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Informed Consent Presented By

Associate Professor Catherine TayNational University of Singapore (NUS)Faculty of Business Administration

Bachelor of Laws (Hons), LondonMaster of Laws, LondonBarrister-at-Law (England)Advocate & Solicitor, Singapore

Author of ‘Medical Negligence’ Book

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Informed Consent

Things can go wrong in surgical procedure and bad outcome and adverse results may result due to human error, negligent or not.

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Informed Consent

You did not inform me of the risk which became a reality. I would not have consented to the operation if I had known of the risks, so you have

- caused my injury and

- failed in your medical duty of care to inform

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Inforrmed Consent

Is there sufficient information to patient’s consent?

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Inforrmed Consent

Consent is an ethical principle

Medical treatment can only be performed with consent of competent pt

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Informed Consent

Giving treatment without consent is failure to respect patient’s autonomy violating an individual’s right of self-determination

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Informed Consent

Consent must be freely given with patient understanding

- the nature

- risks

- benefits

- alternatives

- limitations

of proposed treatment.

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Informed Consent

Any medical treatment given without consent is an action for trespass where damages are payable

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Inforrmed Consent

The consent form is for patient to acknowledge that the nature & purpose of treatment has been

- fully explained - understood and - consented to.

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Informed Consent

Pt never consented to doctor’s negligence but only to risks & complications involved

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Inforrmed Consent

In an emergency, where pt is unable to consent eg unconsciousness, a doctor is justified to carry out emergency treatment based on

- doctrine of necessity or - implied consent

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Informed Consent

Implied Consent

It is presumed that pt would have consented to treatment as it was necessary to save his life or from serious harm

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Doctor’s Legal Duty to Disclose information What is the level or standard

of disclosure to be expected in medical law?

A pt can only give real consent to treatment if he has sufficient information to make a decision for an informed consent

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Checklist - Informed Consent name of operation nature of proposed treatment what the operation involves other treatment options or

alternatives potential complications risks of operation risk of no treatment

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Checklist

special precautions required post-operatively

benefits of treatment limitations of treatment success rate of operation what happens on admission how pt will feel after treatment

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Informed Consent

Information include warning

Warn of any real risk that treatment may be ineffective

Alternative treatments should be told esp. if got choice between surgical & medical procedures

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Informed Consent

The fact that pt asked questions showing concern about the risk would make doctor aware that pt does attach significance to the risk

A lot depends on pt’s way of questioning

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Rogers v Whittaker (1992) A 1:14,000 of blindness turned

into a risk which it was found to be negligent not to disclose

A risk, even if it is a mere possibility, should be regarded as ‘material’ if its occurrence causes serious consequences

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Informed Consent

Once pt ask “How serious?” the operation is, doctor should discuss

- the relative conveniences

- expertise

- possible risks.

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Informed Consent

To say less is misleading & inadequate

Good communication is stressed and is highly desirable between doctor-pt relationship

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Medical Negligence

Failure by doctor to disclose risks of treatment can result in action for negligence

The test which medical negligence is assessed is Bolam test , now modified by Bolitho case

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Bolitho case

Failure of hospital doctor to examine & intubate child experiencing respiratory distress, leading to brain damage through asphyxia

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Bolitho case (1997)

Pt had expert evidence that a reasonably competent doctor would have intubated in those circumstance

- Doctor had own expert witnesses saying that non-intubation was clinically justifiable response

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Bolam Test

A doctor is not negligent if what he has done is accepted current practice by a responsible body of medical opinion

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Bolitho case

House of Lords case

The court must be satisfied that the body of opinion is logical

Clearly this rejection of Bolam test

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Bolitho case

It is now a matter for court & not medical opinion to decide standard of professional care

Bolitho case represented a significant nail on Bolam’s coffin

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Kamalam v Eastern Planttaion Agency(1996) Malaysian case – where Bolam

test not folllowed

A Malaysian judge can now decide on his own disregarding expert medical evidence on the sufficiency of consent – informed consent

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Informed Consent

Medical opinions are still required to assist the court in its deliberation

Bolam test has been challenged & rejected in America, Canada, Australia, South Africa & Malaysia

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Singapore cases

Dennis Matthew Harte v Dr Tan Hun Hoe & Gleneagles Hospital Ltd [1999]

Gumapathy Muniandy v Dr James Khoo & 2 others – July 2001

Pai Lily v Yeo Peng Hock Henry [2000]

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Informed Consent

Highly desirable for doctor to record in his medical notes that

- risks and alternatives were disclosed & - understood by pts,

apart from pt signing consent form

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Medical Ethics

It is no harm to disclose all ‘material risks’ & information to pts as they have a right to do what they want with their own bodies

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Medical Ethics

Pts could choose to do nothing after being informed of options/alternatives& consequences of no treatment

This is respecting pt’s autonomy or self-determination in biomedical ethics

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Medical Ethics

Doctors must abide by the high professional standards

Hippocratic Oath is a moral code concerning beneficence & non-maleficence ie. the pillars of medical ethics – do good, do no harm

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Medical Ethics

Declaration of Geneva

Singapore Physician Pledge

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Principles of Biomedical Ethics1. Autonomy

- decision-making

- respect for individuals

- patient’s rights

2. Beneficence

Do Good

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Medical Ethics

3. Non-Maleficence

Do No Harm

4. Justice

equitable distribution of

benefits & burdens

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Medical Ethics

5. Fidelity

- truth-telling

- confidentiality

6. Veracity

- honesty

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Medical Ethics

Medical ethics must lead medical law

A good medical law is an ethical law

Doctor must practice sound medical ethics

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Complaints & Complaints

Doctors who fail to establish relationship with patients will endanger trust & confidence

Doctor who takes time to explain what and why he propose to do & how much it cost are less likely to be subject of complaints

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Proving Medical Negligence 1. Duty of Care

2. Standard of Medical Care

3. Causation

4. Remoteness (ie suffer damage)

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NEGLIGENCE Is failure to exercise

reasonable care and skill, or

Omission to do something which a reasonable man would do, or

Something which a reasonable man would not do

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Negligence

Careful doctor but still negligent

Things can go wrong –

1. Diagnosis

2. Treatment

3. Information Disclosure

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Standard of Medical Care Careful doctor but still

Negligent

Keeping abreast with latest developments and technology & incorporate them in his practice

Not expected to read every article in medical journals

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Doctor judged by standard or awareness and sophistication to be expected of a doctor in his sort of profession

All doctors not expected to have level of awareness available to a professor

To be judged on what is to be expected of doctor/dentist in regular practice

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If GP fail to refer patient to consultant when reasonable GP would, GP is negligent

No allowance made for inexperience and age

60 year old GP in private practice, must meet same standard of alertness as 30 year GP

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Medical Negligence is a Civil Wrong TORT

Tort = Wrongful Act

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Wrongful Act

Criminal liability

Civil liability

Contractual liable

Tortiously liable

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MEDIATION

LITIGATION

ARBITRATION

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Medical errorsAs to errors of clinical judgement the House of Lords in an important

medical negligence case of Whitehouse V Jordan (1981) had this to

say:

“… Merely to describe something as an error of judgement tells

nothing about whether it is negligent or not. The true position is

that an error of judgement may, or may not, be negligent; it

depends on the nature of the error. If it is one that would not have

been made by a reasonably competent professional man

professing to have the standard and type of skill that the

defendant held himself out as having, and acting with ordinary

care, then it is negligent. If, on the other hand, it is an error that

such a man, acting with ordinary care, might have made, then it is

not negligent.”

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Penal Code

section 93 - recognises that patient got right to know, even if communication may cause death by shock

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END OF SEMINAR

THANK YOU

Associate Professor Catherine Tay National University of Singapore

Dept of Business Policy

Email: fbatayc @ leonis . nus . edu . sg

Website : www . catherinetay . com . sg

Tel : 4695704 or 96951656