case. A 68-year-old woman with COPD was admitted to another hospital's ICU with respiratory failure. She developed ventilator-associated pneumonia and subsequently died. The family alleges the ICU team failed to recognize deterioration and that antibiotics were delayed. Tell me about your approach."

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Candidate Response:

"This is a request to act as an expert witness in a medical negligence case. I would need to understand my duties and approach this systematically."

Examiner: "What are your duties as an expert witness?"

"As an expert witness, my primary duty is to the court, not to the party instructing me. Key duties include:

1. Objectivity and impartiality: Provide honest, unbiased opinion regardless of who instructs me
2. Opinion within expertise: Only opine on matters within my area of expertise as an intensivist
3. Basis for opinion: Explain the reasoning and evidence underlying my opinion
4. Disclosure of limitations: Acknowledge areas of uncertainty or outside my expertise
5. Avoid advocacy: Not to advocate for one party's case

I must provide my genuinely held opinion, even if it is not favorable to the instructing party."

Examiner: "How would you assess whether there was a breach of duty of care?"

"I would apply the Bolam-Bolitho test adapted to the Australian context:

Bolam (1957): The standard of care is that of a 'responsible body of medical opinion.' If the treatment was supported by a responsible body of intensivists, it is not negligent.

Bolitho (1998): The practice must have a 'logical basis.' Even if peers support a practice, the court can reject it if illogical.

I would consider:

1. What was the standard of care for VAP diagnosis and antibiotic timing in ICU?

   • ANZICS-CORE guidelines
   • Surviving Sepsis Campaign recommendations
   • Published evidence on VAP management

2. Was the care provided consistent with that standard?

   • Review the medical records
   • Identify timing of clinical deterioration, recognition, and antibiotic administration
   • Compare against expected practice

3. Contextual factors:

   • What information was available to the treating team at the time?
   • Were there reasonable explanations for any delays?
   • Avoid hindsight bias"

Examiner: "The family's lawyer asks you to comment that the delay 'definitely caused the death.' How do you respond?"

"I cannot make that statement. Causation in medical negligence requires the 'but for' test: 'But for the delay, would the patient have survived?'

This is particularly difficult in ICU patients because:

• They have high baseline mortality
• Multiple factors contribute to outcomes
• VAP itself carries significant mortality regardless of antibiotic timing

I would need to:

1. Review the literature on antibiotic timing and VAP mortality
2. Consider this specific patient's comorbidities and severity of illness
3. Acknowledge that while timely antibiotics improve outcomes, I cannot state with certainty that earlier treatment would have prevented death

I would express my opinion in terms of probability: 'On the balance of probabilities, did the delay contribute to the death?' rather than stating 'definitely.'"

Examiner: "What is hindsight bias and why is it important to avoid?"

"Hindsight bias is the tendency to view past events as having been more predictable than they actually were at the time.

In medicolegal contexts, this means judging the clinician's decisions with the knowledge of the bad outcome, rather than based on what was known at the time of decision-making.

To avoid hindsight bias, I would:

• Focus only on information available to the treating team at the time
• Consider what a reasonable intensivist would have done with that information
• Recognize that a bad outcome does not mean care was negligent
• Acknowledge uncertainty and clinical complexity

A good outcome does not prove good care, and a bad outcome does not prove bad care. The question is whether the clinical reasoning and actions were appropriate given the circumstances."

Examiner: "Good. One final question: if you concluded the care was reasonable, can you still take the case as an expert for the plaintiff?"

"If I genuinely believe the care met the standard, I should decline to provide a report supporting negligence. My duty is to the court to provide an honest opinion. I cannot act as an advocate for a position I do not hold.

I would inform the instructing solicitors of my opinion and offer to provide my report stating that, in my view, the care was reasonable. They may choose not to use my report, but I cannot modify my opinion to support their case."