This article is written by Hardeep Sodhi, an Engineer, MBA and Legal expert. It is based on his experience and research in medical negligence cases, including his own.

It has been published by Rachit Garg.

Introduction

This article seeks to address in a concise manner one aspect of a rather complex field of law – medical jurisprudence. Common understanding as well as laws as they exist are summarised,  and the difficulty of their applicability to the medical field is elaborated.

Consent – as usually understood

Consent is a term very widely used and generally, with no difficulties in such usage. It usually means “to give assent or approval, to agree“. Pre-requisites of consent are an understanding of the issue at hand, and free will.

Consent as per Indian law

Under the Indian Contract Act (ICA), Consent can be clearly understood. It is defined in S. 13 as:

Two or more persons are said to consent when they agree upon the same thing in the same sense.

And “ free” consent is one of the key elements for any valid contract to take place. As set out in iS. 14 of the Indian Contract Act, Consent caused by coercion, undue influence, fraud, misrepresentation or mistake is not free.

In most of the above situations, the affected party can claim damages. In case of a mistake of fact made by one party, the contract is not voidable merely due this reason (S. 22), if made by both parties, it is void (S. 20) . If it is a mistake of law ( S. 21), it may still be executable ( it is not voidable). But if the mistake is that of material foreign law, it has the same effect as a mistake of fact. ( Sections indicated in brackets refer to the Indian Contract Act )

Add into the mix the aspect of “ competence to contract “. S. 11  sets defines a competent person as one or the age of majority, having a sound mind and not disqualified from contracting by any law to which he is subject.

If the damages are not due to any reasons set out above but due to the ‘negligence’ of one party, compensation for the same lies under the law of Torts. The principle here is that of “Restitutio ad integrum”. Simply put, this principle mandates that the amount of compensation awarded ( to one who has suffered due negligence ) should put him/her in the same position that would have been the case if the tortious action had not been committed. So the sufferer may, for example, be awarded damages for direct expenses such as medical bills and property repairs and the loss of future earnings attributable to the injury. This is, of course, highly subjective and controversial.

Not only in the Indian Contract Act, but consent also finds a central place in many other Acts. For instance, Hindu Marriage Act ( Sections 5, 11, and 12(c) ), and several provisions of the Indian Penal Code ( S. 90, for example ). Generally, the provisions may be understood and applied without much difficulty.

So far so good, usually, but difficulties start emerging when the peculiarities of the Medical Field are considered.

Peculiarities of consent in the medical field

Consent in medical situations is a far more complicated matter. Medical negligence is a crime punishable. However, it differs much from our usual perception of a ‘crime’. It is done usually without ‘independent’ witnesses, away from public eyes (in operation theatres). Specifically, in aspects of consent, the following are the stark differences.

Firstly, the two parties (a doctor and a patient) are usually not on an equal footing. On one side is a patient who has implicit trust in the doctor since supposedly, the doctor has the expertise and knowledge to give the patient help that the patient desperately needs. On the other side is a doctor who is, many times, almost like “ God” to the patient. A robust fiduciary relationship exists – indeed it must exist for the possibility of a cure. Try as one might, a patient can never equal an expert doctor as to the facts of his disease and treatments for it.

So, two aspects of invalid consent – undue influence and mistake of fact (at least by the patient) are almost inherently present.

To avoid the possibility of a mistake of fact/misrepresentation a doctor should explain the risks and rewards of his suggested procedure ( operation ) to the patient. This Is supposed to satisfy the criteria of “informed consent” as is required in all cases and elaborated upon by the Honourable Supreme Court as well (as set out in the Samira Kohli case discussed hereunder). Risk, however, by its very definition is a probability and not a certainty. And depends upon factors that can not be completely considered. To a doctor less experienced the same operation may be highly risky while another considers it as having little risk. Likewise, if a patient has undergone, say, a heart stent procedure before, he may consider the next stenting less risky than for someone who is undergoing stenting the first time.

Secondly, in the highly commercial world that we live in, doctors are not left untouched. A doctor – just like any businessman – has commercial considerations. This does not mean there is necessarily a dishonest intent. For example, a surgeon may genuinely believe a cure lies in surgery. Commercial considerations, however, may require him to suggest this surgery as an immediate and only option. In extreme cases, however, this may be due to dishonest intent as well, or overconfidence.

Indeed these considerations may make the doctor consciously or subconsciously downplay the risk of an operation. This is never expressed but presents the doctor with a strong dilemma. If the doctor tells a patient an operation is too risky, the patient may just refuse the operation. A commercial loss. Or, worse, the patient may seek another opinion and the next doctor may say he will manage the risks well. The operation may be a success. And the patient may recount his experience with both the doctors/ hospitals to countless others. Directly affecting reputations and monies each doctor/ hospital may charge. 

The commercial considerations (and for which the Hospital may be more at fault than the doctor) may also reflect in many other not-so-apparent aspects – a doctor giving very little time to listen properly to a patient, misdiagnosis, reading the reports wrong (or not even asking for such reports), hurriedly done operations where the skills required may simply not be provided. 

Thirdly, usually, the element of “ Mens rea”  is taken to be lacking. Which is a necessary element of many crimes. Why would a doctor wish his patient wrong? Instead, the doctor’s reputation (and further $$$) relies upon treating a case successfully. So there is an implied understanding that “the doctor must be right”, thereby making the task of an inexperienced litigant (patient) all the more difficult when he seeks to establish medical negligence. The landmark Supreme Court Judgement – in Jacob Mathew Vs. State of Punjab & Anr.  ( Crl. Appeal 144-145 of 2004 ) which is still settled law in India makes this very clear when it sets out stringent parameters to be followed before a case of medical negligence may be set out against a doctor.

Also, as can be readily understood, the guiding principle of “Restitutio ad integrum” which is very prevalent in cases where harm is suffered by someone simply may not hold in medical cases. One person dies on the operation table or is paralyzed. A female is rendered sterile for life. A patient is rendered blind. And many, many similar situations make clear that no amount of compensation awarded can put one who has suffered damage in the same position that would have been the case if the tortious action had not been committed. Of course, this tortious action could well be not explaining the risks of the surgery/treatment well – i.e. a case of misinformation and/or misrepresentation, if not outright fraud.

Above all these considerations is the fact that the human body is not a machine and yet not fully understood by doctors.

What does the Medical Council of India say about consent?

The Medical Council of India (now replaced by the National Medical Council) has hardly any elaboration on consent. All it says in its (Professional Conduct, Etiquette and Ethics) Regulations, 2002 about Consent as it applies to usual medical cases is:
7.16 Before performing an operation the physician should obtain in writing consent from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be. In an operation which may result in sterility, the consent of both husband and wife is needed.

So, if there is NO operation, there is no need for consent. This is confusing to some extent. What about injections, and tests ( some of which may be invasive and quite risky )? And when and how is this consent to be taken? How much risk is to be elaborated upon? How to evaluate the competence of the patient to give consent? How to make sure that the patient is sufficiently informed so as to give informed consent? The rule is silent on all these aspects. But, it is what it is.

What is the correct procedure for taking consent for medical treatment?

As is clear from the discussions above, the issue of consent in the medical field presents us with a very confusing landscape. The laws as set out (provisions of the Indian Contract Act, for example) cannot be applied as they are to this field although they set out the basic framework. Indeed no totally objective and verifiable laws may be made. Only attempts may be made to make the process of consent in medical cases as close to ‘valid’ consent as possible 

To make matters worse, the country’s premium body tasked with ensuring proper conduct of the doctors – the National Medical Council – has chosen to remain largely silent on this very vexing issue. 

Hence our only resort is the plethora of case laws arrived at from cases that have been adjudicated over the issue of consent in the medical field and the general guidelines we can glean from that. 

Judicial reasoning on medical consent

The landmark case in Indian courts that has elaborated fairly comprehensively on the issue of medical consent is the Honourable Supreme Court Judgement in Samira Kohli vs Dr Prabha Manchanda & Anr, ( Civil Appeal No. 1949 of 2004)  delivered on 16 January 2008. The Honourable Court thoroughly evaluated medical jurisprudence as it has evolved in India, the US, and the UK and finally concluded principles of consent (at Para 32). These are paraphrased as under:

  1. All treatments including surgery require consent. The person consenting should have the capacity and competence to consent, should consent voluntarily and should have adequate information concerning the nature of his treatment.
  2. This “ adequate information” has to be provided by the treating doctor or member of his team. The essence is to enable the patient to make a balanced judgement as to whether he should undergo the treatment being suggested by the treating doctor or not. So the doctor should explain the nature, procedure and purpose of the suggested treatment, and alternatives available, and outline of substantial risks and adverse consequences of refusing treatment. In explaining risks remote or theoretical risks that may cause the patient to be frightened enough to refuse treatment being suggested need not be described.
  3. Consent for only a diagnostic procedure does not extend to a therapeutic treatment. Likewise, consent for a specific treatment does not mean consent for any other treatment, even if performed for the possible benefit of the patient.  The only exception to this is when, during surgery on an unconscious patient,  the other/additional treatment is necessary to save the life and/or the health of the patient and the other/additional treatment cannot be delayed till the patient regains consciousness.
  4. If common diagnostic and operative procedures are being contemplated, common consent for the same may be taken. Similarly, common consent may be taken for a surgical procedure as well as additional or further procedures that may become necessary during the course of surgery.
  5. The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of the treatment, and the risk and consequences attached to the treatment.

The emphasis in bold and underline above is provided by me for clarity.

This judgement leaves open many issues. It discards the doctrine of informed consent as was developed in the US in 1971, in the case of Canterbury Vs Spence. Instead, it stresses upon informing the patient only as much as may be “needed”, per the doctor’s perception, of what is ‘good’ for the patient ( at the time of the Canterbury decision Doctors were rather reticent in clearly elaborating on the risks and in testifying against one another, practices that continue even today). To reach this conclusion, the Hon’ble Supreme Court chose to rely more on the “Bolam test” which evolved in British Jurisprudence in 1957’s case of Bolam vs. Friern Hospital Management Committee. Under this test,  standards of professional conduct ( including that pertaining to consent) are to be evaluated as compared to those of peers. And the peers need not be the “ best “ in their field but only the average. Hence, it is left to the doctor to decide how much risk to tell a patient and, if his body of “ reasonable peers skilled in the art” agreed with his actions, he is not at fault!

Since 2015, the Bolam test has been discarded even in the UK in the case of Montgomery v Lanarkshire Health Board [2015] which clearly sets out :

“84. Furthermore, because the extent to which a doctor may be inclined to discuss risks with a patient is not determined by medical learning or experience, the application of the Bolam test to this question is liable to result in the sanctioning of differences in practice which are attributable not too divergent schools of thought in medical science, but merely to divergent attitudes among doctors as to the degree of respect owed to their patients.

87. ……The doctor is therefore 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.”

Thus, as can be seen, this case imposes a much stronger duty on the doctor to make as complete a disclosure as possible to the patient.

In India, however, Bolam still continues to be a good law!

Hence, as can be seen in the Samira Kohli judgement, there is no mention of “ complete information “ above, only “adequate information “ needs to be given to the patient. This, of course, is highly subjective and suffers from many pitfalls, some of which are elaborated on above. 

Further, in the Samira Kohli judgement, the doctor is tasked with the duty of disclosing “alternatives if any are available”. In actual practice, this has a host of issues. 

Let us take an example to understand this better. Many people suffer from Obesity.  And there are many treatments for the same -dieting and exercising being the usual ones. However, Sometimes bariatric surgery is an option that is explored.

A bariatric surgeon, well-reputed, is approached. He charges a good amount of fees and operates in a reputed hospital.

What will be the response of this surgeon to the efficacy and risk of the treatment offered by him? Will he elaborate completely on the risks? Most probably no, since he has confidence in his abilities and by elaborating completely on the risks he may just frighten the patient away. Again, for obvious reasons, the answer is no!

This is notwithstanding the commercial interest both he and his hospital have in having the patient come in and consent to the operation.

Going further, will this Doctor suggest the alternative of dieting and exercise to the patient? Remember he is NOT an expert in these. So, can he, to begin with, recommend these treatments? And if he does, he loses the patient, obviously. 

So, as can be seen, with the best of intentions and recommendations even from the highest court of the land, things are not as straightforward as they seem. Indeed, each situation is almost unique in its own context and there are a plethora of case laws on the subject of ‘ informed consent’ that have evolved over the years. Some of which I hope to discuss in another article!

Conclusion – Consent in the Medical Field is complicated!

As the discussion above sets out, the issue of proper medical consent continues to confound medical jurisprudence. While there are broad guidelines as per the settled case of Samira Kohli case, that case itself in turn relies upon conclusions arrived at in the Bolam case, which is no longer considered good law even in its country of origin!

Hence it is time that the Indian jurisprudence also took note of the fast-changing, more and more commercialised aspect of medical practice in India and changed its laws accordingly. Hopefully, someone is listening!

References

  1. Code of Ethics Regulations, 2002, https://www.wbconsumers.gov.in/writereaddata/ACT%20&%20RULES/Relevant%20Act%20&%20Rules/Code%20of%20Medical%20Ethics%20Regulations.pdf. Accessed 4 October 2022.
  2. “Bariatric surgery.” Mayo Clinic, https://www.mayoclinic.org/tests-procedures/bariatric-surgery/about/pac-20394258. Accessed 4 October 2022.
  3. “Bolam v Friern Hospital Management Committee (1957) — Healthcare Ethics and Law.” Healthcare Ethics and Law, https://www.healthcareethicsandlaw.co.uk/negligence-1/bolam-v-friern-hospital-management-committee-1957-bolam-test. Accessed 4 October 2022.
  4. “Canterbury v. Spence | Case Brief for Law School.” LexisNexis, https://www.lexisnexis.com/community/casebrief/p/casebrief-canterbury-v-spence. Accessed 4 October 2022.
  5. “Consent Definition & Meaning.” Merriam-Webster, https://www.merriam-webster.com/dictionary/consent. Accessed 4 October 2022.
  6. “Jacob Mathew Vs State of Punjab and Anr. ( Crl. Appeal 144-145 of 2004).” https://main.sci.gov.in/jonew/judis/27088.pdf.
  7. “JUDGEMENT Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland).” The Supreme Court, 11 March 2015, https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf. Accessed 4 October 2022.
  8. “Mens Rea | Wex | US Law | LII / Legal Information Institute.” Law.Cornell.Edu, https://www.law.cornell.edu/wex/mens_rea. Accessed 4 October 2022.
  9. “Restitutio in integrum legal definition of restitutio in integrum.” Legal Dictionary, https://legal-dictionary.thefreedictionary.com/restitutio+in+integrum. Accessed 4 October 2022.
  10. “Samira Kohli Vs Dr Prabha Manchanda And Anr. ( Civil Appeal 1949 of 2004).” Supreme Court of India, 16 January 2008, https://main.sci.gov.in/jonew/judis/30116.pdf. Accessed 4 October 2022.
  11. “Section Details.” India Code: Section Details, https://www.indiacode.nic.in/show-data?actid=AC_CEN_3_20_00035_187209_1523268996428&sectionId=38616&sectionno=13&orderno=13. Accessed 4 October 2022.
  12. “Section Details.” India Code: Section Details, https://www.indiacode.nic.in/show-data?actid=AC_CEN_3_20_00035_187209_1523268996428&sectionId=38617&sectionno=14&orderno=14. Accessed 4 October 2022.
  13. “Section Details.” India Code: Section Details, https://www.indiacode.nic.in/show-data?actid=AC_CEN_3_20_00035_187209_1523268996428&sectionId=38614&sectionno=11&orderno=11. Accessed 4 October 2022.

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