Consent and Disclosure of medical risks Flashcards
Historical Position
doctor knows best - hippocrates - conceal most things from patient as treatment options = limited and often painful so better to not worry/scare patient as they may not want the procedure
Current Position- Informed Consent
now patient makes decisions together with doctor, doctor advises of risks and everything involved in proc - endorsed in GMC guidelines - law is catching up
justifications: consequentialism and deontologys respect for autonomy
criticisms: no legal req to get written consent only verbal and some patients think by signing consent they have forgone their right to change their mind but you can withdraw consent at any point
subjective or objective? - average doctor would decide but also look at specific patient and what is best for them
Legal Consequences for failing to inform
Crime - Assault/Battery - R v Tabassum:
ind who had no med quals but said gynecologist and performed diagnostic procedures on women, no true consent as unaware - guilt for indecent assault
R v Richardson:
dentist failed to inform patients of suspension from practice - not guilty of assault occassioning actual bodily harm - patient knew doctor = qualified dentist prior to suspension so not miseld in term of her skill but just that her licence was suspended
Tort – Trespass to the person - Battery: - courts reluctant to impose this
Not necessary to establish any harm caused by inadequate disclosure, but courts hostile to use of battery in disclosure of risk cases
Chatterton v Gerson (loss of mobility) - patient loss of mobility as result of procedure which they were not aware of
Patient informed in ‘broad terms’ – appropriate action is NEGLIGENCE
Legal Consequences for failing to inform Tort – Negligence: Inadequately informed patient
duty of care - doctor patient rel = rec category of duty
how much info should be disclosed to be considered sufficient?
Bolam v Friern Hospital Management Committee - ECT therapy and wasnt advised of risks, suffered fractured hip (no restraints or relaxants applied - ev on both sides that some doctors would not have applied restraints and court gave away right to call a judgement and said as long as there is one expert that says this is correct practice then doctor gets away with liability
look to the general practice of other medical professionals to determine if it was negligence in term of standard of care provided to patients
Legal Consequences for failing to inform Tort – Negligence: Inadequately informed patient - Sidaway case
Patient suffering from cervical decompression - 1% risk of paraplegia and patient said not informed - rec there is a general duty to patients but it can be rejected based on standard of care
Expressly overruled in Montgomery but courts come back to assess the conflict bet autonomy and paternalism
HR agreed that there is a duty of care that doctors owe to patients, but rejected the claim based on standard of care - rec general duty to patients but can be rejected on breach care which is standard of care
Lord Diplock - Applies Bolam (as ‘a highly educated man of experience’ wished to be informed, but most patients would not even question the treatment – the idea that only patients who seek information should be given that information) - defered to medical professions and didn’t want to interfere with treatment
Lord Scarman – Reasonably Prudent Patient test
◦ Basic Right To be informed of Material Risk (US influence)
◦ Risks which are also special to the patient – patients’ perspective of risk? - subjective perception of risks patients will have
Lord Bridge (Lord Keith agreed): Modified Bolam
◦ Disclosure primarily a matter of clinical judgement, but:
◦ in some cases, even if body of professionals agree, risk may need to be disclosed
◦ Example: substantial risk of adverse consequences 10% of stroke - if there are substantial risks of serious cons then it must be disclosed
Lord Templeman: Modified Bolam
◦ Risk which is ‘special’ in nature (special in magnitude)
◦ Risks which are also special to the patient – patient’s perspective of risk or doctor’s view?
Case law After Sidaway
Gold v Haringey Health Authority
unsuccessful female sterilisation - failure to disclose risk - CoA - did sidaway endorse bolam?
Lord Diplock judgment in Sidaway relied on
Bolitho v City & Hackney Health Authority
Doctor did not arrive in time and failed to intubate an infant who died - Q for courts = did doctor act in accordance with practice accepted as proven by med professional
decision must be ‘capable of withstanding logical analysis’ - court intervened
Court’s willing to interfere with medical opinion - clear this doctor did not withstand logical analysis it was plain negligence - shows they can reject doctors even if doctors were to provide expert ev that some may have arrived late
Pearce v United Bristol Healthcare NHS Trust
Risk of still birth 0.1/0.2% - overdue patient for 2 weeks asked to be induced, not regarded as sufficiently significant risk - not informed and child died
Move towards a reasonable patient test
lord woolf - if there is risk that may affect judgement of a reasonable patient then resp for doctors to tell them - ambiguity as doctors did not regard risk as sig so who defines risk as significant- doctors or patient? - form of recognition that patients decisions matter
Further shift towards reasonable patient test
Chester v Afshar
Chronic back pain, around 2% risk of cauda equina (loss of sensation, bladder and bowel function) - small risk had materialised - even though risk was small it shouldve been shared - first case that uses patient rights are recognised
surgeon = legal duty to patient to warn them of poss serious risks in proc - only wholly exceptional case = objectively in best interests of a patient - lord steyn
serious risks not all risks
ambiguity - is seriousness judged from patient or doctor POV?
causation - dont have to prove patient would have never had procedure just when advised of risk
Birch v University College London Hospital NHS Foundation Trust [
Duty to inform about risks but also about the alternative treatments?
1% risk of stroke not given– alternative of MRI scan not given as option - recommended invasive proc of inserting a catheter in their vein
cranston J - not fully informed consent if not given comparative procedures
Montgomery v Lanarkshire Health Board
mother = diabetic (causes likelihood of complications when giving birth and it materialised) risk was that child was heavier so complication of shoulder dystocia and began to suffocate due to lack of oxygen - patient not informed of the 9-10% risk
some advise given on likelihood of childs weight (4kg) acc 4.25kg
GMC guidelines = patient not offered C section if childs weight was exactly 4kg - doctors followed guidance but did it negligently as failed to assess acc weight
Dr reason for not disclosing risk - if she did then C sections would be carried out for all diabetics and the patient would have wanted it which would be against GMC guidelines and almost forced to carry it out
SC judgement -
rejection of reasonable doctor - rec patient has right to know material risks
acceptance of a partnership model of decision making embodied in GMC guidelines
patient should be advised on inherent risks and alt procedures
confined to disclosure of risks not treatment or diagnosis - bolam still applies to the other two
‘The significance in Sidaway to a patient’s failure to question the doctor is however profoundly unsatisfactory’ Para 58 - overruling Lord Diplock in Sidaway
Test of Materiality
a reasonable person in patients position would be likely to attach significance to the risk or the doctor is or should reasonably be aware that the particular patient would attack sig to it - para 87 montogomery (looking at objective reasonable patient)
Exception – therapeutic privilege, necessity - doctors able to choose to conceal some info when feel it will have an adverse clinical result such as distress or in the case of necessity when patient is being treated in emergency department when there is no time to explain risks of a procedure so only brief explanation is given
Three points noted: Paras 89-92:
- Cannot reduce assessment of whether risk is material to percentages “The assessment is therefore fact sensitive, and sensitive also to the characteristics of the patient” - subjective element - even if there is 1% of risk if it is material it must be revealed
- Doctor’s advisory role involves dialogue – information must be provided comprehensibly “Duty is not fulfilled by bombarding patient with technical information or signature of consent forms”
- Therapeutic exception should not be abused
causation
but for test - would patient refuse treatment if informed of risk - not strict as no way to determine for sure - subjective
disclosure of info cases - subjective/objective - objective as look at reasonable patient
FM v Ipswich Hospital NHS Trust
Caesarean case – failure to disclose risks involved with procedure, felt patient approached this case with benefit of hindsight, no way of showing she would have opted for C section if she knew about risks but regardless her claim was successful
Cautious of placing too much reliance on evidence of Mrs M that she would have had a caesarean section as she now knows the alternative led to F being significantly disabled
Carefully considered evidence satisfied Mrs M would have opted for section even if advice of obstetrician was otherwise
What if the patient would have undergone the procedure at a later date
Chester v Afshar
Not necessary to prove the patient would never have proceeded with the treatment, if they knew of the risk what is important to show they would have considered the options at the relevant point
Holistic patient centred approach
partnership model in making
GMC “Consent: Patients and Doctors Making Decisions Together (2008)”
Not legally binding, but a doctor can have their licence revoked and removed from the register
montgomery judgement reflects much of this guidance
princip 4: no single approach to discussions ab treatment or care will suit every apteitn, some may need more of less info in making decisions - subjective recognised
princip 28: clear, accurate info ab risks of any treatment presented in a way patients can understand, amount of info will depend on each patient and discussions focus on ind sitch and risks to them
princip 31: do your ebst to understand patients views and preferences, mustnt make assumptions about patients understanding of risk or importance they attach to diff outcomes
Effect of Montgomery Case
royal college of surgeons
“NHS trusts risk facing a dramatic increase in the number of litigation pay-outs made if they do not make changes to the processes they use to gain consent from patients before surgery.
criticisms of Montgomery cases - concern expressed but ti did not materialise as NHS trust already insulated themselves from liability by creating consent forms which patients must sign
Timing and Understanding
Information must be disclosed at an appropriate time
Lybert v Warrington Health Authority
Risks disclosed after the sterilisation procedure - invoked in subsequent cases that risk must be disclosed prior to procedure
Al Hamwi v Johnson
risk of miscarriage during the diagnostic procedure; the patient thought the risk was 75% - must make sure patient understands
Montgomery case – doctors should take steps to ensure that patient understood what they were told even if ensuring perfect comprehension is impracticable
doctors must take all reas steps but if patient still doesn’t understand they have done their best in disclosing it
Advice on alternative treatments
Duce v Worcestershire Acute Hospitals NHS Trust
patient suffered from menstrual pain and opted for procedure which was meant to help her deal with the pain but risk inherent in proc (nerve damage) materialised so suffering in constant pain - arg should have been informed of low risk - so two stage test estab:
Two Stage Test:
- what risks assoc with operation would or should have been known to med professional - matter falling within expertise of med prof
- whether the patient should have been told about such risks by reference to whether they were material. This latter issue is for the court to determine
McCulloch v Forth Valley Health Board
died of heart attack due to cardiologist negligence - first complained of chest pains, nausea and vomiting, doctor asked to review ECG and decided didnt fit diagnosis of pericarditis, improved and discharged with antibiotics then readmitted - when saw doctor said no chest pain and saw no reason to prescribe additional med as no pain - few days later suffered cardiac arrest and died
was doctor in breach of duty of care for not giving a non steroidal medicine and whether he was advised and would have taken a non steroidal and not have died - some doctors would have prescribed it but many also supported the doctors opinion, SC dismissed the appeal as followed Montgomery that doctors = duty to inform all reasonable alt treatments rather than all possible alt treats and bolam - doctor does not need to inform of other treat if not reasonable
Two stage test in Duce endorsed
The application of the professional-practice test would ‘avoid an unfortunate conflict in the doctor’s role’.
