Kakasaheb vs Dr Satish Roplekar

Dr. S. M. Kantikar, Presiding Member

This common Order shall decide both the Appeals, which have been filed under section 19 of the Consumer Protection Act, 1986 (in short “the Act”) against the order of the State Consumer Disputes Redressal Commission, Maharashtra (in short, the ‘State Commission’) in CC No. 10/2015, wherein the Complaint was dismissed.

Brief facts that on 30.01.2014, the Complainant - Kakasaheb’s wife Vandana (since deceased, hereinafter referred to as the ‘patient’), for complaints of chest pain, got admitted in Roplekar Heart Care Centre of Dr. Satish Roplekar (OP). The patient was examined by the OP and Coronary Angiography (CAG) was performed, which alleged to have revealed five blockages in the vessels. The OP advised the patient to undergo immediately Coronary Angioplasty and gave the treatment estimate of Rs. 2,50,000/- to the Complainant. It was alleged that at the time of filling the consent form, it was told that Angioplasty procedure would take 45 minutes to 1 hour. On the next day 31.01.2014, the patient was taken to Operation Theatre (OT) at 4 pm, but all of sudden, at 7 pm,  the OP informed to the Complainant about  the death of  patient  during the angioplasty procedure. The Complainant immediately lodged a police complaint against the OP for alleged negligence causing death of his wife. From the Post Mortem (PM) report, the Complainant came to know about the cause of death as “Cardiac tamponed due to rupture of left anterior descending coronary artery during the procedure of percutaneous transluminal coronary angioplasty in a known case of ischaemic heart disease with hypertension”. Therefore, being aggrieved, the Complainant filed the Consumer Complaint before the State Commission and prayed for compensation of Rs. 48,06,480/- and other relief.

The OP –Dr. Roplekar filed his reply and denied the negligence during the procedure and treatment of the patient. He submitted that since year 2010 the patient was suffering from heart problem. On 30.01.2014 she approached the OP with complaints of chest pain and breathlessness i.e. Dyspnea on exertion (DOE -Grade-Ill) a severe nature. The OP clinically examined her and ECG, lab investigations were done. It was diagnosed as ‘unstable angina and high blood pressure’. At the first time patient was detected to be diabetic. Therefore, the Complainant was informed to hospitalize the patient for further management. After admission oxygen inhalation and few medicines were given. Next day at about 10.45 am, the OP again examined the patient along with the ECG and blood reports, accordingly advised CAG to decide further course of treatment.

The OP performed angiography was performed after informed consent of patient and her relative. He denied the allegation about five blockages seen in the angiography. The OP submitted that the CAG revealed 90% long segment stenosis in Left Anterior Descending artery (LAD) and 90 - 95% in the Right Coronary Artery (RCA). It was significant, severe and critical disease that warranted urgent Per Cutaneous Coronary Angioplasty (PTCA). The patient, her husband and her relatives were informed about the PTCA procedure, its benefits and complications. The Complainant deposited only Rs. 85,000/- out of the estimated cost of Rs.2,50,000/- and promised to clear the balance amount before discharge.

He further submitted that Angioplasty procedure was started on 31.01.2014 at 4.00 pm after obtaining informed consent. The angioplasty to RCA was successfully completed without any complications. During the angioplasty of LAD, the long segment was stented with two stents in overlapping manner. The overlapping portion and distended segment need to be dilated with balloon for proper approximation of the stents to the arterial wall. In the instant case the LAD tolerated the first dilatation very well, however while second dilatation a serious complication of perforation of the coronary artery was occurred. Immediately, to seal the perforation as per the standard protocol all the necessary steps were done without any delay. However the patient’s condition deteriorated and the patient expired at 7.00 p.m. At that time, Dr. Ashish Deshpande, the Senior Interventional Cardiologist was present in the OT, who also expressed that it was a bad luck despite every care during angioplasty, the complication occurred and it was not any negligence.

The OP- Dr. Roplekar, in his support, filed affidavit of evidence from Dr. Ashish Deshpande and four other opinions from senior cardiologists namely by Dr. Jagdish Hiremath, Dr.Shirish Hiremath Ruby Hall Centre, Pune, Dr. A. B. Mehta, Jaslok Hospital, Mumbai and Dr. V. B. Pahlajani , Mumbai.

The state Commission upon hearing the parties, appraisal of evidence and the four expert opinions along with opinion from JJ Hospital held that the Complainants failed to prove the medical negligence against the OP. The State Commission dismissed the Complaint. The State Commission further observed that the Complainant paid the balance hospital charges (bill) after one year of incident and then issued legal notice to the OP, which in itself indicates an ulterior motive of Complainant to harass the doctor.

Being aggrieved, both the parties challenged the impugned Order by filing two First Appeals before this Commission. The Complainant filed F.A. No. 956 of 2016 to challenge the dismissal of Complaint. The OP filed F.A. No. 1046 of 2016 seeking compensation for harassment and filing frivolous Complaint.

We have heard the learned Counsel on both the sides. Perused the entire medical record and various literature, standard text books on the subject and inter alia, order of the State Commission.

The learned counsel for Complainant argued that cardiac anesthetist was not available during the procedure of Angioplasty. Therefore, cardiac anesthesia was not given. The coronary perforation was anticipated by OP, but he could not seal it off. The State Commission failed to note that OP was not a CVTS/Cardiac Surgeon, who could be competent to tackle such grave complication. The Counsel further argued that use of covered stent was the basic step in management of coronary artery perforation to stop the bleeding, but the OP failed to do it. Though Graft stent was not used but, it was charged in the bill. The OP failed to perform CABG, because OP was not a Cardio-thoracic Surgeon. Even Dr. Ashish Deshpande was not a Cardiac surgeon. The expert committee of JJ Hospital report supports the case of the Complainant, which held it as failure of standard of care, it mentioned that  "Had the perforation sealed off this patient would have survived but due to the failure of the standard measures used this patient  died due to this complication”.

The learned Senior Counsel for OP argued that the State Commission while dismissing the complaint rightly held that there is no medical negligence and also observed the conduct of the Complainant as an ulterior motive to harass the doctor. Therefore, the State Commission ought to have awarded cost of Rs. 50,00,000/- to OP  towards mental agony, defamation in the society at large, physical harassment, economical loss and wastage of valuable time.

The learned senior Counsel reiterated the evidence file by the OP before the State Commission. He submitted that the patient and relatives were explained about the treatment and its limitations. They agreed for PTCA and gave informed consent. The CD of PTCA was issued and self-explanatory. He brought our attention to the opinion of four experts, who did not find any negligence of OP during PTCA and the complication was efficiently managed as per standard protocol, therefore there was no negligence of the OP.

We have carefully perused the entire medical record, the CD recording and the medical literatures. As per the standard books on Cardiology Grade-III perforation occurs in 2.6% to 17%. In the instant patient, we note that there were distinct long segmental blocks, which needed PTCA with long length stents. In India, stents up to 45 mm long are available. However, in this case good outcome was achieved with the use of 3.5 X 48 mm stent for RCA.  As per ACC/AHA guidelines, CABG was not mandatory for such distinct and long segmental block. The PTCA was performed after informed consent. In case of PTCA procedure cardiac anesthetist is not required; as per practice guidelines, it is an accepted practice that the procedure is performed under local anesthesia and mild sedation. The OP during the PTCA procedure opened Graft Master Stent (Abbott Company) 3 x 16 mm to be used to seal the perforation which did not track and it may not be seen in PM. Therefore, the allegation of complainant about not using the Graft Stent and it was not seen in PM is not sustainable.  It should be borne in mind that in Cathlab, the stock of stents of various sizes of various manufacturer companies are kept on consignment basis and billed only after the use. Moreover, stents are being supplied by different vendors, which bear different dates on the bills. Therefore allegation of complainant about fake bills is not sustainable. We agree with the observation of the State Commission that the Complainant paying the balance bill after a year and then initiating the Complaint, seemed to be an ulterior motive.

We further note that after the complication of perforation, complete resuscitative efforts were made by the OP and his team, but the patient’s condition deteriorated rapidly and she could not be saved. The OPs tried to explain the cause of death to the relatives, but however they were not in receptive mood and due to hostile attitude of the Complainant and his relatives, the OP himself informed the Police Station to register the death as Medico Legal case (MLC).

According to the recommendations of SCAI, American College of Cardiology(ACC) and American Heart Association(AHA) there is no need of onsite Cardiac OT for the Cathlab. Pertinently, the Cathlabs functioning in small cities like Jalna, Beed, Parbhani, Buldhana Cardiac OT is not available. Cardiac OT in real sense not kept "Standby" (as vacant) as routinely PTCA procedure being performed in Cathlab. The serious complication like Cardiac Temponade could be managed in ICCU at bedside.

The evidence on record revealed that informed consent was taken for PTCA Procedure. The Complainant did not file any expert opinion, but he erroneously relied upon the opinion of JJ Hospital.  It is pertinent to note that the OP spoke to the relative of patient- Dr. Vinod Shisode and appraised the Angiography findings. He was physician and practicing cardiologist at MGM Hospital, Aurangabad. He  also suggested to undergo PTCA for the patient, however  the relatives took 3 hours  to make decision. The patient and complainant were given sufficient time to make their decision. Thus, the OP neither performed PTCA hurriedly nor forced for it.

We have carefully perused the opinions (letter of reference) issued by the Cardiologist – Dr. Jagdish Hiremath, Dr. Shirish Hiremath, Dr. A. B. Mehta and Dr. D.B. Pahlajani. We have perused the medical references (literatures / textbooks on cardiology) on guidelines for chest management[Textbook of Cardiovascular medicine, 10th Ed. 2015], initial treatment strategy for unstable Angina / acute coronary syndrome[Cardiology clinics, Coronary Artery Disease, Volume 32, no. 3], ACC AHA guidelines for PCI[Textbook of Cardiovascular medicine, 10th Ed. 2015], Revascularization Strategy and Coronary Perforation[Textbook of Interventional Cardiology, 6th Ed. 2012]. In our considered view, the patient  with ACS symptoms as per scientific norms of cardiology  the OP performed Coronary angiography and treated with multi-vessel angioplasty. The  optimizing the stent apposition to the artery is a necessary step for all angioplasties especially when long stents are used or when the stents are overlapping. However, in the instant case during the stage of optimizing having good result, the artery perforated and led to uncontrollable bleeding leading to death. The coronary perforation is a known complication of PTCA occurring in about 1% of cases. This has to be treated aggressively and sealing of the perforation with covered stent becomes an important step. Simultaneously many other measures like peri-cardiocentesis, auto-transfusion and prolonged balloon inflation of the leaking artery are equally important.

We would like to put more reliance on the opinion of the committee of experts of GMC and JJ Hospital, Mumbai. It is reproduced as below:

Case Summary:-

1) 45yr old lady Mrs. Vandana thakare was admitted to Ruby heart care centre at Aurangabad with diagnosis of acute coronary syndrome on 30/1/14 at 11:35 pm.

2) The patient was subjected to angiography on 31/1/14- which showed significant blocks in two arteries(LAD and RCA).

3) Patient was clinically stable as per the notes post angiography.

4) With consent of patient relatives patient was subjected to coronary angioplasty. Right coronary angioplasty was carried out successfully using one drug eluting stent.

5) The LAD angioplasty was carried out using two overlapping stents since one long stent could not be negotiated across the block. The stent was being post dialted, during the course of which the treating doctor found coronary perforation.

6) He tried to put stent graft to seal the perforation but failed to cross with the stent graft.

7) As the next option prolonged balloon inflation was given at the perforation site, however this did not help to seal the perforation.

8) Ancillary medical treatment including blood transfusion, pericardiocentesis was carried out as required.

9) All measures taken to stabilise the patient were failed and patient deteriorated and declared dead on 31/1/2014 at 7:00 pm.

OPINION:-

Coronary perforation during angioplasty procedure is known complication which can occur in 0.5 -1% cases very well recognised and included in the scientific medical literature. Had the perforation sealed off this patient would have survived but due to the failure of the standard measures used this patient died due to this complication. However this is known complication which can occur in any patient during such procedure. We see no negligence in management of this patient by treating doctor and hospital.

The Complainant filed the opinion of Committee of GMC and Sir JJ Hospital to support his case. On careful reading of the said opinion the Complainant as per his convenience twisted the words and filed the Complaint. It is clear from the opinion from the committee of JJ Hospital there was no negligence in the management of the patient by the treating doctor and the hospital. The chance of perforation depends upon the arterial pathology. It was known complication even after application of appropriate post dilatation strategy. It has high mortality even in the best centers.

In the instant case, we note from the entirety that even after the perforation, the OP and his team of doctors made attempts to salvage the situation. We further note that OP performed ECHO guided peri-cardiocentasis with use of Pigtail catheter to aspirate the hemorrhagic fluid from pericardial space to reduce the tamponade effect. The OP performed prolonged balloon inflation and to drain the blood. The patient was also given auto-transfusion, but unfortunately, the science and the human efforts have to fall short in some cases, which happened in the instant case. Thus, in our considered view, it was not negligence or dereliction of duty of care.

This view dovetails from the decision of Hon’ble Surpeme Court in the case of Achutrao Haribhau Khodwa v. State of Maharashtra[(1996) 2 SCC 634 ], wherein their Lordships observed that in cases where the doctors act carelessly and in a manner which is not expected of a medical practitioner, then in such a case an action in tort would be maintainable. Their Lordships further observed that if the doctor has taken proper precautions and despite that if the patient does not survive then the court should be very slow in attributing negligence on the part of the doctor. It was held as ‘A medical practitioner has various duties towards his patient and he must act with a reasonable degree of skill and knowledge and must exercise a reasonable degree of care’.

We would further like to rely upon the recent judgments of the Hon’ble Supreme Court namely  Bombay Hospital & Medical Research Centre vs. Asha Jaiswal & Ors.[ 2021 SCC OnLine SC 1149 ], Dr. (Mrs.) Chanda Rani Akhouri & Ors. Vs Dr. MA Methusethupathi & Ors.[ 2022 LiveLaw (SC) 391] and S. K. Jhunjhunwala vs. Dhanwanti Kaur and Another[(2019) 2 SCC 282], which has laid down in no uncertain terms that merely because doctors could not save the patient, he/she cannot be held liable for medical negligence.

Based on the discussion above, we do not find that the OP failed in his duty of care. His diagnosis was correct and took correct decision of PTCA for management of coronary blockages. The unforeseen complication was treated with all efforts as per accepted standard of practice. We do not find any medical negligence attributable to the OP. Accordingly, FA No. 956 of 2016, filed by the Complainant, is dismissed. Considering the facts and circumstances, in the entirety, there is no merit in FA No. 1046 of 2016 filed by OP and the same also stands dismissed.

The reasoned Order of State Commission is affirmed and both the Appeals, being devoid of merits, are dismissed.

There shall be no order as to costs.