D.K. Jain, J. President
This First Appeal under Section 19 of the Consumer Protection Act, 1986 (for short 'the Act'), is filed by the wife, son and mother of late Sh. I.J. Divakar, (for short 'the Deceased'), questioning the correctness and legality of order dated 08.07.2008 passed by the Andhra Pradesh State Consumer Dispsutes Redressal Commission (for short 'the State Commission'), whereby their complaint, being CD No. 38 of 2004, alleging medical negligence on the part of the Respondents in treating the Deceased, has been dismissed.
2. The background facts, leading to this appeal, as pleaded in the complaint, are as follows:
The Deceased, aged about 53 years, was working as the General Manager (O&M) in Hyderabad Metro Water Works and Sewerage Board. On 22.04.2002, he developed chest pain. He was removed to Respondent No. 1 Hospital, and was admitted in the intensive care unit. On examination, Respondent No. 2, a Cardiologist, opined that the Deceased had suffered a mild heart attack. He was advised Coronary Angiogram (CAG), an optimum test for the diagnosis of coronary artery disease. CAG conducted on 23.04.2002, showed distal disease with three blocks, viz. in Left circumflex artery (LCx); Left anterior descending artery (LAD) and diagonal branch. The crucial one in LAD to the extent of approx. 95%. It also had mild calcification. To clear the block in LAD, Respondent No. 2 advised balloon dilation – Angioplasty – Percutaneous Transluminal Coronary Angioplasty (PTCA), with Stent. PTCA was planned for 25.04.2002. However, around 1.30 p.m. the Appellants were informed that the said procedure had crashed because of calcification in LAD. Accordingly, Coronary Artery Graft Bypass (CABG), an open heart Bypass surgery, was planned. Around 4 P.M., Respondent No. 4, a Cardiothoracic surgeon, performed the surgery with the assistance of another surgeon, Dr.Shridhar. Respondent No. 3 was the Anaesthetist. On 26.04.2002, the Appellants were informed that the Deceased was doing satisfactorily and was extubated at 9.30 A.M. However, on 27.04.2002, the doctors informed the Appellants that the Deceased was being electively ventilated on CPAP machine and was struggling. A Pneumatic patch was seen in the lungs. He was re-intubated. On 30.04.2002, he developed jaundice and the doctors suspected Pulmonary Thrornbus Embolism (PTE). The Appellants were informed that his condition was deteriorating and his organs were failing. On 08.05.2002, there was renal shut down. Peritoneal dialysis was done. Unfortunately, on 09.05.2002 the Deceased breathed his last. He was declared to have died of Cardio respiratory arrest following CABG for PTCA crash after CAD.
3. Alleging negligence on the part of the Respondents in not having surgical standby when the Deceased was being taken for PTCA and Respondent No. 2 having conducted PTCA, which was not recommended in such cases and caused perforation in the blood vessel by the guidewire due to his inexperience and further there was delay of more than six hours in conducting CABG, because of non-availability of a Cardiac Anaesthetist and Cardiac Surgeon, the Appellants filed complaint, inter alia, praying for a compensation of Rs.34,30,000/- towards medical expenses incurred in the hospital; loss of future earnings of the Deceased; pension, pain and sufferings, etc.
4. The complaint was resisted by the Respondents. All of them filed their respective counter affidavits, denying the allegations. In short, it was pleaded that since the Deceased was having unstable angina, a coronary artery disease, hypertension with history of chronic heavy smoking and was getting recurrent episodes of restrosternal pain even at rest since 10 to 15 days, he was subjected to CAG after explaining seriousness of his ailment to the Appellants. As CAG showed three blocks, it was decided to perform PTCA to LAD, which had 95% block, after obtaining consent of the Appellants. CABG was also performed in the shortest possible time and he was taken off the ventilator after 10 hours of the surgery.
5. The parties filed supporting affidavits by way of evidence. Oral statements of the Affiants were recorded and they were subjected to cross-examination. On application, Dr. Upender Kaul, a Senior Cardiologist answered certain questions, given to him by Counsel for the Complainant, as he refused to depose before the Court Commissioner. The case against Respondent No. 3, the Anaesthetist and Respondent No. 4, the Cardiothoracic surgeon, was, however, given up by the Appellants, stating that there was no negligence on their part in conducting CABG and post-operative care. As a matter of fact, the brother of Appellant No. 1, a doctor, also stated in his statement that Respondents No. 3 & 4 had taken due care of the Deceased after the surgery and, therefore, they were not negligent in treating him.
6. On a detailed analysis of the evidence adduced by the parties, the State Commission has come to the conclusion that there was no evidence of negligence on the part of Respondent No. 2 in conducting PTCA. The State Commission has also observed that a Committee of three Medical Experts, constituted by the Medical Council of India, on the complaint filed by the Appellants, had opined, on the basis of the records placed before them, that the treating doctors seem to have made an attempt to do their best. The State Commission rejected the contention of the Appellants that no informed consent had been taken before conducting CAG, PTCA and CABG, in the following terms:
'Learned Counsel for the complainants contended that no ‘informed consent’ was taken when Angiogram, Angiplasty and Bypass surgery was performed. There was no mention that the patient was unconscious or that he was unable to appreciate the course of treatment administered to him right from the beginning. On the other hand it was noted in the case history that the patient was 'conscious, coherent with some chest discomfort.' The signature of the patient was taken under Ex. A11 'to undergo CAG'. His wife Ratna also signed underneath his signature. His consent was also taken under Ex. A12 for PTCA along with his wife. Obviously as there was crash of Angioplasty, CABG was done on an emergency basis with very high risk. The said fact was mentioned. Under Ex. A13 ‘Informed consent’ was taken from his wife and sister-in-law Smt. I. Mammu Vani attested by Dr. M.K. Sridhar on 25.4.2002 at 2.00 p.m. Under Ex. A14 the consent of PW2 Dr. P.V.N. Rao, brother-in-law of the Deceased was taken attested by Dr. Raja Mohan. Learned counsel for the complainant contended that routine signatures were taken without informing as to the complications that would arise while conducting the operation. The Patient himself was highly educated working as General manager. His brother-in-law is a doctor. All these consent forms are attested by another doctor against whom nothing was stated.'
7. Expressing concern over the conduct of the Appellants in withdrawing their complaint against Respondents No. 3 and 4, the Anaesthetist and Cardiac Surgeon respectively, and giving a clean chit to Respondent No. 2 (referred to in the penultimate paragraph of the impugned order as RW2) the State Commission has concluded as under:
'In fact the patient had developed pneumatic patch in his lungs two days after the operation. While the Bypass surgery was conducted on 25.4.2002, pneumatic patch was developed in the lungs on 28.4.2002. PW2 his brother-in-law himself brought an Intensive Care Specialist Dr. Shyamsunder and Pulmonologist Dr. Vijay Kumar from other corporate hospitals, approved the line of treatment. According to PW2, the Pulmonologist after examining the patient opined that the patch which they were treating as Pneumatic patch was not a Pneumatic patch but it was pleural effusion (collection of fluid in the lungs). He suggested different antibiotics. Liver function tests were also conducted. Till 8.5.2002 except developing pleural effusion, nothing abnormal was detected in the condition of the patient. It may be stated here, that his death was due to multi organ failure. Therefore, it cannot be said that the angioplasty conducted by RW2 resulted in these complications, and ultimately his death. The Deceased was a chronic smoker, and the doctors who examined him were of the opinion, that the smokers will encounter these serious complications, after surgery. When the experts did not point out any mistake in the line of treatment, nor the complainant could show any negligence on the part of RW2, against whom, the complainant and her brother were directing their ire, we do not agree that there was any negligence on his part, more so, when about six specialists attended on him, throughout, round the clock. He survived for more than 13 days after the operation. As we have earlier suggested that, unless it is proved that there was deviation from normal practice, and that RW2 did not adopt that practice, and that the course adopted by RW2 is one which no professional man of ordinary skill would have taken, if he had been acting with ordinary care. He cannot be held guilty of negligence. More over RW2 is related to the complainants. When the Deceased straight went to RW2 he admitted him in the hospital immediately, informed the complainants that he was admitted in the hospital. On that they came. In view of relationship, he must have had confidence in him.
PW2 never complained for any of the treatment. The important surgery was conducted by RW4 the cardiologist. He was left off. At no time, any malice or motive was attributed against RW2. He was there all through attending on the patient. We do not see any negligence on his part.'
8. Hence the present Appeal.
9. Having heard Ld. Counsel for the parties at some length, who, in support of their respective contentions took us through the evidence and some medical literature on the subject, the questions for consideration are: (i) whether there was negligence on the part of Respondent No. 2 in subjecting the Deceased to PTCA, instead of recommending Bypass surgery (CABG) when it was detected that he had approximately 95% blockage in LAD and (ii) whether there was inordinate delay in performing CABG because of lack of cardiac surgical back-up which ultimately proved to be fatal?
10. The test of medical neglignece which was laid down in Bolam Vs. Friern Hospital Management Committee (1957) 1 WLR 582has been accepted by the Hon’ble Supreme Court as providing the standard norms in cases of medical negligence, though interestingly, Bolam test is being questioned in the country of its origin. Therefore, what constitutes medical negligence based on the touchstone of the Bolam’s test is well settled through a catena of decisions of the Hon’ble Supreme Court, including in Jacob Mathew Vs. State of Punjab & Anr. (2005) 6 SCC 1, a three Judge Bench decision; Indian Medical Association Vs. V.P. Shantha and Ors. (1995) 6 SCC 651 and Kusum Sharma & Ors. Vs. Batra Hospital and Medical Research Centre & Ors. (2010) 3 SCC 480. Gleaned from these judgments, broad principles to determine what constitutes medical negligence, inter alia, are: (i) Whether the doctor in question possessed the medical skills expected of an ordinary skilled practitioner in the field at that point of time; and (ii) Whether the doctor adopted the practice (of clinical observation diagnosis – including diagnostic tests and treatment) in the case that is accepted as proper by a responsible body of professional practitioners in the field. In this connection, in Jacob Mathew (supra)the three Judge Bench,elaborating onthe degree of skill and care required of a medical practitioner quoted Halsbury’s Laws of England (4th Edn., Vol.30, para35), as follows:
'35. The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case, is what the law requires, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operation in a different way; …'
11. We shall, therefore, examine the allegation of medical negligence on the touchstone of the aforenoted broad principles. In this regard it would be apposite to refer to some medical literature on the point. In a textbook of Cardiovascular Medicine, edited by Eugene Braunwald, it is noted that available guidelines do not specifically address the issue whether patients with Coronary disease requiring revascularization should undergo PTCA or CABG. It is however, mentioned that because of risk of complications, which may arise with Angioplasty, some guidelines do consider mandatory, at the time of elective PTCA procedures, the presence of an experienced Cardiovascular Surgical team within the hospital to perform emergency coronary Bypass surgery, should the need arise. It is opined that for patients at high risk for acute Myocardial infarction, in whom thrombolytic therapy is contraindicated, emergency PTCA is deemed 'acceptable treatment' even if the patient cannot be transferred expeditiously to a centre with surgical back-up. However, patients with unstable angina should usually be transferred to an institution with a cardiac surgical programme before consideration for PTCA.
12. In a report of the American Heart Association (AHA)/American College of Cardiology (ACC) on guidelines for PTCA circulated some time in the year 1993, under the heading 'Need for Surgical Backup', while observing that Surgical back up, a service that was thought to be essential during the developmental stages of Angioplasty, is still provided in one form or another in most cases of elective PTCA, it is pointed out that at that point of time, 2% to 5% of the patients undergoing PTCA would sustain damage (dissection, intimal disruption, perforation or embolization) to the coronary arteries, requiring emergency surgical intervention. In similar guidelines, issued by AHA/ACC in June 2001, heavily relied upon on behalf of the Appellants, under the caption 'Patient Selection for Angioplasty and Emergency Aotocoronary Bypass at Hospitals without on-site cardiac surgery' the opinion is to avoid intervention in hemodynamically stable patients with significant (≥60%) stenosis of an unprotected left main (LM) coronary artery upstream from an acute occlusion in the left coronary system that might be disrupted by the angioplasty catheter.
13. In Handbook of Cardiac Catheterisation by Graham A.H. Miller, a consultant cardiologist at London, the Author has advised that when selecting patients for PTCA, it is important to assess the amount of myocardium of risk should the vessel become blocked during the procedure. It is opined that when the amount of myocardium of risk is small, it may not be necessary to arrange for theatre cover. However, at the other end of the spectrum patients with stenosis of the Left main stem coronary artery cannot be treated by PTCA. Such patients would be unlikely to survive long enough for emergency coronary artery surgery to be possible if the vessel became occluded during PTCA.
14. What emerges from the medical literature, briefly referred to hereinabove, is that except for blockage of the left main coronary artery, which supplies most of the blood to the major portion of the heart, where CABG may perhaps be is the first option, PTCA is a commonly accepted procedure. Nevertheless, the appropriateness of the procedure in a given situation has to be carefully assessed by the cardiologist keeping in view a host of factors, enumerated in the medical literature. No material has been brought on record on behalf of the Appellants to show that with the nature of the blocks the Deceased had, PTCA is never advised.
15. Therefore, the question for consideration is whether, having regard to the general condition of the Deceased and the projections in CAG, the decision of Respondent No. 2 to go in for PTCA was such that no other cardiologist would have, advised the same procedure? Having carefully perused the evidence on record, which includes the in-patient investigation card and the progress notes from the date of admission of the Deceased in the Hospital, we are of the opinion that the afore-extracted conclusions arrived at by the State Commission do not warrant interference. It is evident from the affidavit of Appellant No. 1 that the decision to go in for PTCA was not taken in a hurry but after due deliberations with Appellant No. 1, her brother and a brother of the Deceased, one of them being a Doctor himself. This fact is borne out from her statement wherein she affirmed that PTCA was not attempted immediately after the CAG on 23.04.2002, as the doctors wanted to decide whether to conduct PTCA or CABG. Accordingly, the Deceased was posted for PTCA on 25.04.2002, with surgical standby. PTCA to LAD long segment tight lesion crashed; the Deceased developed chest discomfort, which subsided with intra coronary NTG and later ECG showed STI elevation in 1, and av1, v2-3; 2D; Echo showed overall good left ventricular function and he was hemodynamically stable. The case was discussed with CT surgeon and family members regarding need for emergency CABG. A number of tests, including chest X-ray, were conducted. Thereafter, Respondent No. 4 performed CABG. It is significant to note that the Deceased was extubated on 26.04.2002 at 9.30 A.M., which showed that his condition was stable, after CABG. There is nothing on record to show that complications like suspected ARDA, PTE, jaundice, etc. had developed after 9.30 A.M.
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on 26.04.2002, due to PTCA, conducted by Respondent No. 2. Respondent No. 4, who had performed CABG, has nowhere stated that there was some lapse or deficiency on the part of Respondent No. 2 during the course of PTCA procedure. He refused to comment on the complaint of the Appellants regarding PTCA. As a matter of fact, it has come on record that the surgery (CABG) was successful and at 9.45 A.M. on 26.04.2002, his BP, HR, PAP etc. were within normal limits after he was extubated. As noted above, three medical experts, two being Senior Cardiologists, have opined that PTCA, with stenting, is an accepted method of treating the condition, the Deceased was, and the treating doctors seem to have made an attempt to do their best. There is no material to disagree with the said expert opinion. We are, therefore, convinced that no medical negligence could be attributed to Respondent No. 2 in the conduct of PTCA procedure by him. 16. As regards the second question as to whether there was inordinate delay in performing CABG, it would suffice to note that in his affidavit and oral testimony Respondent No. 4, against whom the allegation of negligence was dropped, had stated that after the failure of angioplasty in cathlab, 'the operation was organized with all preparation and arrangements of required things in least possible time.' In his cross examination Respondent No. 4 stated that there is no prescribed time limit as such between a failed angioplasty, and a surgery but it has to be done as early as possible. Pertinently, he was not cross-examined on the question as to whether in the instant case, there was undue delay in surgery which resulted in the death of the Deceased. 17. For all the aforesaid reasons, we are not persuaded to hold that the State Commission acted erroneously in dismissing the Complaint pressed only against Respondents No. 1 and 2. We do not find any merit in the Appeal. It is dismissed accordingly but with no order as to costs.