!Recent&Developments&&in&the&Law&of&Consent&

in&Malaysia&&

&&

Medicolegal Seminar Jointly organized by Jabatan Kesihatan Negeri Sabah and MMA

Queen Elizabeth Hospital

12th April 2015!

Raja!Eileen!Soraya!!Messrs.!Raja,!Darryl!&!Loh!www.rajadarrylloh.com.my!

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.!!!!

A&Case&Study&

Gurmit'Kaur'a/p'Jaswant'Singh'v'Tung'Shin'Hospital!![2012]!4!MLJ!260,!HC!

!

The!ParOes!•  The!PlainOff!–!38!year!old!mother!of!4!•  The!1st!Defendant!was!the!hospital!•  The!2nd!Defendant!was!an!Obstetrician!and!Gynecologist!

with!a!pracOce!at!the!1st!Defendant!hospital!

A&Case&Study&

The!PlainOff’s!Case!!!

•  PaOent!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.!!!•  PaOent!informed!the!2nd!Defendant!that!she!planned!to!

conceive!again.!

A&Case&Study&

The!PlainOff’s!Case!!!

• 19!September!2002!paOent!!was!admiYed!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!operaOon!was!done!and!she!was!discharged!on!22!September!2002.!• 30!September!2002!the!paOent!saw!the!2nd!Defendant!for!a!follow!up!and!asked!him!when!she!can!conceive.!!!!

A&Case&Study&

The!Defendant’s!Case!!!

• Treatment!opOons!were!discussed!including!a!hysterectomy.!

• The!paOent!did!not!tell!the!2nd!Defendant!she!intended!to!have!more!children.!!

• The!paOent!telephoned!the!2nd!Defendant!in!mid!September!2002!and!wanted!to!get!treated!as!soon!as!possible.!

• The!2nd!Defendant!advised!the!paOent!to!undergo!a!hysterectomy.!

!!

A&Case&Study&

The!Defendant’s!Case!!!

• 19!September!2002!]!the!paOent!was!admiYed!and!a!full!explanaOon!of!the!hysterectomy!was!provided!in!the!presence!of!the!paOent’s!husband!and!a!nurse.!!

• The!paOent!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!paOent!did!not!know!that!she!underwent!a!hysterectomy!on!19!September!2002.!• She!did!not!believe!that!a!hysterectomy!was!even!discussed!with!the!paOent.!!• PaOent!thought!surgery!was!to!remove!fibroid.!• During!the!follow!up!on!30!September!2002!]!!

o  The!paOent!asked!the!2nd!Defendant!how!long!it!will!take!for!her!to!conceive.!

o  The!2nd!Defendant!told!the!paOent!that!he!had!removed!her!uterus.!

!!

A&Case&Study&

Court’s!Findings!!

•  The! High! Court! found! as! a! fact! that! the! paOent! did! not!understand!what!a!hysterectomy!was.!!

!

•  The! Court! held! that! having! a! consent! form! signed! without!ensuring!that!the!paOent!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!operaOon!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'

Another&Case&Study&

Abdul'Razak'Datuk'Abu'Samah'v'Raja'Badrul'Hisham'Raja'Zezeman'Shah'&'Ors![2013]!3!CLJ!1130,!HC!

The!ParOes!•  The!PlainOff!–!the!paOent’s!husband!•  The!1st!Defendant,!a!colorectal!surgeon,!was!the!doctor!in!

charge!of!the!paOent!•  The!2nd!and!3rd!Defendants!were!consultant!anaestheOsts!•  The!4th!Defendant!was!the!hospital!•  The!5th!Defendant!was!the!Medical!Officer!who!assisted!with!

the!surgery!

A&Case&Study&

Material!Facts!!

•  PaOent!had!intesOnal!obstrucOon!confirmed!by!CT!Scan.!•  Urgent!surgery!was!recommended.!•  The!paOent!regurgitated!a!large!volume!of!stomach!fluid!

which!entered!her!lungs!whilst!anaesthesia!was!being!administered.!

•  The!paOent!died!of!aspiraOon!pneumonia.!•  The!husband!sued!and!claimed!negligence!by!the!doctors!

involved.!

A&Case&Study&The!Evidence!RelaOng!to!Consent!!

!

The!PlainOff!(the!paOent’s!husband)!“Over'the'telephone,'Raja'Badrul'informed'me'that'he'had'to'operate'on'my'wife'that'very'day.'I'agreed'to'the'operaJon”.'

'

'

'

The!Judge!said!that:!“According'to'the'plainJff,'that'was'all'the'first'defendant'said'to'

him'and'the'plainJff'abided'by'the'first'defendant’s'decision'and'recommendaJon.”'

A&Case&Study&The!Evidence!RelaOng!to!Consent!

!

•  It!was!common!ground!that!in!order!to!reduce!the!risk!of!aspiraOon,!pumping!out!stomach!fluid!before!surgery!by!the!inserOon!of!a!Ryles!tube!is!a!recognised!and!recommended!technique.!

•  The!doctors!tesOfied!that!the!paOent!refused!to!have!a!Ryles!tube!inserted!before!inducOon!of!anaesthesia.!

•  The!first!defendant!(surgeon)!asked!the!second!defendant!(anaestheOst)!to!address!this!issue!but!the!second!defendant!was!called!away!on!an!emergency!and!lei!it!to!the!fiih!defendant!(the!medical!officer).!

A&Case&Study&

The!Evidence!RelaOng!to!Consent!The!fiih!defendant!(medical!officer)!tesOfied!that!he!had!explained!to!the!paOent!that!a!Ryles!tube!needed!to!be!

inserted!to!drain!out!the!gastric!content!to!reduce!the!risk!of!aspiraOon!when!she!loses!consciousness.!But!the!paOent!

refused.!!

The!Issue!RelaOng!to!Consent!Was!the!paOent!advised!that!there!was!a!risk&of&death!from!aspiraOon!or!an&increased&risk&of&death!because!of!her!full!

stomach?!

A&Case&Study&The!Evidence!RelaOng!to!Consent!!

•  No#record!to!show!that!the!paOent!had!been!advised!of!the!material!risk!of!proceeding!with!surgery!without!having!a!Ryles!tube!inserted!or!without!the!stomach!being!empOed!of!its!content.!

•  The!paOent’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!paOent!on!the!consent!form.!

•  The!surgeon#assumed!that!the!trainee!had!explained!the!risks!of!surgery!but!could!not!be!sure.!

A&Case&Study&

The!Evidence!RelaOng!to!Consent!Important!:!The!first,!third!and!fiih!defendants!agreed!that!the!

paOent!was!never!informed!nor!counselled!on!the!risk!of!death!due!to!aspiraOon!during!inducOon!of!anaesthesia!especially!when!she!refused!the!inserOon!of!a!Ryles!tube.!!

!When!it!was!suggested!to!the!third!defendant!that!the!paOent!

ought!to!have!been!counseled,!“..the'third'defendant'aQer'a'long'pause'agreed'with'counsel’s'

suggesJon.”'''

A&Case&Study&

The!Findings!of!the!Court!“..the'failure'of'the'first,'third'and'fiQh'defendants'to'inform'the'

paJent'of'the'risk'of'death'from'aspiraJon,'in'fact'the'increased'risk'of'death'because'of'her'full'stomach,'means'

that'the'paJent'had'not'been'informed'of'a'criJcal'risk'factor'that'would'have'been'necessary'for'her'to'take'into'

consideraJon'in'making'her'decision'to'proceed'with'general'anesthesia'and'surgery…”'

'

The!first,!third!and!fiih!defendants!were!found!liable!for!failure!to!discharge!their!duty!of!care.!

A&Case&Study&The!Findings!of!the!Court!

!

'“Ordinarily,' in'a'doctor'paJent'relaJonship,'the'duty'of'care' is'owed'only'to'the'paJent.'However,'there'are'excepJons'to'this'general' principle.' One' such' excepJon' 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' paJent' 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'reproducJve'rights'of'husband'and'wife.''

A&Case&Study&The!Findings!of!the!Court!

!

'In'other'instances,'consent'of'the'next'of'kin'may'also'be'required'in'situaJons' where' the' paJent' is' incapable' of' giving' consent' or'incapable' of' understanding' and' appreciaJng' the' nature' of' the'proposed'treatment'and'the'risk' involved.'Similarly,'consent'of' the'spouse' may' be' required' when' it' is' evident' that' the' paJent' 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]!

24!

MMC&Guidelines&on&Consent&•  The!latest!version!is!dated!26th!November!2013!!•  The!MMC’s!Guidelines!will!be!very! important!once! the!2012!

amendments!to!the!Medical!Act!1971!are!brought!into!force.!!•  A!breach!of!any!of!the!MMC’s!Guidelines!may!be!tantamount!

to! a! “serious'professional'misconduct”!punishable!under! the!Medical!Act!1971.!

!•  The!MMC’s!Guidelines!on!“Consent'for'Treatment'of'PaJents'

by' Registered'Medical' PracJJoners”! are! comprehensive! and!covers!many!related!issues.!!

!

25!

MMC&Guidelines&on&Consent&!MMC!Guidelines!on!“Consent#For#Treatment#of#Pa7ents#By#Registered#Medical#Prac77oners”'covers!the!following!:!!

!•  Necessity!For!Obtaining!Consent!!•  Necessity!To!Warn!PaOents!About!Material!Risks!•  Explanatory!Notes/Documents!•  Circumstances!in!Which!Consent!May!Not!Be!Required!•  PaOents!Who!Are!Young!Persons!(Minors)!•  PaOents!Who!Are!Incapable!Of,!or!Impaired!With,!Decision]Making!Ability!•  Types!of!Consent!!•  WriYen!Consent!•  Pre]requisites!for!Medical!PracOOoner!Taking!Consent!!•  Responsibility!of!Medical!PracOOoner!Taking!Consent!!•  Responsibility!of!Head!of!Department!in!allowing!Consent!Taking!•  Standard!Consent!Form!!•  Prepared!Material!with!InformaOon!about!a!Treatment!•  Faxed!or!Photocopy!Of!Consent!Form!•  AddiOonal!Special!Aspects!on!Consent!!•  Refusal!to!Give!Consent!for!Treatment!!•  !Advance!Care!DirecOves!(or!Living!Wills)!•  Consent!for!Other!Procedures!!

!

26!

MMC&Guidelines&on&Consent&Guideline&No.&3&

Necessity&To&Warn&PaDents&About&Material&Risks:&

&“Every'paJent'as'an'individual'has'a'choice'whether'or'not'to'undergo'a'proposed'procedure,'surgery,'examinaJon'or'treatment.'''

A'medical'pracJJoner'is'obliged'to'disclose'informaJon'to'the'paJent'and'to'warn'the'paJent'of'material'risks'before'taking'consent.'Failure'to' obtain' a' paJent’s' consent' or' disclose' material' risks' may' be'

interpreted' as' a' failure' of' the' standard' of' care' resulJng' in' a'disciplinary'inquiry'by'the'Medical'Council'or'may'even'be'construed'as'a'breach'of'duty'of'care'and'legal'acJon'insJtuted.”!!!

27!

MMC&Guidelines&on&Consent&Guideline&No.&11&&

Responsibility&of&Medical&PracDDoner&Taking&Consent:&&“It' is'generally'required'that'only' fully'registered'medical'pracJJoner'may'take'consent'for'a'procedure,'examinaJon,'surgery,'or'treatment'

d'from'a'paJent,'and'also'perform'the'procedure,'examinaJon,'surgery'or'treatment'd'for'which'that'consent'has'been'taken.”'''

If''consent'was'taken'by'another'pracJJoner'–''“…the'final'responsibility'and'liability'will'rest'on'the'pracJJoner'who'performs'the'procedure,'who'should,'before'performing'the'procedure,'

confirm'the'nature'of'the'informaJon'given'to'the'paJent'by'the'other'pracJJoner'in'the'course'of'taking'consent…”'

'

!

28!

MMC&Guidelines&on&Consent&Guideline&No.&16a&

AddiDonal&Special&Aspects&On&Consent:&&“a. 'Period'of'Validity'of'consent''

It'is!generally'believed'that'for'an'acceptable'standard'of'care,'the'consent'for'an'invasive''procedure'has'to'be'taken'a'reasonable'period'before'the'procedure.'A'reasonable'period'would'be'not'more'than'7'days.'If'during'this'period'

there' is' a' change' in' the' circumstances' or' condiJon' of' the' paJent'requiring'a'review'of'the'procedure'iniJally'planned,'for'which'consent'

had' been' taken,' then' it' is' incumbent' on' the' pracJJoner' to' obtain' a'fresh'consent.”''!

MMC&Guidelines&on&Consent!

Guideline&No.&16c&Consent&for&photographs&and&audioLvisual&recordings&

!“Prior'consent'must'be'obtained'if'the'pracJJoner'is'planning'to'take' clinical' photographs' or' to' make' audiodvisual' recordings'before,'during'or'aQer'an'invasive'procedure.”!

29!

MMC&Guidelines&on&Consent!

Guideline&No.&16g&Consent&for&sterilisaDon,&hysterectomy&and&orchidectomy&

!“Consent'for'sterilisaJon'procedures'in'a'woman'or'man'should'be' given' by' the' paJent' concerned.' Similarly,' hysterectomy'and'orchidectomy' should' also' involve' consent' by' the' paJent.' Any'discussion' between' the' spouses' in' this' respect' does' not' and'should' not' deny' the' rights' of' the' paJent' concerned' in'making'the'final'decision'and'giving'consent”!!NB: !cf!Gurmit’s!Case!and!Abdul!Razak’s!Case!!

30!

MMC&Guidelines&on&Consent!

Guideline&No.&18&Advance&Care&DirecDves&(or&Living&Wills)&

!“A'medical'pracJJoner'should'refrain'from'providing'treatment'or' performing' any' procedure' where' there' is' an' unequivocal'wrihen'direcJve'by'the'paJent'that'such'treatment'or'procedure'is' not' to' be' provided' in' the' circumstances'which' now' apply' to'the'paJent.”!!NB: ! Official! recogniOon! given! by! MMC! to! Advance! Care!

!DirecOves.!

31!

MDC’s&Code&of&Professional&Conduct&& &&

&&&&&&

“Informed' consent' can' only' be' obtained' ' by' a' pracJJoner'who' has' sufficient' training' and' experience' to' be' able' to'explain' the' procedure,' the' risks' and' benefits' and' the'alternaJves.”'

Para&1.4&Consent&

MDC’s&Code&of&Professional&Conduct&

“Dental'pracJJoners'shall'obtain'valid'consent'prior'to'carrying'out'treatment.'For'consent'to'be'valid:d''

a) the'pracJJoner'should'explain'to'the'paJent'the'treatment'proposed,'the'risks'involved'in'the'treatment,'advantages'and'limitaJon'of'that'treatment,'and'alternaJve'treatment'and'costs.'In'other'words,'the'consent''must'be'informed.'The'pracJJoner'should'also'not'give'guarantees'or'make'unreasonable'promises'about'the'outcome'of'the'treatment.'

MDC’s&Code&of&Professional&Conduct&

b)  for'minors'(below'age'18'years),'wrihen'consent'must'be'obtained'from'the'parents'or'legal'guardian.'

'

'

MDC’s&Code&of&Professional&Conduct&c)  If'general'anaestheJc'or'

sedaJon'is'to'be'given,'all'procedures'must'be'explained'to'the'paJent.'The'onus'is'on'the'dental'pracJJoner'to'ensure'that'all'necessary'informaJon'and'explanaJons'have'been'given'either'personally'or'by'the'anaestheJst.'In'this'situaJon'wrihen'consent'must'be'obtained.'“'