Appeared at the time of arguments

For the Appellant                    : Mr. Girish Kumar, Advocate

For the Respondents               : Mr. Aljo K. Joseph, Advocate for R-1

            Ms. Sunita Yadav, Advocate for R-2

Pronounced on: 19^th July  2022 

ORDER

DR. S. M. KANTIKAR, MEMBER

1.      The Appellants have filed the instant Appeal under section 19 of the Consumer Protection Act, 1986 (in short “the Act”), against the impugned Judgment and Final Orders dated 06.11.2015 passed by the Kerala State Consumer Disputes Redressal Commission, Sisuviharlane Vazhuthacadu Thiruvananthapuram (hereinafter referred to as the “State Commission”) in C.C. no. 15/2008, whereby the State Commission dismissed the intervention application filed by the appellants herein.

Brief Facts:-

2.      The Appeal has been filed by the family members of the deceased, Appellant No. 1 and 2 are the mother and father of the deceased, Appellant No. 3 is husband and Appellant No. 4 is the son of the deceased.

3.      Ms. Laxmi Anil (since deceased, hereinafter referred to as the ‘patient’), the wife of Mr. Anil Kumar, was undergoing treatment for renal failure from 15.07.2004 at Government Medical College Thiruvananthapuram. She was also diagnosed as suffering from pericardial effusion, therefore, she was advised to take treatment at a higher center. Therefore, the patient was discharged and on 13.09.2004, got admitted in Amrita Institute of Medical Sciences and Research Centre (hereinafter referred to as the ‘Opposite Party No. 1 / Respondent No. 1 – AIMS Hospital’). At the time of admission, she disclosed complete medical history to the doctors along with previous treatment records. She was advised for dialysis for renal complaint and suggested kidney transplantation at a later stage.

4.      From 14.09.2004, the patient underwent continuous dialysis for a period of 20 days and was discharged on 05.10.2004 and advised to continue the dialysis as on OPD basis. But on 13.10.2004, she again got admitted to the Opposite Party No. 1 – Hospital with aggravated symptoms and she was treated as an inpatient till 20.10.2004 and was discharged again with a direction to continue her dialysis as an outpatient.

5.      The treating doctors informed the relative of the patient that the patient was suffering from Tuberculosis (TB) and the treatment for TB also started along with her dialysis. She was advised to take treatment of TB for at least 6 months. The Hospital also intimated the relatives to get ready for patient’s kidney transplantation. In the meantime, the kidney of the patient’s mother was found suitable for transplantation and thereafter, on 18.01.2005, kidney transplantation was performed and the patient was discharged on 27.01.2005. The further treatment for TB was continued for a period of 4 months and it was completed on 12.05.2005. In the month of June, 2005, the patient went to Dubai and there, she was advised periodical follow-up with Dr. Poulose P. Thomas, a Nephrologist attached to Beihoul Specialty Hospital, Dubai. However, she lost her appetite and started to have irritation in the stomach after taking solid foods and her condition became worse. Therefore, she returned to Thiruvananthapuram on 08.07.2006 and got admitted to KIMS Hospital on 10.07.2006. It was alleged that the doctor started treatment without any test and discharged her on 16.07.2006. But, again she was admitted in the Opposite Party No. 1 Hospital on 18.07.2006, due to difficulty in breathing and she was shifted to ICU on ventilator. However, during treatment, she expired on 14.08.2006. The hospital informed the relatives that the cause of death was due to sepsis. Being aggrieved by the gross negligence of the treating doctors and unfair trade practices at Opposite Party No. 1 Hospital, the Complainants filed the Consumer Complaint before the State Commission, Kerala seeking compensation of Rs. 1 Crore.

6.      The Opposite Parties Nos. 1 and 2 filed their separate replies and denied the allegations. It was submitted that the patient was Type-I diabetes mellitus (DM) since the age of 9 years. She  had renal problems and also pericardial effusion. The pericardial effusion in such cases occurs due to TB. The effusion usually disappears after intensive dialysis sessions. The patient responded anti-TB treatment. She was on maintenance dialysis and underwent kidney transplant on 18.01.2005. She was on immune-suppressive medicines. The patient was   advised the proper combination of TB medicines and the doses were adjusted appropriately according to kidney function tests. Appropriate dosages of TB medicines before and after kidney transplantation were given.  As the patient expressed her desire to go to Dubai, therefore, the Hospital gave consent, but she was advised for periodical check-up without fail. She was also advised to take consultation with Dr. Poulose P. Thomas, the Nephrologist in Dubai. In the cases of sepsis, the organs like lungs, kidney, liver and brain are affected and ICU support was the accepted therapy. The Opposite Party No. 1 denied the wrong combination of drug and wrong doses for TB was given. The doses of TB medicine were adjusted according to her kidney functions. The said treatment was decided by the team of highly qualified Nephrologist, Transplant Surgeon and the Anesthetist.  After renal transplantation, for about five months, there was no complaint and the best possible treatment was given to the patient.  Hence, there was no negligence or shortcoming during the treatment.

7.      The State Commission dismissed the complaint on the ground that Complainants failed to produce no proper evidence to substantiate the allegations of deficiency of service.

8.      Being aggrieved by the Order of State Commission, Complainants have filed the instant Appeal. The grounds in the Appeal that the State Commission did not consider about the treatment aspects of the TB in such case of end stage kidney with hemodialysis. The doses of TB drugs were improper and not for correct duration as per the standard regime of TB, therefore, there was a recurrence of TB. The Opposite Parties performed transplantation without curing the TB. Even the Opposite Party No. 1 charged the patient towards the test to be conducted for the pericardial fluid from AIIMS, New Delhi. It amounts to criminal breach of trust.

9.      Heard the arguments from the learned Counsel for both sides. Perused the medical record inter alia the impugned Order and the relevant medical literature on renal transplant and Tuberculosis.

10.     The learned Counsel for complainant argued that the treating doctors at the Opposite Party No. 1 have not followed accepted standard of practice. The wrong combinations of TB medicines and the dosage were not proper.  The sepsis was not disclosed to them. The learned Counsel for the Opposite Parties reiterated their evidence and submitted that the treatment was done as per standard practice in Nephrology. There was no negligence.  

11.     It is pertinent to note that the patient suffered from two different diseases one chronic renal failure and the second pericardial effusion. The pericardial effusion may be due to kidney failure and/or Tuberculosis. If it was renal failure, then the effusion disappears after intensive dialysis, but if it was due to Tuberculosis, the effusion will not reduce. The patient responded well to the TB treatment. Therefore, the allegation about delay in starting treatment for TB is not sustainable.

12.     The medical record clearly shows that from 03.07.2004, the patient was taking anti Koch’s (TB) treatment (ATT) with four drugs namely RIFA, INH, PZA, ETB. The patient was admitted at AIMS on 13.09.2004 for pre-transplant evaluation and discharge on 05.10.2004. The discharge summary (discussion) is reproduced as below:

“Mrs. Lakshmi was admitted for pre transplant evaluation and initiation of hemodialysis. She was initiated on hemodialysis on 14.09.2014 through a right internal jugular catheter. She was given pack red blood cell transfusion under Azoran cover. She was cleared from Urology, Gastroenterology, Ophthalmology, ENT, Dental and OBG units for rental transplantation. Echocardiogram showed pericardial effusion and she was given intensive daily-hemodialysis for two weeks. Ophthalmologist evaluated her and was found to have non-proliferative diabetic retinopathy. She is being discharged with advice to continue hemodialysis as an outpatient.”

13.     On 13.10.2004, the patient was again admitted in AIMS Hospital for Pericardiocentesis and was discharged on 20.10.2004. The discussion in the discharge summary is revealed as below:

“Ms. Lekshmi was admitted for pericardiocentesis as pericardial effusion persisted inspite of intensive daily dialysis for two weeks. The procedure was done on 13.10 2004. Fluid aspirated was hemorrhagic. Post procedure echocardiogram showed mild pericardial effusion (16 mm posterior to LV) which is loculated. Blood sugar was controlled with adjusting dose of insulin, she had diminished vision (R) eye, which was evaluated by ophthalmologist and was found to have Vitreous and preretinal hemorrhage due to diabetic retinopathy. She is being discharged with advice to continue regular hemodialysis.”

14.     Thereafter, on 15.01.2005, she was admitted for renal transplant under the Consultant, Dr. Unni at AIMS Hospital and the renal transplant was performed on 18.01.2005. She was discharged on 27.01.2005. She was advised to continue the immunosuppressant – Syp. Cyclosporine, Tab. steroid – Wysolone and two drugs for TB namely Tab. INH 200 mg, Ethambutol 400 mg. The antibiotic Oflox 200 mg (BD) was also added.  

15.     We have gone through the medical literature on renal disorders and transplant. In our view, the treatment adopted by the doctors at Opposite Party No. 1 Hospital was as per the standard practice. For the pericardial effusion, heavy dialysis was performed. The tuberculosis was suspected and therefore, the anti-tuberculosis regime was prescribed by the Nephrologist was correct. Before renal transplant, the four drug regime was given for two months and thereafter, the patient was kept on two drugs for TB during post-transplant period. The drugs were given for four months, which is as per the standard of practice. There was no adverse effect due to anti TB medicine on the transplanted kidney.

16.     Admittedly, the patient was DM Type-I since childhood and undergoing treatment for renal failure in Medical College, Tiruvananthapuram. On 15.07.2004, the X-ray chest revealed pericardial effusion. She was advised to take to a higher center and got discharged from Medical College and admitted in the Opposite Party No. 1 Hospital on 13.09.2004. It was diagnosed as end stage kidney disease and she was on maintenance dialysis and planned for kidney transplantation. The pericardial effusion was due to kidney failure and more possibility of Tuberculosis, but despite repeated dialysis, pericardial effusion did not subside. After the treatment with ATT, the pericardial effusion subsided and after renal transplant, the patient was advised to take ATT with two drugs (INH & ETB). After renal transplant,   immune-suppressant medicines to be taken and  such patients  are more prone of developing infections. Her condition was stable and she was permitted to go Dubai, called in January, 2006 and till then, she was suggested to consult Dr. Poulose P. Thomas at Dubai for follow-up. But she came back on 10.07.2006. On return from Dubai, she developed fever and continuous watery diarrhea, dysuria, therefore, on 16.07.2006, she was admitted in emergency in KIMS, Cochin. The blood investigation showed leukocytosis (24600/cmm), severe acidosis. The blood and urine was sent for culture and sensitivity and she was started on Fortum (ceftazidime) and Tab. Flagyl with a provisional diagnosis of Clostridium difficile and Pyelonephritis. There was history of multiple infections in the past three months and she was suffering from loose motions for past one month. Her sugar was uncontrolled. She was given IV fluids and antibiotics based on Culture reports. She was discharged from KIMS and admitted in AIMS for further treatment, but during the course of treatment she expired on 14.08.2006 due to septicemia. In our considered view, by any stretch of imagination was no co-relation between the tuberculosis, renal transplant and   septicemia. The death was neither due to Tuberculosis nor by renal transplantation. It is pertinent to note that it was a successful kidney transplantation, as it is evident from record that the transplanted kidney functioned well till 16.07.2006 for about 1 ½ years.  

17.     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.     Based on the discussion above, we do not find any negligence from the doctors at the Opposite Party No. 1 Hospital. They performed their duties as per the reasonable standards. There was no deficiency during treatment of TB or renal disease. This view dovetails from the judgment of the Hon’ble Supreme Court in Dr. Laxman Balkrishan Joshi Vs. Dr. Trimbak Bapu Godbole and Anr. ⁴

19.     To conclude, we affirm the reasoned Order of the State Commission. There is no merit in the instant Appeal. The same stands dismissed. There shall be no Order as to costs.