DR. S. M. KANTIKAR, MEMBER
1. This present appeal is filed under Section 19 of the Consumer Protection Act, 1986 against the order dated 8.11.2007 passed by A. P. State Consumer Disputes Redressal Commission, Hyderabad (State Commission) whereby the State Commission dismissed the complaint of the complainant.
2. The brief facts relevant to dispose of this appeal are that the complainant/Shri K. S. Sastry’s wife, Mrs. K. Padmavati (hereinafter referred as ‘the patient’) was suffering from upper abdominal pain and consulted Dr. J. M. Gurunath, OP 3/appellant No. 2 on 10.10.2000 at Appollo Hospital. She was put on drip in the emergency room. OP 3 prescribed two antibiotics without conducting any pre-operative tests. The complainant requested the doctor to administer Norfloxacin 400 mg. as it was administered from 14.10.2000 to 19.10.2000 but without conducting any blood culture tests, the OP stopped Norfloxacin. Thereafter, Dr. Rajneesh, Surgeon/OP 4 examined the patient on 19.10.2000 and advised for gall bladder surgery. Accordingly, the patient was shifted to OP 1’s hospital on 20.10.2000 at about 3.00 p.m.. She was taken for Endoscopic Retrograde Cholangad Pancreotography (ERCP) without the consent of the complainant. While performing ERCP under anesthesia/sedative (injection IV), the patient suffered cardiac arrest/broncho spasm (respiratory arrest). Therefore, the complainant suspected about wrong treatment and hence entered in the room where his wife was unconscious and the doctor was trying to revive her condition. Thereafter, she was shifted to MICU. Dr. Mumtaz Ali, Pulmonologist/OP 5, examined the patient and advised Hydrocortisone 100 mg (IV) for every 6 hours alongwith other drugs. The complainant alleged that inspite of repeated requests made to OP 3 that the patient was already suffering from Intestinal Lung Disease/ILD and under treatment with steroids, the OP 3 without conducting necessary Pulmonary Function Tests (PFT), Arterial Blood Gases (ABG), CT Scan of Abdomen and Hepatobiliary Scan, directly performed for ERCP in a negligent manner. The complainant lodged a complaint with the hospital authorities but there was no avail. The patient was shifted to private room on 28.10.2000 and thereafter on 13.11.2000 due to serious condition of the patient, high risk surgery was performed by OP 4. The patient subsequently developed various complications and died on 24.11.2000. The death summary issued by OP 1/hospital did not reveal treatment details. Therefore, aggrieved by the negligent attitude of OPs, the complainant filed a complaint before the State Commission.
3. The OPs resisted the complaint and denied the allegations made against them. OP 3 stated that all precautionary measures with utmost care and caution was taken during treatment of the patient. There was no deficiency in service on their behalf during pre and post operative period. The complainant was covered under Central Govt. Health Service Scheme, therefore, he is not entitled for compensation.
4. The State Commission after considering the pleadings and evidence partly allowed the complaint holding that there was a negligence on the part of O.P. No. 3 and held O.P. No. 1 being the hospital as vicariously liable for the acts of O.P. No. 3. It directed the O.P. 1 and OP 3 to pay Rs.4,00,000/- towards mental agony to the complainant with interest @ 9% p.a. together with costs of Rs.5,000/-. However, the complaint against the other OPs was dismissed
5. Aggrieved by the impugned order, the OP 1/appellant No. 1 and OP 3/Dr. Gurunath filed the instant appeal.
6. We have heard the arguments from both the parties. Learned counsel Mr. Avneesh Garg, for the OP submitted that the State Commission erred in holding OP 3 for negligence in treating the patient and O.P No. 1 being Hospital for vicariously liable. The counsel for OP further submitted that the intestinal lung disease (ILD) was diagnosed long back by lung biopsy. The PFT has no significance as it will only show a restrictive defect. The OP followed standard procedure after taking informed consent on 20-10-2000 at 3-00 p.m. ERCP was performed by O.P. No. 6. The procedure was continuously monitored by the staff at O.P. No. 1. It is submitted that O.P. No. 2 explained that due to the infection in the gall bladder the lungs also got affected. Hence, immediate gall bladder surgery was inevitable. Regarding culture sensitivity test, counsel relied upon the evidence of Dr. Gurunath in his evidence (chief examination) submitted that since the patient was suffering from acute cholecystitis, it was established by ultrasound scan report of abdomen and blood count showing neutrophilic leucocystosis. Therefore, he prescribed injection Zanocin and injection Amikacin which are the drugs of choice for the disease. Such said drugs were not prescribed in a casual manner as alleged by the complainant. Since, cholecystitis was confirmed diagnosis there was no need to conduct any culture sensitivity tests. The patient responded well to these antibiotics. The condition of the patient was improved with Zanocin and Amikacin. He prescribed Norfloxacin at the request of the complainant instead of Zanocin. Both the antibiotics belong to the same of family drug called Fluoroquinolones. The allegation that the patient was not given the full course of Norfloxacin is only a figment of complainant’s imagination. In fact, after administration of antibiotics, within four days of admission i.e. from 14.10.2000 abdominal pain of the patient decreased. He further submitted that after explaining the line of treatment and after getting oral consent from the complainant, the ERCP for the patient was posted on 20.10.2000.
7. The learned counsel for the complainant, Mrs. K. Radha, vehemently argued that on 11.10.2000 Mrs. K. Padmavati was admitted in M/s Apollo Hospital Limited/Opposite Party No. 1. She had past history of Rheumatoid Arthritis and Interstitial Lung disease (ILD), she was on steroidal drugs for the last 10 years. She was also suffering from Hypertension since three years and diabetes mellitus for one year. Dr. Gurunath was the physical in charge of the patient, he performed ERCP and thereafter Laparoscopic Cholecystectomy. It was performed without pre-operative assessment by pulmonary Function Test (PFT) as suggested by Pulmonologist and Gastroenterologist. He further submitted that before ERCP procedure, it is essential to conduct necessary pulmonary Function Test (PFT) and Arterial blood gases test (ABG), C.T. Scan of Abdomen and Hepatobiliary Scan (HIDA). Thus, OP-3 acted in negligent manner done ERCP and fixed a stent in the common bile duct during the procedure.
8. We have perused the evidence and medical record. Also, perused the AIIMS questionnaire and replies available on file. The crux of instant case is, ‘whether the OP/doctor followed standard of practice while performing ERCP? It is an admitted fact that patient was suffering from Acute Cholecystitis. The ERCP was a high risk procedure, the PFT was necessary as suggested by the Pulmonologist and Gastroenterology. Also, the OP failed to take informed consent. As per medical record, the patient was not willing to undergo such high risk procedure.
9. It is pertinent to note that in the progress sheet (page 63/215 of the file), the clinical notes of Dr. Rajneesh revealed that, the diagnosis of patient was acute Cholecystitis with choleycholiasis. He wrote “ERCP + - ?”. Thus, it is meaning by, if the patient is fit, then only, further management was advised. Similarly on page 65/217, the progress sheet reveals “patient and her husband not willing for surgery immediately”. Thus, in our view, in the instant case it was not an informed consent. Regarding submissions of counsel for the complainant about Culture Sensitivity test, at the first instance, the OP-3 treated the patient with two antibiotics like Amikacin and Zanocin, thus, there was no need to do blood culture test initially. In our view, the patient was empirically given anti-biotics for about 29 days from 10.10.2000 to 8.11.2000. But for long standing infection, it was the duty of reasonable doctor to detect causative organism by Culture and Sensitivity test, thereafter treat the patient accordingly. Secondly, patient was already suffering from long standing ILD and had respiratory compromise. OP-3 failed to follow instructions of Pulmonologist or Gastroenterologist about PFT , thus OP 3 had not followed the standard guidelines before doing ERCP examination.
10. As per medical literature on ERCP, the pre-sedation vital signs and oxygen saturation are to be recorded and made available for comparison. Sedation may lower pre-procedural blood pressure and pulse, often as a result of reduced anxiety. The use of intravenous sedatives and/or analgesics for endoscopy requires continuous intravenous access until the patient has recovered. Regarding cardiac arrest, the allegation of complainant that OP has concealed the cause of death mentioned as cardiac arrest in the discharge summary. The clinical notes revealed, 20.10.2000 at 3.30 p.m. patient developed breathlessness and became unresponsive. The patient was shifted to MICU and ECG revealed RBBB. The patient further became pulseless. The immediate cardiac massage was started in MICU. SP O2 was 91 %, which went on decreasing. According to medical literature from the text books of medicines, those are signs of cardiac arrest, thus complaint’s allegation is not sustainable. In this context we have gone through the opinion of Dr. C. L. Venkatrao, who gave his opinion on the summons of State Commission. It is reproduced as below:
“The patient had undergone an ERCP with stent insertion in CBD following which she developed respiratory depression and bronchospasm and was attended to immediately by the doctors. This is a well known complication in patients suffering from Interstitial Lung Disease. The doctors have taken adequate precautions during the procedure. The stent that was introduced in the CBD, helps in clearing the sludge in the CBD. Later the patient underwent a laproscopic cholecystectomy and has recovered well from the surgery.
In his cross examination, he submitted that during the ERCP procedure when there was cardiac arrest it is the duty of the doctors to mention on the same while recording the ERCP events.
The doctor has used the nomenclature of “unresponsive” and this is equal to cardiac arrest following breathlessness.”
11. It is pertinent to note that ERCP carries higher risk in ILD persons than healthy person. In the instant case, patient had past history of RA, ILD, Fibrosing, Alveolitis, DM and Chronic steroid therapy, He underwent ERCP procedure, without any special consent. As per the evidence on record, before surgery on 13.11.2000, the doctors of OP-1 hospital obtained high risk consent from the complainant by informing bad event that are likely to occur, because of problem of Gall Bladder and Common Bile Duct. The doctors obtained consent for surgery on 11.11.2000 but they did not obtained any such consent for ERCP.
12. It is also pertinent to discuss about the report of medical Board of AIIMS which answered several questions forwarded by this Commission. The relevant questions and answers are reproduced as below:
Question No. 4. Is it proper for a physician to not indentify infection for 30 days and treating patient giving antibiotics at random each for fix days and changing the drug often without knowing the infection and what antibiotics are sensitive to it?
Answer. At times the organisms causing infection are not identified and antibiotics are given empirically till a definite cause of the infection is found. Also, if clinical evidence of infection is present and cultures are sterile antibiotics may have to be changed empirically on the basis of the most likely organism that may be present.
Question No 5. When a biopsy done 10 years ago indicates a lung problem. ILD, should the doctor do a CT scan and PFT first to test the existing condition of the lungs? Or, in any such case, should the physician in charge call a Pulmonologist (Lung Specialist ) to examine the existing condition of the patient before taking any decision.
Answer : If a patient has a known chronic lung disease like ILD an evaluation of the disease status should be done. This may include a CT Chest and a pulmonary function test. Ideally a Pulmonologist should be consulted regarding disease activity and patient’s fitness for any invasive procedure
Question No. 8. When a PFT (Pulmonary Function Test) is prescribed for a patient with history of ILD, is it proper to subject to patient to ERCP without conducting such test?
Answer : If PFT has been prescribed in a patient with ILD, the report should be evaluated before any procedure is done.
Question No. 12. What extra precautions are to be taken before subjecting a patient with Lung Diseases like ILD, to ERCP?
Answer : In a patient with severe ILD, a chest physician should examine the patient and give clearance for the procedure.
Question No. 13. When a patient with ILD is subjected to an ERCP, should the doctor monitor, during the procedure, all vital parameters like heart condition, breathing, pulse rate, blood oxygen saturation etc.?
Thus, from bare perusal of AIIMS replies, it is clear that, the OP-3 failed in his duty of care.
13. We have relied upon catena of judgments on medical negligence from Hon’ble Supreme Court viz Dr. Laxman Balakrishna Joshi vs. Dr. Trimbak Bapu Godbole & Anr. AIR 1969 SC 128, Jacob Mathew vs. State of Punjab & another (2005) 6 SCC 1 and Samira Kohli’s case 2008 (1) CTC. On the basis of foregoing discussion and the entirety , we are of the considered view that it was a case of medical negligence due to failure of duty of care. It was not a reasonable practice. Therefore, we do not find any error in the well reasoned order of the State Commission. Accordingly, the appeal is dismissed. No costs.