Appeared at the time of arguments

Pronounced on: 26^th August 2022

ORDER

DR. S. M. KANTIKAR, PRESIDING MEMBER

Brief Facts:

1.       On 11.05.2007, Mrs. Kusum Nehra, mother of the Complainant (hereinafter referred to as the ‘patient’), 68 years, consulted Dr. Ashok Raj Gopal (OP-2), an Orthopedic Surgeon at Fortis Hospital, Noida for her deformities in both the knees and difficulty in walking and bound to wheel chair. The OP-2 advised Total Knee Replacement (TKR) Surgery. On 13.05.2007, the patient got admitted to the OP-1 – Hospital. The blood tests and other investigations were found normal. On 14.05.2007, the OP-2 and his team performed bilateral TKR. It was alleged that on 17.05.2007, despite breathing problem, the patient was shifted from ICU to the ward (room) with Oxygen mask. The on-duty doctor told the Complainant that the mask was displaced in night, therefore oxygen supply was reduced. The breathing problems continued and on 20.05.2007 around 1.00 to 2.00 p.m., she was again shifted to surgical ICU and was put on ventilator at 3.00 p.m.

2.       It was alleged that till 12.06.2007, the OP-2 never disclosed about the real condition of the patient. The Complainant raised few allegations like non-functioning of AC in the room, improper electric supply to the ICU instrument; the attendants were not allowed to visit ICU during 20.05.2007 to 30.05.2007. It was further alleged that on 04.06.2007, the hospital issued one incomplete handwritten case summary, devoid of details of Acinetobacter and Pseudomonas infection. After the death of the patient, the medical record and the remaining discharge summary was issued with the delay till 27.06.2007. Though, the laboratory was inside the hospital, the blood samples for culture and sensitivity (C&S) were taken on 20.05.2007, but the report of presence of Acinetobacter was made available on 23.05.2007. Similarly the ET sample taken on 30.05.2007 was reported on 01.06.2007 as Pseudomonas. Thus, such delay clearly indicates the carelessness during the post-operative period.

Being aggrieved, the Complainant filed the instant Consumer Complaint and prayed for Rs. 1,37,89,556/- and other reliefs.

Defense:

3.       The OPs filed their reply and denied any negligence during the operation or post-operation. It was submitted that a Pre-operative Check-up was done by the anaesthetist and cardiologist and found within normal limits after thorough discussion and understanding of the procedure. The informed written High Risk Consent Form was signed by the patient and the Complainant. The Bilateral TKR under Combined Spinal & Epidural anesthesia was performed by OP-2 and his team on 14.05.2007.  Post-operatively, the patient was shifted to the Surgical ICU (SICU). The vital parameters - heart rate, respiratory rate and blood pressure were normal. Two units of Packed RBCs' were transfused to increase Hb% and to make up the blood loss during major surgery like TKR. On 15.05.2007, Deep Vein Thrombosis (DVT) Prophylaxis with Inj Enoxaparin was started and Graduated Pressure Stockings were applied due to prolonged immobilization of the patient. The patient was shifted from ICU to the ward on 17.05.2007, with O₂ mask. At 10 p.m. on 17.5.2007, the patient’s SPO₂ was (84%), although she was asymptomatic. Her chest X-ray showed B/L mid zone haziness. The air entry was good on auscultation and there were few respiratory crepitations. The Oxygen inhalation by mask was started, which improved the SPO₂ and it remained above 90% overnight. On 17.05.2007 itself, the wounds   were checked,   the wounds were healthy, there was no soakage and the patient was comfortable. The patient remained fairly well till 8:00 pm on 18.05.2007. Thereafter, when her breathlessness increased and oxygen SPO₂ decreased to 91%, immediately, the patient was put on BiPAP support and emergency lab investigations were sent for Hb, TLC, DLC, Serum Proteins, Serum Albumin, D-Dimer and urine for fat globules. The chest X-ray showed bilateral mid zone haziness. Clinically, the infection was suspected and Inj Zosyn (Piperacillin+Tazobactam) was started. In addition, Inj Tiecoplanin and Inj Levofloxacin were started. These are higher generation Antibiotics with broad spectrum of antibacterial activity. The x-ray chest was done on 22.05.2007 after the treatment, which revealed haziness in lung was cleared.

4.       The OPs submitted that the role of the OP-2 was limited only to the surgery of Bilateral TKR. The post-operative care of the surgical wounds was regularly examined by OP-2 and his Ortho team. The wound healed completely and remained healthy. All the surgical staples were removed on 29.5.2007.

5.       On 24.05.2007, the blood culture report revealed Acinetobacter   infection.  The patient’s Total Leucocyte Count (TLC)   increased   and even the X-ray showed increased opacity. Therefore, the antibiotics were revised and as per the C & S report, Inj. Magnex Forte (Cefraporazone & Salbactum) and Inj. Amikacin were started. The Culture Report (01.06.2007) from the endotracheal (ET) aspirate showed growth of Pseudomonas and based on sensitivity, antibiotic was changed to Inj Meropenem. The doctors from the Critical Care team were able to control the growth of the Acinetobacter bacteria. The subsequent blood culture reports on 4.6.2007, 8.6.2007 and 13.6.2007 did not show Acinetobacter. However, the Pseudomonas bacteria failed to respond to the treatment and the patient thereafter developed resistance to most Antibiotics. The patient's condition continued to deteriorate despite all possible efforts till 16.07.2007. Throughout the hospitalization, the patient was constantly monitored and examined by doctors of various specialties viz Critical Care, Cardiology, Pulmonology, Gastroenterology and Nephrology. The patient developed Sepsis with Acute Respiratory Distress Syndrome (ARDS) and multi-organ Failure including Respiratory & Renal kidney failure. Her condition deteriorated further and she suffered cardiac arrest on 16.06.2007 at 2:25 pm. Cardio-pulmonary resuscitation (CPR) was started as per standard ACLS guidelines, but the patient could not   be revived and  was declared dead at 3:48 pm.

Arguments of the Complainant

6.       The learned Counsel for the Complainant vehemently argued that the untimely death of the patient was due to hospital acquired infection. It was due to careless and negligence during post-operative care. He further argued that prior to the admission to the hospital, the patient had no infection or any other major illness. The blood tests and other investigations were normal. He further submitted that the brother-in-law of the Complainant - Mr. R. K. Singh lodged an FIR under Section 304 A IPC against OP-2. It was challenged by the OP-2 before the Hon'ble High Court of Allahabad. It was disposed of on 10.07.2007. Accordingly, the District Magistrate of Gautam Budh Nagar directed the Chief Medical Officer to constitute a team of expert doctors/medical board to enquire in this matter. The Medical Board, vide its report dated 22.12.2007, held that the OP-2 was not guilty of negligence. On 25.02.2008, the Investigating Officer submitted his final report before the court of Chief Judicial Magistrate, Noida. The brother-in-law of the Complainant filed protest petition, but the Court upheld the final report. However, the Court in its Order dated 12.09.2009, observed that as far as the question of generation of bacteria by the infection in the ICU after operation, it creates doubt that the OP-1 may be at fault.

Arguments of the OPs: 

7.       The learned Counsel for the OPs reiterated their evidence. The learned Counsel for the OP-1 submitted that the deceased patient was treated to the best abilities of the Answering opposite parties and as per the standard medical protocol, to be followed with the patients with such complications.

8.       The learned Counsel for OP-2 submitted that Dr. Ashok Raj Gopal was Orthopedic Surgeon having national repute and specialization in the field of Knee Replacement. Presently, he is Chairman & Executive Director - Fortis Escorts Heart Institute, Okhla Road, New Delhi. The Counsel further submitted that the Complainant has not furnished any iota of evidence to substantiate her allegations. The role of OP-2 as an Orthopedic Surgeon was limited to the procedure of bilateral TKR. It was done successfully and the surgical site did not develop any infection. It was healed completely. As per the Death Certificate, the direct cause of death of the patient was "Severe Respiratory and Metabolic acidosis leading to Asystole". It was not, in any way, connected with the TKR Surgery. There was no negligence during TKR surgery. It is supported by the opinion of the Medical Board constituted after the direction of the Hon'ble High Court of Allahabad. Therefore, the subsequent infection, which was contracted, cannot be attributed to the TKR procedure. In fact, the stitches of the wound were removed on 29.5.2007 and the wound was healed satisfactorily. The treating team of doctors performed their duties with reasonable skill and competence in the best interest of the patient. No case of medical negligence is made out.   

Observations & Discussion:

9.       On careful perusal of medical record, it revealed that on 23/05/2007, the patient’s blood culture grew Acinetobacter, a type of bacteria with high virulence. It is known that very sick patients in ICU, who are on ventilator support with multiple tubes and IV Iine can get infected with such bacteria. The patient was already on antibiotics, and the antibiotics were revised on the basis of blood counts. On 27.05.2007, the patient suffered an episode of Acute Hypertension (dangerously High BP) and Left ventricular failure. The Cardiology team attended it immediately and treated successfully. The Culture samples of blood and Endotracheal (ET) aspirate sent on 1.6.2007, showed Pseudomonas bacterial growth. The secretions were regularly aspirated by external suction machines. It is pertinent to note the doctors were able to control Acinetobacter as the blood cultures done on 4^th, 6^th and 14^th June 2007 were negative, but the Pseudomonas infection failed to respond the treatment. The patient, thereafter, developed resistance to most of the Antibiotics.  Later on, despite the entire efforts, the patient’s condition continued to deteriorate and the patient developed Sepsis with Acute Respiratory Distress Syndrome (ARDS) and Multiorgan Failure (MOF) including Respiratory failure and kidney failure.  She developed cardiac arrest on 16.06.2007 at 2.20 pm, despite cardiopulmonary resuscitation performed as per ACLS guidelines, the patient could not be revived and was declared dead at 3:48 pm.

10.     The OP-2, in support of his case, filed opinions from two experts - one from Dr. Yatin Mehta, a Critical Care Specialist, presently Chairman at  Institute of Critical Care & Anesthesiology at Medanta-the Medicity, Gurgaon and Dr. P.K. Dave, Orthopaedic Surgeon, the ex-Director of AIIMS. Both have opined that there was no negligence in the Surgery conducted by OP-2. The subsequent infection contracted by the patient of Pseudomonas and Acinetobacter organism was independent of the surgery in the present case.

11.     We have further perused the opinion of Medical Board dated 22.12.2007, issued by the District Hospital, Noida. The comments are reproduced as below:

1)       Medico-Legal point of view, cause of Death is not established as Autopsy not done.

2)       Reasonable efforts were made to treat the infection by Medical Team in ICU of Fortis Hospital, Noida.

3)       Incidence of death by Acinetobacter/Pseudomonas bacteria producing “Ventilator Associated Pneumonia” in ICU set up is an established fact and reported to have occurred at the best of Medical Centers/Hospitals in the World over.

The Board observed that reasonable efforts were made by the ICU team of Fortis Hospital, Noida to treat the infection. The board had further commented that "Incidence of death by Acinetobacter/Pseudomonas bacteria producing "Ventilator Associated Pneumonia" in ICU set up is an established fact and reported to have occurred at the best of Medical Centers/Hospitals in the World over. The Medical Board opined that there was no evidence of any rashness/omission and/or negligence by the OP-2, while treating the patient. The board also relied upon the Bolam test, which is the accepted benchmark to establish medical negligence.

12.     After major surgeries and in prolonged immobilization of patients, there is risk of developing Blood clot in the deep vein of Legs and pelvis called Deep Vein Thrombosis. As a preventive and precautionary measures, injections Enoxaparin and equipment like graduated compression stockings are used. These measures are started after TKR surgery as a mandatory protocol).

13.     Pseudomonas is a type of bacteria present in Hospital-settings like ICU areas. Patient on ventilators, bed-ridden and immuno-compromised state are at a high risk of infection. Appropriate antibiotics were administered based on the sensitivity report. Antifungals were also added.

14.     The OP-2, whose role as a Surgeon was to operate to the best of his ability with due care and caution, performed TKR successfully and the surgical wound was healed well and the stitches were removed. The subsequent infection and the complication cannot be attributed to the act of the OP-2. The patient was constantly monitored and treated by a team of doctors from various specialties in the Critical Care field, Cardiologist, Pulmonologist, Gastroenterologist and Nephrologist as and when they were required.

15.     In our considered view, the team of doctors performed their duties with reasonable skill and competence. We do not find any deviation from the accepted standard of practice to transfuse 2 units of RRBC after major surgery. As a mandatory protocol and caution, the DVT Prophylaxis in the form of Inj Enoxaparin and graduated pressure Stockings were given. Thus, no case of medical negligence was made out. 

16.     Based on the forgoing discussion, the OP-2, as an Orthopaedic Surgeon and his team, performed TKR and the surgical wound was healed without any complications, the stitches were removed. The subsequent infection which the patient contracted cannot be attributed to the TKR procedure. The patient was constantly monitored by a team of doctors from various specialists in the Critical Care. As and when required, consultation was taken from Cardiologist, Pulmonologist, Gastroenterologist and Nephrologist.  Therefore, no case of deficiency in service or medical negligence is made out. The act was as per the accepted standard of practice.

17.     The Complainant failed to prove his case. The allegations need to be proved with cogent evidence. We would like to rely upon the recent judgment passed by the Hon’ble Supreme Court in Bombay Hospital & Medical Research Centre vs. Asha Jaiswal & Ors.^[1], whereby it was held in paragraphs 32 and 34 of judgment as below:-

32. In C.P. Sreekumar (Dr.), MS (Ortho) v. S. Ramanujam ^[2], this Court held that the Commission ought not to presume that the allegations in the complaint are inviolable truth even though they remained unsupported by any evidence. This Court held as under:

“37. We find from a reading of the order of the Commission that it proceeded on the basis that whatever had been alleged in the complaint by the respondent was in fact the inviolable truth even though it remained unsupported by any evidence. As already observed in Jacob Mathew case [(2005) 6 SCC 1 : 2005 SCC (Cri) 1369] the onus to prove medical negligence lies largely on the claimant and that this onus can be discharged by leading cogent evidence. A mere averment in a complaint which is denied by the other side can, by no stretch of imagination, be said to be evidence by which the case of the complainant can be said to be proved. It is the obligation of the complainant to provide the facta probanda as well as the facta probantia.”

34. Recently, this Court in a judgment reported as Dr. Harish Kumar Khurana v. Joginder Singh & Others^[3]  held that hospital and the doctors are required to exercise sufficient care in treating the patient in all circumstances. However, in an unfortunate case, death may occur. It is necessary that sufficient material or medical evidence should be available before the adjudicating authority to arrive at the conclusion that death is due to medical negligence.

18.     In the obtaining facts and the available evidence on record, it is not feasible to conclusively attribute non-adherence to duty of care and standard of practice, it is difficult to conclusively establish medical negligence / deficiency on the treating doctor and the hospital.

          The Complaint is dismissed. The parties to bear their own costs.