Not doing preoperative ECG in 25-year-old female: is it negligence?

Analysis of the 2.7 lakh compensation awarded by the apex consumer forum

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New Delhi, Februray 24, 2019 :

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 womans cardiac condition before the operation. According to the complaint, Salar was admitted to Ahmedabads 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

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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

Limongi JA, et al. Cardiopulmonary arrest in spinal anesthesia. Rev Bras Anestesiol. 2011;61:110-20.
Pollard JB. Common mechanisms and strategies for prevention and treatment of cardiac arrest during epidural anesthesia. J Clin Anesth. 2002;14:52-6.
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.
Auroy Y, et al. Serious complications related to regional anesthesia: Results of a prospective survey in France. Anesthesiology. 1997;87:479-86.

The author of this artlce is Dr KK Aggarwal , Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)

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