Haryana

StateCommission

CC/4/2015

NIKHIL GARG - Complainant(s)

Versus

MEDANTA MEDICLINIC AND OTHERS - Opp.Party(s)

MEENA BANSAL

27 Jan 2017

ORDER

STATE CONSUMER DISPUTES REDRESSAL COMMISSION HARYANA, PANCHKULA

                                                 

Complaint No     :    04 of 2015

Date of Institution:  19.01.2015

Date of Decision :   27.01.2017

1.     Nikhil Garg son of late Sh. Narender Kumar, Resident of 23, Rajouri Enclave, near New Bus Stand, Ratia District Fatehabad, Haryana.

2.     Smt. Parmla Devi widow of Sh. Narender Kumar, Resident of 23, Rajouri Enclave, near New Bus Stand, Ratia District Fatehabad, Haryana.

                                      Complainants

Versus

1.      Medanta Mediclinic – E-18, Defence Colony, New Delhi through its Managing Director.

2.      Medanta Institute of Liver Transplantation and Regenerative Medicine – The Medicity Sector 38, Gurgaon, Haryana, through its Managing Director.

3.      Medanta Institute of Liver Transplantation and Regenerative Medicine – The Medicity Sector 38, Gurgaon, Haryana, through its Doctor A.S. Soin.

                                      Opposite Parties

 

CORAM:             Hon’ble Mr. Justice Nawab Singh, President.

                             Mr. B.M. Bedi, Judicial Member.

                                                                                                         

Argued by:          Mrs. Meena Bansal, Advocate for Complainants.

                             Mr. B.S. Dogra, Advocate for Opposite Parties.

 

                                                   O R D E R

 

B.M. BEDI, JUDICIAL MEMBER

 

          Nikhil Garg and his mother Smt. Parmla Devi-complainants filed the present complaint averring as under:-

2.                Narendra Kumar (since deceased)-father of complainant No.1 and husband of complainant No.2 was suffering from liver problem. On September 15^th, 2014 Dr. A.S. Soin, Medanta Institute of Liver Transplantation and Regenerative Medicine advised the complainants for liver transplant and offered a package for treatment for Rs.20,75,000/-, the details of which are given below:-

(i)      Pre Transplant charges for both patient and donor on OPD basis                                           Rs.2,00,000/-

          a. Evaluation                                   Rs.0,75,000/-

          b. Investigation and clearances of patient and one donor

                                                                   Rs.1,25,000/-

(ii)      Hospital Liver Transplant Package        Rs.17,50,000/-

(iii)     Post Liver Transplant charges for both patient and donor

                                                                   Rs.1,25,000/-     

                                      Total:                             Rs.20,75,000/-

3.                The patient was admitted in the Medanta Institute of Liver Transplantation and Regenerative Medicine-The Medicity Sector 38, Gurgaon (hereinafter referred to as ‘the Medanta Hospital’) on 01.10.2013. At the time of admission, the complainants deposited the amount of Rs.20,75,000/- with the opposite parties.

4.                Parmla Devi-complainant No.2 made herself available as first donor. However, the opposite parties charged Rs.2.00 lacs besides the amount of package, that is, Rs.20,75,000/-. On 05.10.2014 the opposite parties transplanted liver to the patient but his condition thereafter was not stable though the opposite parties assured about the stability of patient’s condition. 

5.                The opposite parties advised the complainants that the patient had to undergo the second liver transplantation for which the doctors asked to arrange second donor. It was stated that there were 70% chances of success. It was also stated that transplant may likely turn into miracle. The complainant No.1 arranged the second donor namely Bala Devi, who was none else but the wife of real brother of the patient.  On 11.10.2014 all tests (including Hepatitis A) as per advice of Opposite Party No.3 were performed on Bala Devi-second donor for which the opposite parties charged Rs.3,19,039/-. On 12.10.2014 the opposite parties again asked for an amount of Rs.2.00 lacs for second re-transplantation and the same was deposited by the complainants vide receipt dated 12.10.2014 (Exhibit C-6).  The second liver transplantation was done on 17.10.2014, however, it was alleged that second liver transplantation was not done because the patient was continuously on the supportive therapy, that is, ventilator after the first liver transplantation, so second transplantation was not possible. On 18.10.2014 the opposite parties further demanded the amount of Rs.2.00 lacs and the same was deposited by the complainants vide receipt dated 18.10.2014 (Exhibit C-7). Unfortunately, the transplantation remained unsuccessful and the patient died on 22.10.2014.

6.                It was alleged that the opposite parties falsely illumined the complainants that the patient would survive with the following injections and further overcharged for the same:-

                   a.      1^st Cytosorb hemofiltration   Rs.90,000/-

                   b.      2^nd Cytosorb hemofiltration  Rs.90,000/-

                   c.       3^rd Cytosorb hemofiltration   Rs.90,000/-

                   d.      1^st Toraymyxin hemofiltratio Rs.2,50,000/-

e.     2^nd Toraymyxin hemofiltratio Rs.2,50,000/-

7.                It was further alleged that the death of patient occurred only after the first liver transplantation but the opposite parties shifted him to ventilator and did not communicate the same to the complainants. The opposite parties just saved their gross negligence stating that they have transplanted the second liver to the patient. Thus, alleging medical negligence and deficiency in service on the part of the opposite parties, the complainants sought compensation of Rs.93,73,849/- from the opposite parties.

8.                The Opposite Parties contested the complaint by filing their joint written version. It was stated that the patient visited the opposite party No.1 for the first time on 15.09.2014 as a known case of Hepatitis C virus related Chronic Liver disease since May, 2014, with Jaundice for the last 3 months, hepato-renal syndrome (decompensated liver adversely affecting the renal functions and increasing Creatinine to critical levels), hepatic encephalopathy (requiring hospitalization 3 times), ascities and pedal edema (collection of fluid in abdomen and legs respectively) for the last 1 month. The patient was addicted to wine up to 375 ML per day for the last 30 years with abstinence only from last 4-5 months from the day of presentation and was also a tobacco abuser for the last 30 years. After necessary investigations, it was reconfirmed that the patient had Hepatitis C Virus & alcohol related Chronic Liver Disease with de-compensation. The patient was explained about his clinical conditions and about the Liver Transplant Package. He was provided Pre-operative Counseling Form which provided an estimate of standard minimum expenditure which may be incurred for liver transplantation. Thereafter, the patient visited the opposite party No.1 various times for the Liver Transplant workup. As per standard protocol, a detailed evaluation of the patient was carried out to ascertain the fitness levels of the patient for Liver Transplant by conducting the necessary tests.

9.                On 01.10.2014, the patient visited the opposite party No.1 at 08:20 AM in Emergency with complaints of pain in upper abdomen since previous night without any vomit, melena or fever. He was admitted for evaluation, stabilization and management. The patient was examined by the Liver Transplant team and was administered appropriate medication and diagnostic tapping of abdominal fluid under USG guidance was conducted on the patient to rule out Spontaneous Bacterial Peritonitis (SBP i.e. infection in abdominal fluid). The test confirmed SBP with a cell count of 420 (normal being less than 250). On the same day, the patient was also examined by experts teams, that is, Hepatology, Psychiatry, Cardiology and Interventional Radiology. In addition, the patient was already undergoing evaluation for Liver Transplantation. Dobutamine Stress ECHO was conducted on 01.10.2014 which revealed no reversible myocardial ischemia with ejection fraction of 55-56% and CT-Coronary Angiography was further conducted to ascertain risk factors for the recipient which revealed that the patient was suffering from CAD with 20-30% stenosis in proximal and mid LAD and 40-50% stenosis in D2. As the CAD was non critical in nature, so the patient was cleared by the Cardiologist for Liver Transplant surgery. Thereafter on 03.10.2014, test for SBP was repeated. On 04.10.2014 aa routine pre-operative ECHO Cardiogram was conducted which revealed normal findings. The patient and his attendants were explained the diagnosis, suggested surgery, possible outcomes, known risks and complications including risk of wound, infection, bile leak, bleeding, sepsis etc. The patient was a High Risk Case on account of the various co-morbidities that he suffered from. At 05:00 PM, the patient was shifted to Operation Theatre for Living Donor Liver Transplant (“LDLT”). The surgery started at 06:40 P.M. The operation was uneventful, well tolerated by the patient and surgery was completed at 04:00 A.M. on 05.10.2014.  Postoperatively, on 05.10.2014 at 04:15 AM, the patient was shifted to the Liver Transplant ICU in a stable condition with Pulse 86/minute, Blood Pressure as 154/75, Respiratory Rate as 18/minute and 100% Oxygen saturation. The surgery started at 06:40 PM on 04.10.2014 and completed at 04:00 AM on 05.10.2014 and thus it took about 10 hours. At 4:30 AM, the patient was assessed by the Critical Care Team and the Pulse, Blood Pressure, Respiratory Rate and Oxygen saturation were found to be normal. The patient was managed according to the standard post-operative protocol and orders.

                   At 8:10 A.M., Hepatic Vascular Doppler was conducted which revealed normal findings (normal blood flow in the liver) and that the transplanted liver graft was functioning normally. Various post-operative blood investigations were also conducted. At 05:30 P.M. the patient was extubated i.e. ventilator was taken off and oxygen was given by facial mask. Post extubation, the patient was conscious, oriented and spontaneously breathing and was stable and afebrile. On 05.10.2014, the patient’s LFT revealed Serum Billrubin of 6.1 (normal being 0.2-1) SGOT of 332 (normal being 0-42), SGPT of 192 (normal being 0-62) and PT INR of 1.67 (normal being less than 1.3) which in view of the Liver Transplant on 05.10.2014 was acceptable.

                   On 06.10.2014, the patient was conscious, oriented, alert, hemodynamically stable, afebrile and was maintaining good oxygen saturation and urine output was adequate. Hepatic Vascular Doppler was conducted which revealed normal findings (normal blood flow in the liver). At 11:30 A.M. the complainant No.1-Nikhil Garg, met the treating doctors of the Liver Transplant Team and was counseled and informed about the patient’s clinical condition and that the patient was extubated successfully and was doing well. His liver and renal function tests were also improving. USG abdomen was conducted which revealed no free fluid in abdomen. At 7:00 P.M., ECHO was conducted which revealed normal findings.   As a general protocol, after shifting the patient from OT to ICU, the patient’s family was allowed to meet the patient after 1.5 hours. In addition, the family of the patient was allowed to meet the patient in ICU for 15 minutes daily.

                   On 07.10.2014 and 08.10.2014 the patient continued to be conscious, oriented, obeyed commands, alert, hemodynamically stable and was maintaining good oxygen saturation. Hepatic Vascular Doppler was conducted on both the days and revealed normal findings (normal blood flow in the liver). On 07.10.2014 the patient had high blood pressure which was adequately controlled by infusion of Labetalol (Blood pressure controlling medication). On 08.10.2014, from 10:00 A.M. the patient was started on oral sips and on both the days, complainant No.1 was counseled by the treating doctors of the Liver Transplant Team and was informed about patient’s improving condition and he was also informed that the patient was mobilized out of bed and his LTF and CBC were being continuously monitored. On 09.10.2014 the patient continued to be conscious, oriented, alert, hemodynamically stable, obeyed commands, afebrile and was maintaining good oxygen saturation. The patient was also started on liquid diet and at 11:30 A.M. patient’s family was duly counseled about patient’s improving condition. Though, Hepatic Vascular Doppler was conducted which revealed normal findings (normal blood flow in the liver), unfortunately the patient’s Liver Function Tests showed deranged values. So, in view of deranged liver enzymes a Hepatic Doppler was repeated which revealed normal flowing vessels without blockage. Also, due to suspected infection causing deranged liver enzymes, the antibiotics were upgraded. the patient was continued on immune-suppression medications.

                   On 10.10.2014 the patient was conscious, hemodynamically stable, afebrile and was maintaining good oxygen saturation, however, the patient was doing irrelevant talks. As per standard protocol, various tests and investigations were conducted. The patient was continued on broad spectrum high grade antibiotic and anti-fungal medication was upgraded. All possible supportive medical care was given and the patient was continuously monitored for worsening sensorium. Inspite of these measures, in the evening on 10.10.2014 the blood test reports revealed further worsening of Liver Enzymes about which the attendants of the patient were explained. On 11.10.2014, the patient was awake, confused, jaundiced, hemodynamically stable, afrebrile, urine output was adequate and was on oral liquids. Investigations continued to reveal deranged liver functions. In the morning on 11.10.2014, the Liver Transplant Team was telephonically informed by the Pathologist that the preliminary liver biopsy carried out on 10.10.2014, was suggestive of Acute Hepatitis. The complainant No.1 was advised to arrange another donor for a possible re-transplant on an urgent basis if the patient’s condition further deteriorated. The patient was kept under continuous monitoring of the Critical Care Team, Liver Transplant Team and the Hepatologist.  As a supportive measure, Cytosorb dialysis for filtration of inflammatory cytokines from the blood and support the Patient was advised. Before conducting Cytosorb dialysis, it was communicated to the complainant No.1 that there was only a 50% chance of benefit from the procedure and the same was recorded in the Family Communication Record. Cytosorb Dialysis was carried out. The procedure was uneventful and was well-tolerated by the patient. On 12.10.2014 the patient was awake but still confused, jaundiced, disoriented, hemodynamically stable, afebrile, urine output was adequate and was on oral liquids. Inspite of decrease in Liver Enzymes, the patient was critical and doing irrelevant talks. The patient was continued on intensive management comprising of high end antibiotics, anti-virals, anti-fungals, appropriate immune suppressions, IV-fluids support and N acety Cysteane and Alprostadil infusion and it was decided to repeat Cytosorb Dialysis. The patient’s family was informed that the patient was very critical as he was having hepatic encephalopathy. They were again counseled for the urgent need of re-transplantation; however, the patient’s family could not come up with a suitable prospective donor. On 13.10.2014, 2^nd cycle of Cytosorb Dialysis was conducted after which the patient’s Liver Enzymes improved. Unfortunately, the patient was disoriented, semi-conscious, in encephalopathy, low albumin levels.  The patient was continued on intensive management. On 14.10.2014 when patient’s condition deteriorated, the patient’s family arranged a prospective donor namely Bala Rani for evaluation. Accordingly, the donor’s evaluation was started in the evening of 14.10.2014 to ascertain the suitability of liver donation. The evaluation of the 2^nd prospective donor was accelerated and legal formalities were completed in the morning on 16.10.2014 and she (second donor) being found suitable, an approval from the Authorization Committee was obtained for the living donor liver re-transplant. As this was only chance to save the Patient, the treating team of doctors proceeded with the 2^nd Liver Transplant surgery. The patient was shifted to the Operation Theatre for liver re-transplantation. The surgery started at 11:30 PM on 16.10.2014 and completed at 07:30 AM on 17.10.2014. Intra-operative Doppler was conducted which revealed normal flow of blood in the graft. The surgery was uneventful, without complications and well tolerated by the patient. On 17.10.2014 the patient was received in the transplant ICU at 7:45 AM. Post-operative Hepatic Vascular Doppler was repeated which revealed normal findings. However, patient’s condition continued to be critical and the patient’s attendants were informed about the same. On 18.10.2014 though the patient was hemodynamically stable, afrebrile, Hepatic Vascular Doppler revealed that the grafted liver was functioning normally with normal blood flow and his liver enzymes also showed improvement with SGOT at 92 and SGPT at 188. But the patient started to deteriorate with high heart rate, increased bilirubin at 10.6, INR at 2.19 and lactate increased from 3.5 to 4.9. Blood investigations also revealed decreased white cell count being 3220 (normal being 4000-10000), low platelet count and Sepsis marker (Procalcitonin) increased from 4.51 (on 16.10.2014) to 13.21 (on 18.10.2014). His abdominal drain fluid culture revealed infection with Elizabeth Kingia (Bacteria). The above markers were indicative of sepsis. The patient was continued on intensive management comprising of broad spectrum high end anti-biotics, anti-virals, anti-fungals, appropriate immune suppressions, on oxygen support, IV-fluids support and N accety Cysteane and Alprostadil infusion (anti-oxidant and microvascular permeability increasing drugs). On 19.10.2014 as a result of appropriate medication, Toraymyxin Hemofiltration and supportive measures the patient improved transiently with stable vitals, afebrile, adequate urine output, normal Hepatic Vascular Doppler and improving liver enzymes. The patient was continued on same intensive management comprising and supportive care. On 20.10.2014, sedation was stopped. The patient was drowsy and was not responding to commands. Blood investigations revealed further decrease in liver enzymes. The liver could not achieve optimal function due to sepsis patient continued high Bilirubin despite of all possible efforts. On 21.10.2014 Bilirubin continued to rise to 14.1 and Lactate was also critically high at 6.4. On 22.10.2014 at about 6:30, patient suffered sudden cardiac arrest for which Cardio Pulmonary Resuscitation was done by the Critical Care Team but he died at 6:57 P.M. Thus, denying the allegations of the complainants, it was prayed that the complaint be dismissed.

10.              Parties led evidence in support of their respective claims. Nikhil Garg and Parmla Devi tendered their affidavits alongwith documents Exhibit C-1 to C-9. On the other hand, the Opposite Parties tendered affidavit of Dr. Arvinder Singh Soin besides documents.

11.              Counsel for the parties have been heard. File perused.

12.              At the outset, two fold arguments have been raised on behalf of the complainants. Firstly, despite second donor being provided on 11.10.2014, the Liver Transplantation for second time was done on 17.10.2014. Thus, delay in second re-transplant caused damage. Secondly, the opposite parties have charged more than the package amount from the complainants.

13.              Learned counsel for the complainant openly conceded that there is no evidence available with regard to the fact that the second donor was made available to the opposite parties on 11.10.2014. Thus, the allegation not proved by the complainants, therefore contention in this respect is repelled.  

14.              Secondly, regarding charging more than the package clause, a relevant clause given in the policy (Exhibit C-1) reads as under:-

“Package inclusions: Medicines and Consumables upto Rs.6 Lakh, All Investigations upto Rs.2.25 Lakh (Blood Transfusion service Charges, Hematology Lab Charges, Biochemistry Lab Charges, Microbiology Lab Charges, Histopathology Lab Charges, X-ray, ECG, Ultrasound, CT Scan), Surgeon fees, Anaesthetis free, Anaesthesia charges, Operation theatre Charges, Hepatologist’s fees, Intensivist fee, critical care charges.”

“Package Exclusion: Over and Above period of hospital stay, all investigations, medicines and consumables over and above the prescribed limit and some costly medicines like Inj. Zenapax, Inj Simulect, Inj ATG, Inj Novoseven, Inj. Thymoglobulin, dialysis and nephrology related treatment charges, any non-liver transplant consultant visit charges and procedure charges. These would be charged extra.”

“HLA/DNA Test is not included in the package.

“In the event of unexpected complications, additional expenditure may be incurred apart from the above package.”

15.              Thus, in the exclusions, the opposite parties have already mentioned that all the extra was to be charged. Therefore, the complainants were rightly charged.

16.              Besides during the pendency of the complaint, the complainants moved an application with the prayer to constitute Medical Board and the prayer being not opposed, the matter was referred to Post Graduate Institute of Medical Sciences and Research (PGIMER), Chandigarh to obtain the opinion of Board of Specialist Doctors. The report of the Medical Board, PGIMER, Chandigarh reads as under:-

                   “           REPORT OF THE MEDICAL BOARD

                                              PGIMER, Chandigarh.         

Reference: - Medical board constituted vide office order No.EV(9)PGI-MS/MA-63/2016 dated 05.02.2016 in pursuance of the request received from Secretary, State Consumer Disputes Redressal Commission, Haryana, for expert opinion in Complaint No.04 of 2015 titled as Nikhil Garg vs Medanta Mediclinic.

Meeting of the Medical Board consisting of undersigned members was held on 12.02.2016 at 3.00 pm in the office of the chairman. Members of the Medical Board have thoroughly gone through the documents in detail provided along with office orders.

                        After going through the medical records, Medical Board found that as per records the patient Mr. Narinder Kumar, 55 years/Male, UHID No.MM00587654, IP No.12084212, admitted under Dr A.S. Soin in Medanta Medicity, Gurgaon, Haryana, had underwent first living donor Liver transplantation (LDLT) on 05.10.2014 for Ethanol, and HCV related Chronic Liver Disease with decompensation (HE, HRS, Ascites, Jaundice), Coronary Artery Disease, Restrictive Lung Disease. Subsequently as per the records patient developed liver dysfunction and was diagnosed with Hepatitis-A inducted hepatitis with Fulminant hepatic failure. Post liver transplant patient had a rapid downhill course and subsequently underwent Re-transplantation (LDLT) on 17.10.2014. However patient Mr. Narinder Kumar developed Sepsis and Multiorgan failure post 2^nd liver transplantation and succumbed to his illness on 22.10.2014.

Opinion: - Medical Board is of the following opinion:-

           

•           These are the known complications of Living Donor Liver Transplantation.

•      However the board is of the opinion that the family had to bear extra financial burden for the Re-transplantation.

 

Dr. Sandeep Singh Flora Prof.L.Kaman                                Dr.Sunil Taneja

Convener                          Dept of General Surgery  Dept of Hepatology Member”

 

 

17.              There is nothing in the above said report in favour of the complainants and against the opposite parties.

18.              In Naraingiben Subodhchandra Shah & Ors. Vs. Gujarat Research and Medical Institute & Ors III(2012) CPJ 509 (NC), Hon’ble National Commission has held as under:-

“Besides, the complainants themselves having requested this Commission to obtain an expert opinion which goes in favour of the opposite parties, the only inference that can be drawn from this case is that the opposite parties have followed the most desirable and expected course of treatment/operation and if in the process the patient has died, they cannot be held liable merely on the allegation of the complainants. After all doctors can only treat but cannot guarantee the success of a surgical operation which inevitably is fraught with risks.”

19.              In Jacob Mathew v. State of Punjab And Anr., III (2005) CPJ 9 (SC), Hon’ble Supreme Court held that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable.

20.              In State of Punjab v. Shiv Ram & Ors., IV (2005) CPJ 14 (SC), Hon’ble Supreme Court has held that “A Doctor, in essence, needs to be inventive and has to take snap decisions especially in the course of performing surgery when some unexpected problems crop up or complication sets in. If the medical profession, as a whole, is hemmed in by threat of action, criminal and civil, the consequence will be loss to the patients. No doctor would take a risk, a justifiable risk in the circumstances of a given case, and try to save his patient from a complicated disease or in the face of an unexpected problem that confronts him during the treatment or the surgery”.

21.              As a sequel to the foregoing discussion, the complainants have miserably failed to prove their case against the opposite parties. Hence, the complaint is dismissed being devoid of merits.

 

Announced: 27.01.2017

(B.M. Bedi) Judicial Member

(Nawab Singh) President

 

CL