Direndra Rao Jachak vs Usha Mullapudi Cardiac Centre

THE Complainant, Mr. Direndra Rao Jachak (hereinafter referred to as "patient") was a Government school teacher at Dhamtari, Chhattisgarh. For some cardiac problems he consulted Dr. Pramod Jaiswal, a Cardiologist, and underwent Cardiac Catheterisation (Angiography) on 15.2.2001 at Ekvira Heart Institute, Nagpur. As per clinical assessment and Angiography report (Exhibit PW1/1), he was diagnosed with: (a) Rheumatic heart disease moderately severe Mitral regurgitation.

(b) Severe aortic regurgitation.

(c) Dilated LV.

(d) Mild LV dysfunction, Mild PAH.

Dr. Pramod Jaiswal advised the Complainant for Replacement of Aortic and Mitral Valve (AVR + MVR). The complainant came across and had gone through the brochure of Usha Mullapudi Cardiac Centre at Hyderabad, the OP -1 and came to know, that the OP -1 hospital is fully equipped and it is built as per the specification of American Medical Association. The OP -1 claims itself to be a non -profit institute and suggests that ''a stitch in time saves nine''. Thus, with high expectations, all the way from Raipur, the Complainant went to Hyderabad to OP -1 for his treatment (AVR + MVR) on 21.1.2002. The doctors there assured him that he will be fine after the surgery and will lead a normal life. Hence, with those promises, the Complainant got admitted by raising appropriate funds for the operation by the way of borrowings from one of his relative, selling his one acre of land property and a house. On 24.1.2002, the surgery was performed by OP -2, 3 and 4, with an attending doctor (OP -5). Complainant paid a sum of Rs. 1,75,000 on account of surgery, etc. He was discharged on 11.2.2002. The discharge summary (Annexure P -2) revealed about the periprosthetic mild leakage, whereas, the ECHO which was done on 2.2.2002 revealed the moderate leakage. Thus complainant alleged that, it was wilful suppression by OP -2 about the factual position, and also, the OP -2 did not monitor the procedure of repair with Trans -Esophageal ECHO during surgery. Till then, the OP doctors assured him that he will be fine and shall recover soon.

AFTER discharge on 11.2.2002, the complainant returned to Raipur, but as he was still feeling comfortable, he consulted Dr. Ashish Malhotra at Raipur, who, after clinical assessment, the ECG and Colour Doppler study, confirmed that there was a severe leakage and weakening of heart, after the surgery at OP -1. The report dated 6.3.2002 of Dr. A. Malhotra (Annexure P -3) has been placed on record. The patient was again admitted to OP -1 hospital, on 16.3.2002. He was examined by Dr. Sanjeeb Roy (OP -5) and discussed the findings of Dr. A. Malhotra. Thereafter, OP -5 suggested for Re -do surgery. But, as the complainant had exhausted his funds due to first surgery, he expected the second surgery, at free of cost, which was declined by OP and discharged the patient on 20.3.2002. Thereafter, complainant consulted few other Cardiologists namely, Dr. Aziz Khan, on 8.7.2002 at Crescent Nursing Home, Nagpur (Annexure P -5), Dr. K. Gurunath at Bhilai on 28.7.2003 (Annexure P -6). He consulted Dr. C.J. Hemant Kumar on 29.9.2003 at Jaslok Hospital, Bombay (Annexure P -7) wherein it was informed that, the cost of Re -do surgery was Rs. 2,50,000. He also visited Apollo Hospital, Bilaspur on 14.9.2003. On examination, Dr. Jain informed that the first surgery was a mess up and there is high risk in Re -do surgery. (Annexure P -8). Therefore, he alleged that, he became physically handicapped; produced the certificate (Annexure -P9), he incurred more than Rs. 10 lacs as expenses, suffered physical and mental agony. Thus, complainant filed a complaint before this Commission alleging gross medical negligence and deficiency in service on the part of OP and prayed for compensation of Rs. 1,06,45,900 with 18% interest and the cost. The Defence:

The opposite party resisted the complaint and submitted that, the Complainant was given best of the treatment, there was no negligence. The OP -1 is a non -profit Cardiac Trust Hospital, doing about 800 open heart surgeries and about 800 angioplasties, in a year, with mortality and morbidity of less than 3% like any other medical centres in USA. The doctors at OP -1, are fully qualified and possess the requisite skills to perform cardiac surgeries. The OPs, did not give any assurance of total cure to the patient, as it was a high risk surgery. The OP -1 took informed consent (Annexure -OP/2) from the patient; also, his relatives were duly explained about the post surgical mortality and morbidity. The OP submitted that, for two St. Jude Valves Rs. 1,75,000 was charged, which was very reasonable compared to any private Institutions in India. OP also, submitted that the Complainant was suffering with Rheumatic Valvular heart disease from the age of nine years and he had dilated LV. On 16.2.2001 itself, Dr. Pramod Jaiswal, advised him for valve replacement immediately, but, the Complainant approached him, at a very late stage, i.e. after one year. The leak was due to weak aortic annulus tissue and thinned out aortic valve and no growth of tissue on the valve rim surgery. Hence, there was no negligence or omission on the part of OPs. This is a worldwide, known complication of paravalvular leak which can occur, within four to six weeks, after the surgery. For the periprosthetic leakage, the OP -2 advised the complainant for Re -do surgery at very nominal cost of Rs. 10,000 against Rs. 2,50,000 as prescribed at Jaslok Hospital. (Annexure P 7) But, the Complainant did not bother to avail the said benefit. Arguments and findings:

WE have heard Counsel for the both parties, perused the affidavits filed by the parties. The Counsel for complainant, Mr. Sunil Dutta Salwan, drew our attention towards the hospital records, the ECHO report and Surgical notes. He has produced several medical literatures/texts from books on cardiology. The Counsel for OP submitted that in cases of mild to moderate leak, only medical management is advised and not surgical intervention. On 2.2.2002 patient''s blood pressure was under 110/70, the diastolic pressure being within normal limits, indicates absence of significant paravalvular leak. We have perused the copy of progress notes available on record. The Counsel further submitted that all over the world, routinely, the Trans Esophageal ECHO (TEE) is not performed for a mechanical valve replacement, except for the research purpose. Even otherwise, TEE will not prevent incidence of postoperative paravalvular leak after four to six weeks. Routinely, TEE is essential for valve repair and not for mechanical valve replacement. To support his contention, Counsel produced related literature from Journal of Americal College of Cardiology, Vol. 38, No. 1 2001 by Dr. Plehn. Discussion:

WE have perused the medical records on file and noted that, the Complainant was readmitted on 16.3.2002 with congestive heart failure and was treated symptomatically, and improved by 19.3.2002. The echo findings were of significant parivalvular leak and diastolic blood pressure was about 50 mm of Hg. Dr. Sanjeeb Roy and the OP -2 explained to the Complainant and his relative, that the leak can be closed by the Re -do surgery, i.e. putting few more sutures, without replacing the valve. The OPs also told about the cost assessed at Rs. 10,000 only for medicines and material. But, the Complainant did not want to have surgery, since he was not mentally prepared and told the OP that he will come back after three weeks. After going through the medical texts, we are of considered view that, even if the OP did TEE at the time of surgery, it would not help the patient as, the significant leak came after five weeks. The complainant did not opt for Re -do surgery which was advised to him by OP -5 and the other doctors, with whom the complainant consulted. But, he has wasted the precious time from 20.3.2002 to 29.9.2003 i.e. about 1 1/2 years, in the consulting several doctors. Hon''ble Supreme Court observed in several judgments on medical negligence that: "Just because a person suffers a bad outcome from medical treatment, does not mean that they have an automatic right to sue for compensation. A medical error is only considered ''negligent'' if the healthcare practitioner has failed to take ''reasonable care''. The law does not require a doctor to act ''perfectly'', but rather, the law requires that a doctor take ''reasonable care'' in treating and advising a patient. This is not a high or impossible standard to achieve."

Bolam v. Friern Hospital Management Committee, [1957] ruled that:

"It is expected of a professional person that he should show a fair, reasonable and competent degree of skill; it is not required that he should use the highest degree of skill."

WE would like to rely upon the case of Kusum Sharma and Ors. v. Batra Hospital and Medical Research Centre and Ors., : II (2010) SLT 73 : I (2010) CPJ 29 (SC) : (2010) 3 SCC 480 (Two Member Bench), while referring and relying upon landmark judgment on medical negligence in the case of Jacob Mathew v. State of Punjab, reported as : III (2005) CPJ 9 (SC) : 122 (2005) DLT 83 (SC) : VI (2005) SLT 1 : III (2005) CCR 9 (SC) : (2005) 6 SCC 1, the Hon''ble Supreme Court has held as under: "Para 46: ...(i) A doctor is not negligent, if he is acting in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art, merely because there is a body of such opinion that takes a contrary view... A man need not possess the highest expert skill at the risk of being found negligent. It is well established law that it is sufficient if he exercises the ordinary competent man exercising that particular art.

Para 47: Medical science has conferred great benefits on mankind but these benefits are attended by considerable risks. Every surgical operation is attended by considerable risks. We cannot take the benefits without taking risks. Every advancement in technique is also attended by risks.

Para 58: ...we should be doing a disservice to the community at large is we were to impose liability on hospitals and doctors for everything that happens to go wrong.

Para 76: ....A surgeon with shaky hands under fear of legal action cannot perform a successful operation and a quivering physician cannot administer the end -close of a medicine to his patient.

Para 78: It is a matter of common knowledge that after happening some unfortunate event, there is a marked tendency to look for a human factor to blame for an untoward event, a tendency which is closely linked with the desire to punish...

Para 90: .....As long as doctors have performed their duties and exercised an ordinary degree of professional skill and competence, they cannot be held guilty of medical negligence."

FURTHER , this Commission, in the case of Smt. Narangiben Subodhchandra Shah & Ors. v. Gujarat Research and Medical Institute popularly known as Rajasthan Hospital, (OP No. 171/1997) (2012) III CPJ 509 (NC), has, inter alia, at Para 20, observed that: "After all doctors can only treat but cannot guarantee the success of a surgical operation which inevitably is fraught with risks."

It was also held by the Hon''ble Supreme Court in Jacob Mathew''s case as under (Para 26): "No sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitur is not of universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors. Else, it would be counter -productive. Simply because a patient has not favourably respondent to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per se by applying the doctrine of res ipsa loquitur."

In our view, this is one of the "Calculated Risk" cases and not a res ipsa loquitur.

The theory of the calculated risk doctrine is that res ipsa loquitur should not be applied when the injury complained is of a type that may occur even though reasonable care has been taken. This doctrine is an important defence to any doctor sued for professional negligence or Medical negligence, who can produce expert evidence or statistics to show that the accepted method of treatment he employed, had unavoidable risks.

ON the basis of evidence, the medical records and applying the principles laid down by Hon''ble Supreme Court, we are of considered view that, in the instant case, the OPs/doctors (team) were qualified and competent to perform the Cardiac Surgery (AVR+MVR), they have exercised their reasonable competence and skills and gave proper post -operative care/medical advice. From the discharge summary dated 20.3.2002, it is evident that, OPs were ready and willing to do a Re -do surgery but complainant did not avail the offer and never turned back to OP. Also, as per the medical literature, the paravalvular leak is not uncommon, it cannot be related to the surgical intervention. Periprosthetic or paravalvular leakage is due to annular calcification, infection, inadequate fibrous in growth of patient tissue, or weak annular tissue of the patient. Fibrous tissue in growth occurs at sewing ring, where the tissue from the myocardium or the annulus at the aortic valves grow into over the fabric. This tissue growth covers the rough surface of sewing ring of the St. Jude valve preventing the paravalvular leak. Clinical evidence has demonstrated that fibrous in growth was absent in few patients, causing paravalvular leak within four to six weeks. Even perfect surgery at the time of operation does not guaranteed absence of paravalvular leak. He had pledged sutures at the time of aortic valve implantation to present paravalvular leak He had mild to moderate leak, two weeks after the surgery, which was manageable with medicines. The Complainant had significant leak after six weeks of surgery not at the time of discharge on 11.2.2002. Paravalvular leak depends on patient''s risk factors like unusually thinned and weak annulus as in the case of the Complainant. Aortic and annulus fibrous tissue in growth was absent in cash of the Complainant, leading to significant leak after six weeks. This can occur 1 -3%, even in the best medical centres like Mayo Clinic, AIIMS.

BAD results are not necessarily due to medical negligence, the law considers the doctor negligent only when (1) he did not consider the possibility that such a complication might occur, (2) that he failed to watch for it carefully or to recognize it promptly, or (3) to treat in a timely and appropriate fashion. Therefore, on the basis of forgoing discussion, we do not find any basis to hold the OPs liable for any negligent act. As a goodwill gesture, during the argument, the Counsel for OP submitted that, if the patient''s condition is feasible, the OPs are still ready to offer Re -do surgery at nominal costs. But, we find that, after main surgery, already more than a decade elapsed, we don''t know whether patient is fit now for Re -do surgery. Therefore, we direct the opposite party to do complete assessment of patient and perform the Re -do surgery free of costs at their centre, if the patient is willing for or the patient''s condition is fit for the same. Accordingly, the complaint is dismissed. There is no order as to costs.