Dr. Vikas Kumar vs Pardeep Kumar & 5 Ors

Dr. S.M. Kantikar, Presiding Member

This Order shall decide all the four appeals arising from the impugned Judgment /Order dated 21.12.2014 passed by the State Consumer Disputes Redressal Commission, Punjab (hereinafter referred to as the “State Commission”) in Consumer Complaint No. 362/2017, wherein the State Commission allowed the complaint.

For the Convenience the parties are being referred to as mentioned in the Complaint before the State Commission. Mr. Pradeep Kumar & Mrs. Vijay Kumari are identified as the Complainant No. 1 & 2. While Satguru Pratap Singh Hospital is referred to as the OP-1, Dr. Rahul Kohli as OP-2, Dr. Sandeep Guleria as OP-3, Dr. Vikas Kumar as OP-4, and the Insurance Company as OP-5.

The Complainant No.1 Mr. Pradeep Kumar (for short ‘the patient’) was suffering from Chronic Kidney Disease-V (CKD-V) with End Stage Renal Disease (ESRD). He was Hepatitis C Virus (HCV) Reactive underwent kidney transplant. His wife, Vijay Kumari-Complainant No. 2 was the live donor. Prior to transplant the Nephrologist, OP-2, evaluated on both complainants. On 21.12.2015 the T and B cell Cross-match was performed, it was negative. Additionally, anti HLA antibodies, specifically Donor Specific Antibodies Class I & II, was carried out on the same date and found to be Negative. Thus accepted for the kidney transplant, with patient as the recipient and Complainant No. 2 as the live donor. After completing the formalities of approval under Section 9 of the Human Organ Act, 1994, the Renal Transplant was done on 13.03.2016 after obtaining High risk consent from Complainant No. 1. Following the surgery, the patient suffered complications such as pneumonia and a decrease in urine output. On the 7th post-operative day urine output further decreased and rising Serum creatinine level. On 22.03.2016, the Nephrologist (OP-2) conducted a renal biopsy, to rule out rejection. However, the biopsy revealed Acute Tubular Necrosis (ATN). The Serum creatinine level continued to rise and increase in WBC count (TLC). The Renal Doppler was performed on 25.03.2016, it indicated complete blockage of the renal artery. Therefore, on 26.03.2016, surgical exploration with graft nephrectomy was performed. It was alleged that the graft nephrectomy was done without obtaining patient’s consent to remove the transplanted kidney. Thereafter, the patient’s health condition continued to deteriorate, and he developed Hypotension and pleural effusion. He was shifted to Medanta Hospital at Gurugram wherein received treatment for pneumonia, pancytopenia and fluid overload. In Medanta Hospital, he was advised to continue dialysis regularly and informed that transplantation of the Kidney of Complainant No. 2 was at high-risk. Being aggrieved due to deficiency and negligence during the treatment at Opposite parties, the Complainants filed Consumer Complaint no. 362/2017 before State Consumer Dispute Redressal Commission, Punjab, Chandigarh and prayed compensation to the tune of Rs.52,00,000/- on a different head.

The OP No. 1 to 4 filed their respective written version, denying any negligence during treatment of the patient. It was submitted that they treated the patient with standard practice but, the patient and his family member were responsible who took discharge against medical advice (DAMA) from OP-1-Hospltal and exposed him to high risk of infection outside the Hospital.

The OP-2, Dr. Rahul Kohli, submitted that after proper pre-operative work-up and preparation, the patient underwent elective kidney transplant surgery on 13.3.2016 with wife as a live donor. Surgery was totally uneventful with complainant No.1 discharging adequate urine after surgery in the OT itself. After stabilization complainant No.1 shifted to RTU (Renal Transplant Unit). Daily urine output charting and kidney function tests were done. Kidney function checked as blood creatinine level showed gradual improvement on dally basis (from 4.1 mg/dl on 13.3.2016 to 1.9 mg/dl on 20.3.2016). Urine output was adequate and checked daily. The amount of urine after surgery is variable with some patients passing almost 10-12 litres of urine per day and some patients passing 2-3 litres of urine per day. As a routine check of the technical success of surgery, treating doctors got Doppler ultrasound on 2nd or 3rd day of surgery, which was reported on 14.3.2016 (wrongly written as 14.3.2017) as normal blood flow in transplant kidney and vessels. 48 hours after surgery complainant No.1 developed right sided pneumonia and hypotension for which appropriate antibiotics and inotropic support was given. Gradually over next 3 days, the infection and general condition of complainant No.1 improved and he maintained adequate urine output, which started decreasing on day 7 after transplant but his creatinine level was on decreasing trend. Therefore, repeat renal Doppler was done, which again was reported as normal. The serum creatinine started increasing from 8th day of surgery. To rule out any rejection, kidney biopsy was done on 22.3.2016. Soon after kidney biopsy, empirical anti-rejection treatment was also given while waiting for the biopsy report. However, kidney biopsy reported by pathologist on 25.O.2016 did not show any rejection but revealed ATN (Acute Tubular Necrosis). Kidney function did not improve and creatinine level continued to increase from 2.08 mg/dl on 21.3.2016 to 4.08 mg/dl on 25.3.2016 (wrongly written as 25.3.2017). Complainant No.1, however, did not require any dialysis any time during that period. A 3rd Doppler was done on 25.03.2016 (wrongly written as 25.3.2017), which showed absence of blood flow in the kidney and major feeding vessels of the kidney (renal artery as well as Internal iliac artery). In view of complete obstruction of blood flow, angiography procedure was attempted by an Interventional Cardiologist in an attempt to salvage his kidney. However, the procedure was not successful and his angiography revealed total block of internal iliac artery (major feeding vessel to transplant kidney). The clinical situation of complainant No.1 at every moment was explained to his relatives including the need of angiography and subsequent surgery. After written and informed consent of relatives/attendants complainant No.1 was taken for surgical exploration and nonviable transplant kidney was taken out to save the life of complainant No. 1 as a standard protocol of care.

The OP-3, Dr. Sandeep Guleria submitted that the complainants had of their own will and volition opted to under-go the renal transplant procedure with no assurance/inducement and/or allurement on the part of OP no. 3. The tissue compatibility and blood groups were done and found suitable for renal transplant. It was submitted that the complainants were duly informed about the risks involved in renal transplant by the staff members of OP No.1-Hospital. It is evident from the video recording. Similarly signed Informed Consent Forms were taken for different invasive procedures like Femoral Line Insertion, Pleural Tapping, Kidney Biopsy, Ascitic Fluid Tapping, Peripheral Angiography, Intubation and Nephrectomy of Transplanted Kidney (Graft Nephrectomy) stating the major risks involved, such as bleeding, infection, sepsis, intra-abdominal collection, thrombo- embolism, cardio-pulmonary compilation etc.

The OP-4 Dr. Vikas Kumar submitted that no complaint of negligence against him. The insurance Co. OP-5 adopted the reply filed by OP-1 and submitted that as per the terms of the policy, it will act.

The State Commission on hearing the parties, held OP Nos. 1 to 4 negligent and partly allowed the Complaint. It awarded lump sum Compensation sum of Rs.40,00,000/- along with 9% interest & Rs.55,000/- litigation cost to be paid by both the OP Nos. 1 to 4 jointly and severally.

Being aggrieved by the impugned order of the State Commission OP Nos. 1 to 4 have filed separate appeal nos. 344, 415, 427 & 478 of 2020.

Heard the arguments from the learned Counsel for the parties, carefully perused the impugned Order and the treatment record.

The State Commission held that no cross-match/compatibility test was done in the instant case. The recipient (Complainant No. 1) was evaluated by the OP-2 (the Nephrologist) and the necessary pathological tests were carried out on the donor and the recipient. The T and B cell Cross-match done on 21.12.2015 and was negative. Further evaluation for the presence and quantification of anti-HLA antibodies in the recipient was negative. Therefore, there was no problem for the kidney transplant from the Complainant No. 2 as the live donor. Therefore, considering the ERSD condition of the patient, the doctors advised to undergo kidney transplant or else in the alternative he could continue with his weekly dialysis regime. The Complainant No. 1 agreed to go for elective kidney transplant.

Adverting to the non-participation of the Complainant No. 1 in the video counselling, whether it amounts to negligence of the OPs. It is evident from the record that valid informed consents at various stages were obtained from the Complainants. Further, the Complainants have not pleaded about the issue of non-participation of the Complainant no. 1 in the video-counselling and also not conducting the test of HLA tissue typing. In my view, valid consents were taken at the different stages, mere allegation of non-participation in video consent does not amounts to any negligence. In the instant case, HLA Tissue Typing is not required where both the donor and the recipient are blood relatives. As, it was spousal donor, therefore, no Tissue Typing was done.

Kidney transplant surgery was performed on 13.03.2016. It was uneventful and the patient showed adequate urine flow after surgery. He was shifted to Renal Transplant Unit (RTU) and the daily urine output chart and kidney function tests as per protocol were performed. As a routine standard check-up, the Doppler ultrasound of transplant kidney and vessels on 2nd and 3rd day of surgery were found normal. The patient developed on 3rd day, the right sided pneumonia and hypotension. Appropriate antibiotics and inotropes were started. The patient showed improvement gradually. From post-operative day 7, the urine output started decreasing, but serum creatinine was normal, therefore, repeat renal Doppler was done, it was reported as normal. To rule out rejection, the kidney biopsy was done on 22.3.2016 and the empirical anti-rejection treatment was started while waiting for the biopsy report. However, kidney biopsy was reported as Acute Tubular Necrosis (ATN). Thus, it did not show rejection but revealed Kidney function did not improve and creatinine level continued to increase to 4.08 mg/dl on 25.3.2016. However, the patient did not require any dialysis. A Doppler was done on 25.3.2016 revealed absence of blood flow to the kidney and in the renal artery as well as internal iliac artery. Therefore, to rule out complete obstruction of blood flow, angiography procedure was attempted by the interventional Cardiologist in an attempt to salvage the kidney. However, the angiography revealed total block of internal iliac artery (major feeding vessel to transplant kidney). The clinical condition of the patient was explained to the relatives including the need of angiography and subsequent surgery.

It is pertinent to note that surgical exploration and removal of non-viable transplanted kidney was done after obtaining informed consent from the attendants of the patient. It was as per standard protocol to save the life of the patient. The patient was required MICU care but the attendants wanted to take discharge against medical advice (DAMA). The OP-2 to 4 have treated the patient as accepted medical practice.

Reference to Medical Literature:

I took reference from the standard text book ‘Kidney Transplantation: Principles and Practice’(6th Ed.) and few research articles on the subject, which revealed:

Early kidney transplant loss as a result of acute thrombosis of the artery or vein remains a constant and devastating complication with an incidence of 2%. Compared with other forms of vascular surgery, the incidence of thrombosis is low and supports the classic view that renal failure is associated with a bleeding tendency secondary to platelet and clotting factor dysfunction. Arterial thrombosis or infarction of a denervated kidney is often painless and heralded only by loss of graft function. By the time the diagnosis is confirmed by one of the several appropriate imaging modalities, kidney salvage is not a practical option. The more common interruption of the venous drainage can be spectacular with graft rupture and bleeding. It has an equally disappointing prospect for kidney salvage because of the rapidity of the process when occlusion of the renal vein has occurred. Identification of risk factors and preventive management undertaken at the time of transplantation are indicated to minimize thrombotic complications.

The article, ‘Lack of impact of human leukocyte antigen matching in living donor kidney transplantation: experience at Akdeniz University[Transplant Proc, 2005 Sep; 37(7): 2969-72], mentioned that:-

“Despite human lymphocyte antigen (HLA) matching between recipients and unrelated donors being poor, the reported survival rates for these grafts, including spouses, are comparable to those for grafts from living related donors and higher than those for deceased donor kidneys. The graft and patient survival rates for the donor transplantations were higher than those for deceased donor transplantations”.

‘Also in another article, ‘High survival rates of kidney transplants from spousal and living unrelated donors’, wherein it is concluded as, ‘Spouses are an important source of living-donor kidney grafts because, despite poor HLA matching, the graft-survival rate is similar to that of parental-donor kidneys. This high rate of survival is attributed to the fact that the kidneys were uniformly healthy’.

The textbook ‘Medical Complications of Kidney Transplantation – Claudio Ponticelli’, wherein explained ‘HLA histocompatasibility :

There is ample evidence that the results of renal transplantation are influenced by the number of HLA A, B, DR mismatches. However, with newer immunosuppressive agents, the impact of HLA mismatches on graft outcome is diminished. Still, fully-HLA matched recipients have a much better probability of long-term graft survival than that of mismatched patients both in cadaveric (Takemoto et al., 2000) and in living renal transplants (Cecka, 2002). This evidence has led several national and international organizations to assign cadaveric kidneys to six-antigen-matched patients as an absolute priority. Otherwise, the various combinations of mismatch have a lesser impact on transplant results. With the exception of HLA-identical siblings also with living transplants, the impact of HLA compatibility is much lower than in the past. Kidney allografts from unrelated living donors have the same long-term allograft survival as that obtained with kidney transplants from haploidentical siblings or from parents (Gjertson and Cecka, 2000).

To summarise the instant case that it was a case of Type II diabetes with hypertension. Patient was HCV reactive with CKD-V on dialysis. He underwent kidney transplant surgery on 13/03/2016. His wife voluntarily donated a kidney. The pre transplant workup included CDC cross match done twice and DSA (donor specific antibody) done, all were reported negative. HLA matching not done because of spousal donation (assuming 0/6 match). The transplant surgery was uneventful with good diuresis. On 2nd Post-surgery day, Renal Doppler was done, it revealed normal flow in the vessels. On day 3, the patient developed fever and right sided chest infection, for which appropriate antibiotics were given. The patient continued to have gradually improving renal functions with adequate output. On day 7, urine output started decreasing, therefore, the investigation including drug levels and workup was done. In view of no improvement in kidney functions, graft biopsy was done on 22.03.2016 and empirical anti-rejection treatment given with methyl prednisolone. The Biopsy reported on 25.03.2016 revealed no evidence of rejection, but it was suggestive of acute tubular necrosis (ATN). The repeat Doppler showed complete absence of blood flow in renal and internal iliac arteries. It was confirmed by angiogram. As there was no chance of salvaging graft, graft nephrectomy done on 25/03/2016 after counselling and consent. The patient post operatively shifted to ICU care and he continued on regular dialysis and supportive care with antibiotics. Attendants wanted the patient to be shifted to some other hospital, so he was sent LAMA in a stable condition in a conscious state without inotropic support.

To conclude, it was an unfortunate and rare case wherein the Complainant-patient suffered renal artery thrombosis. Admittedly, it was Spousal Kidney Transplant surgery. About 2.5% of the patient suffers post-transplant complication. The Graft biopsy showed no evidence of acute rejection but, it was ATN. The patient was managed as per standard protocol and underwent graft nephrectomy; therefore, he was unfortunately shifted back to regular dialysis.

The Hon’ble Supreme Court laid down certain duties of the doctor. In the case of Dr. Laxman Balkrishan Joshi Vs. Dr. Trimbak Bapu Godbole and Anr.[ AIR 1969 SC 128] it was held that:

"The duties which a doctor owes to his patient are clear. A person who holds himself out ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person when consulted by a patient owes him certain duties, viz., a duty of care in deciding whether to undertake the case, a duty of care in deciding whether treatment to give or a duty of care in the administration of that treatment. A breach of any of those duties gives a right of action for negligence to the patient. The practitioner must bring to his task a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged. In the light of the particular circumstances of each case is what the law requires.

The Hon’ble Supreme Court in Jacob Mathew v. State of Punjab[(2005) SSC (Crl) 1369], which followed the Bolam’s principles and observed that;

"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 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."

Based on the discussion above, I do not find any negligence of the OPs (Appellants) in renal transplant procedure. The donor selection, compatibility and the post-transplant follow-up was as per reasonable standard of nephrology practice. The findings recorded by the State Commission are not sustainable in law. The order passed by the State Commission is set aside and all the four Appeals are allowed. Consequently the Complaint is dismissed.

The Registry is directed to release the amount, if any, deposited by the Appellants before this Commission or the State Commission, with accrued interest, if any, to the respective Appellants within six weeks from today.