Medical Law Flashcards
1
Q
Purpose of the law
A
To establish and define standards of acceptable (e.g. respect for autonomy)
To maintain standards and punish ‘offences’
To protect the vulnerable (e.g. certain ‘consent’ cases must come before a court)
Above all – to achieve the resolution of disputes
2
Q
Types of the law
A
Criminal law Civil law (e.g. Contract & Tort) Public law (e.g. Judicial Review (JR))
3
Q
Sources of law
A
Statute
Common law/ case law
4
Q
Statute - source of law
A
Abortion Act 1967 Human Tissue Act 2004 Human Fertilisation & Embryology Act 1990 Human Rights Act 1998 Mental Capacity Act (MCA) 2005
5
Q
Common Law/ Case Law
A
Judge – made law based on a system of Precedent
Judgements made by higher courts (i.e. Supreme Court & Court of Appeal) have to be followed by lower Courts and in future cases
6
Q
Regulation and professional guidances
A
EU Directive – European Working tine Directive; consumer protection
GMC – licensing of doctors
Regulatory bodies – HSE, PHSO, Human Tissue Authority, HFEA
7
Q
What must a pt establish to make a negligence claim
A
- That they were owed a duty of care
- That the duty of care was ‘breached’
- That they have sustained an injury (loss)
- Injury was ‘caused’ by that breach of duty (causation)
Must be within limitation period
8
Q
Breach of duty
A
‘Failing to act in accordance w/ the standards of reasonably competent medical men acting in the relevant field at the relevant time’
9
Q
Example of something that is not ethical but lawful
A
Under old Human Tissue Act (1961) patients agreed to retention of ‘tissue’ - but didn’t realise this could involve whole organs
10
Q
Example of something that is not lawful but ethical
A
Mercy killings
11
Q
Advance decisions - MCA
A
Refusal of life saving treatment:
18+ and mentally competent
Must be in writing
Be signed and witnessed
Must be clear what treatment is being refused & under what circumstances
State clearly that the decision applies, even if life is at risk
12
Q
Where does the duty of confidentiality come from
A
Legal - HRA 1998, DPA 2008
Professional codes of conduct
Terms of employment
13
Q
Tech problems causing confidentiality issues
A
Misdirected emails where 2 people have similar names
Email forwarding
Info lost, left somewhere or stolen e.g. unencrypted memory sticks, ward/team handover notes
14
Q
Casual convo problems causing confidentiality issues
A
Many improper disclosures are unintentional
Patients in the public eye
15
Q
Social media problems causing confidentiality issues
A
GMC Doctors’ Use of Social Media (2013)
Facebook/ Twitter
Peer Group Forums
16
Q
Consequences of a breach of confidentiality
A
Serious persistent failure to follow GMC guidance puts your registration at risk
Criminal prosecution
Dismissal
Embarrassment and bad publicity for employer
Financial penalty for your employer
17
Q
Who are entitled rot same duty of confidence as adults
A
Young people aged 16-17
18
Q
Sliding scale of competence
A
Younger you are, harder to demonstrate you have ability to make decisions for yourself; perverse – right to consent treatment but not deny
19
Q
What rights does a child have if they are Gilick competent
A
Rights of the child to have confidential advice and treatment more important than any rights of the patient
20
Q
What are child <16 owed if they are not Gilick competent
A
A duty of confidentiality, which may not arise in practice due to inability of giving consent
21
Q
Adults who lack capacity
A
Owed a duty of confidentiality
However, s4(7) MCA 2005 states that people who are in involved in their care should be consulted about their wishes and any relevant values and beliefs
Discussions must be limited and disclosures in the best interest of pt
22
Q
Confidentiality and deceased pt
A
Generally considered that duty of confidentiality survives death
Circumstances in which relevant info has to be disclosed e.g. to assist coroner or when required by law
23
Q
Cases where you can breach confidentiality
A
- Consent of patient (implied or expressed)
- In the patient’s best interests
- Required by Law (statue and judge-ordered)
- For the protection of patients and others – ‘public interest’
24
Q
Breach confidentiality - consent
A
Pt must understand what Is to be disclosed and why
Disclosure kept to a minimum
25
Implied consent - confidentiality
Can disclose info to other members of the healthcare team and family unless pt has explicitly said not to
26
Breaching confidentiality in the best interest of the pt
Emergency situations e.g in A&E
| Only disclose relevant info
27
Breaching confidentiality - law statute
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Public Health (Control of Disease) Act 1984
NHS counter Fraud Investigations
GMC – investigation of a doctor’s fitness to practice
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28
Breaching confidentiality in public interest
To prevent and support detection, investigation and punishment of serious crime
And/or prevent abuse or serious harm to others
Public good outweighs confidentiality obligations
29
Extent of disclosure in the public interest
Proportionate and limited to the relevant details
Each decision must be on its own merits
Wherever possible disclosure should be discussed w/ the individual concerned and consent sought
Record should be kept to show the circumstances in which the decision to disclose was made
Healthcare professionals should not see their role as police informants
30
Police and public interest discussion
Serious crime and national security e.g. murder, rape, treason, kidnapping or serious harm to the surety of the state or to public order, crimes involving substantial financial gain
Theft, fraud or damage to property where loss and damage is not substantial doesn’t warrant breach in confidence
31
Caldicott principles
Staff who have access to personal info should handle them as defined by the Caldicott principles
32
Responsibility of Caldicott Guardians
Safeguarding and governing the uses of patient information within the Trust and acting as the ‘conscience’ of the Trust
33
Right of rectification
Data subjects have the right to correct data if it is inaccurate or incomplete
34
Do clinical opinions count as inaccurate data
Even if it turns out not to have been correct, can allow a patient to add a note to records indicating that they disagree
35
Right of erasure
Allows an individual to request removal or deletion of personal data where the example the data is no longer necessary for the purpose it was collected
Doesn't apply to healthy records
36
What constitutes a battery
Performing the wrong operation
Ignoring a spp prohibition against treatment
Ignoring a withdrawal of consent e.g. continuing to ventilate a patient
Performing unnecessary treatment e.g. procedures that aren’t clinically indicated
37
What constitutes valid consent according to DOH
1. Patient must have capacity to consent to intervention
2. Patient must be appropriately informed
3. Must be given voluntarily – no under any undue influence
38
Key principles of MCA
PLUMB
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Presumption of capacity
Least restrictive
Unwise decisions
Maximise capacity
Best interests
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39
Presumption of capacity - MCA
Most people can make some decisions
40
Least restrictive - MCA
Consider all the ways to promote rights and freedom
41
Unwise decisions - MCA
Remember unwise is not the same as unable
42
Best interests - MCA
If an individual lacks capacity, any decision made/ actions taken must be made in their best interest (in a wider sense)
43
Stages of determining capacity
Stage 1 – is the patient suffering from an impairment of, or a disturbance in the functioning of, the mind or brain?
Stage 2 – does the disturbance/ impairment make a person unable to make decision for himself, at the time. Use a functional test
44
Functional test - capacity
a. To understand the info relevant to the decision
b. To retain that info; or
c. To use or weigh that info as part of the process of making the decision; or
d. To communicate his decision (whether by talking, using sign language or any other means)
45
Mental capacity and mental illness
A patient can still have mental capacity even where they have a mental disorder e.g. schizophrenia: Re C (Refusal of Treatment) [1994] – had gangrene and thought he was doctor so refused treatment
46
Temporary factors that can erode capacity
Shock, pain or drugs
Re MB [1997] – Needle phobia render a patient temporarily incapable of making a decision, needed C-section but was too afraid so doctors did it anyways and won case
47
What should we do for pts who lack capacity
Section 1(5) MCA - If the patient lacks capacity to make a decision, clinicians must act in their ‘best interests’
48
Section 4 MCA
For patients who don't have capacity
- Encourage patient participation and find out their views by speaking to next of kin
- Identify all the relevant circumstances e.g. religion
- Avoid discrimination/ assumptions
- Assess whether the patient will regain capacity
- Does the decision concern life sustaining treatment?
- Duty to consult others
49
Material risk
Would a reasonable person in the patients position attach significance to it, or the DR knows that a patient would attach sig. to it
50
Considerations for material risk
Effect on that patient
The importance to the patient of the benefits/ desire to have treatment Alt. treatments available Risks associated w/ alt. treatment
51
Choosing reasonable alternatives to suggested treatment
Must know about procedure
Must be accepted practice
Must be an appropriate option, not a possible option
Not a variant of current treatment
52
Consent - undue influence
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Consent must be given voluntarily and freely, without pressure or undue influence - DOH
Re T (Adult: Refusal of medical treatment) [1992] – refusal of blood transfusion, undue influence from mother who was a Jehovah witness. Suffered haemorrhage and died
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53
Standard consent forms
Form 1 – adults or children w/ mental capacity
Form 2 – parental consent to treatment/ investigation of a child or YP
Form 3 – procedure spp consent form
Form 4 – adults who lack mental capacity
54
Negligence
Any act or omission which falls short of the standard to be expected
Part of civil law
55
Examples of clinical negligence
Delayed diagnosis or misdiagnosis
Incorrect treatment
Surgical mistakes
Prescribing inappropriate medication
56
Causation - negligence claims
The claimant must show the breach of duty caused (or materially contributed to) the harm or injury
The burden of establishing that the breach caused harm rests w/ the claimant
57
What does a Dr need to successfully defend a negligence claim
Call evidence that shows:
A reasonable body of doctors
Skilled in that particular speciality
Would’ve done just the same as the defendant doctor did
With the exception of consent cases the Bolam test is applied to all aspects of the doctor/ patient rship
58
What should happen if a Dr goes against guidelines
Clear documentation of the reasoning behind the decision should be made
59
How can you discharge your duty of care
Seek advice the assistance from more senior colleagues
Make a note of advice in the medical records: date, time, who spoke to and the agreed plan
The responsibility then falls on the more senior colleague
60
The 'but for' test
To establish causation the claimant must answer “but for the Defendant’s negligence would the harm have occurred to the claimant in any event?”
Balance of probabilities is also used
61
Examples of causation - negligence
Histopathology - Cancer metastasis, reduced life expectancy.
| A&E - non-union led to fixation surgery, decreased ROM
62
Good Samaritan Act
When a doctor, who is not on duty, helps in emergency situation
A doctor has no legal obligation to treat someone who is not his patient
63
Vicarious liability
In respect of the acts and omissions of all their staff committed in the course of their employment
If the healthcare professional negligently performs his duty of care to the patient the NHS is liable
64
NHS indemnity
NHS indemnity introduced in 1990
| All NHS hosp indemnified their own staff against legal liability
65
When did all NHS trusts get covered under the CNST
Since 31 March 1995, all NHS Trusts have been covered under the Clinical Negligence Scheme for Trusts (CNST)
66
Unforgettable medical scandals in the UK
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Western Sussex Hosp – listeria outbreak
Drug -resistant superbugs
Whorlton hall abuse
Stafford Hosp scandal (Mid Staffs)
Bristol Royal Infirmary heart scandals
Alder Hey Hosp organ scandal
Infected blood scandal
```
67
Whorlton Hall abuse
Patients w/ learning disabilities and autism
68
BRI scandal
170 children died due to hosp keeping hearts; Kennedy Enquiry
69
Alder Hey Hosp organ scandal
Retained organs and foetuses; Redfern Enquiry
70
Infected blood scandal
Haemophilia patients given blood infected w/ HIV and Hep B/C
71
Donaldson Report
Prof Liam Donaldson, Chief Medical Officer
At least 105,000 organs retained at hosp and med schools across England
Adequate and free consent was rarely obtained
72
Following the organ retention scandal
Retained Organs Commission (ROC) established in April 2001 until 31 March 2004
Legislation: Human Tissue Act 2004 and Coroners Amendments Rules 2005
Litigation - Claimants BRI as a group shared £3.6 million and had legal costs paid of £1.7 million. Memorial plaque erected at Alder Hey.
73
Impact off medical scandals
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Patient safety – a high priority
Goal is harm-free patient care
Openness/ Transparency/ Accountability
Protecting whistleblowers
GMC – Revalidation every 5 years
Duty of Candour
Changes to Coroner rules
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74
GMC revalidation
Licensed doctors have to revalidate, every 5 years, by having regular appraisals that are based on GMC core guidance – Good Medical Practice (2013)
75
Whistleblowing
Employee speaks out about wrongdoings in the healthcare setting in the public interest
76
Legal framework protecting whistleblowers
Employment Rights Act, 1996
Public Interest Disclosure Act, 1998
Equality Act 2010
The Enterprise and Regulatory Reform Act, 2013
77
Candour
“The volunteering of all relevant information to persons who have or may have been harmed by the provision of services, whether or not the information has been requested and whether or not a complaint or a report about that provision has been made.”
78
When was contractual Duty of Candour put in place
2013
79
When did Duty of Candour become statutory
2014
80
Notifiable pt safety incidents
Any incidents which does or could cause death; severe; moderate or prolonged psychological harm
81
Examples of moderate harm
Unexplained return to surgery
Unplanned readmission
Extra time in hospital
Cancelling treatment
82
Examples of severe harm
Permanent lessening of bodily sensory, motor or intellectual function e.g. removal or wrong limb/ organ
83
What is classified as prolonged harm
For at least 28 days
84
Notifiable pt safety incidents
Any incidents which does or could cause death; severe; moderate or prolonged psychological harm
85
Examples of moderate harm
Unexplained return to surgery
Unplanned readmission
Extra time in hospital
Cancelling treatment
86
Examples of severe harm
Permanent lessening of bodily sensory, motor or intellectual function e.g. removal or wrong limb/ organ
87
What is classified as prolonged harm
For at least 28 days
88
Live birth
A foetus, whatever its gestational age, exits maternal body and subsequently shows any signs of life (voluntary movement
89
Miscarriage
Spontaneous loss of a pregnancy before 24 weeks gestation
90
Legal status of foetus
Foetus does not acquire any legal rights until it can survive independently from its mother
91
Congenital Disability (Civil Disability) ACT 1976
Gives rights to a child born handicapped to sue in negligence in limited circumstances – mother exempted
92
HRA 1998 - Article 2
Everyone’s right to life shall be protected by law (does not apply to foetus – Vo v France)
93
HRA 1998 - Article 3
Prohibition of torture (prolonging life)
94
HRA 1998 - Article 8
Right to private & family life
95
HRA 1998 - Article 12
Men and women of marriageable age have the right to marry and found a family
96
Time period to register a birth
42 days
97
Registering a birth when parents are married
At time of conception or birth, either the mother or father can register the birth on their own
98
Registering a birth if parents are unmarried
Details of both will be on certificate if they sign birth register together, a statutory declaration of percentage is prepared or a court order indicating parental responsibility is taken. Fathers’ details do not have to be included
99
Registering a birth - married same sex couples
Either can register if the child born by donor insemination or fertility treatment
100
Regisyerig a birth - same sex couples (unmarried)
Must get a parental order – cannot get this until 6 weeks after birth
Therefore, birthmother must register
101
What is parental responsibility
Defined in the Children Act 1989 “all the rights, duties, powers, responsibilities and authorities which by law a parent of a child has in relation to the child and his property”
102
How can an unmarried father obtain parental responsibility
Marrying the mother
Having his name registered
Making a parental responsibility agreement with the mother
Obtaining a parental responsibility order fork the court
Obtaining a residence order from the court
Becoming the child’s guardian on the mother’s death
103
When do adoptive parents get parental responsibility
On adoption
104
How do step parents obtain PR
By obtaining a parental responsibility order form the court
105
Do foster parents have PR
No, it either remains with the parents or is shared between the parents and local Authority
106
Do sperm donors have PR
If donation through HFEA licensed clinic, not the legal parent of child (no financial obligation, no rights, not on birth certificate)
If unlicensed clinic, will be legal father of the child
107
Do egg donors have PR
If you give birth, you are the legal mother, even with a donated egg
108
Surrogacy Arrangement Act 1985
“Surrogate mother” – a woman who carries a child in pursuance of an arrangement:
a. Made before she began to carry the child and
b. Made with a view to any child carried in pursuance of being handed over to, and [PR being met} by another person(s)
109
Are surrogacy agreements legally enforceable
No, even if a contract has been signed and expenses of the surrogate has been paid
110
Surrogacy and PR
The surrogate is legal mother unless or until parenthood is transferred to the intended parents (either by parental order or adoption)
Husband of surrogate also has PR
Surrogate has the legal right to keep the child, even if it is not genetically related to her
111
Applying for a parental order
You must be genetically related to a child to apply for a parental order =, i.e., the egg/sperm donor, and in a relationship where you and your partner are either married/ civil partners/ living as partners
You and your partner must also:
- Have the child living with you
- Reside permanently in either the UK, Channel Islands, or isle of Man
112
When must a parental order application be made
When the child is under 6 months
113
Adoption following surrogacy
If neither you or your partner are related to the child, or you’re single, adoption is the only way you can became the child’s legal parent
Subject to Adoptions Act 1976
114
Brainstem death
The irreversible cessation of the integrative function of the brainstem equates with death. and allows the medical practitioner to dx death
115
Purpose of medical certfcation of death
Enables the family to register the death
Provides an explanation of how/ why pt. died
Informs research into health effects of exposure to a wide range of risk factors
116
Who should certify a death
Statutory duty of Dr who attended in the last illness to complete
In a team of Drs – lead Consultant has the ultimate responsibility for this
If you cannot fulfil the above, must refer the death to HM Coroner
117
What does it mean to attend to a pt - death certificate
Dr who cared for pt. during illness that led to death
Must be familiar with PMH, ix and treatment
Seen the pt. in last 14 days, seen the body after death
118
Role of Medical Examiner
All deaths will be subject to either a ME scrutiny or a Coroner’s ix
Agree proposed cause of death and accuracy of MCCD with Dr
Discuss COD with NOK and establish if they have any q’s or concerns with care before death
Inform local morality arrangements
119
What to avoid when writing cause of death
Avoid ‘old age’ alone
Never use ‘natural causes’ alone
Avoid terminal events, mode of dying and other vague terms i.e., terms that do not identify disease e.g., cardiovascular event
120
Two ways to have a post-mortem
Coroner orders it to try and determine cod or
Agreed upon by the hosp and the family to gain fuller understanding of the deceased’s illness or cod and/or to enhance future medical care
121
What needs to be observed during a post-mortem
HTA 2004 and Code of Practice in either case
122
Coroner's post-mortem
Doesn’t require consent of family
Must be done by a suitable practitioner – as soon as reasonably possible
Must comply with HTA 2004 standards
The Coroner must release the body for burial/cremation as soon as practicable usually with 28 days
If PM confirms natural cod; coroner doesn’t need to hold inquest
123
Laws on burial
No law that a body has to be buried in an authorised place e.g., graveyard
Not illegal to bury a body in your back garden as long as you obtain consent from the local authority; keep a burial register and it is not going to poison water supply
124
The cremation (England and Wales) Regulations 2008
The cremation (England and Wales) Regulations 2008
Cremation 4 – usually dr who has seen deceased in last illness
Cremation 5 – confirmatory certificate – nor mainly being done by the Medical Examiner. Speak to Crem 4 drs
Medical referee at crematoria
125
Notifications of death regulations 2019
In force 1 October 2019
Now a duty to report certain categories of deaths to the Coroner
Must inform Coroner as soon as reasonably practicable
May need to inform police if death through to be suspicious
126
What is an unnatural death
Need a suspicion of foul play or other wrongdoing e.g., incl medical treatment for non-fatal conditions which leads to death or respiratory disease (asbestosis) because of employment
Violent death involves an injury of some sort e.g. deliberate killing, accident e.g., cut, fall or RTA, struck by lightening
127
Purpose of Coroner's inquest
Identify who the decreased was
How, when and where the deceased came by his/her death
Is a fact-finding hearing
128
Inquest hearing
Public heating, media can be present
Relatives can attend, ask q’s, be legally represented
Trust’s solicitor or barrister will be there if staff requested to provide written statement/ give oral evidence
129
What determination must a coroner reach during an inquest
```
Name of deceased
The. Medical cause of death
How, when and where the D’cd came by their death
The conclusion (verdict)
Registration particulars
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130
Possible outcomes of an inquest (verdict)
Natural causes – incl fatal medical condns
Accident/ misadventure
Industrial disease of ..
Dependence on drugs/ issue of drugs
Killed himself
Killed unlawfully
Open verdict insufficient evidence – case left open
Neglect
Narrative verdicts – brief description of factual events
Can only be challenged by judicial review
131
Adverse findings of an inquest - neglect
Gross failure to provide basic care
Does not look at clinical judgement
Must be over a period of time
132
Adverse findings of an inquest - Regulation 28 report
Repost on action to prevent future deaths
Coroner now has a duty to issue a report to public authorities’ circumstances which pose a risk of future deaths
A copy of the report is sent to the Chief Coroner who publishes them
133
Donoghue v Stevenson
Mrs D had a ginger beer in a café and the bottle was found to have a decomposing snail inside
Developed gastroenteritis and brought a claim against manufacture
No ‘contractual’ relationship bust she successfully argued a claim in the tort of negligence as manufacturer owed the consumers a duty of care
134
The cost of making mistakes
The annual cost of harm arising from clinical actives during 2019/20 covered by the Clinical Negligence Scheme for Trusts was £8.3 billion, reducing from £8.8 billion for 2018/2019” - NHSR
135
The standard of proof required in a negligence claim
Balance of probabilities” – more likely than not e.g., 51%
136
Hatcher v Black [1954]
Pt suffered s/e from an operation on their throat and sued the surgeon
137
Bolam Test
A mentally ill pt. was given ECT during which P suffered a fractured pelvis and other injuries. Risk could’ve been reduced if relaxant drugs was given but medical professionals were divided on the matter
138
Bolitho
The Bolam test was reviewed and confirmed by the House of Lords in Bolitho
The views of the expert must be honestly and sincerely held
The Courts, not the medical profession, are the final arbiters of the standard of care in clinical negligence claims
Bolam is still good law, but Dr must still be able to show that this opinion has a logical basis
139
What is the Standard of Care that has to be attained
Not that of the highest skilled practitioner but that of the ordinary competent practitioner in that field
Standards are those which were adopted at the time of the negligence, not at the time of the trial.
140
Wilsher v Essex AHA [1986]
The argument that a junior doctor did their best in view of their inexperience, was rejected.
The law requires all medical staff to meet the standard of competence
141
What happens if negligence is proved
Compensation known as “damages” is awarded
| No special rules applied to damages awarded in clinical negligence cases
142
Aim of damages
To put the claimant in the same position as they would’ve been if there was no negligence
143
How many times are damages awarded
Once
144
Provisional damages
Provides the pt. with the option to return to court to seek a further sum of compensation if they deteriorate significantly after orig claim is settled
145
What prevents just anyone from seeking damages
Costs – Loser pays winner’s costs
146
What are general damages awarded for
"Pain, suffering and loss of amenity”
| Based on JSB guidelines and case law
147
What are special damages
Quantifiable losses e.g., past, and future loss of earning, cost of nursing care, aids, and equipment and other out of pocket expenses
148
Good Samaritan Acts - contractual duty
“You must offer help if emergencies arise in clinical setting or in the community, taking account of your own safety, your competence and the availability of ither options for care” – Good Medical Practice – para 26
149
What should be considered when offering help - GSA
Your safety
Your competence
The availability of other options
150
Social Action, Responsibility and Heroism Act 2015
You should:
Make a detailed record of the incident and your involvement
Obtain consent from the pt.
Explain your actions and treatment to the patient
151
CNST
Run by NHS Resolution (NSHR)
Created a pooling arrangement to meet liabilities arising out of pt. claims
“Premiums” for individual Trusts are worked out, depending on the type of Trust, specialities offered, scale of operations and standards achieved
