G. Rajendra vs City Hospital

COMPLAINAN T G. Rajendran, together with his three minor children, filed Consumer Complaint No. 123/2001 against City Hospital, Shimoga with three of its doctors (OPs 1 to 4), Kasturba Hospital, Manipal (OP -5) and New India Assurance Co. (OP -6). The matter arose out of hospitalisation of his wife at OP -1 on 2.7.2000, where she delivered her third child, a normal healthy baby. She underwent Tubectomy operation in the same hospital on 4.7.2000, after which she allegedly lost her consciousness. She was shifted to OP -5 hospital on 5.7.2000 in a vegetative state and was discharged on 2.2.2001, in a ''hopeless state''. Later she died at home on 8.6.2002. The complaint petition, filed prior to her death, before the Karnataka State Consumer Disputes Redressal Commission states that - - "It was all because of the negligence of the opposite party Nos. 1 to 4 that Smt. Manjula was accursed with this inexplicable sorriest suffering. The over -administration of the anaesthetic drug resulted in the cardiac arrest of the patient. The opposite party No. 2 claims to have done first aid and resuscitation of Smt. Manjula within 3 or 4 minutes. He was successful in resuscitating her heart. But unfortunately it had already resulted in the cerebral death of a young charming lady. She is in a vegetative state. She is a living dead body in a word. Doctors say that death is inevitable in her case, but waiting for her death is the worst painful experience."

Therefore, the complainants sought total relief of Rs. 3,85,672 towards all expenses, till the date of the complaint.

THE State Commission, in its order made subsequent to death of Mrs. Manjula, allowed the complaint and directed the OPs (excluding OP -5) to pay compensation of Rs. 2 lakh with 6% interest from the date of the complaint. Both sides have challenged this verdict. In FA/54/2006, the complainants have sought enhancement of the awarded amount to Rs. 18.99 lakh and interest to 12%. On the other hand, in FA/63/2003 the OPs have sought setting aside of the award made in the impugned order. Main Grounds in the Appeal of the Complainants (a) Award of a meagre amount of Rs. 2,00,000 overlooks the fact that the deceased was in the ICU of the Respondent No. 5 Hospital for more than a year and a half and hence only the medication and the hospital charges alone would amount to not less than Rs. 3,85,672.

(b) The State Commission has not taken into consideration that the deceased was an income tax assessee, with turnover of Rs. 24,00,000 in 1999 -2000. Also, that she was in her early thirties. Applying the multiplier of 15 years to her income of Rs. 1,00,000 per year, the loss of future earning ought to have been taken as Rs. 15,00,000.

MAIN Grounds in the Appeal of the opposite parties. (a) The State Commission was wrong in holding that the consent given by the brother -in -law of the deceased was no consent in law. It overlooks the fact that none else had accompanied her at the time of admission on 2.7.2000.

(b) It was also wrong in coming to the conclusion that there was no informed consent for administration of general anaesthesia to the deceased, Manjula.

(c) The State Commission has erred in coming to the conclusion that there was negligence in administering anaesthesia to the deceased and that there was excess dosage of anaesthesia administered to late Manjula.

THE two appeals have been heard at length. Mr. Rajiv Yadav, Advocate has been heard for appellants -G. Rajendra and Others. Ms. Kiran Suri, Senior Advocate assisted by Ms. Aparna Mattoo, Advocate has been heard for City Hospital and others. This Commission also took note of the fact that an application had been made before the State Commission for referring the matter to an independent body of medical experts. But, it had been disallowed by the State Commission. Therefore, this Commission made a reference to the Medical Superintendent, All India Institute of Medical Sciences, New Delhi (AIIMS), seeking appointment of a Board of Medical Experts from relevant disciplines i.e. anaesthesia, gynecology and neurology. It was asked to give opinion on the question whether the procedure followed by the OPs was in accordance with the prescribed protocol in this case. If not, what acts of omission/commission were noticed which went against the prescribed protocol. The AIIMS report of 25.1.2010 was shared with the two sides and they were permitted to file their objections, if any. Permission to cross -examine members of the Medical Board sought on behalf of City Hospital/OP -1 was declined. But, the interrogatories raised by them were sent to the AIIMS. Copies of their response of 30.11.2010 have also been shared with both sides.

COMING to the pleadings and evidence of the two sides before the State Commission, we find that in a very detailed response, OPs 1 to 4 took the stand that the decision to conduct tubectomy was taken on 3.7.2001. At 6.30 p.m. her temperature, pulse BP and general condition were all found to be normal. The patient was asked not to take any food orally after 6.00 a.m. on 4.7.2000, as she had requested for general anaesthesia. By 11.00 a.m. on 4.7.2000 intravenous administration of dextrose was started. The surgery was started by 2.00 p.m. by OPs 2 and 3. It is the case of the OPs that Smt. Manjula was heavily built (weighing 70 kgs). Therefore, OP -3 could not get the required relaxation during the surgery. For this reason OP -4 administered 70 mg of Skolineintravenously and she was kept on 100% oxygen. After full relaxation, she was intubated and anaesthesia was maintained.

THE Written Statement details further developments in following terms: "At that stage, the opposite party No. 4 noticed severe brady -cardia and cardiac asystole in Smt. Manjula. Having noticed, the brady cardia and the cardiac asystole, the opposite party No. 4 immediately administered 0.6 mg of Atropine, and advised the opposite party No. 2 to do the external cardiac massage, which the opposite party No. 2 carried out forthwith. Simultaneously, the opposite party No. 4 also manually ventilated. In about 3 minutes time, cardia of Smt. Manjula was revived. And consequently cardiac monitor showed normalcy and pulse oximeter showed 100% oxygen saturation. Smt. Manjula again recouped herself with spontaneous respiration. Pulse rate was found to be at 100 per minute, B.P. was found to be at 100 per minute, B.P. was found to be at 130/80, pupils were reactive to light. Opposite party No. 4 administered Hydocortisone -200 mg, Lasix -80 mg, Sodobicarbonate -70 ml. After the revival of the heart and the administration of these drugs the opposite party Nos. 3 and 2 completed the surgery of tubectomy and closed abdomen of Smt. Manjula."

The Written Statement further states that she did not regain consciousness and therefore was examined by Dr. Nanjappa, the Physician, at 4 p.m. But, he found her vital functions normal. At 4.30 p.m. Dr. Sunil Shetty, Neurosurgeon examined her and advised administration of I.V. mannital and several others injections with periodicity ranging from half an hour to 4 hours. At 6.30 the patient was seen by Dr. Shivramakrishnan, Neuro -physician, who modified the dosage slightly and constant monitoring of airwave maintenance, TRP and BP. Thereafter, the patient was shifted to Intensive Care Unit.

IT is significant to note that entries in the Operation Note clearly show that after the episode of brady -cardia, during the course of the surgery on 4.7.2000, the patient did not regain consciousness. Subsequent entries of 4.00 p.m., 4.30 p.m., 5.30 p.m., 7.30 p.m. and 9.00 p.m., clearly record that she had continued to remain unconscious. The same situation is recorded in the entries from 8.45 a.m. on 5.7.2000. All these entries are recorded by the anaesthetist/OP -4, Dr. Jayappa. In his affidavit of evidence, he has recorded that late Manjula had no history of asthma, chest pain, convulsion or epilepsy. Her BP was normal after delivery and there was no history of relevance to anesthesia. Thus, admittedly she was a healthy and normal young person when she agreed to undergo tubectomy. The affidavit contains a detailed narration of how during the course of the surgery he was required to administer 70 mg of Skoline to ensure full relaxation of the patient; how this was followed by bradycardia and cardiac asystoles and also how she was revived in about 3 minutes. However his affidavit also records that he advised OPs 2 and 3 to take the opinion of a Physician, a Neuro -Physician and a Neurosurgeon when the patient did not regain consciousness even after one hour. Later in the affidavit, Dr. Jayappa has also recorded that - - "And as discussed to earlier, Smt. Manjula after the administration of Anaesthetic drugs, suffered bradycardia and cardiac asystole. The sufferagemay be due to the advocation of the drugs like skoline, Halothan, or for any other unknown reason or cause. I also learn and understand that as such instances are not unknown in surgical and medical history, even in cases where such does are advocated on part with the accepted medical dosages."

THUS , the evidence of OP -4/Dr. Jayappa and the hospital record (Operation Notes) both lend support to the allegation of the complainant that his wife never regained consciousness after the surgery of 4.7.2000 and that her condition had resulted from the general anaesthesia administered to her. On the question of what could have caused the cardiac asystole in this case, Ms. Kiran Suri, Senior Advocate, arguing on behalf of the OPs, referred to the affidavit of evidence of OP -2/Dr. Mallesh Hullamani. He has relied upon subsequent CT scan and MRI at OP -5 and opined that ''these investigations indicate and establish that late Manjula had a chronic infarct in the left MCA territory prior to her tubectomy''. This could not be diagnosed clinically nor were there any indications to suspect such an anomaly in the clinical diagnosis at OP -1. This opinion of Dr. Hullamani is only a post event surmise. He does not make any specific reference to any investigation report on which it is based. Interestingly, his affidavit also, like that of OP -4, states that the bardycardia and cardiacasystole suffered by late Manjula may be due to the advocation of the drugs like Skoline, Halothane, or for any other unknown reason or cause. However, OP -2 accepts that the condition of the deceased was due to occurrence of hypoxic encephalopathy, despite revival of the heart within about 3 minutes. But, he too, like OP -4, has asserted that it was not a case of excess administration of anaesthesia. But, as per the pleadings of OPs 1 -4, ''by no standard the dosage could be categorised or classified as over dosage, having regard to the body weight of Smt. Manjula''.

AT this point it is necessary to look at the expert report. As mentioned earlier in this order, the record of this case had been referred to the AIIMS for expert opinion. The AIIMS report of 25.1.2010 says that the patient had suffered hypoxemic injury to the brain during the surgery performed on her on 4.7.2000. This injury was likely to have been caused by severe bradycardia, (decrease in heart rate) as noted in the Anaesthetist''s notes.

IN the opinion of AIIMS the only reason for hypoxia in such a scenario could be inability to oxygenate the patient due to: (a) Inability to give mask ventilation with high concentration of oxygen to the patient or difficulty therein after administering Succinylcholine.

(b) Delay in intubation of the patient and ventilation after intubation due to whatever reasons, or

(c) Misplacement of endotracheal tube in the oesophagus instead of trachea (esopheaged intubation).

(d) Inability to detect oesophageal intubation by clinical auscultation or observation of End Tidal CO2 promptly.

The Board has noted that from the perusal of the case notes it is unable to comment as to which of the above four causes actually led to hypoxia in this case. Insofar as, procedure of surgery for tubectomy is concerned, it has categorically held that the procedure followed was as per standard practice. Similar view has been taken by the Board for post event management of the patient.

The management of bradycardia by the OPs is also found to be as per the standard protocol. But, significantly, the AIIMS report says "it is difficult to imagine that merebradycardia could have caused severe hypoxic brain injury in such a case". This has an apparent reference to the note of Dr. Nanjappa in the anaesthesia note, which clearly mentions "H/O" (History of cardiac arrest during surgery, reviewed immediately). The report therefore, says that if it was a case of cardiac arrest it should have been mentioned specifically in the anesthesia and surgery note because cardiac arrest is not the same things as the bradycardia. Interestingly, in the interrogatories, addressed on behalf of the OPs to ARMS question No. 9 in itself carries an indication that it was in fact a case of cardiac arrest as indicated in the first report of the AIIMS and not a case of severe bardycardia as claimed by the OPs. The question reads: "(9) Whether the Board examined the case sheet (3) of the patient under the sub -heading "operational notes", recorded on 4.7.2000, by the operating surgeon containing that "anaesthetist asked to do cardiac massage, cardiac massage given; heart revived" indicating that the operating surgeon was conscious of cardiac arrest and taken the corrective measures immediately? In the wake of this, whether the statement that the operating surgeon did not record the cardiac arrest is ruled out or not -

THE AIIMS report was circulated to the two sides. As already noted, interrogatories raised on behalf of the OPs on the report of 25.1.2010 were addressed to the AIIMS. The response received to each interrogatory in the report of 30.11.2010 has been considered. The subsequent report has fully reiterated the findings in the first report. Replies of the AIIMS to the questions arising from subsequent MRI and CT scan of the brain at Kasturba Hospital, Manipal, shows that the suggestion of the OPs that the condition of the patient was caused by a pre -existing chronic infarct in the brain, has not been accepted by Medical Board, on the basis of the clinical records and healthy heart condition of the deceased.

ON the question whether consent of the Complainant/patient was obtained learned Counsel for the appellants/OPs accepted that no consent was taken on 4.7.2000. She however, argued that consent for tubectomy under general anaesthesia was covered under the consent obtained on 2.7.2000. We are unable to accept the logic of this argument. Admittedly, the decision to perform tubectomy under general anaesthesia was itself taken on 3.7.2000. Therefore, the question of consent for the same being taken a day earlier would not arise at all. Secondly, consent taken prior even to the decision on the choice of procedure can, by no stretch of imagination be ''informed consent''. We, therefore, find ourselves in full agreement with the view of the State Commission that consent given by Shri Jagadish a relative of the deceased, at the time of her admission to the hospital for delivery of a child on 2.7.2000, cannot be taken as consent for tubectomy operation performed on 4.7.2000. The State Commission has also observed that once the patient was taken inside the operation theatre, what happened was known to and could be disclosed only by OPs 1 to 4. Admittedly, as per the medical reports and the evidence of OPs 1 to 4 themselves, the patient was healthy and normal, just before the surgery of 4.7.2000. After the operation she never regained her consciousness. It was therefore for the OPs 1 to 4 to explain what was the reason for the condition that developed and more particularly produce evidence to show that the complications which developed were not due to their negligence. But, the contentions of the OPs are found to be in conflict with their own documents.

THE evidence on record, arguments of the two sides and opinion of medical experts would show that conduct and response of the OPs has left much to be desired. Thus, for example - - (i) There is enough evidence to show that it was a case of cardiac arrest. But, OPs 1 to 4, for some reason best known to them, chose to describe it only as bradycardia. The contention of learned Arguing Counsel for the OPs that ''severe bradycardia and arrest'' is the same as cardiac arrest, does not carry any conviction, in the light of the opinion of experts that cardiac arrest and severe bradycardia are not the same thing.

(ii) In the opinion of AIIMS, the only cause for the hypoxic injury was inability to oxygenate the patient. But, records maintained by the OPs repeatedly note 100% oxygenation of the patient. It makes the record of 100% oxygenation highly questionable.

(iii) In an attempt to explain the occurrence of hypoxia despite ''100% oxygenation'', the OPs have vaguely referred to reports of subsequent tests at OP -5/Manipal Hospital. But, they have completely failed to establish it with evidence, as a pre -existing medical condition. As pointed out by learned Counsel for the complainants, the history of the case, as recorded by OP -5, clearly relates it to the episode of cardiac arrest of 4.7.2000 and treatment with anti -epileptic drugs at OP -1. The Expert Committee of AIIMS has rejected the argument of OPs 1 to 4 as ''very unlikely'' on another ground viz. the deceased was a woman with healthy heart condition.

(iv) The OPs themselves indirectly admit that the drugs used in achieving the required relaxation may have been the cause of bradycardia. The question therefore is that, if this was a known risk of the use of these drugs, as stated in the affidavit of Dr. Jayappa, there is nothing to show how the risk was covered and managed by the OPs.

(v) On behalf of OPs 1 to 4 it was argued that just because the cerebral activity did not revive, despite revival of the heart, negligence cannot be attributed to the handling doctors. In our view, the question is not whether the heart was revived quickly or not. The question is, why did oxygenation of the patient fail? The experts have given four possible reasons for it. The OPs have given none.

In the light of the detailed consideration above, we find no merit in First Appeal No. FA/63/2006 filed by OPs 1 to 4. The same is, therefore, dismissed. First Appeal No. FA/54/2006 filed by the complainants is partially allowed. Considering that the claim in the complaint before the State Commission was based on actual expenditure till filing of the complaint, the fact that the OPs have not been able to disprove it with evidence and the fact that the suffering of the patient (and therefore of the complainants) continued till her death on 8.6.2002, the award amount is enhanced to Rs. 3,85,672, with 6% interest from the date of the complaint.