Pronounced on: 1^st June 2022

ORDER

DR. S. M. KANTIKAR, PRESIDING MEMBER

The facts:

1.       On 28.04.2012, the Complainant Nirmala’s husband K. T. Prasad about 39 years (since deceased, for short the ‘patient’), for his upper abdominal pain, was admitted in M/s Apollo Hospital Enterprises Ltd. at Chennai (for short, ‘OP-1 / Apollo Hospital’). The Gastroenterologist, Dr. Ubal Dhus, (OP-2) examined the patient, CT scan abdomen and the routine investigations were done.  The Radiologist, OP-3 reported CT scan as “pancreas appears swollen with suboptimal parenchymal enhancement particularly in the body and the tail and small area of necrosis infection at neck of pancreas etc”. CT findings were suggestive of acute pancreatitis with diffuse fatty infiltration of liver. It was alleged that the radiologic findings of necrosis (dead cells) was ignored by the OP-2, thus he failed to detect suspected cancer. The patient remained in the hospital for six days and discharged on 03.05.2012 with an advice to come after six weeks. On 16.06.2012, the patient was examined by the OP-2 and diagnosed as Erosive Gastritis. Again on 21.01.2013 the patient was admitted to Apollo Hospital with the complaints of severe upper abdominal pain.  The CT scan of abdomen was done on 22.01.2013. The complainant alleged that despite certain CT findings, the OP-2 casually treated the patient for a week and discharged on 29.01.2013. The patient was dissatisfied with the treatment at Apollo Hospital consulted Dr. K. Nageshwar Reddy at Asian Gastroenterology Hospital, Hyderabad. Again an urgent CT Scan of abdomen was done and the films were compared with earlier CT scan done at Apollo Hospital. The doctors therein (Oncologist & Surgeon) opined that surgical treatment was not possible due to advanced pancreatic cancer. Therefore, Dr. K. Nageshwar Reddy suggested the patient to go to USA for further advanced treatment. In the meantime, the patient sought a second opinion from an internationally reputed surgeon Dr. Kendrick at Mayo Clinic in Rochester, USA. He verified all CT films & reports and opined the same that operative management was not possible. Finally, the patient took treatment at Institute of American Oncology at Hyderabad under Dr. K. N. Reddy for some days. Thereafter, he went for one month at Global Hospital, Bangalore for his liver ailment from 01.07.2013 to 02.08.2013 as in-patient. Thereafter, the patient was again taken to OP-1 Hospital on 03.08.2013 and admitted in the ICU for three days. The doctors expressed their helplessness due to the deteriorating condition of the patient. Lastly, the patient was taken to his native place and admitted in Mother Hospital at Tirupathi, wherein he expired on 07.08.2013. The Complainants alleged that the patient could be saved if properly diagnosed and operated at the initial stage only (i.e. before 16.06.2012). The death of the patient was due to carelessness and negligence of the hospital and the treating doctors. The Radiologists were casual and gave opinion negligently as mild pancreatitis. The Radiologists made two arrow marks to indicate two small tumors which subsequently developed to an un-resectable Pancreatic tumor (Adenocarcinoma). The OPs have violated the national and international guidelines for treatment of pancreatitis and pancreatic cancer. The OP-2 failed to perform biopsy and other tests to confirm the Pancreatic Cancer and also, failed to take an expert opinion. Being aggrieved, the Complainant filed a Complaint against the OP-1 Hospital and the treating doctors - the OPs 2 to 5 for alleged medical negligence causing death of her husband and prayed compensation of Rs. 10 crores with other relief.

Defense:

2.       The OPs filed their written versions and denied any negligence during treatment of the patient. It was submitted the OP-2 examined the patient having epigastric tenderness. The clinically it was diagnosed as acute pancreatitis possibly ethanol related. The patient was thus advised admission and ordered further blood investigations and CT Scan abdomen. Based upon the BISAP score (bedside index for severity in acute pancreatitis) and Ranson’s score the condition of patient clinically classified as mild pancreatitis. The OP-3 was a Radiologist who works as a Consultant and not an employee of the OP-1 Hospital. During follow-up the patient visited the hospital on 16.06.2012, he was completely recovered from pancreatitis and his physical examination was normal. The patient only complained of food stuck in the throat, therefore esophagogastroduodenoscopy(OGD) was performed and medicines were prescribed. 

3.       The CT scan report dated 30.04.2012 revealed a small area of necrosis   at the neck of pancreas and   suggestive of acute pancreatitis with diffuse fatty infiltration of liver. OP-2 denied that it was necrotizing pancreatitis i.e. severe acute pancreatitis. The OP-3 submitted that a CT Scan can differentiate tumour from the necrosis. There was no evidence or any suspicion of tumour from the CT Scan ( dtd 30.04.2012). The necrosis was found in the neck of the pancreas in a small area i.e. 10 mm to be precise. The necrosis was morphologic changes due to tissue cell death i.e. progressive degenerative changes. 

4.       Thereafter, on 21.01.2013 (after 9 months) the patient approached the OP hospital with complaints of severe epigastric pain for 15 days, which was radiating to back, and history of weight loss. The records revealed the patient was recently diagnosed as diabetic and had stopped smoking for about a month back. The patient also had a history of alcohol consumption. Again, the second CT scan was done on 22.01.2013 which was suggestive of carcinoma head of pancreas. On 29.01.2013 CT guided biopsy was suggested, but the patient requested for discharge against the medical advice (AMA).  Thus, it conclusively does not establish suffering from cancer from 30.04.2012.

Arguments:

5.       We have heard the arguments from the learned Counsel on both the sides, perused the entire medical record including the CT scan and other investigation reports. The learned Counsel for Complainant reiterated the entire facts. He submitted that as per the medical literature Acute Pancreatitis with necrosis must be treated with antibiotics and/or surgical removal of necrotic area. However, the treating doctors did not give antibiotics but the medicines were given just to reduce abdominal pain. They were negligent and failed detect the real cause of acute pancreatitis. The weight loss is an important symptom in acute pancreatitis as well as in cancer. The OP-2 admitted that the patient had experienced discomfort and weight loss at the end of year 2012.  In January, 2013 for 2^nd time the patient was admitted in OP-1 hospital. He lost weight about 16.8 kg since 28.04.2012. Initially the OP-2 casually and just on the basis of OGD diagnosed it as ‘erosive gastritis'. The learned Counsel submitted that the Mayo Clinic opined about cancer was so far not treated but diagnosed in January, 2013.

6.       The learned Counsel relied upon medical literature viz. A booklet by Mayo Clinic patient education on pancreas, a booklet on cancer of the pancreas published by National Cancer Institute, US Department of Health and Human services and a booklet on an over view of pancreatic cancer (USA). He further relied upon few judgments of Hon’ble Supreme Court and this Commission viz.

1. Bhajanlal Gupta vs. Mulchand Kharati Ram Hospital,2001(1)CPR 45 (NC)  
2. Deepak vs. Balakrishna and others, 2011 CTJ – 181 (NC);
3. Baby Akanksha vs. Kukrej Nursing Home and
4. Harkant Walljit Singh Jain vs. Gurubox Singh 2003 (1) CTJ – 153
5. V. Krishna Rao vs. Nikhil Superspecialty Hospital; AIR 2002 SC 2931  
6. Dr J. J. Merchant and others vs. Srinath Chaturvedi,
7. District Co-op. Central Bank vs. T. Rajeswari,  2004 (2) CTJ 175
8. K. S. Bhatia vs. Jeevan Hospital; Harloveleen Kaur 2005 CTJ 60 
9. B. B. Santha Vs. Cosmopolitan Hospital, Hyderabad, 1997(1) CTR – 371
10. Aparna Datta vs. Apollo Hospitals Enterprises Ltd.;
11.  Smt. Rekha Gupta vs. Bombay Hospital Trust, 2003 (2) CPJ – 160.

7.       The learned Counsel for Opposite Parties vehemently argued that the Complainants have to prove their case alleged negligence or deficiency during treatment with the help of sufficient evidence. The Complainants have not produced any expert report to substantiate their allegations.  He relied upon the decision of Hon’ble Supreme Court in the case   Nizam’s Institute of Medical Sciences Vs. Prasanth S. Dhanaka & Ors[1].  which held that  the initial burden of making out a case of medical negligence lies on the claimant who alleges medical negligence. The Counsel further submitted that it was misconception that the Complainants were confused with the necrosis as tumour. The summary of Mayo Clinic, USA in any way does not point out any negligence or deficiency of service on the part of the OPs.

8.       He further argued that the necrosis picked up in the CT Scan Report dated 30.04.2012 was not tumour or cancer. During CT with IV contrast (dye) the tumours show enhancement or become bright in scan. Areas with necrosis will not take up the injected contrast/dye because the necrosed dead cells have no blood supply.  Radiologicaly, if such area in the pancreas measures less than 50 HU, then it was confirmatory of necrosis. In the instant case, the HU value was 34, therefore it was necrosis but not a tumour/cancer. It was not a case of severe necrotizing pancreatitis because the other areas of pancreas did not show any necrosis.

9.       He further submitted that the patient was advised by an Oncologist to undergo cervical lymph node biopsy or open biopsy of pancreatic mass. Accordingly on 27.01.2013 the patient was seen by liver transplant team for the feasibility of surgery with the plan to do either laparoscopy or open biopsy. The CT guided biopsy was planned on 29.01.2013. However, the patient requested for a discharge and went against the advice of the OP-2. 

Observations & Reasoning:-

10.     The main issue is whether the Radiologists (OP-4 and 5) failed to diagnose the pancreatic cancer at initial stage in May 2012.

11.     From the medical record it is evident that on 28.04.2012, clinically the patient was diagnosed as ‘Acute Mild Pancreatitis’ with necrosis at the neck of the pancreas. The CT scan films dated 28.04.2012 and 03.05.2012 were reviewed by both the Radiologists and reported it as suggestive of “Acute Pancreatitis with diffuse fatty infiltration of liver”. The pancreas appears to be swollen with suboptimal parenchymal enhancement, particularly in the body and tail and a small area of necrosis at the neck of pancreas. It is pertinent to note that the patient had difficulty in swallowing solid food on 16.06.20212, but no abdominal pain or loss of weight.  His weight was 87 kg and at the time of discharge weight was 89 kg. The OGD showed erosive gastritis and the patient was called for review if the symptoms recur.

12.     On 22.01.2013, the patient again underwent CT abdomen, which showed mass in the body of pancreas; adherent to porto-mesentric confluence, celiac and common hepatic artery. The patient underwent Endoscopic Ultrasound (EUS) guided FNAC on 24.01.2013 and also celiac ganglion block was given for the pain. However, the FNAC report date 25.01.2013 was inconclusive due to scanty sample. We further note that the patient K.T. Prasad, after being discharged from the OP Hospital on 29.01.2013, was periodically hospitalised in different hospitals in Hyderabad till 30.06.2013, viz. Asian Institute of Gastroenterology and American Oncology Institute, Citizens Hospital. Thereafter, he was admitted in BGS Global Hospitals at Bangalore from 01.07.2013 till 02.08.2013.  Then, he came back and got admitted to the OP Hospital on 03.08.2013, but by that time he was in advanced stage of cancer. He was in shock with kidney failure. The poor prognosis was explained. The patient was once again got discharged AMA from the OP Hospital. And got admitted near to his native in Mother Hospital at Tirupati on 05.08.2013, but he died there on 07.08.2013.

13.     During the proceedings before this Commission, we sought an opinion from the Medical Board of AIIMS from the Experts. The Board in its report dated 15.01.2021 ruled out the possibility of Pancreatic Malignancy. The sequence of events is recorded by the board are as below:-

1.       April 2012 – The patient, a 38-year-old male, presented to OP-1 on 28.04.2012, with acute pain in abdomen with history of regular alcohol intake and no history of diabetes. He was subsequently admitted the same day, upon investigations his serum amylase and lipase level were found to be increased. The CT scan imaging (30.04.2012) also showed features consistent with the diagnosis of acute mild pancreatitis. Thereafter, he was diagnosed and treated as mild acute pancreatitis and discharged post recovery on 03.05.2012.

2.       June 2012 – On the routine follow up visit, he complained of dysphagia and underwent endoscopy which showed gastritis and was treated for the same.

3.       November 2012 – He again developed pain in abdomen but did not follow up at OP-1 and was also diagnosed to have Diabetes Mellitus (no exact details available in files).

4.       January 2013 – He had another episode of acute abdominal pain and weight loss. Further investigations were performed including CT Scan, wherein imaging features were suggestive of locally advanced pancreatic cancer with vascular encasement. Subsequent tests and biopsy confirmed the diagnosis of pancreatic cancer.

Based on the sequence of events in the available records, and discussions between the members of the board the Medical Boards has opined as followed:

          The initial clinical presentation, age of the patient, history of alcohol consumption along with negative history of diabetes mellitus as well as radiological Imaging of the patient are consistent with the diagnosis of mild acute pancreatitis, and there were no symptoms or any radiological findings that were suggestive of possible pancreatic malignancy at that point in time (April 2012 – June 2012).

The Complainant filed objections to the report of Medical Board of AIIMS and same were replied by the OP-2. 

14.     We gave our thoughtful consideration to the arguments of the learned Counsel by both sides. As per the Bolam’s Principle[2], 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. 

15.     We would further like to rely upon few judgments on medical negligence from the Hon’ble Supreme Court. In the case of Achutrao Haribhau Khodwa Vs State of Maharashtra[3], it has been held that:

“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.”

In another case of Samira Kohli vs. Dr. Prabha Manchanda & Anr.[4], it was held that:

“it is for the doctor to decide, with reference to the condition of the patient, nature of the illness and the prevailing established practices as to how much information regarding the risk and consequences should be given and how they should be couched in the best interest of the patient. A doctor acting accordingly with normal care and in accordance with a recognized medical practice cannot be said to be negligent merely because body of opinion taken a contrary view. In modern medicine and surgery dissection of the various things a doctor has to do in the exercise of his whole duty of care owned to his patient is neither legally meaningful nor medically practicable.”

16.     The Hon’ble Supreme Court in Kusum Sharma & Ors. v. Batra Hospital and Medical Research Centre and Ors.[5]; discussed the breach of expected duty of care from the doctor,  if not rendered appropriately, it would amount to negligence.  It was held that, if a doctor does not adopt proper procedure in treating his patient and does not exhibit the reasonable skill, he can be held liable for medical negligence.

17.     Based on the discussion and from the entire evidence on record, inter alia, opinion of Expert medical board of AIIMS, the precedents; in our considered view, the OP-2 treated the patient as per the reasonable standard of practice and we do not find failure of standard duty of care. The Complainant has failed to conclusively establish deficiency / negligence on the part of the treating doctors or the hospital.

Accordingly, the Complaint fails, and is dismissed.