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
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
Counsel for the complainant
Counsel for the opposite parties
QUORUM:
SRI THOTA ASHOK KUMAR, HON’BLE MEMBER
Oral Order (As per Sri R.Lakshminarasimha Rao, Hon’ble Member)
1.`75,00,000/- and for reimbursement of medical expenses of`22,00,000/- and costs of the proceedings.
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11. th48. 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.
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38. st ststopposite party too, once or twice during the course of his wife’s 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.
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i) Whether there was deficiency in service on the part of the opposite parties in administering treatment to the complainant’s mother?
ii) To what relief?
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Leucovorin 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 –
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]
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Primary central nervous system lymphoma is usually a B-cell lymphoma that arises within and is limited to the central nervous system (CNS) (1).
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
§ Patient’s neurocognitive function.
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.
The development of successful systemic chemotherapeutic regimens to treat PCNSL has been the focus of recent therapeutic advances for the past 15 years.
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.
Contraindications
Complications
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 0) . 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
High –dose methotrexate is frequently an expensive treatment necause it usually involves hospitalization for a minimum of 4 days to manage the vigorous hydration
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:Contraindications:
Main drug interactions: None
Main side effects:Acute chemical meningitis, seizure, myelopathy when
Cost effectiveness: These drugs at this dosage are relatively inexpensive.
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
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.
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53. The PH level of patient was less than 7 at the time Mabthera 900mg, Zofar 100ml, Methotrexate 4600gms was administered.
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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
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
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68. 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 patient’s 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.
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Ms.Kamala Nagi did not receive adequate hydration before and after the 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 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.
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“I am Dr.hari Kalla, a Medical Oncologist in Abilene, TX, USA.
I think she did not receive adequate medical care.
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
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“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”.
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“ Obviously patient was not given adequate neupogen shots before neutropenia became profound and prolonged.
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“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.
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Q. Do you say that patient was not acidic during the course of the treatment?
Ans: Yes
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Admittedly, I am not conducted urine pH test of the patient before/during/after the 2nd
In my judgment checking urine pH levels was not necessary.
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Ans. 875 ml.
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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
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“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.”
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“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.”
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1. Martin D’Souza 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
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“A charge of professional negligence against a medical man was serious.
82. In CP Sreekumar’s case (supra) the Supreme Court referred to the guidelines laid down in Jacob Mathew’s decision in regard to the medical negligence of a treating doctor.
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
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It is interesting and of relevance to note that the 1st rd rd stopposite party.
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“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.
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Chemotherapy drugs kill not only cancer cells but also the actively proliferating cells like the blood cells (while cells, red cells and platelets).
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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.
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.
c) Serum creatinine> Serum creatinine should be checked daily. .
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(i)
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Their Lordships observed
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99. Thus it cannot be said that the first opposite party had exercised proper care and due vigilance in administering treatment to the complainant’s mother during the first chemotherapy cycle stage till she breathed her last when she suffered cardiac arrest for the second time.
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101. `75 lakh as compensation and`22 lakh for reimbursement of medical expenditure.
102. The negligence on the part of the complainant and his father can be seen from the fact that It is to be considered that the complainant’s mother has already been suffering from cancer and she is not earning member of the complainant’s family.
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
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104. `7 lakhs as compensation to the complainant together with costs of`10,000/-.
KMK*
APPENDIX OF EVIDENCE
For complainant
NIL
For complainant
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Ex.A68 ApolloHospital, date 11.10.09
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Ex.A81 ApolloHospital, date 24.09.09
Ex.A82 ApolloHospital
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Ex.A91 ApolloHospital, date 15.10.09
Ex.A92 ApolloHospital, date 15.10.09
Ex.A93 ApolloHospital, date 11.10.09
Ex.A94 ApolloHospital, date 30.10.09
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For opposite parties
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