1. Informed Consent
Presented By Associate Professor Catherine Tay National University of Singapore (NUS) Faculty of Business Administration Bachelor of Laws (Hons), London Master of Laws, London Barrister-at-Law (England) Advocate & Solicitor, Singapore Author of ‘Medical Negligence’ Book

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

3. 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

4. Inforrmed Consent
Is there sufficient information to patient’s consent?

5. Inforrmed Consent Consent is an ethical principle
Medical treatment can only be performed with consent of competent pt

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

7. Informed Consent
Consent must be freely given with patient understanding
- the nature
- risks
- benefits
- alternatives
- limitations
of proposed treatment.

8. Informed Consent
Any medical treatment given without consent is an action for trespass where damages are payable

9. Inforrmed Consent
The consent form is for patient to acknowledge that the nature & purpose of treatment has been
- fully explained
- understood and
- consented to.

10. Informed Consent
Pt never consented to doctor’s negligence but only to risks & complications involved

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. Informed Consent
Once pt ask “How serious?” the operation is, doctor should discuss
- the relative conveniences
- expertise
- possible risks.

20. Informed Consent To say less is misleading & inadequate
Good communication is stressed and is highly desirable between doctor-pt relationship

21. 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

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

23. 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

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

25. Bolitho case House of Lords case
The court must be satisfied that the body of opinion is logical
Clearly this rejection of Bolam test

26. 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

27. 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

28. 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

29. 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]

30. 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

31. 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

32. 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

33. 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

34. Medical Ethics
Declaration of Geneva
Singapore Physician Pledge

35. Principles of Biomedical Ethics
1. Autonomy
- decision-making
- respect for individuals
- patient’s rights
2. Beneficence
Do Good

36. Medical Ethics 3. Non-Maleficence Do No Harm 4. Justice
equitable distribution of
benefits & burdens

37. Medical Ethics 5. Fidelity - truth-telling - confidentiality
6. Veracity
- honesty

38. Medical Ethics Medical ethics must lead medical law
A good medical law is an ethical law
Doctor must practice sound medical ethics

39. 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

40. Proving Medical Negligence
1. Duty of Care
2. Standard of Medical
Care
3. Causation
4. Remoteness (ie suffer
damage)

41. 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

42. Negligence Careful doctor but still negligent Things can go wrong –
1. Diagnosis
2. Treatment
3. Information Disclosure

43. 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

44. 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

45. 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

46. Medical Negligence is a Civil Wrong  TORT
Tort = Wrongful Act

47. Criminal liability
Wrongful Act
Contractual liable
Civil liability
Tortiously liable

48. ARBITRATION
MEDIATION
LITIGATION

52. Medical errors
As 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.”

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

54. END OF SEMINAR THANK YOU Associate Professor Catherine Tay
National University of Singapore
Dept of Business Policy
leonis . nus . edu . sg
Website : www . catherinetay . com . sg
Tel : or