July 09, 2018
Case name: Manmohan Kaur v. M/s Fortis Hospital & Ors.
In this recent case, the National Consumer Dispute Resolution Commission (NCDRC/ National Commission) was confronted with an intriguing concern pertaining to law of medical negligence. Firstly, whether patient’s “consent” is a mandatory requirement before performance of an invasive procedure? Secondly, whether non-explaining of risk involved in medical procedure by a Doctor amounts to medical negligence?
The National Commission in the case ruled in favour of the Complainant and also slapped a fine on the Hospital and Treating Doctor of Rs. 10 lakhs.
Also read Law on Medical Negligence in India
In the case, the Complainant alleged that no consent was taken from her by the Treating doctor before subjecting her to colonoscopy. Whereas, the Respondents claimed that it was taken but they were unable to produce the same because the form had been destroyed due to water seepage in the room where it was kept along with other records.
The National Commission in view of the facts and circumstances and prevailing judgments governing medical negligence law held that the complainant’s consent for performance of colonoscopy was not taken and hence, the Hospital and treating Doctor were held liable for medical negligence.
Whether or not ‘informed consent’ as understood in the legal and medical parlance, was obtained from the Complainant before subjecting her to colonoscopy procedure?
For deciding the aforesaid issue, the National Commission noted that the question pertaining to ‘consent’ has two limbs :- (i) whether consent of the patient before performing the colonoscopy procedure, is at all necessary and (ii) if so, whether in the present case, a valid consent was taken.?
The National Commission observed that the doctrine of Consent, stems from the notion that every adult human body, with a sound mind, has a right of self-determination and personal autonomy to decide what shall be done with his own body, a fundamental aspect of the right to health – the basic principle, which permeates through all cases.
Thus, the National Commission held that colonoscopy being a medical invasive procedure, performed on a live body, a valid/informed consent was required to be obtained from the Complainant before subjecting her to colonoscopy procedure.
To arrive at its decision the National Commission heavily relied on Supreme Court’s judgment in the case of Samira Kohli Vs. Dr. Prabha Manchanda. In this case, the Supreme Court made the following observations with respect to securing consent of patient before commencing a treatment:
- The doctor has to seek and secure the consent of the patient before commencing a “treatment”
- 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;
- That patient’s 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.
- What is adequate information? The “adequate information” to be furnished by the doctor who treats the patient, should enable the patient to make a balanced judgment 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.
- The National Commission held that 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.
- That the nature and extent of information to be furnished by doctor to the patient to secure the consent need not be of 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.
In view of the aforesaid, the National Commission in this case held that fundamentally, the law requires the disclosure to the patient of information relating to the diagnosis of disease: nature of the proposed treatment: potential risks of the proposed treatment and the consequences of the patient refusing the suggested line of treatment.
That the explanation of such information to the patient by the Treating doctor and the patient’s conscious decision, in this behalf, before venturing into the suggested procedure/treatment, is the basic attribute of an informed consent, which is considered mandatory in every field of surgical procedure/intervention. The only exception to this general rule is the emergency medical circumstances, where either the patient is not in a medical condition or mental state to take a conscious decision in this regard.
That the basic principle of “Consent” demands that before opting for Colonoscopic procedure, the patients must be clearly apprised of the balance of risks and benefits that apply in their own particular situations and participate in the decision making process that flows from this balance.
With reference to the facts of the present case, the National Commission noted that there was not even a whisper that the Treating doctor had explained to the Complainant the pros and cons: the material risks involved and the benefits of the procedure, particularly keeping in view her age and health condition, now being highlighted. Thus, the National Commission held that the facts and evidence did not establish that ‘informed consent’ as understood in legal parlance, was obtained from the Complainant before subjecting her to the said procedure.
Thus, the National Commission held that the Treating doctor as well as the Hospital had failed to obtain a valid consent from the Complainant and the colonoscopy procedure conducted on her was unauthorized, amounting to deficiency in service on their part.
The entire case can be accessed here.
 (2008) 2 SCC 1