National Consumer Disputes Redressal
Kiran Bala Rout vs Christian Medical College And Hospital ... on 10 September, 2001
ORDER
B.K. Taimni, Member
1. This complaint has been brought by the wife of the deceased late Shri Radhakant Rout alleging negligence on the part of the Opposite Party - Christian Medical College & Hospital, Vellore & Ors.
2. The brief facts of the case are that the deceased - Radhakant Rout was diagnosed to be suffering from rheumatic heart in mid 1983. The deceased approached the Opposite Party Hospital in 1985-for the first time where after due examination he underwent a closed heart surgery and was discharged with an advice to come back every year for check up. He came for check up to the Hospital in 1986 and again in 1988 and later on in Oct, 1989. The deceased was advised by the treating Cardiologist OP No. 3 to under go open heart surgery for replacement of two heart valves in 1989 with an estimated expenditure of Rs. 60,000/-. Later on the estimate was raised to Rs. 85,000/-. The deceased after two more check ups in Oct, 1990 and Feb, 1991 and several postponements was operated upon in the OP Hospital by OP No. 2 for double heart valve replacement on 23.9.1991. The delay according to the Complainant was on account of a different opinion given by One Dr. J.P. Das, the then Head of Department of Cardiology in Cuttack who opinied after check up that the replacement of both the valves were not required at that time as the condition of the deceased was much better. After the surgery on 23.9.1991, the deceased was kept in the ICU for 15 days, as he was suffering from breathing problem. The deceased came to the private ward on 7th Oct, 1991 where he started to take normal diets, walking and going upstairs and taking upto 5-10 steps and they were also advised that the patient shall be discharged shortly and requested them to make arrangements for return tickets for home which they booked for 23rd October.
3. Along with other medicines, the patient was also administered medicine Sintrom which is an anti-coagulant which was being administered till 7th Oct., in the dose of 2.00 mg but on the afternoon of 8.10.91, it was increased to 2.5 mg. According to the Complainant, he asked the accompanying doctors "if the patient is doing well with 2.00 mg by he should be given 2.5 mg.". According to the Complainant, the accompanying doctor replied that it was to take a trial. On the third day of the increased dose of sintrom i.e. 11.10.91, the urination lessened, breathing trouble started, lungs-congestion noticed. It is the complainant's case that perhaps OP No. 2 was experimenting the increased dosage using her late husband as a guinea-pig. The Complainant's husband was shifted back to ICU on 13.10.1991. On that day about 9.30 PM to the complainant noticed marked swelling on the right part of the body and when it was brought to the notice of the attending doctors, it was completely ignored. The Complainant was also requested to supply another bottle of blood on 13.10.91 which she could not organise and this blood was donated by an attending doctor. According to the complainant, the swelling which was denied by the OP No. 2 is a clear case of negligence on his part. It is her case that on the morning of 16.10.91, 'Tracheotomy' was done on the deceased without telling her and also in the absence of the complainant. Profuse bleeding was noticed after about 2 hours of Tracheotomy. The bleeding stopped after 5.30 PM. After that, the patient was always in poor condition. The complainant states the surgeon OP No. 2, Dr. Stanley left the country immediately after seeing the patient on 15.10.91. According to the complainant no clear answer was forthcoming from the doctors meaning thereby they were hiding some negligence on the part of the doctors. On 17.10.91 when the complainant's brother-in-law arrived at Vellore the deceased had a low blood pressure. She was also told that her husband was suffering from jaundice and she was also told that he cannot tell her how long her husband would survive. The condition of the deceased improved on 20.9.91 based on readings like blood pressure and heart-beat rate and heart pumping, and urination was better. On 21.10.91 when the complainant went to ICU she saw one doctor giving suction to her husband and the computer reading was haphazard. The BP was 71. Seeing this the complainant got little upset and asked the reason for this whereupon the attending Doctor requested the complainant to wait outside. It is after that the doctors came out and told the complainant about the sad demise of the complainant's husband. On 22.10.91, the hospital handed over the body for cremation. According to the complainant the head portion from the armpit was fully covered with bandage except the face. A doubt arose in the complainant's mind that the internal organs were removed without the knowledge of the complainant which is strictly against the medical rules and Hindu cremation rituals. According to the complainant she had paid an advance of Rs. 85,000/- and another Rs. 10,000/- obtained from PMs Relief Fund while the total bill raised by the OP was Rs. 1,95,355/-. The deceased was survived by his wife - the complainant and two small children. They have claimed Rs. 15.72 lakhs as compensation from the Hospital for the various acts of negligence.
4. The OP in the reply while completely denying the negligence and various allegations levelled by the complainant stated that the deceased Radhakant Rout had gone to the Vellore Hospital for the first time in 1985. The hospital record indicates that the deceased had valvular disease of the heart since 1979 and the developed progressive breathlessness on - exertion since 1984. The deceased also had fever with joint pains in 1965 symptomatic of rheumatic fever, hand been on prophylactic penidure (pencillin preparation) injection from 1979 irregularly. On cardiac investigation he had physical findings consistent with a diagnosis of rheumatic heart disease with tight mitral stenosis with pulmonary hypertension and mild aortic regurgitation in sinus rhythm (heart beat was regular.). He under went closed heart surgery in 1985 and after an uneventful postoperative period, was discharged on 19.10.1985 with an advice to carry on with the prescribed medication and to visit the hospital every year for check up. The patient came for the check up in Oct-86 and he was advised to come in the next year. Meantime, the OP Hospital received a letter from one Dr. P.C. Barma who was a physician at the District Head Quarters Hospitals, Puri, Orissa informing them that the deceased Shri Raut had upper respiratory tract infection with chest infection and his cardiac status had deteriorated. The deceased came to the Vellore hospital again in 1987. Where after investigation it was found out that consequent to respiratory tract infection which he had suffered earlier, his cardiac status had deteriorated and other symptoms were also deteriorating. Proper medication was given and he was asked to come for check up after two years and for this he returned in Oct-89 when after full investigation, it was felt that he now had significant aortic regurgitation with left ventricular hypertrophy (enlargement) and mitral regurgitation. His cardia status was assessed as Class - II and was advised double valve replacement as soon as possible. Then there was a long correspondence in Jan-90 between the deceased and the hospital for the date to be fixed; but some how, the deceased kept postponing and finally he was seen only as an out-patient 19.2.91 and it was noted that his cardiac status had deteriorated further. he was again advised double valve replacement. After several postponement of dates the deseased finally arrived on 9.9.91. He was operated on 23.9.91 by OP No. 2. He was brought to ICU on 23.9.91 and semi-ICU on 25.9.91. Post operatively, he developed a mild fever and a high heart rate but this was brought under control by 30.9.91. He was started on the anticoagulant drug Sintrom initially at a dosage level of 1 mg per day while checking his prothrombin time periodically. By 7.10.91 his condition had stabilised and he was transferred back to the original bed in which he was admitted in the Private ward and all the necessary medication, including sintrom were continued. On 11.10.91 the deceased had developed fever and it was diagonised to be a case of chest infection. On 13.10.91, the deceased's condition further deteriorated wherein pulse rate recorded was over 140/min and a drop in blood pressure. The deceased was transferred to semi-ICU on 13th October, 1991. It became clear that one of the known complications of double valve replacement in patients with advanced valvular disease of long duration was developing in the deceased, as a result of which the patient was having inadequate output of blood from the left ventricle into the aorta because of long infection which was causing breathing problem and 'tracheotomy' was done in order to help the deceased to breathe better. He was still unable to breathe and hence he was maintained on a respirator. However, in spite of the best efforts and all necessary medicines and supportive measures, the patient unfortunately died on 21.10.91. It was also their case that in 1989 the estimated cost of surgery was Rs. 85,000/- but with the passage of time, in 1991 as per the hospital procedure, the cost was revised and it was increased to Rs. 1,10,000/- which was charged from him. It was also stated by the OP that heart surgery has its own risk. OP also stated that it is well recognised that when an artificial valve is implanted in the body of any individual, the clotting tendency occurs and in order to prevent this various anticoagulant medicines are used which in this case was Sintrom. The decision to increase Sintrom from 2.00 mg to 2.50 mg was based purely on the 'prothrombin (P) time' which needs to be kept at one and a half time ratio. As on 8.10.91 PT time was 16 seconds for the 'patient' and 13 seconds for the 'control' as the deceased had not achieved the desired one knout half times ratio, dosage of Sintrom was increased to 2.5. mg. Again when the requisite ratio was achieved on 12.10.91, the dosage of Sintrom was reduced to the maintenance dose on 14.10.91. The allegation about the alleged swelling on the right part of the body and sweating were denied by the OP. The OPs also denied that at the time of giving suction, Dr. Das had done something wrong or was careless. Published literature on 'double-valve replacement' shows that in a total of about 2000 cases reported upto 1992 the mortality during the first month after operation was about 9%. This morality increases when a second operation is done after an initial mitral valvotomy to about 12.5%. According to the OP there was no negligence on the part of the OP vis-a-vis, the treatment and post-operative care done by the OP hospital and doctors.. Hence this complaint needs to be dismissed. IN the rejoinder filed by the complainant, the complainant reiterated the points earlier and held the hospital for negligence resulting the death of her husband. The Complainant also alleges tampering with the Hospital record to hide the negligence on the part of Hospital and its Doctors, respectively.
5. In all, seven affidavits were filed on behalf of the complainant by way of evidence and four affidavits were filed on behalf of the OPs by way of evidence. From then Complainant side only the complainant and one more witness Mr. Netranand Sahoo only were cross-examined whereas from the OP side - OP No. 2 and the other Cardiologist Dr. Jose were brought in for cross-examination.
6. In their affidavit, the complainant reiterated what was given in the complaint. The other affidavits were that of Mr. Nihar Nanda Nayak, Shrinath Behera, Jayanta Nayak, Pradeep Behera, Ramakant Raut. Mr. Nayak was also the patient in the same hospital at the same time and supports in general terms the negligence on the part of the OP No. 2 without any specific act of omission on the part of OP, as well as supported other allegations and sequence of evidence as brought out by the Complainant in her complaint and affidavit which is based on a hearsay. The other affidavits filed by S/Shri Shrinath Behera, Jayanth Nayak, Pradeep Behera, Ramakant Rout are devoid of any substance and contain information as told to them by the Complainant. On behalf of the OP, of the four affidavits filed one was filed by Dr. S. Krishna Swamy the Cardiologist. He also recapitulates the history of the deceased's health from 1985 even though he saw the deseased for the first time in 1987. He on behalf of the OP also denies any tampering of the record relating to the deceased. In support of this he gives several instances and he reiterates that the OP has not been negligent or careless in the treatment of the deceased. The allegation of harsh and unkind words used by the Respondents were also untrue and baseless. The second affidavit is that of Dr. Edwin Ravi Kumar who is currently Professor and Head of the Department of Cardiothoracic Surgery. The death summary was written and signed by him. As an expert witness he reiterates that the narrowing of the mitral valve giving rise to mitral stenosis is only the end result of a chronic illness, rheumatic heart disease. He also states that there is no specific treatment for rheumatic treatment. The administration of sintrom was as per the prescribed procedure and the dosage to the patient was also administered in accordance with the test known as prothrombin Time. This is reflected in pages 336-337 of the compilation of the hospital record which is related to the patient. The increase of the dosage from 2.00 mg to 2.5 mg on 8.10.91 was also 'in-order' as per the stipulated procedure of maintaining one-and-a-half time ratio which is essential for stopping the clotting of the blood. Dr. Jose who is Head of Department of Cardiology in the Respondent Hospital also explains that with his experience he could clearly state that there was no technical flaw in the surgery conducted on the patient. He also denied the improper behaviour of those who were looking after the deceased. Dr. Jacob Jose stated that based on the material on record relating to the deceased which is given in the form of 'compilation' that there has been no negligence on the part of any person(s) connected with the procedures and records disclosed that the deceased received the best possible treatment in every respect.
7. The Complainant and the witness Mr. Netranand Sahoo only were examined through Commission in which she first denied her signature on the authorisation slip to carry out the surgery. She categorically stated that no authorisation was taken before carrying out the surgery on her husband. She also denied, OP No. 3, Dr. Krishnaswamy informing her about the risk in this operation. She was confronted with her statement on oath in her affidavit that there is no record of tracheotomy done on the deceased whereas the compilation record of the hospital at pg. 263 and 394 clearly state '7 AM tracheostomy done ....' She now sate that it is slightly written hence she could not read it. In his cross-examination Dr. Sahu states that he was a student in Madras and he was studying there and not at Vellore. It is the cross-examination of OP No. 2, Dr. John which is the key to the case. In his very lengthy and detailed cross-examination, three points emerged. Firstly, that there are two alternatives available for valve replacement - one is called the mechanical valve and the second is called the bio-prosthetic valve. He also states that the bio-prosthetic valves are implanted in patients who are in the age group of 70 plus. This patient was in late 30's, thus, in his judgment replacement of his heart valve by mechanical valve was right. He denied that his technique has become obsolote. Second point relates to the administration of sintrom. According to him, sintrom is normally administered to the patients in the post operative stage to stop the blood from clotting which can clot when a foreign body is implanted in a human being. The dosage is determined by prothrombin tune ratio. This ratio has to be maintained one and a half times the control value the prothrombin chart at pg. 336-337 of the compilation states that these ratios were not kept up on 8.10.91 when this ratio almost came down to 1.3, necessitating increase in the dosage on 8.10.91, it was reduced on 14.10.91 and then discontinued effective 15.10.91 and no syntrom was administered thereafter. He completely denied that the end of the deceased was caused by an increase in the dosage of sintrom from 2.00 mg to 2.5 mg on 8.10.91. He also stated that the dosage of sintrom is always advised by the senior-most Cardiologist and sometimes by the head of Department or the Professor of the Department. He also clarified that no Sintrom was administered after 14.10.91. when his attention was drawn to pg. 421 of the compilation, he clarified that it is important to know that there was some error in writing the date 16.10.91. The pages go backward and it will be clear that the date indicted on page 421 is 5.10.91, 418 carrying the dates 6/10, 7/10 and so on which indicates there was some error by the staff in writing the date 16/10. He denied that there was any tampering with the record in order to save or hide anything. According to him there have been some over-writings in the compilation but they had to be seen in perspective. he also denied that the compilation of Hospital record relates to some other patient especially when attention was drawn to certain pages of compilation which does not bear his name and also his age has been given 45 where as he was 39. He explains this to be an error of the staff. He emphatically asserted that this 'compilation' relates to the deceased. He explained that the Token numbers at the top of pages in the compilation relate to two numbers one is in the medical record number and the other is the Hospital number. Normally there is only one number but at certain places both of them appear. It should be seen that the name Radhakant Rout was clearly written and it clearly states that this record relates to this patient alone. The expert witness, Dr. Jacob Jose examined on behalf of the OP also supported the action taken by Dr. Stanley in his post operation particularly in the administration of sintrom and increase in the dosage on 8.10.91. He also states that there was no negligence on the part of the hospital or by the doctors in the hospital. He also denied that the Overwritings in the same places or corrections applied by the doctors or nurses amount to tampering of the record.
8. On behalf of the Complainant she herself argued the case. She stated that the patient had gone to Vellore who was a healthy youngman. He had gone for open-heart surgery to Vellore on 9.9.91. According to her, increase in the dosage of sintrom from 2.00 mg to 2.5 mg on 8.10.91, using her late husband as guiena pig to study the effects of increased dosage on heart patients, is the heart of the matter. It is this act of omission or commission which proves the negligence on the part of the hospital which resulted in the death of her husband. She was present at the time when increased dosage of sintrom was prescribed; when she questioned this increase, the doctors did not respond to this. On 11.10.91 temperature again started going up and the breathing problem started on 13.10.91. This was on account of increased dosage of sintrom. Alongwith the breathing problem, urination problem also started as a result of increased dosage of sintrom, yet they did not stop the medicine. On 14.10.91 about 9.00 to 9.30 PM she noticed that the deceased was put on heart-lung machine. She noticed sweating as well as swelling on the right side and she brought this to the notice of the treating doctors but it was ignored by them. She was again asked to organise blood on the night of 13.10.91. According to her, blood is not a commodity which can be got from outside, that evening, blood had to be donated by one of the attending doctors. According to her Tracheotomy was done to hide the negligence as there was breathing problem with the deceased. She argued that the OP No. 2 Dr. John left for foreign tour without making proper arrangements for the patient. There was excessive bleeding noticed by her on 21.10.91 and the sucction procedure was adopted by Dr. Das without the help of any nurse. She also argued that the record maintained by the hospital was improper and does not show that the Tracheotomy had been done. The fact of heavy bleeding after Tracheotomy has not been recorded. According to her even though according to Hospital record sintrom was stopped on 15.10.91 yet the Hospital record shows that the sintrom was administered even on 16.10.91. Even though Dr. John was in Vellore on 15/10, 16/10 he did not visit the patient. She also argued that the initial costs of operation was placed at Rs. 85,000/- yet it was increased to high figure. She also argued that she was given the dead body and she was not sure whether some organs have been removed.
9. On the other hand, Counsel for the OP argued that a closed heart surgery was done on the patient and sintrom chart clearly shows that the required ratio had to be maintained and it fell below the level on 8/10 and which was completely stopped on 15/10. After that it was clearly mentioned that no sintrom was given to the deceased. It is undoubtedly clear that congested cardiac failure carries a higher risk i.e. above 10% because of the lung infection. In the case of this patient Tracheotomy was done to help him breathe better and breathing problem was brought under control by 5.30 AM on the same day. He also argued that there has been no tampering of the record which was produced in original before the Commission. He also stated that suction process does not require two people and can be done by one person and the doctor himself has done it. The learned Counsel for the Respondents also drew out attention to two judgments of the Supreme Court. In Laxman Balkrishna Joshi v. Trimbak Bapu Godbole and Anr. AIR 1969 SC 128 V 56 C 27, the Supreme Court held:
"The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding what treatment to give or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires. The doctor no doubt has a discretion in choosing treatment which he proposes to give to the patient and such discretion is relatively ampler in cases of emergency. (Para 11)".
10. In Achut Rao Haribhau Khodwa v. State of Maharashtra and Ors. (1996) 2 SCC 634, the Supreme Court held:
"A medical practitioner has various duties towards his patient and he must act with a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. This is the least which a patient expects from a doctor. The skill of medical practitioners differs from doctor to doctor. The very nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession and the court finds that he has attended on the patient with due care, skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence. But in cases where the doctors act carelessly and in a manner which is not expected of a medical practitioner, then in such a case an action in torts would be maintainable."
11. According to him, no negligence has been proved against the Respondents. Hence, the complaint need to be dismissed.
12. We have perused the lengthy material on record and heard the arguments. We found that the Complainant has alleged several acts of negligence, some of them could be dealt in brief. The Complainant alleges that Tracheotomy was done on the deceased on 13.10.91 but she was not informed and was done while she was away. The OPs have replied that as the patient was experiencing breathing deficiency as a result of lung congestion, thus in order to ease the breathing facility for the patient, Tracheotomy was done. In our view there is no negligence in this regard as the complainant has neither produced any material or examined any witness to state that all such actions need to be done by the Doctors in her presence. Entry to this effect exists in the Hospital record with which the complainant was confronted. Non mention of bleeding in the Hospital record can not be said to be amounting to negligence. In any case the haemoglobin on 17th October, 1991 on the day Tracheotomy was done, was 10.5 mg, on 18/10 it was 9.2 gm on 19/10 it was 11.2 gm which rebuts any relationship with excessive bleeding and the ultimate end. Doctors are supposed to perform what is in the interest and good for the patient. It is not the Complainant's case that Tracheotomy should not have been done at all. Another act of negligence is stated to be that at the time of giving suction, Dr. Das did it alone without the help of a nurse. OP has clearly stated that it is not necessary for the Doctor to be assisted by a nurse at the time of giving suction. No contrary evidence or literature/authority has been put up before us in this regard by the complainant. We do not find any merit in this allegation. Another allegation ut forward by the complainant relates to reported swelling and seating on the right side of the deceased on 14.10.91, when she noticed it and brought to the notice of the doctors, they did not pay any heed to it. OPs have denied any such thing. There is no evidence to support this point. Even if it is accepted to be true, complaint does not state in any clear term as to what did it result in and what was the negligence knout its have bearing on the ultimate end. No. material/evidence is on record in this regard in the absence of which we are unable to accept the allegations of negligence. Asking her for a bottle of blood at about 9.30 PM on 13.10.91 is also alleged to be an instance of negligence on the part of the Hospital. The fact remains that the deceased did not have to wait for the blood and it was organised and administered to the deceased in time without her help. We do not see any negligence in this regard. Allegation on the escalation of Hospital fees certainly cannot be viewed as medical negligence. It is not even remotedly connected with that. It has been explained by OPs that cost of Surgery, on which the complainant relies related to 1989, whereas the cost of Surgery was revised by the Hospital and only the current/pravelant charges were proposed to be recovered. We do not wish to delve into it as it is not even remotely connected with medical negligence resulting with the death of complainant's husband. However, we hope that keeping in view the facts of the case Resp. Hospital should not press for the recovery of outstanding dues. Allegation of departure of Respondent No. 2 before the discharge of the deceased has also been made. We see that Res-2 attended on the patient on 16th October and left for the overseas trip on 19th. It is no one's cause that the patient was not being properly attended to. There were experienced and well qualified Doctors/Staff in the Hospital to lookafter and attend to the deceased. We do not see any negligence in this regard. Another allegation relates to the apprehension on the part of the Complainant that since the body of the deceased was handed was in a wrapped condition, some vital organs could have been removed by the Respondent Hospital. This has been vehemently denied by the OP. Since the patients in such cases are supplied the necessary inputs through several tubes, and in this case tracheotomy was also done, it cannot be expected of any good hospital to hand over the body in an otherwise unacceptable position. Complainant has not put forward her grounds of apprehension nor is there any evidence or proof in this regard. Hence, we find ourselves not inclined to accept this as an act of negligence. In any case this has nothing to do with medical negligence resulting in the unfortunate death of the Complainant's husband.
13. Even though, no such allegation was made by the Complainant in her affidavit, but during the cross-examination of the Respondent No. 2 Dr. Stanley John, the question of the type of 'valve' also arose. From the material on record it appears that there are tow options available at the time of heart valve replacement - either to implant mechanical valve or a bio prosthetic valve. According to Dr. John who is a renowned Cardiac Thoracic Surgeon, based on literature on the subject and as per their Hospital's practice, mechanical valve has been found to be more durable. According to Dr. John, CMC Hospital started with valve replacement surgery from 1967, using mechanical valves because of durability and thrombogenecity. He maintained that Bio-prosthetic valves are preferred in older age groups - in USA for the patients as old as 90 years it is done. Mechanical valve was used in the instant case, as it is used for the younger group, to which the patient belonged. He also produced material from reputed journals and figures of other Developed countries to support his point. Be that as it may, it is now well established that where the Doctors have to options and they exercise one, this cannot be described to be a negligence, unless the other party is able to prove that the option exercised by the Doctor was palpably wrong. There is no evidence to the contrary and in his cross-examination Dr. John was able to bring enough material in his support. In the absence of any material or evidence to the contrary we find no negligence on the opart of the Respondent 2 in this regard.
14. The crucial and major thrust of the Complainant centres around the fact that patient met his unfortunate end on account of increase in dosage of Sintrom from 2.00 mg to 2.5 mg on 8th October, resulting in all subsequent problems of bleeding, low urination, low B.P. and subsequent Tracheotomy, suction and the death of the deceased. Sintrom is an anti-coagulant. Material on record clarifies this terminology as well as other Terms, and their functions/utility, based on which it would help if these are explained for better appreciation of this case.
Anti-coagulants
15. There are a group of medicine called anticoagulants or blood thinners which prevent the formation of blood clots. Clotting of the blood is a normal protective mechanism of the body so that in case there is a wound it will not continue to bleed, but he blood will clot and act as a plug, preventing further bleeding. This clotting of blood, by a complicated mechanism, occurs when it comes in contact with any foreign material. In valve replacement Surgery since the foreign material in the form of a valve is placed within the flow of blood, there is a great danger that blood clotting can occur on account of this new valve. Because of this all patients who have Valve Replacement Surgery are given medicine to prevent the clotting of blood easily within the heart. There are several such medicines and one of he commonly used drug is called Sintrom. Once a patient has had a Valve Replacement Operation he needs to continue to use this drug for the rest of his life. The dosage of this drug has to be decided for each individual patient by gradually increasing the dose and then doing a test called the prothrombin time which estimates the ability of the blood to clot. In each of these tests a normal control of an individual's blood as well as the blood of the patient who is given Sintrom is tested. Ideally the patients blood should clot in approximately one and half times the time of the control blood clot. This test has to be periodically done, on patients on Sintrom, almost daily or alternate days when the dosage is being determined initially and subsequently at least once a month to ensure that he dosage of Sintrom is correct and prolongs the prothrombin time to only one and half times normal. If the prolongation is less, additional amount of medicines have to be given, or if it is longer, then the amount of Sintrom given has to be reduced. On discharge from the hospital each patient is given a blood in which his prothrombin time result can be entered regularly and the doctor who is looking after him can decide the dose at which the medicine should be given.
16. It is also important to know as to how the dosage of Sintrom is fixed. This is based on prothrombin (P.T.) Test. This has to component-one is in control, which is a normal person and is not taking the Sintrom Tablet and the other is a person who has taken the tablet. Blood samples are taken from the patient in the morning fasting, 8 to 14 hours after the tablet has been taken; the test is done on a person whose blood is not taking the test to ascertain the control value and another test is done on the person having Sintrom tablet getting tow values i.e. one is the patient and the other in control. The patients value divided by the Control will give what is called P.T. ratio which is tried to be maintained at 1-1.5 to 2 times the normal value. We see from the chart that Sintrom was administered starting 25.9.91 with 1 mg, gradually increased to 1.5 mg from 27.9.91 to 2 mg on 6.10.91 and 2.5 mg on 8.10.91. Important point to note is co-relationship of the dosage with P.T. ratio. It is clearly seen that P.T. ratio was not favourable on 5/10 or 6/10 and 8/10, it is only after administering the increased dosage - the bone of contention and germance to the main thrust of alleged negligence - that we see favourable ratio emerging on 12/10. The ratio has to be maintained at all costs. If it is low than there is risk of the patient developing at thrombosis or clot formation and a higher dosage can result in bleeding. It is this ratio which was being attempted to be maintained. Having attained this ratio on 12/10, Sintrom was discontinued from 15/10/91. Related allegation of the complainant is that the Sintrom was given on 16.10.91 as per Hospital record. We find that the hospital record is maintained backwards. Pg. 423 mentions the date 5/10/91, Pg. 418 mentions date of 7.6.91, Pg. 416 mentions date 8.10.91 and so on. Even though at one place in the Nurse's record at Pg. 421 date 16/10 appears it will be naive to accept this anything but an erroneous entry of the date by the nurse. We have also seen the nurse's record dated 16/10/91 appearing at Pages 397-398 of the Hospital record dated 16/10/91 appearing at Pages 397-398 of the Hospital Record/Compilation and are satisfied that Pg. 421 is a case of wrong writing of date. We do not find any substance in this. We see on record that no Sintrom was administered after 15/10. We also see that as per material on record and cross-examination of the main witness Respondent 2 Dr. John that dosage of Sintrom was increased on 8/10 to maintain the requisite ratio in the best interest of the deceased Shri Rout. No evidence - documentary or otherwise has been produced by the complainant in support of her contention that dosage of 2.5 mg of Sintrom was excessive or it had any corelation with the ultimate end. Hence, in our view the complaint has failed to prove her allegation of any negligence on the part of the Respondent in this regard.
17. Another allegation relates to tampering with the Hospital record which was denied by the Opposite Party. These relate to Pages 187, 188 and 189 of the compilation. On page 18, there are certain cuttings and writings of the year - History BOE since 1990, it is clear that the second figure of 9 in 1990 is over written Pg. 187, recommendations have been scored out and on Pg. 189, the year under discharge has been overwritten. Witness Respondent No. 2 stated that he does not know who has over-written this year on Pg. 187 but regarding Pg. 187 he states that recommendations can always be changed by the Doctors. This is not rebutted. Regarding Pg. 189, it is seen that yes there has been overwriting but it i snot disputed that the body of the deceased was handed over on 21.11.91 even though somebody wrote earlier the year as 1992. Name of he deceased Radhakant Rout is clearly written on top. It will be difficult to believe that this was subsequently tampered with. We have also seen the conditions of record at Pgs. 379 to 463. They appear to be quite well maintained and any professional should be able to read it. A doubt was proposed to be created about the two numbers - Hospital No. and Medical No. of the deceased - say on Pg. 385. We have gone through the page and find that the name and the two numbers may not be as good as one wishes - but with naked eye, it is possible to read Radhakant Rout and both the number along with the age of the patient in the case deceased can be read. When we see Pg. 307, the name Rout and Hospital No. comes clearly. We also pages 305, 306 and 308. They clearly relate to the deceased. Complainant is unable to state as to why Hospital will change Pg. 307 and not other pages. What will they gain? Next our attention was drawn to Pg. 475. Hence the complainant wishes us to believe that since the age of Radhakant was written as 45 years against 39 years, hence this record does not concern the deceased. Nothing could be more far from the truth. It is clearly written Order 11, DVR Double Valve Replacement - TAP (Redo) Radhakant - 45 M 27 A - everything is correct except the age and bed number. (It should have been 127B). Merely on this premise, an effort to make us believe that some other patient was operated upon and not the deceased shall be stretching the argument too far.
18. We have carefully gone through the material on record and found that there have been deletions, scoring off and some errors here and there at the staff (nursing) stage but the complainant has failed to prove if these delegations or scoring off, etc., are more than an improper record keeping/maintenance. There are about 480 pages of record and selective errors etc., at certain pages does not lead us to the conclusion of the record having been tampered with.
19. The main case of the complaint hinged on the administration of sintrom. No literature, documentary evidence or otherwise has been brought before us to contradict the material and no expert evidence has been led before us support of the line of treatment especially the administration/dosage of sintrom to the patient. National Commission, in its order in Seturaman Subramanyam v. Triveni Nursing Home and Anr. 1988 CTJ (CP) (NCDRC) held that in the absence of expert evidence on behalf of the complaint, no negligence or deficiency in service could be found against affidavits filed by the doctors. It has been held in several cases that negligence must be established and not presumed - 1999 (CTJ 644 (CP) (NCDRC) Kanhiya Kumar Singh v. Park Medicare & Research Centre.
20. After carefully going thorough the record the arguments advanced by both the parties and the judgements of the Hon'ble Supreme Court and of this Commission referred to above, we find that the complainant has failed to establish any case of negligence on the part of the Respondents, in view of which, the complaint is dismissed.
21. As observed earlier, it is hoped that the Respondent Hospital may not press for the recovery of outstanding dues from the Complainant - widow of the deceased.
22. Keeping in view the facts and circumstances of this case, no order as to costs.