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What Constitutes Informed Consent?

By - Dr. M.s. Kamath
Medico-legal Consultant, Mumbai

Posted on Nov, 2018

The doctor-patient relationship has undergone a sea-change in the last two decades. The advent of literacy and the availability of information technology at one’s fingertips has meant that patients are better informed and more demanding these days than their counterparts a few years ago.

One area in which this change is medico-legally relevant and important is the area of keeping the patient well-informed and taking an appropriate `consent’ for the treatment being meted out to him/his relative.

In law, the concept of `consent’ emanates from the Indian Contract Act which states that no contract can be complete without consent. Since the treatment of a patient by a doctor is contractual in nature, the relevant provisions of the said Act apply squarely in each and every case treated by a doctor at OPD or in-patient level. In medicine, this consent is further refined and improved to include `informed consent’ as the basic principle of treatment meted out to each patient, which has more onerous clauses attached to it than the plain 'consent' in the Indian Contract Act.

The basic premise of valid consent in law is based on the Latin maxim that both the parties should be consensus ad idem (which means that both parties must understand the terms of the thing being contracted with the same meaning at the same time). Any mistake in communication, coercion, suppression of facts or misstatement will make the contract void ab initio (from the moment of inception).

This definition has very serious implications in the concept of `informed consent’ as defined and practiced in medicine. The doctor is expected to inform the patient all aspects of diagnosis and treatment starting from the possible diagnosis, the tests which will be conducted to establish diagnosis, the costs involved, the length of treatment, the possible side or adverse effects of the treatment, the alternatives available for different modalities of treatment, the prognosis and long-term outcome of the treatment. Further modalities such as second opinion, the choice to opt out of treatment at any given time (no matter what the condition of the patient) and recourse to alternative medicine, with the rider that the patient can ask any question in connection with the treatment are also woven into the concept of 'Informed Consent'.

This is a huge burden on the medical profession, since it involves sitting with the patient for a long time, inculcating in him the basic principles of science and medicine, and educating him on all his rights and duties. In countries like India where a large number of patients are literally hanging on to doctors’ coats, this almost becomes an impossible task. Add to this the fact that most patients often `leave it to the doctor’ to take all decisions which are in the patient’s interest and that most doctors neither have the time, inclination or skills to counsel their patients on such `redundant issues’, the scenario is ripe for litigation if and when the patient is dissatisfied with the outcome of treatment. The law, unfortunately, does not recognise any of the above as an excuse for the doctor to keep his patient in the dark or skip the process of informed consent.

The landmark case on the concept of Informed Consent is based on a Supreme Court Order in Samira Kohli vs. Dr. Prabha Manchanda & another, which says:
"A doctor has to seek and secure the consent of the patient before commencing a 'treatment' (the term treatment includes surgery also). The consent so obtained should be real and valid, which means that the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to."

The consent, it must be emphasized, is always to be taken from the patient himself and not from any other person. In exceptional circumstances as in the case of a minor or a person not in a state of mind or consciousness to give such consent, the next of kin or guardian is permitted to give consent for treatment. In emergencies, where nobody is available to give consent, the doctor may take it upon himself or his administration to start treatment without consent, as the law holds that "preservation of human life" is the ultimate goal of the medical profession.

In older children who are capable of understanding what is being explained to them, it is a good policy to take the child’s and the guardian’s consent before commencing treatment. In cases involving the fertility of a man/woman, it is advisable and necessary to take the consent of the spouse/partner before commencing the treatment, because the partner/spouse’s reproductive rights are affected by the treatment.

Medical practitioners often feel that the provisions of informed consent are harsh and tedious, if not difficult to implement in the Indian scenario. The analogy to be given to such doubting Thomases is: when one purchases a new car or an apartment, would not the new owner like to know all aspects of what he is purchasing, including long-term prospects, when purchasing these commodities? To the patient, his body is the most precious commodity, so why should he not be informed of all consequences before he embarks on entering into a contract, which will modify its function and structure?

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Dr. M. S. Kamath is a Medico-legal Consultant at Mumbai. He holds the degrees of M.B., B. S., and LL.M. (Consumer Laws) and has acted as 'amicus curiae' in several consumer matters and is Consultant to several Companies.
Medical Counselling In India - A Forgotten Art?

By - Dr. M.s. Kamath
Medico-legal Consultant, Mumbai

Posted on Nov, 2018

The medical profession in India is very proud - and rightly so – in proclaiming that medical facilities in India are at par with facilities in the western world. The success of 'medical tourism' where patients from all parts of the world (including western countries) come to India for their medical treatment is touted as a shining example of the advances made by Indians in this field.

While these advances cannot be denied, there is a growing number of patients who are disgruntled with their doctors and even accuse the medical profession and its current avatar of 'corporatisation', as an evil which needs to be done away with. The commonest allegation and most of these perceptions arise largely out of `uncommunicative’ and `unresponsive’ doctors who have neither the time or the patience to sit with their patients and/or relatives to explain the basics of their ailments and treatment regimens.

There are several reasons for this growing chasm between doctor and patient. The most important among these is the belief among doctors that technology can be an answer to their patients’ ills and that they cannot afford to `waste time’ in sitting with patients explaining the nitty-gritty of a science they ill understand. There is also the important aspect of Indian doctors being fixated with numbers and targets, wherein the volume of patients seen or attended to is given more importance than the quality of services rendered to patients.

The most important point missed out however is the concept that the patient and his relatives are human beings with emotions and cannot be treated like a motor car whose spare parts are to be changed during a service session. In a country where emotions run high and literacy, particularly of the scientific variety is reduced, this lack of communication can be a potent recipe for disaster, particularly in cases where sudden unexpected events occur in the health of the patient or the results are not as per the expectations of the patient and his near and dear ones. Increasing incidents of attacks on hospital/doctors indicate that the communication gap has widened to such an extent, that violence is resorted to at the slightest pretext by irate citizens upset at the scenario they face.

The easy recourse to litigation, and strict laws in the West have taught their doctors an important lesson that the Indian medical profession would do well to emulate. Ever patient has to be 'counseled' and not just 'treated' for and about his ailment. This concept incidentally, was nurtured in India when physicians of yore were family friends and advisers to their patients as many senior citizens keep saying even today.

The art of counseling is not as simple as many would like to make it out to be. It involves listening to the patient, understanding his problems and socio-economic situation and lifestyle and then turning to the problem at hand and its treatment. The treatment modalities include advice on how to help the patient to fight his own disease, lifestyle modifications for the same, medical and surgical treatment involved, post-treatment attitudes and instructions, knowledge of side effects of medications and when to rush back to a doctor in case of aggravation of the symptoms/disease. Quite a handful of tasks by any reckoning and most importantly, very time consuming by any standards.

'Lack of time' due to burden of work cannot and should not be an excuse for avoiding the counseling of the patient. Heavy schedules, pressure of work and joining the rat race to see as many patients as possible in the least possible time, are the common excuses rolled out by doctors to explain their disinterest in the art of counseling. The west has learnt by bitter experience the outcome of such short-sighted policies and doctors, nurses and counselors there spend hours in talking to patients over several sessions to update them with their disease and their battle against it. Delegating the job to a junior is possibly the worst possible alternative as the patient tends to feel lost with another doctor or gets the feeling that his doctor has no time for him.

The art of counseling is not something one is born with, but a skill that is learnt by teaching and observation. Unfortunately, no medical college in this country teaches these important aspects of treatment to its students, and quite often the very attitudes of seniors reveal a heavy bias towards treatment modalities rather than the soothing skills of sitting and trying to understand the patient’s viewpoint and his response to the ailment. As a consequence, most doctors who graduate from medical college are not only ill-equipped to counsel patients but approach the subject of counseling with a mindset that it is "absolutely unnecessary and a waste of time which could be used in more productive things like treating some more patients".

Inadequate counseling also leaves a huge potential for litigation in the current socio-economic scenario. A patient can approach a court of law asking for justice if he suffers as a consequence of not being adequately informed of life-style changes or side-effects of medication as a result of inadequate counseling. There are no immediate precedents or antecedents of such cases, but law is also an evolving science like medicine and the day will not be far off when the doctor may have to face a Consumer Court for 'deficiency of service' arising out of inadequate counseling. Courts in the USA have already held that pre- and post-treatment counseling is an integral part of treatment, and the precedent will not be lost on the Indian judicial system.

Any disease, and more particularly a chronic one, leaves a scar in the mind of the patient, which needs to be healed with the balm of counseling. Ensuring the mental well-being of the patient and/or the relatives attending on him is an art which doctors steeped in science have to turn to, if they must adopt the skills and efforts required to offer solace and succor to the patient. A common joke doing the rounds of the sick patient is one who says "I am not looking for Allopathy, Naturopathy, Homoeopathy or any other pathy for my ailment – all I need is a little sympathy".

Dr. M. S. Kamath is a Medico-legal Consultant at Mumbai. He holds the degrees of M.B., B. S., and LL.M. (Consumer Laws) and has acted as 'amicus curiae' in several consumer matters and is Consultant to several Companies.
Who Decides The Definition Of 'medical Negligence''?

By - Dr. M.s. Kamath
Medico-legal Consultant, Mumbai

Posted on Nov, 2018

Ever since the Supreme Court of India pronounced in its famous judgement of Indian Medical Association vs. V.P. Shantha, that the medical profession comes within the ambit of the Cosumer Protection Act (CPA), the jury is out among medical professionals on what constitutes ‘Medical Negligence’.

While pessimists have started worrying whether every negative medical outcome or adverse effects constitutes negligence, purists wonder how judges who are incapable of coming to grips with technical issues (leave alone a complex science like medicine) will tackle the cocept of Negligence when the careers and reputations of doctors are at stake in the complaints against them.

What is medical negligence?

There are many definitions of the word medical negligence in law, but the standard definition which usually meets approval by Courts is:

  • Doing an act of omission or commission which another medical professional in similar circumstances would or would not have done.
    To illustrate the point, a physician practicing in a village in Orissa would not be expected to render the quality of service rendered by the All India Institute of Medical Sciences at Delhi with all its specialities afacilities. Again, the treatment of Cataract in 2014 cannot and will not be compared to Cataract Surgery in 1980, when hi-tech instruments and methodologies were unknown.
    Like medicine, lawalso follows a deeply-ingrained philosophy of proof and evidence as the rationale for deciding technical and scientific issues. The law of Negligence as laid down over decades requires the following ingredients to be proved before a judge comes to a conclusion that negligence is established in an instant case:

  • The doctor must have a duty to attend to a patient with due diligence and care

  • This duty of care should have been breached

  • Breach of such duty should lead to some harm/damage to the patient

  • The harm/damage should be proximate to the alleged act of breach of duty.

Most complainants who reach a count of law, normally do so under the misguided concept that if the result of treatment rendered to their patient does not meet their expectations, it is negligence.
Though this is often met by the scientific medical man with ridicule, it is often the duty of the physician to counsel patients well in advance about the treatment planned, its pros and cons, its possible adverse or side effects and the long and short-term prognosis, including the possibility of unexpected accidents. As a common example, the adverse effects of severe thrombophlebitis in a child on an intravenous drip is better explained in advance to the child’s mother and to warn her to keep a look-out for the same, rather than giving ‘lame excuses’ after the event has occurred and led to serious consequences.
While leading evidence, a doctor in court must always emphasize and explain to the court the right steps to be taken in treatment of a disease/ailment, before proceeding to explain how and why he/she has adhered to the same. Courts expect doctors to adhere to Standard Operating Procedures (SOPs) laid down in textbooks of medicine, and any dereliction or divesion from them is looked upon with high suspicion. It thus becomes incumbent for the doctor to produce his medical texts in court, which will vouch for his adhering to the SOPs. The onus of proving negligence then shifts onto the complainant to prove non-adherence to these standards.
It is a well established principle in law, which has been laid down in several judgments by courts all over the world, that if two equally influential schools of thought define treatment of the same patient in different ways, the doctor cannot be held liable for following the diktats of any one of them.
The proof of establishing the existence of such a school of thought, obviously lies on the doctor. Non-peer reviewed treatment is not accepted as ‘standard treatment’ to any part of society and is classified ‘negligence’ unless the treatment is part of a clinical trial and the patient has full information of its pros and cons.
The medical profession also worries about who sets up the “standards of legitimate, accepted medical practice” when courts sit in judgment on their actions. The Supreme Court of India has understood this dilemma clearly and hence made the categorical statement in IMA vs. V P Shantha that the “standard of care in medical negligence cases is still effectively defined by the medical profession itself.” In a nutshell, the profession lays down the standards and the prudent medical profession adheres to them.
All doctors are expected to give `Care' and not `Cure' to their patients. Failure of
treatment is NOT Medical Negligence.

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