ANOOP AWASTHI vs DR. T. KATARIA

In 1954, Lord Denning in Roe v Minister of Health (1954) 2 QB66, said: "We should be doing a dis-service to the community at large, if we were to impose liability on Hospitals and Doctors for everything that happens to go wrong" Complaint:

The complainant, Shri Anoop Awasthi, aged 31 years,(herein referred as a "Patient"), a businessman, qualified electrical engineer, consulted few doctors for tingling and numbness in his

hands and difficulty in walking, in the month of January, 2000. They advised multi vitamins and some treatment. Thereafter, he approached Rajiv Gandhi Cancer Institute, New Delhi/OP 2. On 25.1.2000, CT guided FNAC was performed; it was reported as Metastatic Adenocarcinoma. He was admitted in the hospital/OP 2 MRI and blood tests were advised by Dr. A. K. Vaid and thereafter he was diagnosed as a Cancer patient. On 27.1.2000, CT of Upper Abdomen was conducted, which showed Retroperitoneal Lymphadenopathy, Hepato Splenomegaly with focal lesions in liver. On the basis of those reports, OP-1 gave a fearful picture that the patient would not survive for more than one month. OP-1 put the patient on palliative radiotherapy and started brain radiation from 28.1.2000, for two days. After radiotherapy of brain, patient''s condition worsened with increasing difficulty in speech, walking, standing and required support of two people. A Neurosurgeon named Dr. Usha Nambiar, was called, who, after going through all reports, advised the patient to go for a brain biopsy costing about Rs.65,000/-. The OP/hospital should have conducted PCR tests to diagnose tuberculosis but the OP 2 hurriedly jumped into treatment of Cancer. There are several discrepancies in the discharge summary. The expert committee also failed to take note of several facts like, the OP failed to record past history. Even the FNAC report dated 21.1.2000 did not suggest malignancy in this case, it clearly mentions about "POSSIBILITY OF TUBERCULOS CANNOT BE EXCLUDED". The OPs wasted precious time from 20.1.2000, when the CT was performed showing suspected malignancy " Small Hypodense Lesion in the ? Lobe of liver suggesting deposits." As per true cut biopsy, the OP gave verbal report as known case of malignancy. The OP started radiation, after 8 days of FNAC.

The treatment given at OP/hospital resulted in further deterioration of the condition of patient. Since the wife of patient had doubts, she went to AIIMS on 10.2.2000. The doctors expressed doubts over the diagnosis of cancer. They suggested x-ray, PCR study. The X-ray chest confirmed that the patient was suffering from military mottling predominantly in both lower zones and hilar lympadonpathy, which is suggestive of pulmonary Kochs(TB). The report of AIIMS was that the patient was not suffering from cancer. Therefore, treatment for TB was started and patient was discharged on 6.3.2000, with follow-up instructions. The patient showed improvement in his health.

Therefore, complainant alleged that the OP hospital were negligent in not conducting PCR test and not examined the X-ray properly. OP-1 hurriedly took a decision to treat the patient as a cancer. The patient''s deterioration was due to radiation, which may regain normalcy for more than four to five years. Due to wrongly administration of radiotherapy in the case of tuberculoma of brain, the patient became handicapped and still he is undergoing treatment at AIIMS and consuming costly medicines regularly. Hence, complainant filed the complaint for the negligence and deficiency in service against the OP to the tune of Rs.21,07,104/- alongwith 18% interest. The complainant has filed affidavit evidence, medical record and relevant medical literature on tuberculosis and oncology. Defense:

Dr. Kataria (OP-1) filed his affidavit of evidence. On behalf of OP-2, the affidavit evidence was filed by Dr. Y. P. Bhatia, Chief Executive Officer of the OP/institute. They denied having committed any negligence during treatment of patient. The OP-1 submitted that as per FNAC report, FN/142/2000-RCGI dated 27.01.2000; the patient was investigated as a case of METASTATIC ADENOCARCINOMA. Therefore, based on above report, with signs of cerebral dysfunction and raised intracranial tension, MRI of brain was done. MRI of brain revealed multiple enhancing lesions. The patient had neurological symptoms for a short duration, weight loss and no fever, further no proceeding history of cough, led to clinical diagnosis of a metastatic pathology in the brain. Thus, to prevent further deterioration of neurological status, the complainant was started on cerebral decongestants, anti epileptics and external beam radiation on a palliative basis, of which he received only fractions of each, on 28.01.2000 and 29.01.2000. It is submitted that these steps were taken by the OP-1 in the welfare and interest of the Patient and to avoid further damage.

On 27.01.2000 case of the patient was discussed by the Tumor Board of the OP-2 hospital. Accordingly, it advised True-cut biopsy from the abdominal masses, the tumour markers and ultra sonogram (USG). These were carried out after admission on 28.01.2000 and True-cut biopsy was reported as inadequate for reporting on 29.01.2000. The tumour markers CEA, BHCG, AFP and the USG tests were found to be normal. These tests were carried out to find out the primary site, if any. It was then, on getting confirmed diagnostic results, further schedule of radiotherapy was stopped, immediately and treatment of TB was suggested/ started. (annexure-1). Arguments: We have heard the learned counsel for both the parties.

Argument on behalf of complainants: The learned counsel for the complainant, Shri S. K. Sharma and Shri Updip Singh argued the matter. The complainant was also present in person during arguments. The counsel for the complainant vehemently argued that the opposite parties have not taken proper history. They made wrong diagnosis by FNAC and by CT examination. It was the duty of OP to rule out tuberculosis, before starting the treatment. The FNAC clearly mentioned that tuberculosis cannot be excluded. The OP performed true cut biopsy and gave just verbal report only. The counsel for complainant submitted that the FNAC is a diagnostic test for cancer or TB. Further, the doctor''s at OP institute were negligent in not conducting PCR test and have not examined the X-ray properly, but they came to a hurried conclusion, without any further examination, that the patient was suffering from Cancer, though, it could be TB also. Thus, it was negligence of OP-1, who started cancer treatment, which resulted into deterioration of the condition of the patient. At AIIMS, the doctors re-examined the patient, thoroughly and after conducting a series of tests, diagnosed as "Disseminated Tuberculosis". Patient was kept in the AIIMS for 22 days. After discharge, on 6.3.2000, patient was on treatment of Disseminated TB, for ten months. It showed considerable improvement in the patients health, but due to wrong diagnosis and negligence in treatment at OP Cancer Institute, patient''s health deteriorated, and he suffered mentally and financially.

The counsel further argued that, the discharge summary which is the summation of patient''s treatment. The notes in discharge summary are contradictory to clinical findings of OP doctors. It mentions about diagnosis as a "METASTATIC ADENOCARCINOMA WITH UNKNOWN PRIMARY". The OP-1 started palliative external beam radiation to brain metastasis, from 28.1.2000. The counsel further argued that the medical records are fabricated. The OP issued two discharge cards and there are lot of discrepancies between the 1 and 2 discharge cards. st nd

The 2 discharge card was not issued to the complainant intentionally to conceal two doses of nd radiation. The OP administered radiotherapy without proper and confirmed diagnosis of malignancy, either by tumour markers or confirmed biopsy report. Thus, radiotherapy was unnecessary in the case of patient, who was suffering from tuberculosis. Due to radiotherapy, the patient became immunocompromised. The counsel further argued that the expert opinion from the TMC, Bombay should not be relied upon, because the experts are not competent to opine in this case. The experts are from radiology or radiotherapy department. It should consist of pulmonologist or physician to consider the diagnosis of tuberculosis. The OP failed to conduct diagnostic tests for tuberculosis. Also, he brought our attention to AIIMS report dated 6.3.2000, which reveals that the patient was diagnosed as disseminated tuberculosis involving severely spleen and lungs. Argument on behalf of Opposite parties:

The rival argument advanced by the learned counsel Ms. Mansi Bajaj, on behalf of opposite parties is that there was no negligence at any stage, either from the hospital or from the doctors treating the patient. Counsel further brought our attention to the condition of patient on 27.1.2000, i.e. date of admission to OP hospital. The discharge summary recorded the history of patient as "30 years old male non-diabetic, normotensive came to RGCI with complaints of difficulty in walking, slurred speech and parasthesia from 15 days". The counsel brought our attention to the opinion given by Tata Memorial Centre (TMC), Mumbai.

The counsel further submitted that, the patient concealed his previous illness about Tuberculosis. As, FNAC revealed diagnosis of Metastatic Adenocarcinoma, therefore, to avoid further delay, the OP advised true cut biopsy and thereafter only, started supported palliative radiotherapy. Only two fraction doses of 30 Gy radiation were given, which, as per medical literature, will not cause any harm to the patient. Therefore, as there was no injury to the patient, it was not negligence. Due to the previous health ailments of the patient and as patient was suffering from TB, he was showing signs of tubercular neuropathy. It was not due to 30 gy radiation twice or it will not cause any damage to brain as alleged by the complainant. Findings:

It is an admitted fact that, the Complainant was given only two doses, totalling to 600 units (Cgy) (300 each day for two days i.e. 28.01.2000 and 29.01.2000). It was discontinued from 29.01.2000 immediately, when the relatives of the Complainant, for the first time, brought to the notice of OP doctors about patient''s past history and test report( Annexure-1). We do not accept that the patient became handicapped due to doses of radiotherapy, on 28 and 29 January, th th 2000. We have perused the medical text from textbook of Radiation Oncology Tuberculosis, Tumors of the Brain, Late effects of Cancer Treatment:Radiation and Drug Toxicity. According to it, the tolerance limit of radiotherapy to brain is up to 6000 units (Cgy). Vide Annexure 9, it has been observed that "brain Cells are relatively quiescent and tolerant to irradiation". Medical Text, titled as RADIATION ONCOLOGY, Rationale, Technique, Results (Annexure 10), the relevant text, is reproduced as under:- "No clinical or histological abnormalities were noted after whole brain irradiation with a single fraction 10GY or with 40GY delivered in 20 fractions over 4 weeks". In this case the Patient was prescribed and administered whole brain radiation in view of his clinical presentation. Radiologic findings on MRI and FNAC from abdominal lymph nodes having

been reported as Metastatic Adenocarcinoma. The patient two fractions of whole brain radiation on the protocol from multiple metastases to brain at the rate of 3 Gy/fractions.

It is pertinent to note the symptoms of patient at the time of admission in the OP-2 hospital on 27.1.2000, which are as follows: (i) Difficulty in walking of 30 days duration.

(ii) Paraesthesias half of the body of 15 days duration.

(iii) Slurred speech of 15 days duration.

It clearly goes to show that, in the history sheet, nothing is recorded about past history/illness of the patient. The patient or his family did not disclose the complete history or fever and having cough with expectoration from May, 1999 to the OPs , but it has been admitted by the patient in his complaint. Thus, it was a serious lapse on the part of patient, who is an educated person. It was disclosed by the complainant on 29.01-2000 only. On the same day i.e. on 29.01.2000, even doctors at the OP hospital had confirmed the diagnosis of TB. The OP-1 immediately stopped radiotherapy and started treatment for TB.

We have perused the patient''s reports which show the tests he underwent on 17.1.2000, i.e. prior to approaching the OP. Initially, patient was examined by Dr. Rajesh K. Singh, who investigated him from Ishaan Diagnostics, Dr. Mittal''s Diagnostic Centre. The X ray chest PA view was normal. Therefore, X-ray chest, right lateral was advised. The X-ray chest right lateral view was taken at Mittal diagnostic Centre on 20.1.2000, it revealed a large homogenous opacity in the hilar region, suggestive of enlarged lymph nodes and it was advised ''please correlate clinically, please assess for koch''s and lymphoma. T.B. Elisa, IgM test was performed, it revealed Myco tuberculosis IgG Ab titre 966 units/ml. The ultrasound revealed enlarged retroperitoneal lymph nodes and Mild spleenomegaly at Dr. Mittal''s Diagnostic Centre. FNAC Intra Abdominal Lymphnode was performed which is reproduced as below: "F.N.A.C. INTRA ABDOMINAL LYMPHNODE

REPORT : Fine needle aspirate of intra abdominal paraaortic lymphnode yielded blood mixed aspirate. Smears show low cellularity consisting of mature lymphocytes, plasma cells, immunoblasts, few eosinophils and few collection of histiocytic and epitheliod cells. Some of the smear show benign glandular epithelial cells in sheets and acinar pattern (intestinal glands). Possibility of tuberculosis cannot be excluded, however, due to paucity of adequate cytology material, No conclusive opinion is possible.

ADVISE: Biopsy for histopathological examination."

We have perused the medical record of OP/hospital. The advice on discharge was continued radiotherapy on OPD basis and patient was given steroids in tapering doses. The AIIMS discharge summary reveals that the patient was admitted in AIIMS from 10.2.2000 to 6.3.2000. He was diagnosed as a case of disseminated tuberculosis. His complaint on the date of admission was that he was suffering from fever for one year, cough with expectoration of 10 months,

tingling and numbness for one month, difficulty in walking of 30 days duration and slurred speech for one month. Also, there was neurological deficit. The X-ray chest revealed miliary mottling with right hilar lymphadenopathy. The patient was advised for ATT treatment, it was started on 11.2.2000 for further six months. The condition of the patient showed improvement. The patient spent about Rs.68,295/- as hospital expenditure at opposite party/hospital.

It is pertinent to note that, it is very difficult to diagnose metastatic disease vis-a-vis tuberculomas on the basis of clinical and radiological imaging. For final diagnosis, it needs further serological tests for tuberculosis or a biopsy/ fine needle aspiration from the suspected lesions In the instant case, the clinical symptoms/signs, CT-abdomen, MRI brain and FNAC from the abdominal nodes were suggestive of carcinomatous process. Therefore, OPs started external radiation to avoid further deterioration. The dose of radiation was 30 Gy, it''s not a high dose and was given for two days only. But, at the same time, other diagnostic tests were continued for further investigation and the moment it was diagnosed that the Patient was suffering from T.B., external radiation was stopped forthwith and treatment of T.B. was advised.

As per medical literature, the prognosis of metastatic adenocarcinoma of unknown origin, the expected time of survival will be not more than 6 months. Therefore, the aim of treatment is to control the symptoms and maintain the quality of life of the patient for as long as he is alive. Thus, in our view, the decision of OP-1 was not a negligence.

We do not accept the allegation of complainant that two discharge summaries were issued by OP hospital. The OP doctors had prepared discharge slip of patient on 29.01.2000 at 9.00 am, but not discharged, physically (Annexure 2). In fact, the patient was kept for another 12 hours'' in the hospital, for observation. He was discharged at 9:00 p.m. on 29.01.2000, after final instructions and the billing was done, thereafter (Annexure 3 / DW 2/3). This fact can be seen from the case sheet and records of hospital.

We do not think, the principle of ''Res Ipsa Loquitter'' squarely will apply in the present case. The doctor cannot be held negligent, simply because something went wrong. He will not be liable for mischance or misadventure; or for an error of judgment. He will not be also liable for taking one choice of treatment, out of two or for favouring one school rather than another. The doctor will be only liable when he falls below the standard of a reasonably competent practitioner in his field so much that his conduct might be deserved the censure or inexcusable. We do not find any negligence in the instant case. The radiotherapy was given for two days'', based on preliminary tests. As per medical literature, the chances of survival of patient with the diagnosis of metastatic adenocarcinoma, is less than 6 months. Therefore, it was necessary for doctors to start treatment at the earliest and treat the patient symptomatically, till he is alive.

We have perused the Tata Memorial Centre''s opinion in the instant case. Important text is reproduced as below: "1. Diagnosis of disseminated malignancy and disseminated TB is occasionally challenging in clinical practice.Accuracy of PCR based assays is still a matter of debate.A therapeutic trial of anti-tubercular therapy is also appropriate, which was done subsequently in this case.

In an established histopathological proof of malignancy (Adenocarcinoma in this particular case from abdominal lymph nodes) with brain metatasis, whole

brain radiotherapy to 30 gy/10 fractions is the standard of care.In an occasional case when the histopathological proof is not available, treatment is based on strong clinic-radiological findings (age, extent and sites of involvement, imaging findings, performance score etc.).In a patient with symptomatic brain lesons with a suspicion of a malignancy, time is of essence and appropriate investigations as per the patient''s condition should be as quickly as possible.This has also been appropriately carried out.

Handicapped status is likely to be due to persistence of lesion in the brain stem and previous effects of TB meningitis (at least as per 2003 MRI reports, which is the last report submitted.)Whole brain radiotherapy of 30 Gy/10 fractions is unlikely to cause ataxia, perceived neurological deficits and handicap status ( and less likely if only 2 fractions were given.)

The TMC opinion clearly proves that there will not be any harm to the patient by administration of small doses of radiotherapy ( 30 Gy/10 fractions).

We take a clue from the judgment of Hon''ble Supreme court in Jacob Mathews Case (2005) 6 SCC 1 , wherein it was observed by Hon''ble Supreme Court as under :- "When a patient dies or suffers some mishap, there is a tendency to blame the doctor for this. Things have gone wrong and, therefore, somebody must be punished for it. However, it is well known that even the best professionals, what to say of the average professional, sometimes have failures. A lawyer cannot win every case in his professional career but surely he cannot be penalized for losing a case provided he appeared in it and made his submissions."

In Achutrao Haribhau Khodwa & Others v. State of Maharashtra & Others (1996) 2 SCC 634, the Hon''ble Supreme Court held that, "in the very nature of medical profession, skills differ from doctor to doctor and more than one alternative course of treatment are available, all admissible. Negligence cannot be attributed to a doctor, so long as he is performing his duties to the best of his ability and with due care and caution. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable, if the course of action chosen by him was acceptable to the medical profession.

The Hon''ble Supreme Court in the case Kusum Sharma & Others Vs. Batra Hospital & Medical Research Centre & Others (2010) 3 SCC 480; the bench comprising Hon''ble Justices Dalveer Bhandari and H S Bedi while dismissing the complaint, held that: "Consumer Protection Act (CPA) should not be a "halter round the neck" of doctors to make them fearful and apprehensive of taking professional decisions at crucial moments to explore possibility of reviving patients hanging between life and death." Also said that "Doctors in complicated cases have to take chance even if the rate of survival is low. A doctor faced with an emergency ordinarily tries his

best to redeem the patient out of his suffering. He does not gain anything by acting with negligence or by omitting to do an act," It further observed as, "It is a matter of common knowledge that after some unfortunate event, there is a marked tendency to look for a human factor to blame for an untoward event, a tendency which is closely linked with the desire to punish,"

In para 94 of the said judgment, the Hon''ble Supreme Court had discussed eleven well-known principles in holding the doctor guilty of medical negligence.

In Hucks v. Cole & Anr. (1968) 118 New LJ 469, Lord Denning speaking for the court, observed as under:- "a medical practitioner was not to be held liable, simply because things went wrong from mischance or misadventure or through an error of judgment in choosing one reasonable course of treatment in preference of another. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner, in his field."

No doubt, the OPs failed to make early diagnosis of tuberculosis in this case. Initially, it was diagnosed as Metastatic Adnocarcinoma, and OP started treatment by radiotherapy, as per standard norms. The patient himself concealed past history of cough and fever. We do not find any negligence committed during the treatment of the patient. Thus, we are not inclined to fasten any liability upon OPs for any medical negligence. But, considering the psyche and situation in the instant case, it is certainly shocking to the patient and his family members to know that the patient had cancer. Therefore, in our view, the patient/ complainant deserves to be compensated for mental agony.

Therefore, on the basis of forgoing discussion, we direct the OPs jointly and severally, to pay Rs.2,00,000/- along with interest @6% per annum from the date of filing this complaint, within 90 days from the date of receipt of copy of this order, failing which, the said amount shall carry interest @ 9% per annum, till its realisation. However, there shall be no order as to costs.