Canterbury v Spence – the birth of “informed consent”

A series of posts on patient consent – (2) [ << Previous ] [Next >>]

The Schloendorff Case

In 1914, in the case of Schloendorff v Society of New York Hospitals, [1] Justice Benjamin Cardozo produced perhaps the most widely quoted statement of a patient’s right to self-determination:
“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 for which he is liable in damages”

The decision did draw attention to the fact that there may be a distinction between an act of negligence and “trespass” where interference with the patients right to make choices about their own medical care may be actionable, even if that invasion was ultimately beneficial to the patient.

Salgo – The birth of ‘informed’ consent

Despite the historic significance of the Schloendorff case there were no major advances in the doctrine of information disclosure to patients for many years. Without warning, there was then a flurry of cases where the American courts appeared to embrace the concept of patient self-determination in the non-disclosure case. This new duty started with the premise that information disclosure was the foundation of patient consent.
This new development required a name and initially it was termed “intelligent consent” and then the term “informed consent” was born in 1957 in the case of Salgo v Leland Stanford Jr. University Board of Trustees [2].
Mr Salgo suffered permanent paralysis as a result of a translumbar aortography and brought an action against his physicians both on negligence and for failing to warn him of the risks of paralysis prior to the procedure.
The court found that the physician had a duty to disclose to him “any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment” The court then referred to the term “informed consent”.
Salgo is a negligence case and the duty to obtain “informed consent” was one of a number of issues raised on appeal. The lower court had grounded the duty of the doctor on the basis of the physician’s fiduciary duty.
The quoted language in Salgo comes directly from the amicus brief submitted by the American College of Surgeons to the court. In the decision, there is no analysis of the legal basis of the duty to inform patients however the court did appear to suggest that full disclosure was required, but it did permit an element of physician’s discretion. This ambivalence about the ability of patients to make decisions for themselves is something that continued to be seen in court decisions thereafter.

Canterbury v Spence

In the iconic decision of the court in Canterbury v Spence [3] there is finally the emergence of some of the principles adopted by the Supreme Court in Montgomery v Lanarkshire Health Board [4].
The court in Canterbury recognised that cases based on a failure to provide information were not new but said there was no precedent directly in point to assist them in coming to a decision in this case and they required to revert to first principles in rendering their opinion.
In 1972 the US court appeared to take the rights of the patient more seriously and focused on the patient’s right to self-determination which was said to shape the boundaries of the duty to reveal. This concept underpins the doctrine of consent.
The court identified two duties and assumed that the patient’s personal choices and the duty of the physician tended towards the same end. It has been said that this assumption is flawed in that there can be divergence between the interests and goals of the physician and those of patients. It is important to remember that a patient may make decisions against the advice of their physicians.
Although the test formulated in Canterbury was not accepted in every US state the test has proved to be highly influential in the development of this area of the law.
In the UK Lord Scarman in Sidaway v Bethlem Royal Hospital Governors [5] based his argument on the test enunciated in this US case. The Supreme Court in Montgomery referred to Lord Scarman’s view when defining the test to be applied in the UK when it said:

“The correct position, in relation to the risks of injury involved in treatment, can now be seen to be substantially that adopted in Sidaway by Lord Scarman, and by Lord Woolf MR in Pearce, subject to the refinement made by the High Court of Australia in Rogers v Whitaker.”

Canterbury – The Facts

At trial the claimant and his mother were clear they had not been warned of the risk of paralysis.  Dr. Spence said that he merely mentioned that there may be weakness and accepted that he did not mention paralysis because in his opinion that information might deter the patient from proceeding with the operation.

Canterbury – The use of the professional practice test

In Canterbury, the court rejected the professional practice standard of disclosure. It has been said that the decision swam upstream against a powerful current of support for this standard, which had become firmly established in those jurisdictions adhering to the negligence cause of action.
The court noted that the duty to disclose had gained recognition in a large number of American jurisdictions and that a number of approaches had been used to attempt to determine what amounted to full disclosure.
At that time the approaches were as follows:

1. Prevailing fashion within the medical profession
2. Good medical practice
3. What a reasonable practitioner would have borne under the circumstances
4. What medical custom in the community would demand

It was recognised that the majority of courts dealing with the problem had made the duty dependent on whether it was the custom of physicians practicing in the community to make the particular disclosure to the patient. In that situation, the physician might be held liable but there could be no recovery unless the omission forsakes a practice prevalent in the profession.
The court agreed that the physician’s noncompliance with a professional custom to reveal, like any other departure from prevailing medical practice, may give rise to liability to the patient.
However, the court did not agree that the patient’s cause of action should be dependent upon the existence and nonperformance of a relevant professional tradition.
It was felt that there were formidable obstacles to acceptance of the notion that the physician’s obligation to disclose is either germinated or limited by medical practice. The reality of any discernible custom reflecting a professional consensus on communication of option and risk information to patients was said to be open to serious doubt.
The court saw the danger that what in fact is no custom at all may be taken as an affirmative custom to maintain silence, and that physician-witnesses to the so-called custom may state merely their personal opinions as to what they or others would do under given conditions.
The court identified an inconsistency between reliance on a general practice respecting divulgence and, on the other hand, realisation that the myriad of variables among patients makes each case so different that its omission can rationally be justified only by the effect of its individual circumstances.
Further, to bind the disclosure obligation to medical usage was said to arrogate the decision on revelation to the physician alone. Respect for the patient’s right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves. 
Prevailing medical practice was recognised to have evidentiary value in determinations as to what the specific criteria measuring challenged professional conduct are and whether they have been met, but it did not itself define the standard.

In summary, the physician’s duty to disclose was said to be governed by the same legal principles applicable to others in comparable situations, with modifications only to the extent that medical judgment enters the picture. It was held that the standard measuring performance of that duty by physicians, as by others, is conduct which is reasonable under the circumstances.
Having considered all of the different approaches the court in Canterbury concluded that the duty to disclose arises from phenomena apart from medical custom and practice. It was said that any definition of the scope of the duty in terms of a professional practice is at odds with the patient’s prerogative to decide on projected therapy himself. It was recognised that that prerogative is at the very foundation of the duty to disclose.
Where the medical profession dictates what can be disclosed the court recognised that the patient’s right to know and the physician’s correlative obligation to provide information are diluted.
This is important when considering how the Supreme Court formulated the duty in Montgomery given the court clearly endorsed the approach of Lord Scarman in Sidaway and Lord Scarman derived his approach from the decision in Canterbury.

The nature of the duty to disclose

Having rejected rigid adherence to the professional practice test the court in Canterbury defined the duty of care. The focus was on self-determination and they quoted directly from Schloendorff. It was recognised that consent required the informed exercise of choice. The disclosure made by the doctor should have provided the patient with an opportunity to assess the available options and the risks of such options.
It was held that:

“[T]he patient’s right of self-decision shapes the boundaries of the duty to reveal. That right can be effectively exercised only if the patient possesses enough information to enable them to make an intelligent choice.”

The court recognised that true consent required the informed exercise of a choice, and it said that to enable a choice to be made there must be an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.
It was recognised that the average patient has little of no understanding of medicine and required to look to their doctor/s for enlightenment to enable them to reach an intelligent decision.
Because any decision determining what is to be done to his or her body is the “prerogative of the patient” it was said that the patient makes the decision by means of an acquired understanding of therapeutic alternatives and their hazards. There required to be a ‘reasonable divulgence’ by physicians to the patient to make such decisions possible. The duty was seen to be based in the fiduciary quality of the physician-patient relationship.
The court saw the duty of the physician to warn of the dangers lurking in the proposed treatment. The court recognised that the patient’s reliance upon the physician is a trust of the kind which has traditionally exacted obligations beyond those associated with arms-length transactions.

Canterbury – The standard to be applied

At this point in time the courts had not developed a uniform standard to define the scope of the duty to inform. Some courts had encouraged full disclosure. In Canterbury, the court felt that it was obviously prohibitive and unrealistic to expect physicians to discuss with their patients every risk of a proposed treatment no matter how small or remote.
It was also recognised that a physician could not disclose a risk he was unaware of at the time.
The court considered that the scope of the physician’s communications to the patient required to be measured by the patient’s need and that need is the information material to the decision. The test for determining whether a particular peril must be divulged was said to be its materiality to the patient’s decision and that ‘all risks potentially effecting the decision must be unmasked.”
The court concluded that to safeguard the patient’s interest in achieving his own determination on treatment, the law required to set the standard for adequate disclosure.
It was felt that the physician’s liability for non-disclosure should be determined on the basis of foresight, not hindsight. The issue of non-disclosure should be approached by the reasonableness of the physician’s divulgence in terms of what he knows or should know to be the patient’s informational needs.
On materiality of risk it was held that:

“[a] risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy.”

Topics demanding a communication of information were said to be the inherent and potential hazards of the proposed treatment, the alternatives to that treatment, if any, and the results likely if the patient remains untreated.
The factors that were recognised as contributing to the significance of risk were the incidence of injury and the degree of harm threatened. It was felt that a very small chance of death or serious disablement might well be significant. A potential disability which dramatically outweighs the potential benefit of therapy might require discussion.

The need for expert testimony in non – disclosure cases

In Canterbury, the court set out a view on the use of expert evidence in non-disclosure cases having identified that they did not commend the use of a professional practice test. It was said that the guiding consideration is that medical facts are for medical experts and other facts are for any witnesses expert or not if they have sufficient knowledge and capacity to testify to them. It was noted that many of the issues typically involved in non-disclosure cases do not reside particularly within the medical domain.
The court set out to define examples of permissible uses of non-expert testimony in the non-disclosure cases. It was held that lay witness testimony could competently establish a physician’s failure to disclose particular information on risks, the patient’s lack of knowledge of the risk, and adverse consequences following treatment.
It was considered that experts were unnecessary to demonstrate the materiality of a risk to a patient’s decision on treatment, or to the reasonably expectable effect of the risk disclosure on the decision.
It is suggested that the discussion on the use of expert evidence in Canterbury is of relevance to consideration of this issue post Montgomery. 

Exceptions to the duty of disclosure

In Canterbury, it was said that the physician’s privilege to withhold information for therapeutic reasons must be carefully circumscribed for otherwise it might devour the disclosure rule itself.
It was noted that the privilege does not accept the paternalistic notion that the physician may remain silent simply because divulgence might prompt the patient to forego the therapy the physician feels the patient really needs.
It was recognised that there were two exceptions to the rules of disclosure identified by the court. The first was when the patient was unconscious and incapable of consenting where “harm from a failure to treat is imminent and outweighs any harm threatened by the proposed treatment.”
The second exception is when risk-disclosure poses such a threat of detriment to the patient as to become unfeasible or contraindicated from a medical point of view.

The use of the term “informed consent”

Throughout the decision the court referred to non-disclosure and “intelligent consent” and “intelligent choice”. The court cautioned the uncritical use of the “informed consent” label as potentially misleading. It acknowledged that in the duty to disclose case the focus of attention is more properly on the nature and content of the physician’s divulgence rather than the patient’s consent.

Conclusion

Following the decision in Salgo, the professional standard test was used in some cases in the US to define the extent of the physician’s duty of care in the non-disclosure case. It has been said that Canterbury succeeded in reaffirming that self-determination is the sole justification and goal of informed consent, and that the patient’s need for information rather the physician’s practices must form the basis of any adequate standard of disclosure.
The court did not go as far as introducing a particular patient test now found in Montgomery. It rejected an individual standard and applied the standard of the reasonable person to place a limit on patients’ claims. The reasonable patient standard does not fully embrace principles of self-determination but it is a test closer to the true nature of the principle than the use of the professional practice test.
Despite this limitation it appeared that the stage was set for a patient centred standard in law.
The 1972 case of Canterbury was followed closely by Cobbs v Grant [6] and Wilkinson v Vesey [7] it appeared that some courts had at last recognised the importance of the need for information to allow patients to make informed choices, and that on proper application of the principles the professional practice test could not be permitted to dilute or filter the information given to patients by the medical profession.
In Cobbs v Grant the court required disclosure of ‘all significant perils” defined as “the risk of death or bodily harm, and problems of recuperation.”
Wilkinson held that a physician is bound to disclose all known material risks peculiar to the proposed procedure. The court defined materiality as “the significance a reasonable person, in what the physician knows or should know is his patient’s position, would attach to the disclosed risk or risks in deciding whether to submit or not submit to surgery or treatment.”
However, the professional practice test was not replaced in law in the US and in the UK prior to, and following Sidaway the courts clung to the Bolam test as setting a standard in non-disclosure cases subject to an exception where the risk was material.
In the UK, it was not until the Supreme Court decision in Montgomery that the court acknowledged that the professional practice test is not consistent with the true application of legal principles in this area of law and finally recognised the rights of competent patients to make fully informed choices about their own healthcare.

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[1] 105 N.E.92,93 (NY. 1914)
[2] 317 P.2d 170 (1957)
[3] 464 F.2d. 772, 782 D.C. Cir. 1972
[4] [2015] UKSC 11
[5] [1985] A.C. 871
[6] 8 Cal3d 229
[7] 110 RI 606