Transcript THE HEALTH ACT 1999

CLINICAL
NEGLIGENCE
Professor Vivienne Harpwood
OUTLINE
Brief summary of the basic law
 Focus on problem areas
 Analysis of the recent developments
 Case study – Bolam and Bolitho cases
 The impact of NHS changes
 Analysis of case scenarios
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THE LEGAL FRAMEWORK
CLAIMANT MUST PROVE:
Duty of care owed
Breach of duty
Damage caused by that breach
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Is there a duty of care?
In most healthcare situations this has been
established by precedent.
 If no precedent exists the court must
decide
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THE TEST FOR
ESTABLISHING A NEW DUTY
Foresight
 Proximity
 Is it fair just and reasonable to impose a
duty?
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JUDICIAL POLICY
“The use of the word “policy” indicates that the
court must decide not simply whether there is or
is not a duty, but whether there should or should
not be one, taking into account both the
established framework of the law and also the
implications that a decision one way or the other
may have for the operation of the law in our
society”. Winfield
POLICY CONSIDERATIONS
Economic considerations
 Justice – moral and ethical issues
 Practical implications
 Insurance
 Loss allocation
 “Floodgates” fear of too rapid an
expansion
 Protection of classes of individuals
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THE HUMAN RIGHTS ACT
1998
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It is unlawful for public bodies to act in a
way which is incompatible with a
Convention right.
THE HUMAN RIGHTS ACT
“Public Authorities” must act in accordance
with Convention rights
 Courts
 The Government
 The GMC
 NHS Trusts
 NICE and Healthcare Commission
CONVENTION RIGHTS AND
MEDICAL LAW
The right to life (Article 2)
 The prohibition of inhuman and degrading
treatment and torture (Article 3)
 The right to liberty and security (Article 5)
 The right to a fair trial (Article 6)
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CONVENTION RIGHTS
(continued)
The right to respect for privacy and family
life (Article 8)
 The right to receive and impart information
(Article 10)
 The right to marry and found a family
(Article 12)
 The right not to be discriminated against
(Article 14)
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IMPACT OF HRA ON CLINICAL NEGLIGENCE
An end to blanket immunities for public
authorities
 New routes for claiming damages –
Savage and Rabone cases
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Article 6 of the Convention
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“In determination of his civil rights and
obligations, or of any criminal charge
against him, everyone is entitled to a fair
and public hearing within a reasonable
time by an independent and impartial
tribunal”
DUTY OF CARE: GREY AREAS
Good Samaritan acts
 Members of an indeterminate class
 Wrongful life
 Police, ambulance and other emergency
services
 Psychiatric injury – secondary victims
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GOOD SAMARITAN ACTS
“Doctors are increasingly reluctant to give
medical assistance on aircraft for fear of being
sued if things go wrong.
1000 incidents a week.
There is a steady fall in the percentage of
occasions when a doctor or healthcare
professional responds to a crew announcement
seeking a volunteer".
(BMJ Report 2004)
BREACH OF DUTY 1
General law of negligence – the standard
of care is that of the reasonable person
 Clinical negligence – the standard of care
is that of the reasonable healthcare
professional at the same level and with the
same qualifications
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BREACH OF DUTY 2
The Bolam Test/Defence
 “A doctor is not guilty of negligence if he
acted in accordance with a practice
accepted as proper by a responsible body
of medical opinion….A doctor is not
negligent if he is acting in accordance with
such a practice merely because there is a
body of opinion that takes a contrary view”

Later applications
Whitehouse v Jordan 1980
 Maynard v West Midlands RHA 1984
“I have to say that a judge’s preference for
one body of distinguished opinion over
another also professionally distinguished
is not sufficient to establish negligence”
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Criticisms of Bolam Test
Too protective of doctors
 Judges not permitted to choose between
competing expert views
 “Responsible body” not defined
 A sociological rather then a normative
framework
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CAUSATION

The claimant must prove that the breach
of duty caused or substantially contributed
to the damage suffered.
Science and Law
Scientific proof = 95% probability
 Legal proof = 51% probability – “a balance
of probabilities”

Causation in clinical negligence
Patients often already sick
 Several different possible causes of illness
 Recollections of staff and patients seldom
coincide
 Staff may be in conflict
 Medical records often incomplete
 Dependence on medical experts

Tests to establish causation
“But for” test
 The chain of causation test
 Was there a novus actus interveniens?
 The material contribution test

Complex Cases
Omissions
 Multiple defendants
 Consent
 Loss of a chance

Remoteness of damage
The defendant is only liable for damage
that is of a type which is reasonably
foreseeable
 The courts define the extent of damage
 The thin skull rule
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SOME QUESTIONS ABOUT
BOLITHO
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What were the facts of the case?
What were the issues for the court to decide?
Whose evidence as to the facts (what had
happened) did the trial judge prefer and why?
Was there a breach of duty in this case?
If so, what form would it have taken?
What was the main issue on causation for the
judge to decide?
Bolitho questions continued
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Could anything have been done short of
intubation to avoid the injury to the child?
How many expert witnesses were there and
what were their fields of expertise?
Which experts did the judge prefer and why?
What was the claimant’s theory about what had
happened?
What was the defendant’s theory?
Bolitho continued
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What test had the trial judge applied to
determine the standard of care?
Did the Court of Appeal agree with the trial
judge?
Does the Bolam test or something like it apply to
causation?
What cases support the view that there might be
negligence even if a body of opinion exists to
support the defendant?
Bolitho continued
What was the new/modified test laid down
by the House of Lords?
 Has this new test made a difference in
practice?
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THE BOLITHO TEST
The judge is permitted to choose between
two conflicting expert opinions and can
reject one of those opinions if it is not
“logically defensible”.
BOLITHO: CLINICAL
GOVERNANCE
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Bleeps
“Systems”
Record keeping
Medical back-up
Court recognition of risks and benefits
Application to law on consent – Pearce v Bristol
United HC Trust 1998
SOLUTIONS TO CLINICAL NEGLIGENCE PROBLEM
The development of the Bolitho principle
 The use of guidelines to define standards
 Legal reforms
 Contributory negligence defence
 More radical solutions

The Compensation Act 2006
1
Deterrent effect of potential liability
A court considering a claim in negligence or breach of statutory duty
may, in determining whether the defendant should have taken
particular steps to meet a standard of care (whether by taking
precautions against a risk or otherwise), have regard to whether a
requirement to take those steps might—
(a)prevent a desirable activity from being undertaken at all, to a
particular extent or in a particular way, or
(b)discourage persons from undertaking functions in connection with a
desirable activity.
(Continued)
2 Apologies, offers of treatment or other
redress
An apology, an offer of treatment or other
redress, shall not of itself amount to an
admission of negligence or breach of
statutory duty.
Can Guidelines set the standard?
Definitional problems
 Too many guidelines
 Conflicting guidance
 Difficult to establish place in hierarchy
 Objections from medical profession
 Difficult to enforce
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CLINICAL GOVERNANCE
“A framework through which NHS bodies
are accountable for continuously
improving the quality of their services and
safeguarding high standards of care, by
creating an environment in which
excellence in clinical care will flourish”
“A first class service: Quality in the New
NHS”
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MAIN REQUIREMENTS
Clear lines of accountability
 Implementation of comprehensive
programmes to improve quality using
evidence-based guidelines, compulsory
audit and monitoring
 Establishing risk management policies to
identify and remedy poor performance
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THE NATIONAL INSTITUTE FOR HEALTH
AND CLINICAL EXCELLENCE
THREE MAIN FUNCTIONS:
 Appraises and develops new and existing
technologies
 Commissions and disseminates clinical
guidelines
 Promotes clinical audit and Confidential
Inquiries
NICE Guidelines
Official status close to the top of the
hierarchy
 Disseminated throughout the NHS
 Must be implemented
 Will be monitored regularly by the
Healthcare Commission
 Will provide a normative basis to measure
the standard of care in negligence cases
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Expert’s views
“If guidelines have been produced by a
respected body and have been accepted
by a large part of the profession, a doctor
would have to have strong reasons for not
following that guidance”
Dr Graham Burt of the MDU 1993
Scottish Office Advice
“With the increasing use of guidelines in
clinical practice, they will probably be used
to an increasing extent to resolve
questions of liability. Those who draft, use
and monitor guidelines should be aware of
these legal implications”.
(1995)
OFFICIAL VIEW
“Nice guidelines are likely to constitute a
responsible body of medical opinion for
the purposes of litigation”
 “Doctors are advised to record their
reasons for deviating from guidelines”- Sir
Michael Rawlins
 A deviation may not be regarded as
“logically defensible”
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Sir Michael Rawlins 2003
“I always urge doctors when they depart
from a NICE guideline to record in the
patient’s notes at the time why they did so,
because there is a general legal view that
NICE guidelines will replace the Bolam
test in medical negligence”
 MedEconomics 2003
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A FINAL THOUGHT
“There are very few professional men who will
assert that they have never fallen below the high
standards rightly expected of them. That they
have never been negligent…..What
distinguishes Mr Jordan from his professional
colleagues is not that on one isolated occasion
his knowledge and skill deserted him, but that
damage resulted”
Lord Donaldson in Whitehouse v Jordan.
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