The following appeared in "Times of India", Mumbai Edition on May 27, 2009, page no. 15.
Keep Smiling ... HemantAgarwal
Doctors must take ‘informed’ consent
Backdrop: When an invasive procedure or surgery is required, written consent is a must. How seriously
do doctors act on taking ‘informed consent’? More often than not, doctors treat consent as a mere
formality to safeguard themselves rather than for the purpose of making the patient aware of what he is
letting himself in for. Is such consent valid in the eyes of the law?
Mahesh Kumar, a young boy, was suffering from an ear infection with a foul-smelling discharge emitting
from his ears, combined with giddiness, vomiting and fever. His father took him to Orthonova Institute of
Advance Orthopaedic Surgery and Research where Dr A K Mittal, an ENT Surgeon, examined the child
and advised surgery known as Modified Radical Mastoidectomy costing Rs 26,000. Two days after
surgery, the boy was discharged. However, there was no improvement.
Nine months later,Mahesh’s father took him to AIIMS hospital where the doctors said that the child
had developed facial paralysis due to the nerve of the ear becoming dead. No further surgery was
advised as it could endanger the child’s life. Mahesh’s father, Raj Kumar, filed a complaint before the
consumer forum alleging negligence on the part of Dr Mittal as well as the hospital. The Forum observed
that ‘informed consent’ had not been taken as the consent form neither mentioned the name of the
surgery nor its effects.Since facial paralysis had occurred after the surgery, the Forum held the surgeon
guilty of negligence. It awarded Rs 1.5 lakh as damages, Rs 30,000 as compensation for the mental
agony suffered by the father and Rs 5,000 as costs.
Dr Mittal and the hospital appealed to the State Commission, which expressed serious doubts as to
whether there was medical negligence or deficiency on the part of the surgeon. However, since the
hospital and the surgeon had not taken proper consent from the father and had operated on the child
without explaining the nature of the surgery and the likely complications, it upheld the order of the forum
and even directed payment of 5% interest.
Against this order, the surgeon as well as the hospital filed Revision Petitions before the National
Commission. Their main defence was that the the complainant had not alleged that the operation had
been needlessly done; that such surgeries always involve risks and complications which can even be
possibly fatal; and the consent form listed nerve injury as one of them. They claimed that everything had
been explained, and they could not be held liable for the failure to merely repeat the explanation in the
consent form. However, they had
to concede that the name of the surgery had nowhere been mentioned while taking consent.
The National Commission observed that ‘informed consent’ means consent which is obtained after
giving all information which must be explained in comprehensible nonmedical terms,preferably in the
local language about the diagnosis;nature of treatment;risks involved; prospectus of success; prognosis
if the procedure is not performed (i.e. what can happen if the surgery is not undergone);alternative
treatment. The three ingredients of consent are information, voluntariness and capacity (i.e. the mental
capacity to understand the implications and ramifications of his or her actions).
In keeping with the observations of the Supreme Court in the case of Samira Kohli v/s Dr Prabha
Manchanda & Anr. [I 2008 CPJ 56 (SC)] the Commission clarified that all information would imply
adequate information to enable a patient to make a balanced judgement as to whether or not he should
submit himself to a particular treatment, and would not include remote or theoretical risks which may
unnecessarily frighten a patient in refusing to give consent for the necessary treatment. Also, mere
consent for a diagnostic procedure could not be treated as consent for treatment.
The Commission found that in the present case, the consent form did not indicate the name of the
surgery, the procedure and techniques to be followed, and the likelihood of facial paralysis as a
complication. So it held that informed consent had not been obtained. Accordingly,the commission held
that it was a clear-cut case of negligence. The compensation awarded was confirmed, and the petitions
were dismissed with further costs of Rs 10,000 payable by the hospital as well as the surgeon to the
complainant. Impact: Doctors may be busy. But they cannot forget that they are dealing with human
life. It would be prudent to spend some time to explain facts, rather than waste years in litigation which
only damages their reputation.