Namrita Diwan And Ors. vs Dharamsheela Cancer Hospital And Research Centre And Ors.

MRS . Anant Verinder Singh, the complainant, (since deceased hereinafter referred to as "Patient") was diagnosed as a patient of Central Nervous System -Non Hodgkin''s Lymphoma (CNS -NHL) in the month of June, 2005. She was given one cycle of methotrexate and two gamma knife radiations. Then she was reviewed by a Tumour Board at the Army Hospital Research and Referral (AHRR) at Delhi Cantt. Depending on the stage of cancer, the Tumour Board, advised the patient for further Chemotherapy by combination of two drugs Rituximab and Temozolamide. The patient, on 30.5.2006, was taken to Dharamsheela Cancer Hospital and Research Centre (DCHRC) where Dr. P.K. Bansal, the Oncologist, reviewed the case, and agreed to treat the patient by administration of combination therapy and radiation as advised by Army Tumour Board. Hence, on 9.6.2006, on the assurance of Dr. P.K. Bansal, the treatment was commenced at DCHRC; but the patient was administered only single drug Temozolamide, which has no role in CNS -NHL. It resulted in weakness and no cure or control of cancer was seen. Thereafter, it was inevitable, and as a life saving measure, the patient was administered radiation. (Annexure -IX and X). The treating doctor had clearly indicated on 11.8.2006 (Annexure -IX) and on 21.9.2006 (Annexure -XI), that the patient would be administered Rituximab. The complainant alleged that, despite written advice and the repeated request by the patient''s attendant/son, the treating doctor deliberately administered only Temozolomide to the patient. The OP doctor stated that the efficacy of this drug was not clinically proven on human beings and OP can choose different line of treatment, other than AHRR Tumour Board. Therefore, the patient was forced to undergo the appropriate salvage treatment of Rituximab at another hospital to control the tumour. Till October 2006, the patient completed three cycles of Temozolomide in OP Hospital, by which she became severely weak and was bedridden with osteoporosis, multi -organ toxicity, neutropenia. Therefore, it was a negligence, professional incompetence, and deliberate mala fide intentional act of the OP. It was a violation of the Hippocratic Oath and an indirect way of performing Ethunasia. Hence, the complaint was filed initially by the patient, but she died during pendency of this case, therefore, her legal representatives (LR), son Mr. Vikram Singh and daughter Mrs. Namrita Diwan, were brought on record. The complainants prayed for total compensation in the sum of Rs. 1,05,00,000 from the OP and also to initiate criminal proceedings under Section 299, I.P.C. against the doctor and treating hospital. In support of their prayer, the complainant produced Annexures I to XI. Defence:

THE OP resisted the complaint by filing written version and respective affidavit evidences. The patient took treatment of Gamma Knife and chemotherapy by Methotraxae form other hospitals and then admitted at DCHRC under the care of Dr. P.K. Bansal. The OP denied that, AHRR Tumor Board advised the combination of two drugs Rituximab and Temozolamide, Tumour Board had not given any such specific prescription for Rituximab and Temozolamide, and about the dosage and/or, duration of treatment. Also, the injection Rituximab was highly expensive (about Rs. 1 lac), having serious side effects and minimum/doubtful utility. Accordingly, OP decided to continue treatment with oral Temozolamide and radiotherapy to brain, and not to use Rituximab. OP denied that use of Temozolomide has no role to play in CNS NHL. However, the OP kept option of using Rituximab in future, if clinical condition, so warranted. As there was no reduction in size of tumour after 3 cycles of Temozolamide, whole brain RT was administered. Post RT, the MRI showed complete resolution of the lesion and the patient was discharged in a stable condition. Therefore, the treatment administered by OP hospital was correct, and there was no negligence. Submissions:

The complainant, Mr. Vikram Singh was present in person, argued the matter and submitted his written arguments also. He reiterated the facts mentioned in his complaint. He further submitted that the treatment given by Dr. P.K. Bansal for CNS -NHL was not correct. The doctor withheld Rituximab unnecessarily, which caused extensive damage and increased sufferings to the patient. Temozolomide is used for treating Malignant Gliomas and Astrocytomas and not for NHL. Therefore, it led to low blood counts and possibility of infection. Hence, it was a serious medical negligence on the part of OP. The Complainant referred to International Prognostic Index; stating that prognosis of NHL depends on the type of such disease at the time of diagnosis. He has made reference to International Prognosis Index which state that, the patient with proper treatment had 73% of 5 years of overall survival rate. But, due to wrong medication her life span was reduced and she survived for only 2 years. He has relied upon authorities of the Hon''ble Supreme Court:

"(a) Samira Kohli v. Prabha Manchanda & Anr., : II (2008) SLT 25 : I(2008) CPJ 56 (SC) : (2008) 2 SCC 1.

(b) Jacob Mathews v. State of Punjab and Anr., : III (2005) CPJ 9 (SC) : VI (2005) SLT 1 : 122 (2005) DLT 83 (SC) : III (2005) CCR 9 (SC) : (2005) 6 SCCC 1."

THE learned Counsel for OP -1 -Dr. M.C. Gupta, vehemently argued that, the OP hospital doctor adopted standard medical treatment, they are not bound to follow the AHRR Tumour Board''s direction. The OP hospital had independent Tumour Board, which took decision on the treatment of said patient, therefore, she was treated with only Temoxzolamide. The Counsel brought my attention to several medical literatures, and the judgments of Hon''ble Apex Court. A recent report in the European Journal of Cancer (Annexure 6) titled as "salvage chemotherapy with Temozolamide in Primary CNS Lymphomas" clearly states that "This is the first prospective trial assessing single agent activity in PCNSL (Primary CNS Lymphoma) at failure, although some patients had a poor PS and had been heavily pre -treated. Temozolomide yielded 26% objective responses and was, well tolerated without any major toxicity." Findings:

PERUSED the medical records which revealed that the patient was suffering from CNS -NHL, treated with gamma knife outside and also received high dose Methotrexate and Cytrabine, which she could not tolerate. At Fortis Hospital, the drug was administered at the instance and by the force of the Complainant, but it was stopped midway because of its toxic effects. It is pertinent to note that, in the span of one year, the patient was treated at various (five) hospitals namely, Apollo, Batra, Vimhans, Dharmshila and Rockland Hospitals, where, they have not administered Rituximab. Then, she was referred to Dharmsheela Hospital (OP) for further management. Interestingly, the unsolved question to my mind is that when the Army Hospital RR prescribed treatment by combination of Rituximab and Temozolamide, why did it not administer AHRR. The recurrence and relapse is known in malignant tumors like CNSNHL. OP had administered Temozolamide in 3 doses, which did not show any response, thereafter as per recommendation of Tumour Board of the Dharamsheela Cancer Hospital (OP) whole brain RT was given to the patient, and the patient responded completely. It is noted that the patient had suffered Bilateral Pulmonary Thombosis which was recorded by Army Hospital on 29.6.2006. Thus, the drug Rituximab was not advisable, which may cause further pulmonary problems. Therefore, I do not find any iota of prima facie evidence of medical negligence. The death of patient was not due to any negligence of OPs. With reference to medical literature, the primary CNS lymphoma is an aggressive tumour, well known for recurrences. It has poor prognosis though it responds well to chemo and radiotherapy, and 3 -4% patients survive up to 5 years. I am of considered opinion that the OPs have treated the patient after the decision of Tumor Board of OP -2 hospital. The report dated 24.8.2007 (Annexure 3), issued by the fact finding committee consisting of highly qualified medical experts, including the former Director of AIIMS, states that "it is well known that Rituximab is a monoclonal antibody recommended for systemic lymphoma, but its role in CNS lymphoma, is not standard. There is no evidence recommending its use in CNS lymphoma, in the literature. The use of Rituximab in brain cancer is very limited because this drug does not cross the blood -brain barrier. It is well known that Rituximab injection can be led to serious and even fatal allergic reactions, such as angioneurotic edema, anaphylactic shock and bronchospasm. The expert opinion of Dr. Meenu Walia (Annexure 7) also supports the view of OP. The Hon''ble Supreme Court observed that if two different valid treatments are available, then a doctor can choose one and it does not amount to negligence. In the case "Achutrao Haribhau Khowa and Others v. State of Maharashtra and Others, : IV (2006) CPJ 8 (SC) : I (1996) CLT 532 (SC) : (1996) 2 SCC 634, it was held as follows:

"The skill of medical practitioners differs from doctor to doctor. The very nature of the profession is such that there may be more than one course of treatment which may be advisable for treating a patient. Courts would indeed be slow in attributing negligence on the part of a doctor if he has performed his duties to the best of his ability and with due care and caution. Medical opinion may differ with regard to the course of action to be taken by a doctor treating a patient, but as long as a doctor acts in a manner which is acceptable to the medical profession, and the Court finds that he has attended on the patient with due care -skill and diligence and if the patient still does not survive or suffers a permanent ailment, it would be difficult to hold the doctor to be guilty of negligence."

Also, it is a well -established principle that if a doctor is duly qualified, possessing ordinary skills and performed his duty to the best of his ability, with due care and caution, then the said doctor cannot be held guilty of medical negligence. The Hon''ble Apex Court in its Judgment in the case Jacob Mathew v. State of Punjab, : III (2005) CPJ 9 (SC) : VI (2005) SLT 1 : 122 (2005) DLT 83 (SC) : III (2005) CCR 9 (SC) : (2005) 6 SCC (1), observed as follows: - -

"Negligence is the breach of a duty caused by omission to do something which a reasonable man guided by those considerations which ordinarily regulate the conduct of human affairs would do, or doing something, which a prudent and reasonable man would not do."

THEREFORE , on the basis of entirety of facts and foregoing discussion, I am of view that Dr. P.K. Bansal, the OP -1, had properly administered the treatment to the patient, with his clinical acumen and experience. It was a reasonable and standard medical practice. I don''t find any negligence on the part of OPs, therefore, the complaint is hereby dismissed. There shall be no order as to costs.