National Consumer Disputes Redressal
Amarnath Kakkar vs Escorts Heart Institute And Research ... on 10 September, 2015
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 270 OF 2001 1. AMARNATH KAKKAR N - 4 GREEN PARK EXTN. NEW DELHI - 110016 NA ...........Complainant(s) Versus 1. ESCORTS HEART INSTITUTE AND RESEARCH CENTRE LTD. OKHLA ROAD NEW DELHI - 110025 NA 2. - - ...........Opp.Party(s)
BEFORE: HON'BLE MR. JUSTICE J.M. MALIK, PRESIDING MEMBER HON'BLE DR. S.M. KANTIKAR, MEMBER
For the Complainant : Ms. Sumita Kapil, Advocate and
Ms. Astha, Advocate For the Opp.Party : For the Opposite parties Nos. 1,3 &4 : Mr. Akshay Chandna, Advocate for
Mr. Sajad Sultan, Advocate
For the Opposite party No.2 : Mr. Madhukar Pandey, Advocate with
Ms. Manjira Dasgupta, Advocate
Dated : 10 Sep 2015 ORDER
DR. S.M. KANTIKAR, MEMBER
The complainant Amarnath Kakkar took his wife Mrs. Om Kakkar at OP-1 i.e. Escorts Heart Institute and Research Centre Ltd. (EHIRC) and underwent surgery by Dr. Trehan, Dr. A.K. Omar and Dr. Atul Bhatia. The patient was operated for Aortic Valve Replacement (AVR) and Mitral Valve Replacement (MVR), who suffered gross negligence and deficiency in service provided by OPs resulted into her death on 22.05.2001.
Complaint:
The sequence of events are that, the complainant Amarnath Kakkar's wife Mrs. Om Kakkar (since deceased, hereinafter referred to as "patient") consulted Dr. Kler at (EHIRC) for her heart problem and underwent angiography on 13.02.2001. Thereafter, on 20.02.2001, she consulted Dr. Trehan (OP-2) with her angiography reports, who advised for Aortic Valve Replacement (AVR). Accordingly, on 26.02.2001, she got admitted in (EHIRC) under immense faith in Dr. Trehan, who will carry out her surgery. The surgery was assured for AVR, but on 05.03.2001, Dr. Trehan performed surgery AVR and MVR (Mitral Valve Replacement). On 11.03.2001, she developed some complications in evening, upon which she was shifted to ICU, there was no bed, hence, she was shifted to bed no. 304. She was monitored till her discharge on 14.03.2001. However, at the time of discharge, she was having slight fever, which the OP was as normal. Post-operative follow-up was suggested by regular Prothrombin Time (PT) test to monitor INR and temperature record. The patient came for follow-up on 20, 21 and 22 March, 2001. On 20.03.2001, alternative stitches were removed; the doctor was satisfied with the healing. About her fever, she brought it to the notice of Dr. Omar (OP-3), who told that it's a natural effect after major surgery and nothing to worry. He prescribed some medicines and called her after one month. The remaining stitches were removed on 23.03.2001. She also met Dr. Bhatia on 23.03.2001 and informed him about continuous fever; he advised some tests and continued Cardarone 200 mg for another seven weeks. Subsequently, on 14.04.2001, she had severe pain in the right leg and she was having fever also, which was not sub-sided. The fever was persisting for over a month since surgery, hence, she got worried. Hence, she again consulted Dr. Omar on 20.04.2001 and discussed about pain in right leg and also shown temperature chart maintained by the complainant. He prescribed Tab. Combiflam only for pain relief. It was also informed that, if fever does not respond, patient will have to be admitted for antibiotic therapy. He also advised blood culture, Widal and urine culture tests.
Again on 27.04.2001, patient met Dr. Omar at Heart Command Centre with all results and informed him about persistent fever. On 03.05.2001, she met Dr. Omar with the complaint of severe pain and numbness in the left arm and also there was coldness in the left arm up to fingertips. On 04.05.2001, x-ray chest was taken and Dr. A. Sharma prescribed antibiotic and anti-malarial course (Tavanic 500 mg for five days). On 08.05.2001, Dr. Omar continued the same medicines for three days further.
The complainant sought appointment with Dr. Trehan directly, but the hospital staff told that Dr. Trehan would meet post-operative patients only. On 12.05.2001, the patient met Dr. Bhatia and informed about persisting fever. Again on 15.05.2001, Dr. Omar was consulted, he expressed that "Mataji, itne kum bukhar ke liye fikar na Karen. Aap thermometer na lagaye to pata bhi nahi chalega ki bukhar hai." He further recommended blood culture and urine culture and other tests. On 16.05.2001, she started taking Paroavid at about 23.30 hours in the night her temperature shot up to 104ºF with severe shivering. On 18.05.2001, at about 2.00 a.m. she had splitting headache and immediately progressed into coma. The complainant rushed to OP hospital, CT was performed, which revealed massive intra cranial haemorrhage. Thereafter, she was shifted to Vimhans for higher treatment. But, the patient remained in coma for four days, never recovered and died on 22.05.2001. It was alleged that, the OP produced the blood culture report at very late stage on 20.07.2001 i.e. after death, it was found reported as Staphylococcus aureus infection.
Therefore, alleging negligence in the treatment performed DVR instead of AVR without any informed consent. The patient further suffered cerebral haemorrhage and coma, due to deficiency in the duty of care by OPs which did not diagnose the cause of continuous postoperative fever due to Staph. Aureus infection. Hence, patient suffered cerebral haemorrhage and subsequently death.
Defense:
6. The OPs denied all allegations and negligence on their part. Filed a written version and affidavits. As per reply, the patient was admitted for AVR surgery on 26-02-2001. However, she was also a case of Moderate Mitral Stenosis inasmuch as her Mitral Valve Area (MVA) was only 1.25 to 1.4 cm square whereas the normal MVA is 2.5 to 4 cm square , thus it was suggestive of Double Valve Disease. Both the Cardiac Evaluation Forms dated 13-02-2001 and 26-02-2001 mentioned about the patient was having Mitral Valve Disease along with severe Aortic Valve Disease. Therefore, in the best interest of patient, the DVR was performed to avoid another surgery. On 05-03-2001 Trans Esophageal Echocardiography (TEE) was done after the procedure revealed that both the Prosthetic Valves were functioning normally. During follow up Echo done on 12-03-2001 showed that both the Valves were functioning normally, and there was no thrombus or vegetation, hence there was no infection whatsoever. TEE was conducted even after 45 days of surgery i.e. on 21-04-2001 which again confirmed that both the Prosthetic Valves were functioning normally and there was no thrombus or vegetation i.e. there was no evidence of any infection.
7. The OP clarified about, patient's raised TLC during post-operative period was due to a non-specific response to the tissue injury/surgery, which stabilizes gradually thereafter. In the present case also Patient's TLC stabilized at 9100/cmm on 14-03-2010 i.e. the date of discharge. Therefore, overall OP took all care of the patient during hospitalisation, surgery and in the post-operative period. The patient was properly investigated, the team of doctors treated her. Therefore, there was no negligence on the part of OPs, who are not liable in the instant case.
Arguments:
On behalf of Complainant:
8. The learned counsel for the complainant, Smt.Dr. Sumita Kapil, argued on the following issues:
(i) the OP performed DVR instead of AVR as promised;
(ii) as the patient was above 60 years of age, the OP should have used biological valves instead of prosthetic valves;
(iii) as per the discharge summary, it is clear that patient suffered unexplained fever. The OP failed to investigate the cause of fever. Patient suffered Infective Endocarditis (IE) which led to formation of vegetations in the prosthetic valves which was cause of embolism or bleeding in the brain;
(iv) the OP did not follow the Duke's criteria, the INR values;
(v) the OP failed to diagnose the pain and numbness in legs which the patient felt constantly after April, 2001;
(vi) the OP performed defective tests i.e. failed to detect staph aureus and considered the TLC count variation. The TEE findings were defective which did not show vegetations; hence diagnosis of IE was not done. It was the cause of Intra Crania Haemorrhage for which OP- Escorts Hospital failed to treat, but hurriedly shifted the patient to VIMHANS;
(vii) lastly, the blood culture showed Staph aureus organism, the report should have been given within 2 to 3 days after collection of sample, but in fact the report was given at very late stage on 16-05-2001 i.e. 4 days prior to death. In this context, the counsel has brought our attention towards the several culture reports performed on the sample of urine, aortic valve, mitral valve and the chest wound. Also furnished medical literature from (a) the Journal of American Heart Association, (b) Guidelines on Preventive Diagnosis & Treatment of IE and (c) Davidson's Principles & Practice of Medicine.
Arguments on behalf of Opposite Parties:
9. The learned counsel Mr. Madhukar Pandey for OP-2 and Mr. Sajad Sultan for OP-3 argued the matter, they reiterated the submissions made in their evidence. The counsel for OP 2 submitted that, the role of OP 2 was limited to the patient's DVR Surgery conducted surgery on 05.03.2001 whereby prosthetic valves were placed in both Aortic and Mitral Valves. There was no negligence in the operation. The patient was discharged in stable condition on 14.03.2001. Thereafter, the patient was under care of competent team of competent doctors at OP 1/hospital, like Dr. A. K. Omar (MD) Cardiac Physician, Dr. Atul Bhatia (MD) Cardiac Electrophysician, Dr. Anita Arora (MD) Microbiology, Dr. Ashok (MD) Internal Medicine and Dr. Vikram Sarabhai (MD) Puylmonologist. There was no harassment to the patient. He was at full liberty to approach OP 2 in his chambers but she did not contact him for any further treatment. During the stay in the hospital i.e. from 13.2.2001 to 14.3.2001 and thereafter, for about 45 days after the discharge, she did not have any sign of infection. It was confirmed by TTE and temperature chart maintained in the Hospital. In the hospital, the patient never had temperature during her entire stay in the hospital/OP 1 under care of OP 2 except for two occasions even where patients temperature was not more than 38°. On the day of discharge, she was afebrile. The TLC levels were initially on higher side due to surgery, which were stabilized at 9100/cmm on 14.3.2001 i.e. the date of discharge. The blood cultures done four times did not show growth of any organism. The culture report of mitral valve, chest wound and urine did not show growth of any organism. Thus there were no signs of infection.
10. Learned counsel for the complainant filed literature titled about Duke criteria, which mentions in summary that, echocardiography and blood cultures are the cornerstone of diagnosis of IE. TEE must be performed first, but both (Transthoracic Echo) TTE and TEE should ultimately be performed in the majority of cases of suspected or definite IE. In the present case, the patient did not have any Duke's Major or Minor criteria for IE because the blood cultures shown negative result.
It was also brought to our notice that since the blood samples for culture were given on 16.05.2001 on OPD basis by the patient, the reports had to be collected by her relatives after 72 hours by showing receipt. On 18.05.2001 at 3.50 am the patient suffered intra-cranial hemorrhage for which she was shifted to VIMHANS, New Delhi for neurological treatment at 6.45 am in the morning of 18.5.2001.
Observations and Reasons:
About DVR:-
11. We have perused the medical record, the ECHO reports taken at different stages of treatment. The details as:-
27-02-2001: ECHO:-Sever AS with Moderate MR.
01-03-2001: TEE:- (After admission to OP-1 before surgery):-
Thickened calcified deformed Severe Aortic Stenosis (Max PG 106 mmHg, AVA 0.6 cm square) Thickened Calcified Moderate Mitral Stenosis (MS), Mean PG 7.3 mmHg(normal Mitral Mean PG is 0 to 2 mmHg), MVA 1.5 cm square (normal MVA 2.5 to 4.0 cm square), Moderate MR The Mitral Valve appeared rheumatic and doming of mitral leaflet was noted.
Accordingly, we are of considered view that, the TEE report confirmed the status of valves as, thickened calcified deformed, severe Aortic Stenosis (AS) and Moderate Mitral Stenosis (MS), therefore the combined procedure of DVR was decided. As per evidence of OP, the decision was taken in consultation with the patient and her husband, relatives. Thereafter, the informed Consent Form and High Risk Consent Form was signed by the Patient in the presence of the Complainant, for DVR surgery. Even otherwise, the operating surgeon can take decision, in the interest of patient. Therefore, we don't think there was any negligence or any over enthusiasm of the OP-2 to perform DVR.
12. The other contention of complainant was about non availability of OP-2 during follow-up. It is well known fact that, in India, Dr. Naresh Trehan OP-2 is a Cardiothoracic and Vascular Surgeon. The DVR by prosthetic valves was performed by him with his team of doctors on 05-03-2001.The patient was under observation of team of doctors from OP-2 till her discharge i.e. 14-03-2001. Patient was stable; both the valves were functioning properly. The medical record clearly revealed us , that after discharge, patient was under the care of doctors of OP No.1 and the resident doctors in the hospital. The direct telephone number of the OP-2 was given to the patient on discharge, on which the patient could contact or have approached OP-2 even at his chamber.
13. It should be borne in mind that, it is not mandatory or practically possible for the senior operating surgeon or consultant to remain with the patient for 24 hours. The major surgeries are performed by a team of competent doctors; therefore the post operative follow up can be done any one of that team. In the instant case, till discharge, the patient was under observation of competent doctors working under the OP-2. Thus, the complainant's allegation is not sustainable.
14. The counsel for OP-2 submitted that, the allegation of IE has been made for the first time during oral arguments now. There is nothing mentioned either in the complaint or in the evidence. It is not supported by any expert opinion. On this point, we do not agree with the counsel for OPs. This is the case of alleged medical negligence; the complainant can raise the vital issues to prove his case. In this instant case, we do not find any need to seek expert evidence. Our view dovetails from the case of V Kishan Rao v/s Nikhil Super Speciality Hospital & Anr. (2010) 5 SCC 513, the Hon'ble Supreme Court has held in that it is not necessary to refer each and every case routinely and blindly for expert opinion.
15. We also do not find any relevance to the use of Biological valves instead of Prosthetic/Mechanical vales. In this context we have perused the medical literature filed by the complainant from the book "Davidson's Principles & Practice of Medicine" Page 633 in support of her contention that Biological Valves are better for patients over 65 years of age. It states that;
"Biological Valves have advantage of not requiring anticoagulants to maintain proper function, however, many patients undergoing valve replacement surgery especially Mitral Valve Replacement will have fibrillation that requires anticoagulation anyway. Biological valves are less durable than mechanical valves and may degenerate 7 or more years after implantation, particularly when used in Mitral position. They are more durable in Aortic position and when used in older patients and so are particularly appropriate for patients over 65 undergoing aortic valve replacement."
We are not very much convinced because, as per literature, the patient undergoing MVR should be implanted with Mechanical Valve as Biological Valves are less durable in Mitral position. Therefore, the decision of OP-2 to implant Mechanical valves in both the Aortic and Mitral positions was correct. The decision was in the best interest of patient and it was not a deviation from the Standard of Practice.
About IE and Intracranial Hemorrhage:
16. In our observation, after DVR surgery the OP-2 performed periodic TEE post operatively to rule out presence of any thrombus or vegetations on the Mechanical/prosthetic valves, as MRI is not advisable in such patients. Even after 45 days of discharge both the Prosthetic Valves were functioning normally without any evidence of thrombus or vegetations. The Blood Culture and Urine Culture conducted on 21-04-2001 were sterile. In general, the Duke criteria should be fulfilled in order to establish the diagnosis of endocarditis. Considering overall picture, it is clear that patient was never fit in the modified Duke's Criteria to be diagnosed as Infective Endocarditis.
17. As per the medical record, all the blood culture reports of the patient till 25.04.2001 did not show growth of any organism. It was for the first time on 16.05.2001, patient's visited in OPD, and the Blood Culture was performed and reported after incubation for 48-72 hours. However, the same report was collected only on 20.07.2001 after her death. It was revealed growth of microorganism Staphylococcus Aureus. Hence, it was not a hospital acquired infection as patient was discharged on 14.03.2001 (2 months prior).
18. Even Intracranial Hemorrhages concerned there was no evidence third Minor Criteria of Vascular Phenomena such as major arterial emboli, septic pulmonary infracts, mycotic aneurysm till 16.05.2001. Hence, the intracranial hemorrhages had no correlation with the DVR surgery performed almost 2 months prior. It can possibly occur in any person even otherwise including the patient who was a cardiac patient on Acitrom doses.
19. As per medical record, the patient was admitted in OP-1 as an emergency with intracranial haemorrhages in the night/early morning of 18-05-2001 at 3.50 am. The CT scan of head revealed large intracranial haemorrhage and hence the patient was shifted to VIMHANS, for neurological management at 6.45 am. The patient was not administered Acitrom while in OP-1.
Reference from judicial decisions:
20. Since, the present case is based upon an allegation of deviation from ordinary professional practice, it is worth to refer Lord President Clyde in Scottish case Hunter v Hanley 1955 SC 200, wherein it has laid down the following requirements to be established by the patient to fasten liability in case of negligence committed by a doctor:
"To establish liability by a doctor where deviation from normal practice is alleged, three facts require to be established. First of all it must be proved that there is a usual and normal practice; secondly it must be proved that the defender has not adopted that practice; and thirdly (and this is of crucial importance) it must be established that the course, the doctor adopted is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care. There is clearly a heavy onus on the pursuer to establish these three facts, and without all three, his case will fail."
21. In the case Achutrao Haribhau Khodwa and Ors. v State of Maharashtra and Ors. (1996) 2 SCC 634, the Hon'ble Supreme Court, held that, "in the very nature of medical profession, skills differs from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession."
22. In the case of Kusum Sharma Vs. Batra Hospital (2010) 3 SCC 480, laid down that, Negligence cannot be attributed to a doctor so long as he performs his duties with a reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the Medical Profession.
23. On the basis of entire discussion, we do not find any deficiency or negligence on the part of OP-2 and other doctors who treated the patient. It was the practice as per accepted standards norms. Therefore, the complaint is hereby dismissed. The parties are directed to bear their own costs.
......................J J.M. MALIK PRESIDING MEMBER ...................... DR. S.M. KANTIKAR MEMBER