Practicing medicine has become very challenging today; more so because the doctor is now required to be equally well-versed in legal aspects as much as he is expected to be proficient in his clinical knowledge.

The concept of informed consent has undergone a radical change over the years. Informed consent has now become an absolute legal necessity and it is the only safeguard available to the doctor as protection from malpractice claims. Unprecedented compensations amounting to more than one crore have been awarded.

In its judgment in “Dr. Balram Prasad versus Dr. Kunal Saha & Others”, the Hon’ble Supreme Court of India awarded a compensation of Rs. 6.08 crores to Dr Kunal Saha. After addition of interest, this figure increased to Rs. 11 crores. Rs one crore each was also awarded as compensation in the judgements in Nizam Institute of Medical Sciences vs Prasanth S Dhananka and Ors and Dr. (Mrs.) Indu Sharma vs Indraprastha Apollo Hospital, April 2015. The result is a huge increase in the number of cases filed against doctors; unfortunately, many of these are on frivolous grounds.

Then there have been four landmark judgements on informed consent, delivered not only by the highest court of India but also the highest foreign courts. 

All these judgments should be read by all doctors.

A doctor cannot delegate the duty of taking informed consent to his junior staff. Last year, the Supreme Court of Pennsylvania in Shinal vs Toms, 162 A.3d 429 (Pa. 2017) has held that “the duty to obtain informed consent belongs solely to the physician and that it is non-delegable… a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patients informed consent. Informed consent requires direct communication between physician and patient, and contemplates a back -and -forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent. The duty to obtain the patients informed consent belongs solely to the physician.”

The landmark judgement of Supreme Court of India in the case of Samira Kohli vs Dr. Prabha Manchanda & Anron 16 January, 2008 has summarized principles relating to consent as follows in section 32.

1. “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 is consenting to.
2. The adequate information to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.

   iii.        Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.

1. There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.
2. 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 treatment, and the risk and consequences attached to the treatment.”

The UK Supreme Court took quite the opposite stance to Samira Kohli vs Dr Prabha Manchanda on informed consent in the matter of Montgomery v Lanarkshire Health Board in 2015. Subsequent to this judgement, Bolam test has legally become an ineffective tool to establish standard of care in cases of alleged medical negligence. It allowed the doctor the right to withhold information about risks associated with the proposed treatment, if he believes that the particular treatment is the only hope for a cure for the patient. Post-Montgomery judgement, doctors in the UK have now to take care now 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 would be whether “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." “The “therapeutic exception” is not intended to enable doctors to prevent their patients from taking an informed decision. Rather, it is the doctor’s responsibility to explain to her patient why she considers that one of the available treatment options is medically preferable to the others, having taken care to ensure that her patient is aware of the considerations for and against each of them.” This ruling has also taken away the therapeutic privilege of the doctor.

In the case of Dr Hadiza Bawa-Garba vs GMC, the UK Supreme Court charged Dr Hadiza Bawa-Garba and two nurses with manslaughter by gross negligence for the preventable death from sepsis of a 6-year-old boy with Down syndrome in 2011. Her name was erased from the medical register following an appeal by the GMC. She was held responsible for a sequence of failings.

1. “She did not recognize the early features of sepsis in the child and as such appropriate antibiotic treatment was delayed.
2. She appeared not to recognize the implications of seriously deranged blood gas results and failed to fully communicate the implications to her consultant.
3. When the child suffered a cardiac arrest there was a further problem as the patient was wrongly identified as another child for whom a DNACPR order applied.

Inquiry revealed that multiple errors and failings contributed to the mishap. No one cause could be found that led to the death of the patient.

1. Dr Bawa-Garba had only recently returned to work following maternity leave
2. She was covering the work of another registrar, with her supervising consultant teaching on a different site, and the two junior colleagues, for whom she had supervisory responsibility, had no pediatric experience.
3. She was expected to review unwell patients and perform procedures on six wards over four floors, field the GP calls and struggle without a functioning IT system.
4. The patient was shifted to a bed previously occupied by a patient with a DNR order; that change had been made without her knowledge. She was blamed for failing to recognize this.”

This judgement discounted system errors that may have contributed to the death of the patient. It also shows that “to err is human” can no longer be a defence, at least in the UK for the time being. But this is a case that is waiting to happen in India.

Dr KK Aggarwal

Padma Shri Awardee

Vice President CMAAO

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA