State Consumer Disputes Redressal Commission
N.Shashank Reddy S/O Mr.N.Venkat ... vs 1. Dr.Svss Prasad, Medical Oncologist ... on 30 January, 2013
BEFORE A.P STATE CONSUMER DISPUTES REDRESSAL COMMISSION AT HYDERABAD C.C.NO.28 OF 2010 Between: N.Shashank Reddy S/o Mr.N.Venkat Ramana Reddy Plot No.321, Road No.10C, MP/MLA Colony Jubilee Hills, Hyderabad-031 Complainant A N D 1. Dr.SVSS Prasad, Medical Oncologist, Apollo Hopsitals, Apollo Health City Campus Jubilee Hills, Hyderabad-033 2. Dr.Vijayanand Reddy Director Department of Oncology Apollo Hopsital, Apollo Heath City Campus Jubilee Hills, Hyderabad-033 3. Apollo Hospital Apollo Health City Campus Jubilee Hills, Hyderabad-033 rep. by its director Opposite parties Counsel for the complainant M/s K.V.Simhadri Counsel for the opposite parties M/s Indus Law Firm QUORUM: SRI R.LAKSHMINARASIMHA RAO, HONBLE MEMBER
AND SRI THOTA ASHOK KUMAR, HONBLE MEMBER WEDNESDAY THE THIRTIETH DAY OF JANUARY TWO THOUSAND THIRTEEN Oral Order (As per Sri R.Lakshminarasimha Rao, Honble Member) ***
1. The complaint is filed seeking direction to the opposite parties for payment of compensation an amount of `75,00,000/-
and for reimbursement of medical expenses of `22,00,000/- and costs of the proceedings.
2. The complainants mother was suffering from headache for 15 days and on 22.09.2009 she was taken to Dr.Rajesh Reddy who is attached to the opposite party no.3-hospital, who advised for MRI scan of brain which revealed that the complainants mother was suffering from high grade Glioma cancer which requires the patient to undergo surgery. The patient consulted Dr.Alok Ranjan of the opposite party no.3-hospital and he advised for immediate surgery. The doctor clarified that the cancer had not spread to other parts of the patients body.
3. The patient consulted the second opposite party who advised for complete PET scan of the patients body on 24.09.2009 which revealed small activity near lymph nodes(near lungs). The second opposite party advised for biopsy of the part near the lymph nodes on 25.09.2009 and the second opposite party advised to continue the same medicine for a period of 3 to 4 days by which time the biopsy report would be made available . Biopsy report of the lymph nodes revealed no malignancy and the second opposite party suspected it to be TB of the lymph nodes and he advised for biopsy of the lesion in the brain of the patient which was done on 1.10.2009 which revealed CNS primary Lymphoma.
4. The patient was admitted to the opposite party no.3-hospital where the first opposite party being a member of team of doctors of the second opposite party worked in tandem to treat the patient and decided to adopt DeAngelis Protocol as the line of the treatment. The complainant discussed his mothers case with the first opposite party and requested him to take suggestion of his relative, Dr.Praveen Reddy, who studied in DM Hematology and DM oncology and who spoke to Dr. DeAngelis, the author of DeAngelis protocol. Dr.Praveen and the first opposite party discussed the patients case by exchanging emails . The complainant dropped the proposal to take his mother to the US even after he had made arrangement for obtaining the VISA, for the first opposite party assured him of the best treatment to his mother at the third opposite party a leading Corporate Hospital maintaining high standard.
5. Bone marrow biopsy was conducted on the day of admission, i.e, 6.09.2009 and the next day a minor surgery was performed near the patients chest to put a port for infusing saline and on 8.10.2009 first Chemotherapy was started by infusing 2700mg High Dosage Methotrexate (MTX), Vincristine, Mabthera and Procarbizine. During post induction of Chemotherapy, after 24 hours Leucovorin rescue was given at every 6 hours interval . Methotrexate levels were not monitored on 9.10.2009 and 10.10.2009 to check the blood samples to eliminate presence of toxins. Methotrexate has to be flushed out starting 24 hours of infusion in the body to minimize the risk of complications caused by the toxins. The tests were not advised by the first opposite party and the patient was suspected to have suffered from TB for treatment of which disease, Dr.Bhargava had given medication.
6. The patient was discharged from the opposite party no.3-hospital on 11.10.2009 with the first opposite party advising certain medication till the patients next visit and he had not prescribed for daily blood test such as CBP, serum creatine etc., and to check Methotrexate levels and monitor other changes every day due to occur during the post-chemo period. The first opposite party advised the patient to take normal diet without any restriction on the food and he advised for blood test including the patients TLC count after three days and he had deviated from regime of follow up prescribed by DeAngelis protocol.
7. On 15.10.2009 the patient was given intra-thecal chemotherapy from her bone marrow for the medicine to get directly injected into the patients brain and after three hours the patient was discharged from the third opposite party hospital. The first opposite party advised the patient to use the same medicine that was prescribed on 11.10.2009 and asked for the blood test after six days i.e, 21.10.2009 leaving the patient without monitoring for a period of six days. From 12.10.2009 till 18.10.2009 the patient had taken normal food as suggested by the first opposite party and on 18.10.2009 she complained of dizziness and drowsiness and the blood test had shown her sodium levels decreasing drastically to 108 as against normal levels ranging from 134 to 145.
8. The patient was shifted to MCU(Medical ICU) and she was infused with Sodium Bicarbonate. The opposite parties had not prescribed any special food high in sodium content to combat the low sodium levels. On 22.10.2009, the patients sodium level went up to 114 and she was shifted from the ICU to the room. The doctors recommended the patient to have 10 gms salt every day which could be taken in the form of butter milk or any liquid or salt and not to take more than 2-2 liters of liquids to ensure that the salts would not be flushed out through urine. The next day, the patient s sodium levels went up to 126 and the nurse against the doctors advice that no more than 2to 2 liters of liquid be given, had employed a wrong measuring glass which measures 250 ml as a result of which the patient was given additional fluids such as milk, butter milk, juices , water etc.,.
9. From 24.10.2009 to 29.10.2009, the patients sodium levels hovered around the 125 mark despite the patient having lot of salty food and salts directly which was investigated by the patients family members and they found that due to the use of wrong measuring glass the patient had taken 2 1/2times more amount of water and the sodium was flushing out through urine which was not corrected by the opposite parties which immediately resulted in state of trauma and suffering to the patient which took 9 days for correction of the sodium levels of the patient as against normal time of 2 to 3 days . On 27.10.2009 the patients sodium levels were brought to normal.
10. On 27.10.2009 the first opposite party started the second chemotherapy cycle without checking her urine PH level to make sure that it was more than 7 and infused Mabthera 900 mg in 10NS over 6 hours between 7.30 PM and 1.30AM, Inj zofer 16mg in 100 ml NS at 1.30 AM and Methotrexate 4600gms in 300 ml at 2.00 AM -4.00 AM. There was delay in starting second chemotherapy cycle as the patient developed hyponatremia after the first chemotherapy cycle due to drop in sodium levels which was not corrected for 9 long days. The first opposite party decided to infuse higher dose of the medicine during the second chemotherapy cycle without conducting the standard pre-treatment hydration and alkalinization of urine.
11. The first opposite party has not advised to check the blood levels and PH levels on day to day basis to check the toxicity of MTX levels in the body of the patient in deviation of the procedure prescribed by DeAnelis protocol. The first opposite party is not having experience to deal with the complications arising out of high dose administration of HDMTX and he failed to exercise reasonable care and necessary precautions to minimize the complications of chemotherapy. Leucovorin Rescue was given after 48 hours of infusion of Methotrexate instead of starting it at 24th hour and to be continued every 6 hours for at least 72 hours or until the serum MTX level file gone down below 1X 1048. The first opposite party had not checked the MTX level and PH level and failure to administer Leucovorin proved fatal and it led to complications such as renal failure and extreme toxicity.
12. The third opposite party discharged the patient while she was suffering from toxic fever caused by high MTX levels and on 29.10.2009 and 30.10.2009 while the patient was still in the third opposite party hospital, the physician forgot to administer one of the chemo drugs, Vincristine which was given at the instance and interference of the complainants cousin who is a doctor working with the third opposite party hospital. At the time the patient was discharged, she complained of chills (shivering ) and after examining her temperature, the doctors informed that she could go home. The doctor advised to take 2 neuphogenashots to increase the blood TLC count in the patients body which should have been 5 to 7 shots.
13. Within one hour after discharge, the patients temperature began to run high and the first opposite party advised the patient to take dolo 650mg and Cifran instead of advising for admission of the patient in the hospital. As and when Dolo was taken, the patients temperature used to come down and after its effect ceased, her temperature used to run high. On 2.11.2009 the first opposite party advised the patient to go for blood test instead of advising her for hospital admission in view of the highly metatoxic chemo regimen. On 3.11.2009 the patients family members informed the first opposite party that her temperature could not be controlled and she developed sores in her throat. The first opposite party felt inconvenience that they were disturbing for a small fever and he spoke rudely to the complainants father. The patients family members decided to shift her to another hospital.
14. Having come to know the behavior of the first opposite party which resulted in shifting of the patient to another hospital, the second opposite party warned the first opposite party that serious action would be taken against him if he misbehaves with any patient or the patients family members. The patients family members complained to the CEO of the third opposite party hospital. The first opposite party examined the patient and advised for admission stating that the temperature suddenly shot up and there was infection spreading in the patients body. The second opposite party examined the patient and found her very weak. The first opposite party summoned Dr.Lavanya , infection specialist who advised for blood test which reveals that the patient s kidneys were badly affected.
15. The patients kidneys were affected due to the belated administration of Leucovorin rescue which was given after 48 hours of infusion of Methotrexate instead of at the 24th hour which resulted in suppression of bone marrow and administration of vancomycin and Amicacyn made the situation worse. The blood transfusion was belatedly advised. On 4.11.2009 the patient was given whole range of antibiotics for treating fever and infection and as her kidneys were further damaged, mild dose of antibiotics were given . On 5.11.2009 the patients condition was further deteriorated and she was admitted in ICU as she needed constant monitoring of her BP and pulse rate.
16. On 9.11.2009 the patients urine out put was decreased and she was put on dialysis. Her body was in a septic shock. The acidosis levels increased and the process became irreversible. On 10.11.2009 the patient developed minor cardiac arrest and recovered herself and she was sedated and was put on ventilator support. Her TLC count did not improve and her condition remained serious on 11.11.2009 and at night she developed cardiac arrest and on 12.11.2009 she succumbed to the illness.
17. The first opposite party has not exercised due care and diligence in treating the patient . She was 54 years at the time of her death and was a healthy person prior to the detection of the disease and she was cooperative during the course of treatment. She was in charge of entire administration of the house and her contribution to the family cannot be measured in terms of monetary value. Had the chemotherapy was administered with due care, she would have recovered from the disease.
18. The opposite parties resisted the claim on the premise that the patient was admitted in the third opposite party hospital under the care of the first opposite party after a thorough discussion with the complainant, her husband and relatives. They were explained that CNS Lymphoma is a cancer in the brain which needs aggressive treatment with chemotherapy as per DeAngelis protocol to expect a good response and that it is fraught with complications. They were explained that complications such as neutropenia microsites, nephrotoxicity can occur in the course of treatment.
19. To the query of the complainant whether to take the patient to USA, the first opposite party after explaining the line of the proposed treatment and complications thereof left the choice to the complainant and his father and they were informed that serum methotrexate level checking which is done in USA is not available in the third opposite party hospital and they would do the alternative method. In NIMS, Hyderabad, MNJ Cancer Institute, Hyderabad, Kidwai Memorial Cancer Institute, Bangalore and Gujarat Cancer and Research Institute, Ahmadabad and Indo American Cancer Institute, Hyderabad there is no facility to check serum methotrexate levels and high methotrexate is given to patients taking precautions to manage methotrexate levels. After the complainant and his father decided to get the patient treated in the opposite party no.3-hospital, she was admitted in the hospital.
20. As there is no provision to check the serum methotrexate levels, precautions to prevent toxicity are taken in the form of good hydration, maintaining good urine output, alkalinization and leucovorin rescue starting 24 hours from start of methotrexate administration. Leucovorin rescue is given more frequently and for longer duration i.e., every 6 hours for 48-72 hours by which time the serum methotrexate levels came down lower than the risky levels. In the literature provided by the complainant in Volume II- pages 129, 130, 131, it can be seen that the leucovorin rescue was not needed for more than 44-48 hours, even in patients receiving methotrexate as high as 12g/m2-which is 5 times higher than the dose that the patient received. The patient was given leucovorin 15mg every 6 hourly for 72 hours. Patient was given IV fluids for hydration and sodium bicarbonate injection and sodamint tablets for alkalinization.
21. Bone marrow biopsy was done as part of standard of care for staging the disease. On 7.10.2009 a port was put for administration of intravenous infusions without having to poke the patient for IV lines repeatedly which was done on request of the patients family members and keeping in view of patients comfort as also part of standard of practice in view of long duration treatment and possible difficulty in accessing to IV lines in the course of time. The patient was passing good amount of urine and she was well hydrated. She was given Leucovorin rescue which was started 24 hours from start of methotrexate every 6 hourly for 12 doses (72 hours), by which time the methotrexate would be completely eliminated from her body. This was the standard of care that is followed in India and which was earlier informed to the complainant and his relatives.
22. CBP, serum creatine, serum electrolytes were checked in the evening of 10.10.2009 and all the values were normal. The patient was well and she was passing good amount of urine. As the condition of the patient was satisfactory she was discharged with advice to get CBP check on 14.10.2009 and come on 15.10.2009 for intrathecal methotrexate chemotherapy. She was advised to take cooked food, boiled water and maintain hygienic habits to prevent infections as the patient undergoing chemotherapy can develop neutropenia and infections. Due care and diligence was advised to be exercised.
23. The patients blood count was alright on 14.10.2009 and she was given intrathecal chemotherapy on 15.10.2009. She was advised blood test on 21.10.2009 for next cycle chemotherapy and she was asked to report immediately in case of any problem. Blood tests and other tests were not advised daily without any reason. HDMTX monitoring includes clinical assessment and lab assessment and depending on the clinical assessment and need was very much taken care of .
24. The patient was admitted on 19.10.2009 with complaint of drowsiness and the first opposite party advised for CBP, serum creatine and serum electrolytes intravenous normal saline and a broad spectrum of antibiotics. The reports showed severe hypernatremia with a serum sodium level of 107 mEg/I and the patient was shifted to ICU for management of hypernatremia on the same day as per the standard of care. After further assessment, she was advised to take higher salt containing food on 20.10.2009.
25. The patient was shifted to her room from ICU after the drowsiness disappeared and sodium level went up to 114 mEg/I and as there was improvement in her general condition. For the low sodium level management, advice of nephrology expertise was obtained. There was no wrong measuring glass nor were any excess liquids given to the patient leading to late recovery of sodium levels. Sodium level of 125 is though lower than normal is not dangerous and the opposite parties waited till it to cross the normal level of 130mEg/I for them to give further chemotherapy. Hypernatremia can occur due to various causes including chemotherapy drugs like Vincristine and anti-tuberculosis drugs and suspecting the same anti tuberculosis treatment was stopped. These factors could have led to late recovery of the patient. There is no prescribed time within which the abnormality is supposed to recover and there was no mistake or lapse on the part of the opposite parties in treating the sodium levels.
26. On 27.10.2009, the opposite parties checked the CBP, serum electrolytes and serum creatine which were found normal. The patients urine output was normal and soda mint tablets were started for alkalinization of the urine ad chemotherapy was started on 28.10.2009 between 6.14 and 1.30 PM , Mabthera was infused into the patient. After hydration and antiemetic treatment given to the patient before and after infusing Mabehera, Methotrexate was given to her from 2.00 PM on 29.10.2009 and the second cycle of chemotherapy was concluded. As adequate hydration and alkalinization was given and as the urine output was good, the first opposite party subscribed to the view that it was not necessary to check the urine PH repeatedly as it would not influence any change in the treatment.
27. The Leucorvorin rescue was started at 24 hours after Methtrexate at 2.00 AM on 30.10.2009. The 12 doses of 6 hourly leucorvorin for 72 hours would remove all traces of Methotrexate from the body which is the standard of care followed across the country to minimize the complications of chemotherapy. The complainant with mischievous intention is seeking to encash on a inadvertent entry crept in the medical record so as to project as if there was delay in starting Leucovorin. There was no delay in treating the sodium levels of the patient. The second cycle of chemotherapy was successfully completed and patient had none of the complications of hypernatremia, neutropenia, renal failure and septicemia at the time of discharge.
28. The first opposite party is a medical post graduate with DM in Medical Oncology from Cancer Institute, Chennai and he was trained in high dose chemotherapies and bone marrow transplantation in Hammersmith Hospitals, London. Before admitting the patient in the opposite party no.3 hospital, the complainant was satisfied about the credentials of the first opposite party. Dr.Praveen was actively following the treatment of the patient with the first opposite party and at no point of time there was any complaint against the first opposite party. The first opposite party was open to discussion with the complainants relatives including Dr.Praveen and he was exchanging ideas in treating the patient.
29. As the patient had hypernatremia after the first chemotherapy which can occur due to Syndrome of Inappropriate Anti Diuretic Hormone, a complication of Vincristine, the first opposite party waited till 30.10.2009 to observe the patient for recurrence of any drowsiness and after seeing that the patient tolerated the treatment given that far well, she was administered Vincristine and there was no complaint of feverishness. Cifran and neupogen injection were prescribed and further shots would be advised if the blood TLC falls on the further checkups. Neupogen would cause body pains and feverishness. There is no way determining the number of shots that would prevent the occurrence of low TLC and low TLC can occur despite any number of neupogen shots.
30. On 2.11.2009 the patients husband called the first opposite party and informed him of the persistent fever in the patient and the first opposite party advised for CBP and instead of reporting on the same day, he informed the first opposite party on 3.11.2009 on phone that the report has shown normal TLC count. The first opposite party advised for change of antibiotics and for the patient to report at the third opposite party hospital. The relatives of the patient who are doctors were closely monitoring the condition of the patient and if there was requirement for hospitalization, they would have also suggested. The first opposite party had not spoken rudely to any of his patients and he always gives patient hearing to the patient and his relatives.
31. The first opposite party is the consultant for the third opposite party hospital for the past 14 years and he is not subordinate to anybody in the third opposite party hospital. The patient developing soars in her throat is not an unexpected situation. Dr.Lavanya was asked to see the patient as inputs by her would benefit the patient. The blood report has shown low TLC count contrary to normal count reported by the patients husband. Serum creatine is elevated. The patient had fever and oral microsites. Neutropenic fever can affect kidney and liver function. Mucositis and neutropenia are complications of chemotherapy and they were treated in the standard fashion.
32. TLC count of the patient on the day of her admission to the third opposite party was 800/cu.mm and neupogen injections were given to facilitated increase in the count. Methotextrant and other drugs are likely to cause low TLC counts. TLC count can be low even though the earlier count on the previous day is normal. Even though counts are normal, fever and infection occurring in the patient can affect kidney and liver function. Leucovorin rescue was provided after 24 hours of methotrexate infusion . Vancomycin and Amikacin were given to the patient in the modified as is done in patients with nephrotoxicity. The drugs had not contributed to worsening of patients condition.
33. There was no delay in blood transfusion and it was done as per regular standard practice. 43% of CNS lymphoma patients are known to develop complications of neutropenia, 36% develop thrombocytopenia, 10% develop anemia and 3% develop renal failure. Since her admission on 3.11.2009 the patient was given broad spectrum of antibiotics in adequate doses and as her condition was deteriorating she was shifted to ICU on 5.11.2009 where despite all measures, her TLC count had not improved. Continued septicemia leads to deterioration of kidney function and lack of urinary output. The patient was dialyzed. The septicemia also led to shock, hypotension and the patient needed ventilator care.
34. The patient developed cardiac arrest on 11.11.2009 and she was revived and she succumbed on 12.11.2009 to her illness. Acidosis may not respond to the treatment in seriously ill patients. Once the patient develops low TLC, it is quite possible that on such chemotherapies life threatening infections are possible to occur resulting in further fall in blood count and renal function compromise hepatitis compromise would occur which causes more infections and recovery of counts and kidney and hepatic functions become difficult. Irreparability is a term used to describe the patient s condition in the last 24-48 hours and not in the beginning of the occurrence of low counts. Many patients recovered from irreparable condition due to the treatment provided by the opposite parties . The patients condition deteriorated despite the best possible care provided to her.
35. The patients body colour turning into black from light brown can be decided by conducting autopsy and further laboratory analyses. The nurses have marked the time of administration of methotrexate as 2.00 a.m. to 4.00 am in the column dated 28.10.2009 instead of 29.10.2009. The instructions were issued at 1.00 p.m. on 28.10.2009 and after procuring the drugs from the pharmacy stores, the patient was shifted to chemotherapy ward at 4.30 p.m. and chemotherapy was started with Mabthera at 5.30 p.m. and in the sequence, methotrexate was given from 2.00 a.m. to 4.00 am. On 29.10.2009 which is clearly borne by all other notes by the nurses and medical staff in the medical record of the patient.
36. It is submitted that the body colour of a patient can change in illness and what has caused the change can be ascertained only by conducting autopsy and further laboratory analyses. Laboratory parameters monitoring was done as was felt necessary for facilitating treatment of the patient using the clinical judgment as is the standard of practice in such cases. During the patients stay in the hospital, opposite parties were monitoring the clinical well-being, urine output, serum electrolytes, serum creatinine, blood counts. . Principle behind the guideline provided in a protocol is important and the treating clinicians judgment in the application of the guideline and safety measures for the patient is paramount. Adoption of protocol on oncology practice is to adopt the schedule of the drugs and dosages. It is inherent on oncology practice to take the necessary precautions as needed with the available facilities for efficient administration of the drugs. The dosages, drugs, schedules are changed/modified according to the clinical situation in the patients best interest.
As such there cannot be any straight jacket formula, which as to be adopted. Whatever is mentioned in a protocol is a guideline/schedule to be applied keeping in view the condition of the patient and depending upon the patients response to the treatment.
37. De Angelis protocol was adopted as it is the best and commonly adopted protocol for CNS lymphoma patients. The protocol schedules usage of high dose methotrexate as one of the many drugs in the protocol; high dose methotrexate treatments are regularly used in patients with this as well as other cancers and with the precautions as have been followed in our patient. Pancytopenia i.e., anemia, neutropenia and thrombocytopenia were the most noted complications in DeAngelis protocol, as mentioned by the complainant himself and the patient developed the complications.
38. The patients family including the complainant were informed multiple times as to proposed line of treatment and the risk involved during and post chemotherapy and the steps to be taken to minimize the risk. The patient was largely cooperative during the course of the treatment except few times when she either didnt want to go to ICU or stay in ICU for longer periods. The complications had occurred despite the best possible care. The complainants father was happy with the care provided and had no grievance during the course of the treatment. He had an excellent rapport with 1st opposite party. He was a spiritually inclined man as the 1st opposite party knew him from the beginning and was visiting temples frequently and had offered prasadam to the 1st opposite party too, once or twice during the course of his wifes treatment. The opposite parties have treated the patient with due care and caution and there was no negligence or lapse on the part of the opposite parties and therefore they prayed for dismissal of the complaint.
39. The second opposite party and the third opposite party adopted the written version filed by the first opposite party.
40. The complainant and two other witnesses have been examined as PWs 1 to 3 and the documents filed by him are marked ExA1 to A110. On behalf of the opposite parties, the opposite party no.1 filed his affidavit and no documents have been marked.
41. The learned counsel for the complainant and the opposite parties have filed written arguments.
42. The points for consideration are:
i) Whether there was deficiency in service on the part of the opposite parties in administering treatment to the complainants mother?
ii) To what relief?
43. POINT NO.1: The complainants mother was admitted to the opposite party no.3-hospital for treatment of CNS Lymphoma on 6.10.2009. At the time of admission of the patient, the complainant has stated that the first opposite party promised that the third opposite party would provide best possible treatment to his mother and believing the words of the first opposite party the complainant dropped the proposals of taking his mother to the USA for the purpose of the treatment. The opposite parties would contend that he discussed the line of treatment with the complainant and his son. The complainant has stated that believing the version of the opposite party no.1 that best treatment would be administered at the opposite party no.3 hospital, changed his mind and dropped the proposal of getting the patient treated in US.
44. The complainants mother stated to have suffered from severe headache on 24.9.2009. The second opposite party performed complete petscan of the patients body and advised for biopsy of lympnodes as also her brain. The second opposite party analyzed the biopsy report and other test reports and diagnosed the patient with primary CNS lymphoma on 6.10.2009.
45. It is not disputed that the opposite party no.1 explained the line of treatment and about the disease CNS Lymphoma which is a malignant lesion in the patients brain which needs aggressive treatment with chemotherapy as per DeAngelis protocol to expect good response and that the treatment was fraught with complications like neutropenia, mucusotis, nephrotoxitis.
46. The opposite parties contended that there is no provision for checking the serum methotrexate levels and precautions can only be taken to prevent toxicity such as hydration, maintaining good urine output, alkalinzation and administration of leukovorine rescue within 24 hours from the time methotrexate is administered. The complainant has submitted that opposite party no.1 has not exercised reasonable and standard care in treating the patient during post chemotherapy stage and deviated from DeAngelis protocol.
47. The literature on administration of Leucovorin and laboratory monitoring during treatment provides for, the following information:
Leucovorin administration Leucovorin rescue should be started within 24 to 36 hours of the start of the MTX infusion. Most American patients receive a racemic mixture of d, l leucovorin (leucovorin or leucovorin calcium ). However, the I-isomer is the biologically active moiety (ie , has the capacity to rescue cells from MTX toxicity [48], and an intravenous preparation of I-leucovorin is now commercially available in the US (LEVOleucovorin, Fusilev) it is dosed at one-half that of d, I leucovorin.
A variety of dosing schedules have been published, but most administer 10 mg/m2 IV or is mg/ms of leucovorin calcium orally ( or 5 mg/m2 of levoleucovorin IV ) every six hours until plasma MTX levels are less than 0.05 to 0.1 microM. The size and number of leucovorin doses do not appear to be critical in patients who have normal MTX clearance [7]. Even doses of 10 to 15 mg/m2 are ofter in excess of those required to achieve rescue in such patients[49]. In contrast, higher concentrations of leucovorin are needed if rapid elimination of MTX is compromised by renal insuffienciency.
Laboratory monitoring during treatment Serum creatinine and electrolytes as well as plasma MTX levels should be followed daily. A rise in the serum creatinine above normal values indictes renal dysfunction and the potential for delayed MTX elimination [49]. It is mandatory that all patients receiving HDMTX have plasma MTX levels determined after dosing. Monitoring of serum creatinine alone is inadequate since there are large interindividual variations in MTX clearance and a poor correlation between serum creatinine and MTX clearance [52-54].
It is customary to assay plasma MTX levels at 24,48, and 72 hours after the start of the MTX infusion. Leucovorin doses are then adjusted based upon the MTX drug levels, and hydration/alkalinization is continued or increased provided that adequate urine output can be maintained. Drug levels should continue to be monitored with ongoing alakaline hydration and leucovorin rescue until they are <0.05 to 0.1 microM(<0.05 to 0.1 microgram/mL) Management or prolonged high plasma MTX levels Delayed renal elimination can result in elevated plasma MTX levels for as long as two to three weeks, which increases systematic toxicity. Risk factors contributing to delayed clearance of MTX include urine PH<7, less than 3l/m2 of IV fluid hydration per 24 hours, high body mass index, use of comedications with nephrotoxic potential or known interference with MTX elimination.
Augmenting urine output Since the rate of MTX elimination is dependent on urine output, hydration and urinary alkalinization should be continued or increased, provided that adequate urine output can be maintained.
Increased dose and frequently of leucovorin Because the reversal of MTX action by leucovorin is competitive, proportionately higher leucovorin concentrations are required to achieve rescue in the presence of high MTX levels [7,49,60]
48. The complainants mother was admitted in the third opposite party hospital on 6.10.2009, bone marrow biopsy was conducted upon her on the same day as also that on 7.10.2009 a minor surgery was performed near her chest to put a port for infusion of saline and on 8.10.2009. The first chemotherapy cycle was started whereby 2700mg high dose methotrexate (NTX) vincrixtine, mabthera and procarvizine were infused and about 24 hours thereafter, leucovorine rescue was given to her at every six hour interval. Thus there is no controversy in respect of the first cycle of the chemotherapy. The learned counsel for the complainant has relied upon the literature in regard to the protocol DeAngelis protocol and other protocols in the matter of treatment of primary CNS Lymphoma and HDMTX.
49. DeAngelis protocol and the other protocols meant for the treatment of CNS Lymphoma and HDMTX read as under:
Primary central nervous system lymphoma is usually a B-cell lymphoma that arises within and is limited to the central nervous system (CNS) (1). It occurs with a markedly increased incidence in the immunosuppressed population, particularly those with AIDS, but its incidence has been rising in the past two to three decades in the immunocompentent population. Despite the threefold-increased incidence in the immunologically normal host, it remains a relatively rare primary brain tumor-approximately only 1000 new patients are diagnosed each year in the United States. Despite the relative rarity of PCNSL, it has become an important brain tumor to recognize because definitive treatment can result in cure in some patients.
Treatment :
Treatment should focus on obtaining a complete remission.
Durable remission always requires the use of chemotherapy.
Treatment must be efficacious but must not compromise the Patients neurocognitive function.
Corticosteroids Corticosteroids are the standard initial medical treatment for almost all patients with an intracranial lesion identified on neuroimaging. They rapidly relieve symptoms, often within hours, by reducing perilesional edema. However, cortico steroids act as a chemotherapeutic agent in patients with PCNSL. Thus, cortico steroids can cause regression or even complete disappearance of a PCNSL lesion, occasionally within days (fig.1). Institution of steroid therapy before obtaining tissue for biopsy can result in a false-negative specimen resulting in a delay in diagnosis. This also applies when sampling the CSF or performing a vitrectomy in patients with ocular lymphoma. Therefore, whenever PCNSL is considered in the differential diagnosis of brain lesions seen on MRI, corticosteroids should be withheld until diagnostic tissue has been obtained. Steroids are rarely necessary in an emergency situation.
Chemotherapy The development of successful systemic chemotherapeutic regimens to treat PCNSL has been the focus of recent therapeutic advances for the past 15 years. It is clear that hig-dose methotrexate is the single most important drug for the treatment of PCNSL (400,5). The addition of this agent to cranial irradiation or, in some cases, the use of high-dose methotrexate-based regimens alone has resulted in a substantial improvement in outcome. Median survivals are 30 to 60 months, and 5 year survival rates are approximately 25% (Table2). High-dose methotrexate has been used as a single agent or in combination with other drugs such as procarbazine and vincristine. It is unclear whether there is definitive advantage of one approach over the other; however, there are theoretic reasons having to do with drug resistance that suggest combination chemotherapy may be better than single-agent treatment.
Most regimens deliver high-dose methotrexate intravenously, usually on an every other week schedule. However, McAlister et al. (8) developed a procedure using blood-brain barrier disruption with intra-arterial mannitol followed by intra-arterial chemotherapy. This is done in an effort to get drugs past the blood-brain barrier and into the nervous system. This regimen is designed to be used as chemotherapy-only approach and has yielded increased survival, as chemotherapy-only approach and has yielded increased survival, with a median of about 40 months. It has not been widely adopted because it is cumbersome, labor intensive, expensive, and associated with acute procedural complications such as seizures and arterial injury.
Standard Procedure Methotrexate is given in a dose equal to or greater than 3.5 g/m2 . It is infused over 1to 2 hours and followed by vigorous hydration, leucovoring rescue, and sodium bicarbonate to alkalinize the urine. The patient must have a urine pH checked with every void, and it must be maintained in the alkaline range. Vigorous hydration begins after the mehotrexate at 1500 to 1800cc/m2 for the first 24 hours and is then increased to 2000 cc/m2/d over the subsequent 48 hours. Methotrexate levels are measured daily for 72 hours or until levels are below 10-8 M. Electrolytes, blood urea nitrogen and creatinine are also measured daily.
Contraindications known hypersensitivity to methotrexate; renal insufficiency with a creatinine clearance less than 50 cc/1.73 m2.
Complications Acute complications include renal insufficiency with diminished methotrexate clearance. This can usually be managed with prolonged hydration and forced diuresis; dialysis is rarely required. Continued hydration and increased doses of leucovorin are used until the methotrexate level has fallen to 10-8 M. Significant renal toxicity precludes further methotrexate. Pulmonary or hepatic toxicity precludes further methotrexate. Pulmonary or hepatic toxicity is a rare occurrence.
The most significant delayed complication of high-dose methotrexate is its potential to damage cognitive function. When methotrexate and cranial irradiation are combined in the treatment of PCNSL, significant neurotoxicity is seen in at least one third of patients. The risk of theis toxicity is greatly influenced by the age of the patient at diagnosis and treatment. Patients older than age 60 years have a more than 90% incidence of severe cognitive impairment if followed for 4 to 5 years after treatment (60) . Younger patients have a substantially reduced risk, but even they have a 30% incidence if followed for upwards of 7 years. There are fewer data on the risk of significant neurotoxicity from regimens that employ chemotherapy alone, either single-agent or combination regimens. However, there is mounting evidence that chemotherapy alone carries less risk of neurotoxicity in older patients and achieves the same survival as chemotherapy combined with irradiation . This has also been studied in those patients who undergo blood-brain barrier disruption. No delayed cognitive problems have been reported in these patients (8). However, there is substantial experimental evidence to suggest that this approach gets significant drug into normal regions of brain as well as into tumor. Methotrexate is a known neurotoxin and has the potential to cause significant leukoencephalopathy by itself when high concentrations reach normal brain tissue repeatedly. Conventionally administered high-dose methotrexate can achieve comparable disease control with less risk of toxicity.
Cost effectiveness High dose methotrexate is frequently an expensive treatment necause it usually involves hospitalization for a minimum of 4 days to manage the vigorous hydration necessary to prevent the patient the patient from going into renal failure. Hogh-dose methotrexate can be given on an outpatient basis, but frequently the elderly patients who develop PCNSL and have neurologic deficits are not able to manage the necessary oral hydration and monitoring of their urine pH. Outpatients must come daily to check their methotrexate levels, electrolytes, blood urea nitrogen and creatinine.
Intrathecal chemotherapy Intrathecal chemotherapy has been used to supplement systemic treatment for many patients with PCSNL and certainly for those with documented leptomeningeal involvement. This rationale is based on the fact that focal leptomeningeal infiltration is seen in virtually all autopsy specimens of PCSNL, even in patients with a negative CSF cytologic exanimation. Only three drugs- methotrexate, cytarabine, and thiotepa- can be used for intrathecal administration. Methotrexate and cytarabine are most commonly used for PCSNL, most treating physicians start with methotrexate. Intrathecal drugs are best administered by using an Ommaya or intraventricular reservoir.
Standard dosage: Methotrexate, 12mg/dose; cytarabine, 50mg/dose; thiotepa, 10mg/dose.
Contraindications: Hydrocephalus or evidence of impaired CSF flow.
Concurrent cranial radiation is a relative contraindication.
Main drug interactions: None Main side effects: Acute chemical meningitis, seizure, myelopathy when administered by the lumbar route, chronic leukoencephalopathy, dementia.
Cost effectiveness :
These drugs at this dosage are relatively inexpensive.
Workup The following should be ordered in an immunocompetent patient whose computed tomography (CT)/MRI scan suggests PCNSL:
Withhold corticosteroids, as their use may complicate diagnosis Chest radiograph to rule out metastatic disease Complete blood count (CBC) HIV testing Slit-lamp examination for vitreous lymphoma Lumbar puncture for cells, glucose, protein, and cytology in the cerebrospinal fluid (CSF) Other Tests Liver function tests Because the mainstay of treatment for many patients is high-dose methotrexate, hepatic function must be evaluated. Tests should include serum bilirubin (total/direct), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase.
Twenty-four-hour urine collection for creatinine clearance Patients being considered for methotrexate chemotherapy must have a glomerular filtration rate (GFR) of greater than 100 mL/min, because inadequate renal clearance enhances methotrexate toxicity.
Medical Care The goal of treatment is eradication of contrast-enhancing mass lesions and microscopic infiltration of brain, spine, leptomeninges, and vitreous. Successful therapy in immunocompetent patients leads to a median survival duration as long as 44 months. Treatment must be designed to maximize efficacy and minimize toxicity to cerebral white matter.
The decision to offer chemotherapy as the sole initial treatment modality, therefore, must be made while keeping in mind that optimal dose and timing are still under investigation. Current active protocols for the treatment of PCNSL have been described by Hoang-Xuan and Delattre.
50. The learned counsel for the opposite parties has contended that the complainant has not adduced any experts evidence and the evidence of Dr.Praveen does not support the case of the complainant and that Dr.Praveen was informed about the line of treatment by the first opposite party.
51. It is not disputed that the first opposite party adopted DeAngelis protocol which indisputably is the best commonly adopted protocol for treatment of CNS Lymphoma. The high dose methotrexate which is one of the main drugs used in patients suffering from cancer may lead to certain complications. The learned counsel for the complainant has contended that the opposite parties no.1 and 2 deviated from DeAngelis protocol while administering second cycle of chemotherapy to the patient whereas the learned counsel for the opposite parties has submitted that administration of drugs by having protocol in hand can be done by any person and it is dose of drugs and change of the dosage of the drugs on assessment of the patients tolerability and also the assessment of the physician which does matter in the course of treatment to the patient.
52. It is true, clinical assessment as well as assessment made on laboratory test reports conjointly would decide the dosage of drug to be administered to a patient suffering from CNS Lymphoma. Equally, it is true that protocol particularly the DeAngelis protocol which is admittedly the common protocol adopted worldwide in the treatment of CNS Lymphoma is an important process in the treatment and cannot be deviated from.
53. The complainant has stated that the first opposite party had started the second chemotherapy cycle without checking the patients urinary PH level. The PH level of patient was less than 7 at the time Mabthera 900mg, Zofar 100ml, Methotrexate 4600gms was administered. He has stated that there was delay in infusing the chemotherapy cycle since the patient developed hyponetramia after first cycle of chemotherapy due to dropping sodium level and the same was not corrected which required 9 days period to be corrected.
54. The first opposite party on the other hand stated that patient was good amount of urine and she was hydrated and she was also given leucovorine before she was discharged after first chemotherapy cycle was completed. During the period from the date of her discharge till the second chemotherapy started, the first opposite party contends that the patient contacted him on 14.10.2009 on which date her blood count was alright and she was adised blood test on 21.10.2009 for next cycle of chemotherapy and two days prior to that i.e., on 19.10.2009 she complained of drowsiness upon which the first opposite party advised for CBP, Serum Creatine and Serum electrolytes and broad spectrum antibiotics. She suffered from severe hyponetramia for treatment of which she was shifted to ICU.
55. In the light of statement of the first opposite party that the sodium level of the patient was below normal and it had gone upto 114mEg/L and there was improvement in general condition of patient and that sodium level of 125mEg/L though lower than normal is not dangerous and he waited for it to cross the normal level of 130mEg/L. According to him hyponetramia can occur due to various causes including chemotherapy drugs like Vincristine and anti-tuberculosis drugs and suspecting the same he stopped the treatment which according to him contributed for slow recovery of the patient.
56. On 5.11.2009 the patients condition was deteriorating and she was admitted to the ICU and on 6.11.2009 to 8.11.2009 there was no change in the condition of the patient. As seen from the record the condition of the patient remained same as it did not improve or deteriorate. On 8.11.2009 her urine output had was decreased and she was dialyzed. The acidosis levels increased and on November 2009 she developed mild cardiac arrest. The complainant states that the patient recovered herself from the cardiac arrest whereas the opposite parties contend that they had revived the patient.
It is borne from the record that the patient was revived by the opposite parties as also from the statement of the first opposite party it can be culled out that they being present at ICU could state the fact better than the complainant.
57. The complainant has complained of failure of the opposite parties to assess the condition of the patient on 28.10.2009 and their failure to infuse, the drugs to minimize the complications or toxicity, renal failure, septicemia and neutropenia in terms of DeAngelis protocol.
58 It is beyond any dispute that maintaining adequate hydration and good urine output are essential for rapid clearance of high dose methotrexate. As seen from the literature extracted hereinabove, most protocols recommend minimum of 2.5 to 3.5 ltrs by M2 of IV fluid hydration per day commencing from the previous day about 4 to 12 hours prior to the initiation of the MTX infusion. Another important factor in the line of the treatment of MTX is the Ph level of urine as MTX precipitates in acid urine and maintaining the urine Ph of 7.0 or > 7 increases MTX solubility and prevents its precipitation in renal tubules and decreases the chance of renal damage. As urine pH>7 and to maintain it in the same range until plasma MTX level are decreased to less than 0.1 microM.
59. The literature on importance of Hyderatgion and Urinary alkalinization reads as under:
Prevention and management of HDMTX toxicity The quiding principles for prevention of HDMTX toxicity, namely maintaining urine output, urinary alkalinization, monitoring serum creatinine, electrolytes, and plasma MTX concentrations, and pharmacokinetically-guided leucovorin rescue, are also the cornerstones of management for patients who develop early signs or renal dysfunction and delayed MTX elimination.
Hydration and urinary alkalinization Maintaining adequate hydration and urine output are essential for rapid clearance of MYX. Most protocols recommend at least 2.5 to 3.5 liters/m2 of IV fluid hydration per day, staring four to 12 hours prior to the initiation of the MTX infusion.
The PH of the urine should be measured at baseline. As noted above, MTX precipitates in acid urine; maintaining the urine PH 7.0 or higher increases MTX solubility, prevents drug precipitation in renal tubules, and drastically decreases the chance of renal damage. In clinical practice it is customary to begin the MTX infusion only after the urine PH is > 7.0 and to maintain it in this range until plasma MTX levels have declined to less than 0.1 microM.
Urinary alkalinization is most easily accomplished by adding ampules of sodium bicarbonate to each liter or IV fluid hydration. This accomplished both fluid hydration and urinary alkalinization.
As with continuous administration of IV bicarbonate-containing fluid, the urine Ph should be > 7.0 before the MTX infusion is begun and urine PH must be monitored closely until serum MTX levels are below 0.1 microM to ensure that the urine is still adequately alkalinized.
60. The first opposite party has stated that he did not advice for urine pH level as the patient was hydrated and her urine output was normal. A careful perusal of the statement of the first opposite party in the backdrop of the medical records would show that the patients pH level was not monitored nor her urine output was constantly normal.
The opposite parties contention that in view of adequate hydration of the patient there was no necessity for assessing her pH urine level is not necessary has no force and does not hold water as it forms essential feature of DeAngelis protocol.
61. The opposite parties had not monitored the serum creatine, electrolytes, CBP, plasma MTX level of the patient for a continuous period 3 days after a HDMTX was infused. The complainant has stated that the opposite party no.1 failed to do the tests at any point of time after the first and second cycles of chemotherapy which resulted in series of complications and resultantly the patient died of the complications of chemotherapy and not as a result of CNS primary lymphoma.
62. The first opposite party would state that the pH check before the first cycle of chemotherapy showed that the patient was able to alkalize the urine without alkalinization measures and alkalinization measures were continued before and after HDMTX administration. As also he felt that he did not deem it necessary to have pH level test done.
63. The patients TLC count was found to be low on 3.11.2009 and she suffered from elevation of serum creatine and she suffered from fever and oral mucocitis and jaundice. Neucropenic fever can affect kidney and liver function and mucocitis and neutropenia are complications of chemotherapy. The slight difference in the argument of the opposite party and the complainant lies in that area where the opposite parties contend that the complications suffered by the complainant were the result of chemotherapy whereas the complainant submits that his mother suffered the complications as a result of the opposite parties failure to monitor the pH urine level of the patient and belated administration of leucovorine rescue. The complainant states that leucovorine rescue was administered after 48 hours of infusion of methotrexate whereas the opposite parties submit the leucovorine rescue was very much provided after 24 hours of methotrexate leucovorine rescue and the complainant had taken advantage of a wrong entry in the discharge summary which is falsified by the other entries in the same medical record.
64. The contention of the opposite parties that leucovorine was started 24 hours after methotrexate infusion on 30.10.2009 with 12 doses of 6 hourly leucovorine for 72 hours to remove the traces of methotrexate from the patients body does not find support from the medical record, the opposite parties failed to show that there was adequate hydration to the patient.
65. In the absence of any provision for checking the serum methotrexate levels, adequate precautions to prevent toxicity ought to have been taken by the opposite parties. Except contending that the complainant has failed to produce any experts evidence the opposite parties have not established that they were diligent and had taken reasonable care in rendering treatment to the patient.
66. Methotrexate when given in excess of 500 mg/m2 is known as High Dose Methotrexate. 4600mg was given to the complainants mother. Multiple potential adverse effects in the body of the patient are prone to be caused either due to high dose or due to long duration of the drug remained in the patients body.
The speedy cleanse of Methotrexate from the patients body can be achieved by adequate hydration and maintenance of alkalized state of the body. About 90% of the administered MTX is eliminated through kidneys and MTX precipitates and crystallizes in acidic urine blocking the kidney tubules leading to damage of the kidneys of the patient.
67. The complainant has stated that hydration can be said to be adequate if the urine PH of the patient is more than 7.0 and his mother was not given adequate hydration and alkalinization which led to complications of her renal failure. The medical literature strictly recommends checking the urinary PH prior to administering HDMTX and the first opposite party without checking PH level infused HDMTX to his mother.
68. The medical record shows that the first opposite party has checked the PH level of the complainants mother once before commencing the first chemotherapy cycle. The complainant has stated that the dose of Methotrexate for the first chemotherapy cycle was low compared to its dose administered during the second chemotherapy cycle and the first opposite party without checking the PH level of the patient proceeded to start second chemotherapy cycle which led to the patients renal failure. Admittedly, the first opposite party has checked the PH level of the patient for one time for the entire period of treatment involving two chemotherapy cycles. The first opposite party attempts to support his not conducting the test on the premise that there was adequate hydration and alkalinization of the urine of the patient which made him not feel the necessity of checking the pH urine level.
69. Dr.Narotham R.Thudi ,MD and Dr.Hari Kolla clinical oncologists and Hematologists expressed their opinion that the complainants mother did not receive adequate hydration before and after the chemotherapy Dr.Narotham R.Thudi has pointed out the following deficiency in the treatment of the patient:
Ms.Kamala Nagi did not receive adequate hydration before and after the chemotherapy. There is no record of her urine pH being checked prior to starting the Methotrexate chemotherapy.
Leucovorin was started at 48 hours after Methotrexate instead of 24 hours and there is no record of checking Methotrexate levels which is a very crucial step in preventing complications.
Patient was prematurely discharged from the hospital. She should have been kept in close observation until Methotrexate level becomes undetectable, while monitoring her blood counts, kidney function and electrolytes.
She did not receive adequate doses of Neupogen or antibiotics for prophylaxis.
There was a delay in identifying the infection and other chemotherapy related complications (mainly kidney failure) early which I believe led to life threatening complications. Prompt recognition & treatment would have prevented these complications.
70. Dr.Hari Kalla opined that Neupogen was not started when the patient suffered from fever and antibiotics were not properly used resulting in the patient suffering from sepsis with shock. He observed as under:
I am Dr.hari Kalla, a Medical Oncologist in Abilene, TX, USA. I have practices for 6 years as a medical oncologist and hematologist. I reviewed the case records of Ms.Kamala Nagi.
I think she did not receive adequate medical care. She needed methotrexate level, Leucovorin resque within 24 hrs of High dose Methotrexate. Neupogen, with prophylactic Antibiotics should have been started when she had fer.
Sepsis with shock could have been prevented with proper use of antibiotics, and Neupogen.
I think that inadequate medical care led to all the complications and death.
Thank you for this opportunity and asking me for an expert opinion.
71. Coupled with the opinion of the aforementioned two doctors, the relative of the complainant Dr.Praveen Reddy who is oncologist and hematologist and presently practicing in the US is examined as PW3 and he stated that he furnished the DE Angelis protocol to the first opposite party to be used for the patient and it was mentioned in the protocol that prior to stating of chemotherapy, adequate hydration along with sodium bicarbonate was to be given and chemotherapy not to be started till the Urinary PH is 8 or greater and after completion of the high dose Methotrexate the urinary PH has to be monitored. He has stated that there was negligence on the part of the first opposite party in the following words:
In my opinion the treating physician completely failed:
i) To follow the pre and post chemotherapy instructions as per the guidelines
ii) To anticipate the treatment related complications
iii) To prevent or minimize the treatment related complication.
iv) To identify the treatment related complications at early stage.
It is very obvious that due to this inadequate medical care Ms.Kamala developed renal failure, metabolic acidosis, profound pancytopenia, septic shock and finally died.
72. PW3 has observed that the opposite parties have not shown minimum care to avoid the preventable complications which the complainants mother developed during the second chemotherayrpy cycle. He has opined :
Obviously patient was not given adequate neupogen shots before neutropenia became profound and prolonged. Once patient develops neutropenic fever, severe renal failure and multi organ failure, their bone marrow can never recover in spite of giving neupogen shots. So these preventable complications should be anticipated and adequate growth factors should be given. Once neutropenia becomes severe for a prolonged period it is very difficult and practically impossible to correct it.
73. Dr.Praveen has stated that the first opposite party had not followed the recommended protocol and he did not take adequate recommended precautions in the following terms:
If Mrs.Kamla had experienced these severe and prolonged complications in spite of aggressive and adequate precautions as outlined in the literature and the recommended protocol, her family can completely understand and agree with Dr.Prasad. But it is very obvious that he did not provide all the adequate recommended precautions. The very fact that she developed every single possible expected complication to the maximum severity proves that the care is not adequate. It is without any doubt that Ms Kamala died due to the treatment related complications which could have been completely prevented.
74. The first opposite party in his cross examination stated that he is conversant with De Angelis protocol of which literature he received from PW3 and DeAngelis protocol mandates checking of serum MTX after administering chemotherapy. He has stated that he had been in touch with PW3 before the administration of the treatment to the complainants mother and he has admitted that in the written version it is stated that it was not necessary to check the urine PH repeatedly as it would not influence any changes in the treatment. He has stated that the patient was not acidic and admitted that the reports revealed her urine acidic which he declared that not relevant. The questions put to him and his answer in the cross examination read as under:
Q. Do you say that patient was not acidic during the course of the treatment?
Ans: Yes Q. As per the medical records of the Apollo volume No.1 at page No.293 to 298 of complainants book equivalent to page No.298 to 303 of the opposite parties, copy volumn no.1 shows that the patient urine pH was acidic?
Ans. Yes it is true that patient urine was acidic, witness adds these reports are not relevant to the time of administration of chemotherapy.
xxxx Admittedly, I am not conducted urine pH test of the patient before/during/after the 2nd cycle chemotherapy. Witness as this alkalinisation measures in the first cycle have shown that urine was alkaline.
In my judgment checking urine pH levels was not necessary.
Q. have you update yourself with medical literature i.e., upto date journal and DeAngelis protocol?
Ans. Yes Q. If yes how do confident with upto date journal P.No.121 to Vol.2 internal page 11 which incidcates that inclindical practice it is customary to begin the MTX infusion only after the urine pH is greater than equal to 7.0 and to maintain it in this range until plaxma MTX levels have declined to less than 0.1 micron?
Ans. As in my judgment the urine pH would be 7 or more and the plaxma MTX levels would be 0.1 micron with my measures I have not felt it necessary to measure the levels the same principles applies DeAngelis protocol.
Q. How much hydration was the patient given before/during/after 24 hours. 2nd cycle of chemotherapy?
Ans. As per the medical record of the hospital in respect of the patient at page no.385 Vol.1 of the complainant Book equivalent to at page no.391 of the opposite partis.
Book 1600 ml. of IV fluid were given before/during/after put together on 28.10.2009 and 29.10.2009 Q. How did you arrive at the figures the 1600 ml. of IV fluids to the patients? How much before/during/after?
Ans: before =100ml. during=60o0ml (100+1.0) after=800ml. which would be ending at 11.00 a.m. on 30.10.2009.
Q. If that the case what would be the dose you have given from 6.00 p.m. on 28.10.2009 to 6.00 p.m. 29.10.2009?
Ans. 875 ml.
75. The learned counsel for the complainant has relied upon the decisions of the Honble Supreme Court:
1) NIMS Vs Prashant N Dhananka and others (2009) VI SCC 1
2) Marghesh K Parikh (minor) vs Dr.Mayur H Mehta (2011) 1 SCC 31
3) Savita Garg Vs Director National Heart Institute (2004) VIII SCC 56
4) Malaykumar Ganguly Vs Dr.Sukumar Mukherjee (2009) IX SCC 221
76. In Malay Kumar Ganguly, the Supreme Court has considered the impact of the treating doctor not following the medical record protocols laid down by experts and it held that :
The standard of duty to care in medical services may also be inferred after factoring in the position and stature of the doctors concerned as also the hospital; the premium stature of services available to the patient certainly raises a legitimate expectation. We are not oblivious that the source of the said doctrine is in administrative law. A little expansion of the said doctrine having regard to an implied nature of service which is to be rendered, in our opinion, would not be quite out of place.
AMRI makes a representation that it is one of the best hospitals in Calcutta and provides very good medical care to its patients. In fact the learned Senior Counsel appearing on behalf of the respondents, when confronted with the question in regard to maintenance of the nurses register, urged that it is not expected that in AMRI regular daily medical check-up would not have been conducted. We thought so, but the records suggest otherwise. The deficiency in service emanates therefrom. Even in the matter of determining the deficiency in medical service, it is now wellsettled that if representation is made by a doctor that he is a specialist and ultimately it turns out that he is not, deficiency in medical services would be presumed.
77. The medical literature would support the plea of the complainant that checking of PH urine level of the complainants mother prior to her undergoing each of the two chemotherapy cycles at the third opposite party hospital is essential. Once the complainant has discharged initial onus cast upon him, it is for the opposite parties to prove that they had exercised reasonable care and caution while subjecting the patient to chemotherapy and during the post chemotherapy stage. The first opposite party has stated that medical literature would not be the sole guide to determine the course of treatment and on clinical assessment and laboratory assessment he administered treatment to the patient .
78. In Savita Garg(supra) it was observed that the doctors and the hospital has the obligation to discharge the burden of proof once the patient had discharged the initial onus of proof as :
Once an allegation is made that the patient was admitted in a particular hospital and evidence is produced to satisfy that he died because of lack of proper care and negligence, then the burden lies on the hospital to justify that there was no negligence on the part of the treating doctor/ or hospital. Therefore, in any case, the hospital which is in better position to disclose that what care was taken or what medicine was administered to the patient. It is the duty of the hospital to satisfy that there was no lack of care or diligence. The hospitals are institutions, people expect better and efficient service, if the hospital fails to discharge their duties through their doctors being employed on job basis or employed on contract basis, it is the hospital which has to justify and by not impleading a particular doctor will not absolve the hospital of their responsibilities.
79. In Marghesh K.Parekhs case (supra), the National Commission allowed the appeal preferred by the doctor and set aside the order of the State Commission on the ground that Dr.Aswin Bhamar has stated that there could be 10 other reasons for gangrene to set in. the Supreme Court referred to its decision in Jacob Mathews case to make distinction between civil and criminal liabilities in cases of medical negligence and it also referred to its judgment Marti F D Souza wherein a direction was given to the consumer fora to issue notice to the doctor or hospital and for the criminal court to refer the matter to committee of doctors for its opinion whether there is prima facie case of medical negligence. The Apex Court has also referred to its decision in V.Kishan Rao Vs Nikhil Super Specialty Hospital (2010) V SCC 513 by which decision the proposition laid down in Martin D Souzas case held to be not consistent with the law laid down by the larger bench in Jacob Mathews decision.
80. The learned counsel for the opposite parties have relied upon the following decisions:
1.
Martin DSouza Vs Mohd Ishfaq, (2009) III SCC 1
2. Philip India Limited Vs Kunjeer Kuneer and another AIR 1975 Bombay
3. C.P.Sreekumar Vs S.Ramanujam (2009) VII SCC 130
4. State of Punjab Vs Shivram (2005) VII SCC 1
81. In Philip India Limited (Supra) it was held that the professional negligence of medical practitioner has to be considered on a different footing than the negligence ordinarily attributed to the other professionals. The Supreme Court observed that:
A charge of professional negligence against a medical man was serious. It stood on a different footing to a charge of negligence against the driver of a motor car. The consequences were for more serious. It affected professional status and reputation. The burden of proof was correspondingly greater. As the charge was so grave, so should the proof be clear.
82. In CP Sreekumars case (supra) the Supreme Court referred to the guidelines laid down in Jacob Mathews decision in regard to the medical negligence of a treating doctor. The line of treatment chosen by the doctor was held to be a erroneous and not amounting to medical negligence. Their Lordship observed that :
It would, thus, be seen that the appellant's decision in choosing hemiarthroplasty with respect to a patient of 42 years of age was not so palpably erroneous or unacceptable as to dub it as a case of professional negligence
83. In Shivrams case (supra) the Supreme Court dealt with cause of action for a patient to file complaint against the doctor in the matter of failed sterilization. It was held that failure due to natural causes would not provide any ground for claim.
84. The first opposite party has stated that Leucovorin administered to the complainants mother within 24 hours of methotrexate infusion and not 48 hours after the drug being infused to the patient. Admittedly, there is an entry in the medical record which goes to show that leucovorin rescue was not administered to the patient within 24 hours from the time Methotrexate was infused to the patient. The first opposite party has dubbed the entry in the medical record as wrong entry. He has stated that other entry in the medical record falsifies the contention of the complainant. The first opposite party has not substantiated as to what is the other entry in the medical record that would falsify the plea of the complainant that leucovorine was not administered in proper time.
85. The learned counsel for the opposite parties has contended that the complainant has not filed the TLC report dated 2.11.2009 which show suppression of material fact on the part of the complainant. The first opposite party has deposed that the complainants father has informed that the TLC count of the patient on 2.11.2009 was normal as per the record and the complainant has not produced the report. The complainant has denied the statement of the opposite party no.1. The complainant has stated that :
It is interesting and of relevance to note that the 1st opposite party himself stated in the same para 16 that TLC count can be that low even though an earlier count on the previous day is normal. The patients TLC counts were checked in a different diagnostic Centre on 3.11.2009 morning prior to admitting to 3rd opposite party hospital and it was found to be 3500 (normal:4500 -11000). But the report came after admitting to 3rd opposite party hospital. It should be noted that patients husband reported the TLC counts of previous (02.11.2009) to 1st opposite party.
86. According to the first opposite party, the TLC count of the patient may be low even when the TLC count on the previous day is normal. He has stated that :
It is submitted that on the day of admission on 3.11.2009, the TLC count was low( 800/cu.mm) as seen in the hospital. In fact on day 7 of chemotherapy, TLC can be low even though previous days count are normal
87. Thus it can be said that the information furnished by the complainants father in regard to the TLC count of the patient is of no significance as the TLC count even if was normal and it may change and become low the next day.
88. The first opposite party has attempted to support his decision stating that neutropenic fever in early stages cannot cause organ damage. He has stated that on 3.11.2009 the patient was brought on his insistence to the third opposite party hospital and she was found to be ill and had a low TLC elevated serum creatine and bilirubin. He has deposed that infection with or without neutropenia can cause organ damage at any stage and the more prolonged the infection more the damage. According to him infection was there evidenced by fever even before neutropenia was seen.
89. As against what is stated by the opposite party, the complainant has stated that :
Chemotherapy drugs kill not only cancer cells but also the actively proliferating cells like the blood cells (while cells, red cells and platelets). So blood counts drop gradually after the chemotherapy drug (HDMTX) administration and reach the lowest point, called nadir.
Blood counts stay at such low levels for a few days and then gradually recover. During this period when the while blood cells are low (neutropenia) patients are susceptible for infections.
If neutropenia is prolonged the risk of getting infections and sepsis will be increased.
90. It can be concluded that neutropenic fever at early stage cannot cause any organ damage. However, when neutropenia persists and fever continues, bacteremia sets in, it can lead to septicemia which may result in multiorgan failure.
The first opposite party has stated that continuous septicemia leads to kidney function deterioration and lack of urinary output. The septicemia in the case of complainants mother led to shock, hypotension, acidosis and the patient was put on ventilator.
91. The first opposite party had checked the methotrexate level once as against the protocol of checking for atleast 72 hours or till the levels reach 0.1 microM after infusion of MTX. He has checked the urine pH level for only once as against the protocol providing for its check up at least 72 hours after infusion of MTX. As seen from the medical record adequate hydration of the patient was not made.
She was given 3200 ml on the first day and 875 ml on the second day whereas the protocol recommends 700% more than the said quantity. The first opposite party would contend that infusion of other fluids was the cause for hydration of the patient to the limit of 3200 ml on the first day.
92. From the time the first chemotherapy cycle was done, the patients serum creatine, Electrolytes, blood urea nitrogen were no checked for a period of three days which is against the mandate of the protocols mentioned above including DeAngelis protocol.
93. It is essential to mention the essence of conducting tests prescribed in DeAngelis and HDMTX protocols which may be summarized as under:
a) pH Level > pH level should be always maintained above ? before/during/after chemotherapy (HDMTX) to prevent drug precipitation in renal tubules and drastically decrease the chance of renal damage. IN clinical practice, it is customary to begin the HDMTX infusion only after the urine pH is >7.
b) MTX Level > It is also customary to check plasma MTX levels at 24, 48, and 72 hrs after the start of the HDMTX infusion.
By checking MTX levels the toxicity levels of the body can be known thereby altering/modifying the medical dose, etc. If toxicity in the body remains longer then the patient suffers from renal failure, septicemia etc.
c) Serum creatinine> Serum creatinine should be checked daily. A rise in the serum creatinine above the normal levels indicates renal dysfunction and delayed MTX elimination. If levels are above normal then patients medical dose will be adjusted accordingly to prevent/ minimize life threatening complications.
94. The first opposite party at the time when the complainant and his father made arrangement for the patient getting treated in America, informed them that the facilities available at the time third opposite party hospital would meet the requirement of treating the complainants mother. However, he has not informed them the testing equipment in regard to the test to be conducted for checking the MTX level was not available at the third opposite party hospital. He states that the checking equipment is also not available in Indo American Cancer Institute and NIMS Hyderabad, Gujarat Cancer and Research Institute Ahmedabad, Christian Medical College Vellore and Kidwai Memorial Institute for cancer Bangalore and all these instatitutions there is no facility to check the serum methotrexate level and high dose methotreaxite treatment is given to the patient by taking precautions in managing the methotroxiate level.
95. The first opposite party has denied that he had not informed the complainant and his father about the non-availability of MTX level measuring equipment at the third opposite party no.3. He had admitted in his cross examination that he did not inform PW3 that there was no MTX measuring equipment in the opposite party no.3 hospital. The failure of the first opposite party in informing the non-availability of MTX measuring equipment at the third opposite party hospital prior to the time the patient was admitted, to the complainant his father and PW3 would not amount to obtaining consent rather informed consent.
96. The Supreme Court Samira Kohli Vs Dr.Prabha Manchanda (2008) 2 SCC 1 had dealt with the concept of the consent that is required to be taken by the doctor treating/performing surgery and the condition of the patient at the time of giving her consent as to whether she is conscious and able to pursue the consequences that were explained to her.
97. The Supreme Court summarized the principles relating to consent as follows :
(i) A doctor has to seek and secure the consent of the patient before commencing a 'treatment' (the term 'treatment' includes surgery also). The consent so obtained should be real and valid, which means that : the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.
(ii) The 'adequate information' to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
(iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.
(iv) There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery.
(v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.
Their Lordships observed The basic principle in regard to patient's consent may be traced to the following classic statement by Justice Cardozo in Schoendorff vs. Society of New York Hospital - (1914) 211 NY 125 : 'Every human being of adult years and sound mind has a right to determine what should be done with his body; and a surgeon who performs the operation without his patient's consent, commits an assault for which he is liable in damages."
98. Admittedly, the complainant was residing in US prior to the time his mother was diagnosed with CNS Lymphoma. The complainants relative PW3 is practicing Oncology in America. The complainant made arrangement for getting his mother treated in US where MTX level measuring equipment is very much available which plays vital role in the treatment for CNS lymphoma. The opposite parties had not obtained informed consent from the complainant or PW3 as also from the patient at the time of her admission in opposite party no.3 hospital.
99. Thus it cannot be said that the first opposite party had exercised proper care and due vigilance in administering treatment to the complainants mother during the first chemotherapy cycle stage till she breathed her last when she suffered cardiac arrest for the second time.
100. As noticed hereinabove, the opposite parties failed to undertake the course of action suggested by the authors and the essential steps in DeAngelis protocol.
We are of the opinion that the opposite parties had not exercised due diligence and relevant care in administering treatment to the complainants mother particularly in the circumstances where the patient was prone to high risk of infection due to the nature of disease and the toxic effect of the drug administered.
101. The complainant claimed `75 lakh as compensation and `22 lakh for reimbursement of medical expenditure. At the time of quantifying the amount to be granted as compensation, several parameters have to be considered. The complainant stated that his mother was aged about 54 years at the time of her death and his wife delivered a child and he is deprived of his mothers presence and her love affection as also that his father had lost consortium.
102. The patient was suffering from CNS lymphoma. A cancer patient is prone to high risk and her leading healthy life as also complete span of life is a weighing factor in determining the amount to be awarded as compensation. The negligence on the part of the complainant and his father can be seen from the fact that the complainants father informed the first opposite party a day prior to the day of the patients admission on 3.11.2009 that her TLC count was normal. It is to be considered that the complainants mother has already been suffering from cancer and she is not earning member of the complainants family. The complainant would have incurred the same expenditure for treatment of his mother as she was detected with CNS Lymphoma even if she has not expired. The Supreme Court has considered the circumstances in which compensation has to be granted. It was held that :
We must emphasize that the Court has to strike a balance between the inflated and unreasonable demands of a victim and the equally untenable claim of the opposite party saying that nothing is payable. Sympathy for the victim does not, and should not, come in the way of making a correct assessment, but if a case is made out, the Court must not be chary of awarding adequate compensation. The compensation that we speak of, must to some extent, be a rule of the thumb measure, and as a balance has to be struck, it would be difficult to satisfy all the parties concerned. It must also be borne in mind that life has its pitfalls and is not smooth sailing all along the way (as a claimant would have us believe) as the hiccups that invariably come about cannot be visualized. Life it is said is akin to a ride on a roller coaster where a meteoric rise is often followed by an equally spectacular fall, and the distance between the two (as in this very case) is a minute or a yard. At the same time we often find that a person injured in an accident leaves his family in greater distress, vis- `-vis a family in a case of death. In the latter case, the initial shock gives way to a feeling of resignation and acceptance, and in time, compels the family to move on. The case of an injured and disabled person is, however, more pitiable and the feeling of hurt, helplessness, despair and often destitution enures every day. The support that is needed by a severely handicapped person comes at an enormous price, physical, financial and emotional, not only on the victim but even more so on his family and attendants and the stress saps their energy and destroys their equanimity.
103. In view of the ratio laid in the aforementioned decision and on application of the principles to the facts of the present case we are inclined to award an amount of Rs.7 lakh as compensation to the complainant.
104. In the result the complaint is allowed directing the opposite parties to pay a sum of `7 lakhs as compensation to the complainant together with costs of `10,000/-. Time for compliance four weeks.
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MEMBER Dt.30.01.2013 KMK* APPENDIX OF EVIDENCE WITNESSES EXAMINED For complainant for opposite parties NIL NIL EXHIBITS MARKED For complainant Ex.
A1 Death Certificate of Smt. N. Kamala, date 12.11.2009 Ex.
A2 Admission Card, date 03.11.2009 Ex.
A3 Death Summary (Discharge Summary), date 12.11.2009 Ex.
A4 Initial Assessment sheet, date 03.11.2009 Ex.
A5 Admission Record, date 03.11.2009 Ex.
A6 Consent form for transmission of blood, date 03.11.09 Ex.
A7 Consent form for procedure Surgery, Treatment, Anesthesia High Risk content, date 03.11.09 Ex.
A8 Nursing Assessment & Clinical Chart, date 03.11.09, 04.11.09 & 05.11.09 Ex.A9 Doctors Daily Progress Report, date 03.11.09, 04.11.09 & 05.11.09 Ex.A10 Nurses Chart, date 03.11.09, 04.11.09 & 05.11.09 Ex.A11 Progress Report, date 09.11.09 Ex.A12 Drug chart, date 03.11.09, 04.11.09 & 05.11.09 Ex.A13 Investigation Chart, date 06.11.09,07.11.09 & 08.11.09 Ex.A14 Drug chart, date 04.11.09, 05.11.09 Ex.A15 Non-Drug orders, date 03.11.09, 04.11.09 Ex.A16 Investigation, date 03.11.09, 04.11.09 Ex.A17 Nursing Assessment & Clinical chart, dated 09.11.09 to 10.11.209 Ex.A18 Doctors Daily Progress Report, date 09.11.09 Ex.A19 SOS STAT medication , date 09.11.09 to 12.11.09 Ex.A20 Non-Drug orders, date 09.11.09, 10.11.09, 11.11.09 & 12.11.09 Ex.A21 Investigations, date 09.11.09, 10.11.09, 11.11.09 & 12.11.09 Ex.
A22 Progress Report, date 10.11.09 Ex.A23 Nurses Chart, date 08.11.09, 09.11.09 Ex.A24 Investigation, date 11.11.09 & 12.11.09 Ex.
A25 Intake output chart, date 09.11.09 Ex.A26 Diabetic monitoring chart, date 11.11.09 & 12.11.09 Ex.A27 ECG Reports, date 03.11.09 Ex.A28 Special Monitoring form for Narcotics, date 12.11.09 Ex.A29 Blood Transporter Record form for Narcotics, date 03.11.09 Ex.A30 Special Monitoring form, date 08.11.09 to 12.11.09 Ex.A31 Investigation chart, dated 08.11.09 to 11.11.09 ExA32 Diabetic monitoring chart, date 09.11.09 & 11.11.09 Ex.A33 Investigation sheet, dated 03.11.09 to 07.11.09 Ex.A34 Diabetic Chart, date 06.11.09 to 07.11.09 Ex.A35 Blood component & Transmission Record form, dated 03.11.09 to 11.11.09 Ex.A36 Dialysis Record, dated 09.11.09 Ex.A37 Discharge of Summary, dated 30.10.09 Ex.A38 Admission note, dated 19.10.09 Ex.A39 Authorization for investigation, procedure, treatment & release of information and payment, date 19.10.09 Ex.A40 Chemotherapy consent form, date 28.10.09 Ex.A41 Nursing Assessment & Clinical Chart, date 19.10.09 to 21.10.09 Ex.A42 Doctors Daily Progress Report, date 19.10.09 to 24.10.09 Ex.A43 Nurses Chart, date 19.10.09 to 24.10.09 Ex.A44 Drug Chart, date 19.10.09 Ex.A45 Non-Drug orders, date 19.10.09 to 24.10.09 Ex.A46 Investigation, date 19.10.09 to 24.10.09 Ex.A47 Nursing Assessment & Clinical Chart, date 25.10.09 to 26.10.09 Ex.A48 Doctors Daily Progress Report, date 25.10.09 to 30.10.09 Ex.A49 Nurses Chart, date 26.10.09 to 30.10.09 Ex.A50 Drug Chart, date 19.10.09 to 30.10.09 Ex.A51 Non-Drug orders, date 25.10.09 to 30.10.09 Ex.A52 Investigation, date 25.10.09 to 28.10.09 Ex.A53 Intake output chart, date 23.10.09 to 29.10.09 Ex.A54 Diabetic chart, date 21.10.09 Ex.A55 Provisional Report CT/M & I/NM/V, date 25.10.09 Ex.A56 Family meeting record, 27.10.09 Ex.A57 In house Transfer form, date 27.10.09 Ex.A58 Admission card, date 06.10.09 Ex.A59 Discharge Summary, date 20.10.09 Ex.A60 Admission note & Admission Record, date 06.10.09 Ex.A61 Consent form / Chemotheraphy consent form date 07.10.09 Ex.A62 Nursing statement & clinical chart, date 06.10.09 to 08.10.09 Ex.A63 Doctors daily progress report, date 06.10.09 to 11.10.09 Ex.A64 Nurses chart, date 06.10.09 to 11.10.09 Ex.A65 Drug chart, date 06.10.09 to 11.10.09 Ex.A66 Investigation, date 07.10.09 to 10.10.09 Ex.A67 Prescription of Dr. Rajesh, date 23.09.09 Ex.A68 Prescription of Apollo Hospital, date 11.10.09 Ex.A69 Prescription of Dr. Vijay Anand, date 28.09.09 Ex.A70 Prescription of Dr. Vijay Anand, date 29.09.09 Ex.A71 Prescription of Dr. Vijay Anand, date 24.09.09 Ex.A72 Prescription of Dr. Allok Ranjan, date 23.09.09 Ex.A73 Prescription of Dr. Vijay Anand, date 06.10.09 Ex.A74 Prescription of Dr. S. V. S. S. Prasad, date 19.10.09 Ex.A75 Prescription of Dr. Vijay Anand, date 06.10.09 Ex.A76 Prescription of Dr. Vijay Anand, date 30.10.09 Ex.A77 Whole Body & Brain PET-CT Scan, date 24.09.09 Ex.A78 MRI Brain Spectroscopy with contrast, date 23.09.09 Ex.A79 Histopathology Report, date 06.10.09 Ex.A80 MR Angio Brain Vessels, date 22.09.09 Ex.A81 Bills of Apollo Hospital, date 24.09.09 Ex.A82 Apollo Hospital in patient bills, date 06.10.09 to 11.10.09 Ex.A83 Inpatient Account Deposit Bill , date 19.10.09 to 30.10.09 Ex.A84 Inpatient Account Deposit Bill , date 01.10.09 to 02.10.09 Ex.A85 Inpatient Account Deposit Bill , date 11.10.09 Ex.A86 Inpatient Account Deposit Bill , date 27.10.09 & 30.10.09 Ex.A87 Inpatient Account Deposit Bill , date 28.10.09 Ex.A88 Inpatient Account Deposit Bill , date 06.10.09 to 07.10.09 Ex.A89 Inpatient Account Deposit Bill , date 06.10.09 to 07.10.09 Ex.A90 Inpatient Account Deposit Bill , date 09.11.09 Ex.A91 Receipt of Apollo Hospital, date 15.10.09 Ex.A92 Receipt of Apollo Hospital, date 15.10.09 Ex.A93 Receipt of Apollo Hospital, date 11.10.09 Ex.A94 Receipt of Apollo Hospital, date 30.10.09 Ex.A95 Bill of Lucid Diagnostics, date 14.10.09 EX.A96 Bill of Lucid Diagnostics, date 23.09.09 Ex.A97 Bills of Apollo Pharmacy, date 27.09.09 to 29.10.09 Ex.A98 Bills of Apollo Pharmacy, date 04.11.09 Ex.A99 Bills of Apollo Pharmacy, date 02.10.09 Ex.A100 Details of Apollo Bills, date 03.11.09 to 12.11.09 Ex.A101 Email from S.V.S.S Prasad to Dr Praveen, date 06.10.09 Ex.A102 Ex.A101 Email from S.V.S.S Prasad to Dr Praveen, date 07.10.09 Ex.A103 Email from S.V.S.S Prasad to Dr Praveen, date 07.10.09 Ex.A104 Detail of treatment from CNS Lymphoma, date 07.10.09 Ex.A105 De Angelis Protocol, ate 07.10.09 Ex.A106 Text on medical literature to treat primary CNS Lymphoma, date 07.10.09 Ex.A107 Therapeutic use of High dose Methotrexate, date 07.10.09 Ex.A108 USA MRV Visa Fee Deposit Slip, date 07.10.09 Ex.A109 Journal of Clinical oncology Ex.A110 MPV for CNS Lymphoma For opposite parties NIL ` Sd/-
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