National Consumer Disputes Redressal
Mulkh Raj vs Jaipur Golden Hospital And Ors on 25 April, 2018
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI CONSUMER CASE NO. 70 OF 2007 1. MULKH RAJ S/o. Sh. OmParkash,
R/o. 62, Shivam Encalve, Rohtak, Haryana 2. Pinki Dhemja W/o. Mulakh Raj R/o. 62, Shivam Encalve, Rohtak, Haryana ...........Complainant(s) Versus 1. JAIPUR GOLDEN HOSPITAL AND ORS Through its Director, Situated at, 2 Institutional Area, Rohini, New Delhi - 110 085 2. DR. RAJESH SETH A - SB / 38, Shanti Kunj, Pashim Vihar Delhi - 110 063 3. Dr. Umesh Nautiyal, Consultant, Jaipur Golden Hospital A Unit of Jaipur Golden Chritable Clinical Laboratory Trust, Situated at 2, Institutional area, Rohini, New Delhi - 110 085. 4. DR. R.K. SEXSENA, SURGEON, JAIPUR GOLDEN HOSPITAL A UNIT OF JAIPUR GOLDEN CHARITABLE CLINICAL LABORATORY TRUST, SITUATED AT 2, INSTITUTINAL AREA, ROHINI, NEW DELHI - 110 085. 5. DR. RAJESH SETH, JAIPUR GOLDEN HOSPITAL A UNIT OF JAIPUR GOLDEN CHARITABLE CLINICAL LABORATORY TRUST, SITUATED AT 2, INSTITUTIONAL AREA, ROHINI, NEW DELHI - 110 085. 6. DR. N.K. ARORA, JAIPUR GOLDEN HOSPITAL A UNIT OF JAIPUR GOLDEN CHARITABLE CLINICAL LABORATORY TRUST, SITUATED AT 2, INSTITUTIONAL AREA, ROHINI, NEW DELHI - 110 085. ...........Opp.Party(s)
BEFORE: HON'BLE MR. DR. S.M. KANTIKAR,PRESIDING MEMBER
For the Complainant : Mr. Neeraj Dutt Gaur, Advocate For the Opp.Party : For Opposite Parties 1 to 3
:
Mr. Jos Chiramel, Advocate
Mr. Archit Jhingan, Advocate
For Opposite Parties 4 & 5
:
Mr. Prateek Gupta, Advocate
Dated : 25 Apr 2018 ORDER ORDER
Complaint :
The businessmen Mulkh Raj / Complainant No.1 (for short 'the patient') was suffering from hypertension and kidney problem. In December 2006, he consulted Dr. Umesh Nautiyal/OP-2 at Jaipur Golden Hospital/ OP-1. OP-2 after examination diagnosed that patient as a case of End Stage Renal Disease(ESRD) i.e. had bilateral kidney problem. Therefore, dialysis was started from 5.12.2006.The OP-2 suggested the patient that, the OP-1/Hospital is a specialized centre for Renal/Kidney Transplant (RT) and better to undergo RT, for comfortable future life and to reduce expenses towards frequent dialysis. Pinki Dhemeja, the wife of patient had agreed to donate her kidney.Pre-renal transplant assessment of the patient and the donor was performed in the OP-1/hospital between 18.12.2006 to 21.12.2006andcalled them for renal transplant on 25.12.2016.It was alleged that Dr. Nautiyal has given final date of transplant operation after sending the samples of donor and recipient to Dr. Lal's Pathology Lab(for short 'Lal Lab'), New Delhii.e. before the receipt ofreport from Lal Lab. It was alleged that OP/doctors had concealed the fact about the weak tissue cross match between the patient and donor. According to the Lal lab's report, it was not suitable match, the HLA Phenotype was poorly matched and the B- Cell cross-match was controversial, because high B cell antibodies titre was found in a recipient/patient.It was detrimental to graft survival.If it was made known to the patient, he could not have opted for Renal Transplant. Without having tissue matching report, OP-2 and Dr.P.K.Saxena/OP-3 have performed RT.For rejection or acceptance of new graft (transplanted kidney), high dose of injection Zenapaxand constant monitoring of the graft was necessary.Patient bought Zenapax injections as prescribed by OP-3, which were to be used during RT for spouse donor.The Complainant alleged that during operation, Zenapax injections were not kept in the refrigerators, but were placed in front of the heater.Therefore, injections became hot, which OP-3 has refused to administer to the patient during surgery.The injections were expensive about Rs.36,000/- each, therefore complainanthad sustained huge financial loss. The complainant further alleged that the OPs 2 and 3 had performed the operation without conducting pre-operative ultrasound (USG). Immediately after operation, OP doctors started giving Lasix injection from 26.12.2016 onwards.They have prepared false report that sufficient urine was passed immediately after operation.The daily urine sheets maintained were false and bogus one.All the reports were prepared at one time with the same pen and ink.There was no clear correlation between the fluid intake and output.On 26.12.2006, after RT, patient was kept in ICU; he had pain in abdomen/stomach.On third day, i.e. 28.12.2000,OP-2 and OP-3 visited the ICU and noted that test reports were not satisfactory. The Serum Creatinine and Blood Urea values were on higher side. On the next day i.e. 29.12.2006, OP2, OP-3 and Dr.Rajesh Seth/OP-4, the Ultrasonologist came into ICU; conducted USG and Doppler study for blood flow in the kidney.OP-2 and OP-3 were discussing that the graft was rejected and it was because of administration of defective injection Zenapax ; thereforeOP-3 stopped subsequent injection of Zenapax.There was no blood flow, therefore Graft biopsy was performed on 30.12.2006 and 3.1.2007.It was alleged that, till the patient's discharge from OP-1 hospital, treating doctors have never disclosed that, it was a case of early graft dysfunction.The OP doctors were aware that RT was failed,but theThe patient was discharged from OP-1 on 20.1.2007 with instruction to come for dialysis after 8 days. OP/doctors also have falsely assured that, the transplanted kidney will start functioning within 4 to 6 weeks. The condition of patient became worse, therefore in critical stage patient had approached the St Thomas Hospital at Chennai on 1.2.2007 and in the midnight his dead kidney was removed (nephrectomy).
The complainants other allegation was that, the RT performed at OP-1 was illegal, because OP-1 did not possess license for RT.Moreover, total package for RT told by OP-1 was about 1.75 lakhs, including medicines and other expenses which were deposited in two installments within 31.12.2016. However,OP-1 has raised the bill for Rs.2,77,231/-, butpatient hadpaidRs.2, 47,651/- for total expenditure.
The Complainant No.1 -Mulkh Rajand his wife Pinki Dhameja /Complainant No. 2 have filed this complaint onunder Section 12 of the Consumer Protection Act, 1986 (for 'Act') against the alleged medical negligence and unfair trade practicesadopted by OP-1 and their doctors during RT against Jaipur Golden Hospital/OP-1 and five other doctors working there, who are arrayed as OPs 2 to 5.
2. Defense:
The OPs have filed their written version and denied entire allegations. It is submitted that the patient was suffering from moderate to severe Chronic Kidney Failure since December, 2004. Thereafter, for two years, he did not consult the OP-2. On 1.12.2006, he was admitted in OP-1/hospital with ESRD and after dialysis, he was told the requirement of transplant, if he could arrange the donor. The patient arranged his wife as a kidney donor. After proper evaluation of patient and the donor from Dr. Lal Path Lab, RT was performed at OP-1 on 26.12.2006, by the qualified team of doctors viz. Dr. Nautiyal, (OP-2), Dr. Saxena (OP-3). During entire hospitalization period, care of patient was proper as per the standard norms. The patient was put on triple drug immune-suppression including injection Zenapax and the graft produced good amount of urine during day 0/1/2 post-operatively. Thereafter, the urine output was 1.5 litre for few days. The USG and Doppler study were conducted on 29.12.2006 by qualified Radiologists, OP-4 and OP-5. However, rising values of Blood Urea and Creatinine, after dialysis; first graft biopsy was done on 30.12.2006, it did not show adequate renal tissue, therefore repeat biopsy was done on 03.01.2007. It's Histopathology report revealed " Acute Cortical Necrosis Renal allograft ? diffuse ? Patchy, necrosis. Thus, it was suggestive of graft dysfunction. The graft dysfunction was persisted till 11.1.2007; to enable the patient to get second opinion, the patient was given case summary dated 11.1.2007. The patient was not advised for urgent graft nephrectomy and he was maintained on the dialysis, because adequate amount of urine was being produced by the transplanted kidney and there was some hope that Patchy Cortical Necrosis may recover in few days. After all follow-up instructions, patient was discharged on 20.1.2007. Thereafter, he visited OP-1/hospital as outpatient during 22.1.2007 to 29.2.2007 and on 30.01.2007. Dialysis was done on 24.1.2007 and 29.1.2007. Thereafter, patient got his graft nephrectomy done at St. Thomas Hospital in Chennai on 2.2.2007. Therefore, according to OPs there was no negligence during entire treatment of the patient at any stage like pre-operative, operative and post-operative period. The OP-1 had admitted that, at the relevant period in 2007, their license for RT was under renewal process.
3 Arguments:
Both the parties have filed their respective written arguments along with medical literature. I have heard the arguments from learned counsel for both the parties.
3.1 Arguments on behalf of the Complainants:
The learned Counsel for complainants, Mr. Neeraj Dutt vehemently argued the matter. He was accompanied with the Complainant-1 Mulkh Raj. The counsel made submissions as:
3.1.1The counsel submitted that, the Zenapax Injection is used during RT surgery for the patient with poor cross match of spouce/unrelated kidney donor. As, in the instant case Zenapax injection was not kept in the refrigerator, but it was placed beside the heater, which became very hot and therefore, Dr. Saxena/OP-3 refused to administer it during RT. The Zenapax injections were expensive.Thus due to negligence of OPs, complainant had sustained huge financial loss.
3.1.2 The counsel further submitted that, OP-2 had concealed about the weak tissue cross match between donee and the donor. If had it been disclosed initially to the complainants, then the patient never agreed for the RT. The doctors have conducted operation on the donor and donee without pre-ultrasound assessment, which was mandatory. It was admitted by Dr. N. K. Arora (OP-5) before Medical Council of India (for short 'MCI'). Similarly, Dr. Umesh Nautiyal /OP-2 intentionally has not answered it before MCI about the pre-operative USG, but he gave false size of kidney. The counsel further submitted that, on 29.12.2006, the USG and urine output reports prepared by hospital were false and forged. Before RT, patient's urine output was approximately 1 liter, but after RT, no urine was passed, which clearly indicates the failure of RT, but to conceal this fact, the OPs prepared false reports. Injection Lasix was started immediately after operation from 26.12.2006 and the false reports were prepared to show that sufficient urine was passed immediately after operation. In each and every report, the output of urine was more than input and the urine volume was increasing daily. The daily urine sheets were bogus and thus, they have been prepared at one time with the same pen and ink. The OP/hospital staff has not mentioned about water consumed by the patient with the medicine, but same was mentioned as sip of water. There are several tempering in the medical record. The counsel submitted that the medical board of AIIMS has also held that there was mismatch between intake and output, with respect to graft dysfunction. He further submitted that, to save the skin of OPs/the doctors, the Board intentionally did not consider the entire treatment file.
3.1.3 The counsel further submitted that, during post-operative period on 29.12.2006, Doppler test was conducted by OP-4 in ICU in presence of OP-2 and OP-3, but gave false report about presence of blood flow in the kidney. The OP 4 and 5 have clearly admitted in their written version. Even the OP-5 /Dr. N. K. Arora had admitted before MCI that there was no blood flow on 29.12.2006 on USG and Doppler study. Till the discharge of patient from hospital the doctors have concealed the fact of early graft dysfunction. The decision of Delhi Medical Council (DMC) was based upon bogus and false reports of urine and ultrasound. The MCI was pleased to remove name of the Administrator of OP-1 Dr. D. K. Baluja, Dr. R. K. Saxena (OP2), Urologist and Dr. Umesh Nautiyal,(OP-2) Nephrologist from the Indian Medical Register for a period of one month. The counsel further submitted that, the OP-3 did not remove the dead kidney immediately; even the OP-5 reported it by USG performed on 8.1.2007. It was further caused pain and infection. Therefore, to get rid of the patient, OP shifted him on 8.1.2007, from ICU to the ward and directed to discharge on the next day. The nurse removed the stitches on the wound during severe pain, which caused severe bleeding on the bed, gaping of wound and internal organs from abdomen were protruding out. OP-3 had done nothing, but the junior doctor on the bed itself stitched the wound without administering local anesthesia. Patient was not taken to operation theatre. The attitude of OPs was reluctant and doctors were ready to discharge the patient with intention to let him die. On 11.1.2007, the condition of the patient became very serious but the doctors gave false assurances to the family members. On 14.1.2007, when the patient's conditions become very worse, he was taken to OT and without knowledge and consent of the patient AV Fistula was created. The medical board of AIIMS has accepted that OP had not taken any consent for AV Fistula. The patient was discharged from OP-1 on 20.1.2007 with false and bogus discharge summery. The patient was advised to come for dialysis after 8 days, despite knowing his worse condition.
3.1.4 The OP doctors have clearly accepted that the kidney was failed and dead kidney was to be removed; but, at the time of discharge, the OPs assured that within four to six weeks, kidney will start to function. Even after discharge, the condition of patient became worse. They visited the OP-1 hospital again on several occasions on 22, 24, 27, 29 and 30 of January, 2007; every time, doctors at OP-1 was requested to remove the dead kidney ,but dialysis was performed on 24.1.2007 and 29.1.2007. Thereafter, the patient had gone to St. Thomas Hospital, Chennai on 1.2.2007 where the Graft Nephrectomy was done on 02.02.2007 and since then the complainant is on dialysis. Thus, considering the situation, it is clear that the OPs have tried to murder the patient, which amounts to gross medical negligence and against the professional ethics.
3.1.5 The counsel further submitted that, on the date of operation the OP/hospital was not having license for the RT under the Transplantation of Human Organs Act, 1994.There was no full time Nephrologist as mandatory requirement for RT. The DMC and MCI have categorically made strong observations on it and MCI has removed the names of Dr. R. K. Saxena, Urologist ,Dr. Umesh Nautiyal, Nephrologist, and Mr. D. K. Baluja, the Administrative Head of the Institution from the Indian Medical Register for the period of one month.
3.2 Arguments of behalf of Opposite Parties:
On behalf of OPs, learned counsel, Mr. Jos Chiramel vehemently argued and submitted that the OP/hospital and treating doctor have followed the standard protocol of renal transplant and denied medical negligence.
3.2.1 He submitted that, the patient had consulted OP-2 in OP-1/Hospital in December, 2004, he was suffering from moderate to severe Chronic Kidney failure. Thereafter, the patient did not consult OP-2 for two years. On 1.12.2006, the patient was diagnosed as a case of ESRD and got admitted in OP-1/Hospital. The patient was discharged on 5.12.2006, and called him on 8.12.2006 for dialysis. He was also told about the facility and advantages of RT. The patient told that his wife is ready to donate her kidney. USG was performed for both (the couple) on 1.12.2006, but Complaint No 1 had deliberately concealed his USG report. On 18.12.2006, the patient was admitted in OP-1 for further investigations and he was discharged on 21.12.2006. His wife (donor) was also investigated as out-patient. The tissue matching and cross matching samples were sent to Lal Path Lab on 20.12.2006. The patient was admitted in OP-1 on 25.12.2006 along with his wife, being the spouse donor. After the informed consent (explained about success/failure and risk involved), on 26.12.2006, the patient and donor were taken into OT. Both the surgeries (removal of kidney and transplant) were smooth and uneventful. The patient was put on triple drug immune-suppression including induction by Zenapex. On post-operative for day 0 / 1 and 2, the graft produced good amount of urine i.e. 2.7 litres , 5.6 litres and 3.6 litres respectively. Thereafter, the urine out-put was around 1.5 litres for few days. On 29.12.2006, OP-4 had conducted USG and Doppler study. As, the Blood Urea and Creatinine values were on higher side, graft biopsy was done on 30.12.2006, but renal tissue was inadequate for comment, therefore, the repeat biopsy was done on 3.1.2006 and it was reported as " Acute Cortical Necrosis, Renal allograft ? diffuse ? Patchy ". Thus, it was suggestive of severe graft dysfunction. Accordingly, to seek a second opinion, patient was given the case summary dated 11.1.2007. It was further stated that adequate amount of urine was being produced by the transplanted kidney, which means there are chances of recovery of patchy cortical necrosis. Therefore, immediate nephrectomy was not advised, but the patient was advised for dialysis for some period. The family members were informed that, if the graft dysfunction persists then graft nephrectomy will be performed, and accordingly patient was discharged from OP-1 on 20.1.2007.
3.2.2 In nutshell, the submissions on behalf of counsel for OPs are; the injection 'Zenapax' was administered with the specific direction and there is no co-relation between the administration of 'Zenapax' injection and renal blood flow. The doctors treated the patient properly after renal transplant and the regular urine output was noted. The renal biopsy was advised because of raised Blood Urea and Creatinine. The renal biopsy revealed ATN ; therefore, it was the case of renal graft rejection. Thereafter, the patient was treated conservatively by medicines and hemo-dialysis. AV fistula was created for the purpose of regular future dialysis. The counsel submitted that the OP-1 center was authorized for renal transplant and the license was valid till 3.8.2006 and under renewal process. The hospital team for renal transplant surgery is well equipped having full time Nephrologist.
4. Reasons and Findings:
I gave thoughtful consideration to the arguments from both the parties. I have perused the affidavit evidences, entire medical record of OP-1 hospital, the order dated 2.1.2009 passed by DMC, the AIIMS expert board opinion and the related medical literature on the ESRD and Renal transplant. From the medical record, it is an admitted fact that the patient, Mulkh Raj was diagnosed case of ESRD and underwent Renal Transplant from the kidney donor his wife on 26.12.2006 at Jaipur Golden Hospital. It was performed by team of Dr. R. K. Saxena/OP-3. After the RT, immunosuppressant -induction with 1L2 receptor blocker - Zenapax, for maintenance was given by Tacroinlinus + MMF + steroids. Thereafter, the patient was switched to Rapamycin + MMF + steroids. Initially, the graft produced good amount of urine i.e. 2.7 L, 5.6 L and 3.6 L post-operative day 0, 1 and 2. Thereafter, it was around 1.5L for few days and then it was increased to around 2.5 to 2.9L. But, the renal parameters revealed rising trend, therefore, the patient was dialyzed and graft biopsy was performed to know the reason. The histopathology report revealed Acute Cortical Necrosis (ACN)? Diffuse? Patchy. Therefore, the patient was kept on Maintenance Hemodialysis (MHD). The abdominal surgical wound was re-explored in view of oozing of blood on two occasions, but there was no active bleeding. Therefore, the patient was discharged on 20.1.2007 with advise for medication and follow up. At the time of discharge, the patient was passing around one litre of urine per day. Thereafter, the patient had visited the hospital OPD on 22.1.2007, 24.01.2007, 29.1.2007 and 30.1.2007. The patient thereafter underwent transplant kidney nephrectomy on 2.2.2007 at St Thomas Hospital/ KOIT (Kidney Disease and Institute of Organ Transplantation), Chennai.
5. Now, the question is whether the negligence was occurred during the treatment (RT) of the patient and whether there were lapses during the pre-operative assessment/ treatment at OP/Hospital. On perusal of medical record, it is revealed that the patient got admitted in Jaipur Golden Hospital on 2.12.2006 for pre-operative investigations and dialysis. The kidney donor( patient's wife Pinki) was also examined, her laboratory investigations were done on 4.12.2006 and she was found to be compatible kidney donor for her husband. The patient was evaluated and confirmed that he was the case of ESRD. Initially, he was taken up on the program of Renal Replacement Therapy (RRT) and was stabilized on maintenance Hemodialysis (MHD) via Internal Jugular Vein by a Dual lumen catheter. After preliminary investigation, he was discharged in a stable condition on 5.12.2006 and asked to come for regular dialysis from home at least twice a week. The patient and his wife (donor) were admitted in OP/Hospital on 18.12.2006 further to complete remaining investigations and discharged on 21.12.2006 and called on 25.12.2006 for renal transplant, which was fixed on 26.12.2006. Thus, the donor's investigations were performed on out-patient basis. Dr. Lal Path Lab report dated 21.12.2006, the HLA - ABC and DR Tissue Cross Match report confirmed a "Negative cross match". As per the report, B-cell cross match was unequivocal. Thus, it was ideal for renal transplant. The OP had explained the patient that the donor being biologically unrelated, therefore, there was need for injection 'Zenapax'. The tissue matching report from Dr. Lal Path Lab was available on the date when operation was fixed. In my view, it was not a case of rejection of kidney. It was a graft dysfunction. In the case of rejected kidney, there will be less urine as a time advances and it was not in the instant case. It was the wrong perception of the patient that, as per Dr. Lal Path Lab's report the donor was not suitable for RT. The complainant also alleged that Zenapax injection was given in the case of poor cross match and the injection was not kept in the refrigerator. It is pertinent to note that, RT was performed only after permission from the transplant committee of the hospital. Dr. Umesh C.D. Nautiyal explained the patient and his wife about the details of renal transplant and after signed informed consent, the renal transplant was performed on 26.12.2006. Therefore, in my view, the OP/the treating doctors and the Nephrologist have followed the standard procedure in the instant case. Moreover, the Negative cross matching is pre-requisite for renal transplant. Thus, I do agree with the allegations of the patient and do not find any negligence in the pre-operative work-up of patient and the donor.
6. The next question arises for consideration is that whether OP doctors had performed the RT negligently and whether during post-transplant period care was not proper? It is an admitted fact that, RT was performed on 26.12.2006, but unfortunately it resulted into Graft rejection. The complainants have alleged that, that graft rejection was noted on 29.12.2006 by USG and Doppler study. It was due to administration of defective Zenapax injection. I have perused the drug literature of Zenapax and it revealed that, all over the world injection Zenapax is routinely used in all spouse related/unrelated RT and procedure for administration is standardized all over the world. The patient was put on triple drug immunosuppression subsequent to induction therapy by Injection Zenapax, but he suffered acute graft dysfunction in the post-operative period and the same was maintained properly. As the graft function was not improving and the cause was not clear, the renal biopsy was attempted on 30.12.2006, which failed. Therefore, a repeat biopsy was performed on 3.1.2007, which revealed diffused/patchy cortical necrosis, thus, suggestive of acute graft necrosis. From medical record it is transpired that, Initially, the graft produced good amount of urine for day 0, 1 and 2 i.e. 2.7 L. 5.6 L and 3.5 L; then it it was around 2.5 to 2.9 L. Thereafter, daily 1.5 L urine was produced. However, despite proper urine volume, the values of Blood Urea and Serum Creatinine were increasing, therefore, the USG and Doppler study was performed on the transplanted kidney on 29.12.2006 and it revealed normal blood flow in the grafted kidney. The kidney size, shape and outline was normal, The cortical thickness was 14 mm(normal) and the cortical medullary differentiation was well maintained. Therefore, in my view, the allegations of complainants that absence of flow of blood in the kidney is not sustainable and so far, the rejection of the graft was not on account of defective Zenapax injection. Thus, the transplant procedure was carried out as per the standard of practice. The USG/Doppler study performed on 8.1.2007 showed no blood flow. The chances of recovery of graft function was considered, but, in case of diffuse necrosis , then the graft becomes non-functional and it would require nephrectomy (removal of kidney). It is pertinent to note that the adequate amount of urine was being produced by the transplanted kidney and was some hope of recovery therefore, immediate nephrectomy was not advised and therefore , for few days conservative management was planned and AV fistula was created on 14.1.2007 and patient was initiated on MHD (Maintenance hemodialysis). It is transpired that, the family members of the patient were given the case summary dated 11.1.2007 to enable them to seek opinion from other institutions or nephrologist. The patient had sought opinions from several renal transplant centre in Delhi, Ahmadabad and Chennai, who have endorsed that, the line of treatment adopted by OPs was correct. During the graft dysfunction, which was persistent, the patient remained on maintenance hemodialysis (MHD). The patient had complained of oozing of blood on two occasions after removing the skin, stitches, and same was re-explored on 15.1.2007, did not reveal active bleeding and thereafter he was discharged on 20.1.2007 in stable condition with proper advise.
7. I have perused the AIIMS medical board opinion dated 24.05.2011. The relevant paragraphs are reproduced as below:
"As per the records available, the work-up of the donor & recipient were done according to standard guidelines. The donor underwent cross-match (-ve) and also other investigations including Hemogram, blood chemistry, RFT, LFT, Chest X-ray ECG to assess the suitability for anesthesia & Surgery. Similarly the recipient was also worked up by relevant investigations and was optimized prior to rental transplant.
According to transplantation operation notes, done on 26.12.2006, the surgical procedures for both donor & recipient were uneventful.
Post-operatively, the patient was continued on immunosuppressive medicines as per standard protocols. Patient had early graft dysfunction as evidence, by rising blood urea & serum creatinine. Ultrasound and Colour doppler evaluation were done on 29.12.2006 which revealed normal flow in the main renal vessels and normal ultrasonic appearance of kidneys. Graft biopsy was attempted on 30.12.2006 which failed and subsequent biopsy was done on 03.01.2007 which revealed diffuse/patchy cortical necrosis. The patient was appropriately started on maintenance Hemodialysis after construction of AV fistula.
Hence, the medical board had come to the conclusion that no medical negligence was evident from the records of the patient.
8. The complainant has filed M.A. No. 1131 of 2011. In the interest of justice, this Commission vide order dated 5.12.2012, has referred the matter back to the Medical Board for giving short supplementary opinion on certain points and also directed the parties to file draft questionnaire, which can be sent to the Medical Board of AIIMS for their consideration. In compliance to the said order, the Medical Board had answered to the questionnaire filed by both the parties and sent the report on 6.3.2012 stating that, there was no negligence. However, the Board has expressed about some discrepancy between recorded weight and expected weight. It has also expressed that there is no evidence that the patient was in any way adversely affected on account of non-performing graft nephrectomy prior to 2.2.2007. The Board had agreed with the findings of DMC and MCI ethics committee on the relevant points. The Board gave the supplementary opinion. It is reproduced as below:
"It is submitted that the Medical Board had taken into consideration the reports of Medical Council of India, Delhi Medical Council & had also taken into consideration the reports of Dr. N. K. Arora. We have also gone through the discharge summary of K.T.S. Thomas Hospital, Chennai as well as records pertaining to the treatment which the patient received between 03.01.2007 to 20.01.2007. Having gone through the questionnaire and replied to the questions to the best of our judgment, medical board stands by its earlier opinion on this case sent on 24.05.2011."
Thus, considering the AIIMS board opinion, there was no deficiency or medical negligence from the OPs.
9. Regarding the issue of Kidney transplant license of the OP-1/Hospital, I have perused the relevant documents and the initial registration certificate of OP-1/Hospital under "THOA 1994" dated 3.8.2001. Admittedly, it was valid for the period of five years from the date of issue, meaning thereby it was valid up to 3.8.2006. It is pertinent to note that the complainant, Mulkh Raj had procured information under RTI from DGHS. The RTI information vide letter dated 4.11.2008 revealed that the OP-1 was registered for renal transplant facilities under THOA till 3.8.2006 and renewal of registration of said hospital could not be done as hospital was not having full time Nephrologist.
10. Further, I have perused number of correspondences between OP-1 and DGHS, the office notes and the inspection reports of the committee constituted for licensing of OP/Hospital. It revealed that on 26.12.2008, the inspection team had recommended the registration of OP-1/Hospital for RT facilities under THOA, 1994 for five years from the date of issue. Accordingly, on 9.1.2009, OP-1/Hospital was issued the registration certificate (Form No. -12) of DGHS, Nirman Bhawan, New Delhi. I have perused the affidavit filed by OP-1/Hospital before Hon'ble High Court of Delhi in writ petition (civil) No. 43 of 2010. It was stated that from 2.8.2006 to 9.1.2009, total 16 kidneys transplants were carried out. The last transplant was carried out on 10.4.2007 and thereafter, OP-1/Hospital has not carried out any kidney transplant pending decision of the renewal of registration. All the cases were successful except Mulkh Raj and that too, solely on account of graft failure, it was one of the known complications of renal transplant. It was done after informed written consent from the patient as well as the donor.
11. To know more about the Renal diseases and Transplant, I took reference from the medical text books viz. "Schrier's Diseases of the Kidney", the Oxford text book (2012) , the " Kidney Transplantation - Principles and Practice" by Peter Morris/Expert Consult (2013). It revealed, the Acute Tubular Necrosis (ATN) is common after kidney transplantation. It is multi-factorial and represents one of the main causes of the delayed graft function. Its impact on graft and patients survival is documented.
Conclusion:
A successful transplant surgery of kidney does not mean that the transplant is indeed successful. To say the RT successful is when the body accepts the new organ and its functioning, which becomes the most critical part. For many patients of ESRD their kidneys fail to work, and dialysis and kidney transplants are the only two remaining options. Around the world, yearly chronic kidney diseases over seven lakh deaths occur.
12. In the catena of judgments, the Hon'ble Supreme Court and this Commission discussed about the medical negligence. In Jacob Mathew's Case, (2005) SCC (Crl.) 1369, Hon'ble Supreme Court has observed that the higher the acuteness in emergency and the higher the complication, the more are the chances of error of judgment. The court further observed as under:-
"25......At times, the professional is confronted with making a choice between the devil and the deep sea and he has to choose the lesser evil. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Which course is more appropriate to follow, would depend on the facts and circumstances of a given case. The usual practice 39 prevalent nowadays is to obtain the consent of the patient or of the person in-charge of the patient if the patient is not be in a position to give consent before adopting a given procedure. So long as it can be found that the procedure which was in fact adopted was one which was acceptable to medical science as on that date, the medical practitioner cannot be held negligent merely because he chose to follow one procedure and not another and the result was a failure."
It further observed that, "When a patient dies or suffers some mishap, there is a tendency to blame the doctor for this. Things have gone wrong and, therefore, somebody must be punished for it. However, it is well known that even the best professionals, what to say of the average professional, sometimes have failures. A lawyer cannot win every case in his professional career but surely he cannot be penalized for losing a case provided he appeared in it and made his submissions."
In another case of Achutrao Haribhau Khodwa and others versus State of Maharashtra and others (1996) 2 SCC 634, Hon'ble Apex Court has observed as follows:
"The skill of medical practitioners differs from doctor to doctor. The very nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession, and the Court finds that he has attended on the patient with due care skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence."
In the instant case the doctors were qualified and they have performed their duty as per the standards of Renal Transplant.
13. Therefore, considering the entirety, and applying precedents from the judgments discussed supra and the medical literature , in my view, the patient was treated at Jaipur Golden Hospital (OP-1) with reasonable care during pre-operative, operative and post-operative period. . The team of doctors consists of Dr. Nautiyal, Dr. R. K. Saxena are qualified in their respective fields. OPs-4 and 5 are also qualified Radiologist. I do not find fault with their USG and Doppler studies. The patient suffered graft dysfunction or rejection despite all proper care and surgery; it was not due to any negligence or deficiency in service of the treating doctors. The AIIMS medical board and DMC also did not find negligence against the OPs.
14. Adverting to the allegation of the complainant that, the OP-1 hospital was not holding valid license during the period when he underwent RT at OP-1 hospital. There was no full time Nephrologist as mandatory requirement for RT. The DMC and MCI have made strong observations on this point. In my view the OP/hospital has violated the Transplantation of Human Organs Act, 1994. The DMC and MCI have categorically made strong observations on it. The recommendation of MCI Ethics Committee is reproduced as below;
"The Ethics Committee considered the matter with regard to appeal by Mr. Mulkh Raj Dhamija against order dated 02.01.2009 of Delhi Medical Council and found that these doctors - Dr. D. K. Baluja, Administrative Head, Jaipur Golden Hospital, New Delhi, Dr. R. K. Saxena, Urologist and Dr. Umesh C. D. Nautiyal, Nephrologist have performed the surgery in an institution where there was no valid license for contemplating surgery at that time. Hence, the Ethics Committee feels that this type of practice should be condemned strongly and recommends their names to be removed from the Indian Medical Register for a period of one month."
In my view, the OP-1 hospital before accepting the patient for RT, was duty bound to disclose the about status of their license or refer the patient to an authorized institute. The non-disclosure amounts to an unfair trade practice by the OP-1 hospital and as well as the treating doctors (OP-2 and 3). Therefore, OP1, 2 and 3 shall be liable for the same under Section 2 (1) (r) (1)(ii) of the Act .
15. It should be borne in mind that, patients put so much trust in their doctors and hospitals. The institutions and doctors shall not operate in a vacuum, but they are mandated to current regulatory norms and stay within the legal and professional framework and strictly adhere to its mandated rules and regulations. Further, such regulations ensure greater public good by reposing faith in the medical practitioner who is duly qualified, registered and updated as per current norms and regulations. By an institution purporting to having held a license in the past for certain medical procedures or interventions does not automatically bestow any privileges or an unrestricted license to continue doing such procedure/s once their license has expired or revoked or suspended or anything which has the same or similar effect. Would an airline company allow a pilot to fly its airline with several hundred passengers in absence of a pilot`s license or where a license has been revoked or suspended? The answer will be a resounding "No". Likewise a doctor , who, with the full knowledge that he is indeed working or surgically operating in such an institution which has its license to offer certain treatments specifically discontinued, and more particularly in sensitive areas of Organ donations and Transplantation, such doctors even if licensed under current medical regulations and on the state medical register cannot justify their acts or absolve themselves by taking recourse behind their claim of holding license to practice. They cannot feign innocence and ignorance of absence of license of the parent institution which they are an inextricable part and parcel of and hold a position of responsibility towards. This in my opinion amounts to negligence covert and contributory even if not overt.
Thus, lack of a license will raise a presumption that the care was negligent; it was professional misconduct and grave unfair trade practice; and in the larger public interest (patients) such institutions/doctors to be treated with heavy hand to curb such practices. In the instant case, license of OP-1 hospital for Renal Transplant under THOA, 1994 was expired on 3.8.2006, thus it was not in existence at the time when patient was treated. Even though, the doctors at OP-1 hospital were continued to perform renal transplants till 2009; it amounts to an unfair and unethical practice.
16. Based on the foregoing discussion, though I do not find any medical negligence caused by the OPs, but keeping the view of Unethical and Unfair Trade Practices, the OP-1 hospital including the doctors OP 2 and 3 are held liable under Section 2 (1) (r) (1) (ii) of the Consumer Protection Act,1986. The complaint is partly allowed. It is ordered that, the hospital/OP-1 shall pay Rs.10 lakhs and the OP-2 and 3 shall pay Rs.5 lakhs jointly and severally to the Complainant No.1 within six weeks from today; failing which, respective OPs shall liable to pay interest at 9% p.a., till it's realization.
However, the parties shall bear their own costs.
...................... DR. S.M. KANTIKAR PRESIDING MEMBER