KERALA STATE CONSUMER DISPUTES REDRESSAL COMMISSION SISUVIHARLANE VAZHUTHACAUD THIRUVANANTHAPURAM

APPEAL NO.204/2012

JUDGMENT DATED :30.09.2014

(Appeal filed against the order in CC.No.283/2007 on the file of CDRF, Ernakulam order dated : 30.09.2011)

PRESENT

SRI.K.CHANDRADAS NADAR            : JUDICIAL MEMBER

1. The Managing Director,

Amrita Institute of Medical Science,

And Research Centre,

Amrita Enterprises Pvt.Ltd, (AIMS),

Amrita Lane, Elamakkara.P.O

Kochi – 26

2.Dr.Meenakshidhar,                                              APPELLANTS

Amrita Institute of Medical Science,

And Research Centre,

Amrita Enterprises Pvt.Ltd, (AIMS),

Amrita Lane, Elamakkara.P.O

Kochi – 26

3. Dr.Sujithra.S

Amrita Institute of Medical Science,

And Research Centre,

Amrita Enterprises Pvt.Ltd, (AIMS),

Amrita Lane, Elamakkara.P.O

Kochi – 26

4. Dr.Nidhin,

Amrita Institute of Medical Science,

And Research Centre,

Amrita Enterprises Pvt.Ltd, (AIMS),

Amrita Lane, Elamakkara.P.O

Kochi – 26

(By Adv.Sri.Vinay Menon)

VS.

1. Unnikrishnan,

S/o.Velayudhan,

Chulliyil House,

Nenmanikkara village

And Desam,

Mukundapuram.P.O

Puthukkadu – 680301

2. Sajitha,

W/o.Unnikrishnan,

Residing at

Chulliyil House,

Nenmanikkara village

And Desam,

Mukundapuram.P.O

Puthukkadu – 680301

3. National Insurance Company,

Ernakulam Branch,

Ernakulam

(R1 & R2 by Adv.Pramod & Resmi Pramod)

(R3 by Adv.Sri.Prasanna kumar Nair)

JUDGMENT

SRI.K.CHANDRADAS NADAR            : JUDICIAL MEMBER

                Appellants were opposite parties 1 to 4 in CC.No.283/2007 in the CDRF, Ernakulam. The complainants were the father and mother of Midhila Krishnan who died at the age of nine years after an operation done at the hospital of Amritha Institute of Medical Sciences and the Research Centre, Elamakkara to correct squint in her right eye. The second opposite party assisted by opposite parties 3 to 6 who were doctors attached to the first opposite party hospital performed the operation on 04.04.2007. The complainants alleged that the death of their child was due to negligence in the administration of anaesthesia. It is further alleged that sufficient pre-operative precautionary measures had not been taken before performing the operation. Further the opposite parties failed to sufficiently explain the risk factors involved in such a surgical procedure before obtaining consent from the complainants. They also alleged that the records in the hospital relating to the surgical procedure of their child were manipulated and corrected by the opposite parties. The complainants claimed a compensation of Rs.20,00,000/- (Twenty lakhs) from the opposite parties.

            2.        Before the Consumer Forum opposite party no.4 filed separate version and opposite parties 1 to 3 and 6 filed joint version. The fourth opposite party contended that he was doing first year DNB Training in Anaesthesiology . He joined that course on 17.07.2006. The operation of the child was done on 04.04.2007. He only observed the procedure and had no power to take independent decision as regards the operation. There was no negligence for laches attributable to him. Hence the complainants were not entitled to any relief from him.

            3.        Opposite parties 1 to 3 and 6 contended that Amritha Institute of Medical Sciences and Research Centre is a prestigious institution providing specialized medical services to the public at concessional rates. They are providing medical help and treatment to the poor people free of cost as a charitable measure. The first opposite party is not a company registered under the Indian Companies Act. The affairs of the hospital are being managed by the Medical Director. These opposite parties admitted that CM Midhila Krishna daughter of the complainants came to the outpatient department of the first opposite party on 29.03.2006 with complaint of squint. After a complete and thorough evaluation the girl was found to have divergent squint with myopia and amblyopia in her right eye. As the parents wished surgical correction of squint at the earliest her operation was scheduled to 04.04.2007. The patient was taken to the theatre at 7.55 am on 04.04.2007. The surgery was not a major one. It can be done on an adult person on local anaesthesia. Since the operation was being done for a child it was done under General Anaesthesia. This was informed to the parents much earlier. The patient had undergone usual pre-operative check ups and she was found normal without any pre-existing disease. She was given anaesthesia at 8.30 am and the surgery started at 8.45 am. It is incorrect to say that the patient died during surgery. It is also incorrect to say that the child lost consciousness due to negligent application of anaesthesia. The child was put under general anaesthesia as per informed consent and plan. She had underwent standard pre-anaesthetic check up on 02.04.2007 and was found to be fit to under go squint surgery. Hence she was admitted for surgery on 03.04.2007. Risks of general anaesthesia and squint surgery were explained to the complainants and they agreed for the surgery.

            4.        The second routine review of the case was done at the operation room and was also normal. She was taken for surgery around 8 am. Induction of anaesthesia under standard monitoring condition and using standard doses of routinely used anaesthetic drugs with proper and reasonable clinical care was smooth and the patient was handed over to the surgeon at 8.45 am. The procedures adopted were as per medical practice followed during surgery. An anaesthasiologist continuously monitored all vital parameters and these were found satisfactory. The squint micro surgery was conducted as per reasonable standards. The child was stable with normal vital parameters and normal systemic arterial saturation. Towards the end of the surgery when last stitches were being taken (at 10.20 am) the patient developed sudden cardiac asystole. The surgeon was immediately asked to stop surgery and code blue was initiated. Cardio pulmonary resuscitation was initiated immediately and injection atropine and adrenaline were also given. The child was successfully resuscitated and the blood pressure improved. As the surgeon had to take a few more stitches the same were put completing the surgery. Within minutes there was another episode of cardiac arrest (at about 10.30 am) and full resuscitative measures as per protocol were initiated. Arterial lines and central venous lines were placed and blood gases were sent.  The cardiac activity returned and ionotropic support was started. Brain protective measures were also initiated. The child was placed on a ventilator and blood gases were repeated to correct abnormalities. The opposite parties had informed the first complainant about the repeated slowing down of the heart beat of the child. After the child was stabilized she was shifted over to an ICU with continuous monitoring and ventilation. Soon after the arrival in the ICU the child underwent another episode of asystole. Standard resuscitation protocols were initiated again and the patient was revived. Blood gases revealed persistent metabolic acidosis which was corrected. A paediatric cardiologist was called and an echo cardiogram was done which revealed impaired bilateral ventricular function. As the child was having intermittent episodes of bradycardia and asystole it was decided to place a trans venous placing wire. A senior cardiologist was also consulted. All the events were explained to the complainants periodically. The child was taken to catheterization laboratory around 2.40 pm and wire was placed under fluoroscopic guidance. Ultra sound B Scan of the eye showed no abnormalities by and in or behind the eye ruling out any ocular abnormality. She was shifted back to the ICU. While shifting from the cathlab the child again had asystole and was massaged. Then she was placed on ventilator though the blood pressure was around 70 mm Hg systolic. The extremities were cold and there was no urine output. The child's condition did not improve despite maximum support given to improve the circulation. Finally when her heart stopped at 6.10, the child was declared dead and the complainants were informed immediately. Every development relating to the condition of the child was informed to the parents and every possible care was given to the child. The allegations to the contrary are not correct. The first opposite party hospital does not insist for payment of the balance treatment expenses in case of death of a patient. This is because of humanitarian consideration, the first opposite party being a charitable trust. The claims of the complainants are absolutely baseless. The opposite parties had no liability to pay any compensation to the complainants. There was no deficiency in service on their part.

            5.        Before the Consumer Forum the first complainant gave evidence as PW1. The doctor who conducted postmortem examination on the body of the deceased girl was examined as PW2. Exts.A1 to A7 were marked on the side of the complainants. The sixth opposite party was examined as DW1. One expert witness was examined on the side of the opposite parties as DW2. Ext.X1 is the enquiry report submitted by the board constituted for the purpose. DW2 was the head of the department of Ophthalmology, Medical college Hospital, Thiruvananthapuram and one of the members of the Board.  No documentary evidence was adduced on the side of the opposite parties. The Consumer Forum held that for three reasons the opposite parties committed deficiency in service but exonerated opposite parties five and six from liability. Opposite parties 2, 3 & 4 were held responsible for the deficiency in service. As the employer the first opposite party was held vicariously liable for the negligence of opposite parties 2,3 & 4. The Consumer Forum, further directed the first opposite party solely to discharge the liability. Since the hospital was insured with the seventh opposite party, Insurance company it was directed to pay the compensation of Rs.6,00,000/- fixed by the Consumer Forum. Opposite parties 1 to 4 are challenging the correctness of the order of the Consumer Forum. The questions that arises for decision in this appeal are ; Firstly, whether the conclusion that there was negligence and deficiency in service on the part of the appellants can be sustained and secondly, the quantum of compensation payable in case the answer is in the affirmative.

            6.        Midhila Krishna aged 9 years who succumbed to death during operation to correct squint in her right eye was the daughter of the complainants. Admittedly, Midhila Krishna was taken to the first opposite party hospital on 29.03.2007 with complaint of squint in her right eye. After diagnosis of squint with myopia and amblyopia as the parents wanted surgical correction, the surgery was scheduled on 04.04.2010 and the girl was admitted in the hospital on the previous day. According to the appellants usual pre operative check ups revealed that she was normal without any pre existing decease, She was taken to the operation theratre at 7.55 am on 04.04.2007. After second routine pre operative check ups she was given anaesthesia at 8.30 am and the doctors started surgery fifteen minutes later. Repudiating the allegation that the child died during surgery, the appellants have contended that induction of anaesthesia was smooth and the patient was handed over to the surgeon at 8.45 am. Surgery performed under standard conditions and standard procedures proceeded smoothly. But towards the end of the surgery when the last few stitches were being taken at about 10.20 am the patient suddenly developed cardiac asystole. Cardio pulmonary resuscitation along with injection atropine and adrenaline were given and the child was successfully resuscitated. There after the surgery was completed by putting few more stitches. Then the child sustained cardiac arrest again. Full resuscitative measures yielded result and the child was stabilized and shifted to ICU. But the child suffered another episode of asystole. All the procedures available to save the child were done. Senior cardiologist was consulted but while shifting the child from cathlab she again sustained asystole. She was massaged and brought to intensive care unit. But her condition did not improve and finally succumbed to death at 6.10. pm.

7.        But the opposite parties do not have a definite reason as to the cause of death of the child. So the evidence requires to be scanned to see what was actually the cause of death as well before deciding whether there was negligence or deficiency in service on the part of the appellants. As mentioned earlier PW2  who was the professor of forensic medicine, Thrissur medical college conducted postmortem examination on the body of the deceased girl .Ext.A3  is the postmortem report. During her postmortem examination bits of brain, lungs, heart, liver, kidney, spleen and adrenal glands were preserved for histopathological examination. It is mentioned in the postmortem report itself that histopathological examination result was received on 12.04.2007 and the same is appended with Ext.A3 postmortem report. The report of histopathological examination conducted by the department of pathology Govt medical college, Thrissur signed by the professor of pathology is part of Ext.A3 produced before the Consumer Forum. Obviously, based on the postmortem findings and results of histopathological examination of the body parts the finding given by PW2 in Ext.A3 is that those were consistent with death due to hypoxia  following induction of anaesthesia. Immediately it needs be mentioned that the opposite parties do not admit this and according to them incident of asystole occurred towards the end of the surgery when last few stitches were being done. It is also pertinent to refer Ext.X1 report submitted by the team of four doctors who were constituted to enquire into the death of the girl. After perusing the case records relating to the girl and collecting evidence from all concerned including the doctors who treated the child according to whom bradycardia followed by asystole occurred towards the end of the surgery and it was reversed by injection atropine and resuscitative measures. The subsequent procedures claimed to have been done are also referred to. Then the committee considered two hypotheses as stated by the appellants. 1. Asymptomatic myocardiae disfunciton due to either cardiomyopathy or myocarditis which might have resulted  in further myocardial disfunciton secondary to effects of anaesthetic agents administered in accepted normal doses 2. Idiosyncratic severe myocardial depressant action of appropriately given anaesthetic agents leading to synus bradycardiac asystole and failure to respond to standard resuscitative measures. In order to unravel the enigma cardiac histopathology was essential.  The committee suggested that that may done with the permission of the court and the cardiac tissue if available or slides may be sent to All India Institute of Medical Sciences, New Delhi were the advance test with even electron microscopy is available. The committee also saw the video recordings of the microscopic surgery. They observed that suture material is invisible to the naked eye. Dissection of eye muscle is not done during postmortem examination. The video pictures may be scrutinized by computer experts to verify whether it is that of the child in question. As cornia is visible biometric comparison with previous photographs is possible to confirm identify. So the concluding opinions of the enquiry committee were (1) Cardiac histopathology at All India Institute of medical Sciences is to be done 2. Biometric and computer experts opinion as to identify the video recordings as to ascertain identity and chronology is to be sought. The committee further observed that till the above two highly expert opinions are obtained they are unable to tell that there is negligence on the part of the doctors involved.

            8.        So actually Ext.X1 report does not exonerate the appellants from negligence or deficiency in service. On the contrary serious doubts as to the procedure adopted by the appellants are thrown open for consideration. It is pertinent to notice that the committee suspected as cause of death, effects secondary to anaesthetic agents or errant action of anaesthetic agents but  at once it may mentioned that the opposite parties do not admit that anything connected with anaesthesia was the ultimate cause of death. On the contrary, sudden development of bradycardia followed by asystole according to them was the cause of the death.

            9.        Then the oral evidence adduced requires to be scanned to see whether the conclusions arrived at by the Consumer Forum are sustainable. PW1 the first complainant is not an expert in the medical field. PW2 conducted postmortem examination on the body of the deceased girl. During examination by the learned counsel for the opposite parties he was asked about occculo cardiac reflex (OCR ) He explained that when the eye muscles and tissues around the eye pad are handled it may result in cardiac arrest through the vagus nerve. This is called OCR. It may be mentioned that if the case of the appellants that bradycardia followed by asystole happened towards the end of the surgery when the last stitches were being taken is believed. OCR is the possible cause of death. Then the complainants have a case that the incident of OCR could have been prevented by intravenous administration of atropine at the start of the surgery.  According to DW1, when squint surgery is carried out without administering atropine it may result in OCR especially in children. In this case, the evidence clearly suggests that atropine was administered only after the first episode of cardiac arrest. The evidence of PW2 will have to be read and understood along with the evidence of DWs 1 &2. The suggestion put to PW2 during cross examination was that the medicine glycopyrolate was among the drugs mentioned to have been given at 8.30 am on 04.04.2007. To this question PW2 answered that only half of the word could be seen. Then the learned counsel who appeared for the opposite parties with some amount of arrogance tried to humiliate PW2 rather than trying to elicit relevant facts. The attempt also was that the conclusions in the postmortem report were made before getting the report from the histopathology department. That this is incorrect can be seen from Ext.A3 and the facts referred to earlier. Explaining why the many reasons for hypoxia are not mentioned in the postmortem report the doctor deposed that the development happened during squint operation of a girl aged nine years after giving anaesthesia. He also explained that had surgery been performed in the eye he would have certainly opened the eye during postmortem examination. He tried to feel the presence of sutures on the eye but could not find any sutures. He insisted that during postmortem examination when felt by hands the suture thread should have been felt by him if actually sutured. This is another circumstance which is surely indicative of the fact that the episode of asystole happened much prior to the operation not as claimed by the opposite parties when the last few stitches were being taken.

            10.      It remains to be seen whether the evidence of the opposite parties in any way helps to arrive at a definite conclusion regarding the disputed facts. DW1 is the sixth opposite party and was the head of department of anaesthsiology in the first opposite party hospital. He explained that at page 31 of Ext.A7 the medicines administered previous to surgery are mentioned. The medicine glycopyrolate is one among them. But it is written as glyco because of lack of space. The suggestion was from the word glyco alone, it can not be said for sure that it is glycopyrolate. DW1 claimed that glycopyrolate has sialogoguic effect. The suggestion was that the said medicine is mainly use d to reduce secretion from mouth. He answered that it is also used for drying up secretion. He admitted that glycopyrolate has less vagolytic effect. He further admitted that to control oculocardiac reflexes atropine is more effective than glycopyrolate. The reasons for not giving atropine before surgery was that it has its own side effects like severe increase in heart rate which can cause problem for the surgery. He claimed that glycopyrolate is not inferior to atropine as a pre operative medicine in squint surgery. He reiterated the case of the opposite parties that the first cardiac arrest has happened at 10.20 am. He admitted that retro bulbar block was not given at 10.20 am but was given at 8.30 am. He admitted that this can not be seen from Ext.A7 records and added that it was the surgeon who have that medicine. But this version is not in tune with the duties of an anaesthesolioigst and it is his primary duty to leave the patient in a stabilized condition before the surgeon. He denied the suggestion that cardiac arrest happened because the level of oxygen in the blood of the patient fell considerably. According to him the second cardiac arrest was at 10.30 am.

            11.      The evidence of DW1 is to be considered along with the deposition of DW2 to the head of ophthalmology department in Trivandrum medical college. She was one among the members of the enquiry committee who filed Ext.X1 report the conclusions in which were referred to in detail. To remind the final conclusion was that in order to say whether there was medical negligence or not, Cardiac histopathology report from All India Institute of Medical Sciences along with biometric and computer experts opinion of the video recordings as to ascertain the identity and chronology were required. According to her in squint surgery retro bulbar block is applied as a type of local anaesthesia. Regarding a child of aged 9 years during squint surgery general anaesthesia is usually used. In her experience in squint surgery retro bulbar block is not applied before the surgery. According to her retro bulbar block is given either by the junior doctor or surgeon and not by the anaesthetist. According to her OCR is very rarely seen. It is characterized by brady cardia and some times by cardiac arrest. Only anaesthesiologist can say whether atropine is the most effective medicine to prevent OCR. The evidence of anaesthesiologist is already referred to .In her experience retro bulbar block is not given along with general surgery because it has side effects. Instead peribulbar bloxk is given but the medicine is the same. She explained that OCR can occur even when retro bulbar block is being given. 

            12.      So the evidence adduced on the side of the opposite parties largely centres around the case of the opposite parties that the incident of brady cardia followed by cardiac arrest happened at a very late stage during surgery. In this regard, the case of the opposite parties is highly suspicious and the circumstances are already highlighted. Atropine appears to be the best medicine to be applied to prevent incidents of OCR and atropine was not given during pre operative stage. The risk from OCR is admittedly high in children. So basically there is no evidence to upset the conclusion of the consumer forum that pre operative procedure followed in the first opposite party hospital was not adequate. As indicated already, it is highly doubtful whether OCR and consequent brady cardia was the cause of the death of the child. Rather the possibility is that some anaesthetic mishandling happened. Of course, this is not admitted by the opposite parties. They have no case either that it is an anaesthetic accident for no fault of theirs or due to some reason beyond their control. In short, there are several unexplained circumstances surrounding the death of the child which points out to the deficiency in service on the part of the opposite parties and attempt to hide the same.

            13.      Another reason why the consumer forum found that there was deficiency in service on the part of the opposite parties is that the special risk factors involved in squint surgery were not explained to the parents of the child before obtaining consent. It is seen from the records that the consent obtained was a routine one. There is no attempt to explain the special risks involved in a squint surgery like the occurrence of OCR and consequent complications. When asked about this DW1 the sixth opposite party admitted that special risk factors were not explained to the parents but added that in the case of administration of any  anaesthesia risks are involved and every body knows this. At page 30 of Exts. A7 (series), it is written “ allergic reaction to drugs  - details not known” . This page is written by the department of anaesthesiology during the squint surgery of the child. As indicated already the opposite parties have no case that any allergic reaction ultimately caused the death of the child for no fault of theirs. Then why all attempts were made to make out a different case as the cause of death of the child is a mystery and points out to some fault of the opposite parties and it remains as a fact that the special risks factors involved were not explained to parents of the child before obtaining their consent. In short, the consumer forum was justified in finding that there was deficiency in service on the part of the appellants in relation to the squint surgery of the daughter of the complainants.

                        14.      The Consumer Forum exonerated opposite parties five and six from liability. There is no appeal against that finding. In the absence of clear evidence as to the extent of deficiency in service of each of the opposite parties the Consumer Forum slapped liability on the hospital and directed the insurance company to pay the compensation to the complainants. The said direction also needs no interference.

            15.      Coming to the quantum of compensation awarded the consumer forum rightly noted that guess work is involved in fixing the quantum and fixed the quantum of compensation taking into account the probable factors relevant to decide the loss to the parents and the compensation awarded appears to be reasonable. In short, there is no merit in the appeal.

Accordingly the appeal is dismissed but without costs.

K.CHANDRADAS NADAR        : JUDICIAL MEMBER

Be/

KERALA STATE

CONSUMER DISPUTES

 REDRESSAL COMMISSION

 SISUVIHARLANE

VAZHUTHACAUD

THIRUVANANTHAPURAM

APPEAL NO.204/2012

JUDGMENT

 DATED :30.09.2014

                                                                                                                                       BE/