Analysis
of the 2.7 lakh compensation awarded by the apex consumer forum
Recently the apex consumer forum directed three
doctors to pay Rs 2.7 lakh for "gross-negligence" and
"mismanagement" that led to the death of a woman after she suffered a
cardiac arrest during an operation and slipped into a coma and never recovered
from it.
The National Consumer Disputes Redressal Commission
(NCDRC) said
that it was a "serious lapse" on the part of the doctors to not
assess the woman's cardiac condition before the operation. According to
the complaint, Salar was admitted to Ahmedabad's Samved hospital on October 20,
2004. She suffered a cardiac arrest during the surgery the next day. She was
shifted to another hospital where she remained in coma till her death on
November 18, 2005.
Complainant
The wife (i.e. Memunaben Salar) of the
Petitioner/Complainant was advised by Dr. Ramilaben Jain to undergo
hysterectomy at an estimated cost of Rs.10,000/-. On medical advice, the
Petitioner took his wife to Respondent No.2 who examined the Complainant’s wife
and advised her to get operated as soon as possible. The wife of the Petitioner
was admitted in Respondent No.1 hospital. Respondent No.2 informed that she
would be discharged within five days after the operation and the entire
treatment would cost around Rs.30,000/-, which included room charges, fees and
other relevant expenses. The wife of the Petitioner was admitted in the
hospital on 20.10.2004. The operation was to be conducted on 21.10.2004. The
wife of the Petitioner was aged 25 years and was a healthy person. She was
taken to the operation theatre at 9:00AM, where Respondents No.2 to 5 were
present. After a lapse of 2 hours, Respondent No.2 came out of the operation
theatre and told the Petitioner and his relatives that the health of the
patient suddenly deteriorated during the course of operation, due to which the
operation was aborted, and her life was taken out of danger by providing
Cardiac Massage. Thereafter, she went into coma and later she was taken to ICCU
for keeping her under observation.
The Petitioner alleges
that there was no oxygen cylinder in the operation theatre. The same was, therefore, brought from another ward,
which led to delay in supply of oxygen to the patient. The patient was also
given more than the required anaesthesia and the pre-operating tests were not
done properly.
Respondent No.2 and 3 assured the Petitioner that
the health of the patient would improve in a short span of time. The patient
had gone into coma due to the negligence of Respondents No.2 to 5. Respondent
No.1 discharged the patient on 10.11.2004 at 10: 30 hours and the patient were
transferred to the Civil Hospital by force accompanied by Respondent No.3 and
5. Complaint regarding the said incident was filed at the Naranpura Police
Station being no. 1068/2004 dated 10.11.2004 and a panchnama was also made. The
wife of the Petitioner remained in coma till her death in the Civil Hospital on
18.11.2005.
Hence, the Complaint was filed by the Petitioner
against the Respondents alleging deficiency in service. The Petitioner had to
pay Rs.1,50,000/- to the Civil Hospital for the treatment of his wife, Rs.80,000/-
were spent on medicines and tests at Respondent No.1 hospital and Rs.25,000/-
towards expenses of travel and lodging. The Petitioner sought Rs.2,00,000/- for
the loss of life of his wife. The Petitioner alleged that Respondents No.1
to 5 were jointly and severally liable for the negligence and sought a total
compensation of Rs.4,55,000/-.
Respondents
The Petitioner had filed a false Complaint with an
ulterior motive to make money from the Respondents. It was admitted that the
deceased was under the treatment of Dr. Ramilaben and she was advised operation
for the removal of uterus. It was further stated that Dr. Zubedaben had advised
her to undergo the operation as soon as possible and she had told that if all
went well, then the patient would be discharged from the hospital within five
days. On 20.10.2004, Memunaben (wife of the Petitioner) was admitted in
Respondent No.1 hospital for removal of uterus and the operation was fixed for
21.10.2004. There was no dispute regarding the fact that she was not given food
since night of 20.10.2004.
At the start of the
operation and on making the incision on the patient, Memunaben got Cardiac
Arrest (stoppage of the heart beat). As soon as the heart stopped, Respondent
No.3 Dr. Kashyap Shah undertook remedial measures and started the heart. Thereupon, Respondent No. 2 stopped the operation and
stitched the incision. Respondent No.3 went outside the operation theatre and
informed the relatives of the patient that the patient suffered cardiac arrest
and that she would not be taken out of the operation theatre till the situation
improves and later would be shifted to the ICCU. Meanwhile the required
medicines and treatment were administered.
It was stated by them that the Petitioner was
required to prove his case properly with the opinion of an expert. The
Complaint could not prove negligence of the Respondents and the Complaint was,
therefore, to be dismissed. The life of the patient was saved, by the Cardiac
Massage that was given by Respondent No.3 Dr. Kashyap Shah, but the patient had
gone into coma. It was denied that there was no oxygen cylinder in the
operation theatre. The second floor had central oxygen supply system. The
oxygen cylinder was called for shifting the patient to the ICCU from the
operation theatre. The patient was not kept without oxygen even for a
second. It was also denied that the health of the patient was not checked
before the operation. The relevant blood test, x-ray, chest, ECG, Sonography
etc. were verified before the operation. Dr. Kashyap Shah examined the
patient on 02.10.2004 and the required preoperative instructions were given. It
was stated by the Respondents that Samved is a Private hospital and doctors
from outside were given permission to operate in the hospital. Doctors admit
their patients and carry out the necessary treatment. The hospital simply
provided the required services. There was no other responsibility of the
hospital.
The Petitioner had not paid the ICCU charges of the
hospital till date. The hospital discharged the patient on the advice of the
doctor.
The Petitioner had not paid any charges to
Respondent No.1. The Petitioner was not pressurized by Respondent No.1 to shift
the patient. It was the Petitioner who told Respondent No.3 that he was a poor
person and would not be able to afford the hospital expenses, due to which he
requested shifting to the Civil Hospital, where free treatment could be
obtained. On the request of the Petitioner, Respondent No.3, along with
Respondent No.5 accompanied the patient to the Civil Hospital and the patient
was admitted there. The patient was examined properly. Anaesthesia was given as
per relevant protocol. There was no question of an over dose of spinal
Anaesthesia. The Cardiac Meter, Pulse Oximeter and NIBP were started before the
operation and anaesthesia was given. Thus, surgery was conducted after
taking adequate precautions.
A healthy person could get Cardiac Arrest during
the operation and Cardiac Massage was given immediately, and the heart was
revived. The Hypoxic Brain damage, however, was not due to overdose of
anaesthesia. Cardiac Arrest is a complication of Spinal Anaesthesia but not
that of the operation. Respondent No. 4 Dr. Rachna Shah was an assistant to
Respondent No.2 and she did not work independently due to which there could be
no negligence or responsibility on her part. Respondent No.5 Dr. Himanshu Mehta
took the patient to the Civil Hospital from Samved Hospital and that too at the
behest of Dr. Kashyap Shah. Thus, he did not come in direct contact with the
patient in any manner. He was not present in the operation theatre and
therefore was not responsible. In view of all the above, the Complaint filed by
the Petitioner ought to be dismissed. Respondents No.1, 4 and 5 have given the
purshis and stated that they would adopt the argument of Respondent No.2 and 3.
Analysis
|
Judgment
|
Comments
|
|
Once cardiac arrest takes place, its management
is another very important aspect in reviving the patient. Though, the
operation notes speak of cardiac massage being given, perhaps referring to
Cardio Pulmonary Resuscitation (CPR) and also 3 D.C. shocks, there is
no mention in the records as to the time taken to get the heart beat back
and it is well-known that delay in reviving the patient could lead to hypoxic
damage which has happened in this case.
The Respondent ought to have mentioned the
duration of cardiac arrest, especially when the condition could not be
revived neurologically. All this indicates that the Complainant’s wife went
into subsequent conditions because of gross-negligence and mismanagement on
the part of the Respondents.
|
Once cardiac arrest occurs, the first aid is CPR
and Defibrillation. It is a standard procedure.
Chances of recovery are 90% in first minute of
cardiac arrest and 10% in 10 minutes of cardiac arrest.
The very fact that the patient did not die of
arrest means the CPR was partially successful and was attempted as per
protocol.
Neurological damage does not mean negligence and
even cardiac arrest leading to death does not mean negligence.
|
|
The Respondents contended that cardiac arrest is
a complication of spinal anaesthesia and not a result of the operation. It is
admitted by the Respondents that cardiac arrest is a known complication of
spinal anaesthesia. In such a case, an ECG should have been taken by the
Respondent to conduct a thorough pre-operative check-up of the condition of
the patient and more so her heart.
As seen from the record, last ECG was
conducted way back on 25.05.2004.The present operation is an elective
operation and was not done on emergency basis. The Respondents had all the
time to do thorough investigations before taking the patient to the operation
theatre. They should have taken another ECG after her admission in
the hospital on 20.10.2004 and on assessing her cardiac status proceeded with
the operation.
Failure on the part of the Respondents in not
assessing the cardiac condition of the patient before the operation is
certainly a serious lapse on their part, knowing full well that cardiac
arrest is a known complication in spinal anaesthesia.
|
The patient was 25 years old, which is not a
heart attack prone age and that too a female.
Recommendations of the 2014 American College
of Cardiology/American Heart Association (ACC/AHA) and
European Society of Cardiology/European Society of
Anesthesiology (ESC/ESA) guidelines on noncardiac surgery are:
1. Do ECG in patients with known cardiovascular
disease, significant arrhythmia, or significant structural heart disease
unless the patient is undergoing low-risk surgery (surgery associated with
<1% morbidity or mortality such as ambulatory surgery)
2. A preoperative ECG if done in asymptomatic
patients without known cardiovascular disease is rarely helpful.
3. ECG abnormalities are not part of either the
revised cardiac risk index (RCRI) or the National Surgical Quality
Improvement Plan (NSQIP) because of the lack of prognostic specificity
associated with these findings.
4. In women, ECG is anyways unreliable.
5. The rationale for obtaining a preoperative ECG comes from the utility of having a
baseline ECG should a postoperative ECG be abnormal. This is only for 40+
individuals.
6. For those patients who receive a preoperative
ECG, it is done to valuated for the presence of Q waves or significant
ST-segment elevation or depression, which raises the possibility of
myocardial ischemia or infarction, left ventricular hypertrophy, QTc
prolongation, bundle-branch block, or arrhythmia [not for age 25].
|
|
In the present case, the Complainant’s wife
travelled by bus to Ahemdabad and walked into the Hospital on 20.10.2004. She
was taken to the operation theatre at 9:00AM and was administered spinal
anaesthesia. After the surgeon made first incision, the patient went into
cardiac arrest. According to the notes of the operation, she was given
cardiac massage and D.C. shocks and heart beat was restored but the patient
went into coma. She remained in coma until her death on 18.11.2005. The
Complainant alleged that oxygen was not available in the operation theatre,
overdose of anaesthesia was given and required pre-operative tests were not
done.
The Respondents contend that there is a central
oxygen supply system in the hospital and oxygen cylinders were brought to
shift the patient from the operation theatre to
ICCU. The patient was not kept without oxygen
even for a second. As regards administration of spinal anaesthesia, the
Respondent stated that anaesthesia was given by relevant system that is set
and in proper amount. There was no question of overdose of spinal
anaesthesia. The cardiac meter, pulse meter and NIBP were started before the
operation and anaesthesia was given later. All precautions were taken and
thereafter the surgery was started.
|
She was healthy and asymptomatic.
1. Why was hysterectomy planned at age 25 is not
clear.
2. Her ECG was normal in May. So there was rightly
no need for a repeat ECG.
3. Most likely she died of a primary arrhythmia
disorder, which may be unrelated to surgery.
4. History of sudden death in the family may be one
thing to ask in the family
5. The idea is to find the cause so that somebody
else in the family should not die in future.
6. Postmortem genetic testing should have been
advised.
|
|
The wife of the Complainant Memunaben Salar was
admitted in Respondent No.1 hospital on 20.10.2004 and operated on
21.10.2004. During the operation, she suffered cardiac arrest and went into
coma. She was discharged from the hospital on 10.11.2004 and shifted to the
Civil Hospital where she died on 18.11.2005.
As can be seen from the sequence of events
the period of limitation would start from the
date of her death, i.e., on 18.11.2005 and the
complaint was filed on 09.07.2007 before the
District Forum well within the period of limitation, as has been detailed in
the order of the District Forum and the State Commission.
|
|
Cardiac arrest during anesthesia and perioperative
period is a matter of grave concern for any anesthesiologist. Occasionally,
unexpected bradycardia and asystole may develop during the administration of
spinal anesthesia in apparently healthy and young patients (1). Cardiac arrests
during spinal anesthesia are described as “very rare,” “unusual,” and
“unexpected” but are actually relatively common (2,3). In the literature, the
reported incidence of cardiac arrest is 6.4 ± 1.2 in 1,00,00 patients (4).
The risk of major cardiac complications (cardiac
death, nonfatal MI, nonfatal cardiac arrest, postoperative cardiogenic
pulmonary edema, complete heart block) vary according to the number of risk
factors. The following combined rates of nonfatal MI, nonfatal cardiac arrest,
and cardiac death is seen in various studies:
·
No risk factors: 0.4%
·
One risk factor: 1%
·
Two risk factors: 2.4%
·
Three or more risk factors: 5.4%
In this case, the combined risk is 0.4% but not
zero.
In the matter of Samira Kohli vs Dr. Prabha
Manchanda & Anr. Appeal (civil) 1949 of 2004, dated 16/01/2008, the
three-judge Bench observed:
“…Lord Bridge however
made it clear that when questioned specifically by the patient about the risks
involved in a particular treatment proposed, the doctor’s duty is to answer
truthfully and as fully as the questioner requires. He further held that
remote risk of damage (referred to as risk at 1 or 2%) need not be disclosed
but if the risk of damage is substantial (referred to as 10% risk), it may have
to be disclosed… (24)”
We may note here that
courts in Canada and Australia have moved towards Canterbury standard of
disclosure and informed consent – vide Reibl v. Hughes (1980) 114 DLR (3d.)
1 decided by the Canadian Supreme Court and Rogers v. Whittaker - 1992 (109)
ALR 625 decided by the High Court of Australia. Even in England there is a
tendency to make the doctor’s duty to inform more stringent than Bolam’s test
adopted in Sidaway. Lord Scarman’s minority view in Sidaway favouring
Canterbury, in course of time, may ultimately become the law in England. A
beginning has been made in Bolitho v. City and Hackney HA - 1998 1 AC 232 and
Pearce v. United Bristol Healthcare NHS Trust 1998 (48) BMLR 118. We have
however, consciously preferred the ’real consent’ concept evolved in Bolam and
Sidaway in preference to the ’reasonably prudent patient test’ in Canterbury,
having regard to the ground realities in medical and health-care in India. But
if medical practitioners and private hospitals become more and more
commercialized, and if there is a corresponding increase in the awareness of
patient’s rights among the public, inevitably, a day may come when we may
have to move towards Canterbury. But not for the present… (33)”
Canterbury requires disclosure of all risks, even
less than 1% to the patient as part of informed consent.
Unpredicted deaths do occur during surgery, but
their incidence is less than 1%. Patients are usually not counselled about the
rare risks associated with the surgery.
In India, Bolam test is accepted and not the
Canterbury. But if such cases come up more frequently, then even rare
complications would need to be informed to the patient. This would only create
more unrest among the people.
References
1. Limongi JA, et al. Cardiopulmonary arrest in spinal
anesthesia. Rev Bras Anestesiol. 2011;61:110-20.
2. Pollard JB. Common mechanisms and strategies for
prevention and treatment of cardiac arrest during epidural anesthesia. J Clin
Anesth. 2002;14:52-6.
3. Bajwa SK, et al. Cardiac arrest in a case of undiagnosed
dilated cardiomyopathy patient presenting for emergency cesarean section.
Anesth Essays Res. 2010;4:115-8.
4. Auroy Y, et al. Serious complications related to regional
anesthesia: Results of a prospective survey in France. Anesthesiology.
1997;87:479-86.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical
Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA
No comments:
Post a Comment