Consent to medical treatment and information requirements for a valid consent for medical treatment.

Consent to medical treatment and information requirements for a valid consent for medical treatment.

                                     Dr KS Dhillon LLM

‘Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient’s consent, commits an assault’...Benjamin Cardozo, Supreme Court justice, USA

It is trite law that a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out [1]. There is detailed jurisprudence in English law as far as consent to medical intervention  is concerned.The question is whether the patient is asked to consent to physical intervention or to the risks associated with that intervention [2]. Hence there are two types of consent, the ‘real consent’ and an informed consent.

The Tort of Battery and ‘Real’ Consent

A doctor commits a legal wrong of battery or assault if he subjects a patient to physical intervention without valid consent or alternative legal justification.
Legally, for consent to the physical intervention, all that the patient needs to know is, what that physical intervention will involve. Broadly there are three category of situations which can lead to a charge of battery. The most common situation is when a patient is subjected to treatment against his/her will [3]. Sometimes it may involve a situation where a procedure other than the one consented to is carried out [4] or where a patient is deliberately and fraudulently misled [5].
The information provided when obtaining a consent has to be relevant and the information need not be elaborate. The Court in Chatterton v Gerson [6] pointed out that ‘once the patient is informed in broad terms of the nature of the procedure that is intended, and gives her consent that consent is real’. Hence the patient only needs to understand the general nature of the operation for the consent to be valid and therefore the law terms it as ‘real’ consent.
The standard for deciding what information needs to be disclosed to the patient to make the patient ‘broadly aware’ of the nature of intervention and obtain a ‘real’ consent to prevent action in battery is determined by the medical profession [6].
For ‘real’ consent there is no requirement to provide information about risk involved and about other options available. For these reasons ‘real’ consent is easily obtainable.
Informed consent to medical procedure is a more complicated matter.

The Tort of Negligence and ‘Informed Consent

None disclosure of a non-negligent risk associated with an intervention by the clinician, could be actionable in negligence if the risk eventuates since valid consent to those risks was not obtained. Such a consent is known as informed consent. There is a definite difference between ‘real’ and ‘informed’ consent and the information required for informed consent is therefore very different. When giving an informed consent not only information about the the nature of the procedure is needed but also information about the risks associated with the said procedure is needed. Having to consent to possible risk raises the question of alternative procedures and their corresponding risk and also the possibility of non-intervention.
In English law it is evident that doctors have a duty to inform the patient of alternative treatment which have lower risk [7]. Even if the risk is not lower it is duty of doctors to inform the patient of alternative interventions [8].
A failure to disclose the risk and benefits of a procedure and alternative intervention does not render a ‘real consent’ invalid but it would mean that the doctor has not obtained an informed consent.
Action of battery is regarded as inappropriate for interventions without informed consent because the law believes that doctors act in good faith and in the interest of the patient when they carry out medical treatment [6]. Battery on the other hand is associated with bad faith and it is usually carried out intentionally [9]. Therefore, the Courts believe that the doctor must have inadvertently failed to disclose a risk and could not have battered a patients in whose best interest they are acting.
The courts are usually reluctant to entertain a tort of battery in medical cases even when a wrong intervention is performed. A claim in negligence, can in principle, be sought in such cases. Bristow J in Chatterton v Gerson [6] however, felt that trespass would be the appropriate cause of action in such a case.
The level of information required to avoid a charge of battery when obtaining a ‘real consent’ is low. All that is necessary is to make the patient  ‘broadly aware’ of the nature and purpose of the action by reference to the reasonable doctor’s view of what is relevant. The same however is not true as far as informed consent is concerned.
Till 2015, the English Courts used to take a similar position to setting standards, as for ‘real consent’, where a reasonable doctor’s view prevailed, when taking an informed consent.
In Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [10] relying on the Bolam test [11] the House of Lords held that a patient would be considered to have been adequately informed about the risks if the doctor had disclosed risks which the medical profession thought was reasonable to disclose.
However, in 2015 this reliance on the reasonable doctor’s view changed. In  Montgomery v Lanarkshire Health Board, the Supreme Court  departed from Sidaway in how standards are set by declaring that information
about risks and alternative treatments should no longer be based on Bolam.
The court held that the doctor is:
‘under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’ [8].
Hence, when obtaining informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor.
Though the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not. There appears to be significant differences between what the doctor and the patient views as relevant information for medical treatment.  The large numbers of high profile legal challenges concerning non-disclosure of medical risk information, in English law, bears testimony to this fact [12].

What are the elements of full informed consent?

Following the decision by the Supreme Court in Montgomery it has become important that the patient is given an opportunity to be an informed participant in his/her health care decisions. The following points have to be taken into consideration and discussed when obtaining an informed consent:

• The nature of the procedure or intervention has to discussed and the patient should be made to understand what is involved
• The patient has to be made aware of reasonable alternatives to the proposed intervention which are available
• All the relevant risks, benefits, and uncertainties related to each alternative has to be discussed with the patient
• The doctor has to make sure that the patient comprehends the information provided. The discussion should be carried on in layperson's terms
• The patient must be willing to accept the intervention proposed by the doctor

This gives rise to the next question.

How much information is considered "adequate"?

In the past the reasonable physician standard was used to determine how much information has to be provided. That would mean that the doctor would decide how much information to provide the patient about the intervention based on the common practice among doctors. The courts have found that this standard is inadequate since it has become apparent that doctors do not provide a lot information. In the reasonable physician standard the focus is on the doctors rather than on the patient and is inconsistent with the concept of patient autonomy and with the goals of informed consent.
Currently most jurisdictions use the reasonable patient standard for informed consent. It involves providing information which an average patient would want to have to participate in the decision making process.
Patients have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation.
There is a legal duty for the doctor to warn the patient about material risk inherent in the proposed treatment or intervention. ‘Material’ risk was defined in Rogers v. Whitaker  [13]. A risk is ‘material’ in a given circumstance if a reasonable person in the patients position, if warned of the risk, is likely to attach significance to it or if the doctor is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. Known risks that are common though their detriment is slight and those that are uncommon but their outcome is severe should be disclosed. It is also important to know whether knowing about a risk is likely to influence a patient’s decision. Failure to disclose these risks may be a breach of the doctors duty of care to the patient and this could give rise to legal action for negligence.

Pre-prepared material/brochure and informed consent

Prepared patient information forms and brochures (translated when necessary) are sometimes used in hospitals before obtaining informed consent. These material can be useful for the patient to stimulate discussion about the procedure and its risks and it helps the doctor to guide the direction of the discussion. This material however cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent. The doctor still has to make sure the patient is aware of the intervention planned and all material risks involved. The doctor has to ask the patient if any of the information provided is unclear. It is the doctor's duty to make sure that the pre-prepared material is up to date, accurate and appropriate for the patients. An inadequate or inaccurate information sheet would mean that that the patient was inadequately informed and this could have legal implication if litigation ensues. When additional information is provided to the patient it should be specifically noted by hand on the information sheet. Interpreters have to be used when there are language problems. In some countries professional interpreters are used when dealing with non-English speaking patients [14].

When can the duty to inform be breached?

The duty to inform the patient cannot usually be breached. However there are two situations where the duty to inform may be breached.

1. Rarely a situation may arise, where the patient expressly directs the doctor to make the decisions and does not want any information that is being provided. In such situations the doctor should at least provide the  basic information about the diagnosis and treatment.
2. On other occasions the duty to inform may be breached when the doctor exercises “therapeutic privilege” and withholds the information, when he holds a reasonable belief that disclosure of the risks could prove damaging to the patient’s health. Here the doctor has to make a judgment call, on reasonable grounds, that the information provided could cause serious harm to the patient’s physical or mental health. Several factors govern therapeutic privilege and this can include the personality, temperament or attitude of the patient as well as their level of understanding. Other factors include the nature of the treatment to be provided and the likelihood and severity of adverse effects which can result from the treatment.

Exercising ‘therapeutic privilege’ denies the patient his /her right to participate in decision making and this privilege should be sparingly used. The scope of this privilege remains uncertain and consultation with other colleagues is useful when making a decision to exercise ‘therapeutic privilege’ [14].

What information should the doctor provide the patient when obtaining the informed consent?

When obtaining an informed consent the following points should be brought up in the discussion with the patient:

1. The possible or most likely illness that the patient has;
2. The planned approach to investigations and treatment, including what the approach entails
3. The expected benefits of the intervention
4. The common side effects and material risk associated with the intervention
5. Whether the procedure is experimental or is conventional and established
6. The person who would be carrying out the procedure
7. Are other options for diagnosis and treatment available
8. The degree of uncertainty involving the the diagnosis and outcome of the intervention
9. What is the likely outcome of not undergoing the intervention for diagnosis and or treatment
10. Long term physical and non-physical adverse effects associated with the proposed intervention [14].

Conclusion

From the legal point of view a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out.
A legal wrong of battery or assault can easily be avoided by obtaining a ‘real consent’ by informing the patient in broad terms the nature of the procedure that is intended. The nature of information to be given to patient to obtain ‘real consent’ is determined by the medical profession.
Obtaining an informed consent on the other hand is more complicated. The law in this area has changed over the years. When obtaining an informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor as in the past. Patients now have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation. It is now the legal duty of the doctor to warn the patient about material risk inherent in the proposed treatment or intervention.
Prepared patient information forms and brochures can be used to provide information to the patient. These forms, however, cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent.
The duty to inform can very rarely be breached. Doctors should use ‘therapeutic privilege’ to withhold information from patients very sparingly, because it denies the patient his /her right to participate in decision making.
Although the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not.

References

1. Mental Capacity Act 2005 s.
2. Chico V and Taylor MJ. Using and disclosing confidential patient information and the English common law: What are the information requirements of a valid consent? Medical Law Review, Vol. 26, No. 1, pp. 51–72.
3. Re B (Adult, refusal of medical treatment) [2002] 2 All ER 449; Re C (Adult, refusal of treatment) [1994] 1 All ER 819.
4. Devi v West Midlands RHA [1980] CLY 687.
5. Appleton v Garrett (1997) 8 Med LR 75.
6. Chatterton v Gerson[1981] QB 432, 443.
7. Birch v University College Hospitals NHS Trust [2008] EWHC 2237 (QB).
8. Montgomery v Lanarkshire Health Board [2015] UKSC 11.
9. Wilson v Pringle [1987] QB 237.
10. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1.
11. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
12. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1; Montgomery v Lanarkshire Health Board [2015] UKSC 11; Chester v Afshar [2004] UKHL 41; Al Hamwi v Johnston and another [2005] EWHC 206 (QB) and Pearce v United Bristol Healthcare NHS Trust [1998] EWCA Civ 865.
13. Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479.
14. Policy Directive -- Consent to Medical Treatment - Patient Information. Ministry of Health, NSW, Australia at http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2005_406.pdf accessed on 19/4/18.

Fractures of the distal femur

                                     Fractures of the distal femur 

                                                  Dr KS Dhillon FRCS

Introduction

Distal femur fractures are not common and can be difficult to treat. In the 1960s the common mode of treatment of such fractures was conservative. However with the advent of better fixation devices in the 1970s, surgical fixation of the fractures became the standard mode of treatment. The functional outcome of treatment of such fractures, though many would believe is poor, is according to the literature surprisingly good. Despite the development of post-traumatic osteoarthritis in about a third of the patients the functional outcome remains good in majority of the patients.

Anatomy of the distal femur

The femur becomes trapezoidal in cross section distally where it forms the  knee joint. The medial condyle extends more distal than lateral condyle at the knee joint and the anatomical axis is about 6 to degrees valgus. The posterior halves of the medial and lateral condyles extend posteriorly beyond the posterior cortex of the femoral shaft. In the axial plane the medial femoral cortex slopes about 25 degrees and the lateral cortex slopes about 10 degrees.
The hamstring muscles and the quadricep muscle pull the distal fracture fragment proximally, the adductor magnus displaces it into varus and the gastrocnemius extend the distal fragment.

Epidemiology

Distal femur fractures account for about 6% of all femur fractures and are 10 times less frequent than proximal femur fractures (1).  The most widely used classification for distal femur fractures is the AO/OTA classification (1).

Classification of distal femur fractures.

The AO/OTA classification is widely used to classify the distal femur 

fractures. The fractures are broadly divided into three types. Type A, B and C.

Classification

The distal femur fracture represented by the number 33 and subdivided into three groups:
    1. 33A-- extra-articular metaphyseal fractures which are subdivided into three
         33A.1—simple metaphyseal fracture
         33A.2--- metaphyseal wedge fracture
         33A.3--- metaphyseal complex fracture
    2. 33B-- partial articular fracture which are also divided into three
          33B.1 – lateral sagittal fracture
          33B.2 – medial sagittal fracture
          33B.3--- frontal (Hoffa). Type B3 can be subdivided into three
                          B3.1---anterior and lateral flake
                          B3.2—unicondylar posterior
                          B3.3 – bicondylar posterior

   3. 33C-- complete articular with both condyles detached from the metaphysis.
           33C.1-- articular simple and metaphyseal simple fracture
           33C.2 --- articular simple and metaphyseal multifragmentary fracture
           33C.3 --- multifragmentary articular and metaphyseal fracture
   

Treatment of distal femur fractures

Fractures of the distal femur are fortunately uncommon. They constitute about 0.4% of all fractures and about 3% of femoral fractures[2]. The treatment of these fractures is difficult. In 1966 Stewart et al [3] claimed that "fractures in the distal third of the femur continue to perplex the surgeon. Whether they are transverse, oblique, or comminuted, or supracondylar or intercondylar in a T, Y or V fashion their management still evokes much controversy because of the consistently poor results obtained". However over the years the outcome of treatment has improve with better fixation devices.

Conservative treatment

On rare occasions distal femur fractures can be treated conservatively with a hinged brace and early knee mobilization. Such treatment is useful in patients with undisplaced fractures, in patients who are non-ambulatory and those who are unfit for surgery.

Surgical treatment

Various devices such as external fixators, nails, plates and screws are available to stabilize fractures of the distal femur.

External fixation

External fixators are used to temporarily immobilize the fractured bone till soft tissue healing is adequate for internal fixation of the fracture especially in open fractures. This technique cannot be used for definitive treatment of distal femur fracture because it does not provide adequate stability and it immobilizes the knee joint.

Antegrade intramedullary nailing

Antegrade nailing is indicated in type A extra-articular fractures of the distal femur. It is the method of choice for treatment of segmental femur fractures involving the distal femur.

Retrograde intramedullary nailing

Retrograde nailing is suitable for patients with extra-articular distal femur fracture who have concomitant fracture of the tibia (floating knee) which can be treated though the same approach.
Screw fixation
Type B fractures can be treated with screw fixation through the medial or lateral approach to the condyles. With little or no displacement percutaneous screw fixation is possible. The use of two 6.5 mm screws is  more effective than several 3.5 mm screws for osteosynthesis of these fractures [4]. In the fixation of Hoffa fractures, lag screws placed posterior to anterior provided more stable fixation than anterior posterior placement[5].

Angled blade plate

The 95 degree angled blade plate can be used for stabilization of the supracondylar and intercondylar fractures of the distal femur. The blade plate is preshaped to fit the anatomy of the distal femur.the blade is seated about 2 cm proximal to the knee joint line and the tip of the blade should not protrude beyond medial cortex to prevent damage to the medial structures.

Dynamic condylar screw (DCS)

The 95 degrees DCS is used for similar indications as the angle blade plate. Here the blade is replaced by a cannulated screw which attaches to the plate. The placement is similar to the blade plate.
Plates
There are various plates available to stabilize the distal femur fractures. The older version is the condylar buttress plate and the newer version are the locking condylar buttress plate and the locking compression plate. Plates are useful for fixing more fragile bone especially in the elderly. Biomechanical studies appear to show that locking plates are better than other modes of fixation [6].
A cochrane database systematic review by Griffin et al [7] in 2015, however, found that the currently available evidence for interventions used in treating fractures of the distal femur in adults, is incomplete and insufficient to inform current clinical practice.

Outcome of treatment of distal femur fractures

There is paucity of literature on the long term outcome of treatment of distal femoral fractures.
Egund and Kolmert [8] retrospectively reviewed 62 patients with distal femur fractures at a mean follow up of 5 years. Some of the patients were treated with traction and others had open reduction and internal fixation. They found that displaced bicondylar fractures healed mostly with varus and anterior angulation, medial unicondylar fractures with varus and lateral unicondylar fractures with valgus angulation. Most of the healed supracondylar fractures showed varus angulation. Three patients (5.8%) developed arthrosis in the femoro-tibial (grade I or II) and 14 patients (27%) had OA of  the patellar area. Intercondylar or transcondylar diastasis, or step off of 3 mm or more predisposed the patients to osteoarthritis.
Rademakers et al [9] conducted a retrospective study to analyze the long-term (5–25 years) functional and radiologic outcome of surgically treated intra-articular fractures of the distal femur. They studied 67 consecutive patients with intra articular fractures of the distal femur. Thirty-two patients had a long term follow up with functional and radiological evaluation . At a mean follow-up of 14 years (range 5–25 years), the mean range of knee flexion was 118° (range 10–145°). The Neer score showed good to excellent results in 84% of the patients and HSS score was good to excellent in 75% of the patients. Patients with isolated fractures of the distal femur had significantly better functional scores (Neer/HSS 90 points) compared with those with multiple fractures.
The Ahlbäck score showed a moderate to severe posttraumatic osteoarthritis in 36% of all patients. Despite the OA, 72% of the patients  scored a good to excellent functional result. Ten percent (seven patients) of the patients had deep wound infection and in two patients the infection became chronic and they had knee arthrodesis.
Thomson et al [10] reported a 50% incidence of OA in 22 patients (23 fractures) with type C distal femur fractures who were followed up for a mean period of 80 months (6.6 years). The physical function component of the SF-36 was approximately 2 standard deviations below the US population mean. None of the patients had a subsequent knee replacement.
Another long term follow up study of supracondylar fractures of the femur was published  by Kolb et al (11). They retrospectively studied the outcome in 41 patients with supracondylar fracture of the femur. Eighty percent of the patients were followed up for a mean of 9.5 years (7-12 years). They found that the mean Neer score was 82 points with a score of 89 points in isolated supracondylar fractures and 72 points in patients with associated fractures. The results were good to excellent in 82% of the patients. No mention was made of OA of the knee in this study.

Conclusion

Fractures of the distal femur are not common. They can occur in isolation or may occur in combination with other fractures. The AO/OTA classification of distal femur fractures is widely used and has prognostic significance. Unlike in the past, distal femur fractures are now routinely treated surgically. Various fixation devices are available. There is no evidence of superiority of one device over the other. The functional outcome of treatment is good to excellent in vast majority of the patients.The outcome is better in patients with isolated fractures as compared to those with combination injuries. About one third of the patients develop post-traumatic osteoarthritis. Despite the presences of post-traumatic OA, over 70% of the patients with OA have good to excellent functional outcome.

References

1. Florian Gebhard, Phil Kregor, Chris Oliver. AO Surgery Reference - AOTrauma - AO Foundation at https://www2.aofoundation.org Accessed on 10/11/2016. 
2. Court-Brown M, Caesar B. Epidemiology of adult fracture: a review. Injury. 2006; 37: 691-697.
3. Stewart M J., Sisk T D. Wallace S L. Fractures of the distal third of the femur. J. Bone Joint Surg. 1966; 48-A: 784-807.
4. Khalafi A, Hazelwood S, Curtiss S, Wolinski P. Fixation of the femoral condyles: a mechanical comparison of small and large fragment screw fixation. J Trauma. 2008; 64: 740-744.
5. Jarit GJ, Kummer FJ, Gibber MJ, Egol KA. A mechanical evaluation of two fixation methods using cancellous screws for coronal fractures of the lateral condyle of the distal femur (OTA type 33B). J Orthop Trauma. 2006; 20: 273-276.
6. Ehlinger M, Ducrot G, Adam P, Bonnomet F. Distal femur fractures. Surgical techniques and a review of the literature. Orthopaedics & Traumatology: Surgery & Research. 2013; 99(3): 353-360.
7. Griffin XL, Parsons N, Zbaeda MM, McArthur J. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010606. doi: 10.1002/14651858. CD010606.pub2.
8. Egund N and KolmertL. Deformities, Gonarthrosis and Function After Distal Femoral Fractures, Acta Orthopaedica Scandinavica. 2009; 53:6: 963-974.
9. Rademakers MV. Kerkhoffs GMM, Sierevelt IN, Raaymakers EL, Marti RK. Intra-Articular Fractures of the Distal Femur: A Long-Term Follow-up Study of Surgically Treated Patients. Journal of Orthopaedic Trauma. 2004;18 (4): 213-219.
10. Thomson AB, Driver R, Kregor PJ, Obremskey WT. Long-term functional outcomes after intra-articular distal femur fractures: ORIF versus retrograde intramedullary nailing. Orthopedics. 2008 Aug;31(8):748-50.
11. Kolb K, Grutzner P, Koller H, Windisch C, Marx F, Kolb W. The condylar plate for treatment of distal femoral fractures: a long-term follow-up study. Injury. 2009;40(4):440–8. doi: 10.1016/j.injury. 2008.08.046.

Orthopaedic surgeon as an expert witness in medicolegal proceedings

         Orthopaedic surgeon as an expert witness in medicolegal proceedings

                                                    KS Dhillon LLM

Introduction

Orthopaedic surgeons are increasingly being requested by solicitors to provide medical reports for medicolegal proceedings and to appear in court as an expert witness. There is not much information available to malaysian orthopaedic surgeons who are increasingly getting involved in such medicolegal work. This area of expertise is not included in our undergraduate or postgraduate curriculum. The Malaysian Medical Council (MMC) website provides some information under the section on ‘Ethical Code & Guidelines’ and subsection ‘Expert Witness’ (1). The latest amendment of the section on expert witness by the Malaysian Medical Council was at its meeting on 17 May 2016 (2). However the amendments do not amount to significant reforms.

Expert Witness Guidelines

The Malaysian Medical Council Expert Witness Guidelines define who is an expert witness and what qualifications are necessary to be an expert witness. It also outlines the responsibilities of an expert witness. The guidelines describes what expert evidence is and what a expert report should contain. It also advises on what to do when there is conflict of interest with regards to the patient or any other party.
In the introductory preamble of the guidelines the following paragraph appears ‘[t]he MMC’s guidance “Good Medical Practice” sets out the principles which underpin good care. When registered medical practitioners (“RMP”) act as expert witnesses, they take on a different role from that of a RMP providing treatment or advice to patients. However, the principles set out in “Good Medical Practice” also apply to RMPs who are expert witness’.
A in depth reading of the good medical practice guidelines shows that the guidance is mainly about doctor patient relationship and not about how to be a good expert witness. There should be a distinction between an individual who is a patient and who is a litigant.The rules that govern dealing with a patient and that when acting as an expert witness are different. However the Malaysian guidelines do not provide any clarity on this subject.
The Australian guideline on ‘Good Medical Practice’ on the other hand makes a clear distinction between these two roles (3). At 8.7 under the heading ‘Medico-legal, insurance and other assessments’ the guideline states that ‘[w]hen you are contracted by a third party to provide a medico-legal, insurance or other assessment of a person who is not your patient, the usual therapeutic doctor–patient relationship does not exist’. In such a situation good medical practice involves being courteous and alert to the needs of the person and to obtain consent and also to explain the reason  for the assessment and after the assessment to provide an impartial report. If any unrecognised serious medical problem is discovered during the examination, it is the duty of the doctor to inform the person or his/her treating doctor.
Probably the most comprehensive guidelines for doctors is the American Medical Association (AMA) Code of Medical Ethics 2016 (4). The guidelines have a separate comprehensive section on medical testimony at section 9.7.1. This section stresses on the importance of medical evidence in various administrative and legal proceedings and obligation of doctors to assist in the administration of justice. The guideline emphasises on the need to be honest and impartial and that the testimony should not be influenced by financial consideration. The guideline warns against receiving compensations that are ‘contingent on the outcome of litigation’.
Doctors who act as fact witnesses, for their patients, in legal claim, must remember the importance of confidentiality. The testimony should reflect facts of the case and honesty is of paramount importance.
Expert witnesses should only testify in their area of training and experience. The testimony should be objective and independent and it should reflect  the ‘current scientific thought and standards of care that have gained acceptance among peers in the relevant field’ at the time when the incident happened. Theoretical testimony should be avoided but if that is not possible, then the basis of the theory should be characterised.
In the USA, state medical licensing board and the specialty societies are entrusted with the responsibility of assessing ‘claims of false or misleading testimony and issuing disciplinary sanctions as appropriate’, to maintain high standards of medical testimony.
In the USA several medical specialities have established their own guidelines based on the ethical standards set by AMA (5). The American  Academy of Orthopaedic Surgeons (AAOS)  has produced its own code of medical ethics and professionalism for orthopaedic surgeons (6).
 In the UK, similar guidelines are available for witnesses of fact and expert witnesses. The guidelines are set in a 4 pages document produced by the General Medical Council in 2013(7). It stresses on the need for honesty, confidentiality, competence, knowledge, being up to date and the need to work within the limits of one's competence, beside being always impartial. It also reminds the doctors that in providing medical testimony the doctor’s overriding duty is to the court, irrespective who is instructing or paying the doctor.
The guidelines, however, are silent about other important aspects of medical testimony such as judicial immunity of expert witness, penalty for false testimony and possible sanctions by regulatory bodies.

Judicial Immunity of the Expert Witness

Historically, in English law, witnesses in legal proceedings have enjoyed judicial immunity since Cutler v Dixon: KBD 1585 (8). Evidence provided by an expert witness was protected from civil liability. The basis of this immunity is public policy considerations where there is an assumption that if there is a risk of civil proceeding based on the evidence, then the witness will not be willing to provide frank and full evidence. This however changed when the Supreme Court of the United Kingdom on 30 March 2011 abolished this immunity in Jones v Kaney [2011] UKSC 13, by a 5-2 majority (9). The majority was of the opinion that the reason for the immunity, that the witness would be reluctant to provide true opinion and that there may be a proliferation of vexatious claim is no longer tenable. The majority were of the opinion that the court has to respect the fundamental rule that every wrong should have a remedy which is the cornerstone of any system of justice. However the immunity to a defamation civil suit would continue.
Following this decision in Jones v Kaney things may change for both the expert witness and the maybe for the client as well, although the British Courts do not believe it will happen. Now that a client who believes he has been wronged by the expert testimony may file a legal redress against the expert which in turn may result in shortage of experts available who are willing to testify. So far this landmark decision is not binding in Malaysia and judicial immunity of the expert witness remains.
In Australia too the doctrine of immunity for expert witnesses is still in force.  In Commonwealth of Australia v Griffiths[10] the court confirmed that the key objectives of the doctrine is to make sure that the expert witness is able to  give evidence freely; and also to make sure that the same evidence is not tried repeatedly in multiple actions. This immunity, as in UK, does not extend to considerations of the expert’s conduct by the regulatory professional bodies.
In the USA there has been a gradual erosion of the expert immunity over the years and now most courts ‘view professional witness malpractice as an actionable claim’ (11). Most often the party hiring the expert sues the expert for negligence and less often the expert hired by the opposing counsel gets sued (11).
What happens if the expert witness provides false testimony?

False testimony

A doctor who provides false testimony under oath or lies in his deposition when acting as an expert can be prosecuted for the crime of perjury. The statement made must, however, be “material” to the subject of the proceeding.There is no immunity for lying in sworn testimony. The prosecution for perjury is carried out by the government prosecutors and not by any of the parties involved in the litigation.
In Malaysian law, false evidence is defined under section 191 of Act 574, of the penal code. The Act defines false evidence as ‘whoever, being legally bound by an oath, or by any express provision of law to state the truth, or being bound by law to make a declaration upon any subject, makes any statement which is false, and which he either knows or believes to be false, or does not believe to be true, is said to give false evidence’.
The punishment for false evidence is provided for under section 193 of the same Act. It states that ‘whoever intentionally gives false evidence in any stage of a judicial proceeding, or fabricates false evidence for the purpose of being used in any stage of a judicial proceeding, shall be punished with
imprisonment for a term which may extend to seven years, and shall
also be liable to fine…’ (12).
Besides the government, state authorities or professional bodies can also mete out punishment for expert witness malfeasance.

Sanctions by state authority and/or professional body. 

There are three systems that operate to regulate expert medical testimony in most countries. This would include the legislature, the judiciary and medical regulatory bodies such as the medical council or the medical professional organizations (13). There are precedents in the USA and the UK where medical regulatory bodies have taken disciplinary action against doctors for expert witness malfeasance.
In the USA, Dr Austin, a neurosurgeon and member of American Association of Neurological Surgeons (AANS), had his membership suspended by the AANS after he testified as an expert for the plaintiff against Dr Ditmore, another member of AANS. At the conclusion of the malpractice trial, Dr. Ditmore complained to the AANS about Dr. Austin’s medical testimony. Investigations by the AANS showed that Dr. Austin’s
testimony did not have evidentiary basis and had violated AANS expert witness guidelines and the AANS ethics code. Dr. Austin subsequently sued the AANS,without success (14).
In the UK, the most well known case of disciplinary action by General medical Council (GMC) for expert witness malfeasance was that involving Professor Sir Roy Meadow. His name was struck off the medical register by the Fitness to Practise Panel (FPP) of the General Medical Council (GMC) in 2005, following a complaint by Sally Clark’s father. He was found guilty of serious professional misconduct for providing statistical evidence that was inaccurate and misleading at the trial of Sally Clark who was convicted of killing her two children. She was, however, subsequently released after the second appeal.   
Professor Meadow appealed to the High Court and the High court in February 2006 allowed his appeal and quashed the order of the GMC. The GMC appealed to the Appeals Court in July 2006. At the Appeal Court, the Master of the Rolls, Sir Anthony Clarke MR, broke down the appeal into two parts, the first being whether an expert witness has immunity from disciplinary proceeding by the GMC for evidence given by him at legal proceedings. The second was an appeal by the GMC to squash the High Court Judge’s ruling that Professor Meadow was not guilty of serious professional misconduct.
 The Appeals Court unanimously concluded that FPP had jurisdiction to entertain the allegations against Professor Meadow, which in essence meant that there is no expert witness immunity from disciplinary proceeding by the GMC for evidence given in legal proceeding.
The Appeals Court with a majority of two to one upheld the decision of the High Court Judge that Professor Meadow was not guilty of professional misconduct and dismissed the GMC appeal on this important matter (15).
A more recent case, in UK, involved a paediatric neuropathologist, Dr Waney Squier (16). A panel of the Medical Practitioners Tribunal Service (MPTS), the statutory successor to the FTPP, decided to strike her name off the medical register for expert witness malfeasance in the “shaken baby” cases. She appealed to the High Court. At the High Court, the judge, Mr Justice Mitting acquitted her of dishonest testimony and he found that the tribunal's determinations were “in many significant respects flawed.”
The judge made several interesting concluding observations. He was of the opinion that since this case before the MPTS was a complex case which required ‘an understanding of the context in which expert evidence is given in a court’, it would have been proper to have a lawyer with judicial experience as the chair of the inquiry. The rules of General Medical Council (Constitution of Panels, Tribunals and Investigation Committee) 2015 do not prohibit such an appointment. The Judge’s comments probable meant that if a lawyer with judicial experience had been appointed as the chair, the shortcomings in the tribunal's determinations could have been avoided. This would have prevented pain and suffering for the accused and also save time and money for all parties involved.
In the UK, doctors can be prosecuted again after acquittal by the GMC, although there is law against double jeopardy in most countries. The Council for Healthcare Regulatory Excellence (CHRE) has the powers to refer a doctor to the High Court after they have been acquitted of of serious professional misconduct by the GMC. The first case of this nature involved Dr Ruscillo (a GP) who was found to be not guilty of serious professional misconduct by the GMC but the CHRE felt it was an unduly lenient penalty.
The Council appealed the acquittal and Dr Ruscillo challenged the appeal.The case went to the Court of Appeal and the court held that this acquittal could be a subject of an appeal according the law (17).
Although, regulatory bodies such as the Malaysian medical council and the GMC do mete out punishment to errant expert witnesses, these regulatory bodies can also err.

Failings of the regulatory bodies

The body that regulates and sanctions doctors in Malaysia is the Malaysian Medical Council. The president of the Council is the director general of health and the council has 11 elected members who are doctors and three nominated member from the civil service who are also doctors. In addition there 18 nominated member from six universities who are also doctors (18) Hence in Malaysia the doctors set the standards and they regulate themselves. In the UK too, self-regulation which provided a lot of freedom in dealing with problems within the profession was the norm till the GMC came under lot of condemnation following the Bristol Inquiry (19) and Shipman Inquiry (20).
Between 1991 and 1995 at the Bristol Royal Infirmary cardiac unit there was an unusually high death rate among children going for heart surgery due to poor care, and poor team work. The problems were brought to light by whistleblower, consultant anaesthetist Dr Stephen Bolsin who could not get a job in UK after the exposure and had to migrate to Australia.The Bristol inquiry resulted in several reforms by the government and professional bodies.
Dame Janet Smith headed the Shipman Inquiry which looked into issues arising from the case of Dr Harold Shipman (GP) who murdered over 200 of his patients. The inquiry did a thorough forensic examination of the GMC and found it to be severely wanting. The GMC had been accused of being a judge and prosecutor (21). Dame Janet Smith’s fifth report which was over 1000 pages long made several recommendation for reforms to the GMC (22).
There have been many amendments to the 1983 medical act (UK) and last being in 2016. The GMC is an independent body which now has lay members besides the medical members. Complaints against doctors are investigated by the GMC. Two senior GMC staff who are known as case examiners (one medical and one non-medical) look into the complaints and they can come to the following conclusion:

• No further action
• Issue a warning
• Agree undertakings - for example to re-train or work under supervision.
• Refer the case to a medical practitioners tribunal (MPT) of the Medical Practitioners Tribunal Service (MPTS) when action on registration may be appropriate.

The Medical Practitioners Tribunal Service is an independent body which reports to GMC twice a year and also to parliament. It carries out hearings for doctors whose fitness to practise is suspect. The tribunal has both medical and lay members.
Although there have been major reforms in the the regulatory bodies in the UK, to date no such reforms have been carried out in Malaysia. The Malaysia Medical Council is not an independent body unlike the GMC. It is an arm of the ministry of health and is financed by the ministry of health. It is regulated by doctors with no representatives from advocacy groups and the council has no lay members to represent the lay complainants (23). The MMC appears to be ‘largely representative of stakeholder groups in the medical profession’ (23). The public perception is that as far as the MMC is concerned the medical profession comes first and that the regulatory process does not appear to safeguard public interest (23). Inquires on the scale of the likes of the Bristol and Shipman inquiry have not and are unlikely to happen in Malaysia in future.

Conclusion

More and more malaysian orthopaedic surgeon’s are getting involved in medicolegal work especially in third party personal injury claims and also some in medical negligence proceedings. However there is not much information available to these surgeons to prepare them for this new role which is very different from the usual one of providing treatment or advice to patients. The rules that govern dealing with a patient and that when acting as an expert witness are different and the Australian Medical Council has made a clear distinction between the two roles, although the MMC believes that the same rules apply to both roles.
Since 2011, UK law does not provide judicial immunity to expert witnesses against civil proceeding. Proceedings against defamation remain in the UK. However, in Malaysia, expert witnesses still enjoy immunity against civil proceedings. There is no immunity for expert witnesses, from criminal proceeding, for false testimony.
Regulatory bodies such as the the MMC and the GMC can take disciplinary action against doctors for expert witness malfeasance. This can include erasure of the name from the medical register.
Failings of the GMC had invited a lot of public criticism in the past which led to a series of reforms to improve its function and image. However no major reforms have occurred in the MMC over the years although the malaysian model of governance is usually based on the British model.

References

1. Official portal of Malaysian Medical Council. Safeguarding patients, guiding doctors at http://www.mmc.gov.my/index.php/ethical-code-guidelines, acessed on 4/9/2017.
2. Expert witness at http://www.mmc.gov.my/images/contents/ethical/Expert%20Witness_17052016.pdf,  accessed on 4/9/2017.
3. Good medical practice: a code of conduct for doctors in Australia at http://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx, accessed on 4/9/2017.
4. AMA Code of Medical Ethics at https://www.ama-assn.org/delivering-care/ama-code-medical-ethics, accessed on 4/9/2017.
5.  Kass JS and Rose RV. Ethical Challenges for the Medical Expert Witness. AMA Journal of Ethics. 2016; Volume 18, Number 3: 201-208.
6. Code of medical ethics and professionalism for orthopaedic surgeons at https://www.aaos.org/WorkArea/DownloadAsset.aspx?id=31334, accessed on 5/9/2017.
7. Acting as a witness in legal proceedings  at http://www.gmc-uk.org/Acting_as_a_witness_in_legal_proceedings.pdf_58832681.pdf, accessed on 4/9/2017.
8. Cutler v Dixon KBD ((1585) 4 Co Rep 14b, [1585] 76 ER 886,[1585] EngR 96).
9. Jones v Kaney SC 135 Con LR 1, [2011] 2 WLR 823, [2011] BLR 283, [2011] 2 AC 398, [2011] 14 EG 95, [2011] 2 All ER 671, [2011] UKSC 13, UKSC 2010/0034.
10. Commonwealth of Australia v Griffiths and Another (2007) 70 NSWLR 268; [2007] NSWCA 370.
11.  Bal BS. The Expert Witness in Medical Malpractice Litigation. Clin Orthop Relat Res. 2009 Feb; 467(2): 383–391.
12. LAWS OF MALAYSIA, Act 574, PENAL CODE, as at 1 January 2015, at http://www.agc.gov.my/agcportal/uploads/files/Publications/LOM/EN/Penal%20Code%20%5BAct%20574%5D2.pdf. Accessed on 9/92017.
13. Kesselheim AS and Studdert DM, Role of Professional Organizations in Regulating Physician Expert Witness Testimony, JAMA. 2008;299(14):1667-1668.
14. U.S. District Court for the Northern District of Illinois. Austin v. American Ass'n of Neurological Surgeons, 120 F. Supp. 2d 1151 (N.D. Ill. 2000).
15. General Medical Council v Meadow [2006] EWCA Civ 1390.
16. Squier v GMC [2016] EWHC 2739 (Admin).
17. Ruscillo v The Council for the Regulation of Health Care Professionals [2004] EWCA Civ 1356.
18. Malaysian Medical Council at http://www.mmc.gov.my/index.php/council, accessed on 11/9/2017.
19. Learning from Bristol: the report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984 -1995, at http://webarchive.nationalarchives.gov.uk/20090811143746/http://www.bristol-inquiry.org.uk/ accessed on 11/9/2017.
20. The Shipman report at http://webarchive.nationalarchives.gov.uk/20090808160144/http://www.the-shipman-inquiry.org.uk/fifthreport.asp, accessed on 11/9/2017.
21. Smith R. The GMC: expediency before principle. BMJ. 2005 Jan 1;330(7481):1-2.
22. The General Medical Council, The Shipman Inquiry: The fifth report at http://www.gmc-uk.org/6a_The_Shipman_InquiryThe_Fifth_Report.pdf_25398772.pdf, accessed on 11/9/2017.
23. Nik Rosnah & Wan Abdullah. Medical Regulation in Malaysia: Towards an Effective Regulatory Regime.Policy and Society, 2002;21(1): 96-124.