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
patient's 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 patient's 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.
i. “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.
ii. 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.
iv. 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.
v. 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.
- “She did not recognize
the early features of sepsis in the child and as such appropriate
antibiotic treatment was delayed.
- She appeared not to
recognize the implications of seriously deranged blood gas results and
failed to fully communicate the implications to her consultant.
- 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.
- Dr Bawa-Garba had
only recently returned to work following maternity leave
- 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.
- 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.
- 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 AwardeeVice
President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care
Foundation of India
Immediate Past National
President IMA
