National Consumer Disputes Redressal
Basudeo Prasad Maheshwari Ors. vs Indraprastha Apollo Hospitals And Ors. on 15 April, 2008
Equivalent citations: 3(2008)CPJ34(NC)
ORDER
B.K. Taimni, Member
1. This complaint has been filed by the complainant, Basudeo Prasad Maheswari, alleging medical negligence on the part of the opposite parties, namely, Apollo Hospital and Dr. M.C. Garg.
2. Very briefly the case leading to filing the complaint were that the complainant went to the first opposite party hospital on 20.2.1998 complaining of breathlessness, where after he was referred to second opposite party Dr. M.C. Garg. His ECG was done and the complainant was asked to come next day and got Holter ECG done. The second opposite party after seeing the ECG, Holter ECG and blood test reports, advised the complainant to get a permanent pace maker implanted costing about Rs. 1,25,000. Since this much money was not immediately available, the complainant requested sometime to arrange for the funds, whereupon he left for home-town on 2.3.1998. While at Lalitpur, his home-town, the complainant felt pain in the left side of the chest, upon which he contacted Dr. Ashok Saxena, a family physician, who advised him to rush to Jhanshi to consult Dr. Praveen Kumar, a Heart Specialist, whereupon he was admitted in Happy Family Nursing Home, Jhanshi on 2.3.1998. The complainant received treatment from Dr. K.K. Gupta at this nursing home. Dr. Praveen Kumar was also called to examine the patient, who confirmed the heart attack and the treatment of MI was given. The condition of the complainant worsened further and the complainant suffered a second severe heartattack on 3.3.1998, which in medical terminology is known as Adam Stroke Syndrome, which is a very critical stage. It is the case of the complainant that on the advice of opposite party No. 2, the Nursing Home at Jhanshi moved him about 8 kms. away, where a temporary pace maker was implanted and was brought back to Happy Nursing Home the same day. It is the case of the complainant that after second MI, the walls of the heart got damaged permanently and the V.H. function of the heart got reduced to 35%. The complainant again approached the opposite party on 7.3.1998 where he was admitted to Intensive Cardiac Care Unit (ICCU) where his pace maker was removed and another temporary pace maker was fitted. His temperature shot-up, which could not be controlled in spite of high doses of multiple antibiotics. The fever continued and on 14.3.1998, despite seeing no respite/improvement in the complainant's condition, the complainant was discharged with the advice to come back after the fever had subsided for elective permanent pacing. On 30.3.1998 the complainant felt pain in the chest and the complainant's son contacted the second OP who advised him to get the ECG done for which Dr. R.N. Sainee was called, who advised to get Angiography done. Whereupon, the second OP was contacted on phone for Angiography but the second OP said that there is no possibility, as nurses of OP No. 1 were going on strike. In these circumstances, the complainant was got admitted in National Heart Institute, New Delhi for Angiography and discharged on 24.4.1998. In the Angiography's report it was mentioned that there were blockade in the coronary arteries to the extent of 90%, 80% and 70%, for which the complainant was advised by-pass surgery of the heart, which was got done at Escort Heart Research Institute on 15.4.1998. Specific instances of medical negligence have been mentioned in paras 16 to 19 of the complaint, which reads as follows:
16. That despite such high fever, the respondents discharged the complainant with the advice to return to the hospital after the fever had subsided for fitting of permanent pace maker through operation.
17. That when the complainant first contacted Dr. M.C. Garg on 20.2.1998, he failed to give proper advice and did not advise full tests such as Angiography. Moreover, before advising fitting of permanent pace maker, respondents did not make proper diagnosis which were very important to ascertain whether the permanent pace maker was really required for the complainant. No tests apart from Holter were got done and wrong advice was given in the most casual manner.
18. That the age and problems of the complainant required that the first test that should have been suggested by the respondent No. 2 ought to have been Angiography, which would have brought out the complete picture of the condition of the heart of the patient and saved him of two massive heart attacks and permanent damage to the walls of the heart which reduced the VH function of the hear, that he. underwent due to improper advice, and also saved him of the amount of physical and mental agony he had to undergo as a result of the same and also saved him and his relatives of the heavy financial losses that they underwent as a consequence of the aforesaid events. This gross negligence on the part of the respondent No. 2 resulted in wrong diagnosis due to which it could not be diagnosed that the heart of the complainant was having a major problem as all the three major vessels of the heart were having almost complete blockade. This wrong and negligent diagnosis of the respondent No. 2 resulted in two massive heart attacks to the complainant due to which he would have lost his life but for some skilful and timely treatment at Jhansi, a place about 90 kms. away from Lalitpur.
19. That had the respondents been careful and not grossly negligent, the complainant would have got all the possible tests performed, specially, Angiography to evaluate the condition of the complainant's heart and the complainant would have been able to get the By-pass Surgery done without having to suffer of two massive heart attacks, permanent damage to heart, resultant MI Psychosis and two surgeries for fitting of temporary pace makers which were not at all required. The real problem remained undiagnosed and the age of the complainant, i.e., 75 years, was not considered at which age any cardiac problem cannot be left undiagnosed and Angiography was most essential considering the age and nature of problem of the complainant. That the fact that no fitting of permanent pace maker was done as the same was not required after the By-pass Surgery was performed, goes into show that the diagnosis of the respondent No. 2 was totally wrong.
3. Thus, alleging medical negligence on the part of the opposite parties, this complaint has been filed praying for a compensation of Rs. 28 lakh.
4. Notice was issued to both the parties, who have filed their written versions.
5. In the written version filed by the OP No. 1, the allegations have been denied and it has been stated that answering opposite party is a multi-speciality hospital providing specialised diagnostic curative and surgical care in various disciplines. The hospital is equipped with the latest state of art technology and facilities. On merits, it is stated that the complainant first came to the hospital on 20.2.98 and he was examined by the opposite party No. 2 in OPD. It was observed through clinical impression that the complainant had sinus bradycardia with effort intolerance which required further evaluation and suggested ECG, T3, T4, TSH, 24 hours Holter monitoring, 2D echo Doppler, Haemogram, Urea, Electrolytes and Creatinine and liver functions test. He was reviewed on 24th February, 1998 when it was noted that thyroid functions (T3, T4, TSH) were normal and 24 hrs. Holter Monitoring has shown sinus pauses upto 2.4 sees. (Heart rate upto 25 beats/mt.) with minimum hourly heart rate at: 34/mt. and maximum 7 min., heart rate upto 145/mt. There were atrial premature beats, runs of atrial premature beats and occasional premature ventricular beats. All these findings were consistent with the diagnosis of sinus node dysfunction. It is pertinent to mention here that the sinus node in a human heart is the site of pulse generator and when it does not function properly, it manifests the way, the Holter report had shown. Therefore, the complainant was advised to undergo permanent pace maker implantation.
6. It was further stated that there was no cause for immediately going in for Angiography, as according to medical norms/practices world over, first of all, there were no scientific reasons and medical indications to suggest invasive procedure of coronary Angiography as the complainant did not present with any symptoms of chest pain of cardiac in nature, related to coronary artery disease. It was stated that the complainant was advised 2D echo Doppler as base line investigations as part of cardiac assessment, which the complainant failed to have at that stage for reasons best known to him. Nor did the complainant follow the advice of permanent pace maker implantation. On second admission on 7.3.1998 the complainant was febrile and the heart rate was 92/mt, regular, BP 150/100 mmHg. He was under sedation with by diazepam and his lungs showed bilateral crepts. The CVS examination showed presence of S4 and no other abnormal findings on systematic examination were noted.
7. He was treated properly and given necessary aid and since he was under high doses of antibiotics, the patient was discharged on 14.3.1998. It has been further stated that this was a case of systematic bacterial infection due to staphylococcus and the fever was due to staphylococcus and not due to malaria as alleged in the complaint. It is also their case that in whole of the complaint there is no allegation of medical negligence on the part of the first OP.
8. The second OP filed separate written version. In this written version besides taking preliminary objections, on merits, it has been stated that the complainant has not come with clean hands before this Commission for the simple reason that complainant did not follow the medical advice given in time and switched over to various Doctors, Nursing Homes and Hospitals for medical treatment in between. It was his case that he examined the patient and gave the advice as per accepted scientific and medical norms. It was also stated that the complainant had mentioned to the OP of being diagnosed as a case of Mitrol Valve Prolopse (MVP) in 1995. He did not have any complaints in relations to respiratory or gastrointestinal system and had stated that he is on medication as Aspirin 1 tablet a day. He was examined and his cardiac vascular system revealed heart rate of 48/mt., sinus rhythm and BP 140/90 mmHg. Heart sounds were normal and there was no additional heart sounds or murmur audible. Lungs were clear with normal breath sounds. Abdomen and Central Nervous System examinations were essentially normal clinically there were no features of hypothyroidism. This has given a clinical impression that it was sinus bradycardia with effort intolerance which required further evaluation. Therefore, the complainant was suggested ECG, T3, T4, TSH, 24 Hours Holter monitoring, 2D echo Doppler, Haemogram, Urea electrolytes and Creatinine, and liver functions tests. The second OP reviewed the complainant on 24.2.1998 when based on the available clinical tests reports, OP found that sinus pauses upto 2.4 sees, with atrial premature beats runs of atrial premature beats and occasional premature ventricular beats. Whole of these findings was consistent with the diagnosis of sinus node dysfunction. He further clarified that the sinus node in a human heart is the site of pulse generator and when it does not function properly, it manifests the way, the Holter report has shown. It is in this background that the complainant was advised to undergo for permanent pace maker. The complainant was also advised to have 2D echo Doppler, but this was not followed by the complainant. It is further stated that when the complainant again came on 7.3.1998 in the first OP hospital when his heart rate was 92/mt, regular, BP 150/100 mmHg. The complainant was under sedation by Diazepam. Lungs showed bilateral crepts. CVS examination showed presence of S4 and no other abnormal functions were seen on systemic examination. The patient was in febrile condition as the complainant was already on temporary pacing, he was put on nitroglycerin, heparin and other cardiac medications. In the meantime complainant was left under close monitoring and observations of his vital signs especially temperature trend. In view of this background of developing thrombophletis at I/V site on 4th March, 1998 and later developing psychiatric symptoms followed by retention of urine, the possibility of systemic infection with bacteraemia was kept in mind. While in hospital, he coughed up very dirty thick (infective) blood tinched sputum and continued to run Pyrexia. All the investigations were done for cause of pyrexia. Repeated urine culture, blood culture, sputum culture, Haemogram including for malarial parasite, LFT, urea Creatinine, Creatinine, cardiac enzyme. Haemogram repeatedly showed high leukocyte count with raised neutrophils and high ESR suggestive of acute bacterial infection but no malarial parasites was demonstrated in the blood film. Initially, complainant was started on I/V augmenting (antibiotic) but upto 10th March, 1998 as no growth was reported in blood culture and he continued to remain febrile, combinations of antibiotics were started to treat him aggressively, keeping in mind specially that infection is likely to be introduced through the I/V route earlier on 4th March when he developed thrombophlebitis with fever and was treated with antibiotics and again antibiotics were continued in vie w of developing retention of urine followed by catheterisation. In all probabilities, the organisms were not sensitive to the antibiotics, he received at that-early stage and infection continued which was manifested later, with abnormal psychiatric symptoms, which can happen in elderly with systemic infections followed by retention of urine for which he was done catheterisation. As he was already on antibiotic, the culture may not show any growth of bacteria and one has to do repeated cultures from various sites through which the infection is likely to enter into the body and that is why sputum culture of the complainant was sent which showed mixture of organisms of doubtful pathogenecity. Urine culture was done on 8th March, 1998 which showed growth of staphylococcus aureus and aerobic spore bearers. On 10th March, 1998, as at the temporary pace maker site some discharge was seen with surrounding skin area oedematous and erythematous, this pace maker lead was removed and another temporary pace maker lead was inserted through a new site (left groin), in order to control the infection and a swab was taken from the site which was sent for culture. As the swab culture report initially was suggestive of gram positive cocci growth, most likely to be due to staphylococcus, colxacillin was added in place of augmentin. The detailed swab culture report confirming the growth of staphylococcus aureus and sensitivity test for various antibiotics, dated 14th March, 1998 did not arrive in the ward, by the time the patient already left the hospital. Urine examination also snowed 12-15 pus cells per high power field.
9. In summary, the above result indicates that the complainant was having pyrexia due to staphylococcus aureus bacteraemia, with systemic manifestations of pneumonia, urinary tract infection and CNS symptoms of psychiatric manifestation. Such patients have to be treated aggressively with best-known contribution of antibiotic in this situation of acute myocardial infarction till one gets support from the laboratory about the organisms and their sensitivity by particular antibiotics.
10. It is the case of OP No. 2 that at no stage the complainant was complaining post myocardial infarction angina for which one would have thought of suggesting this investigation at an early date. During his stay at the hospital, complainant did not develop any features of cardiac failure either. He was discharged on 14.3.1998 on his request.
11. OP No. 1 denied ever receiving any call from the son of the complainant about the advice of Dr. Saini to get the Angiography done on 30.3.1998. It was specifically denied that the Angiography should be done and because of improper advice, patient had to suffer two massive heart attacks. Whatever was done by the OP was as per accepted medical norm and no case of medical negligence can be fastened against him.
12. Both the parties have filed the affidavits. Cross-examination was done through interrogatories of all the three parties. Written submissions along with medical literatures, have been filed by the both the parties.
13. We heard the complainant's son in person and learned Counsel for the opposite parties in extenso and perused the material on record.
14. We like to reproduce the specific instances of medical negligence alleged by the complainant in the 'synopsis' filed on behalf of the complainant which reads as under:
1. OP Nos. 1 and 2 failed to evaluate the exact cause of breathlessness of the complainant and wrongly advised him to have permanent pace-maker based merely on ECG, Blood Tests and 24 hours Halter Monitor Test (Ex. C-2). No other non-invasive cardiac tests, e.g., Trade Mill/Stress Thallium or Echo Cardiology which were basic cardiac tests were got done by him.
2. OP No. 2 failed to appreciate that breathlessness itself is a major symptom of heart disease and required proper investigation particularly so in a patient of 76 years.
3. OP No. 2 wrongly diagnosed that the complainant was suffering from sinus node dysfunction and required permanent pace maker whereas, complainant did not require any pace maker. Till date, no pace maker is fixed to the complainant. Had he followed the advise of OP Nos. 1 and 2, complainant would have remained exposed to heart attack and his ultimate death, since he did not need a pace maker at all.
15. Before us also three issues were framed by Mr. Hariom Maheswari, son of the complainant, who argued the case in person. The specific instances of medical negligence spelt out by him are:
1. That the opposite parties failed to diagnose the true condition of the heart;
2. That the opposite parties wrongly diagnosed that he had sinus node dysfunction and required pace maker with the result that within a short time the complainant had a massive heart attack; and that,
3. had Angiography been done earlier subsequent, events would have been avoided.
16. Before we deal with these issues, it may be germane to point out the contested stand of the parties on two issues before we take up the alleged issues of medical negligence.
17. The learned Counsel appearing for the OP No. 1 argued that the complainant was advised several tests like ECG, T3, T4, TSH, 24 hours Holter monitoring, 2D echo Doppler, Haemogram, Urea, Electrolytes and Creatinine and liver functions tests but the complainant never underwent any Doppler Test which was non-invasive in nature and would have given some indication of the status of the heart. This has been very forcefully stated in the written version filed by the opposite parties, as also in their affidavit filed by way of evidence as well as the argument advanced by the learned Counsel for the opposite parties.
18. It is the case of the complaint that they were never advised Doppler Test and what they were advised by opposite party No. 2 vide his prescription dated 24.2.1998, was "permanent pace maker implantation". Hence, there was no question of any Doppler Test got done. Having gone through the material on record, we find that in the written version filed by the OP Nos. 1 and 2, there is clear reference of OP No. 2 having suggested test for ECG, T3, T4, TSH, 24 hours Holter monitoring, 2D echo Doppler, Haemogram, Urea, Electrolytes and Creatinine and liver functions test. Admittedly, no rejoinder has been filed by the complainant, hence there is nothing on record, to meet this point on behalf of the complainant. The complainant is also silent on this important point, in the affidavit filed by way of evidence before us, whereas the factum of this 'advice' having been given to the complainant, has been reiterated in the affidavits filed by OPs that the complainant did not undergo 2D Eco Doppler Test despite being advised to do so. If one was to take into consideration the document dated 24.2.1998, which singularly states about the 'pace maker implantation', then the other tests, which admittedly, the complainant underwent, also find no reference in the document dated 24.2.1998. There is no dispute that the other tests like Holtermonitoring, ECG, Blood Tests, etc. the patient underwent, which also do not find any mention in the document dated 24.2.1998, then the question arises before us is, as to under what condition and on whose advice did he undergo these tests? This has not been clarified by the complainant. It is not in dispute that the complainant did undergo ECG as also the Holter-monitoring test, immediately after admission. Learned Counsel for the OP No. 1 showed us the hospital record, in original, in which there is clear reference to all the tests including Holter-examination test and also Doppler Tests. In view of this we find that the complainant has not come out with clean hands and is trying to withhold the information, which was within his knowledge. The complainant is not an illiterate person, he is an Advocate by profession.
19. The second point germane to issue, is that in the complaint filed before us, there is no reference that temporary pace maker was installed at Jhansi though. There is reference to this in his affidavit but we are constrained to observe that the complainant has been less than fair in his cross-examination when he stated, "I got temporary pace-maker implanted at Happy Family Hospital, Jhansi by Dr. K.K. Gupta. I do not remember the date of implantation of temporary pace maker but it was before 7.3.1998". As part of the same cross-examination, he later on states, "It is wrong to suggest that I jumped into misadventure to get treatment at Hospital at Jhansi where no proper arrangement and specialty was there to handle such cases and Pace Maker Implantation. The pace maker was not installed at Happy Family Hospital, Jhansi but it was installed, somewhere else, by some other doctor which was around 8 kms away from there. I was senseless at that time. I do not know the name of doctor who implanted the temporary pace maker. I do not know whether it was a clinic or a hospital where the pace maker was implanted. I do not know the name or the qualifications of the doctor who implanted the pace maker. It is incorrect to suggest that I got the pace maker implanted by an unqualified person".
(Emphasis supplied)
20. Before us also it was vehemently argued by Mr. Maheswari, that the implantation was done by some person whose details are not available, at a place, which was about 8 kms away from Happy Family Hospital. When we asked for the record about the person or the place where implantation was done, he was unable to produce anything. On the contrary, the cat comes out of the bag, when we see Happy Family Hospital's record dated 5.3.98 where it is recorded, "...temporary pace maker was implanted at 12.30 a.m.... Patient remained comfortable." It appears that the complainant is making deliberate and conscious effort to mislead us throughout.
21. Now dealing with the issue Nos. 1 and 2 framed by us (P-16) together, of alleged medical negligence on the part of the opposite parties, we find that it was the case of the complainant that the breathlessness was symptomatic of heart-disease and Angiography should have been done. He also relied upon the medical literature, namely, 'Hutchison's Clinical Methods, Twentieth Edition', Davidson's Principles and Practice of Medicine --A Textbook for Student and Doctors', 'A.P.I. Text Book of Medicine', and 'Harrison's Principles of Internal Medicine'.
22. Interesting enough, the learned Counsel appearing for the first opposite party hospital also relies upon the same material whereas the learned Counsel for the second party, namely, Dr. Garg, relies upon the medical literature produced by him by written version filed by him and especially, 'Guidelines issued by American Cardiologist for Coronary Angiography' and Other Literature.
23. Shorn of frills, as we see, the basic issue raised before us is, had the Angiography been done on the complainant then subsequent events would not have occurred. The learned Counsel for the complainant relied upon the following extract from 'Hutchison's Clinical Methods':
The diagnosis of coronary artery disease depends greatly on an accurate history. The symptom of angina pectoris may be described by the patient as a pain, tightness, unpleasant sensation or even a feeling of breathlessness.
24. As also the following extract from 'Davidson's Principles and Practice of Medicine':
Breathlessness (Dyspnoea) Breathlessness or dyspnoea is a common symptom of cardiac disease. It is commonly defined as a subjective awareness of increasing work in breathing, but the mechanisms responsible for this sensation are incompletely understood and may differ according to the circumstances.
External dyspnoea. This is breathlessness, which comes on during exertion and subsides on resting. It is commonly due either to heart failure or to lung disease. Some patients with angina describe breathlessness rather than chest pain on exertion.
(Emphasis supplied) As also the Differential Diagnosis of Dyspnoea:
Cardiac failure Exertional dyspnoea Pulmonary oedema Paroxysmal nocturnal dyspnoea Orthopnoea Respiratory disease Asthma Chronic obstructive lung disease Pneumonia Pulmonary neoplasm Laryngea/tracheal obstruction Other Anaphylaxis Severe anaemia Toxic gas inhalation Psychogenic dyspnoea.
25. Neither any such symptoms were noticed, nor is it the case of the complainant, that he had any of these symptoms.
The complainant also relies upon the following:
Sinus tachycardia. This is defined as resting sinus rate of more than 100 per minute. It is a feature of anxiety, fever hyperthyroidism and acute circulatory or cardiac failure. Except in infants, the rate seldom exceeds 160 per minute.
Sinoatrial Disease (the Sick Sinus Syndrome) The features are listed in the information box below.
Common feature of Sinoatrial Disease Sinus bradycardia Sinoatrial block (sinus arrest) with pauses or escape rhythms Paroxysmal supraventricular tachycardia Paroxysmal atrial fibrillation Altrioventricular block Sinoatrial disease may occur at any age, but is most common in the elderly. The underlying pathology is not understood but fibrosis or degeneration of the sinus node is sometimes present. The condition is an important cause of syncope and presyncope. A permanent pace maker may benefit patients with severe symptoms due to spontaneous bradycardias or dradycuridas induced by drugs required to prevent tachyarr hythmias. However, permanent pacing does not improve Prognosis and is not indicated in patients who are asymptomatic.
(Emphasis supplied)
26. It is the case of 2nd OP, that as per Holter's Monitoring Report, it was a clear case of sinus bradycardia and he suggested further action accordingly. No material/expert opinion had been produced, that test/finding of OP-2 was not correct, thus leading to wrong advice. In view of this, plea of the complainant has no legs to stand on.
27. From the same, he also relies upon the following material under the heading clinical features:
The clinical features are listed in the information box (p. 310). The cardinal symptom is pain, but breathlessness, syncope, vomiting and extreme tiredness are common. The pain occurs in the same sites as for angina but is usually more severe and lasts longer. It is most often described as a tightness, heaviness or constriction in the chest. At its worst the pain is one of the most severe which can be explained and the patient's expression and pallor may vividly convey the seriousness of the situation.
Many patients are breathlessness and in some this is the only symptom; a few develop pulmonary oedema at the onset. Syncope may occur and the blood pressure falls particularly if the patient is upright, or from the development of a serious arrhythmia or heart block. Vomiting is common, particularly in the more severe cases. It may also result from morphine given for pain relief. In rare cases the infract may go unnoticed until endocardial thrombosis resulting from it leads to systemic embolism.
28. These symptoms were noticed in Happy Family Nursing Home at Jhansi. It is important to note that despite this, that hospital did not suggest Angiography but did exactly what OP No. 2 had advised way back on 24.2.1998.
And also under the heading 'complication of infarction' Sinus bradycardia does not usually require treatment, but if there is hypotension or ventricular escape, atropine may be given (03 mg, i.e. every 5 min to a maximum of 1.5 mg.) Heart block complicating inferior infarction often responds to atropine and a temporary pace maker is needed only if this drug is ineffective in preventing hypotension. Heart block complicating anterior infarction is an indication for the prophylactic insertion of a temporary pace maker, as asystole may suddenly supervene. Asystole sometimes responds to cardiac massage, and following this a pace maker electrode should be inserted.
29. The complainant also relies upon the following extract from 'A.P.I. Text Book of Medicine' under the heading 'Cardiac Catheterisation':
...
Subsequent years have seen further extension of cardiac catheterisation as a diagnostic tool as well as therapeutic modality. Amongst the latter uses are the introduction of balloon coronary angioplasty by Gruntzig in 1977 and intracoronary administration of thrombolytic drug in acute evolving myocardial infarction.
Indications Diagnostic:
(i) To define cardiovascular anatomy in patients with congenital or acquired heart disease.
(ii) To determine intracaidiac/intravascular pressures and measure flow (cardia output, regional blood flow) for calculation of physiological parameters.
(iii) To determine transvalvular gradients across cardiac valves and to identify and quantify valvular regurgitation.
(iv) To measure ventricular function.
(v) To perform coronary Angiography in suitable cases.
(vi) For electophysiological studies to localise the site of heart block and the nature and pathways of cardiac arrhythmias.
(vii) In the intensive care unit for measurement of haemo-dynamic data in critically sick patients.
(viii) To perform endomyocardial biopsy.
Therapeutic:
(i) For intracoronary or intrapulmonary artery administration of thromobolytic agents.
(ii) For performing valvular or vascular dilatation (coronary, pulmonary artery branch, aorta, etc.) or related procedures (atherectomy, etc.)
(iii) For atrial septostomy in selected patients with congenital heart disease.
(iv) For non-surgical closure of an atrial septal defect, ventricular septal defect or patent ductus arteriosus in carefully selected cases. It is also required for selective therapeutic embolisation of vessels.
(v) For temporary/permanent cardiac pacing.
(vi) For non-surgical destruction of foci of cardiac arrhythmias and pathways of aberrant conduction in the management of resistant supraventricular and ventricular arrhythmias.
(vii) For removing a foreign body from the cardiovascular system.
(emphasis supplied)
30. It is pertinent to note that in cases/condition in which the complainant was, 'therapeutic' advice is 'temporary/permanent pace-making'. From the above material, we find that if based on Holter Examination Report, the OP No. 2, arrived at the conclusion that the complainant was having a problem of sinus bradycardia and advised 'permanent pace maker implantation' it is, in our view, as per literature produced before us. No other expert opinion has been led to counter/rebut the line of treatment suggested by OP No. 2.
31. As far as the allegation of improper diagnoses of sinus dysfunction, is concerned we find that according to holter-monitoring report, carried out by OP No. 1, clearly records, "24 hours Holter monitor recording shows period of sinus bradycardia with junction rhythm with sinus pauses upto 2.4 sees and atrial ectopics as well as ventricular ectopics (infrequent)".
32. This factum of the complainant having sinus bradycardia has been reiterated by the OP No. 2. There is no material brought on record by the complainant challenging the finding returned by the second OP that the complainant was having problem of sinus node dysfunction.
33. In fact OP No. 2, in his reply to interrogatory No. 3 clearly states, the nature of heart trouble was sinus node dysfunction, which means that the sinus-node, which is responsible for proper heart beat and where the impulse for heart beat is generated, was not functioning properly. Holter Monitoring Report indicates heart beat of 34/mt (minimum) to 145/mt (maximum). This is a serious condition for which the only treatment is a permanent pace maker'.
34. It is specifically stated that the statement in the Happy Family Hospital records, "changes of hyperacute MI had reverted to normal in 1 hour" clearly shows that it was in fact not an MI but an attack of angina because the changes produced by my ocardial infarction last long and not merely for a very short time. It is again specifically stated that as per the records of the Happy Family Hospital dated 5.3.1998, the "at 1 a.m., his pulse suddenly slowed down and patient went into long sinus arrest (Probably Stokes - Adams syndrome). On the one hand, such observation confirms the original diagnosis made by the respondent that the patient was suffering from sinus node dysfunction. On the other hand, such observation shows that the doctor concerned merely indulged in speculation and mentioned the possibility of Stokes-Adams syndrome in a very loose and unscientific manner. The diagnosis of Stokes-Adams syndrome, which is caused by atrio-ventricular heart block (blockage of impulse going from the sinus node to the ventricle of heart) can be very easily made by an ECG. The fact that such diagnosis is left loose and is not confirmed by ECG findings casts a huge shadow of doubt upon the competence and facilities available with the treating hospital/doctors in the specialty of cardiology".
35. This remains unrebutted by any expert evidence opinion.
36. Mr. Maheshwari wishes to rely upon the medical literature, "Davidson's Principles and Practice of Medicine" relating to the f actum that permanent pacing does not improve prognosis and is not indicated in patients who are asymptomatic. But nothing has been brought on record by the complainant that the complainant was, in any way, asymptomatic. There is no expert opinion brought on record to rebut the findings recorded by OP-2.
37. Learned Counsel for the OP also wishes to rely upon the same material and emphasised on the 'Heading Common patients of sinoatrial disease' of which first feature is sinus bradycardia. The case of the OP is that this is the case of Sinus Bradycardia hence he was justified in suggesting implantation of permanent pace maker.
38. We also see on record the same medical literature, that sinus bradycardia does not usually require treatment but if there is hypotension or ventricular escape, atropine may be given. Heart block complicating inferior infarction often responds to atropine and a temporary pace maker is needed only if this drug is ineffective in preventing hypotension. It was the case of the complainant that the patient was having hypertension and not hypotension. The suggested treatment was, what was given by the Happy Family Hospital after recording myocardial infarction on 4th and 5th March, 1998.
39. It may be relevant to reproduce here the medical literature (Davidson's Principles and Practice of Medicine) produced by the complainant, which reads as under:
UNSTABLE ANGINA Unstable angina is anginal pain coming on at rest or minimal exertion, either as a new phenomenon or against a background or chronic stable angina. There may be acute St segment elevation or depression on the ECG during symptoms, but permanent ECG changes or enzymatic evidence of infarction are absent.
Table 8.6 comparison between coronary angioplasty and coronary artery by-pass grafting.
PTCA Surgery
Predominately Single vessel Left main stenosis
used for disease Three vessel
Two Vessel disease
disease
Unstable angina
Morality < 1% < 1%
Neurological None 5% seldom
complications permanent
Hospital stay 24-36 h 7-10 days
Recurrence 30% PTCA may 10% in 1 year then
be repeated 5% per year
Complications Vascular Infection would
Pain
Mechanism
Most cases of unstable angina are due to rupture of an atheromatous plaque in coronary artery. Either the partially detached 'cap' of the plaque, or associated thrombus, cause severe narrowing of the vessel.
Management Patients should be admitted to hospital because there is a 10-15% risk of progression to acute myocardial infarction. Initial treatment is with aspirin 300 mg daily to inhibit platelet activation, bed-rest, and a beta-blocker {e.g. metroprolol 100 mg b.d.) to minimise disturbance of the ruptured plaque. Nifedipine can be added to the beta-blocker but shold not be used alone-vorapamil or diltiagem are preferable if bcta-blockers are contraindicated. If pain persists, intra-venous nitrates should be started (e.g. isosorbidedinitrate 1-2 mg/h) and the patient referred for coronary Angiography. This often shows an isolated severe coronary stenosis which can be treated with angioplasty. If pain settles, the patient can gradually be mobilised as for myocardial infarction, and exercise testing undertaken after 3-4 weeks when the plaque has stablised.
MYOCARDIAL INFARCTION This is myocardial necrosis occurring as a result of a critical imbalance between coronary blood supply and myocardial demand.
It is usually due to the formation of occlusive thrombus at the site of rupture of an atheromatous plaque in a coronary artery. The thrombus usually undergoes spontaneous lysis over the course of the next few days, but by this time the damage has been done.
In its mildest forms the infarct may be unrecognised ('silent') and be disclosed subsequently only by ECG evidence; at the other end of the range there is permanent severe disability or death. At the onset of the illness, sudden death, presumably from ventricular.
Clinical features of Myocardial Infarction Symptoms Pain-like angina but persistent and more severe Anxiety-may be fear of impending death Vomiting Physical findings Pallor, sweating and other signs of autonomic activity Tachycardia (occasionally bradycardia) Low systolic pressure and reduced pulse pressure Frequent extrasystoles Fibrillation or asystole, may occur immediately, and many of the patients who die do so within the first hour. If the patient survives this most critical stage, the liability to dangerous arrhythmias remains, but diminishes as each hour goes by. The development of cardiac failure reflects the extent of myocardial damage; its severity may range from slight reduction in skin perfusion and basal lung crepitations at one end to acute circulatory failure at the other. Cardiac failure is the major cause of death in those who survive the first few hours of infarction.
Clinical Features The clinical features are listed in the information box (p. 310). The cardinal symptom is pain, but breathlessness, syncope, vomiting and extreme tiredness are common. The pain occurs in the same sites as for angina but is usually more severe and lasts longer. It is most often described as a tightness, heaviness or constriction in the chest. At its worst the pain is one of the most severe which can be explained and the patient's expression and pallor may vividly convey the seriousness of the situation.
Many patients are breathlessness and in some this is the only symptom; a few develop pulmonary oedema at the onset. Syncope may occur and the blood pressure falls particularly if the patient is upright, or from the development of a serious arrhythmia or heart block. Vomiting is common, particularly in the more severe cases. It may also result from morphine given for pain relief. In rare cases the infract may go unnoticed until endocardial thrombosis resulting from it leads to systemic embolism.
PHYSICAL SIGNS OF MYOCARDIAL INFARCTION Signs of sympathetic activation Pallor, sweating Tachycardia Signs of vagal activation Vomiting, sometimes bradycardia Signs of impaired myocardial function Raised JVP Narrow pulse pressure 3rd heart sound Quiet 1st heart sound Diffuse apical impulse Lung crepitations Signs of tissue damage Fever Pericardial friction rub Complications Arrhythmias Murmur of ventricular septal defect, mitral regurgitation At any time after the first 12 hours or so the patient may recognise that a different pain has developed, even though it is at the same site. It is worse, or only appears, on inspiration and may be altered by a change of position. It is due to pericarditis consequent on the infarct, and the diagnosis is confirmed if a pericardial rub is heard.
40. Myocardial Infarction (MI): A plain reading of the literature makes it clear to us that none of the symptoms outlined above were shown by the complainant. It is important to note that many patients are breathless and in some this is only a symptom...vomiting is common...." What was the cause of breathless in this case? Was it a disease or only a symptom? Keeping in mind this to be symptom, as there was no other corroborative evidence of serious coronary disease, if OP No. 2 arrived at a conclusion it did, after Holter Monitor Examination, he cannot be faulted. There is no expert evidence to rebut the findings of OP No. 2 vomiting episode occurred at Jhansi at a later date, which will have no bearing in the finding of OP No. 2 in the first instance.
41. In our view, the material in the medical literature reproduced above, does not help the complainant. Holter's Monitoring Report remains unchallenged by any expert evidence and secondly non-invasive Doppler Test was not got done by him to help diagnose the ailment. Thus, in our vie w, no case of medical negligence has been made out against the OPs.
42. Much has been made by the complainant that on account of the failure on the part of the OP No. 2, to having not done the Angiography, the complainant suffered two episodes of myocardial infarction. It is important to note that the complainant was not under the charge of OP No. 2, but was in the Happy Family Hospital, who is not a party before us. This hospital notes that on 4.3.1998 at 00.30 hrs. the complainant had evidence of hyper acute inferior MI, some vomiting and then reverted to normal in one hour. This could be said to be a mild MI. Happy Family Hospital on 5.3.1998 again records episode of inferior MI, subsequent to which a temporary pace maker was implanted at 12.30 a.m. and patient remained comfortable.
43. Two things are clear from this record, that in both incidents on 4th and 5th March, 1998, MI was in inferior region, which means inner wall of the heart and what was done by the hospital was implanting a temporary pace maker. Even that hospital did not suggest Angiography even when the complainant was in that hospital for another two days after these episode(s). In the medical literature produced by the complainant 'A.P.I. Text Book of Medicine' under the heading 'Cardiac Catheterisation' one of the therapeutic remedy is 'for temporary/permanent cardiac pacing' and this is precisely what was suggested by the OP No. 2 on 24.2.1998. On the basis of above we are satisfied that as per the report of the Holter Monitor examination, the complainant was showing features of sinus bradycardia, which remains unchallenged and unrebutted either -by any medical literature or by way of any expert evidence. The complainant has brought on record two affidavits of Dr. A.K. Saxena, and Dr. R. Satish Aggarwal. We are not dealing with them at this late stage as they have been brought on record at this stage of argument, i.e., on 26.3.2008; after a gap of eight years from the date of filing the complaint, especially when they cannot be cross-examined.
44. Now dealing with Issue-3 (P-16), Mr. Maheshwari drew our attention towards the medical literature filed by the OP No. 2, relating to the 'Guidelines for Coronary Angiography. He was permitted to argue his case as to in which class or in which column would he fall/to justify Angiography? In the written submission, specifically, on this point, it was the case of the complainant that he will fall in the first class, which is reproduced as under:
Setting Class I Class II Class III
(APPROPRIATE) (EQUIVOCAL) (INAPPROPRIATE)
1 2 3 4
Asymptomatic 1. Evidence of high 1. Presence of > 1 1. As a screening test
patients with risk on non but < 2 mm of for coronary artery
known or invasive testing ischemic ST disease in patients
suspected depression who have not had
coronary during exercise, appropriate non-
disease confirmed as invasive testing
ischemia by an independent non-
stress test. invasive
2. Individual whose 2. presence of 2. After coronary
occupation involves two or more bypass surgery or
the safety of others. major risk factors percutaneous
and a positive transluminal
exercise test in angioplasty when
male patients there is no evidence
without known of ischemia, unless
coronary heart with informed consent
disease. for research purposes.
3. Individuals in 3. Presence of 3. Presence of an
certain occupations prior myocardial abnormal ECG
that frequently infarction with exercise test alone,
required sudden normal left excluding categories
vigorous activity ventricular listed in classes
function at rest I & II.
and evidence of
ischemia by non-
invasive test, but
without high-risk
criteria.
4. After successful 4. Before high
resuscitation from risk noncardiae
cardiac arrest that surgery in
occurred without patients with
obvious pre- evidence of
cipitating cause ischemia by non-
when a reasonable invasive testing,
suspicion of
coronary artery
disease exists.
45. Except making a bald observation, nothing has been shown to us, as to what is the evidence on record of the complainant was 'a symptomatic patient with known or suspected coronary disease' and that he fell in the category of a patient having evidence of high risk of non-invasive testing. Neither there is any expert evidence nor is there any material to support his contention. This is not even the case of the complainant.
46. We have carefully gone through the material and found that the complainant is unable to satisfy us if he would fall in any category of class I, necessitating Angiography in the first instance. The Medical Literature brought on record by him does not help him in this case. The learned Counsel for the OP No. 2 has brought on record, 'Braunwaid : Heart Disease", in which it is clearly held that in the case of 'sinus node dysfunction' with documented symptomatic bradycardia, is a definite indicator for permanent pacing. As we have already held that as per the holter monitoring report, which remains unchallenged and unrebutted, the complainant was having 'sinus node dysfunction' and was advised permanent pacing.
47. As a last ditch effort, it was argued by the complainant that in the Angiography done subsequently at the National Heart Institute, there is no indication of any sinus node dysfunction, he has drew our attention to the "Cardiac Catheterisation Report" of National Heart Institute on this point. We have very carefully gone through this diagram and report. Nowhere in the Cardiac Catheterisation Report, there is any rebuttal that the complainant did not have sinus node dysfunction. In fact, the point has not been touched at all.
48. Last instance of alleged medical negligence is that the complainant was discharged from the OP No. 1 hospital on 14.3.98, without curing the complainant of simple fever and discharged him in febrile condition, despite two heart attacks suffered by him on 4th and 5th of March, 1998. It was complainant's case that what the complainant was suffering from, was Malaria and not with any other infection. The proof is that he responded to the anti-malaria medicines given by his daughter Dr. Pratibha Bansal.
49. It is the case of the OPs that all the investigations were done to get at the cause of pyrexia. Repeated urine culture, blood culture, sputum culture, Haemogram including for malarial parasite, etc. were done, which brought out function of high ESR suggesting acute bacterial infection. He was kept on high doses of antibiotics. Urine culture was done on 8.3.1998, which showed growth of 'staphylococcus' aurous and aerobic spore bearers. Requisite treatment was started and upon getting the culture report, medicine 'cloxacillin' was added in place of 'Augmentin'. Some reports were received after the patient had left on 14.3.1998 on his own volition.
50. Two points came up for consideration, firstly, there is no material on record to support the plea of the complainant that Dr. Pratibha Bansal, the daughter of the complainant, gave anti-malarial treatment and the complainant responded to it. There is neither any prescription nor any affidavit of the said Doctor Pratibha Bansal to support his above plea. Secondly, we see on record, only the affidavit of the complainant in support of his above plea. We are unable to appreciate as to why any affidavit of any attendant or any other person, is not filed in support of his above plea. It could not be the case of the complainant that he being 76 years of age with alleged coronary problem, was all alone at the time of discharge and he left alone from the hospital.
51. In the aforementioned circumstances, we see no merit in the plea of the complainant. It is interesting to note that no query has been made on this point in the interrogation posed by the complainant to OP No. 1. Query on this point has been made to OP No. 2 in the interrogatories served on him and this has been rebutted by OP No. 2. There is no independent evidence on this point of any relative of the complainant to support his this plea.
52. We are, in this case, dealing with the case of medical negligence. Emanating from several judgments of Supreme Court, House of Lords, Privy Council and Halsbury's Law of England, the Hon'ble Supreme Court had occasion to deal with this whole issue of 'medical negligence' in its judgment in the case of Jacob Mathew v. State of Punjab and Anr. . Two things emerge clearly from this judgment, firstly, the onus of proving 'medical negligence' is on the complainant, and secondly, what is medical negligence? and they go on to hold that professional may be, held liable for negligence either-
(i) when he was not possessed of requisite skills which he professed to have possessed; or
(ii) when he did not exercise, with a reasonable competence;
and goes on to add that standard to be applied would be that by an ordinary competent person exercising ordinary skill in that profession for which they rely upon the Bolam Test.
53. In the case before us it is not the case of the complainant that OP especially OP No. 2 was not possessed of the skills and the qualification. Based on the material on record especially the finding that the complainant had sinus node dysfunction resulting from Holter's Monitoring Examination and advice of implantation of permanent pace maker as also seeing the medical literature on record, it cannot be said that he did not exercise skill which he possessed.
54. Halsbury's Laws of England Vol. 6 (3rd Edition), Para 22 lays down as to what is negligence, which reads as under:
22. Negligence: duties owed to the patient--A person who holds himself oat as ready to give medical (a) advice or treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person, whether he is a registered medical practitioner or not, who is consulted by a patient, owes him certain duties, namely, a duty of care in deciding whether to undertake the case; a duty of care in deciding of that treatment to give: and a duty of care in his administration of that treatment. (b) A breach of any of these duties will support an action for negligence by the patient(c).
(Emphasis supplied)
55. Again it is not the case that the OP No. 2 did anything wrong by deciding to undertake the case. It is not in dispute that he had the requisite qualification to do so. As per material on record, and after carrying out the requisite tests, his decision to suggest implantation of permanent pace maker was what was suggested and remains uncontradicted by any expert evidence, hence, the OP cannot be held liable, of not having taken due care of the complainant.
56. In the aforementioned circumstances, we find that the complainant has completely failed to prove any medical negligence on the part of the opposite parties, in view of which this complaint is dismissed. We refrain from imposing any cost, as the complainant is now 80 years old.