Tamil Nadu
StateCommission
CC/47/2010
R.Muthukrishnan - Complainant(s)
Versus
Apollo Hospitals Enteerprise Ltd,Rep by its Medical Superintendent - Opp.Party(s)
S.Radhakrishnan
26 May 2015
ORDER
BEFORE THE STATE CONSUMER DISPUTES REDRESSAL COMMISSION, CHENNAI
Present: Hon'ble Justice Thiru R. Regupathi PRESIDENT
Thiru J. Jayaram, JUDICIAL MEMBER
Tmt. P. Bakiyavathi MEMBER
C.C. No. 47 / 2010
Dated this the 26th day of MAY. 2015
Shri R. Muthukrishnan, ]
B/F1, Golden Jubilee Gardens, ]
Rajaji Nagar, ]
Pallavaram, ] Complainant
Chennai – 600 043 ]
Vs.
1. The Apollo Specialty Hospitals, ]
Represented by the Medical ]
Superintendant ]
2. Dr. Revathy Raj, ]
Consultant in Paediatric, Haematology ]
& Bone Marrow Transplantation ]
3. Dr. Jose M. Easow, ]
Consultant – Medical Oncology,
Haematology & Bone Marrow
Transplantation
4. Dr. Ranjan Kumar Mahopatra, ]
Medical Oncologist ]
5. Dr. N. Ramesh, Opposite Parties 1 to 5
Medical Oncologist
This complaint coming up before us for final hearing on 07-11-2014 and on hearing the arguments of both sides and upon perusing the material records, this Commission made the following Order:
Counsel for Complainant: - M/s S. Radhakrishnan
Counsel for 1st Opposite Party: - M/s T.M. Pappiah
Counsel for Opposite Parties 2 to 5: - M/s S.D.S Philips
J. JAYARAM, JUDICIAL MEMBER
The case of the complainant is as follows:
The complainant is the father of Master R.M. Vijaram, 12 years old boy. The complainant took his son to the 1st opposite party hospital for illness of his son and they first consulted one Dr. S.G. Ramanan attached to the 1st opposite party hospital on 11-02-2008 and after examining the boy, he referred the boy to Dr. Revathy Raj, the 2nd opposite party attached to the 1st opposite party hospital. The 2nd opposite party examined the boy and she diagnosed the problem as Acute Myeloid Leukaemia and the boy was given treatment under chemotherapy in remission and there were no specific complaints. Though there was no specific physical discomfort and though the medical report dated 12-12-2008 was normal, the boy was compelled and prevailed upon to undergo Haplo Identical Stem Cell Transplantation Treatment expeditiously and urgently, and the boy was admitted in the 1st opposite party hospital for BMT treatment on 03-12-2008 and Haplo Identical Stem Cell Transplantation treatment was done on 16-12-2008 and his son died on 17-04-2009. In the death certificate issued by the 1st opposite party it is noted that death was due to post BMT Febrile Neutropenia, CMV Nephropathy and acute renal failure, and the test report on 04-09-2008 issued by the Department of Microbiology attached to the 1st opposite party hospital indicated that Cytomeglovirous IgG was positive and he requested for the medical records of BMT treatment given to his son, by a requisition letter dated 29-09-2009 and he received the medical records only on 11-11-2009 instead of the mandatory 72 hours as per MCI regulations, 2002 after a reminder letter dated 01-11-2009. Before commencing the BMT treatment, no test was done to rule out the possibility of the presence of CMV virus, since he was tested as CMV IgG positive as per the medical test report dated 04-09-2008 and no periodical tests were done after the BMT treatment to detect the presence of Cytomegala Virus till he developed complications and the test for Cytomegalo virus was advised on 29th day of post BMT, that is 14-01-2009 and up to day 34, the opposite parties did not detect the infection by Cytomegalo virus. Soon after, the boy developed complications, the infectious diseases specialist Dr. Abdul Gafoor, attached to the 1st opposite party was consulted on 04-02-2009 and Dr. Abdul Gafoor prescribed a medicine named Foscarnet, but this medicine was not available with the pharmacy attached to the 1st opposite party hospital and no steps were taken to procure the above medicine, viz. Foscarnet prescribed by the Infectious diseases specialist Dr. Abdul Gafoor, and instead another medicine named Gancyclovir was continuously administered to the boy even after the boy became Gancyclovir resistant as noted in the medical record dated 09-02-2009 and also in the death summary dated 17-04-2009.
2. In the medical report dated 09-02-2009, it was mentioned that the medicine Cidofovir would be administered instead of Gancyclovir since the boy became resistant to Gancyclovir, but even that medicine Cidofovir was not available in the pharmacy. The medicine Gancyclovir is a stem cell depressant, and the complainant was informed that Haplo Identical Stem Cell Transplantation is a high risk treatment and the requisite medicines viz. Foscarnet and / or Cidofovir were not kept ready as a precautionary measure to combat any post-operative CMV affliction before commencing the BMT treatment. When the condition of the boy started deteriorating and alarmingly depressing the chief attending doctor, Dr. Revathy Raj, the 2nd opposite party went abroad leaving the boy under the care of Dr. S.G. Ramanan.
3. No specialist doctors viz. opposite parties 2 to 5, who were also consultants in the BMT treatment as was evident from affixing their signatures in the death summary attended on the boy from 10-04-2009 to 17-04-2009 as is evident from the medical records wherein no signature of the opposite parties 2 to 5 was affixed in the medical records in confirmation of the opposite parties 2 to 5 for having attended during the period from 10-04-2009 to 17-04-2009 only the duty doctor attached to the 1st opposite party hospital attended.
4. The complainant had spent Rs.36,55,678-52 towards the costs of medical expenses pertaining to BMT including pre-BMT medical expenses, Stem Cell Donor medical expenses and opposite party bills, and incurred expenses of Rs.1,63,200/- for transportation from his home to hospital.
5. The complainant sent a legal notice on 11-03-2010 seeking compensation for deficiency in service and medical negligence besides refund of the medical expenses and transportation expenses. The 1st opposite party sent an interim reply on 31-03-2010 denying all allegations in the legal notice sent by the complainant and sought four weeks time to send a detailed reply but they did not send any detailed reply as mentioned in the interim reply.
6. The complainant’s counsel applied to Government General Hospital, Chennai for details about Haplo Identical Stem Cell Transplantation under the Right To Information Act and reply was received adducing medical negligence and deficiency in service on the part of the opposite parties 1 to 5 and in reply it has been mentioned that Cytomegalo virus would certainly infect the patients who undergo Stem Cell Transplantation and that periodical tests viz. weekly tests have to be performed upto 8 to 12 weeks after transplantation to monitor the affliction of Cytomegalo virus to combat the affliction of CMV in Stem Cell Transplantation patients and the medicine Foscarnet is well suited for CMV positive patients and also who are resistant to the medicine Gancyclovir which is evident from the reply to the RTI application and the boy had undergone a Stem Cell Transplantation and at the same time he was administered a medicine which is known as Stem Cell depressant.
7. The opposite parties 1 to 5 had been negligent and have rendered deficient medical services and owing to the negligence and deficiency in service on the part of the opposite parties, he has suffered financial hardship and mental agony to himself and to his family besides the irreparable loss of his son.
8. In the complaint, the complainant had prayed for direction to the opposite parties to refund the cost of medical treatment a sum of Rs.36,55,678-52, and to reimburse the cost of transportation a sum of Rs.1,63,200/- and to pay Rs.25,00,000/- towards compensation for negligence and deficiency in service resulting in the death of the complainant’s son and to pay a sum of Rs.15,00,000/- as compensation for mental agony and financial stress and to pay costs.
9. The 1st opposite party filed version, which was adopted by opposite parties 2 to 5, stating as follows:
The complainant approached the 1st opposite party during Feb 2008 for treatment of his son, Master Vijayaram. Consultants Dr. Ramanan and Dr. Revathy Raj attended on the patient. The consultants were not attached to the 1st opposite party hospital and they are only consultants. The complainant’s son was diagnosed as suffering from high risk Acute Myeloid Leukemia (AML), and as Dr. Ramanan felt that the child required high quality care, the patient was referred to Dr. Revathi Raj for specialized advice and the patient received the highest standard of care. The patient present with a high concentration of white cell count of 75,000 complex Karyotyping – t (7,14) high dose Chemotherapy treatment could be done only as an inpatient the patient was admitted as an inpatient.
10. Even after two initial cycles of chemotherapy as per UK MRC AML Protocol, the patient did not respond and so the Specialist Dr. Jose and Dr. Ramanan were consulted by the complainant and as per the complainant’s concern a very high risk schedule of treatment called CAT Chemotherapy was used in refractory AML, and the patient responded to this treatment and was in remission, but such response is only for a short period and is not durable and the patient as per expert opinion needed transplantation. The complainant was advised that the survival chance without transplantation was close to 0% and even with high risk transplantation survival rate is only 5 to 10%. It was also explained to the complainant that the chemotherapy treatment will suppress the immune system of the patient and there could be several side effects / infection to the patient. The patient had developed tuberculosis of the abdomen with high fever caused due to the suppression of immune system with chemotherapy which was managed by ante tuberculosis drugs after an extensive pre-BMT worked up the patient was in reasonable fitness for a transplantation after 5 cycles of chemotherapy. When the patient’s family members were checked for as donors, none of them matched with the patient. Dr. Jose helped with an extensive worldwide search for stem cell donor, but the type was peculiar and no matches were found in over 20 Million donors including cord and marrow. Further, cycles of chemotherapy were continued while the search was in progress to prevent a relapse while waiting as time was the crucial factor, the patient was advised to undergo Haploidentical Stem Cell transplantation. The main risk involved was advised as the immunity system takes a very long time to recover viz. 100 days to 1 year, which is the case in routine transplant and subjecting the patient to infections and relapse. This is insisted only in case where no family or other donor is available for a patient and when the patient cannot wait for months together.
11. The patient was also referred to CMC, Vellore, for expert opinion and Prof. Mammen Chandy had seen the patient and the family were advised to proceed with the haploidentical BMT either at CMC or Apollo Specialty Hospital. The complainant chose the 1st opposite party hospital on the basis of the excellent standards of care rendered to the patient. Haploidentical transplantation is a novel procedure where mismatch stem cells are treated with monoclonal anti bodies to prevent graft vs. host diseases - a dreaded complication of mismatch transplantation.
12. The 1st opposite party has to get special permission to import them and the processing requires special instruments to be brought in from Delhi and the transplantation was performed on 16-12-2008.
13. To perform detailed unrelated search requires over 12 hours of the expert’s time to organize the CV34 selection for the patient was huge as it is not part of the routine work and the time and the effort spent with a noble intention to save a life has not been well appreciated by the complainant. The parents of the patient were explained and counselled by the doctors and every step for several hours and their consent was obtained at every stage. There were doctors in the family of the patient and the patient’s relatives living abroad were also informed by the doctors.
14. The possibility of survival without transplantation was close to 0%, and the haploidentical transplantation offered 5 to 10% chance of survival and the complainant and his wife were fully aware of the same and they insisted upon the doctors for the high risk transplantation before relapse and in spite of the best efforts, the child died on 17-04-2009.
15. The allegations made by the complainant that there was no life threat to the patient as evident from the lab report on 11-11-2008 and the discharge summary dated 11-12-2008 and that he was compelled to accept haploidentical stem cell treatment, are denied. The viral infections and relapse are the major causes of death post BMT. The patient died of a combination of CMV and acute Myeloid Leukemia. CMV is a virus, present in the blood in 95% of the normal population. CMV reactivation and infections and complications are seen only when there is severe immune suppression as in graft vs. host diseases, use of ATG and in haploidentical BMT.
16. As regards, the allegation that there was undue delay in forwarding the medical records, there was some delay in retrieving old records and due to administrative reasons and pressure of work and it is pertinent to note that all the vital records including test reports were already furnished to the complainant much earlier. Further, the medical records was kept ready for handing over to the complainant, but no one came to collect it and so they were sent by post on 01-11-2009.
17. Prior to BMT, the doctors performed CMG IgG and M on the patient and donor to check CMG status. In the present case, both the donor and the recipient were positive and this was mentioned in the BMT protocol and the patient’s parents were fully aware of this result, but being positive is not a reason to withhold BMT as this is one of the reasons that most patients undergo transplantation have to face when their immunity system is down and the parents were fully made aware of this result before the transplantation.
18. CMV Monitoring is done weekly at their unit after transplantation using a highly sensitive PCR method and this was done to perfection in this case from the time of engraftment. The services of infectious diseases Specialist Dr. Abdul Gafoor were utilized and all steps to monitor viral load were taken. CMV IV G test does not help after transplantation and PCR is the recommended test. CMG virus does not circuit in the blood unless the immune system is down as in the case of BMT, Kidney, Liver and Heart transplantations. After transplantation, the IVG levels do not help monitoring the diseases for CMV and PCR method is required only after the white blood cells recover. In the present case, it was done from the time of engraftment well before any onset of complications.
19. The allegations made in paragraphs 21 and 22 in the complaint are denied that test for CMV was advised on day 29 of post BMT and up to day 34, the opposite party had not detected the infection as per the alleged admission in the death summary.
20. The complainant was well informed about the high risk as in the case of haploidentical transplantation, the immune system takes a very long time to recover and all the problems were explained to the complainant and his wife and the chance of cure which was less than 10% was consented to by them as being informed and consent for high risk treatment. Dr. Abdul Gafoor is a highly qualified Infectious Disease Specialist, who helped to monitor and guide other experts in the treatment of infections of the patient during transplantation period.
21. Gancilovir is the best standard drug for CMV. In resistant cases of CMV infection Foscarnet and Cidofovir are not used as the first line drugs in post BMT CMV infections and are used only when the patient is not responding to the standard drugs given as the former drugs are highly toxic. As these drugs are not used commonly in India, they cannot be kept in stock in the pharmacy and there is no such clearance from DCGI for stocking the drug and also the high cost of medication (each vial costs more than Rs.50,000/-) and at least 5 to 6 vials may be required and they have limited storage shelf life and such medications can only be imported on specific requirement and upon DCGI approval, that too on compassionate basis. All measures to help procure life saving drugs in the complainant’s son’s case were taken immediately through this opposite party’s pharmacy and Medihauxe International and only with their help the said drugs were ultimately procured. The drug Ganciclovir is a standard drug of treatment, though it also has side effects on the blood cells and the kidneys and the side effects were monitored during therapy of the said drug and treatment was started with monitoring of the CBC daily or on alternate days. This opposite party denies the complainant’s allegations made in paragraphs 25 to 27 that the medicines prescribed by Dr. Abdul Gafoor were not available with their pharmacy and that no steps were taken to procure the same and that had it been made available in time the life of the complainant’s son could have been saved and that instead of making arrangements to procure the said medicines prescribed by Dr. Abdul Gafoor a medicine named Ganciclovir was administered and that the requisite medicines viz. Foscarnet and Cidofovir were not kept ready as a precautionary measure to combat any post operative CMV virus affliction.
22. The allegations made by the complainant that no test was done on periodical basis for any possible virus infection; and the pharmacy attached to the 1st opposite party hospital did not stock the medicines which are the essential medicines prescribed by the specialist to combat Cyto Megali Virus are denied. The CMV viral load continued to increase in the patient as he was using his graft slowly with the return of leukaemic cells and a test called Fish was performed documenting the same where the donor cells from the mother carrying XX Chromozomes started declining as the CMV infection escalated. Ganclovir works well as long as the immunity as a adjunct, but in the present case, a combination of relapse and CMV accounted for the mortality.
23. The patient had undergone stem cell transplant treatment and at the same time, he was administered a medicine which is a lone stem cell depressant and the stem cell at depressants such as septran and Ganciclovir are essential to the treatment of BMT patients and they are used routinely with close monitoring of blood counts.
24. The allegation in para 34 of the complainant is that when the patient’s condition started deteriorating and alarmingly depressing, Dr. Revathi Raj went abroad leaving the patient under the care of Dr. S.G. Ramanan, is denied.
25. Dr. Ramanan is an expert in Oncology for over 20 years and he has vast experience in palliative care and Dr. Revathi Raj has gone to Sydney to help an ailing relative and she had made several calls from Sydney regarding the patient’s condition and also she spoke to the patient’s mother.
26. The allegations of the complainant that the patient was normal without any specific complaints as mentioned in the discharge summary dated 12-11-2008, and without keeping ready the essential medicines as a precautionary measure to combat any post BMT CMV virus infection as the patient was earlier infected by CMV as is evident from the test report dated 4-9-2008, are denied.
27. The medical literature produced by the complainant is supportive of the line of treatment given by the consultants is in no way indicates any kind of deficiency in service or negligence in the treatment of the patient.
28. The allegations that not keeping the requisite medicines as a precautionary measure to combat any possible post-BMT virus infection, not performing any right test to detect any infection until the complications arose, not performing any pre-BMT virus infection test, not taking any steps to procure the requisite medicine prescribed by the Specialist Dr. Abdul Gafoor. Dr. Revathi Raj, the chief attending doctor going on leave leaving the patient under the care of Dr. S.G. Ramanan, who had earlier referred the patient and that all these amount to gross negligence and deficiency and dereliction of duty, are denied.
29. None of the specialists in the transplant team charged professional fee for the patient and they took great care of him providing the highest standard of care, and there is no negligence or deficiency in service on the part of the opposite parties.
30. Both the parties filed proof affidavits, Ex.A-1 to A-24 have been marked on the side of the complainant, and Ex.B-1 to B-51 have been marked on the side of the opposite parties.
31. Points for consideration are:
i) Whether there is negligence or deficiency in service on the part of the opposite parties as alleged in the complaint;
ii) Whether the complainant is entitled to claim compensation from the opposite parties;
iii) To what relief the complainant is entitled.
32. Point Nos.1 & 2:
The complainant has filed his complaint claiming compensation from the opposite parties on account of the negligence and deficiency in service in treating his son resulting in his death.
33. The case of the complainant is that his son was admitted in the 1st opposite party hospital, suffering from Acute Myeloid Leukemia (AML) on 03-12-2008. Further, after the treatment – Chemotherapy and Bone Marrow Transplant (BMT) treatment, he died of Acute Myeloid Leukemia (AML), post-BMT, Febrile Neutropenia, CMV, Nephropathy and acute renal failure. The complainant alleges that there is negligence on the part of the opposite parties in treating his son leading to his death.
34. It is pertinent to note that no medical evidence or medical opinion are placed before us and so we have to decide the issues considering the other available evidence and invoking the doctrine of res ipsa loquitur, as laid down by the Hon’ble Supreme Court in the case of V. Kishan Rao vs. Nikhil Super Specialty Hospital and another – III (2010) CPJ – 1 SC.
“In the opinion of this Court, before forming a opinion that expert evidence is necessary, the Fora under the Act must come to a conclusion that the case is complicated enough to require the opinion of an expert or that the facts of the case are such that it cannot be resolved by the members of the Fora without the assistance of an expert opinion. This Court makes it clear that in these matters, no mechanical approach can be followed by this Fora. Each case is to be judged on its own facts. In a case where negligence is evident, the principle of res ipsa Loquitur operates and he complainant does not have to prove anything as the thing (res) proves itself – in such a case, it is for respondent to prove that he has taken care and done his duty to repel the charge of negligence”.
35. The main points to the decided in the complaint are whether Chemotherapy followed by Bone Marrow Transplantation (BMT) / Haploidentical stem cell transplant is warranted in the facts and circumstances; and whether there is negligence or deficiency in service in the treatment and procedure followed by the opposite parties.
36. It is alleged in the complaint that though as per the discharge summary Ex.A-2, dated 12-11-2008, his condition was in remission with no specific complaints and there was no physical discomfort suffered by the boy and even though as per the lab report Ex.A3, dated 12-12-2008 everything was normal, the complainant was compelled and prevailed upon to undergo haploidentical stem cell transplant treatment for his son expeditiously.
37. Ex.A-2, which is the discharge summary dated 12-11-2008 issued by the 1st opposite party reads as follows:
“History of Present Illness:– Master Vijayaram, 12 years old, male, a known case of AML - in remission came for haploidentical Bone Marrow Transplantation with no other specific complaint”.
38. The contention of the complainant is that after the initial treatment of Chemotherapy, the boy was in remission and there was no other specific complaint and while so, there was no need for BMT treatment / Haploidentical stem cell transplant as claimed by the opposite parties. We have to note that remission does not denote cure, but it means there is proper response to the particular treatment and it is under control. We have to note that it is only a temporary relief and it is not durable and relapse of the disease at any moment is possible. Therefore, the contention of the complainant in this regard is untenable.
39. In this context we have to consider whether proper consent had been obtained from the complainant. In the death summary Ex.A10, issued by the 1st opposite party, it is stated as follows:
Hospital Course
“Vijayaram was admitted and evaluated. After explaining the high risk nature of the transplant with 40 - 50% mortality rate, Myeloavlative conditioning regimen with FLU / TBI / CY / ATG was started on 4-12-2008”.
Therefore, we find that as per Ex.A-10, the procedure involved high risk to the extent of 40 – 50% mortality”.
40. In Ex.B-37, which is the ‘informed consent’ form for BMT, it is stated as follows:
“High risk consent explained to the father of the patient, haplo graft – relieves + infection can cause mortality of 50% in the first 120 days”.
41. Thus as seen from Ex.A10 and Ex.B37, the mortality rate is 50%, and there is high risk of 50% in BMT and it indicates that the chance of survival after BMT is 50 %, but contrary to this, as per the version filed by the opposite parties, the survival chance was close to 0% and even with high risk transplant, the survival is only 5 to 10%, and again it is repeated in the version that survival without transplant was close to 0%, and the haploidentical transplant offered 5 to 10% chance of survival; and it is further confirmed in the version that the complainant and his wife were fully aware that the chance of cure was less than 10% and they insisted on the high risk transplant before relapse; and it is further stated in the version that the complainant was well informed about high risk in the treatment as in the case of haploidentical transplant, the immune system takes long to recover and all potential problems were explained to the complainant and his wife that chance of cure was less than 10% and even then the parents gave the consent for the high risk treatment.
42. We find glaring inconsistency in respect of rate of risk after BMT / Haploidentical stem cell transplant, between the version filed by the 1st opposite party (survival chance 5 – 10 %) and the death summary Ex.A10 (Survival chance 50%) and the ‘informed consent’ form Ex.B37 (Survival chance 50%). The Hon’ble Supreme Court and the Hon’ble National Commission have stressed the significance of ‘Informed Consent’ as follows:
i) In the case of Samira Kohli – Vs – Dr. Prabha Manchanda & another, reported in 2008 (1) CTC 392, - The Hon’ble Supreme Court of India, has held as follows:
”Medical Negligence – Consent – Nature of Consent required in cases of medical treatment or surgery – Difference between ”real consent” and “informed consent” – In relationship of Doctor and patient consent means grant of permission by patient for act to be carried out by Doctor such as diagnostic, surgical or therapeutic procedure – Consent of patient to treatment including surgery stems from inviolable nature of right of patient in regard to his body and his right to decide whether he should undergo particular treatment or surgery or not – Consent should normally be express unless it is obviously implied – Consent is said to be real when (a) patient gives consent voluntarily without any coercion; (b) patient has capacity and competence to give consent; and (c) patient has minimum of adequate level of information about nature of treatment procedure to which he is consenting to – “Informed Consent” includes above basic ingredients but in addition to them imposes obligation on Doctor to disclose adequate and necessary information to patient to secure his consent – Adequate and necessary information should be such that patient should be in position to make balanced judgment as to whether he should submit himself to particular treatment or not”.
ii) In the case of Nizam Institute of Medical Sciences – Vs – Prasanth S. Dhananka & Ors – reported in 2009(4) Supreme 165, the Hon’ble Supreme Court has held as follows:
”Consent that is given by a person after receipt of the following information the nature and purpose of the proposed procedure of treatment, the expected outcome and the likelihood of success, the risks, the alternatives to the procedure and supporting information regarding those alternatives, and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful”.
iii) The Hon’ble National Commission has laid down as follows, in Revision Petition No.4084 / 2008, dated 24-07-2014, in the case of Dr. G. Swaminathan vs. G. Rajendran:-
“While all three were different procedures, the written consent on all three occasions is identically worded and reads”:
“I hereby give my full consent for treatment of the patient admitted in the hospital to undergo operation, to undergo all types of test to find out the cause for the disease, for infusion of blood, to give anesthesia and I declare that no one will be held responsible in any unpleasant event”.
“The Revision Petition carries no explanation as to how such a generally worded consent was relevant to specific procedures. Learned counsel for the petitioners too has made no attempt to explain it. Therefore, the only inference that can possibly be drawn is that none of the three procedures were specifically explained at the time of obtaining consent of the complainant”
43. Thus, the averments regarding survival rate after BMT in the version and the death summary Ex.A-10, and the consent form Ex.B-37 obtained from the complainant are inconsistent and misleading. It is patently evident that the ‘Informed Consent’ has been obtained from the complainant on misrepresentation of the material fact and the vital information that the survival rate is 50 % whereas the fact remains that survival chance is only 5 to 10% and the mortality rate is very high to the extent of 90 – 95%, as repeatedly stressed in the version. Therefore, the very purpose of getting consent is ‘defeated’ in this case. Therefore, we hold that the consent obtained from the complainant in Ex.B-37 for the treatment, and the procedure of BMT is an invalid one and it is a matter of serious concern. This amounts to serious negligence and gross deficiency in service on the part of the opposite parties.
44. According to the opposite parties, as stated in the version, BMT is a novel / new procedure. We come to know that the procedure is not a well established one, and further the facts relating to the novel procedure were not communicated to the parents of the boy and it amounts to suppression of material facts and had the opposite parties 1&2 divulged the factual position to the complainant and his wife that the survival rate in the BMT procedure is only 5 to 10 %, no prudent person / the complainant in this case would have agreed for the highly risky Haploidentical stem cell transplant treatment for their son. We hold that this amounts to further deficiency in service on the part of the opposite parties 1 & 2.
45. Another contention of the complainant is that the 2nd opposite party who was the chief doctor treating the boy, went abroad after BMT and during that period of her absence, no concerned specialist doctor visited the boy in the hospital and only the Duty Doctor M. Deenadayalan attended on him. We can understand that going abroad placing some other specialist doctor to attend on the patient till her return is quite acceptable, and there is nothing wrong about it; but in this case, the boy was in a very critical condition from 10-04-2009 to 17-04-2009 and as seen from the progress notes Ex.A-14 series, on these days, no specialist doctor / panel doctor ever attended on him till his death on 17-04-2009. It is contended by the opposite parties that the parents of the boy were not inclined to accept further escalation therapy and so the specialist doctors had nothing to do, and this contention is quite untenable. In the absence of 2nd opposite party, the concerned specialist doctors / panel doctors ought to have visited the boy at least, even though no escalation treatment was done. This amounts to further gross negligence and deficiency in service on the part of the opposite parties 1 & 2.
46. The other contention of the opposite parties is that before doing BMT / Haploidentical stem cell transplant procedure, no test was conducted to find out whether the patient was having Cytomegalo virus (CMV). We find that a test has been taken on 4-9-2008 before the BMT treatment commenced. The further allegation that no periodical test and weekly monitoring of CMV was done is unsustainable, in view of the investigation reports Ex.B-41 series, which runs to 1027 pages.
47. Another submission of the complainant is that one of the causes of death mentioned in the death certificate is Neutropenia and as we find in medical literature, if the medicine Gancyclovir is given overdose, it would cause Neutropenia and stem cell depression and in the present case, Neutropenia and stem cell depression are found which indicates that the medicine Ganciflovir was given in overdose. We cannot come to such conclusions hypothetically, based on assumptions and presumptions.
48. It is further contended by the complainant, that there are many lapses and deficiencies in the medical treatment rendered by the opposite parties, in that, prior to BMT treatment, no test was done to rule out the possibility of CMV infection and no periodical tests were done after BMT treatment to detect the presence of CMV and weekly monitoring was not done and on day 29 post-BMT, CMV test was advised to be done and till day 34 post-BMT no detection of CMV which tests should have been done on weekly basis and that to combat CMV infection, the prescribed medicine Foscarnet was not available in the hospital, and the medicine was not kept ready as a precautionary measure and even after the disease became Gancilovir resistant, the same medicine was administered and the medicine Civofovir was not available with the hospital or the pharmacy attached to the hospital, and Ganciclovir was given in over dose, which is a stem cell depressant causing Neutropenia
49. It is further contended by the opposite parties, that both the tests CMV IgG and CMV IgM were done prior to BMT treatment and that IgG was positive and acceptably more than 90% of the Indian population is CMV positive and microbiology CMV test was done and as per the recent report of CMV IgM is negative; and further weekly monitoring of CMV was done by blood PCR – CMV viral load which is the basis pre-emptive therapy.
50. It is further submitted by the opposite parties that Gancilovir is a standard drug used for the treatment of CMV and Cidofovir and Foscarnet are second line drugs for CMV infection resistant to Ganciclovir and since Foscarnet was not available, Cidofovir was started.
51. The further submission of the opposite parties would be that, donor cells were dropping from 95% to less than 50% which means that the disease relapsed and disseminated and CMV infection occurred simultaneously resulting in mortality. Administration of Ganciflovir is essential. Moreover, CMV risk occurred since the immune system of the patient became low and therefore it cannot be equated that administration of Ganciclovir stem cell depressant and further the viral load was considerably reduced after administering Cidofovir. The question of administering overdose medicine did not arise and the patient died due to relapse of the disease.
52. In the version, it is stated that CMV monitoring was done weekly at their unit after transplantation using a highly sensitive PCR method and this was done to ….. from the time of engraftment. The services of the Infectious Diseases Specialist Dr. Abdul Ghafoor were utilized and all steps to monitor viral load were taken. CMV, IvG does not help after transplantation and PCR is the recommended test.
53. It is relevant to note that as stated by the opposite parties in their version, the patient was referred to Christian Medical College Hospital, Vellore for expert opinion and Prof. Mammen Chandy saw the patient and advised them to proceed with the haploidentical BMT.
54. We have to take note of the following decisions of the Hon’ble National Commission in the case of V.K. Sharma vs. Bharti Eye Foundation & Anr. – II (2010) CPJ 94 (NC), where it is held that “just because the complainant not responded favourably to treatment, no negligence can be attributed to the opposite party”, and in the case of Prabha Ojha vs. Neel Mani, reported in I (2010) CPJ 62 (NC), it is held as follows: “It is by now well settled that onus of proof is on the party who alleges medical negligence. This has further been elaborated in subsequent judgments that mere statement of parties are not enough; allegation of negligence has to be proved with the help of expert medical opinion. Admittedly, in the present case, the petitioner has not brought on record any expert evidence to show as to what the doctor did was not to be done as per accepted medical practice or what he should have done as per accepted medical practice which he failed to do.
55. The counsel for the complainant submitted a number of citations; but they are not necessary for deciding this case, and hence the citations are not reproduced here.
56. It is significant to note that the complainant has not chosen to cross-examine the opposite parties or to serve interrogatories / questionnaire to elicit the required facts and so the averments in the proof affidavits filed by the opposite parties remain unrebutted and uncontroverted.
57. As we know, it is a case of dreaded disease of blood cancer, and due to suppression of immune system during the treatment, there can be several side effects inviting host of diseases such as Tuberculosis, and the patient has been treated with a holistic approach. Therefore, the various omissions and commissions pointed out by the complainant in the preceding paragraphs are unsustainable and we hold that there is no negligence or deficiency in service in treating the boy in terms of the medicines and the procedure adopted by the opposite parties.
58. It is pertinent to note that there is no allegation that the opposite parties are not duly qualified or they are without reasonable skill. We have to note that the 2nd opposite party is a highly qualified specialist Doctor, and the other opposite parties are also experts in their field and the 2nd opposite party has adopted UK MRC AML Protocol in treating the patient. The opposite parties have treated the boy following standard medical protocol and we find no deficiency or negligence in the treatment part.
59. On consideration of the entire materials on record, we hold that no negligence or deficiency in service is established against the opposite parties 3 to 5, and so the complaint is liable to be dismissed as against them, and we further hold that there is negligence and deficiency in service on the part of the 1st and 2nd opposite parties,
(i) in obtaining consent from the complainant on misrepresentation of material facts; and
(ii) in conducting the high risk BMT / Haploidentical stem cell transplant treatment without proper ‘informed consent’ of the complainant; and
(iii) suppressing the material facts relating to the BMT / Haploidentical Stem Cell transplant treatment without disclosing them to the complainant; and
(iv) The 2nd opposite party, who is the Chief Doctor, went abroad without arranging some other specialist doctor / panel doctor and consequently no specialist doctor, concerned in the treatment and surgery visited the patient / complainant’s son in the hospital during her absence from 10-4-2009 till the death of the patient on 17-4-2009.
60. For the aforesaid reasons, we hold that there is deficiency in service on the part of the opposite parties 1&2 and that the complainant is entitled to compensation from the opposite parties 1&2, and the points are answered accordingly.
61. Point No.3: The complainant has claimed Rs.36,55,678-52 towards refund of cost of medical treatment, and Rs.1,63,200/- towards reimbursement of the cost of transportation, and a sum of Rs.25,00,000/- towards compensation for negligence and deficiency in service, and a sum of Rs.15,00,000/- towards compensation for causing mental agony and financial stress, and has claimed Rs.78,18,878-52/- as total compensation
62. Having regard to the facts and circumstances of the case, and considering the various relevant factors, we feel that an award of Rs.20,00,000/- would be the reasonable compensation for the negligence and deficiency in service on the part of the 1st and 2nd opposite parties, and a sum of Rs.3,00,000/- would be the reasonable compensation for mental agony suffered by the complainant and his family, and the point is answered accordingly.
63. In the result, the complaint is partly allowed, directing the opposite parties 1&2 to pay jointly and severally to the complainant, a sum of Rs.20,00,000/- (Rs. Twenty Lakhs only) for the negligence and deficiency in service on their part, and a further sum of Rs.3,00,000/- (Rs. Three Lakhs only) to the complainant for mental agony and sufferings.
The complaint is dismissed as against the opposite parties 3 to 5, without costs. No order as to costs in the complaint.
Time for compliance two months from the date of receipt of copy of the order. In case of default in complying with the order, the amounts shall carry interest at the rate of 12% p.a. from the date of default till compliance.
P. BAKIYAVATHI J. JAYARAM R. REGUPATHI
MEMBER JUDICIAL MEMBER PRESIDENT
LIST OF DOCUMENTS FILED BY THE COMPLAINANT :
Sl.No. | Date | Descriptions |
Ex.A1 | 11.02.2008 | Copy of Ref letter |
Ex.A2 | 12.11.2008 | Copy of Discharge summary |
Ex.A3 | 12.12.2008 | Copy of Lab report |
Ex.A4 | 03.12.2008 | Copy of BMT Admission slip |
Ex.A5 | 17.04.2009 | Copy of Death Certificate |
Ex.A6 | 29.09.2009 | Copy of Requisition letter for medical records |
Ex.A7 | 01.11.2009 | Copy of Reminder letter for Medical records |
Ex.A8 | 04.09.2008 | Copy of Lab report testing CMV positive |
Ex.A9 | 14.01.2009 | Copy of Medical records advising CMV test |
Ex.A10 | 17.04.2006 | Copy of Death Summary |
Ex.A11 | 04.02.2009 | Copy of Medical record of Foscarnet prescription |
Ex.A12 | 09.02.2009 | Copy of Medical record and Drug charts |
Ex.A13 |
| Copy of Leaflet for Gancyclovir |
Ex.A14 | 10.04.2009 to 17.04.2009 | Copy of Medical Records indicating only duty doctor attended |
Ex.A15 | 25.10.2008, 12.11.2008, 18.12.2008, 17.04.2009 and OP bills | Copy of Pre BMT, Donor medical bill and BMT bill including OP bills |
Ex.A16 | 11.03.2010 | Copy of Legal Notice |
Ex.A17 | 13.03.2010, 15.03.2010 | Copy of Acknowledgement cards |
|
|
|
Ex.A18 | 31.03.2010 | Copy of Interim Reply Notice |
Ex.A19 | 30.12.2009 | Copy of RTI letter |
Ex.A20 | 05.03.2010 | Copy of Reply to RTI Notice |
Ex.A21 |
| Copy of CMV Infection RTI reply |
Ex.A22 |
| Copy of Weekly tests for CMV RTI reply |
EX.A23 |
| Copy of Foscarnet suitability |
Ex.A24 |
| Copy of Summary of Medical bills |
LIST OF DOCUMENTS FILED BY THE OPPOSITE PARTIES :
Sl.NO | Date | Descriptions |
Ex.B1 series |
| Copy of Patient Registration Form Copy of Doctor Order of Admission Copy of Admission Checklist Copy of Patient Registration Record Copy of Admission Form Copy of Admission Slip Copy of History and Finding on Admission |
Ex.B2 |
| Copy of General consent |
Ex.B3 |
| Copy of Consent For systemic Therapy for Cancer |
Ex.B4 series |
| Copy of Consent for Procedures Under Local Analgesia |
Ex.B5 series |
| Copy of consent form for Transfusion of Blood/Blood Components |
Ex.B6 series |
| Copy of Consent for Systemic Therapy for Cancer |
Ex.B7 series |
| Copy of Consent for Anesthesia |
Ex.B8 series |
| Copy of Consent for Surgery |
Ex.B9 series |
| Copy of Pediatrics case sheet |
Ex.B10 series |
| Copy of Doctors letter |
Ex.B11 series |
| Copy of Consultation Request |
Ex.B12 series |
| Copy of In-patient-case sheet |
Ex.B13 series |
| Copy of Intraoperative Nursing Record |
Ex.B14 series |
| Copy of Nursing Admission Assessment-Pediatric |
Ex.B15 series |
| Copy of Transfer Information Sheet
|
Ex.B16 series |
| Copy of Pre Operative Checklist |
Ex.B17 series |
| Copy of Anesthesiology |
Ex.B18 series |
| Copy of Operation Notes |
Ex.B19 series |
| Copy of Post operative orders |
Ex.B20 series |
| Copy of Antibiotic Chart |
Ex.B21 series |
| Copy of Body Weight & Abdominal Girh |
Ex.B22 series |
| Copy of Investigation Reports Chart |
Ex.B23 |
| Copy of I.V.Fluid Plan |
Ex.B24 |
| Copy of Department of Dietetics |
Ex.B25 |
| Copy of National Marrow Donor Program Cord List Report |
Ex.B26 series |
| Copy of Stem Cell Transplant Summary |
Ex.B27 series |
| Copy of Haplo Identical Transplantation High Risk AML |
Ex.B28 series |
| Copy of Progress Sheet and Doctors Order |
Ex.B29 series |
| Copy of Clinical Chart |
Ex.B30 series |
| Copy of Bone Marro Transplant Flow Sheet |
Ex.B31 series |
| Copy of Transfusion Sheet |
Ex.B32 series |
| Copy of Allogenic Peripheral Stem Cell Transplantation Protocal |
Ex.B33 series |
| Copy of Consent for ‘Do Not Resuscitate” |
Ex.B34 series |
| Copy of Fluorescence Instity Hybridization Report |
Ex.B35 series |
| Copy of Home Medication Form |
Ex.B36 series |
| Copy of Allogenic H.identical transplant |
Ex.B37 series |
| Copy of Informed consent for Bone Marrow Transplantation (BMT) for Haemato-oncfological patients |
Ex.B38 series |
| Copy of Nurses Chart
|
Ex.B39 series |
| Copy of Low Count Measures Chart |
Ex.B40 series |
| Copy of Vitala Monitoring Chart |
Ex.B41 series |
| Copy of Investigation Report |
Ex.B42 series |
| Copy of Fluid Balance Chart |
Ex.B43 series |
| Copy of B.M.T. Observation Chart |
Ex.B44 series |
| Copy of B.M.T.Flow Chart |
Ex.B45 series |
| Copy of B.M.T. Culture Chart |
Ex.B46 |
| Copy of Acknowledgement |
Ex.B47 series |
| Copy of Discharge Check list |
Ex.B48 series |
| Copy of Discharge Summary |
Ex.B49 |
| Copy of Death Summary |
Ex.B50 |
| Copy of Medical Certificate of Cause of Death |
Ex.B51 |
| Copy of Death Report |
P.BAKIYAVATHI J.JAYARAM R.REGUPATHI
MEMBER (J) MEMBER PRESIDENT
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