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MEDICAL LAW &
ETHICS
DR PAUL CHAN
DEPUTY DIRECTOR (CLINICAL)
Adv Dip (Med Sci), MBBS, MBA (Healthcare Management)
Estimated death due to Medical
Errors
Malaysian Primary Care
Professional Negligence and
Medical Malpractice
 Malpractice: professional misconduct
or demonstration of an unreasonable
lack of skill with the result of injury,
loss, or damage to the patient.
 Negligence: unintentional action that
occurs when a person performs or
fails to perform an action that a
reasonable person would or would not
have committed in a similar situation
Fraud
 Deliberate misrepresentation or
concealment of facts from another
person for unlawful or unfair gain
 Getting more in the healthcare
fraternity
Professional Liability
 Civil liability cases
◦ Doctors may be sued under a variety of
legal theories
 Physical conditions of the premises
◦ Institution may be liable when regulatory
standards have been violated
 Illegal sale of drugs
What can we do?
Protect yourself
 Liability insurance
 Medical Indemnity insurance
 Malpractice insurance
Settlement
 Out of court
◦ Mediation
◦ Payment (Ex-Gratia)
 Court
◦ Judge to decide
Medicolegal
History
Bolam Principle
 Bolam vs Friern Hospital Committee
(1957)
 Your are not right when your colleague
‘says’ you are right
“I myself would prefer to put it this way, that he is not guilty of
negligence if he has acted in accordance with a practice
accepted as proper by a responsible body of medical men
skilled in that particular art. .... Putting it the other way round, a
man is not negligent, if he is acting in
accordance with such a practice, merely because there is a
body of opinion that would take a contrary view”
Bolam Test
 States that a doctor would not be
considered negligent if their practice
conformed to that of a responsible
body of medical opinion skilled in the
field.
 Medical profession will arbitrate on
what was reasonable information to
provide or withhold.
Bolitho v City & Hackney Health
Authority (1997)
“His Lordship further held that ‘if it can be
demonstrated that the expert medical
opinion is not capable of withstanding logical
analysis, the judge is entitled to hold that the
body of opinion is not responsible”
Roger v Whitaker (1999)
“where it was held that ‘[the standard of care]
is not determined solely or even primarily by
reference to the practice, followed or supported
by a responsible body of opinion in the relevant
profession or trade. It has to be decided
‘whether it was reasonable for one or more of the
steps to be taken.... [and this] was not for
expert medical witnesses to say whether those steps
were or were not reasonable”
Cases
Case 1
 28 years old P3
 SVD, uneventful
 Discharge from ward 2 days later
 Persistence pain and PV discharge
 Came back to hospital
 Gauze left in the vagina
Case 2
 Post MVA
 Head hit the windshield of car
 Multiple shattered glass over neck wounds
 T&S done, glass remove, pt discharge.
 Pain persist, visited JPL 3x, then admitted
 ETD MO remove glasses, discharge pt
 Problem persist. Came back 8 months later.
Xray done, retained glasses
 Paid ex-gratia
Case 3
 9/12 child, fever + cough for 2 days and
eye gazing
 ETD at 12mn, MA seen, Diagnosed Viral
fever then discharge
 Went to district MO (ETD) when fever
persist, AGE, discharged
 20 mins later, went back to district,
worsening eyes gazing, refer to
secondary hospital, then admitted
 Died due to meningitis
 Ex Gratia : RM14.4k
Case 4
 19 yrs old, headache + vomiting x 1/52
 Treated symptomatically and discharged
 2 days later came back, symptomatic
treatment, then discharge
 3rd and 4th visit – casualty (migraine)
 5th visit – worsening. CT: SOL
 Died on the following day
 Payment : RM66.5k
Case 5
 An anaesthetist gave anaesthesia to a patient with an intra-
orbital abscess. The abscess was drained by the
ophthalmologist, who also gave an intravitreal injection of
antibiotics. The patient has sued the ophthalmologist. The
patient's solicitor served a subpoena, with RM300, on the
anaesthetist to be a witness. The solicitor also requested that
the anaesthetist give a detailed account of her involvement.
 Doctor asked whether she has to attend court.
COMMENTS
 1. The anaesthetist has to attend court as a subpoena has
been served. She can charge a witness fee.
 2. The detailed account amounts to a medical report.
Consent must be obtained from the patient (via the solicitor)
and a fee can be charged for writing the medical report.
 3. Please refer to the attached sheet on Subpoena and
Witness Fees.
Case 6
 An Obstetrician & Gynaecologist treated a lady with second degree prolapse
uterus with a cystocoele. Under spinal anaesthesia while attempting a
vaginal hysterectomy the patient sustained a two cm bladder tear during the
dissection.
 After discussing with the patient and the patient's husband the doctor did a
total abdominal hysterectomy. The bladder was repaired from the vaginal
approach. A continuous bladder drainage was instituted.
 Two days postop, urine leaked from the vagina. The patient was examined
under G.A. and a one centimetre bladder tear was noted. This was repaired
in two layers. Again continuous bladder drainage was done.
 She was discharged on third postop day. On the ninth postop day she was
reviewed. There was no urine leaking. The continuous bladder drain was
removed. On the fourteenth postop day the patient returned with urine
leaking.
 The obstetrician and gynaecologist referred her to a urologist. The urologist
delayed the repair to three weeks later to get optimal result. The bladder
repair was successful.
 The obstetrician and gynaecologist received a Writ of Summons one day
Case 6 .. cont
 COMMENTS
 1. On lacerating the bladder the member should have
asked for help from a urologist.
 2. If no urologist was available the obstetrician and
gynaecologist should have completed the hysterectomy.
The bladder should be drained continuously. The
obstetrician and gynaecologist should refer the patient
to the urologist as soon as possible.
 3. In today's setting unless the obstetrician and
gynaecologist is urologically trained lesions of the
kidney, ureter, bladder and urethra should be managed
by a urologist.
 4. The case could not be defended. It was settled out
of court for a sum without admission of liability.
Case 7
 In October 2006 a 42 year old female was diagnosed as grade II infiltrating,
ductal carcinoma of the breast - Right mastectomy and axillary clearance were
performed in October 2006.
 She underwent a course of chemotherapy and radiotherpy from November 2006
to February 2007.
 In March 2008 she presented with pain in the left sternoclavicular area. C.T. Scan
of the area reported nothing abnormal.
 In June 2008, during follow up she yet complained of pain in the left
sternoclavicular area. An ultrasound of the abdomen revealed multiple liver
secondaries.
 A re-staging C.T. Scan confirmed metastatic disease in the liver and medial end
of the left clavicle. She was advised to undergo a course of chemotherapy.
 A meeting between patient, oncologist and radiologist was held to discuss the
missed findings of the C.T. Scan of March 2008.
 She lost confidence in her doctors in Malaysia and sought chemotherapy
overseas.
 The oncologists and radiologists overseas have confirmed that the metastases
were present at the medial end of the left clavicle in the C.T. Scans of March
2008.
 The patient succumbed to her illness in June 2009.
 In March 2012 the oncologist and radiotherapist and the hospital received a letter
of demand for general and special damages of RM462,416.00.
Case 7.. cont
 1. Oncologist and radiologist should have admitted the error in the
interpretation of C.T. Scans of March 2008 and apologized
immediately.
 2. Giving an apology is not an admission of liability. In many
incidents an immediate apology has diffused the situation. In this
instance a letter of demand was issued to the radiologist, oncologist
and the hospital because of the delay in tendering the apology.
 3. The radiologist has missed the findings in the C.T. Scan of
March 2008. He bears the responsibility of the error, but the
oncologist cannot be exonerated as he had the clinical advantage of
examining the patient and correlating the clinical findings with the
C.T. Scan findings.
 4. The deceased's estate has not continued to pursue the matter. If
the matter is pursued, an out of court settlement should be
considered with the radiologist bearing the bulk of the damages.
Open Disclosure & Apology
“If a patient has suffered serious harm for whatever
reason, the doctor should act immediately to put
matters right. The patient must receive a proper
explanation about the short and long term effects.
When appropriate the doctor should offer an
apology.”
Good Medical Practice, MMC
Ethical Obligation
Harm to the patient
Take Immediate Action To Put Matters Right
Offer Proper Explanation – Short and Long Term
Effects
Offer an Apology (when appropriate)
Legal Obligation
Statute
Section 27(1)(a) of the Private Healthcare Facilities and
Services (Private Hospitals and Other Private Healthcare
Facilities ) Regulations 2006 :
“(1) The licensee or person in charge of a private healthcare
facility or service shall take reasonable steps to ensure that a
patient is –
(a) Provided with information about the nature of his medical
condition and any proposed treatment, investigation or
procedure and the likely costs of the treatment, investigation
or procedure;”
Legal Obligation
Common Law
“I personally think that in professional negligence
cases, and in particular in medical negligence cases,
there is a duty of candour resting on the professional
man…it is but one aspect of the general duty of care,
arising out of the patient/medical practitioner or
hospital authority relationship and gives rise to rights
both in contract and in tort.” [emphasis added]
per Lord Donaldson MR in
Naylor v Preston [1987] 2 All ER 353
Consent
The Law on Consent
As a general rule no doctor may treat anyone
without his or her consent.
Without consent any interference with a
person’s body is a trespass to that person.
Case 8 – Landmark Trial
Abdul Razak Datuk Abu Samah v Raja Badrul Hisham
Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC
The Parties
• The Plaintiff – the patient’s husband
• The 1st Defendant, a colorectal surgeon, was the
doctor in charge of the patient
• The 2nd and 3rd Defendants were consultant
anaesthetists
• The 4th Defendant was the hospital
• The 5th Defendant was the Medical Officer who
assisted with the surgery
Case 8 – Landmark Trial
Abdul Razak Datuk Abu Samah v Raja Badrul
Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ
1130, HC
Material Facts
• Patient got intestinal obstructions diagnosed by CT
scan
• Patient was in Termeloh Hospital
• Referred to HKL for surgery under 1st Defendant.
• Patient reached HKL, 1st Defendant was in a
conference and instructed 2nd defendant to take
consent for surgery
Case 8 – Landmark Trial
Abdul Razak Datuk Abu Samah v Raja Badrul Hisham
Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC
Material Facts
• 2nd Defendant wanted to insert ryles tube but patient
refused.
• Explained the risk of aspiration pneumonia to the
patient, patient still refuse.
• 1st defendant saw the patient and talked with plaintiff
on the phone about the risk of aspiration without the
ryles tube as well as the function of the ryles tube was
to decompress the stomach
Case 8 – Landmark Trial
Abdul Razak Datuk Abu Samah v Raja Badrul
Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ
1130, HC
Material Facts
• Patient still refuse. 1st defendant took high risk
consent. Patient signed the consent and additional
verbal consent over the phone with plaintiff
• 2nd defendant was busy, and 3rd defendant was
called in to help
• Rapid sequence induction because of no ryles
tube to minimize aspiration
Case 8 – Landmark Trial
Abdul Razak Datuk Abu Samah v Raja Badrul
Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ
1130, HC
Material Facts
• Patient died due to aspiration pneumonia
• Plaintiff sued for negligience
Case 8 – Landmark Trial
Evidence Related to Consent
The Plaintiff (The patient’s Husband)
“Over the phone, Raja Badrul informed me that he had
to operate on my wife that very day. I agreed to the
operation”
The Judge said that:
“According to the plaintiff, that was all the defendant
said to him and the plaintiff abided by the 1st
defendant’s decision and recommendation on”
Case 8 – Landmark Trial
Evidence Related to Consent
• It was common ground that in order to reduce the risk of
aspiration, pumping out stomach fluid before surgery by
the insertion of a Ryles tube is a recognized and
recommended technique.
• The doctors testified that the patient refused to have a
Ryles tube inserted before induction of anesthesia.
• The first defendant (surgeon) asked the second defendant
(anaesthetist) to address this issue but the second
defendant was called away on an emergency and left it to
the fifth defendant (the medical officer).
Case 8 – Landmark Trial
Evidence Related to Consent
The 5th defendant (Medical Officer) testified that he
had explained to the patient that a Ryles Tube
needed to be inserted to drain out gastric content to
reduce the risk of aspiration when she loses
consciousness. But the patient refused.
Issues Related to Consent
Was the patient advised that there was a risk of
death from aspiration or an increased risk of death
because of her full stomach?
Case 8 – Landmark Trial
Evidence Relating to Consent
• No record to show that the patient had been advised of the
material risk of proceeding with surgery without having a
Ryles tube inserted or without the stomach being emptied
of its content.
• The patient’s consent for surgery was obtained by the
surgeon’s surgical trainee who was not called as a
witness.
• No witness to the signature of the patient on the
consent form.
• The surgeon assumed that the trainee had explained
the risks of surgery but could not be sure
Case 8 – Landmark Trial
Evidence Relating to Consent
Important : The first, third and fifth defendants agreed that the
patient was never informed nor counselled on the risk of death due
to aspiration during induction of anaesthesia especially when she
refused the insertion of a Ryles tube.
When it was suggested to the third defendant that the patient
ought to have been counseled,
“..the third defendant after a long pause agreed with counsel’s
suggestion.”
Case 8 – Landmark Trial
Findings in Court
“..the failure of the first, third and fifth defendants to inform
the patient of the risk of death from aspiration, in fact the
increased risk of death because of her full stomach, means
that the patient had not been informed of a critical risk
factor that would have been necessary for her to take into
consideration in making her decision to proceed with
general anesthesia and surgery…”
The first, third and fifth defendants were found liable for
failure to discharge their duty of care.
Case 8 – Landmark Trial
The Findings in Court
“Ordinarily, in a doctor paJ ent relaJ onship, the duty of care is
owed only to the paJ ent. However, there are exceptions to this
general principle. One such exception arose in the case of
Gurmit Kaur a/p Jaswant Singh v Tung Shin Hospital & Anor
[2012] 4 MLJ 260 where the High Court held that the consent of the
patient herself was insufficient as the consent of the husband
was not obtained for a hysterectomy as required under the consent
form. I can see the obvious logic for the husband's consent to be
obtained in cases of hysterectomy as it involves the joint
reproductive rights of husband and wife.
Case 8 – Landmark Trial
The Findings in Court
In other instances, consent of the next of kin may also be
required in situations where the patient is incapable of
giving consent or incapable of understanding and
appreciating the nature of the proposed treatment and the
risk involved. Similarly, consent of the spouse may be
required when it is evident that the patient is dependent
on the spouse to make decisions in regards to the
proposed medical treatment or when it is evident to the
doctor that the decisions are being made jointly by both
spouses in respect of the treatment for one of the spouses.”
- Vazeer Alam Mydin JC at para [45]
A Case Study
Gurmit Kaur a/p Jaswant Singh v Tung Shin Hospital
[2012] 4 MLJ 260, HC
The Parties
• The Plaintiff– 38 year old mother of 4
• The 1st Defendant was the hospital
• The 2nd Defendant was an Obstetrician and Gynecologist with a
practice at the 1st Defendant hospital
A Case Study
The Plaintiff’s Case
• Patient was referred to the 2nd Defendant for treatment of
a cervical polyp.
• 30 April 2002 – Polyp was removed and ultrasound
revealed an enlarged uterus due to fibroid.
• Patient informed the 2nd Defendant that she planned
to conceive again.
A Case Study
The Plaintiff’s Case
• 19 September 2002 patient was admitted for removal of
fibroid.
• Only her name and IC number were filled up in the form.
• The contents of the form were not explained.
• The operation was done and she was discharged on
22 September 2002.
• 30 September 2002 the patient saw the 2nd Defendant for
a follow up and asked him when she can conceive.
A Case Study
The Defendant’s Case
• Treatment options were discussed including a hysterectomy.
• The patient did not tell the 2nd Defendant she intended to
have more children.
• The patient telephoned the 2nd Defendant in mid
September 2002 and wanted to get treated as soon as
possible.
• The 2nd Defendant advised the patient to undergo
a hysterectomy.
A Case Study
Defendant’s Case
• 19 September 2002 - the patient was admitted and a full
explanation of the hysterectomy was provided in the
presence of the patient’s husband and a nurse.
• The patient signed the consent form.
• 20 September 2002 - the hysterectomy was carried out and
was successful.
A Case Study
Did the Doctor explain to the patient that he
was recommending a hysterectomy and did
the patient know what that meant?
A Case Study
The Judge’s Analysis
•She believed that the patient did not know that she underwent
a hysterectomy on 19 September 2002.
•She did not believe that a hysterectomy was even discussed
with the patient.
•Patient thought surgery was to remove fibroid.
•During the follow up on 30 September 2002 :
o The patient asked the 2nd Defendant how long it will take for
her to conceive.
o The 2nd Defendant told the patient that he had removed her
uterus.
A Case Study
Court’s Findings
• The High Court found as a fact that the patient did not
understand what a hysterectomy was.
• The Court held that having a consent form signed without
ensuring that the patient understands is not sufficient.
A Case Study
Court’s Findings
• The Court also held that the husband’s consent should also
have been obtained. This is because of the nature of the
consent form (“Agreement by Husband/Wife) and the fact
that the nature of the operation meant that the wife could
no longer conceive.
A Case Study
The Court’s Ruling
The Judge held that the Defendants were liable for negligence
and awarded a sum of RM120,000 for general damages and
interest
In the News!
2 April 2014. NST
Conclusion
 Medico-legal environment heavier
 Consent
 Code of Professional Conduct
 Consent : http://goo.gl/5R1aiZ
 Confidentiality : http://goo.gl/e1GK0F
 Good Medical Practice
http://goo.gl/Ttx0xE
 www.mmc.gov.my
Medical Ethics and Malpractice

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Medical Ethics and Malpractice

  • 1. MEDICAL LAW & ETHICS DR PAUL CHAN DEPUTY DIRECTOR (CLINICAL) Adv Dip (Med Sci), MBBS, MBA (Healthcare Management)
  • 2. Estimated death due to Medical Errors
  • 4.
  • 5. Professional Negligence and Medical Malpractice  Malpractice: professional misconduct or demonstration of an unreasonable lack of skill with the result of injury, loss, or damage to the patient.  Negligence: unintentional action that occurs when a person performs or fails to perform an action that a reasonable person would or would not have committed in a similar situation
  • 6. Fraud  Deliberate misrepresentation or concealment of facts from another person for unlawful or unfair gain  Getting more in the healthcare fraternity
  • 7. Professional Liability  Civil liability cases ◦ Doctors may be sued under a variety of legal theories  Physical conditions of the premises ◦ Institution may be liable when regulatory standards have been violated  Illegal sale of drugs
  • 9. Protect yourself  Liability insurance  Medical Indemnity insurance  Malpractice insurance
  • 10.
  • 11.
  • 12. Settlement  Out of court ◦ Mediation ◦ Payment (Ex-Gratia)  Court ◦ Judge to decide
  • 14. Bolam Principle  Bolam vs Friern Hospital Committee (1957)  Your are not right when your colleague ‘says’ you are right “I myself would prefer to put it this way, that he is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art. .... Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that would take a contrary view”
  • 15. Bolam Test  States that a doctor would not be considered negligent if their practice conformed to that of a responsible body of medical opinion skilled in the field.  Medical profession will arbitrate on what was reasonable information to provide or withhold.
  • 16. Bolitho v City & Hackney Health Authority (1997) “His Lordship further held that ‘if it can be demonstrated that the expert medical opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not responsible”
  • 17. Roger v Whitaker (1999) “where it was held that ‘[the standard of care] is not determined solely or even primarily by reference to the practice, followed or supported by a responsible body of opinion in the relevant profession or trade. It has to be decided ‘whether it was reasonable for one or more of the steps to be taken.... [and this] was not for expert medical witnesses to say whether those steps were or were not reasonable”
  • 18. Cases
  • 19. Case 1  28 years old P3  SVD, uneventful  Discharge from ward 2 days later  Persistence pain and PV discharge  Came back to hospital  Gauze left in the vagina
  • 20. Case 2  Post MVA  Head hit the windshield of car  Multiple shattered glass over neck wounds  T&S done, glass remove, pt discharge.  Pain persist, visited JPL 3x, then admitted  ETD MO remove glasses, discharge pt  Problem persist. Came back 8 months later. Xray done, retained glasses  Paid ex-gratia
  • 21. Case 3  9/12 child, fever + cough for 2 days and eye gazing  ETD at 12mn, MA seen, Diagnosed Viral fever then discharge  Went to district MO (ETD) when fever persist, AGE, discharged  20 mins later, went back to district, worsening eyes gazing, refer to secondary hospital, then admitted  Died due to meningitis  Ex Gratia : RM14.4k
  • 22. Case 4  19 yrs old, headache + vomiting x 1/52  Treated symptomatically and discharged  2 days later came back, symptomatic treatment, then discharge  3rd and 4th visit – casualty (migraine)  5th visit – worsening. CT: SOL  Died on the following day  Payment : RM66.5k
  • 23. Case 5  An anaesthetist gave anaesthesia to a patient with an intra- orbital abscess. The abscess was drained by the ophthalmologist, who also gave an intravitreal injection of antibiotics. The patient has sued the ophthalmologist. The patient's solicitor served a subpoena, with RM300, on the anaesthetist to be a witness. The solicitor also requested that the anaesthetist give a detailed account of her involvement.  Doctor asked whether she has to attend court. COMMENTS  1. The anaesthetist has to attend court as a subpoena has been served. She can charge a witness fee.  2. The detailed account amounts to a medical report. Consent must be obtained from the patient (via the solicitor) and a fee can be charged for writing the medical report.  3. Please refer to the attached sheet on Subpoena and Witness Fees.
  • 24. Case 6  An Obstetrician & Gynaecologist treated a lady with second degree prolapse uterus with a cystocoele. Under spinal anaesthesia while attempting a vaginal hysterectomy the patient sustained a two cm bladder tear during the dissection.  After discussing with the patient and the patient's husband the doctor did a total abdominal hysterectomy. The bladder was repaired from the vaginal approach. A continuous bladder drainage was instituted.  Two days postop, urine leaked from the vagina. The patient was examined under G.A. and a one centimetre bladder tear was noted. This was repaired in two layers. Again continuous bladder drainage was done.  She was discharged on third postop day. On the ninth postop day she was reviewed. There was no urine leaking. The continuous bladder drain was removed. On the fourteenth postop day the patient returned with urine leaking.  The obstetrician and gynaecologist referred her to a urologist. The urologist delayed the repair to three weeks later to get optimal result. The bladder repair was successful.  The obstetrician and gynaecologist received a Writ of Summons one day
  • 25. Case 6 .. cont  COMMENTS  1. On lacerating the bladder the member should have asked for help from a urologist.  2. If no urologist was available the obstetrician and gynaecologist should have completed the hysterectomy. The bladder should be drained continuously. The obstetrician and gynaecologist should refer the patient to the urologist as soon as possible.  3. In today's setting unless the obstetrician and gynaecologist is urologically trained lesions of the kidney, ureter, bladder and urethra should be managed by a urologist.  4. The case could not be defended. It was settled out of court for a sum without admission of liability.
  • 26. Case 7  In October 2006 a 42 year old female was diagnosed as grade II infiltrating, ductal carcinoma of the breast - Right mastectomy and axillary clearance were performed in October 2006.  She underwent a course of chemotherapy and radiotherpy from November 2006 to February 2007.  In March 2008 she presented with pain in the left sternoclavicular area. C.T. Scan of the area reported nothing abnormal.  In June 2008, during follow up she yet complained of pain in the left sternoclavicular area. An ultrasound of the abdomen revealed multiple liver secondaries.  A re-staging C.T. Scan confirmed metastatic disease in the liver and medial end of the left clavicle. She was advised to undergo a course of chemotherapy.  A meeting between patient, oncologist and radiologist was held to discuss the missed findings of the C.T. Scan of March 2008.  She lost confidence in her doctors in Malaysia and sought chemotherapy overseas.  The oncologists and radiologists overseas have confirmed that the metastases were present at the medial end of the left clavicle in the C.T. Scans of March 2008.  The patient succumbed to her illness in June 2009.  In March 2012 the oncologist and radiotherapist and the hospital received a letter of demand for general and special damages of RM462,416.00.
  • 27. Case 7.. cont  1. Oncologist and radiologist should have admitted the error in the interpretation of C.T. Scans of March 2008 and apologized immediately.  2. Giving an apology is not an admission of liability. In many incidents an immediate apology has diffused the situation. In this instance a letter of demand was issued to the radiologist, oncologist and the hospital because of the delay in tendering the apology.  3. The radiologist has missed the findings in the C.T. Scan of March 2008. He bears the responsibility of the error, but the oncologist cannot be exonerated as he had the clinical advantage of examining the patient and correlating the clinical findings with the C.T. Scan findings.  4. The deceased's estate has not continued to pursue the matter. If the matter is pursued, an out of court settlement should be considered with the radiologist bearing the bulk of the damages.
  • 28. Open Disclosure & Apology “If a patient has suffered serious harm for whatever reason, the doctor should act immediately to put matters right. The patient must receive a proper explanation about the short and long term effects. When appropriate the doctor should offer an apology.” Good Medical Practice, MMC
  • 29. Ethical Obligation Harm to the patient Take Immediate Action To Put Matters Right Offer Proper Explanation – Short and Long Term Effects Offer an Apology (when appropriate)
  • 30. Legal Obligation Statute Section 27(1)(a) of the Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities ) Regulations 2006 : “(1) The licensee or person in charge of a private healthcare facility or service shall take reasonable steps to ensure that a patient is – (a) Provided with information about the nature of his medical condition and any proposed treatment, investigation or procedure and the likely costs of the treatment, investigation or procedure;”
  • 31. Legal Obligation Common Law “I personally think that in professional negligence cases, and in particular in medical negligence cases, there is a duty of candour resting on the professional man…it is but one aspect of the general duty of care, arising out of the patient/medical practitioner or hospital authority relationship and gives rise to rights both in contract and in tort.” [emphasis added] per Lord Donaldson MR in Naylor v Preston [1987] 2 All ER 353
  • 33. The Law on Consent As a general rule no doctor may treat anyone without his or her consent. Without consent any interference with a person’s body is a trespass to that person.
  • 34. Case 8 – Landmark Trial Abdul Razak Datuk Abu Samah v Raja Badrul Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC The Parties • The Plaintiff – the patient’s husband • The 1st Defendant, a colorectal surgeon, was the doctor in charge of the patient • The 2nd and 3rd Defendants were consultant anaesthetists • The 4th Defendant was the hospital • The 5th Defendant was the Medical Officer who assisted with the surgery
  • 35. Case 8 – Landmark Trial Abdul Razak Datuk Abu Samah v Raja Badrul Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC Material Facts • Patient got intestinal obstructions diagnosed by CT scan • Patient was in Termeloh Hospital • Referred to HKL for surgery under 1st Defendant. • Patient reached HKL, 1st Defendant was in a conference and instructed 2nd defendant to take consent for surgery
  • 36. Case 8 – Landmark Trial Abdul Razak Datuk Abu Samah v Raja Badrul Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC Material Facts • 2nd Defendant wanted to insert ryles tube but patient refused. • Explained the risk of aspiration pneumonia to the patient, patient still refuse. • 1st defendant saw the patient and talked with plaintiff on the phone about the risk of aspiration without the ryles tube as well as the function of the ryles tube was to decompress the stomach
  • 37. Case 8 – Landmark Trial Abdul Razak Datuk Abu Samah v Raja Badrul Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC Material Facts • Patient still refuse. 1st defendant took high risk consent. Patient signed the consent and additional verbal consent over the phone with plaintiff • 2nd defendant was busy, and 3rd defendant was called in to help • Rapid sequence induction because of no ryles tube to minimize aspiration
  • 38. Case 8 – Landmark Trial Abdul Razak Datuk Abu Samah v Raja Badrul Hisham Raja Zezeman Shah & Ors [2013] 3 CLJ 1130, HC Material Facts • Patient died due to aspiration pneumonia • Plaintiff sued for negligience
  • 39. Case 8 – Landmark Trial Evidence Related to Consent The Plaintiff (The patient’s Husband) “Over the phone, Raja Badrul informed me that he had to operate on my wife that very day. I agreed to the operation” The Judge said that: “According to the plaintiff, that was all the defendant said to him and the plaintiff abided by the 1st defendant’s decision and recommendation on”
  • 40. Case 8 – Landmark Trial Evidence Related to Consent • It was common ground that in order to reduce the risk of aspiration, pumping out stomach fluid before surgery by the insertion of a Ryles tube is a recognized and recommended technique. • The doctors testified that the patient refused to have a Ryles tube inserted before induction of anesthesia. • The first defendant (surgeon) asked the second defendant (anaesthetist) to address this issue but the second defendant was called away on an emergency and left it to the fifth defendant (the medical officer).
  • 41. Case 8 – Landmark Trial Evidence Related to Consent The 5th defendant (Medical Officer) testified that he had explained to the patient that a Ryles Tube needed to be inserted to drain out gastric content to reduce the risk of aspiration when she loses consciousness. But the patient refused. Issues Related to Consent Was the patient advised that there was a risk of death from aspiration or an increased risk of death because of her full stomach?
  • 42. Case 8 – Landmark Trial Evidence Relating to Consent • No record to show that the patient had been advised of the material risk of proceeding with surgery without having a Ryles tube inserted or without the stomach being emptied of its content. • The patient’s consent for surgery was obtained by the surgeon’s surgical trainee who was not called as a witness. • No witness to the signature of the patient on the consent form. • The surgeon assumed that the trainee had explained the risks of surgery but could not be sure
  • 43. Case 8 – Landmark Trial Evidence Relating to Consent Important : The first, third and fifth defendants agreed that the patient was never informed nor counselled on the risk of death due to aspiration during induction of anaesthesia especially when she refused the insertion of a Ryles tube. When it was suggested to the third defendant that the patient ought to have been counseled, “..the third defendant after a long pause agreed with counsel’s suggestion.”
  • 44. Case 8 – Landmark Trial Findings in Court “..the failure of the first, third and fifth defendants to inform the patient of the risk of death from aspiration, in fact the increased risk of death because of her full stomach, means that the patient had not been informed of a critical risk factor that would have been necessary for her to take into consideration in making her decision to proceed with general anesthesia and surgery…” The first, third and fifth defendants were found liable for failure to discharge their duty of care.
  • 45. Case 8 – Landmark Trial The Findings in Court “Ordinarily, in a doctor paJ ent relaJ onship, the duty of care is owed only to the paJ ent. However, there are exceptions to this general principle. One such exception arose in the case of Gurmit Kaur a/p Jaswant Singh v Tung Shin Hospital & Anor [2012] 4 MLJ 260 where the High Court held that the consent of the patient herself was insufficient as the consent of the husband was not obtained for a hysterectomy as required under the consent form. I can see the obvious logic for the husband's consent to be obtained in cases of hysterectomy as it involves the joint reproductive rights of husband and wife.
  • 46. Case 8 – Landmark Trial The Findings in Court In other instances, consent of the next of kin may also be required in situations where the patient is incapable of giving consent or incapable of understanding and appreciating the nature of the proposed treatment and the risk involved. Similarly, consent of the spouse may be required when it is evident that the patient is dependent on the spouse to make decisions in regards to the proposed medical treatment or when it is evident to the doctor that the decisions are being made jointly by both spouses in respect of the treatment for one of the spouses.” - Vazeer Alam Mydin JC at para [45]
  • 47. A Case Study Gurmit Kaur a/p Jaswant Singh v Tung Shin Hospital [2012] 4 MLJ 260, HC The Parties • The Plaintiff– 38 year old mother of 4 • The 1st Defendant was the hospital • The 2nd Defendant was an Obstetrician and Gynecologist with a practice at the 1st Defendant hospital
  • 48. A Case Study The Plaintiff’s Case • Patient was referred to the 2nd Defendant for treatment of a cervical polyp. • 30 April 2002 – Polyp was removed and ultrasound revealed an enlarged uterus due to fibroid. • Patient informed the 2nd Defendant that she planned to conceive again.
  • 49. A Case Study The Plaintiff’s Case • 19 September 2002 patient was admitted for removal of fibroid. • Only her name and IC number were filled up in the form. • The contents of the form were not explained. • The operation was done and she was discharged on 22 September 2002. • 30 September 2002 the patient saw the 2nd Defendant for a follow up and asked him when she can conceive.
  • 50. A Case Study The Defendant’s Case • Treatment options were discussed including a hysterectomy. • The patient did not tell the 2nd Defendant she intended to have more children. • The patient telephoned the 2nd Defendant in mid September 2002 and wanted to get treated as soon as possible. • The 2nd Defendant advised the patient to undergo a hysterectomy.
  • 51. A Case Study Defendant’s Case • 19 September 2002 - the patient was admitted and a full explanation of the hysterectomy was provided in the presence of the patient’s husband and a nurse. • The patient signed the consent form. • 20 September 2002 - the hysterectomy was carried out and was successful.
  • 52. A Case Study Did the Doctor explain to the patient that he was recommending a hysterectomy and did the patient know what that meant?
  • 53. A Case Study The Judge’s Analysis •She believed that the patient did not know that she underwent a hysterectomy on 19 September 2002. •She did not believe that a hysterectomy was even discussed with the patient. •Patient thought surgery was to remove fibroid. •During the follow up on 30 September 2002 : o The patient asked the 2nd Defendant how long it will take for her to conceive. o The 2nd Defendant told the patient that he had removed her uterus.
  • 54. A Case Study Court’s Findings • The High Court found as a fact that the patient did not understand what a hysterectomy was. • The Court held that having a consent form signed without ensuring that the patient understands is not sufficient.
  • 55. A Case Study Court’s Findings • The Court also held that the husband’s consent should also have been obtained. This is because of the nature of the consent form (“Agreement by Husband/Wife) and the fact that the nature of the operation meant that the wife could no longer conceive.
  • 56. A Case Study The Court’s Ruling The Judge held that the Defendants were liable for negligence and awarded a sum of RM120,000 for general damages and interest
  • 59.
  • 60. Conclusion  Medico-legal environment heavier  Consent  Code of Professional Conduct  Consent : http://goo.gl/5R1aiZ  Confidentiality : http://goo.gl/e1GK0F  Good Medical Practice http://goo.gl/Ttx0xE  www.mmc.gov.my