Transcript Document

Royal College of Surgeons of England
“Surgery - in Difficult Times”
Thursday 27th November 2014
“Operating within the Law:
avoiding the legal pitfalls”
Mr Leslie Hamilton LLM FRCS
Cardiac Surgeon, Newcastle
RCSE DPA Northeast
Assistant Coroner, Durham
Multiple Jeopardy - MPS
COMPLAINT
DISCIPLINARY
CRIMINAL
PROCEEDINGS
INQUEST
GMC
CLAIM
“Within the Law”
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Criminal Negligence (gross negligence manslaughter)
Clinical Negligence: case law (common law)
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Mental Capacity Act 2005 (? in Trust induction)
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Bolam, Sidaway, Bolitho, Chester v Afshar (consent)
capacity, best interests
Coroners and Justice Act 2009 (implemented July 2013)
Duty of Candour (Trust legal responsibility): moderate harm ….
Human Rights Act 1998 (ECHR – Article 8: right to life)
Human Tissue Act 2004: retention of tissue
Data Protection Act 1998 – computers, memory sticks  encryption
Confidentiality – see GMC guidance 2009
GMC review for advice on Confidentiality
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•The Abortion Regulations 1991 5
•The Access to Health Records Act 1990 5
•The Access to Medical Reports Act 1988 7
•Blood Safety and Quality Legislation 8
•The Census (Confidentiality) Act 1991 10
•The Children Act 2004 10
•The Civil Contingencies Act 2004 11
•The Civil Evidence Act 1995 12
•Commission Directive 2003/63/EC (brought into UK law by inclusion in the Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003) 12
•The Computer Misuse Act 1990 13
•The Congenital Disabilities (Civil Liability) Act 1976 14
•The Consumer Protection Act (CPA) 1987 15
•The Control of Substances Hazardous to Health (COSHH) Regulations 2002 16
•The Copyright, Designs and Patents Act 1990 16
•The Crime and Disorder Act 1998 17
•The Criminal Appeal Act 1995 18
•The Data Protection Act (DPA) 1998 18
•The Data Protection (Processing of Sensitive Personal Data) Order 2000 25
•The Disclosure of Adoption Information (Post-Commencement Adoptions) Regs 2005 26
•The Electronic Commerce (EC Directive) Regulations 2002 26
•The Electronic Communications Act 2000 27
• The Environmental Information Regulations (EIR) 2004
•The Freedom of Information (FOI) Act 2000 29
•The Gender Recognition Act 2004 32
• The Gender Recognition (Disclosure of Information) (England, Wales and Northern Ireland) (No. 2) Order 2005 33
•The Health and Safety at Work etc Act 1974 33
•The Human Fertilisation and Embryology Act 1990,as amended by the Human Fertilisation and Embryology (Disclosure of Information) Act 1992 34
•The Human Rights Act 1998 35
•The Limitation Act 1980 38
•The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 39
•The National Health Service Act 2006 39
•The NHS Trusts and Primary Care Trusts (Sexually Transmitted Diseases) Directions 2000 40
•The Police and Criminal Evidence (PACE) Act 1984 41
•The Privacy and Electronic Communications (EC Directive) Regulations 2003 42
•The Public Health (Control of Diseases) Act 1984 and the Public Health (Infectious Diseases) Regulations 1988 42
•The Public Interest Disclosure Act 1998 43
•The Public Records Act 1958 45
•The Radioactive Substances Act 1993 45
•The Regulation of Investigatory Powers Act 2000 46
•The Re-use of Public Sector Information Regulations 2005 47
•The Road Traffic Acts 49
•The Sexual Offences (Amendment) Act 1976, sub-section 4(1), as amended by the Criminal Justice Act 1988 49
All just common sense?
Criminal Negligence
Gross Negligence Manslaughter
 “wilful neglect” (if don’t die)
 “gross breach of duty of care”
R v Bateman (1925)
The doctor must be proved to have shown such disregard
for the life and safety of others as to amount to
a crime against the State and
conduct deserving of punishment.
Gross Negligence Manslaughter
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no precise definition
Jury decides: “breach of duty was grossly negligent”
Lord Mackay:
“You should only convict a doctor of causing death by
negligence if you think he did something which no
reasonably skilled doctor would have done”
Recent thoughts?
“Unless a doctor sets out deliberately to harm a patient
the chances of a criminal prosecution
are almost vanishingly small”.
“When patients sue”.
John de Bono
Barrister 3 Serjeants Inn, London
BMJ Careers 23rd April 2011
1 August 2011
1 August 2011
David Sellu
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66y old colorectal surgeon
private hospital
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(November 2013)
orthopaedic patient – knee replacement
post op abdominal problems (perforation)
23 hours to get to theatre (delayed CT scan)
errors in statements, inconsistent evidence
“numerous occasions when your care fell far below that
which could reasonably be expected
of a consultant colorectal surgeon”.
“no alteration of medical records
which would have been a significantly aggravating factor”
“praised your ability and dedication” .. “skill and care for patients ..”
2.5 years imprisonment (not suspended)
Clinical Negligence
Civil Court – “balance of probabilities”
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Duty of Care (standard = Bolam)
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“experts” needed to give opinion on standard of care
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Breach of Duty of Care (need to blame)
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Harm (foreseeable)
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Causation (breach of duty caused the harm)
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“but for” test
… so who was Bolam?
Mr Bolam
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diagnosis: depression
advised: ECT (electro-convulsive therapy)
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(1957)
Webber M BMJ 2008; 337: a2998 (patient experience)
consent: not warned of risk of fracture
treatment: no relaxant drugs, no restraint
outcome: # hip
sued: duty of care - “failure to warn of risks”
outcome: lost
  small risk, need not be told
Mr Bolam (1957)
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Mr Justice McNair (direction to the Jury – one of last)
“The test is the standard of the ordinary skilled man exercising
and professing to have that special skill. A man need not possess
the highest skill … .
A doctor 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.
… a standard of practice recognised as proper by a reasonable body
of opinion
… not negligent … merely because there is a body of opinion that
takes a contrary view. “
Chester v Afshar
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Miss Carole Chester
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Mr Afshar, Consultant Neurosurgeon
Chester v Afshar
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Miss Carole Chester: young professional (journalist)
history: (in 1994)
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(2004 – House of Lords)
6 y h/o recurrent back pain
severe episode, “hardly walk”,  bladder control
professional trip abroad – back injection – wheelchair
referred for surgery (as PP  issues around contract law)
Mr Afshar “distinguished Consultant Neurosurgeon with much experience”
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0.9 – 2% risk of “cauda equina syndrome”
did he or did he not warn? (he said “yes”, she said “no”)
 Judge decided: no (he “preferred” Miss Chester’s evidence) = FACT
NB keep good notes
Miss Chester
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Case:
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operation performed negligently  experts agreed: no
failure to warn:
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she won  Afshar appealed  House of Lords
House of Lords (5 Law Lords)
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3 to 2 majority
even though the “failure to warn” was not the cause of her injury ..
… and would have had the operation (compare with Sidaway !)
… but at another time
therefore “the risk would not have materialised” (statistics!)
she won
Chester v Afshar
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(2004 – House of Lords)
Lord Steyn:
“.. as a result of the failure to warn, she cannot be said to have
given informed consent to surgery in the full legal sense.”
“In modern law, medical paternalism no longer rules and a
patient has a prima facie right to be informed of a small, but
well established risk of serious injury as a result of
surgery.”
What would a reasonable / prudent patient want to know?
1st Principle of Ethics: Autonomy
“Every human being of adult years and sound mind has a
right to determine what should be done with his own
body.
A surgeon who performs an operation without the
patient’s consent commits an assault for which he is
liable in damages”.
Justice Cardozo (1914)
Schoendorft v Society of New York Hospitals 1914 (106 NE 93)
Consent … a process
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When?
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uninvited physical contact (Civil: trespass / Criminal: battery)
before you examine, treat or care for …
How?
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non – verbal (implied)
verbal
written (consent form)
 absence is a problem
 presence of a “consent form” is no defence
 if the patient can show … not given necessary information
 Consent is not a signature on a piece of paper
Consent .. a process
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giving your patient the information they need to make an decision
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Who should … ?
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person treating the patient (not your F1!)
capable of performing the procedure / understanding the risks
specially trained to seek consent (may be asked for evidence)
BMA: “doctor who recommends
that the patient should undergo the intervention”
Best practice: sign form at time?
Consent … a process
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What?
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diagnosis and prognosis (natural history of their condition)
options for treatment including no treatment
purpose (expected benefit)
likelihood of success (published outcomes?)
who is responsible / who is involved (right to choose)
risks
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“serious adverse outcome” and “occur frequently” (? 1%)
Rogers v Whitaker (1992) 175 CLR 479 HC (Aus)
 sympathetic ophthalmitis (after removal of eye ): 1 in 14,000
 “a risk is material if a reasonable person … if warned of the risk
would be likely to attach significance to it”
Consent … a process
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What
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(after Chester v Afshar)
DH  “a failure to warn a patient of a risk of injury inherent in
surgery, however small the possibility of the risk occurring,
denies the patient the chance to make a fully informed decision”.
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“Ask 3 Questions” (www.askshareknow.com.au/ )
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what are my options?
what are the possible benefits and harms of those options?
how likely are each of those to happen to me?
Consent – a process
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When?
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in advance, time to reflect
how long in advance?
 depends on the magnitude of the surgery and risks
 no time limit on validity of consent form
 sign at time of discussion? (copy to take away)
 check on admission if anything changed
 you sign that section (patient does not need to sign)
GMC: sufficient time and information to make an
“informed decision”
Consent
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Legal capacity
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Acting voluntarily
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Appropriate information
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Past: what would an “average” / “Bolam” doctor tell the patient?
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Now  what would a “prudent patient” want to know?
 sets out the key principles of
good decision-making
 takes account of changes in the
law, in particular about making
decisions when patients lack
capacity (MCA)
 reflects the shift in
professional and public attitudes
towards more patient-centred
care
 contains practical advice on
sharing information and
discussing treatment options
 includes guidance on how to
approach discussions about risk
Mental Capacity Act 2005
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“vitally important piece of legislation” (? Trust induction)
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capacity = ability to make a decision
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5 principles: 1st .. assumed to have capacity …
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capacity: time and decision specific
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2 stage test  2 questions: (on balance of probabilities)
 is there impairment / disturbance of mind or brain?
 unable to make that decision at the time it has to be made?
who decides? – you do
Advance Decision (“living will”) to refuse – legally binding
Lasting Power of Attorney (LPA)  consent for medical treatment
IMCAs: access to notes
Court of Protection
DNACPR form (? AND)
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June 2014 Court of Appeal: Tracey v Cambridge UH NHSFT
Lung cancer  prognosis 9 months
RTA  fracture cervical spine  ventilated (COPD)
DNACPR form without consultation with patient / family
Article 8 ECHR: Right to respect for private and family life
Lord Dyson MR:
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“no uncertain terms .. decision as to how to pass the closing days and
moments of one’s life and how one manages one’s death touches in the
most immediate and obvious way a patient’s personal autonomy, integrity,
dignity and quality of life”.
“should be a presumption in favour of patient involvement”
Duty of Candour
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Mid Staffs – Robert Francis
Dalton / Williams report
November 2014
“identifiable patient safety incident”
“moderate harm”
verbal apology
written apology
And Finally … Operating within the Law
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“Good Medical Practice” (and consent guidance)
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Know your limitations, ask for help
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Communication: 71% claims (MPS)
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Keep good records (never alter ..)
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Apologise if things go wrong
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If involved in any investigation  be open and honest
2013
White Park Bay, Antrim Coast, Northern Ireland
Thank you.
Leslie Hamilton
on behalf of the N. Ireland Tourist Board