Appeared at the time of arguments

For the Complainant       :  Ms. Rupali S. Ghosh, Amicus Curiae          

For the Opp. Parties       : For the Opp. Parties : Mr. Yakesh Anand Advocate

  With Ms. Deepshikha, Advocate for OP-1

  Dr. Vikram for OP-2

  Dr. Bipin K. Dwivedi, Advocate with

Pronounced on:    31 March  2023

ORDER

Dr. S.M. KANTIKAR, PRESIDING MEMBER    

1.       The Present Complaint has been filed under section 21(A)(i) of the Consumer Protection Act, 1986 (for short “the Act 1986”) by  Ravinder (hereinafter referred to as the ‘Complainant’) against the  Opposite Parties   ESIC Hospital & its 2 Doctors  seeking compensation   of Rs.1.04/- Crore  for the alleged act of medical negligence causing  death of Complainant’s mother.

2.       The relevant facts are that, on 22.09.2011 the  Complainant’s mother Hemawati, 59 years of age (since deceased hereinafter referred to as ‘the Patient’)   visited the ESIC Hospital (OP No. 1) for the complaints of  fever  fo a month. She was examined and advised  chest X-ray , Complete Blood Count (CBC) and Sputum examination. The Chest X-ray revealed Pleural Effusion and a cavity in left lung.  The sputum for AFB was negative. The patient consulted Dr. Vikram Vinayak (OP No. 2) a Chest and TB Specialist who prescribed DOTS (TB medicines) for 14 days, however despite consuming medicines, the condition of the patient day by day kept on deteriorating. She further she suffered breathlessness.

3.       Again, on 11.10.2011 X-ray Chest was done, it revealed increase in volume of pleural fluid. The   sputum for AFB test was still negative, but  again for next 14 days prescribed DOTS. On 17.10.2011 the first Pleural aspiration was performed. 5 to 10 ml of pleural fluid was   sent  cytological examination to Dr. Sherry Khanna (OP No. 3). She reported it on 25.10.2011, as negative for malignant cells. It was alleged that the OP No. 2  was on leave and no alternate doctor available in the OPD to show cytology report. Later on the OP No. 2 after going through the cytology report again prescribed DOTS medicines with   cough syrup. On 21.12.2011, the patient was admitted to OP No.1 hospital for complaints of breathlessness and intermittent fever. On 02.01.2012 second pleural aspiration was performed, about 1620ml (3 bottles of 540ml size bottle) of pleural fluid aspirated. Further within one week on, third time pleural aspiration was done on 09.01.2012  and patient was   discharged on 10.01.2012 with advise  to continue  medicines and review in medicine OPD after 2 weeks.

4.       However, within 3 days, again the Patient suffered  breathlessness and  admitted in emergency to Sarvodya Hospital. There, it was diagnosed as massive left pleural effusion with Dyspnea. The left Intra Costal Drain (ICD) was put, IV antibiotics and DOTS were continued. The ICD showed drainage of about 2.5 L of pleural fluid mixed with blood. Thereafter, patient was discharged from Sarvodaya Hospital with a   chest drain tube. Approx. after 7 months, on 16.08.2012, the Patient was referred from General Hospital, Gurgaon to Safdarjung Hospital, New Delhi with complaint of dry cough, mild fever, chest pain for 7 days. The patient was diagnosed as “Bronchogric Carcinoma with B/L malignant pleural effusion with Diabetes mellitus with cranial metastases”. On 30.08.2012 the patient was discharged from Safdarjung Hospital and she expired on 08.09.2012.

5.       The Complainant alleged that the Opposite Parties failed to make correct diagnosis of malignancy and wrongly treated the patient with DOTS though all the test reports and the X-rays have no signs of Tuberculosis. The doctors failed to conduct the biopsy of the pleura to rule out malignancy. Due to delayed diagnosis, the patient died.  Being aggrieved the Complainant filed this Complaint with the following prayer:

1. A compensation of Rs. 82 Lacs against physical damage, pain, and death caused to the patient due to the grave laxity, undue negligence, wrong medications and bogus patho-cytology by the Opponents.
2. A compensation of Rs. 22 Lacs against the mental stress and depression suffered by the applicant and other family members, due to the loss of the above said patient of being their caretaker and head of the family.

Defense:

The Opposite Parties filed their respective Written Versions and denied the allegations of medical negligence.

6.       The Opposite Party No. 1 – ESIC Hospital raised  objections on maintainability of Complaint that an attempt   to bring the Complaint  within the pecuniary jurisdiction of this  Commission, the complaint was filed for claim of more than Rs. 1 crore. The Complaint bad for  non-joinder of necessary/proper party(ies). The entire Complaint is based on the discharge summary issued by the   Safdurjung Hospital with the  findings of  malignant  pleural fluid.   The OP-1 denied any negligence during treatment of the patient. Since the patient showed signs and symptoms of Tuberculosis and even the report of the Chest X Rays were indicative of the same, the DOTS treatment was started and   advised to continue. As the pleural fluid cytology report dated 18.10.2011 was negative for malignant cells,  clinical diagnosis of Tuberculosis was affirmed. The Patient attended OPD for follow-up during September, 2011 to January, 2012.  She was admitted also and underwent  Chest X-ray and various tests. All reports were suggestive of Tuberculosis and negative for malignant cells. Therefore  no treatment for cancer was recommended. The OP No. 1 further submitted that from January, 2012 to August, 2012, treatment details of patient were not available and also he was not sure about DOTS taken or not by the patient.  

7.      The OP -2 Dr. Vikram Vinayak submitted that initially from 22.09.2011 to 17.10.2011 treated with broad spectrum antibiotic and Category I - DOTS treatment. The pleural effusion tapping was done twice 23.12.2011 and 09.01.2012, the cytology report was negative for malignant cells. The patient was elderly, therefore anti-TB treatment (ATT) was started to minimize the discomfort. The patient was given empirical standard treatment as per the policy of Govt of India. , but the patient did not come for follow-up after January 2012.

8.       The OP-3 –Dr. Sherry Khanna of Pathcare (P) Ltd. raised objections on maintainability of the Complainant and submitted that the Complainant is not consumer qua him. The OP-3 submitted that the Complainant was wrongly trying to compare the report dated 17.10.2011 issued by him with the report issued by Safdarjung Hospital on 26.08.2012. The test done at Safdarjung Hospital was after a gap of nearly one year.  

Arguments:
We have heard the arguments from the learned Counsel for both the sides. Perused the material on record, inter alia, the Medical Record and gave our thoughtful consideration.

9.       Arguments on behalf of Complainant:

The learned Counsel for the Complainant reiterated the facts and evidence. He submitted that all Chest X-ray reports, pleural fluid cytology and Sputum were negative for TB. The Adenosine Deaminase (ADA) level was less than 40, it also ruled out Tuberculosis. Therefore the patient was wrongly diagnosed as Tubercular Pleural Effusion and for 113 days DOTS was given in OP no. 1 hospital. The doctors would have conducted the pleural biopsy to rule out malignancy /tuberculosis.  He also submitted that at the time of discharge from the hospital, the OP no. 1 and OP no. 2 have made contradictory statements with regard to the patient’s medical condition. The treatment of ATT was continued; therefore Cancer remained undiagnosed and untreated. The patient suffered continuous pain till her death. She died of cancer in September 2012. The OP No. 2 has failed to diagnose the real cause for the Pleural Effusion, but treated continuously for TB.   

10.     Arguments on behalf of Opposite Parties:

The learned Counsel for the Opposite Parties reiterated their evidences.  Dr.Vikram (OP-2) was present in person. They have filed the medical literature, National guidelines on Tuberculosis and few judgments of Hon’ble Supreme Court and this Commission.

11.     The crux of the instant case is whether the diagnosis of tuberculosis was wrong and OP-2 failed to diagnose malignancy in the instant case.

i)       From the medical record with pleadings and evidence, we note that the patient was examined in OPD by OP-2  at ESI Hospital (OP-1). The clinical presentation was suggestive of TB, therefore DOTS-I was advised. Further, OP-2 tapped the Pleural Fluid  and the cytology was reported by the Pathologist (OP-3) at Pathlab as negative for malignant cells. It supported the diagnosis of TB. Thus, the doctors at OP-1 continued with DOTS-I treatment, the patient was treated as per the standards. Thereafter, she was admitted in the OP-1 Hospital from 21.12.2011 till 10.01.2012. The pleural effusion was tapped regularly. At the time of discharge, patient was categorically advised to come for follow-up after 2 weeks to OP No -1, but she  chose to go to a private hospital - Sarvodaya Hospital and there also diagnosed and  treated for TB during 13.01.2012 to 20.01.2012. 

 ii)     Admittedly, after a gap of 8 ½ months from the discharge from OP-1, the patient had gone to Safdarjung Hospital and the pleural effusion  was diagnosed as a malignant pleural effusion. The Complainant just relied upon the discharge slip of Safdarjung Hospital   that the OPs were negligent for wrong diagnosis and treatment. The complainant in his support merely produced internet printouts, not brought any opinion from medical expert to prove negligence of OPs. 

12.     We have gone through various literatures on diagnosis and treatment of Tuberculosis from the standard Medicine, Pathology textbooks, from WHO manuals. Perused the National guidelines for treatment of tuberculosis.  

13.     A pleural effusion is an excessive accumulation of fluid in the pleural space. It can pose a diagnostic dilemma to the treating physician because it may be related to disorders of the lung or pleura, or to a systemic disorder. Patients most commonly present with dyspnea, initially on exertion, predominantly dry cough, and pleuritic chest pain. To treat pleural effusion appropriately, it is important to determine its etiology. However, the etiology of pleural effusion remains unclear in nearly 20% of cases. Thoracocentesis should be performed for new and unexplained pleural effusions.

14.     The Tuberculous pleuritis is a common manifestation of extra pulmonary TB. It is the most common cause of pleural effusion in many countries. Conventional diagnostic tests, such as microscopic examination of the pleural fluid, biochemical tests, culture of pleural fluid, sputum or pleural tissue, and histopathological examination of pleural tissue, have known limitations.  The gross appearance of the pleural fluid may suggest a particular cause. For example, turbidity of the pleural fluid can be caused either by cells and debris (i.e., empyema) or by a high lipid level (i.e., chylothorax). A uniformly blood-stained fluid narrows the differential diagnosis of the pleural effusion to malignancy, trauma (including any recent cardiac surgery), pulmonary embolism, and pneumonia. 

15.   Several factors influence the diagnostic potential of pleural fluid cytology[1]- [2]. The sensitivity of pleural fluid depends primarily upon the free floating malignant cells. These features, however, may not be present, either with a malignancy that does not shed off malignant cells in to the pleural fluid, or a malignancy that is largely necrotic and releases cells that are non-diagnostic. The extent of spread of malignancy is also very important. If a malignancy is confined up to the visceral pleura, both pleural fluid as well as closed needle biopsy (FNAB) of parietal pleura will fail to obtain diagnostic samples from malignant lesion, leading to false negative results. Reactive mesothelial cells pose a major problem during pleural fluid analysis. However,  a large, refractory pleural effusion, whether a transudate or exudate, must be drained to provide symptomatic relief. Management of exudative effusion depends on the underlying etiology of the effusion.  

16.     In the instant case the pleural fluid cytology study did not reveal malignant cells. The pleural fluid reports dated 23.11.2011 and 9.1.2012 from Dr.Khanna’s Pathcare were reported by pathologist (OP-3). The cytospin smears from fluid were prepared and found mature lymphocytes and reactive mesothelial cells.  There was no evidence of malignant cells. It is pertinent to note that 10 months later on 26.08.2012 the pleural fluid cytology done at Safdarjung hospital was suspected as malignancy. In our view, it was neither wrong diagnosis nor failure of duty of care from the OPs. The treating doctor, based on clinical findings and cytology report treated the patient for tuberculosis.

17.     The treatment of DOTS-I advised by OP-2 was as per reasonable standard of treatment in TB patients[3]. If there is no microbiological evidence of tuberculosis in an ill patient with a pyrexia of unknown origin, even if the chest film is normal and the tuberculin test negative, a therapeutic trial of specific antituberculosis chemotherapy is indicated and this should be started whether or not biopsies of liver and bone marrow have been taken for culture of acid fast bacilli[4] (AFB). It was also mentioned that no patient with pyrexia of unknown origin, particularly those who are elderly, immunosuppressed or immigrants, should be allowed to deteriorate and die undiagnosed without having such a trial of antituberculosis therapy.

18.     The reliance be put on the observations made by Hon’ble Supreme Court in the case of Vinod Jain vs. Santokba Durlabhji Memorial Hospital & Anr.[5], which are reproduced as below:

9. A fundamental aspect, which has to be kept in mind is that a doctor cannot be said to be negligent if he is acting in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art, merely because there is a body of such opinion that takes a contrary view (Bolam v. Friern Hospital Management Committee [Bolam v. Friern Hospital Management Committee, (1957) 1 WLR 582 : (1957) 2 All ER 118 (QB)] ). In the same opinion, it was emphasised that the test of negligence cannot be the test of the man on the top of a Clapham omnibus. In cases of medical negligence, where a special skill or competence is attributed to a doctor, a doctor need not possess the highest expert skill, at the risk of being found negligent, and it would suffice if he exercises the ordinary skill of an ordinary competent man exercising that particular art. A situation, thus, cannot be countenanced, which would be a disservice to the community at large, by making doctors think more of their own safety than of the good of their patients.

10.  This Court in another judgment in Jacob Mathew v. State of Punjab [Jacob Mathew v. State of Punjab, (2005) 6 SCC 1 : 2005 SCC (Cri) 1369] dealt with the law of negligence in respect of professionals professing some special skills. Thus, any individual approaching such a skilled person would have a reasonable expectation of a degree of care and caution, but there could be no assurance of the result. A physician, thus, would not assure a full recovery in every case, and the only assurance given, by implication, is that he possesses the requisite skills in the branch of the profession, and while undertaking the performance of his task, he would exercise his skills with reasonable competence. Thus, a liability would only come, if:

(a) either the person (doctor) did not possess the requisite skills, which he professed to have possessed; or

(b) he did not exercise, with reasonable competence in a given case, the skill which he did possess.

18. We appreciate the pain of the appellant, but then, that by itself cannot be a cause for awarding damages for the passing away of his wife. We have sympathy for the appellant, but sympathy cannot translate into a legal remedy. We cannot fault the reasoning of the NCDRC. Thus, the result is that the appeal is dismissed, leaving the parties to bear their own costs.

19.     To conclude, the treating doctor OP-2 acted in accordance with accepted practice and guidelines. He is a Chest and TB Specialist, possesses requisite skills and reasonable competence in the treatment of TB.  In our considered view, no negligence is attributable to the hospital or treating doctor and the pathologist. The Complainant failed to prove his case. 

The instant Consumer Complaint is dismissed. The Parties to bear their own costs.