HEALTH CARE LAW

Introduction

Before a patient submits to any form of medical treatment, the common law requires that the health care professional first obtain the patient’s consent. The consent requirement in medical law is founded on the idea that every competent and conscious adult patient has the right to chose whether to subject their body to medical examination. The right to make autonomous decisions also bestows upon patients the right to refuse medical treatment even if the reasons for the refusal are ‘irrational, unknown or even non-existent’. In these circumstances, the health care professional must adhere to the patient’s wishes despite the fact that refusing treatment is contrary to the patient’s best interests.

If the patient does consent to treatment, the doctor must ensure that the consent is valid so as to avoid any claims of professional negligence. In order for the consent to be valid, English law requires, inter alia, that the patient receive information about the ‘nature’ of the treatment. However, it is important to note that unlike the United States and Canada, there is no formal doctrine of informed consent in England. In the North American jurisdictions a patient must receive information concerning ‘the nature of the treatment, its expected benefits, its material risks and side effects, alternative courses of action and the likely consequences of not having the treatment’. Although the English law acknowledges that doctors have a duty to disclose, exactly what and how much information doctors are required to give their patients has been the matter of judicial debate for the past 50 years. The question then is twofold: to what extent have the courts in England acknowledged the importance of patient autonomy in medical practice and what limits have the courts set on the amount of information a doctor is required to give a patient before it can be said that the patient’s consent was informed and therefore valid?

In Bolam v. Frien Hospital Management Committee the Court held that it was ‘entirely up to the medical profession to decide how much information they should have to give patients’. According to the decision of McNair J. in Bolam, a doctor can avoid a claim of professional negligence, insofar as the information provided (or not provided) to the patient was in ‘accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’. In other words, a doctor can escape liability if the doctor proves, through expert testimony, that the doctor’s failure to warn a patient of a particular risk was in line with ‘good medical practice’. This holds true even if other professionals within the medical field would have chosen to alert the patient of the dangers related to the medical treatment. The decision in Bolam suggests that there are limits on a patient’s right to refuse or consent to treatment by placing the issue of informed consent in the hands of the medical profession.

Since Bolam, the English courts have attempted to develop a more patient-centered approach to the question of how much information a doctor is required to provide a patient. These decisions demonstrate the courts’ willingness to depart from the ‘doctor knew best’ approach developed in Bolam and reveal the courts’ reservations about the medical professions ability to correctly determine ‘how much information is required for protecting the rights of self-determination of their patients’. However, a close reading of these cases suggest that the English courts are still reluctant to make a marked departure from Bolam and focus on protecting doctors instead of safeguarding a patient’s right to autonomy. As Pattinson notes, ‘the case law focuses on what the doctor must volunteer, whereas a more patient-centered approach would require the doctor to ask the patient what he wants to know’.

The purpose of this paper will be to explore the extent to which Bolam underpins judicial decisions on informed consent. The first part of this paper will examine the Bolam decision in detail and outline some of the concerns and problems arising from this decision. The second part of the paper will explore the court’s interpretation and application of Bolam and the implications on informed consent that arise in the decisions of Chatterton v. Gerson and Sidaway v. Governors of Royal Bethlem Hospital. This part will also consider some of the challenges that have been raised against Bolam in the case of Bolitho v. City and Hackney Health Authority. Lastly, the paper will include a discussion of two recent cases and examine how they have impacted on the notion of informed consent.

Bolam and Informed Consent

Bolam, a voluntary mental patient at Friern Hospital, was advised by his doctor, Dr. Affrey, to undergo electroconvulsive therapy (‘ECT’) in an attempt to treat his severe depression. As a result of the ECT treatment, Bolam suffered several fractures to his pelvis. Consequently, Bolam filed a negligence claim against Friern Hospital Management Committee, arguing that Dr. Affrey was both negligent in the execution of the ECT treatment and in failing to warn him of the risk of injury. In McNair, J’s address to the jury, he noted that in determining whether or not the defendants were guilty of negligence, the test to be adopted was whether Dr. Affrey had failed ‘…to act in accordance with the standards of reasonably competent medical men at the time’. McNair J, added that so long as the practice adopted by Dr. Affrey was deemed to be acceptable by a ‘responsible body of medical opinion’, then it did not matter if there were other competing opinions. As Grubb notes, ‘Put another way, to prove breach of duty a patient would have to show that no responsible doctor would have done what was done’. McNair J. applied this professional practice standard to the issue of failure to warn holding that insofar as Dr. Affrey’s inaction, in terms of his failure to communicate the risks associated with ECT, accorded with ‘good medical practice’ then he could not be held liable. McNair, J. further noted that even if it could be shown that the information provided by Dr. Affrey was insufficient and unsupported by a ‘responsible body of medical opinion’, Bolam would have to prove that had he received a proper warning he would have refused to have treatment. The jury ultimately concluded that Dr. Affrey’s failure to warn Bolam of the risk of fracture did not fall ‘below a proper standard of competent professional opinion’.

The test for negligence in Bolam allows for different schools of medical opinion and permits the medical profession to judge what information should be disclosed to a patient. As Grubb notes the Bolam test ‘…reflects a philosophy of paternalism, according to which the doctor is the better judge of what should inform the medical transaction’. Bolam is founded on the belief that only doctors have the necessary knowledge and experience to ascertain what information should be imparted on a patient. However, Grubb and Lesser note, even though a doctor has the requisite knowledge to recognize the advantages and disadvantages of a particular treatment, only a patient is in a position to determine whether to consent to treatment based on their own assessment of the risks, benefits and alternatives to the procedure. Furthermore, because Bolam presupposes that decisions regarding disclosure are entirely medical, it ignores the fact that a patient’s decision to refuse treatment may be based on non-medical reasons. For instance, a patient may decide to post-pone or reject medical treatment because they want to seek a second opinion, update their will or deal with a family crisis. If doctors ignore these non-medical reasons for refusing treatment and decide not to warn a patient of certain risks because it may lead to a refusal of treatment that is medically beneficial, they may in turn deny a patient the opportunity to decide what is truly in their best interests.

On the other hand, the concern raised by the medical profession in Bolam is that disclosure of certain risks, even if minimal, may increase the patient’s anxieties about a medical procedure resulting in a refusal to accept treatment which is in their best interests. Although a valid concern, it does not follow that patients should be denied information simply because they may be troubled by the information. Moreover, as Grubb points out that there is ‘no such body of learning concerning what information a patient should be told which all doctors accept and draw upon. Thus, the idea of a professional standard of disclosure may proceed from a completely false premise’..

Interpretation and Application of Bolam

Since Bolam the courts have attempted to refine the Bolam test and move towards a theory of informed consent that better protects patient autonomy. However, the problem is that these cases also tend to retreat back to Bolam by framing the issue of informed consent from the perspective of the doctor and not the patient.

In Chatterton, Miss Chatterton decided to undergo a procedure to alleviate the pain she had endured near a hernia scar in her right groin. Dr. Gerson performed the operation and claimed that it was his normal practice to inform patients that the procedure was not always successful and that it may lead to ‘numbness over an area larger than the pain source itself’. Unfortunately, the operation did not relieve Miss Chatterton’s pain and she agreed to undergo the same procedure 10 months later. During the second operation, Dr. Gerson did not repeat the information he first provided to Miss Chatterton. The repeat procedure also proved unsuccessful and Miss Chatterton, in addition to continuing to suffer pain, experienced numbness in her right leg. Miss Chatterton initiated a claim against Dr. Gerson arguing that her consent was invalid because Dr. Gerson did not disclose the risks associated with the second procedure. Miss Chatterton also argued that Dr. Gerson had failed in his duty to provide her with enough information for her to make an informed decision.

In analyzing Miss Chatterton’s claims, the Court of Appeal expanded on the Bolam test holding that a doctor is required to inform a patient ‘in broad terms of the nature of the procedure’ and must disclose any ‘real risk of a misfortune inherent in the procedure’. Thus, instead of giving the medical profession the discretion to decide what information must be relayed to a patient prior to obtaining valid consent, doctors must at least state in broad terms what the operation entails and its effects.

Although Chatterton affords more rights to the patient, the Court of Appeal still deferred to the medical profession in respect of the way in which information is to be communicated. Bistow J. speaking for the Court of Appeal, held that doctors are only under a duty to explain the nature of the operation and its implications in a manner that a ‘responsible doctor in similar circumstances would have done’. Thus, Chatterton appears to reaffirm the principles in Bolam by suggesting that what information is departed on a patient should be taken from the point of view of what the doctor thinks is best rather than what a patient would want to know in order to make an informed choice. As Lesser argues, ‘If patients have a right to make all the appropriate decisions, they must also have a right to all information for decision-making: the limits are set, not by what it is medically advisable or beneficial for them to know, but by what they need to know in order to make an informed assessment before deciding what to do’.

In Sidaway, the House of Lords affirmed Chatterton’s interpretation and application of Bolam. The majority of the House of Lords held that the Bolam test should apply in situations where a doctor provides information regarding the disadvantages of a medical procedure. Mrs. Sidaway underwent an operation to ease the pain she was suffering in her neck and arm resulting from a deformity in her spine. There was a 1%-2% risk that the operation would result in nerve root or spinal cord damage. Mrs. Sidaway was not informed of these dangers and as a result of the procedure was left partially paralyzed. The issue before the House of Lords was whether or not English law imposes a duty upon doctors to warn patients of all the risks inherent in a medical procedure and if so, whether there are limits on the extent of the disclosure?

Although there appears to be no clear ratio in Sidaway, the majority of the judges held that the doctrine of informed consent does not exist in English law and that the information a doctor tells or does not tell his patient will be judged on the basis of what a responsible body of doctors would decide is appropriate. However, in Lord Bridge’s opinion if there is a ‘substantial risk of grave adverse consequences’, a doctor is required to disclose this risk regardless of whether or not there is a body of medical opinion suggesting otherwise. As Lord Bridge states, ‘I am of the opinion that the judge might in certain circumstances come to the conclusion that disclosure of a particular risk was so obviously necessary to an informed choice on the part of the patient that no reasonably prudent medical man would fail to make it. The kind of case I have in mind would be an operation involving a substantial risk of grave adverse consequences, as, for example, the ten per cent risk of a stroke…’. Lord Bridge seems to suggest that had the risk associated with the procedure been in the 10% range, the court would have found in favour of Mrs. Sidaway – regardless of whether expert testimony suggested that it was not standard practice to disclose this risk. Thus, Lord Bridge qualified the Bolam test in two ways. First, Lord Bridge acknowledged that there are situations where the risks associated with a procedure are so severe that any medical opinion suggesting that these risks should not be disclosed would be considered bad practice. Second, Lord Bridge states that it is ultimately within the discretion of the court, rather than the medical profession, to decide what information doctors should release to their patients prior to obtaining consent. Similarly, Lord Templeman stated that doctors should point out to their patients any ‘special’ risks relating to the medical procedure.

Both Lord Bridge and Templeman limit the Bolam test by advocating for an approach that emphasizes a patient’s right to receive information on the adverse effects of a proposed treatment. However, as Grubb points out, the underlying principle is still that enunciated in Bolam, namely that the relevant test in determining whether or not a doctor is under a duty to disclose a particular risk will be based on what the medical profession regards as relevant. Hence, the majority favoured the approach in Bolam holding that insofar as the information communicated by the doctor ‘conformed to a responsible body of medical opinion in deciding what to tell and what not to tell his patient, he discharged his duty properly’.

Unlike the majority, Lord Scarman was of the dissenting opinion that a patient’s right to autonomy is of the utmost importance and should be protected. According to Lord Scarman in order for consent to treatment to be valid a patient must receive sufficient information relating to the treatment. Lord Scarman further maintained that it is not up to the medical profession to decide how much and what kind of information should be communicated to a patient based on ‘prevailing medical practice’. Although Lord Scarman did not advocate for a doctrine of informed consent that requires doctors to disclose every detail, he stated the ‘right of a patient to make his own decision whether he will or will not undergo the treatment proposed…requires that the doctor be under a duty to inform his patient of the material risks inherent in the treatment’. Lord Scarman noted that the test for determining whether a risk is ‘material’ is ‘whether in the circumstances of the particular case the court is satisfied that a reasonable person in the patient’s position would be likely to attach significance to the risk’.

However, Lord Scarman went one step further stating that the patient’s right to information may be limited by the doctor’s ‘therapeutic privilege’ which allows a doctor to refuse to disclose information that ‘posed a serious threat of psychological detriment to the patient’. This exception to a patient’s right to obtain adequate information is, as Grubb notes, a ‘reversion to the paternalism of Bolam‘ because it protects the medical profession at the expense of patient autonomy. As Pattinson points out, therapeutic privilege gives doctors the power to override patient autonomy by allowing them to decide whether warning a patient of a certain risk would cause psychological harm and result in the patient’s refusal of treatment. For example, if a particular course of treatment carries a risk of amputation, and the doctor is aware that the patient suffers from dysmorphophobia, or a fear of being deformed and would refuse treatment on that ground, then according to Lord Scarman the doctor would be relieved of his duty to warn the patient of that particular risk. Thus, the courts in England appear to move towards a principle of informed consent based on a ‘concern for patients’ rights’ and at the same time revert back to the ‘medical paternalism’ inherent in the Bolam decision.

Challenges to Bolam

The decision of the House of Lordsin Bolitho addressed the approach to professional negligence laid down in Bolam. Although the court in Bolitho was not concerned with the duty to inform, but rather with the amount of care a doctor is expected to provide to a patient, this decision represents the beginning of a line of cases undermining Bolam. Lord Browne-Wilkinson determined that a doctor could escape liability in respect of diagnosis or treatment if the doctor could establish that his/her actions ‘accorded with sound medical practice’. What is noteworthy however is that Lord Browne-Wilkinson affirmed Lord Scarman’s dissenting opinion in Sidaway holding that it is up to the courts to decide whether the exponents of the body of medical opinion relied on by the doctor were logical and sensible. Bolitho represents a redefining of the relative roles of the medical profession and the courts in determining the content of the duty doctors owe to their patients. Hence, the decision in Bolitho is the beginning of a movement in English case law towards a theory of informed consent that strips the medical profession of its power to make unilateral decisions concerning the amount and content of disclosure.

Recent decisions that have impacted the notion of informed consent in English Law

The question then is whether the courts, since Bolitho and Sidaway,have continued to move towards an approach to informed consent that is more patient-centered. In Pearce v. United Bristol Healthcare NHS Trust, the Court of Appeal established that the standard adopted in Bolitho was equally applicable to cases dealing with the duty to inform. Mrs. Pearce had requested that her doctor either induce her pregnancy or perform a caesarian section because she was already two weeks overdue. The doctor refused Mrs. Pearce’s request stating that it was improper to undergo such medical intervention because of the risks associated with such procedures. The doctor did not however advise Mrs. Pearce that if the baby was born without any interference from the hospital there was a 1%-2% risk that the baby would be stillborn. After giving birth to a stillborn baby, Mrs. Pearce sued the hospital for failure to warn. In examining the content and extent of the duty to inform of the risks in this case, Lord Woolf fused the decisions in Sidaway and Bolitho concluding ‘that if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk…’. Although Lord Woolf did not define ‘significant risk’ he suggested that while ‘it is not possible to take in precise percentages’, a risk in the range of 1%-2% is not considered significant.

The courts decision in Pearce departs from the Bolam test because it establishes that the standard on which to determine what information a doctor must tell a patient is based on ‘what a reasonable patient would want to know’ rather than what a responsible body of medical opinion deems appropriate. On the other hand, the paternalistic nature of Bolam underpins the decision in Pearce because ‘the reasonable person is still determined by the doctor and this may be different than what the patient wants to know’. While the decision in Pearce appears to advance a pro-patient approach to informed consent, its focus remains the same as Bolam namely, ensuring that doctors still have a say in what information should be given to patients.

According to Pattinson, ‘causation is often the claimant’s biggest hurdle’ because it requires establishing that had the patient received the information the doctor negligently failed to provide, the patient would never have agreed to the procedure. In the recent House of Lords decision in Chester v. Afshar, Miss Chester underwent spinal surgery in an attempt to alleviate the pain she was suffering in her lower back. The procedure included a ‘small (1%-2%) but unavoidable risk’ of nerve damage and paralysis. As a result of the operation, Miss Chester was left partially paralyzed. Miss Chester claimed that the doctor was negligent in his failure to warn her of the risk of neurological damage. In addition, Miss Chester argued that had she been advised of the consequences of the procedure she would not have consented to the procedure without first obtaining a second opinion and exploring other alternatives.

In examining the issue of causation, the House of Lords decided, that it was ‘necessary to depart from conventional causation principles to vindicate Miss Chester’s right to autonomy’. The majority of the House of Lords held that not only does a patient have a right to be informed of the risks inherent in a medical procedure, but also that a causal link between a patient’s injury and a doctor’s failure to warn can be established where the patient proves that had he/she received adequate information the injuries sustained ‘would not have occurred when it did’. Pattison states, ‘All that is required is that the patient is thereby deprived of the opportunity of exercising a choice, which seems to require him to prove only that he would not have consented to the treatment at that time’. Thus, as Sarah Devaney remarks, ‘In reaching the decision they did, the House of Lords gave legitimacy to assertions that the law of England and Wales requires patients to be properly informed about proposed treatment, a claim which until now had little weight’.

Conclusions

In Bolam the court established that the amount of information a doctor is required to disclose to a patient in order to obtain valid consent will be based on what a responsible body of medical opinion determines to be proper. The Bolam test is highly paternalistic and creates tension between patient autonomy and professional autonomy by giving doctors the right to govern a patient’s ability to make informed choices. After Bolam, the courts appeared to move in the direction of establishing a doctrine of informed consent that is based more on what a patient wants to know.

In Chatterton the Court of Appeal extended the patient’s right to information by holding that at the very least a doctor is required to disclose information concerning the nature and implications of the proposed treatment. At the same time however, the Court of Appealreverted to the principles in Bolam holding that the extent of a doctor’s duty to warn is based on what a responsible doctor in the same situation would do.

Approximately four years later, the majority of the House of Lords in Sidaway was reluctant to adopt a patient-centered approach to informed consent and reaffirmed the Bolam test. Even the dissenting opinion of Lord Scarman on the issue of therapeutic privilege,suggests that the courts are willing to override a patient’s right to make an informed choice on the basis that the ‘doctor knows best’. Nevertheless, the House of Lords in Bolitho challenged the professional standard approach in Bolam holding that the court, and not the medical profession, is the ultimate judge of whether or not the body of medical opinion supporting a doctor’s decision is rationally founded. Yet, Lord Browne-Wilkinson also made it clear that his decision in Bolitho was not applicable to situations where a claim of negligence had been made against a doctor on the issue of failure to warn.

More recently, the English courts have emphasized the importance of patient autonomy and the right of patient’s to make decisions which impact on their lives. In Pearce,and Court of Appeal held that the content and amount of disclosure should be based on what a reasonable patient would want to know. In Chester, the House of Lords modified the traditional approach to causation making it easier for a patient to establish a claim in negligence on the basis of a failure to warn. Although the case law in its totality suggests that the ‘content of the duty to inform may be more than just Bolam simpliciter’ this paper suggests that these decisions demonstrate that the courts still defer to the paternalistic standard in Bolam by preferring to safeguard professional autonomy over patient autonomy.

Bibliography

Books and Articles

  • Brazier, Margaret. Medicine, Patients and the Law (3rd edn. Penguin Books, London 2003).
  • Grubb, A. (ed.) Principles of Medical Law (2nd edn. OUP 2004).
  • Lesser, Harry. ‘The Patient’s Right to Information’ Chapter 10 in Margaret Brazier and Mary Lobjoit (eds.) Protecting the Vulnerable; Autonomy and Consent in Health Care (Routledge, New York 1991).
  • Lindley, Richard. ‘Informed Consent and the Ghost of Bolam’ Chapter 9 in Margaret Brazier and Mary Lobjoit (eds.) Protecting the Vulnerable; Autonomy and Consent in Health Care (Routledge, New York 1991).
  • Pattinson, Shaun D. Medical Law and Ethics (1st edn. Sweet & Maxwell, London 2006).

Internet Sources

  • The College of Physicians and Surgeons of Ontario, ‘CPSO Policy Statement; Consent to Medical Treatment’ (CPSO website January/February 2006) , accessed 18 December 2007.

Cases

  • Bolitho v. City and Hackney Health Authority [1998] P.I.Q.R. P10.
  • Pearce v. United Bristol Healthcare NHS Trust [1999] E.C.C. 167.
  • Sidaway v. Governors of Royal Bethlem Hospital [1985] AC 871.