1. Professor Vivienne Harpwood2016
Consent to treatment
Professor Vivienne Harpwood2016

2. CONSENT DEFINED
The voluntary and continuing permission of the patient to receive a particular treatment based on an adequate knowledge of the purpose, nature and likely risks of the treatment including the likelihood of its success and any alternatives to it. Permission given under any unfair or undue pressure is not consent. Mental Health Act Code of Practice (2008, para 23.31)

3. Consent to what? Disclosure of confidential data
Focus of workshop on scenarios dealing with consent to treatment in range of situations
Adults with capacity
Adults lacking capacity
Children

4. The Law of Consent
Liability in battery for touch treatments where no consent obtained, consent obtained by fraud or duress, or capable patient has validly refused treatment.
Liability in negligence if consent obtained but inadequate information given by doctor about risks

5. Battery
If adult capable patient is treated without obtaining her or his consent, or in the face of a refusal, the doctor is liable in the tort of trespass to the person.
Battery a form of trespass to the person
Intentionally bringing about a harmful or offensive contact with the person of another.

6. Negligence: Chatterton v. Gerson [1981] Q.B. 432
."...it would be very much against the interests of justice if actions which are really based upon a failure by the doctor to perform his duty adequately to inform were pleaded in trespass [battery].“
Once the patient is informed in broad terms of the nature of the intended procedure, and gives her consent, that consent is real, and the cause of the action on which to base a claim for failure to go into risks and implications is negligence, not trespass. Of course, if information is withheld in bad faith, the consent will be vitiated by fraud.

7. Bad Faith and Fraud
Appleton and others v Garrett [1997] 8 Med LR 75 dentist carried out unnecessary treatment. Withheld information deliberately and in bad faith from patients. Dentist liable in trespass and damages awarded for pain suffering and loss of amenity, cost of treatment from a top dentist to rectify subsequent problems, and aggravated damages for feelings of anger and indignation. Patients received damages ranging from £15,000 to £28,000.

8. NEGLIGENCE AND DISCLOSURE OF INFORMATION
Elements in an action for negligence for failure to give adequate treatment information
A duty to disclose the risk
Breach of the duty to disclose
Causation - the damage suffered must have been caused by the breach of duty But see now the House of Lords decision in Chester v Afshar [2004] UKHL 41

9. Early Case Beatty v Cullingworth BMJ (1896)
Before doing an operation, surgeons should be careful to explain what they propose to do and get unequivocal consent from the patient, or if the patient is not in a condition to give consent, from the patient’s nearest friends. Such consent should either be in writing or distinctly expressed before witnesses.

10. Purpose of Consent
Clinical purpose enlisting patient’s faith and confidence in the efficacy of the treatment is a major factor contributing to the treatment's success.
Legal purpose to provide those concerned in the treatment with a defence
Legal/Ethical purpose recognition of the patient's right of self-determination.

11. The Right to Self-Determination (Re T (1992)
“An adult patient who ... suffers from no mental incapacity has an absolute right to choose whether to consent to medical treatment, to refuse it, or to chose one rather than another of the treatments being offered... This right of choice is not limited to decisions which others might regard as sensible. It exists notwithstanding that the reasons for making the choice are rational, irrational, unknown or even non-existent”.

12. The Right of Self-Determination (Re T (1992)
Prima facie, every adult has the right and capacity to decide whether or not he will accept medical treatment, even if a refusal may risk permanent injury to his health or even lead to premature death.

13. Human Rights Act 1998
Article 8 everyone has the right to respect for his home, his privacy, and his family life
No interference unless necessary in a democratic society, and in accordance with law, to protect health or the rights of others.
Article 3 No-one to subjected to torture or to inhuman and degrading treatment.
Article 5: Right not to be detained without lawful authority.

14. (DOH Reference Guide to Consent 2009)
If an adult with capacity makes a voluntary and appropriately informed decision to refuse treatment (whether contemporaneously or in advance), that decision must be respected, except in certain circumstances defined by the Mental Health Act 1983 This is the case even where this may result in the death of the person (and in the death of an unborn child, whatever the stage of the pregnancy).

15. Pearce v. United Bristol Healthcare N.H.S. Trust (1998) 48 BMLR 118
In determining what information to provide a patient, doctor must have regard to all relevant circumstances, including the patient’s ability to comprehend the information and the physical and emotional state of the patient. Normally, it is a doctor’s legal duty to advise a patient of any significant risks which may affect the judgment of a reasonable patient in making a treatment decision Lord Woolf MR

16. Pearce v. United Bristol Healthcare N.H.S. Trust (1998) 48 BMLR 118
If a patient asks about a risk, it is the doctor’s legal duty to give an honest answer.

17. Developments since Pearce
Birch v University College Hospital NHS Foundation Trust [2008] Cranston J
“My view is that in the special circumstances of this case the hospital should have discussed with her the different imaging methods catheter angiography and MRI and the comparative risks. Had it done so Mrs Birch would have declined cerebral catheter angiogram and avoided her stroke. Given that Mrs Birch was known to be a diabetic, and this more likely to develop complications and that the chances of an aneurism were low, catheter angiography had risks outweighing the benefits

18. The Doctor’s Duty
To take into account all the relevant considerations, which include the ability of the patient to comprehend what he has to say to his or her and the state of the patient at the particular time, both from the physical point of view and the emotional point of view...

19. The Doctor’s Duty: Which risks to disclose
It is important to notice that to be ‘significant’ a risk need not be one, which would have altered the patient’s decision to consent to the treatment. A lesser level of importance may suffice. The risk must be one that a “reasonable patient” would consider relevant to, rather than determinative of, his or her decision.

20. Chester v Afshar [2002] 3 All ER 552
Patient referred to eminent neurosurgeon for operation for back pain removal of three discs. Agreed to have operation but not informed of small but known risk of paralysis (1% - 2%) Patient suffered paralysis. The Court of Appeal held that the causal link not broken by fact that claimant unable to prove that she would not have had the operation at some time in the future.

21. Chester v Afshar House of Lords
The House of Lords held by a 3-2 majority that the defendant had been negligent in informing the patient of the risk of paralysis, and that the claimant was entitled to damages even though that failure to inform had not, on a strict application of the but for test resulted in the injuries suffered by the patient. Doctrine of informed consent given priority over the rules of causation.

22. The Prudent Patient Test
Based upon the information needs of the patient, rather then on a clinical assessment of best interests.
Based on law in other common law jurisdictions

23. The Prudent Patient Test
Rogers v Whitaker [1993] 4 Med LR 79 Patient almost blind in one eye, consulted an ophthalmic surgeon and asked about possible complications if an operation was performed, but did not ask specifically whether sympathetic ophthalmia (damage to the other eye) could result. She made clear her wish for information and to be informed of the possible risks, expressing concern that no damage should befall her good eye. One in 14,000 risk. Patient rendered blind in the good eye as a result of the operation. Court rejected Bolam approach.

24. Montgomery v Lanarkshire HB 2015
Important Supreme Court decision
Facts of case
Key points
Confirms move from paternalism to autonomy;
Assessing the significance of risks is fact-sensitive and cannot be reduced to percentages;
To advise patients correctly, the doctor must have a dialogue with the patient;
The therapeutic exception allowing doctors to assess the ability of the patient to cope with information, and to withhold certain details, is very limited indeed, and should not be abused.

25. Advice emerging from Montgomery
Give information to help patients to make informed decisions;
Present the information clearly tailored to the individual;
Give patients balanced, accurate information about the risks, complications, side-effects of proposed treatment;
Ensure that the amount of information about risks, complications and side effects relates to the needs of the individual patient and what he or she wants or needs to know.
Facilitate a discussion involving the patient;
Explain any adverse outcomes from the various options, including the option of doing nothing.

26. Lord Kerr and Lord Reed
“Quite apart from the risk of injury to the baby (a risk of about 1 in 500 of a brachial plexus injury, and a much smaller risk of a more severe injury, such as cerebral palsy, or death), it is apparent from the evidence ……….that shoulder dystocia is itself a major obstetric emergency, requiring procedures which may be traumatic for the mother, and involving significant risks to her health”.

27. Baroness Hale’s view
It is impossible to consider any particular procedure in isolation without also engaging in dialogue concerning its alternatives. Pregnancy provides a powerful illustration. If either mother or child is at an increased risk from vaginal delivery, doctors should volunteer the advantages and disadvantages of that option compared with a caesarean section.

28. Adults Lacking Mental Capacity
If patient unconscious or incapable of making a decision treatment may be given if necessary in the patient’s best interests. Mental Capacity Act 2005, s 5.
Incapacity defined in ss 2 and 3 of the MCA 2005, process for determining best interests defined in s 4
Mental Health Act 2007 Deprivation of Liberty Safeguards
Cheshire West Case

29. Causation
Once the claimant has established breach of duty s/he must go on to establish that the breach caused the damage. That is to say s/he must show, on the balance of probabilities, that if he had been given adequate information he would not have had the operation.

30. The Mental Capacity Act 2005: Principles
(1) Capacity is presumed unless incapacity is established by those alleging it.
Section 3 Incapacity test inability by reason of mental disability to
understand and retain information relevant to the decision,
use or weigh the information as part of the process of arriving at a decision (including inability to believe the information), or
communicate his decision by any means.

31. The Mental Capacity Act 2005: Principles
(2) All reasonable steps must be taken to help a person to make the relevant decision

32. The Mental Capacity Act 2005: Principles
(3) A person is not to be treated as unable to make a decision merely because the decision is unwise (Re T (Adult Refusal of Treatment) [1992] 3 WLR 782). (4) Acts done for people who lack capacity must be in their best interests (In Re F (Mental Patient : Sterilisation) [1990] 2 AC 1). The balance sheet approach.

33. Best interests
Take into account person’s past and present wishes and feelings, beliefs and values which might be likely to influence decision, and any other factors which s\he would be likely to consider if able to do so. If practicable and appropriate, decision maker must consider the views of anyone named by the person to be consulted, any carer or person interested in his welfare, any donee of a lasting power of attorney granted by the person, and any deputy appointed by the Court of Protection.

34. Best Interests
Wishes and feelings of the patient expressed when capable must be considered by decision makers in determining what is in the patient’s best interests (Mental Capacity Act 2005, s 4(6)) as must the views of any person nominated by the patient to be consulted (s 4(7)).

35. The Mental Capacity Act 2005: Principles
(5) Regard must be had before any act is done, to whether it is the least restrictive way of achieving its necessary purpose, in other words, to the European Convention principle of proportionality. The least restrictive approach should be taken.

36. Mental Capacity Act 2005 Revamped Court of Protection ss 45-46.
Declarations s 15
Advance decisions ss
Lasting Powers of Attorney ss and ss
Power of Court of Protection to make decisions and appoint Deputies ss 16 – 20.
Independent Mental Capacity Advocates ss

37. Personal Welfare Decisions
Both deputies and donees of lasting powers of attorney can make decisions about personal welfare, including consenting to treatment. A decision refusing life sustaining treatment may only be made by the donee of a lasting power of attorney if it has been specifically granted by the donor of the power (s 11(7)-(8)). Such a decision may not be made by a court appointed deputy (s 20(5)).

38. Care and Treatment of Adults Lacking Capacity
Sections 5 and 6 of the 2005 Act provide a general defence to acts of care and treatment, which may involve restraint and restriction of liberty of a mentally incapacitated person.

39. The Section 5 Criteria
(1) D should take reasonable steps to establish whether P lacks capacity in relation to the particular matter;
(2) D should reasonably believe that P lacks capacity in relation to the matter
(3) D should reasonably believe that it will be in P’s best interests for the act to be done.

40. Pause to examine scenarios
Note the role of the courts
Seldom necessary to go to Court
Court of Protection
Family Division of High Court

41. Deprivation of Liberty Safeguards
The Mental Capacity Act Deprivation of Liberty safeguards were introduced into the Mental Capacity Act 2005 through the Mental Health Act 2007 The MCA DOL safeguards apply to anyone: - aged 18 and over - who suffers from a mental disorder or disability of the mind – such as dementia or a profound learning disability - who lacks the capacity to give informed consent to the arrangements made for their care and / or treatment and - for whom deprivation of liberty (within the meaning of Article 5 of the ECHR) is considered after an independent assessment to be necessary in their best interests to protect them from harm.

42. DoLs
The safeguards cover people in hospitals and care homes registered under the Care Standards Act 2000
The safeguards are designed to protect the interests of an extremely vulnerable group of service users and to: - ensure people can be given the care they need in the least restrictive regimes - prevent arbitrary decisions that deprive vulnerable people of their liberty - provide safeguards for vulnerable people - provide them with rights of challenge against unlawful detention - avoid unnecessary bureaucracy

43. Cheshire West Case
“If it would be a deprivation of my liberty to be obliged to live in a particular place, subject to constant monitoring and control, only allowed out with close supervision, and unable to move away without permission even if such an opportunity became available, then it must also be a deprivation of the liberty of a disabled person. The fact that my living arrangements are comfortable, and indeed make my life as enjoyable as it could possibly be, should make no difference. A gilded cage is still a cage.” (Baroness Hale)

44. Best interests What are “best interests”? Assessors to be trained
Role of local authorities
Role of healthcare professionals
Cases going to Court of Protection
Still an issue with definition of “Deprivation of Liberty”

45. ROLE OF COURT OF PROTECTION
Supervises the framework in MCA;
Makes declarations on person’s capacity to make particular decision;
Makes decisions for people without capacity;
Appoints deputies to make decisions on person's welfare, giving or refusing consent to treatment, and property and affairs;
Rules on the validity of LPAs;
Deals with DoLS issues
Determines the meaning or effect of LPA’s.
Has power to make declarations on validity of advance decisions

46. MCA Involvement of Third Parties
Independent Mental Capacity Advocates
Lasting Powers of Attorney
Court Appointed Deputies

47. Children and Consent
Consent of child under 16 valid if child Gillick competent (Gillick (1986))
Children Family Law Reform Act 1968, s 8.
Mental Capacity Act does not apply to people under the age of 16.

48. Parental Consent
Duty of those with parental responsibilities to seek necessary medical for children. If they don’t they risk prosecution for child neglect.
Parental responsibilities include responsibility to consent to treatment on child’s behalf.
Child cardiac patients at Bristol Royal Infirmary

49. Children and Refusal
Refusal by competent child of any age up to 18 may be overridden by parent or court if necessary in child’s best interests

50. Key points on Consent
Consent is necessary to examine or treat competent patients.
Adults are presumed to be competent
Patients may be competent to make some health care decisions but not others
Giving and obtaining consent is a process, and a dialogue, not a one off event
Doctors should respect the autonomy of their patients
Patients should be given sufficient information about options, benefits and risks

51. Key points on Consent
Competent adult patients entitled to refuse treatment even treatment that would clearly benefit their health
Children can give consent for themselves in certain circumstances
It is always best for the person actually treating to seek consent
Consent must be given voluntarily not under duress
Consent can be written, oral or non-verbal

52. Key points on Consent
No-one can give consent on behalf of an incompetent adult – the decision for doctor acting in patient’s best interests.
Unless the power to consent has been conferred under the MCA 2005 on a donee under a Lasting Power of Attorney, a deputy appointed by the Court of Protection, or the Court of Protection consents

53. Key points on Consent
An advance decision by a competent patient is valid and applicable if it was made by the patient when capable, is clear and specific about which treatments are being refused, and is sufficient in scope to cover the situation which has currently arisen.
If life sustaining treatment is to be refused by advance decision the decision must be in writing AND APPROPRIATELY SIGNED.

54. Most Important Principle
Treat patients as individuals and with dignity and respect