JUSTICE V.K. JAIN, PRESIDING MEMBER

          Late Dr. S.J.S. Paul, husband of the complainant No.2 and father of complainant No. 3 and 5  and aged about 60 years at the relevant time was diagnosed with High Stenosis.  Based upon the angiography report revealing the aforesaid ailment, he consulted opposite party No.2 Dr. Mullasari Ajith, who advised him to undergo CABG surgery.  He allegedly told the patient that the aforesaid surgery was a safe procedure with complication rate of less than one percent.  Opposite party No.3 Dr. Rajan told him that the aforesaid was a simple procedure and he could resume normal work after two weeks.  On 09.7.2007, late Dr. Paul was admitted in Madras Medical Mission Hospital and the prescribed surgery was performed on 11.7.2007.  After the surgery, he was shifted to ICU.  It is alleged that late Dr. Paul was not connected to Pulse oximeter, which was necessary to monitor the saturation level and the relatives were not allowed to stay with the patient.  In the morning of 13.7.2007, complainant No.3, who had been waiting outside the ICU to meet her father, was informed by the Medical Superintendent of the Hospital that her father had respiratory arrest the previous night.  On enquiry, the complainants were informed that since Dr. Paul had developed respiratory problem in the ICU, his chest had to be reopened and the same had then been left open when hemodynamic parameters fell down during attempt to close the chest.  The case of the complainants is that late Dr. Paul developed respiratory problem on account of negligence during the post-operative stage.  In this regard it is also alleged that on several occasions, the complainant found the ICU to be without doctors and even the nursing staff was inadequate.  This is also the case of the complainant that leaving the operated part of the chest open further exposed Dr. Paul to severe problems, infection, bleeding, septicemia etc. This is also their case that no consent from them was taken either for opening the chest or for later closing the same.  Yet another allegation of the complainants is that the opposite parties delayed consultation with a Neurologist, who came to be consulted after 8.00 p.m. on 13.7.2007.  On 15.7.2007, Dr. Paul was allegedly subjected to Apnoea test which is done to ascertain whether a person is brain dead or not. But no prior consent was taken from them to conduct the said test.  Dr. Paul remained in comatose state and on life support system with irreversible brain damage from 15.7.2007 onwards. Eventually he was declared dead on 28.7.2007.  The delay in resuscitation, according to the complainants, has been suggested as the most probable cause of severe brain damage.  This is also the allegation of the complainants that opposite party altered the preliminary history of Dr. Paul in the death summary in order to show family history of heart disease, whereas in fact he had no such family history.  It is further alleged that though in the discharge summary, there was no reference to Dr. Paul having Dyspnoea, the words DOE which are the abbreviation for Dyspnoea, were used in the death summary.  It is also alleged that on several occasions, Dr. Paul was not connected to Pulse Oximeter nor competent staff remained present regularly in the ICU.  Alleging negligence in the treatment of late Dr. Paul, the complainants are before this Commission, seeking compensation as detailed herein below:

1. Rs. Fifty Lacs to the Complainants No. 2 to 6 towards compensation for loss of income;

2. Rs. Fifty One Lacs to complainants No. 2 to 6 as compensation for loss of companionship, mental trauma and harassment;

3. Rs. Sixty Lacs & Seventy Thousand towards expenses incurred in the hospital;

4. A sum of about Rs.4.5 lacs incurred by the complainants in bringing doctor from abroad to India;

5. Rs. Twenty Lacs to the Complainants No. 2 to 6 as punitive damages.

2.      The complaint has been opposed by the opposite party No.1 Madras Medical Mission, which has also filed the affidavit of its Honorary Secretary Dr. K. Jacob by way of evidence.  In its reply, opposite party No.1 has admitted the surgery performed on late Dr. S.J.S. Paul on 11.7.2007, shifting him to the ICU of the Hospital on that date, as well as his de-intubation.  It is alleged that at about 4.20 a.m. on 13.7.2007, Dr. S.J.S. Paul developed de-saturation and therefore was immediately re-intubated following hyperventilation.  He had sinus bradycardia and hypotension.  He was immediately attended by cardiac surgeon Dr. Rajesh and anesthetist Dr. Ravi (opposite party no. 5 and 6 respectively).  A cardiac massage was immediately initiated, but, since the blood pressure did not improve despite external massage, his chest was reopened and internal cardiac massage was given.  The Operating Cardiac surgeon Dr. S. Rajan was informed and he arrived within few minutes.  The patient was shifted to the Operation Theatre to check the grafts and for the closure of the chest.  The grafts were found to be functioning normally, but the attempt to close the chest did not succeed as the blood pressure dropped after sternal approximation. He was further shifted out of the operation theatre with chest open with skin closure.  It is also stated in the written version filed by the opposite party No.1 that   in opening the chest in the ICU, they were dealing with a case of medical emergency and such emergency situation are only an extension of the original surgical procedure, for which no consent is required.  It is also claimed that there was no delay in resuscitation of Dr. Paul.  It is further stated that after resuscitation and shifting to ICU on 13.7.2007, Dr. Paul had some involuntary jerky movements which were initially attributed to the recovery of muscle relaxants after anesthesia but since the said jerks continued, a Neurologist Dr. V. Shankar was consulted who opined that it was Myoclonic jerks.  An EEG was performed which did not reveal any discernible cerebral activity.  A repeat EEG was also done by the Neurologist Dr. M.R. Sivakumar, who reported features consistent with brain death.  The Apnoea test was done with informed consent but the results of the test were indeterminate.  It is further stated that chest closure was performed on 14.7.2007 in the cardiac theatre, for which no separate consent was required.  It is also claimed that Madras Medical Mission is one of the most well equipped and well manned ICU in the country and there is bedside monitoring by the nurses whereas physicians are available round the clock to monitor the patients.  It is also alleged that pulse oximeter saturations, arterial blood gases and other hemodynamic parameters are continuously monitored in the ICU and documented on the ICU charts.  

3.      The first question which arises for consideration is as to whether any consent from the patient or his family members was required either before opening his chest for the purpose of giving internal massage on 13.7.2007 or for closing the chest on 14.7.2007.  The consent taken on 10.7.2007 before performing the surgery to the extent it is relevant reads as under:

          “I request Dr. Rajan and associate of his / her choice to perform the following procedure (s) Coronary artery bypass grafting upon me…”

          I recognize that during or consequent to the procedure (s), unforeseen conditions may require additional or different procedures than those explained.  I request that my physician(s) and associates perform those procedures as, in their professional judgement, are desirable”.

In view of the aforesaid advance consent, no separate consent for opening the chest of the deceased, for the purpose of giving internal massage to him was required since the saturation level of the patient dropped during the postoperative stay in the ICU of the hospital. Moreover, since the saturation level of the patient dropped to 78%, an emergency situation happened in the ICU requiring immediate intervention.  Since external massage did not improve the blood pressure of the patient, it became necessary to give internal cardiac massage to him.  That obviously, could not have been done without opening his chest.  Considering the critical condition of the patient at that time, it was not possible to obtain the advance consent of the family members of the patient.  As far as the patient himself is concerned, he certainly could not have been in a position to give such a consent, his saturation having dropped to a dangerous level.  Had the doctor first contacted the family members of the patient and taken their informed consent before opening the chest in order to give internal cardiac massage, the life of the patient would have been in a grave risk and the doctors attending to the patient would have guilty of negligence in his treatment by not giving immediate internal cardiac massage to him.  As far as closure of the chest is concerned since it was only a completion of the procedure which started in the morning of 13.7.2007 by opening the chest of the patient, no consent for such a closure was required.  It cannot even be suggested that the chest which had been opened on 13.7.2007, could have been indefinitely kept open. The chest came to be closed as soon as the physical condition of the patient permitted the said closure.  Therefore, it cannot be said that there was deficiency on the part of the opposite parties in rendering services to the patient by not obtaining consent either for opening his chest on 13.7.2007 or for closing the chest on 14.7.2007.

4.      The complainants have not alleged any negligence in the pre-surgical procedure or in the surgery of the deceased, their case being that the opposite parties were negligent in the post-operative treatment and management of the patient. 

5.      It has been specifically alleged in para 11 of the complaint that the hospital had not connected a pulse oximeter to Dr. Paul, which was necessary for knowing the oxygen saturation level of the patient.  The aforesaid allegation has not been expressly denied by the opposite party, while responding to para 11 of the complaint, though it has been generally stated in para 22 of the written version that pulse oximeter saturation arterial blood gases and other hemodynamic parameters are continuously monitored in the ICU and documented on the ICU charts. In my view, had pulse oximeter been continuously connected to the patient, the opposite party would have expressly stated so particularly while responding to para 11 of the complaint.  More importantly, there is no evidence of a pulse oximeter having actually been connected to late Dr. Paul during his stay in the ICU of the hospital.  No such endorsement is found on the medical record, relating to his treatment in the ICU.  The opposite party has not filed affidavit either of any doctor or of any nurse posted in the ICU of the hospital at the relevant time to say on oath that a pulse oximeter had continuously and uninterruptedly been connected to Dr. Paul, leading to continuous monitoring of his oxygen saturation. On the other hand, complainant No. 3 Dr. Miss Christina Priya Mary P. Paul has expressly stated in her affidavit by way of evidence that Dr. Paul while admitted in the hospital on several occasions was not connected to pulse oximeter.  She was more specific in para 9 of her affidavit by way of evidence and stated that the hospital had not connected a pulse oximeter to Dr. Paul which was necessary to know the oxygen saturation of the patient.  Thus, the deposition of Dr. Miss Christina Priya Mary P. Paul as regards pulse oximeter having not always been connected to Dr. Paul remains virtually unrebutted. 

6.      The learned counsel for the opposite parties drew my attention to the charts maintained in the ICU where saturation levels of late Dr. Paul were regularly recorded, and contended that without connecting the patient to a pulse oximeter, it would not have been possible to note down and record the oxygen saturation level of the patient.  The aforesaid charts show that the vital parameters of the patient were checked and record on hourly basis.  One possibility is that a pulse oximeter was continuously connected to the patient and the SaO₂ level were recorded from the monitor or otherwise on hourly basis.  The other possibility is that though the patient was not continuously connected to pulse oximeter, his vital parameters, including SaO₂ level were checked every hour and noted in the ICU charges.  Since there is no evidence of a pulse oximeter having continuously and uninterruptedly been connected to Dr. Paul, the inference would be that the paramedical staff was checking and recording the vital parameters including SaO₂ level on an hourly basis. The pulse oximeter in an ICU is connected to a cardiac monitor placed at the bedside of the patient and alarm in the monitor is set at the desired level.  If the saturation level falls below the preset level, the alarm / buzzer in the cardiac monitor is activated.  Therefore, 24 hours monitoring of the saturation is possible only if the pulse oximeter is uninterruptedly connected to the bedside cardiac monitor.  Had late Dr. Paul been continuously connected to a pulse oximeter, an alarm would have been sounded when the saturation level dropped to 78%.  However, there is no evidence of any such alarm having actually sounded.  No doctor or para-medico posted in the ICU at the relevant time been examined by the opposite parties to prove any such sounding of alarm nor any affidavit of such an doctor or para-medico been filed.  In fact, there is overwriting even on the time of 4.20 a.m. recorded in the ICU chart and it appears that initially 4.30 a.m. was written which was later changed to 4.20 a.m.  Even if the said overwriting is ignored, the fact remains that there is no evidence either of a pulse oximeter having been connected to the patient on a continuous basis nor of any alarm having sounded when the saturation dropped to 78% at about 4.20 a.m. on 13.7.2007.  The best evidence in this regard being in possession of the opposite parties and the said evidence having not been produced an adverse inference needs to be drawn against them for not producing the said evidence.  Since whether the patient was continuously connected to a pulse oximeter or not is a question of fact, to be answered on the basis of the evidence produced before the Commission.  The opinion of the Medical Board of AIIMS would not be relevant on this issue.  In these circumstances, I have no hesitation in holding that late Dr. Paul was not continuously connected to a pulse oximeter though his saturation levels were being monitored and recorded on hourly basis.  To this extent, the opposite party No. 1 was negligent in rendering services to the patient, during his stay in the ICU of the hospital. 

7.      The complainants have filed the opinion from one Dr. K.M. Shyamaprasad, who is a cardiothoracic surgeon in support of their case.  In his affidavit by way of evidence Dr. K.M. Shyamaprasad has inter-alia stated that there was a lack of alertness on the part of the ICU staff to detect early signs of something going wrong.  It appears to Dr. Shyamaprasad that brain damage had occurred because of delayed resuscitation, which is a clear cause of negligence.  Thus, the only negligence alleged in the treatment of late Dr. Paul in the ICU of the hospital is the alleged delayed resuscitation.  The progress report of the patient recorded in the ICU shows that at 4.20 a.m. he had got desaturated his saturation being 78%.  He was hyperventilated and then re-intubated.  The progress report further shows that he had an episode of sinus, bradycardia and hypotension, his heart rate at that time had fallen to 36 bpm.  He was connected to pace maker though the pacing was not captured the pacer then had a sudden arrest and therefore, cardiac massage was initiated.  Injection, dopamine, adrenaline, atropine were given to him and his chest was then reopened in the ICU.  After opening the chest, internal cardiac massage was given to him, as a result of which the heart rate picked up.  The aforesaid report does not indicate any delay on the part of the doctor or the para medical staff in the treatment of the patient, once it was found that his saturation had dropped to 78%.  There is no evidence of the firefighting treatment on the patient having not been initiated immediately after the drop in the saturation level was noted at 4.20 a.m.  There is no evidence of the drop in the saturation level having been noticed at any time prior to 4.20 a.m.  It would be pertinent to note here that the saturation level at 3.30 a.m. about 50 minutes before the drop in the saturation level came to be recorded was 94% which was within the safe limits, the safe level being 90%.  Therefore, I hold that once the drop in the saturation level was noticed, there was no delay in undertaking the resuscitation.

8.      It was contended by the learned counsel for the complainants that there was delay in consulting the Neurologist as well as in conducting the EEG test.  He also contended that despite advice of Neurologist, CT scan was not performed.  The said contention however, was repelled by the learned counsel for the opposite party, who submitted that there was no delay either in consulting the Neurologist as soon as the need for Neurologist evaluation was felt or in conducting the EEG test.  As regards the CT scan, the learned counsel or the opposite party contended that in view of the report of the EEG test, the said scan was not found necessary.  In this regard, he pointed out that EEG report was seen by the Neurologist, who   thereafter did not reiterate his earlier instruction for a CT scan.  In my view, since in the opinion of Dr. K.M. Shyamaprasad, who is the only expert produced by the complainants, the negligence in the treatment happened because of the delayed resuscitation and it was the delayed resuscitation which damaged the brain, I need no go into the question as to whether the CT scan was necessary or not.  Though, one of the complainants herself is a qualified doctor, her testimony has to be considered and evaluated with caution, she being an interested witness.  This is more so, when no negligence in the treatment of the patient was found by the Medical Board of AIIMS.

9.      Vide order dated 08.10.2009, this Commission requested the Director of the All India Institute of Medical Sciences to constitute a panel having expertise in the disciplines of Cardiologists and Neurologists for a prima-facie opinion as to whether there was any negligence on the part of all or any of the treating doctors in the treatment of Dr. Paul.  Pursuant to the aforesaid directions of this Commission a Board consisting of Dr. S.K. Choudhary, Addl. Professor, Department of CTVS as Chairman, Dr. Achal Srivastava, Associate Professor, Deptt. Of Neurology as Member, Dr. Ambuj Roy, Asstt. Professor, Department of Cardiology as Member, Dr. Parag Gharde, Asstt. Professor, Department of Cardiac Anesthesia as Member, and Dr. Mahesh R., Department of Hospital Administration as Member Secretary was constituted by the AIIMS.  The Medical Board met on 16.3.2010 and thereafter, had detailed examination of the documents and discussions on 17, 18, 19 and 20 March, 2010.  The Medical Board was of the opinion that a reasonable care and expertise was exercised in the management of the patient.  The Board did not find any element of negligence, incompetence or deficiency in patient selection, pre-operative evaluation, operation and post-operative management.  No request was made by the complainants either to cross-examine the expert doctors nor did they seek to serve any interrogatories to be answered by them.

          In his opinion Dr. M.R. Girinath, Chief Cardiovascular Surgeon at Apollo Hospitals, Chennai, has inter-alia stated that if cardiac arrest does occur, resuscitation has to be carried with immediate effect and no time should be wasted for discussing with relatives even if they happen to be present in the ICU.  He further stated that nowhere in the world a doctor is expected to take the consent of the relatives before commencing resuscitation procedure since a delay of even two or three minutes in starting the resuscitation measures, could have fatal consequences.  According to him, in obese patients, it is difficult to resuscitate with external cardiac massage and that is why, the attending doctor had to resort to open cardiac massage by opening the chest in ICU itself for internal cardiac massage.  According to him, the attending doctors have used the standard protocol for this particular case.  He further stated that it is also a standard practice to defer sternal closure until the patient stabilizes.  According to him, informed consent need not be taken again since this a continuation of the initial cardiac surgery.  In his opinion, insertion of chest tubes, re-intubation and ventilation, re-sternotomy, internal cardiac massage, chest closure are considered as part of the extended operation procedure itself, for which no separate consent is required.

10.     The learned counsel for the complainants has drawn my attention to certain discrepancies between the handwritten death summary and the typed version of the said summary.  It is pointed out that in the hand written death summary it was recorded that there was no history of chest pain / breathlessness / palpitation whereas in it typed version, it is recorded that there was a family history of heart disease and class II-II DOE on exertion.  It is also pointed out that in the hand written death summary, it is recorded that at 10.30 p.m., the patient insisted that the breath taking exercises, spirometry and nebulization be skipped, inspite of continued persuasion by the staff, whereas in the typed death summary it was recorded that the patient was obeying command and was given frequent chest physiotherapy, nebulization and breathing exercises.  The discrepancy with respect to DOE on exertion was sought to be explained by the hospital by way of a response sent to the complainant on 21.1.2008, relying upon the observations of Dr. Ajit recording that the patient was “asymptomatic at rest but Class II-III Dyspnoea on exertion”.  The aforesaid observation recorded by Dr. Ajit, according to the hospital, was documented in the typed death summary.  This is also the case of the hospital that since the aforesaid observation was recorded by Dr. Ajit on a carbon copy of the admission report, it did not find mention in the discharge summary which was prepared on the basis of the original admission report.  As regards the family history of the heart disease it was submitted by the learned counsel for the hospital that at the time of admission, the patient had informed that his brother had undergone heart surgery at Railway hospital, which they interpreted as Coronary Artery Bypass surgery, but when the death summary was issued, complainant No.3 clarified that the brother of the deceased had Aortic Valve replacement and therefore, in the death summary, it was change to family history of heart disease.  The learned counsel for the complainants however, submitted that the aforesaid recording was an act of afterthought in order to justify the insertion made in the typed death summary.  He further submitted that had the aforesaid symptoms been recorded by Dr. Ajit on physical examination of the patient, the said observation would have found mention in the hand written death summary.  He also pointed out in this regard that no affidavit of Dr. Ajit has been filed in order to prove that on physical examination of the patient, he had noticed Class II-II Dyspnea on exertion.  Some other discrepancies in the medical record have also been alleged in the written submissions filed by the complainants on 19.9.2016.  However, I need not go into the alleged interpolation / tampering in the record of the hospital since even if the allegations of interpolation are true, that by itself, does not prove the negligence on the part of the opposite parties in the treatment of the patient at the hospital.  At the same time, a hospital is expected to maintain a true, honest and correct record of the treatment of the patient in the hospital and any tempering or falsification of the said record would be highly deplorable and need appropriate action on the part of the concerned State Government by which the hospital has been licensed.  Any interpolation of the medical record of the patient would also be an act unbecoming of the conduct of a doctor, besides being unethical and therefore, if such an act is proved, the concerned Medical Council would be expected to take appropriate disciplinary action against the doctors, if any, involved in the said interpolation / tampering.    The complainants therefore, are granted liberty to approach the concerned State Government as well as the Medical Council, with complaint of the alleged interpolation / tampering of the record.  If such a complaint is made, the concerned State Government and / or the Medical Council will investigate the matter and will take appropriate action, if on investigations, the allegations are found to be correct.  

11.    The next question which arises for consideration is as to what amount the complainants are entitled as compensation on account of negligence of the hospital (opposite party No.1), in  not keeping the patient continuously connected to pulse oximeter.  As noted earlier, an ICU, the pulse oximeter is connected to a cardiac monitor which constantly displays the vital parameters such as BP, heart rate and arterial blood oxygen saturation.  If a pulse oximeter is connected to the patient, his saturation levels are always on display on the bed side cardiac monitor.  An alarm in the cardiac monitor can be set as the desired level so as to alert the doctor and the paramedical staff of any material deviation from the desired levels of BP, heart rate of arterial blood oxygen saturation.  If the saturation level falls below the level at which the alarm is set, an alarm is sounded and the doctor or the paramedical staff, on hearing the alarm immediately rushes to the bed of the patient and starts requisite treatment so as to restore the saturation level of a safe level.  Even if a nurse is always on duty on the bed side of the patient, the alarm sounded by the cardiac monitor would draw her attention to the saturation level of the patient and she would be able to inform the doctors on duty who can then rush to the patient and start the desired treatment.  If the patient is not continuously connected to a pulse oximeter linked to the cardiac monitor, and his saturation level is checked on an hourly basis, as seems to have been done in this case, it is quite possible that the drop in the saturation level of the patient is not noticed immediately and by the time it is noticed during the periodic checking and monitoring, the patient has suffered an irreversible damage.

12.    However, since it is not known at what time the saturation level fell below the critical level of 90%, it cannot be known whether the failure of the hospital to continuously connect the patient to the pulse oximeter had delayed the initiation of his resuscitation in the ICU or not.  One possibility is that the saturation level fell below the 90% earlier than it was noticed at 4.20 a.m. and therefore, had the patient been continuously connected to a pulse oximeter, the alarm in the bedside cardiac monitor would have got activated, the resuscitation would have started immediately thereafter and possibly the patient would not have suffered irreversible damage to his brain.  The other possibility is that the saturation level had fallen below 90% at or around 4.20 a.m. when it was noticed and therefore, even if the patient was connected to a pulse oximeter on a continuous basis, that would not have impacted the result of the resuscitation efforts.  In that case, even in the event of the patient having been continuously connected to a pulse oximeter, the extent of damage suffered by his brain would have been the same.  Considering all these facts and circumstances, I am of the considered view that though some compensation must necessarily be paid by the hospital to the complainants, the extent of compensation should not be the same as in a case of death resulting from the negligence in the treatment of a patient.  In the facts and circumstances of the case, an all-inclusive compensation of Rs.10,00,000/-, in my view, would meet the ends of justice in this case.

13.    For the reasons stated hereinabove, opposite party No.1 The Madras Medical Mission is directed to pay compensation quantified at Rs.10,00,000/- to complainants No. 2 to 6, along with the cost of litigation quantified at Rs.25,000/-.  The amount of compensation shall also carry interest @ 9% per annum from the date of filing the complaint, till the date of payment.  The payment, in terms of this order, shall be made within six weeks from today.   As regards the alleged tampering / interpolation in the record, the complainants are granted liberty to approach the concerned State Government as well as the Medical Council with complaint of the alleged interpolation / tampering of record.  If such a complaint is made, the concerned State government and / or Medical Council will investigate the matter and will take appropriate action, if on investigations, the allegations are found to be correct.