“Informed Consent – Why is it so hard?”€¦ · Implied Contract. Dr Roger Dennett, ADA NSW...

“Informed Consent –

Why is it so hard?”

Roger DennettADA NSW Advisory Services

Dr Roger Dennett, ADA NSW Advisory Services ASE 24 Feb 2016

The pillars that form the process of informed consent.

What information should be provided?

How much information is enough? When is more required?

What does the DBA and the law expect regarding consent?

What do patients recall of what they are told?

How do you prevent a claim being successful on the grounds of

a lack of informed consent?


ASE February 2016 Dr Roger Dennett, ADA NSW Advisory Services Peer Advisor


Implied Contract


Duty of Care

Valid or Informed?Valid:

The type of consent required to avoid a civil claim for

assault and battery and a criminal charge of assault (the

bare or minimum level)

Informed:

The type of consent required to avoid a finding of

negligence (civil claim) and a finding of unprofessional

conduct – AHPRA/DBA (the ideal and achievable level)


Assault & Battery“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 patient’s consent, commits an assault.”

Schloendorff v Society of New York Hospital (1914)

This principle was approved by the High Court of Australia in Marion’s Case (1992) CLR 218


Hippocrates & Paternalism“The “Father of Medicine” born around 460 BC; Physician, Teacher

Defined what it was to be a surgeon – referring to being “well kempt, honest, calm, understanding, dedicated ……….”

Hippocratic Oath refers in part to the importance of keeping of information from the patient - which if provided to him may cause him to make poor decisions about his health.

The concept of medical paternalism was that the physician knew best and should make the decision in the best interests of the patient.



Informed Consent Case Law

• Schloendorff v Society of New York Hospital 1914

• Bolam v Friern Hospital Management Committee 1957

• Truman v Thomas 1980

• Rogers v Whitaker 1992

• Chappel v Hart 1998

• Hookey v Paterno 2009

In the District Court of Sydney

Plaintiff: Miss AdventureDefendant: Dr Omission

Particulars of Negligence

Failed to provide any information (or any adequate information) concerning alternative options for treatment

Failed to provide any warning (or any adequate warning) of the

risk of oro-antral communication……………………………..


Restorative Services8%

Prosthodontics - Other1%

Prosthodontics - Implants10%

Prosthodontics - Dentures2%

Prosthodontics - Crown & Bridge12%

Preventative, Prophylactic & Bleaching Services

1%

Periodontics0%

Orthodontics12%

Oral Surgery10%

Not related to treatment

5%

Health fund matter12%

General Services0%

General issues(s) regarding or involving treatment

15%

Endodontics7%

Diagnostic Services2% Not specified

1%

Treatment related to Complaints in 2015

Informed Consent PrinciplesA process of education and communication that enhances the

doctor-patient relationship and prepares the patient for the potential of a less-than-ideal outcome

Dentists can be liable for a complication merely because the patient was not informed of the potential risks before consenting to treatment ……


Informed ConsentPatients must be provided with sufficient information about the condition, investigation options and associated cost, treatment options and associated cost, benefits, consequences, possible adverse effects or complications/risks and the likely result if treatment is not undertaken. This information allows the patient to make an informed decision about their health care.

The practitioner must warn of a material risk inherent in the proposed treatment (Rogers v Whitaker 1992 HCA)

Failure to do the above may amount to a breach of the duty of care the practitioner owes to take reasonable care and could give rise to a legal action for negligence.



A legal definition, which can only be determined by the Court, wherein a practitioner treating a patient has not exercised a reasonable standard of care; that standard that could reasonably be expected of a practitioner taking into account his or her level of practice and the particular circumstances of the case in question.

Negligence


Informed Consent Inadequate when?

Consent is deemed inadequate when a material risk is not

adequately discussed with the patient, and therefore the dentist has

breached their duty of care. Were the injury suffered as a

consequence of the risk not being discussed (Rogers v Whitaker

1992), or the patient not being advised of the consequences of no

treatment (Truman v Thomas 1980) or not having a referral to a

more experienced clinician (Chappel v Hart 1998), the injury may be

compensable….

The DBA Code of Conduct (March 2014) provides:

3.5 Informed consent

Informed consent is a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved…Good practice involves:

(a) providing information to patients or clients in a way they can understand before asking for their consent

(b) obtaining informed consent or other valid authority before undertaking any examination or investigation, providing treatment (this may not be possible in an emergency) or involving patients or clients in teaching or research, including providing information on material risks


Informed Consent PrinciplesThe law should recognise that a doctor has a duty to warn

the patient of a material risk in the proposed treatment. A risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significanceto it………”

Rogers v Whitaker (1992)


The National Health and Medical Research Council (NHMRC) recommends that practitioners discuss:

(a) The possible or likely nature of the illness (b) The proposed approach to investigation and treatment including: what the proposed approach entails, the expected benefits, common side effects and material risks, whether the procedure is conventional or experimental and who will undertake the intervention(c) Other options for diagnosis and treatment(d) The degree of uncertainty of the diagnosis and any therapeutic outcome(e) The likely outcome of not having the diagnostic procedure or treatment, or of not having any procedure or treatment at all(f) Any significant long term physical, emotional, mental, social, sexual, or other outcome which may be associated with the proposed intervention(g) The time and cost involved including any out-of-pocket expenses


(c) when referring a patient or client for investigation or treatment, advising the patient or client that there may be additional costs, which he or she may wish to clarify before proceeding

(d) when working with a patient or client whose capacity to give consent is or may be impaired or limited, obtaining the consent of people with legal authority to act on behalf of the patient or client and attempting to obtain the consent of the patient or client as far as practically possible

(e) Being mindful of additional informed consent requirements when supplying or prescribing products not approved or made in Australia

(f) documenting consent appropriately, including considering the need for written consent for procedures which may result in serious injury, or death.


Fees and informed financial consent

(a) Patients or clients should be made aware of all the fees and charges involved in a course of treatment, preferably before the health service is provided

(b) Discussion about fees should be in a manner appropriate to the professional relationship and should include discussion about the cost of all required services and general agreement as to the level of treatment to be provided.


A signed consent form is not conclusive evidence of consent.

Obtain ‘real consent’:

“I should add that getting the patient to sign a pro forma expressing consent to undergo the operation ‘the effect and nature of which has been explained to me’… should be a valuable reminder to everyone of the need for explanation and consent.

But it would be no defence to an action based on trespass to the person if no explanation has in fact been given. The consent would have been expressed in form only, not in reality.”

Chatterton v Gerson (pt sued under tort of battery)


Informed Consent Principles

“Proper consent is a process, not a form ….. it cannot be delegated to any other person ….”

Prof. John E deBurgh Norman


Documenting Consent

1. Consent obtained in writing will assist practitioners in any subsequent legal proceeding as it will support their view that the treatment has been discussed with the patient and that consent has been obtained.

2. Document a patient’s refusal to consent.

3. Document consent obtained from a ‘person responsible’.Your records are your evidentiary advantage - so do not lose it!


Consent DocumentationCurley, AW: “Dental Implant Jurisprudence: Avoiding the Legal

Failures”; JCDA 2001

“Patients seldom prevail in claims involving lack of informed consent where the record of the consent discussion that took place is well documented and a signed, dated and witnessed consent form is used….”



INFORMED CONSENT

I am in agreement with the treatment plan as discussed with my Endodontist.

I am fully aware of the risks, warnings and side effects of endodontic

treatment as explained by my practitioner and as described in the “treatment

information pamphlet”. I understand the cost associated with this treatment

and these costs will be due and payable at the completion of each visit.

I have had the opportunity to ask questions about my treatment. All my

questions in respect of this treatment have been addressed and answered to

my satisfaction by my practitioner.

I hereby consent to the proposed treatment:

Assault & BatteryIf you proceed with treatment in the absence of valid consent, you will be committing what is known as the intentional tort of trespass to the person. This is a common law (judge made law) cause of action. The trespass to the patient can be in the form of an assault (contact not required) and/or a battery (contact required).

Criminal charges can also be laid for such a trespass to the person.


Who wants this publicity?SMH 29 November 2013




• An "arrogant" Sydney dentist who unnecessarily filed down the teeth of elderly nursing home residents in the pursuit of money has escaped jail.

• Andrew Istephan will instead serve his two-year sentence by way of an intensive correction order.

• The former Liberal deputy mayor of Hurstville was accused of performing unnecessary major dental surgery on 12 nursing home residents, some of whom had dementia.

• A jury found him guilty in October of five counts of assault, but failed to agree on the other seven counts.



• In sentencing the 34-year-old at the Sydney District Court on Friday, Judge David Frearson said he had engaged in the "deliberate, callous and systematic exploitation of the residents with the view of financial reward".

• Motivated by greed, Istephan had been ‘‘arrogantly dismissive’’ of the fundamental human right for bodily integrity, the judge said.

• ‘‘The frail and elderly have a right to be treated with dignity and respect,’’ he said.• ‘‘It’s wholly reprehensible to exploit the elderly for financial gain.’’

When consent will be invalid


White v Johnston [February 2015] NSWCA 18

This recent case is authority for the principle that where a dentist is solely motivated by an unrevealed non-therapeutic purpose, the patient’s consent is not valid and there will be assault and battery.

Capacity to consent


Capacity


A practitioner needs to be able to assess the patient’s mental state and cognition. It is the practitioner’s responsibility to determine whether a patient is capable of understanding the general nature and effect of the treatment and whether they are able to give consent (we are talking about the “bare minimum level” here).

Sufficiency of capacity is seen as a spectrum and the more serious the consequences of the decision, the higher the level of capacity that must be demonstrated. For example, consider the difference between the capacity required to consent to a one surface restoration and the capacity required for a full clearance and implant retained dentures.

Capacity


Capacity


Examples of when a patient may not have capacity to consent:

1. Too young

2. Mental illness

3. Intellectual disability

4. Dementia

5. Impaired by alcohol or substance

6. Unconscious (definitively will not have capacity to consent!)

Capacity - Minors


Determining the competence of a minor (a person under the age of 18) to consent to treatment (or refuse treatment) can be complex.

A minor is capable of giving informed consent when he or she “achieves a sufficient understanding and intelligence to enable him or her to understand fully what is proposed”.

This test comes from the English case of Gillick v West Norfolk AHA (1986) 1 AC 150 which has been applied for many years when providing health services to minors.

The practitioner must decide on a case by case basis whether the minor has sufficient understanding and intelligence to enable him or her to understand what is proposed.

Capacity - Minors


When the parents don’t see eye to eye:

Unless the Family Court orders otherwise (parenting orders), each parent has full

responsibility for each of their children under the age of 18. Either parent can

consent to treatment on behalf of the child (assuming the child does not have

capacity to consent).

However, the court can order that one parent has the responsibility for making

health care decisions for the child (parenting order).

If there is no such parenting order and the parents are in dispute as to whether

treatment should be provided, then the practitioner needs to make a decision based

on what is in the best interests of the child.

Capacity - Minors


DBA Code of Conduct (March 2014) says:

3.6 Children and young people

Caring for children and young people brings additional responsibilities for practitioners… Good practice involves:

• placing the interests and wellbeing of the child or young person first;

• considering the young person’s capacity for decision making and consent; in general, where a practitioner judges that a person is of a sufficient age and of sufficient mental and emotional capacity to give consent to a service, then that person should be able to request and provide informed consent to receive services without the consent of a parent, guardian or other legal representative.

When Consent will be invalidDean v Phung [2012] NSWCA 223 (unnecessary treatment presented as necessary)

On 19 December 2001 Mr Dean was injured in the course of his employment when a piece of timber struck him on the chin causing minor injuries to his front teeth. His employer arranged for him to see Dr Phung, a dentist. Over a period of a little more than 12 months, the dentist carried out root canal therapy and fitted crowns on all of Mr Dean’s teeth. The treatment was undertaken during 53 consultations at a cost of $73,640.

Mr Dean commenced proceedings against the dentist for negligence and trespass to the person. Mr Dean alleged that the treatment was unnecessary and ineffective, and the dentist must have known that to be so. Mr Dean sought exemplary damages. Dr Phung admitted liability in negligence but, in relation to trespass to the person, relied on a defence of consent.


When Consent will be invalidDean v Phung [2012] NSWCA 223

Expert: “All of Dr Phung's treatment for Mr Dean would be described as inexcusably bad and completely outside the bounds of what any reputable dental practitioner might prescribe or perform. The treatment was obviously unnecessary and improper and it is the nature of a gratuitous aggravation of any existing injury.”



Expert: “I find it difficult to understand how Dr Phung could proceed to remove every nerve of every tooth in the patient's head without wishing to confirm his diagnosis and treatment regime with a special endodontist or someone experienced in managing facial pain. In 25 years as a Specialist Prosthodontist with a subspecialty of facial pain management I have never experienced or read of in the literature a treatment plan of this nature. All the root canal therapies performed by Dr Phung were inadequate and needed to be redone.

“In my opinion, based on the history and radiographs available to me, sensitive teeth should have been treated with sedative dressings and time…. fractures in the teeth probably should have been repaired using resin restorations where indicated. If pain persisted referral to a specialist endodontist was warranted. I do not believe that any ordinary skilled dentist in 2002 would have performed the irreversible treatment carried out by Dr Phung or have perceived such a treatment plan was warranted.”



Expert: “This OPG [orthopantomogram] supports my initial opinion that Mr Dean was in excellent dental health prior to the accident and subsequent treatment by Dr Phung. Apart from the four small spot fillings done by Dr Phung the OPG shows that Mr Dean had had no previous dental fillings of any note. Periodontal bone support was excellent and the temporomandibular joints were of normal contour. All in all, Mr Dean's mouth was very healthy and there was nothing to suggest the need for the amount of treatment subsequently provided by Dr Phung.”



The court noted that the expert opinion suggested one of two possible inferences: Dr Phung was so incompetent that he did not realise that the course of treatment was without clinical justification; or he knew there was no clinical justification and/or did not care.

Mr Dean submitted that the more plausible inference was the dentist knew there was no clinical justification for the course on which he embarked or, at best, was reckless as to whether it would have any beneficial effect on Mr Dean. His primary, if not his sole, purpose must have been his own financial improvement.

The court held the preferable inference is that the dentist probably did not believe at the time that he carried out the treatment that it was necessary given the injury suffered by Mr Dean.



The court examined the issue of consent and found that where the nature of the procedure had been misrepresented, consent was vitiated. Dr Phung was found to have acted fraudulently, at least in the sense that he was reckless as to whether the treatment administered was either appropriate or necessary. As a result, the treatment constituted a trespass to the person.


Good Communication“Good communication is fundamental to good clinical practice. Accurate

diagnosis and successful treatment largely depend upon the art of listening and speaking to patients. A poor relationship with patients can result in misunderstandings, complaints and litigation.

A strong correlation has been demonstrated between poor communication and dental litigation.”

-Medical Defence Union


What Do Patients Recall?Harvard Medical School Risk Management Foundation:

“Patients can suffer genuine amnesia regarding pre-treatment discussions, including information given for consent purposes…”

“…studies have indicated that an average patient retains less than 35% of what they are told…”



What Do Patients Recall?Dr Mark Johnstone Thesis Study:

144 respondents:

• Over half desired information about complications that had a

prevalence of less than 1%

• Overall information recall poor

• Only 3 patients were able to recall more than 3 complications!

• Recall was less in male patients over 65

• Recall was less in those with only high school education


Written information = Better Recall?

Layton & Korsen (1994): British Journal of Oral & Maxillofacial

Surgery 32, 34-6

194 patients undergoing extraction third molars:

“Patients who received additional written information had

significantly better recall of lip and tongue dysaesthesia warnings

when compared with patient who received only verbal warnings…..”


Informed Consent EndoSelbst AG(1990) J Endo 16: 387-90 “Understanding informed consent

and relationship to adverse treatment events in endodontic therapy”

Study where 43 USA Endodontists reporting 3,308 adverse events:

• Mid treatment & retreatment referrals higher incidence of problems• Possibility of trt failure, over/under fills, pain, swelling, damage to

existing restorations must be disclosed prior to trt to obtain satisfactory informed consent.

Informed Consent – The Steps- Provide Diagnosis & Information- Discuss Options and Material Risks- Provide Fees information (informed financial consent)- Answer questions- Prognosis?- Document Consent


Good CommunicationThe PORT Principle

•Pictures, Pamphlets & Drawings for patients•Options•Risks•Talk

-Medical Defence UnionDr Roger Dennett, ADA NSW Advisory Services ASE 24 Feb 2016

Good CommunicationWhen discussing the treatment plan with a patient:

• Avoid dental jargon• Be calm, attentive and approachable• Establish good eye contact• Best not with patient in the dental chair• Remember that the average patient retains only 35% of what they are told• Draw diagrams and retain in records

-Medical Defence Union


Questions for GPD doing endo!Ask yourself these questions:

Can I do it well? Can I do it without harming the

patient? Can I do it in a minimum number of

appointments? Can I provide the patient with a

good prognosis & outcome?



Case ExampleAn endodontic file fractured during root canal treatment and a small

fragment remained in the root. The dentist decided to leave the

fragment and complete the filling as it was unlikely to be

problematic. Unfortunately he didn‘t think it necessary to tell the

patient. Two years later another dentist pointed out on the X-ray

the “broken instrument lodged in her tooth”. She claimed that the

dentist had “deliberately tried to cover up his shoddy work” and

complained to the Health Care Complaints Commission.

What Do General dentists not warn about?

• Possibility of the failure of treatment

• Possible Fracture of endodontic files during

instrumentation

• Presence of MB2 canals

• Endodontics following crown preparation

• Inability to properly instrument canals

• Discolouration

• Weakness/restorability of tooth


What Do General dentists not warn about?

Mulvay and Abbott ADJ 1996, 41:2 pg 134

“Previous studies have reported that between 2 and 15%

of teeth restored with full crown restorations show

subsequent signs of pulpal disease which necessitates

endodontic therapy”.


Informed Consent-Endodontics

Aquilino SA, Caplan DJ J Prosthet Dent. 2002 Mar;87(3):256-63

“Endodontically treated teeth not crowned after obturation were

lost at a 6 times greater rate than teeth crowned after

obturation…… a strong association between crown placement

and the survival of endodontically treated teeth was observed.”

Endodontic failures

Failure to find and hence treat, one or more canals

Perforation of the root

or bifurcation

Endodontics

Success rates in the high 80% oft quoted from retrospective studies - if protocols followed.

Success can’t be guaranteed.

Consider advice re prognosis ie poor, fair, guarded, good

Advise of all options and warnings of failure

Discuss potential of failure – options for retreatment

Endodontics

Problems of procedure:

Broken/separated instruments

Failure to warn about potential for failure in compromised situations

Over and under filling of canal

Endodontics

Separated Instrument:

most common legal problem

Rotary NiTi

over-use when should be used in conjunction with hand files due to canal curvatures


The Second Dentist!

Be respectful of your colleagues!“For reasons best known to himself, Dr X extracted the wrong teeth…”“As a result of Dr X’s mistake, there is a strong possibility of nerve or

root damage…”“Should any of the above occur, the responsibility will rest squarely on

the shoulders of Dr X”“His ineptitude and unprofessionalism has left a question mark over

Patient Y’s dental health…”

“P.S. Please retain this letter for legal and insurance purposes”


Information & Consent Documentation

• Give out written information to patient about risks and likely outcomes

• Give them to read and assimilate information

• Provide expectation of outcomes/prognosis

• Allow the patients time to consider and opportunity to ask questions

• Once patient has decided, document with signed consent


“A true professional has no

right other than to be a

continuous student”

“Informed Consent – Why is it so hard?”€¦ · Implied Contract. Dr Roger Dennett, ADA NSW...

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