Medical Law Consent, Battery: Information and Voluntariness

1
Medical Law Consent, Battery Information and
Voluntariness

• Prof Orla Sheils
• Department of Histopathology
• TCD

2
Principal Issues

• Importance of consent morally and legally
• Elements of battery
• Elements of consent
• Distinction between battery and negligence
• Nature and purpose
• Relevance of fraud

3
Purpose of the law of consent

• To protect the ethical principle that each person
  has a right to self-determination and is entitled
  to have their autonomy protected.
• Breach of this amounts to the tort of battery and
  may constitute a criminal offence.
• Trespass to the body

4
Issues of consent

• Crime of battery
• Tort of battery
• Tort of negligence

5
INFORMED CONSENT-Definition

• Informed consent means the knowing consent of an
  individual or their legally authorised
  representative, so situated as to be able to
  exercise free power of choice without undue
  inducement or any element of force, fraud,
  deceit, duress or any form of restraint or
  coercion.

6
Issues of Consent

• A person gives informed consent when, with
  substantial understanding and in the substantial
  absence of control by others, they intentionally
  authorise a professional to do something.
• Range of ethical concepts used to justify
  informed consent
• self-determination,
• dignity,
• autonomy,
• freedom,
• privacy.

7
Issues of Consent

• Most influential concept in writing on consent
  autonomy.
• Self-determining moral agent
• Moral claim that it is wrong to treat others in
  such a way that prevents them from shaping their
  own lives in accordance with their own
  intentions, plans and values.

8

• Consent in medical procedures can usually be
  obtained by presenting the patient with a consent
  form to sign.
• The consent form exists to demonstrate that a
  process of communication has taken place during
  which the patient has learned about his/her
  illness and treatment options and reached a point
  where they can decide, on an informed basis to
  proceed with, restrict, or decline the proposed
  intervention.

9

• The doctrine of consent operates to reflect the
  self-autonomy of the patient.
• In many jurisdictions it is now regarded as a
  fundamental human right.
• In Ireland, this fact is well established. The
  Supreme Court has stated that
• "The requirement of consent to medical treatment
  is an aspect of a person's right to bodily
  integrity under Article 40, s. 3 of the
  Constitution" (In re a Ward of Court 1996 2 IR
  79 at 156, Denham J.).

10

• The Supreme Court in the same case made it clear
  that
• "If medical treatment is given without consent
  it may trespass against the person in civil law,
  a battery in criminal law and a breach of the
  individual's constitutional rights" (ibid).
• Thus, before undertaking medical treatment of any
  sort whatsoever, a healthcare professional must
  obtain the consent of the patient.

11

• Legal requirements focus on disclosure and
  comprehension. Influenced by risk management,
  litigation fears, avoidance of harm, protection
  of rights.
• Moral elements
• From the moral viewpoint informed consent is more
  concerned with the choices of the patient and
  maintaining trust in the doctor-patient
  relationship. Legal consent is concerned with
  protecting bodily integrity, avoiding injury and
  risk.

12

• For consent to be valid a patient must have
• capacity
• it must be voluntarily given,
• there should be no duress
• Information regarding risks, benefits,
  side-effects and alternatives must be given so
  that the patient is able to make an informed
  decision as to whether or not to proceed with
  treatment.

13

• Five elements are crucial in the concept of
  informed consent
• Disclosure
• Comprehension
• Voluntariness
• Competence
• Agreement.

14
Central issues for consent

• Is the person competent
• Is the consent voluntary
• Is it adequately informed

15
Capacity

• Patient must be able to communicate their choice.
  
• Capacity is decision-specific.
• A patient should not be regarded as lacking
  capacity merely because they do not take their
  doctors advice or make a decision that would
  ordinarily be regarded as imprudent

16
Consent and Law

• ECHR
• Forced treatment against wishes would breach a
  persons rights under article 3 not to be
  subjected inter alia to inhuman and degrading
  treatment

17
Constitution
Article 40.3.2 of the Irish Constitution states
- The State shall, in particular, by its laws
protect as best it may from unjust attack and, in
the case of injustice done, vindicate the life,
person, good name and property rights of every
citizen. THIS MEANS THAT Each of us has a right
to have our bodily integrity protected against
invasion by others.
18
Schloendorff v Society of New York Hospital
(1914) Justice Cardozo

• Every human being of adult years and sound mind
  has a right to determine what shall be done with
  his own body, and a surgeon who performs an
  operation without his patients consent commits
  an assault for which he is liable in damages.
• Right to self determination includes right to
  refuse treatment or select an alternative.

19
Consequences

• The consequences of an unauthorised and
  unjustified invasion of bodily integrity include
  -
• Civil claims for compensation
• Criminal liability for battery (unlikely except
  in cases of non consensual touching by a
  clinician)
• Investigation for alleged misconduct by
  professional regulatory body

20
Valid Consent

• The Law Reform Commission in its report into
  Vulnerable Adults and the Law (2006) states that
  the informed consent requires the following
  elements to be satisfied -
• Prior disclosure of sufficient relevant
  information by the medical practitioner to the
  patient to enable an informed decision to be
  made about the treatment
• Given by a person with the necessary capacity
  at the time to decide whether or not to consent
  to the proposed treatment
• In a context which allows the patient to
  voluntarily make a decision as to whether to
  consent or decline the proposed treatment

21
Types of consent

• Express
• Patient explicitly agrees to what is proposed by
  doctor
• Brushett v Cowan (Newfoundland CA)
• Muscle and Bone bx
• Alleged no consent for bone bx
• Held-bone bx was part of the ongoing
  investigation fell within express consent given.

22

• Pridham v Nash
• Exploratory laparoscopic procedure
• Adhesions lysed
• Consent to investigative procedure
• Lysis found to be necessary, additional, curative
  procedure
• Person must be informed in broad terms of the
  nature of the intended procedure.

23
Types of consent

• Implied
• Implied consent becomes a form of estoppel
  whereby a patient, although he did not actually
  agree to an intervention, is estopped from
  denying he did so.
• Actions speak louder than words
• If a person opens their mouth and sticks out
  their tongue, they cant complain if a doctor
  depresses tongue with a spatula.
• OBrien v Cunard SS Co (1891)
• Small pox vaccination

24
Implied Consent

• While implied consent is one possible
  justification for an intervention it is not
  necessarily the most appropriate.
• Doctors justification for treating an
  unconscious patient must rest in the doctrine of
  necessity recognised by HoL in Re F (1990)

25
INFORMED CONSENT Express or Implied

• Patients must be allowed to decide whether they
  agree to a proposed treatment even if a refusal
  will lead to their harm. Similarly, patients must
  be allowed to withdraw consent to treatment at
  any time.

26
INFORMED CONSENT Exceptions to the Rule

• It is generally acknowledged that there are two
  exceptions to the common law rule
• Therapeutic Privilege - this arises where the
  failure of the doctor to disclose is justified in
  the interest of the psychological wellbeing of
  the patient. This limited disclosure should be a
  very rare event and that the reasons not to
  disclose should be recorded in the patient's
  notes.
• The mere fact that the patient might become upset
  by hearing the information, or might refuse
  treatment, is not sufficient to act as a
  justification for nondisclosure of information.

27

• Emergency - in an emergency life-threatening
  situation where the patient is unable to consent
  or to appreciate what is required a healthcare
  professional, acting in the best interests of the
  patient, may administer the necessary medical
  treatment to save the life or preserve the health
  of the patient without formal consent.
• However, the treatment given should be only that
  which is immediately necessary for the patient's
  well being. If some coincidental and non-urgent
  problem is encountered during an emergency
  procedure it should not be dealt with until
  consent can be obtained at a later time.

28
EXCEPTIONS

• Imposing medical treatment without consent may be
  permissible in exceptional circumstances, such
  as -
• To save life in an emergency, where the
  patients wishes are not known.
• Where the patient is in an irrational state
  because of impaired consciousness.
• Where the patient has a highly infectious and
  dangerous disease and treatment is the only
  means of avoiding spread of the disease.

29
Defence of Necessity
Medical treatment should not be given without the
informed consent of the patient or patients
proxy. Acting from necessity may legitimise an
otherwise wrongful act. The court will examine
whether the benefit anticipated by the clinical
intervention outweighed the consequences of
adhering strictly to the law. Treatment
permissible in such circumstance is limited to
that necessary for the immediate survival and
well-being of the patient.
30
Marshall v Curry (1933) 3 DLR 260 The plaintiff
claimed damages when a surgeon removed a testicle
during agreed surgery for a hernia repair. The
surgeon argued that the testicle was diseased and
its removal was necessary to safeguard the
plaintiffs health. The Court found that removal
was necessary and it would have been unreasonable
to put off the surgery.
31
Williamson v East London City Health Authority
(1998) 41 BMLR 85

• The plaintiff consented to the removal and
  replacement of a leaking breast implant. During
  surgery a more serious condition was diagnosed
  and the surgeon performed a subcutaneous
  mastectomy.
• The Court found -
• The plaintiff had not consented to the second
  procedure
• If asked to do so, she would not have given her
  consent
• She was awarded compensation notwithstanding the
  court found she would have needed to undergo the
  surgery at some stage.

32
Consent to Treatment
An adult (age 18 and over) of sound mind has the
absolute right to give or refuse consent to
medical treatment even if it may result in
death. R v Ward of Court (Witholding Medical
Treatment) (No 2) (1996) 2 IR 79 Medical
treatment may not be given to an adult of full
capacity without his or her consent
33
Mental Capacity

• Having mental capacity means that a person is
  able to make their own decisions, namely -
• Understand the information given to him or her
• Retain that information long enough to be able
  to make a decision
• Weigh up the information available to make the
  decision
• Communicate his or her decision

34
In Re a Ward of Court (witholding consent to
treatment) (No. 2) (1996) 2 IR 79 Denham J The
loss by an individual of his or her mental
capacity does not result in any diminution of his
or her personal rights recognised by the
Constitution, including the right to life, the
right to bodily integrity, the right to privacy,
including self-determination and the right to
refuse care or treatment.
35
Legal Capacity Adults
Everyone aged 18 and over is presumed to be
competent to give consent for themselves unless
the opposite is demonstrated. Medical treatment
may not be given to an adult of full capacity
without his or her consent. No one can consent
or refuse consent on behalf of a competent adult
patient. A competent adult, in anticipation of
future incapacity may give another competent
adult an enduring power of attorney to include
the making of decisions with regard to healthcare.
36
Legal Capacity Adults
In practice, the views of next-of-kin/family
members are often taken into account by
clinicians, but their overriding guiding
principle is to act in the best interests of
their patient. Where conflict or doubt arises an
application to make the patient a ward of court
should be made. If the patient is made a ward of
court, all decisions about medical treatment are
made by the President of the High Court. The
one exception is emergency treatment to preserve
life.
37
Legal Capacity Adults
In Re a Ward of Court (witholding consent to
treatment) (No. 2) (1996) 2 IR 79 Denham J The
familys view as to the care and welfare of its
members carries a special weight. A court should
be slow to disagree with a family decision as to
the care of one of its number if that decision
has been reached bona fidesit is a factor to
which the court should give considerable weight.
38
Adults with Intellectual Disability

• The Law Reform Commission has recommended the
  enactment of capacity legislation, which would
  make provision for substitute and assisted
  decision-making structures in the event an adult
  is deemed to lack capacity.
• The position in Ireland with regard to consent to
  treatment of adults who lack capacity is grey and
  undecided.

39
Adults with Intellectual Disability

• However, the following practices have evolved
  over the years
• If the person's mental condition or disability is
  such that it does not impair his/her ability to
  understand the nature, purpose and effect of the
  proposed treatment/procedure, then he/she can
  consent (or decline) to it.
• If a patient lacks capacity consideration needs
  to be given as to whether they are likely to
  regain capacity in the near future (e.g. regain
  consciousness). If this is likely then treatment
  can be delayed until that time, provided it is
  safe to do so.

40
Adults with Intellectual Disability

• If the person's mental condition is such that
  he/she is unable to comprehend the proposed
  treatment/procedure and every effort has been
  pursued to make that information accessible to
  that person, then the practice in this country
  has been to obtain the consent of the next of
  kin.
• While it may be the practice, there is, in fact,
  no legal or common law basis.
• Common law has made It clear that no one can
  express consent on behalf of the adult patient.
• The relatives should be included in the decision
  making process.
• The ideal situation is for the decision to
  reflect a consensus view between the healthcare
  professional and those closest to the patient.
• It is only the best interests of the patient that
  are relevant and not the interests of other
  parties.

41
Patients with Mental Disorders

• There is no legislation in Ireland governing
  consent to treatment of adults with mental
  disorders.
• Accordingly, Common Law principles apply.
• To treat such adults for their mental disorder
  without obtaining their consent is unlawful
  unless it is an emergency and/or life-threatening
  situation.
• When dealing with such a category of vulnerable
  persons and with all persons, doctors must always
  act reasonably in the best interests of the
  patient.
• This should include a consideration of
  alternatives (if any) and/or less invasive
  procedures to the one proposed.

42
Legal Capacity Minors
The courts distinguish between giving and failing
or refusing to give consent. In re R (a minor)
(Wardship Consent to Treatment) (1991) 4 All
E.R. 177 Lord Donaldson MR held that the failure
or refusal of a Gillick competent child to
consent is a very important factor in the
doctors decision whether or not to treat, but
does not prevent the necessary consent being
obtained from another competent source. The
minors refusal could be disregarded if a parent
gave consent.
43
Children - Ireland

• Doctors must be familiar with the recent
  legislation covering the treatment of children.
• Section 23 of the Non-Fatal Offences against the
  Person Act, 1997 provides that a minor who has
  attained the age of 16 years can consent to
  surgical, medical or dental treatment.
• Under Subsection 3 of Section 23, practitioners
  can still proceed as formerly on the parents'
  consent.

44
Who can obtain Consent from Patients or Guardians?

• Permitting junior doctors to obtain informed
  consent can lead to problems.
• Junior doctors may not have the necessary
  knowledge or experience to be in a position to
  explain the options available for treating the
  condition in question, the likely outcome and the
  risks attached to each one.
• Someone suitably qualified or experienced to
  understand the proposed treatment and risks
  involved should secure consent.
• Healthcare professionals have an obligation not
  to delegate responsibility for securing consent
  to someone they know or suspect to be
  under-qualified for the task.

45
Communication

• Issues a Prudent Doctor might Address in Simple
  Language when taking Consent to Treatment -
• Explain the diagnosis
• Identify the main treatment options
• What are the benefits of each option?
• What are the risks associated with each option?
• Success rates both personal and nationally
• Why is a particular option being recommended
• What is likely to happen if the patient chooses
  to do nothing?
• How will the treatment affect the patient and
  for how long?

46
Communciation - Consent Issues
WHEN? Give the patient as much time as possible
to consider all options and ask questions. Taking
consent to an elective procedure on the morning
of same is frowned upon by the courts. WHERE? Some
where private where the patient will not be
anxious about other patients overhearing the
conversation. BY WHOM? Let the seniority of the
clinician performing the procedure act as a
guideline.
47
Document All Communications

• Prepare explanatory leaflets about the procedure
• Record in the chart all communications about
  the proposed treatment and advices given
• Pay particular attention to the consent form
  and elaborate on advices given

48
Information
Chester v Afshar (2005) AC 134 (HL) 143 Lord
Steyn stated - A rule requiring a doctor to
abstain from performing an operation without the
informed consent of the patient serves two
purposes. It tends to avoid the occurrence of
the particular physical injury the risk of which
a patient is not prepared to accept. It also
ensures that due respect is given to the autonomy
and dignity of each patient.
49
Withholding information

• A patient may wish not to participate in the
  decision making process concerning their
  treatment or care.
• If such a situation occurs the patient, if
  willing, should be asked to sign a waiver stating
  that he/she does not wish to discuss the matter
  following advice being offered.
• If the patient does not sign a waiver then their
  request not to be given additional information
  should be recorded in the patient's record.

50
What Patients should be told

• Information which the patient needs to know
  before deciding whether or not to consent to
  treatment
• Details of the diagnosis and prognosis, and the
  likely prognosis if the condition is left
  untreated.
• Uncertainties about the diagnosis including
  options for further investigation prior to
  treatment.

51

• The purpose of a proposed investigation or
  treatment
• details of the procedures or therapies involved,
  including subsidiary treatment such as methods of
  pain relief, and how the patient should prepare
  for the procedure.
• Explanations of the likely benefits and the
  probabilities of success and a discussion of any
  serious or frequently occurring risks and of any
  lifestyle changes which may be caused by, or
  necessitated by, the treatment.
• Advice about whether a proposed treatment is
  experimental.

52

• How and when the patient's condition and any side
  effects will be monitored or re-assessed.
• A reminder that patients can change their minds
  about a decision at any time and that they always
  have the right to a second opinion.
• Give the name of the doctor who will have the
  overall responsibility for the patient and
  explain, where appropriate, that no guarantee
  about who will carry out the procedure can be
  given.
• Where applicable, details of costs or charges
  which the patient may have to meet.

53

• Be aware of the distinction, which the Courts
  have made in recent years in elective and
  non-elective surgery.
• In the case of elective surgery the duty to
  disclose information to the patient is much more
  onerous, particularly where there may be serious
  or material risks associated with the proposed
  procedure.

54
Irish Case Law on Disclosure

• Test case Dunne v National Maternity Hospital
  1989 Finding of negligence. (Woman with twins.
  One died, other developed cerebral palsy.)
• Supreme Court held that to establish negligence
  the plaintiff would have to prove that the
  defendant doctor had been
• guilty of such failure as no medical
  practitioner of equal specialist or general
  status and skill would be guilty of if acting
  with ordinary care.
• Endorsing the professional practice standard.
  But court did not accept Bolam test completely
  also held that the doctor would not be protected
  if there were defects in the practice that would
  be obvious to anyone giving it due consideration.
  
• Walsh v Family Planning Services 1992
  Disclosing the risks inherent in a vasectomy.
• Unanimous view of all the judges elective as
  opposed to therapeutic procedures should be
  subject to more rigorous disclosure standards.
  Patients should be warned of even remote risks.

55
Geoghegan v Harris 2000 negligence in
carrying out dental implant.

• Patient said he would not have had procedure even
  if there was only a 0.1 chance of nerve damage.
  But judge adopted the reasonable patient standard
  since he was keen to have the procedure it
  seems reasonable to conclude that given the very
  small risk and the great benefit a reasonable
  person would have consented.
• Importance of this case the doctor must give
  warning of material risk. For elective surgery
  this means even remote risk (statistics are
  irrelevant). Moving in direction of greater
  legal recognition of patient autonomy (at least
  in elective area).

56
Fitzpatrick vs White 2007 Informed ConsentThe
Reasonable Patient Test

• Facts of the case
• Mr. Fitzpatrick was appealing an earlier High
  Court decision by White J.
• The plaintiff in the instant case suffered eye
  muscle slippage and subsequent double vision
  following a cosmetic operation to relieve a
  long-standing convergent squint in the Royal
  Victoria Eye and Ear Hospital in 1994.

57
Kearns J

• In his judgement Kearns J elaborated on three
  legal principles
• a) the obligation to warn,
• b) the content of the warning and
• c) the timing of the warning.
• Only the final principle was actually applicable
  to the appeal decision, but Kearns J clarified
  the Irish legal situation in relation to the
  standard of care to be exercised by doctors in
  giving warnings of proposed treatments.

58
Kearns J the patient has the right to know and
the practitioner a duty to advise of all material
risks associated with a proposed form of
treatmentMateriality includes consideration of
both (a) severity of the consequence and (b)
statistical frequency of the riskThe reasonable
man, entitled as he must be to full information
of material risks, does not have impossible
expectations nor does he seek to impose
impossible standards.
59

• Mr. Justice Kearns found that the plaintiff
  should have been informed of the risk of
  neuropathic pain. Accordingly, he had not given
  his informed consent to the surgery.

60

• He then went on to decide whether, as argued by
  the plaintiff, he would not have undergone the
  surgery had he been made aware of this risk. Two
  tests were applied -
• Objective
• He found that a reasonable patient, looking
  objectively at all the circumstances of the
  plaintiff, on the balance of probabilities, would
  have undergone the surgery.

61
(2) Subjective When he examined the particular
features of this case, he found that the
plaintiff had long been embarrassed by the state
of his teeth and would have assumed the less than
1 risk of developing neuropathic pain, for the
benefit of having much improved teeth.
62
Battery

• Person need not suffer harm to recover damages in
  battery
• Harm is assumed as the tort protects from
  symbolic harm as well as that which results in
  injury
• Battery may be committed even if doctor acts in
  patients best interests
• Elements required
• Intentional, unlawful touching

63
Examples

• Mohr v Williams (Minnesota)
• ear surgery
• Re. F(mental patient sterilisation) Lord Goff
• Principle of necessity

64
Necessity

• Where no one is capable of giving consent for an
  adult patient who does not have the capacity to
  give consent himself for whatever reason, Lord
  Goff in Re F. seized upon the fact that-
• "There exists in the common law a principle of
  necessity which may justify action which would
  otherwise be unlawful ..." p. 74 A.

65
Necessity

• The basic requirements, applicable to such a case
  of necessity, are that to fall within the
  principle-
• "... not only
• must there be a necessity to act when it is not
  practicable to communicate with the assisted
  person, but also
• the action taken must be such as a reasonable
  person would in all the circumstances take,
  acting in the best interests of the assisted
  person", p. 75H.

66

• Battery does not require proof of causation.
• Burden of proof rests on the defendant to prove
  consent was valid.

67
3 broad categories where patient can be misled

• What is being done
• Who is doing it
• Risks and consequences of the conduct

68
Appleton v Garrett (1995)34 BMLR 23(QBD)What is
being done

• Dentist struck off for gross over treatment
• Withheld information in bad faith
• Altered charts
• Recording fillings where he previously noted
  caries free teeth
• Held none of the claimants consented
• They agreed to therapeutic intervention but got
  something quite different

69
R v Maurantonio (1967) 65 DLR 2d672 (Ontario
CA) Who is doing it

• If deception causes misunderstanding as to the
  nature of the act consent is vitiated
• Maurantonio was not medically qualified, so the
  nature of consent was altered
• R v Tabassum (2000)2Cr App R 328
• Where the identity of the person affects the
  understanding of what is being done the patient
  who misunderstands does not validly consent.

70
R v Richardson (1998) 42 BMLR 21 (CA)

• Dentist suspended from practicing
• Treated patients without complaint from them
• Her failure to inform could lead to a civil claim
  for damages but is not the basis for criminal
  liability
• Patients agreed to dental work and that is
  precisely what they got consent valid.

71
Voluntariness

• Forced treatment
• Compulsory vaccination
• Removing bullets needed for evidence
• Sedating inmates of hospital to protect other
  patients/staff

72
Re T 1992 4 All ER 649 1992 9 BMLR 46 (CA)

• 34yo female pregnant, pneumonia
• Mother JW
• Refusal of blood transfusion
• Held overturned refusal of consent due to undue
  pressure from mother

73
Advance Care Directives

• An "advance directive" or "living will" involves
  a patient specifying in advance how they would
  like to be treated in the case of future
  incapacity.
• Now recognised in the English courts there is no
  legislation or case law in Ireland, which has
  considered advanced care directives and therefore
  no indication of the extent, if any, to which
  they would be legally recognised.
• Give valuable evidence of the patient's prior
  wishes and could be taken into consideration,
  together with any evidence available from other
  sources, such as close relatives, when deciding
  on treatment.

74
Provision for Patients of Differing Cultures and
Language

• These patients must receive the appropriate
  written and oral information they need in order
  to make a rational decision.
• Provision must also be made for staff to
  communicate appropriately with patients.
• Interpreters must be informed of the obligation
  of confidentiality and if deemed necessary and
  desirable be asked to sign a confidentiality
  agreement.

75
Suggested Reading

• Medical Law
• Ian Kennedy and Andrew Grubb
• Law and Medical Ethics
• Mason, McCall Smith, Laurie
• Medicine Ethics and the Law
• Deirdre Madden