Sarala Srinivas (Deceased) and Others Vs. M/S. Harvey Hospital Ltd. and Others - Court Judgment

Excerpt:
this petition coming before us for hearing finally on 25.04.2011. upon hearing the arguments of the counsels on both sides, perusing the material papers on records, this commission made the following order: m. thanikachalam j, president 1. this is a complaint filed under sec.15 of the consumer protection act, claiming a compensation of rs.20 lakhs, on the basis of medical negligence and deficiency in service. 2. brief facts necessary for the disposal of the case:  the husband of the 1st complainant (deceased) viz. srinivasan, father of the complainants 2 and 3, was admitted in the 1st opposite party hospital, on 14.12.97, for medical investigation. even prior to that, diagnostic angiogram was performed on 14.8.1997, and on that basis alone, angioplasty was performed, in the month of december 1997. thus the opposite parties are guilty of negligence, even in the initial stage. 3. the 2nd opposite party, who treated srinivasan, has administered straightaway ionic dye, resulting the fatality. because of the negligence committed viz. without giving test doze, ironic die of 5 ml., was administered, it caused problem resulting anaphylaxis, preceding falling of blood pressure. for 12 hours, though the opposite parties have attempted to revive the heart, including femoral femoral cardio pulmonary bypass, which was not necessary and even not taking to icu, where as attended only at cath lab, they were unable to save the life of srinivasan, thereby all the opposite parties have committed deficiency in service, failing to adopt the expected standard of care, ane even they have not informed the problem to complainants, further they have also failed to furnish the records to the complainants, despite notice issued. thus it is clear, due to the negligence and improper treatment of the opposite parties, srinivasan died, leaving behind the complainants, causing mental agony, loss of earning etc., for which the complainants are entitled to a sum of rs.2000000/-, as a whole. thus claiming, a consumer complaint was filed before this commission. 4. the defence (by all the opposite parties) in brief as follows: thiru. a.j. srinivas, visited the first opposite party, as an out patient in september 1996, thereafter, he came to the 1st opposite party on 14.8.1997. a diagnostic coronary angiogram was done by the 2nd opposite party, administering 5 ml. of trazograf ionic dye, after confirming that there was no allergic reaction to the ionic dye, then administering 120 ml. of ionic dye, thereby angiogram was successfully completed, which revealed two vessel coronary artery block. despite advise given for angioplasty, at the request of mr. srinivas, since he has to attend some wedding inthe family, it was postponed, which was known to his relatives, by name dr. jayaprakash, and premkumar, who accompanied dr. srinivas 5.  on 14.12.97, for percutaneous transluminal coronary angioplasty (ptca), he underwent pre-catheterisation investigation, including testing for various medicines and dye. following the procedure, srinivas wheeled in, for angioplasty on15.12.97 at 10.00 a.m, wherein access to the heart was achieved, and the 2nd opposite party administered 5 ml of ionic dye at 10.30 a.m., as a first dose, to delineate the obstruction in obtuse marginal i branch of circumflex (om1). at that time, srinivas complained burning sensation, indicating, reddish discoloration etc., it was clear indication of anaphylaxis. 6. the 2nd opposite party tried to resuscitate srinivass heart, by administering anti-anaphalysis drug through, already inserted catheter and later by cardiac massage, which was informed to the relatives of srinivas, through dr.jayaprakash. the bp of srinivas kept falling despite administering anti anaphylaxis measure and inotropic drugs, and closed chest massage was started to sustain circulation. all the attempts to revive the heart, was not successful, and therefore a surgical team lead by 3rd opposite party, instituted femoro femoral cardio-pulmonary by pass support, and to provide better flow rate, chest was opened and conventional cpbp instituted, using right artrial to ascending aortic cannulation. even thereafter for continuous 12 hours attempt, as prudent doctors, the function failed, and the patient was declared dead 11.30 p.m on 15.12.97. during the entire 13 hours of medical emergency, both the 2nd and 3rd opposite parties, have put in tremendous effort and medical acumen, to save the life of srinivas, they were unable to rectify the same, despite advanced life support used at the time of byepass. therefore, the averments in the complaint, that they have not been informed, and test dose was not given, are all imaginary. in the case of extreme sensitivity, even a test dose dye is enough to claim the life of the patient, and in this view also, non-giving of the test dose even assuming, cannot be faulted, in the case of srinivas, as negligence. at any point of time, the opposite parties have not committed any breach of duty, as a practicing cardiologist, for the past 20 years, having held several position, in various government medical colleges. 7.  femoral bye pass, cannot be faulted, since it was done, when the other attempts had failed, that too, when the patients cardio pulmonary system was failing. the fact that srinivas died, does not mean that the doctors have committed negligent or deficiency in service. as seen from the pleadings, ignorance of knowledge of disease, and procedures on the part of the complainants, cannot be construed as negligence, and willful deficiency in the service of the opposite parties, warranting any compensation. the complainants have not paid for any medicine, or blood used for srinivas, that can be seen, even from the statement of account. in fact, the complainants are actually due to pay a sum of rs.1,70,312/-, being the amount due for the medical treatment rendered, for which notice was sent. the opposite parties and their medical teams, are extremely competitive and qualified, to perform the procedure adopted and no procedure could be faulted and infact not faulted by the complainant, thereby showing there was no deficiency in service. hence the claim of the complainants, for exorbitant amount, lodged on vexatious unfounded plea, should be dismissed, with exemplary cost. 8. the parties have filed affidavits, and on behalf of the complainants three documents were exhibited as ex.a1 to a3, on behalf of opposite parties ex.b1 to b25, were exhibited. in addition, the 3rd complainant, has been examined as pw1. the 2nd opposite party was examined as rw1 and the 3rd opposite party was examined as rw2. based on the pleadings, and considering the documents produced on either side, the following points are framed for decision. 1. whether the opposite parties have committed negligent act, deficiency in service in not giving test dose, before administering ionic dye?whether the opposite parties have committed negligence and deficiency in service, while treating srinivas at the time of angioplasty?whether the opposite parties have followed the correct procedure in treating srinivas, following the protocol, taking care as prudent doctors, expected to be?whether srinivas, died due to medical negligence said to have been committed by the opposite parties?whether the complainants are entitled to compensation, if so to what amount, against which opposite party?9. point no.1 to 4  late a.j. srinivas, hereinafter called ‘patient, was admitted in the 1st opposite party hospital, on 14.12.1997, for angioplasty, since he had heart ailment. prior to that date, admittedly as pleaded in the written version, not under challenge, the patient approached the 1st opposite party on 14.8.97, and on that date, a diagnostic coronary angiogram was done, by the 2nd opposite party, a renowned cardiologist, qualification not under cloud. the angiogram, which was successfully completed, revealed two vessel coronary artery block, for which the 2nd opposite party advised the patient, to go for angioplasty, as early as possible. the patient taking angioplasty, as selective procedure, for the reasons best known to him, postponed the surgery, probably to attend a marriage in the family. after the said marriage, on 14.12.1997, the patient was admitted in the 1st opposite party hospital, where he was tested routinely, for pre catheterization, including other necessary test, as pleaded in the written version. after test and examination, when he was taken to cathlab for angioplasty, at 10.00 a.m on 15.12.97, the 2nd opposite party adopted the procedure, access to the heart was achieved. it appears there was some obstruction in omi, and to delineate the obstruction, the 2nd opposite party administered 5 ml. of ionic dye, which caused burning sensation to the patient, changing reddish colour also, over the face, front of his chest, which are the indications of anaphylaxis. the 2nd opposite party, as well as the 3rd opposite party, informing the events taken place, to the complainants, attempted their best to revive the heart, but fate was otherwise, resulting the death of the patient on the same day, at 11.30 p.m declared so. above facts are beyond controversy. the complainants who are the legal heirs of the patient, leveling many allegations, attributing medical negligence, wrong treatment, claimed a compensation of rs.2000000/-, which is opposed. 10. the learned counsel for the complainants urged before us, that before administering ionic dye, the 2nd opposite party should have given test dose, which he failed, should be construed as deficiency in service. a further submission was made, that even after the indication of anaphaylaxis procedure adopted by the opposite parties are unwarranted, and infact they have not followed the correct procedure, which also should be taken as medical negligence. it was also urged, without taking the patient to icu, treatment given in cathlab itself, improper. 11. per contra, submissions were made on behalf of the opposite parties, since originally test dose was given, no reaction, it may not be necessary once again to give test dose, before administering ionic dye, and in this case, even before adopting the procedure for angioplasty, test dose was given and since there was no reaction, a first dose, to delineate under omi, ionic dye was given, which cannot be faulted, since no complication had taken place previously. after the indication of anaphylaxis, not only the 2nd opposite party, but also the 3rd opposite party, and their teams have put all their best efforts to revive, but unfortunately they were unable to revive the heart, which cannot be termed as negligent act, and in support of the same, they drew our attention to some medical literature, enlightening the medical terms, and the procedure followed. 12. we feel it may be proper on our part to extract the same as such, in order to appreciate and ascertain the performance of the opposite parties, as available in the literature itself.  anaphylaxis: it is an iodiosyncratic reaction, manifest either locally or systemically, of a living body to any allergen (i.e) proteins, pollens, dust, snake venom, chemicals, drugs like penicillin and contract media, etc., this can cause any reaction from mild itching, redness, urticarial swellings to severe reaction like, kidney failure, respiratory distress, severe cardiovascular collapse (shock). trazograf ionic dye these are iodine based contract media (dye) which are opaque to x-rays. these universally used for studying the anatomy and flow in blood vessels anaphylaxis is sell documented on administration of these contrast materials (minor-major-catastrophic). coronary angiogram study of anatomy and distribution of heart arteries by injecting contrast (dye) media into them and passing x-rays through the body and filming the continuous moving images either on film or as computerized digital data on cds. percutaneous transluminal coronary angioplasty (ptca) this is a treatment for narrowing in coronary arteries (heart arteries) wherein a catheter mounted balloon is used to distend and dilate the artery. it does so by squeezing the atheroma (fat deposit) causing the narrowing. for these procedures alone, after taking angiogram, elsewhere in august 1999, the patient was admitted in hospital, in the month of december 1999. cath lab a catheterization laboratory is an integral part of the sterile cardiac surgical suite wherein catheterisation of the heart (passing thin tube called catheter into cavities and arteries of the heart) is performed for diagnostic studies like oxymetry, pressure studies, catheter lies, ventriculography and angiography. cardiopulmonary bypass this is a temporary diversion of all blood from the body to artificial heart and lung machine. this will facilitate stopping, temporarily, the heart and lung to perform surgery or give support. in short the work of the heart and lung are taken over temporarily by the machine. bearing in mind, the above definitions, or the procedures or explanation, the case should be scanned then and there. 13. burden of proof: in a case of medical negligence, the initial burden is upon the complainants to prove, that the treating doctors, failed to perform certain procedure or they have followed incorrect procedure, against the protocol, resulting complications. in the process adopted by the doctors, while treating the patient, any known complication had occurred on its own, then it may not be proper on our part, to fix any culpability or negligence, or deficiency in service, on the part of the doctor, and if we do so, taking into account the death of the patient alone, that will led to collapse of medical profession, which should be avoided, generally. from the material produced, we feel, this complainants failed in their duty. 14. legal principles in the celebrated judgement, rendered by the apex court, in jacob mathew case (2005 vi scc) page 1, a constitutional bench had an occasion to consider the medical negligence, pertaining to the criminal law, as well medical negligence , coming under the heading tort. while considering the nature of profession, as well as number of previous decisions, including other reported judgments, while dealing the case under medical negligence, coming under tort, it is observed “negligence in the context of the medical profession necessarily calls for a treatment with a difference. to infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. a case of occupational negligence is different from one of professional negligence. a simple lack of car, an error of judgement or an accident, is not proof of negligence on the part of a medical professional. so long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed”. 15. ordinarily, no doctor on earth will act against the interest of the patient, since that would affect their career. this point was also considered by the apex court, and it is said “no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. a single failure may cost him dear in his career. even in civil jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors. else it would be counter productive. simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur”. 16. it can be observed safely, that the doctors should have taken sufficient precautions, especially when they deal serious cases of touching the heart of a man, which alone gives movement, life, action and everything for a living person. that is why as we have already pointed out, if a doctor is to be blamed, prima-facie, then for that we should have evidence, which is lacking in this case, whether it is in the form of separate expert opinion, or in the form of any evidence, that could be taken from the case records maintained by the opposite parties, themselves, while giving treatment. here the doctrine of res ipsa loquitur cannot be made applicable, considering the complicity of the case, which we will discus infra. 17. the learned counsel for the opposite parties also brought to our notice many national commission decision, where it is repeatedly held, that the onus is on the complainant to prove the medical negligence or deficiency in service, and if no expert evidence and no challenge of treatment was brought, made out then it is impossible for the consumer forum, to accept the case of the complainant, only on the basis of something untoward incident had taken place, and in this view, in rishi pal sing and ors. vs. aligarh muslim university and another, reported in 2007 (1) cpr 433 (nc), it is held, that “where no evidence was led by complainant to show as to what should have been done by the op (medical attendant) which was not done or what was done, which should not have been done, the complainant about medical negligence is liable to fail” which is once again reiterated in n. krishna reddy vs. christian medical college and hospital, and another, reported in 2002 cpj 260 nc, where the important point decided was “medical negligence must be established and not presumed. in the absence of expert evidence on behalf of the complainant, no negligence or deficiency in service could be found against the affidavits filed by hospital and doctors”, following the dictum laid down by the supreme court in ajay gupta vs. dr. pradeep aggarwal and ors., reported in 2007 (3) cpr 117 (nc) “where the doctor followed established medical procedure in surgery, and treatment, then the doctor should not be held liable for negligence or deficiency in service. 18. it is also the settled position of law, no negligence can be attributed where the treating doctor has acted with a reasonable decree of skill, care and knowledge. here the skill or qualification of 2 and 3 opposite parties not questioned, even doubted. having the above principle in mind, now we have to see the case on hand. 19. cause of death:  the 1st complainants husband a.j. srinivas, who was treated in the hospital of the 1st opposite party, for angiogram, followed by angioplasty, expired on 15.12.97, due to “massive anaphylaxis contrast induced with severe cardiovascular collapse-with prolonged myocardial and pulmonary support”, admittedly as seen from the death certificate (ex.a1). in the discharge diagnose procedure also, issued by the opposite parties (ex.b23), the same is reiterated, indicating secondary procedure as “peritoneoul immolussive coronary angioplasty cardiopulmonary bypass with coronary artery bypass grafting”. there itself, the complication is noted as massive collapse. if the above things had happened due to the negligent act of the cardiologist, viz. 2nd opposite party or the surgeon viz. 3rd opposite party, we would not be hesitating to slap an order against them, for negligence, deficiency in service. 20. evidence on behalf of the complainant :  a case, was filed in 1999 claiming a sum of rs.20,00,000/- as compensation. on behalf of the complainant, except ex.a1 to a3, no other documents produced and except one of the complainant, who has no medical knowledge, no other person/ witness especially doctor, has been examined, as expert witness. in the complaint also, based upon the reply notice issued by the opposite party, general accusations were made, and no specific medical negligence was brought to our notice, by pleadings. thus, we would say unhesitatingly, that on behalf of the complainants, no sufficient, adequate, required evidence was produced to label the acts of the opposite parties, as negligent or deficiency in service, as repeatedly by courts. 21. submissions of the complainants:  the learned counsel for the complainants urged before us, that before administering ionic dye, no test doze was given, should be construed as most and important negligent act. a further submission was made, that the angioplasty was made, based upon the old angiogram, that should be also faulted as negligent act. further submissions were made, as if femoral bypass was no necessary, but performed, that should be construed as deficiency or negligence on the part of the opposite party. another attempt was also made to say that the opposite parties failed to furnish necessary records, further submitting that after anaphylaxis indication, the patient was not taken to the intensive care unit, whereas treatment said to have been given continued in the cath lab, which itself should be construed as deficiency. 22. on the other hand, the learned counsel for the opposite parties, drawing our attention to the various case records, maintained by them with reference to the treatment given to the patient from the month of august 1997, urged before us that at no point of time, opposite parties have committed any negligent act, and infact as qualified, skilled doctors, in their respective field, they adopted all precautionary measures, in their treatment, and when an unexpected incident had taken place, they followed all the necessary steps, as expected from the prudent doctor, to revive the heart, but failed, that cannot be termed as deficiency in service, as ruled by the national commission, as well as the apex court, inviting our attention also to the rulings quoted above. 23. reasons and conclusion, based on facts:- admittedly, as seen from ex.b1, on 13.8.1997, the patient approached the 1st opposite party/ hospital, where he was tested, taking angiogram. at the time of taking angiogram/procedure, as pleaded in the written version , 5 ml. of trazograf ionic dye was initially administered, and after confirming that there was no allergic reaction to the ionic dye, 120 ml. of ionic dye was then administered, and the angiogram was successfully completed, which is evidenced by ex.b1, not in dispute. in the complaint, though this fact was not elaborately pleaded, as seen from paragraph 1, taking of angiogram performed on 14.8.1997 was not challenged. therefore, we can safely come to the conclusion, that at the time of taking angiogram, ionic dye was administered cautiously, and that had not caused any problem, to the patient, in other words, he was not allergic or reactive creating any problem, and that is why the doctor have also empathetically pleaded in the written version, “angiogram was successfully completed”. for not performing angioplasty forthwith, the reasons given by the opposite parties, as given by the patient, are not very much clouded, by letting in any evidence, and very fact srinivasan approached the opposite party, in the month of december 1997, for angioplasty would itself suggest that he might have had some duties to perform, i.e., attending the marriage or performing the marriage, as the case may be, and that was the reason he postponed, and came to the hospital in the month of december 1997 for further treatment. 24. it is not the case of the complainant, or the opposite parties, that after taking angiogram, in the month of august 1997, any change had taken place in the blood vessels, or in the body, and therefore the doctors having any unquestionable clarification or doubt, had chosen to perform the angioplasty, without going for another angiogram, unnecessarily causing the pinch of the purse of mr.srinivasan, and his family members, which cannot be faulted. no evidence or literature was also brought to our notice, that new angiogram should be taken, like the nature of this case. so the submission of the learned counsel for complainant, as if on the basis of the old angiogram, angioplasty performed should be faulted, is not acceptable to us. 25. patient was admitted in the 1st opposite party hospital on 14.12.97 for ptca. as pleaded in the affidavit of the 2nd opposite party, it is the version of the opposite parties also, which is supported by the documents, the patient underwent routine pre-catheterization investigation, including testing for various medicines and die, before going for angioplasty. as pleaded by the 2nd opposite party, the team explained to the patient as well as family members, and obtained consent also, as seen from ex.b3=b21, not only that under ex.b4. the patient had given consent for operation, anesthetics and other medical services, not under challenge. further, informed consent was also obtained from mr. srinivasan, wherein he was explained the risk involved, and having had the knowledge of risk, he has also given consent, i.e., informed consent for ptca, as disclosed under ex.b22. 26. as rightly pointed out by the learned counsel for complainants, in the case record dt.14.12.97, we find no specific information, regarding test doze given on 14.12.97, or on 15.12.97. taking advantage of this fact, a submission was made that the opposite parties have committed deficiency in service, in not administering test doze of ionic die. but as seen from ex.b2, we find an entry regarding the test doze given on 12.8.97, on which date there was no reaction or allergic, as indicted by us supra, based upon ex.b1. the same ionic die was administered, as test doze of radio contrast medium, since the guiding catheter failed to move further, because of 99% obstruction of omi. at that time alone, as recorded in the cathlab incident report, the 2nd opposite party had noticed red flush creeping on to the face and chest, rashes over the face, and the patient was informed burning sensation as pleaded, which was rightly recognized by the 2nd opposite party, because of his rich experience, as” anaphylaxis shock” to the radio contrast medium. 27. effect of ionic die (trazograf ionic dye 76% (10gm) at later point of time, the 3rd opposite party reported the matter to the manufacturer of this medicine, who had re-analyzed the report, on the subject and confirmed, that there is nothing wrong in the medicine. they have also informed the doctor, that the effect of trazograf 76% also, when administered, which reads as seen from ex.b16, “it is reported that when given by intravenous route, the diatrizoates may cause various adverse reactions ranging from nausea, vomiting, flushing to convulsions, paralysis, cardiac respiratory failure etc. occasionally, anaphylactoid or hypersentivity reactions occur. death also been reported due to acute renal failure which may follow intravenous administration”. based upon certain reference, there also they have assured, that each and every batch of trazograph 76% is subjected to rigid testing fro sterility etc. thus it is seen, a tested / certified competent medicine was administered to the patient, and therefore in injecting the medicine in this case, i.e injecting ionic die cannot be perse faulted. the adverse effect of this also available in the literature, which reads under the heading “adverse effect and treatment” “many of the effects of ionic monomeric contrast media can be attributed to the high osmollity which is a feature of these agents; reducing the osmalality through altering the ionic or molecular profile produces a reduced incidence of adverse effects. the route and sped of administration, and the volume, concentration and viscosity of the solution also affect the incidence of adverse effects. most reactions occur within 5 to 10 minutes of injection, but they may be delayed”, and we find in the literature, what are the precautions to be adopted also. therefore, the allergic reaction, which had taken place when administrated, that too intially test doze of 5 ml. cannot be per se faulted, as negligent act, or deficiency in service, which is the usual practice, to delineate the obstruction on omi, which is also certified by the “international heart institute of montana”. therefore, under the above said circumstances, we are unable to find fault with the 2nd opposite party, in administering 5 ml., of ionic die, as first dose to delineate the obstruction in omi. the doctor, being best judge, in their field, that too, while handling the patients, thought fit, in view of the previous test dose given to the patient, it may not be necessary to go for once again, since they have applied the same kind of medicine to the patient to delineate the obstruction in omi, and that is why in the record also it is noted, on 12.8.97, test doe was given. no literature was brought to our notice, that each and every time, test doze of this kind should be administered, that too when the patient was in the table of cathlab when the doctor accessing to the heart through femoral artery and vain. for these reasons, injecting or administering ionic at 10.30 am on 15.12.97, following indication of anaphylaxis, we are unable to fix any negligent act, or deficiency in service, on the part of the 2nd opposite party, who alone did this. 28. after anaphylaxis treatment adopted any deficiency? the learned counsel for the petitioners, though made an operative attempt to argue, that the subsequent procedure followed by opposite parties 2 and 3, were incorrect, we find no materials to suport. pw1 has not spoken anything about the treatment, given by the opposite parties 2 and 3, and infact he is incompetent. immediately, after the indication of anaphylaxis and blood pressure falling, that too, when there was no signs of ischemia, the 2nd opposite party resuscitate the late srinivasan by administering anti-anaphylaxis drugs, inotrophic drugs, including administering other medicines, through already inserted catheters, followed by cardiac massage. it is the specific case of the 2nd opposite party, that the incident was reported to the relatives of the patient also, and we find no reason to ignore this plea. a relative doctor of the complainant was present throughout, and he was also informed about the condition of the patient, who in turn informed to the complainants, is the case of opposite parties 2 and 3, not rebutted by filing any affidavit, by the said doctor. 29. the 2nd opposite party unable to manage the situation/ problems, immediately summoned the 3rd opposite party, who is a cardio thoracic surgeon. he has filed an affidavit, stating that the 2nd opposite party commenced closed chest massage to sustain circulation, and they commenced the procedure of intubation by endotrcheal tube to provide oxygen and mechanical ventilation. he has further sworn in the affidavit, at the request of the 2nd opposite party, he and his surgical team, instituted cardio vascular support initially, by intra aortic balloon pump, which is a heart support devise, later they adopted femoral cardio pulmonary bypass in accordance with standard resuscitation procedures to provide adequate systematic profusion. thus, he explained what are the procedure to be followed, in the case of this nature, and what are the procedure he and his team have followed, which are also supported by the affidavit of the 2nd opposite party, not only that, as witnesses also, they have informed this commission, about the nature of treatment required, nature of treatment given, not committing any deviation not erased. rw1 and rwii, where subjected to cross examination, by complainant. during the cross examination also, nothing has been elicited to infer suggestively atleat, they should have committed some deviation, at some point of time, elsewhere. the learned counsel for complainant, taking advantage of some reference, regarding control room, which was not supported by rwii, attempted to argue, that immediate attention was not given, and we are unable to accept this argument. everything had taken place, admittedly in the cathlab, which form part of sterile, cardiac surgical suit, as indicated above. to support the life, to revive the heart and solve the problems, as far as possible, all the necessary equipments are available, or could be made available, within no time, since cath lab or catheterization laboratory, is an integral part of the highly cardiac surgical suit, and therefore not taking the patient to icu, we cannot attribute negligence, or deficiency in service. icu is meant for taking proper care, after treatment, such as operative or angioplasty, where except constant monitoring, other life saving equipments necessary for surgery, may not be available. therefore, the submission of the learned counsel for complainant, that the opposite party failed to take the patient to icu, has no relevance at all, in this case. 30. the competency or the qualification of the doctors, viz. opposite parties 2 and 3, are not at all challenged, which is well explained in their affidavit also. such qualified persons/ doctors, when the patient was attacked by anaphylaxis, had bestowed their best attention, sraining their nerves, including surgery to revive fighting, struggling for more than 11 hours, but unfortunately the end of the patient came, for which if at all we can accuse the fate, if we have faith, not the doctors, who did their best, to save their patient. the procedures adopted by 2nd and 3rd opposite parties were also, stage by stage noted in the case records, and the case records, maintained by the nurses also would reveal that the patient had no problem, prior to angioplasty. thus based upon the hope, being the skilled doctor, they have attempted to solve the blockage, and unfortunately, unforeseen incident complication had taken place, and when the doctors had shown their best skill, not deviating from any procedure, no negligence could be attributed to them, as repeatedly, held by the apex court. 31. the records maintained by the doctors are also not challenged before us. when the doctors were cross examined by the complainant, it was not pointed out to them, with reference to the case record, that “so and so” procedure adopted by them, are against the standard procedure or outmoded procedure, that should be taken as medical negligence, leading to deficiency in service. 32. there appears to be, some dispute regarding the payment of medical bill, which we are not very much concerned in this case. for the non-payment of the medical bill, or stopping the payment of cheque, the 1st opposite party had filed a suit, and it is also said a decree has been obtained, which is questioned, as unethical, and we refrain from giving any finding on this point, which cannot be the subject matter of the consumer forum. thus analyzing the case from all probable and possible angle, applying the settled proposition of law, though the complainants 2 and 3 had lost their father, during angioplasty, we are unable to fix any culpability or negligent act or deficiency of service, on the part of the opposite parties, and in this view, only on the basis of the death alone, no question of compensation or refund of medical expenses would arise in the absence of proof for medical negligence. hence concluding that the opposite parties have not committed any medical negligence or deficiency in service, while treating srinivas. and srinivas had not met the death due to any medical negligence, we answer the points 1 to 4 against the complainants. 33. point no.5 in view of our findings on point no.1 to 4, the complainants are not entitled to any amount for the damage, loss of earning, mental agony, and hence this point is answered, in the negative. 34. in the result, the complaint is dismissed. under the facts and circumstances of the case, there will be no order as to cost.

Judgment:

This petition coming before us for hearing finally on 25.04.2011. Upon hearing the arguments of the counsels on both sides, perusing the material papers on records, this commission made the following order:

M. THANIKACHALAM J, PRESIDENT

1. This is a complaint filed under Sec.15 of the Consumer Protection Act, claiming a compensation of Rs.20 lakhs, on the basis of medical negligence and deficiency in service.

2. Brief facts necessary for the disposal of the case:

 The husband of the 1^st complainant (deceased) viz. Srinivasan, father of the complainants 2 and 3, was admitted in the 1^st opposite party hospital, on 14.12.97, for medical investigation. Even prior to that, diagnostic angiogram was performed on 14.8.1997, and on that basis alone, angioplasty was performed, in the month of December 1997. Thus the opposite parties are guilty of negligence, even in the initial stage.

3. The 2^nd opposite party, who treated Srinivasan, has administered straightaway Ionic dye, resulting the fatality. Because of the negligence committed viz. without giving test doze, ironic die of 5 ml., was administered, it caused problem resulting anaphylaxis, preceding falling of blood pressure. For 12 hours, though the opposite parties have attempted to revive the heart, including femoral Femoral cardio pulmonary bypass, which was not necessary and even not taking to ICU, where as attended only at cath lab, they were unable to save the life of Srinivasan, thereby all the opposite parties have committed deficiency in service, failing to adopt the expected standard of care, ane even they have not informed the problem to complainants, further they have also failed to furnish the records to the complainants, despite notice issued. Thus it is clear, due to the negligence and improper treatment of the opposite parties, Srinivasan died, leaving behind the complainants, causing mental agony, loss of earning etc., for which the complainants are entitled to a sum of RS.2000000/-, as a whole. Thus claiming, a consumer complaint was filed before this commission.

4. The defence (by all the opposite parties) in brief as follows:

Thiru. A.J. Srinivas, visited the first opposite party, as an out patient in September 1996, thereafter, he came to the 1^st opposite party on 14.8.1997. A diagnostic coronary angiogram was done by the 2^nd opposite party, administering 5 ml. of trazograf ionic dye, after confirming that there was no allergic reaction to the ionic dye, then administering 120 ml. of ionic dye, thereby angiogram was successfully completed, which revealed two vessel coronary artery block. Despite advise given for angioplasty, at the request of Mr. Srinivas, since he has to attend some wedding inthe family, it was postponed, which was known to his relatives, by name Dr. Jayaprakash, and Premkumar, who accompanied Dr. Srinivas

5.  On 14.12.97, for Percutaneous Transluminal Coronary Angioplasty (PTCA), he underwent pre-catheterisation investigation, including testing for various medicines and dye. Following the procedure, Srinivas wheeled in, for angioplasty on15.12.97 at 10.00 a.m, wherein access to the heart was achieved, and the 2^nd opposite party administered 5 ml of ionic dye at 10.30 a.m., as a first dose, to delineate the obstruction in Obtuse Marginal I Branch of Circumflex (OM1). At that time, Srinivas complained burning sensation, indicating, reddish discoloration etc., it was clear indication of anaphylaxis.

6. The 2^nd opposite party tried to resuscitate Srinivass heart, by administering anti-anaphalysis drug through, already inserted catheter and later by cardiac massage, which was informed to the relatives of Srinivas, through Dr.Jayaprakash. The BP of Srinivas kept falling despite administering anti anaphylaxis measure and inotropic drugs, and closed chest massage was started to sustain circulation. All the attempts to revive the heart, was not successful, and therefore a surgical team lead by 3^rd opposite party, instituted femoro femoral cardio-pulmonary by pass support, and to provide better flow rate, chest was opened and conventional CPBP instituted, using right artrial to ascending aortic cannulation. Even thereafter for continuous 12 hours attempt, as prudent doctors, the function failed, and the patient was declared dead 11.30 p.m on 15.12.97. During the entire 13 hours of medical emergency, both the 2^nd and 3^rd opposite parties, have put in tremendous effort and medical acumen, to save the life of Srinivas, they were unable to rectify the same, despite advanced life support used at the time of byepass. Therefore, the averments in the complaint, that they have not been informed, and test dose was not given, are all imaginary. In the case of extreme sensitivity, even a test dose dye is enough to claim the life of the patient, and in this view also, non-giving of the test dose even assuming, cannot be faulted, in the case of Srinivas, as negligence. At any point of time, the opposite parties have not committed any breach of duty, as a practicing cardiologist, for the past 20 years, having held several position, in various Government medical colleges.

7.  Femoral Bye pass, cannot be faulted, since it was done, when the other attempts had failed, that too, when the patients cardio pulmonary system was failing. The fact that Srinivas died, does not mean that the doctors have committed negligent or deficiency in service. As seen from the pleadings, ignorance of knowledge of disease, and procedures on the part of the complainants, cannot be construed as negligence, and willful deficiency in the service of the opposite parties, warranting any compensation. The complainants have not paid for any medicine, or blood used for Srinivas, that can be seen, even from the statement of account. In fact, the complainants are actually due to pay a sum of Rs.1,70,312/-, being the amount due for the medical treatment rendered, for which notice was sent. The opposite parties and their medical teams, are extremely competitive and qualified, to perform the procedure adopted and no procedure could be faulted and infact not faulted by the complainant, thereby showing there was no deficiency in service. Hence the claim of the complainants, for exorbitant amount, lodged on vexatious unfounded plea, should be dismissed, with exemplary cost.

8. The parties have filed affidavits, and on behalf of the complainants three documents were exhibited as Ex.A1 to A3, on behalf of opposite parties Ex.B1 to B25, were exhibited. In addition, the 3^rd complainant, has been examined as PW1. The 2^nd opposite party was examined as RW1 and the 3^rd opposite party was examined as RW2. Based on the pleadings, and considering the documents produced on either side, the following points are framed for decision.

1. Whether the opposite parties have committed negligent act, deficiency in service in not giving test dose, before administering ionic dye?

1. Whether the opposite parties have committed negligence and deficiency in service, while treating Srinivas at the time of angioplasty?
2. Whether the opposite parties have followed the correct procedure in treating Srinivas, following the protocol, taking care as prudent doctors, expected to be?
3. Whether Srinivas, died due to medical negligence said to have been committed by the opposite parties?
4. Whether the complainants are entitled to compensation, if so to what amount, against which opposite party?

9. POINT No.1 to 4

 Late A.J. Srinivas, hereinafter called ‘patient, was admitted in the 1^st opposite party hospital, on 14.12.1997, for angioplasty, since he had heart ailment. Prior to that date, admittedly as pleaded in the written version, not under challenge, the patient approached the 1^st opposite party on 14.8.97, and on that date, a diagnostic coronary angiogram was done, by the 2^nd opposite party, a renowned cardiologist, qualification not under cloud. The angiogram, which was successfully completed, revealed two vessel coronary artery block, for which the 2^nd opposite party advised the patient, to go for angioplasty, as early as possible. The patient taking angioplasty, as selective procedure, for the reasons best known to him, postponed the surgery, probably to attend a marriage in the family. After the said marriage, on 14.12.1997, the patient was admitted in the 1^st opposite party hospital, where he was tested routinely, for pre catheterization, including other necessary test, as pleaded in the written version. After test and examination, when he was taken to cathlab for angioplasty, at 10.00 a.m on 15.12.97, the 2^nd opposite party adopted the procedure, access to the heart was achieved. It appears there was some obstruction in OMI, and to delineate the obstruction, the 2^nd opposite party administered 5 ml. of ionic dye, which caused burning sensation to the patient, changing reddish colour also, over the face, front of his chest, which are the indications of anaphylaxis. The 2^nd opposite party, as well as the 3^rd opposite party, informing the events taken place, to the complainants, attempted their best to revive the heart, but fate was otherwise, resulting the death of the patient on the same day, at 11.30 p.m declared so. Above facts are beyond controversy. The complainants who are the legal heirs of the patient, leveling many allegations, attributing medical negligence, wrong treatment, claimed a compensation of Rs.2000000/-, which is opposed.

10. The learned counsel for the complainants urged before us, that before administering ionic dye, the 2^nd opposite party should have given test dose, which he failed, should be construed as deficiency in service. A further submission was made, that even after the indication of anaphaylaxis procedure adopted by the opposite parties are unwarranted, and infact they have not followed the correct procedure, which also should be taken as medical negligence. It was also urged, without taking the patient to ICU, treatment given in cathlab itself, improper.

11. Per contra, submissions were made on behalf of the opposite parties, since originally test dose was given, no reaction, it may not be necessary once again to give test dose, before administering ionic dye, and in this case, even before adopting the procedure for angioplasty, test dose was given and since there was no reaction, a first dose, to delineate under OMI, ionic dye was given, which cannot be faulted, since no complication had taken place previously. After the indication of anaphylaxis, not only the 2^nd opposite party, but also the 3^rd opposite party, and their teams have put all their best efforts to revive, but unfortunately they were unable to revive the heart, which cannot be termed as negligent act, and in support of the same, they drew our attention to some medical literature, enlightening the medical terms, and the procedure followed.

12. We feel it may be proper on our part to extract the same as such, in order to appreciate and ascertain the performance of the opposite parties, as available in the literature itself.

 Anaphylaxis:

It is an iodiosyncratic reaction, manifest either locally or systemically, of a living body to any allergen (i.e) proteins, pollens, dust, snake venom, chemicals, drugs like penicillin and contract media, etc., This can cause any reaction from mild itching, redness, urticarial swellings to severe reaction like, kidney failure, respiratory distress, severe cardiovascular collapse (shock).

Trazograf ionic dye

These are iodine based contract media (dye) which are opaque to X-rays. These universally used for studying the anatomy and flow in blood vessels

Anaphylaxis is sell documented on administration of these contrast materials (Minor-Major-Catastrophic).

Coronary Angiogram

Study of anatomy and distribution of heart arteries by injecting contrast (dye) media into them and passing X-rays through the body and filming the continuous moving images either on film or as computerized digital data on CDs.

Percutaneous Transluminal Coronary Angioplasty (PTCA)

This is a treatment for narrowing in coronary arteries (Heart arteries) wherein a catheter mounted balloon is used to distend and dilate the artery. It does so by squeezing the atheroma (fat deposit) causing the narrowing.

For these procedures alone, after taking angiogram, elsewhere in August 1999, the patient was admitted in hospital, in the month of December 1999.

Cath Lab

A catheterization laboratory is an integral part of the sterile cardiac surgical suite wherein catheterisation of the heart (passing thin tube called catheter into cavities and arteries of the heart) is performed for diagnostic studies like Oxymetry, pressure studies, catheter lies, ventriculography and angiography.

Cardiopulmonary Bypass

This is a temporary diversion of all blood from the body to artificial heart and lung machine. This will facilitate stopping, temporarily, the heart and lung to perform surgery or give support. In short the work of the heart and lung are taken over temporarily by the machine.

Bearing in mind, the above definitions, or the procedures or explanation, the case should be scanned then and there.

13. Burden of Proof:

In a case of medical negligence, the initial burden is upon the complainants to prove, that the treating doctors, failed to perform certain procedure or they have followed incorrect procedure, against the protocol, resulting complications. In the process adopted by the doctors, while treating the patient, any known complication had occurred on its own, then it may not be proper on our part, to fix any culpability or negligence, or deficiency in service, on the part of the doctor, and if we do so, taking into account the death of the patient alone, that will led to collapse of medical profession, which should be avoided, generally. From the material produced, we feel, this complainants failed in their duty.

14. LEGAL PRINCIPLES

In the celebrated judgement, rendered by the Apex Court, in Jacob Mathew case (2005 VI SCC) page 1, a Constitutional Bench had an occasion to consider the medical negligence, pertaining to the criminal law, as well medical negligence , coming under the heading tort. While considering the nature of profession, as well as number of previous decisions, including other reported judgments, while dealing the case under medical negligence, coming under tort, it is observed “Negligence in the context of the medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of car, an error of judgement or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed”.

15. Ordinarily, no doctor on earth will act against the interest of the patient, since that would affect their career. This point was also considered by the Apex Court, and it is said “no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors. Else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur”.

16. It can be observed safely, that the doctors should have taken sufficient precautions, especially when they deal serious cases of touching the heart of a man, which alone gives movement, life, action and everything for a living person. That is why as we have already pointed out, if a doctor is to be blamed, prima-facie, then for that we should have evidence, which is lacking in this case, whether it is in the form of separate expert opinion, or in the form of any evidence, that could be taken from the case records maintained by the opposite parties, themselves, while giving treatment. Here the doctrine of res ipsa loquitur cannot be made applicable, considering the complicity of the case, which we will discus infra.

17. The learned counsel for the opposite parties also brought to our notice many National Commission decision, where it is repeatedly held, that the onus is on the complainant to prove the medical negligence or deficiency in service, and if no expert evidence and no challenge of treatment was brought, made out then it is impossible for the consumer forum, to accept the case of the complainant, only on the basis of something untoward incident had taken place, and in this view, in Rishi Pal Sing and Ors. Vs. Aligarh Muslim University and Another, reported in 2007 (1) CPR 433 (NC), it is held, that “Where no evidence was led by complainant to show as to what should have been done by the OP (Medical attendant) which was not done or what was done, which should not have been done, the complainant about medical negligence is liable to fail” which is once again reiterated in N. Krishna Reddy Vs. Christian Medical College and Hospital, and another, reported in 2002 CPJ 260 NC, where the important point decided was “Medical negligence must be established and not presumed. In the absence of expert evidence on behalf of the complainant, no negligence or deficiency in service could be found against the affidavits filed by Hospital and doctors”, following the dictum laid down by the Supreme Court in Ajay Gupta Vs. Dr. Pradeep Aggarwal and Ors., reported in 2007 (3) CPR 117 (NC) “Where the doctor followed established medical procedure in surgery, and treatment, then the doctor should not be held liable for negligence or deficiency in service.

18. It is also the settled position of law, no negligence can be attributed where the treating doctor has acted with a reasonable decree of skill, care and knowledge. Here the skill or qualification of 2 and 3 opposite parties not questioned, even doubted. Having the above principle in mind, now we have to see the case on hand.

19. Cause of death:

 The 1^st complainants husband A.J. Srinivas, who was treated in the hospital of the 1^st opposite party, for angiogram, followed by angioplasty, expired on 15.12.97, due to “massive Anaphylaxis Contrast induced with severe cardiovascular collapse-with prolonged myocardial and pulmonary support”, admittedly as seen from the death certificate (Ex.A1). In the discharge diagnose procedure also, issued by the opposite parties (Ex.B23), the same is reiterated, indicating secondary procedure as “Peritoneoul immolussive Coronary Angioplasty cardiopulmonary Bypass with coronary artery bypass grafting”. There itself, the complication is noted as massive collapse. If the above things had happened due to the negligent act of the cardiologist, viz. 2^nd opposite party or the surgeon viz. 3rd opposite party, we would not be hesitating to slap an order against them, for negligence, deficiency in service.

20. Evidence on behalf of the complainant :

 A case, was filed in 1999 claiming a sum of Rs.20,00,000/- as compensation. On behalf of the complainant, except Ex.A1 to A3, no other documents produced and except one of the complainant, who has no medical knowledge, no other person/ witness especially doctor, has been examined, as expert witness. In the complaint also, based upon the reply notice issued by the opposite party, general accusations were made, and no specific medical negligence was brought to our notice, by pleadings. Thus, we would say unhesitatingly, that on behalf of the complainants, no sufficient, adequate, required evidence was produced to label the acts of the opposite parties, as negligent or deficiency in service, as repeatedly by courts.

21. Submissions of the complainants:

 The learned counsel for the complainants urged before us, that before administering ionic dye, no test doze was given, should be construed as most and important negligent act. A further submission was made, that the angioplasty was made, based upon the old angiogram, that should be also faulted as negligent act. Further submissions were made, as if femoral bypass was no necessary, but performed, that should be construed as deficiency or negligence on the part of the opposite party. Another attempt was also made to say that the opposite parties failed to furnish necessary records, further submitting that after anaphylaxis indication, the patient was not taken to the intensive care unit, whereas treatment said to have been given continued in the cath lab, which itself should be construed as deficiency.

22. On the other hand, the learned counsel for the opposite parties, drawing our attention to the various case records, maintained by them with reference to the treatment given to the patient from the month of August 1997, urged before us that at no point of time, opposite parties have committed any negligent act, and infact as qualified, skilled doctors, in their respective field, they adopted all precautionary measures, in their treatment, and when an unexpected incident had taken place, they followed all the necessary steps, as expected from the prudent doctor, to revive the heart, but failed, that cannot be termed as deficiency in service, as ruled by the National Commission, as well as the Apex Court, inviting our attention also to the rulings quoted above.

23. Reasons and conclusion, based on facts:-

Admittedly, as seen from Ex.B1, on 13.8.1997, the patient approached the 1^st opposite party/ hospital, where he was tested, taking angiogram. At the time of taking angiogram/procedure, as pleaded in the written version , 5 ml. of Trazograf Ionic Dye was initially administered, and after confirming that there was no allergic reaction to the ionic dye, 120 ml. of ionic dye was then administered, and the angiogram was successfully completed, which is evidenced by Ex.B1, not in dispute. In the complaint, though this fact was not elaborately pleaded, as seen from paragraph 1, taking of angiogram performed on 14.8.1997 was not challenged. Therefore, we can safely come to the conclusion, that at the time of taking angiogram, ionic dye was administered cautiously, and that had not caused any problem, to the patient, in other words, he was not allergic or reactive creating any problem, and that is why the doctor have also empathetically pleaded in the written version, “angiogram was successfully completed”. For not performing angioplasty forthwith, the reasons given by the opposite parties, as given by the patient, are not very much clouded, by letting in any evidence, and very fact Srinivasan approached the opposite party, in the month of December 1997, for angioplasty would itself suggest that he might have had some duties to perform, i.e., attending the marriage or performing the marriage, as the case may be, and that was the reason he postponed, and came to the hospital in the month of December 1997 for further treatment.

24. It is not the case of the complainant, or the opposite parties, that after taking angiogram, in the month of August 1997, any change had taken place in the blood vessels, or in the body, and therefore the doctors having any unquestionable clarification or doubt, had chosen to perform the angioplasty, without going for another angiogram, unnecessarily causing the pinch of the purse of Mr.Srinivasan, and his family members, which cannot be faulted. No evidence or literature was also brought to our notice, that new angiogram should be taken, like the nature of this case. So the submission of the learned counsel for complainant, as if on the basis of the old angiogram, angioplasty performed should be faulted, is not acceptable to us.

25. Patient was admitted in the 1^st opposite party hospital on 14.12.97 for PTCA. As pleaded in the affidavit of the 2^nd opposite party, it is the version of the opposite parties also, which is supported by the documents, the patient underwent routine pre-catheterization investigation, including testing for various medicines and die, before going for angioplasty. As pleaded by the 2^nd opposite party, the team explained to the patient as well as family members, and obtained consent also, as seen from Ex.B3=B21, not only that under Ex.B4. The patient had given consent for operation, anesthetics and other medical services, not under challenge. Further, informed consent was also obtained from Mr. Srinivasan, wherein he was explained the risk involved, and having had the knowledge of risk, he has also given consent, i.e., informed consent for PTCA, as disclosed under Ex.B22.

26. As rightly pointed out by the learned counsel for complainants, in the case record dt.14.12.97, we find no specific information, regarding test doze given on 14.12.97, or on 15.12.97. Taking advantage of this fact, a submission was made that the opposite parties have committed deficiency in service, in not administering test doze of ionic die. But as seen from Ex.B2, we find an entry regarding the test doze given on 12.8.97, on which date there was no reaction or allergic, as indicted by us supra, based upon Ex.B1. The same ionic die was administered, as test doze of radio contrast medium, since the guiding catheter failed to move further, because of 99% obstruction of OMI. At that time alone, as recorded in the cathlab incident report, the 2^nd opposite party had noticed red flush creeping on to the face and chest, rashes over the face, and the patient was informed burning sensation as pleaded, which was rightly recognized by the 2^nd opposite party, because of his rich experience, as” anaphylaxis shock” to the radio contrast medium.

27. Effect of ionic die (Trazograf ionic dye 76% (10gm)

At later point of time, the 3^rd opposite party reported the matter to the manufacturer of this medicine, who had re-analyzed the report, on the subject and confirmed, that there is nothing wrong in the medicine. They have also informed the doctor, that the effect of Trazograf 76% also, when administered, which reads as seen from Ex.B16, “It is reported that when given by intravenous route, the diatrizoates may cause various adverse reactions ranging from nausea, vomiting, flushing to convulsions, paralysis, cardiac respiratory failure etc. Occasionally, anaphylactoid or hypersentivity reactions occur. Death also been reported due to acute renal failure which may follow intravenous administration”. Based upon certain reference, there also they have assured, that each and every batch of Trazograph 76% is subjected to rigid testing fro sterility etc. Thus it is seen, a tested / certified competent medicine was administered to the patient, and therefore in injecting the medicine in this case, i.e injecting ionic die cannot be perse faulted. The adverse effect of this also available in the literature, which reads under the heading “adverse effect and treatment” “Many of the effects of ionic monomeric contrast media can be attributed to the high osmollity which is a feature of these agents; reducing the osmalality through altering the ionic or molecular profile produces a reduced incidence of adverse effects. The route and sped of administration, and the volume, concentration and viscosity of the solution also affect the incidence of adverse effects. Most reactions occur within 5 to 10 minutes of injection, but they may be delayed”, and we find in the literature, what are the precautions to be adopted also. Therefore, the allergic reaction, which had taken place when administrated, that too intially test doze of 5 ml. cannot be per se faulted, as negligent act, or deficiency in service, which is the usual practice, to delineate the obstruction on OMI, which is also certified by the “International heart institute of Montana”. Therefore, under the above said circumstances, we are unable to find fault with the 2^nd opposite party, in administering 5 ml., of ionic die, as first dose to delineate the obstruction in OMI. The doctor, being best judge, in their field, that too, while handling the patients, thought fit, in view of the previous test dose given to the patient, it may not be necessary to go for once again, since they have applied the same kind of medicine to the patient to delineate the obstruction in OMI, and that is why in the record also it is noted, on 12.8.97, test doe was given. No literature was brought to our notice, that each and every time, test doze of this kind should be administered, that too when the patient was in the table of cathlab when the doctor accessing to the heart through femoral artery and vain. For these reasons, injecting or administering ionic at 10.30 am on 15.12.97, following indication of anaphylaxis, we are unable to fix any negligent act, or deficiency in service, on the part of the 2^nd opposite party, who alone did this.

28. After anaphylaxis treatment adopted any deficiency?

The learned counsel for the petitioners, though made an operative attempt to argue, that the subsequent procedure followed by opposite parties 2 and 3, were incorrect, we find no materials to suport. PW1 has not spoken anything about the treatment, given by the opposite parties 2 and 3, and infact he is incompetent. Immediately, after the indication of anaphylaxis and blood pressure falling, that too, when there was no signs of ischemia, the 2^nd opposite party resuscitate the late Srinivasan by administering anti-anaphylaxis drugs, inotrophic drugs, including administering other medicines, through already inserted catheters, followed by cardiac massage. It is the specific case of the 2^nd opposite party, that the incident was reported to the relatives of the patient also, and we find no reason to ignore this plea. A relative doctor of the complainant was present throughout, and he was also informed about the condition of the patient, who in turn informed to the complainants, is the case of opposite parties 2 and 3, not rebutted by filing any affidavit, by the said doctor.

29. The 2^nd opposite party unable to manage the situation/ problems, immediately summoned the 3^rd opposite party, who is a Cardio Thoracic Surgeon. He has filed an affidavit, stating that the 2^nd opposite party commenced closed chest massage to sustain circulation, and they commenced the procedure of intubation by endotrcheal tube to provide oxygen and mechanical ventilation. He has further sworn in the affidavit, at the request of the 2^nd opposite party, he and his surgical team, instituted cardio vascular support initially, by intra aortic balloon pump, which is a heart support devise, later they adopted femoral cardio pulmonary bypass in accordance with standard resuscitation procedures to provide adequate systematic profusion. Thus, he explained what are the procedure to be followed, in the case of this nature, and what are the procedure he and his team have followed, which are also supported by the affidavit of the 2^nd opposite party, not only that, as witnesses also, they have informed this commission, about the nature of treatment required, nature of treatment given, not committing any deviation not erased. RW1 and RWII, where subjected to cross examination, by complainant. During the cross examination also, nothing has been elicited to infer suggestively atleat, they should have committed some deviation, at some point of time, elsewhere. The learned counsel for complainant, taking advantage of some reference, regarding control room, which was not supported by RWII, attempted to argue, that immediate attention was not given, and we are unable to accept this argument. Everything had taken place, admittedly in the cathlab, which form part of sterile, cardiac surgical suit, as indicated above. To support the life, to revive the heart and solve the problems, as far as possible, all the necessary equipments are available, or could be made available, within no time, since cath lab or catheterization laboratory, is an integral part of the highly cardiac surgical suit, and therefore not taking the patient to ICU, we cannot attribute negligence, or deficiency in service. ICU is meant for taking proper care, after treatment, such as operative or angioplasty, where except constant monitoring, other life saving equipments necessary for surgery, may not be available. Therefore, the submission of the learned counsel for complainant, that the opposite party failed to take the patient to ICU, has no relevance at all, in this case.

30. The competency or the qualification of the doctors, viz. Opposite parties 2 and 3, are not at all challenged, which is well explained in their affidavit also. Such qualified persons/ doctors, when the patient was attacked by anaphylaxis, had bestowed their best attention, sraining their nerves, including surgery to revive fighting, struggling for more than 11 hours, but unfortunately the end of the patient came, for which if at all we can accuse the fate, if we have faith, not the doctors, who did their best, to save their patient. The procedures adopted by 2^nd and 3^rd opposite parties were also, stage by stage noted in the case records, and the case records, maintained by the nurses also would reveal that the patient had no problem, prior to angioplasty. Thus based upon the hope, being the skilled doctor, they have attempted to solve the blockage, and unfortunately, unforeseen incident complication had taken place, and when the doctors had shown their best skill, not deviating from any procedure, no negligence could be attributed to them, as repeatedly, held by the Apex Court.

31. The records maintained by the doctors are also not challenged before us. When the doctors were cross examined by the complainant, it was not pointed out to them, with reference to the case record, that “so and so” procedure adopted by them, are against the standard procedure or outmoded procedure, that should be taken as medical negligence, leading to deficiency in service.

32. There appears to be, some dispute regarding the payment of medical bill, which we are not very much concerned in this case. For the non-payment of the medical bill, or stopping the payment of cheque, the 1^st opposite party had filed a suit, and it is also said a decree has been obtained, which is questioned, as unethical, and we refrain from giving any finding on this point, which cannot be the subject matter of the consumer forum. Thus analyzing the case from all probable and possible angle, applying the settled proposition of law, though the complainants 2 and 3 had lost their father, during angioplasty, we are unable to fix any culpability or negligent act or deficiency of service, on the part of the opposite parties, and in this view, only on the basis of the death alone, no question of compensation or refund of medical expenses would arise in the absence of proof for medical negligence. Hence concluding that the opposite parties have not committed any medical negligence or deficiency in service, while treating Srinivas. and Srinivas had not met the death due to any medical negligence, we answer the points 1 to 4 against the complainants.

33. Point No.5

In view of our findings on point No.1 to 4, the complainants are not entitled to any amount for the damage, loss of earning, mental agony, and hence this point is answered, in the negative.

34. In the result, the complaint is dismissed. Under the facts and circumstances of the case, there will be no order as to cost.