National Consumer Disputes Redressal
Irene Pais vs Dr. Anil Pinto & Anr. on 14 August, 2015
NATIONAL CONSUMER DISPUTES REDRESSAL COMMISSION NEW DELHI FIRST APPEAL NO. 327 OF 2009 (Against the Order dated 15/04/2009 in Complaint No. 305/1998 of the State Commission Maharastra) 1. IRENE PAIS S/o Late Mrs. Irene Winifred Pais, R/o 18/B/205, Zenith CHS, Bhavani Nagar, Marol, Mumbai - 400 059 Maharastra. 2. Mrs. Dorothy Cecelia Pais Daughter-in- law of Late Mrs. Irene Winifred Pais, R/o 18/B/205, Zenith CHS, Bhavani Nagar, Marol, Mumbai-400 059, Maharastra. ...........Appellant(s) Versus 1. DR. ANIL PINTO & ANR. Denisandra, Gokhale Road North, Dadar Mumbai - 400 028 2. HOLY FAMILY HOSPITAL Trustees, St. Andrews Road, Bandra Mumbai - 400 050 3. LIC OF INDIA - ...........Respondent(s)
BEFORE: HON'BLE MR. JUSTICE D.K. JAIN, PRESIDENT HON'BLE MRS. M. SHREESHA, MEMBER For the Appellant : For the Appellants : Ms. Manisha Ambwani, Advocate For the Respondent : For the Respondents : Mr. Santosh Paul, Mr. Arvind Gupta and Ms. Swati Singh, Advocates Dated : 14 Aug 2015 ORDER D.K. JAIN, J., PRESIDENT
1. This First Appeal, under Section 19 of the Consumer Protection Act, 1986, (for short "the Act") is directed against the order, dated 15.04.2009, passed by the Maharashtra State Consumer Disputes Redressal Commission, at Mumbai (for short "the State Commission") in Complaint Case No. 305 of 1998. By the impugned order, the State Commission has dismissed the Complaint, alleging medical negligence against the Respondents, Opposite Party No.1 and 2, respectively in the Complaint.
2. Succinctly put, the facts giving rise to the present Appeal, as culled out from the Complaint, are as under:-
2.1 The Complainant was the mother of Alfred Pais (hereinafter referred to as "the Patient"). In the month of August 1997, the Patient experienced pain in the upper abdomen, for which he consulted, one Dr. Robin Pinto, a Cardiologist. He advised the Patient to undergo a Sonography. The test revealed a stone in the gallbladder. In order to have an expert opinion, in August 1997 itself, the Patient consulted, Dr. Anil Pinto, Opposite Party No.1, (hereinafter referred to as the "treating Doctor") at the Holy Family Hospital, Opposite Party No.2, (hereinafter referred to as "the Hospital"). Agreeing with the diagnosis, he advised Laparoscopic Cholecystectomy, a surgical procedure to remove gallbladder with small incisions in the abdomen. As advised, the Patient got admitted in the Hospital on 31.08.1997. Pre-operative Blood Tests revealed that the Patient was suffering from Jaundice, probably, due to slipping of the stones from gallbladder and getting stuck in the bile duct. The treating Doctor advised the Patient to have the stones removed from the bile duct by a procedure known as Endoscopic Retrograde Cholangio-Pancreatography (ERCP), in which a tube is inserted into the bile duct through the mouth/stomach and the stone is removed. On 01.09.1997, the patient underwent the said procedure at SMS Endoscopy Centre at Bhatia Hospital by Dr. Amit Maydeo. The stones were removed. However, while removing the stones, the Surgeon observed a thick dark bile and frank pus in the gallbladder. In order to drain the bile better and help to clear the infection, Dr. Maydeo put a stent. He also opined that once the jaundice and infection had subsided, the Patient could be subjected to Cholecystectomy for removal of the gallbladder. The Patient was discharged from the Hospital on 04.09.1997, with the advice to take Udilive Tablet, an Ayurvedic medicine for the liver ailment, for 10 days and to report back to the treating Doctor after two weeks.
2.2 On 19.09.1997, the Patient consulted the treating Doctor, who, after subjecting the Patient to certain tests, i.e. Biochemical Test for Bilirubin, Sugar and Blood Counts, advised him to get himself admitted in the Hospital on 26.09.1997, for Laparoscopic Cholecystectomy, which was scheduled for 27.09.1997. On Patient's informing the treating Doctor that he also had Hernia, the treating Doctor advised Laparoscopic surgical procedure for removal of the gallbladder and an Open Surgery for repair of left inguinal Hernia, simultaneously. As scheduled, the Patient was operated upon at 7.00 a.m. on 27.09.1997. Around 10.40 a.m., the treating Doctor informed the relatives of the Patient that though the procedures/surgeries were successful but there was some bleeding due to a cut in the blood vessel, which had been attended to. While in the ward, on 28.09.1997 at about 2.30 a.m., the Patient developed fever and breathlessness. When his condition deteriorated, he was shifted to the Emergency Ward at 3.30 a.m. and after examination, the treating Doctor informed the relatives that he had developed some infection, which would be attended to and in a couple of days he would be shifted to the ward again. At 6.00 a.m., the Doctors in the Emergency Ward noted in the case papers that the Patient was possibly in 'early septicaemia' and his hemoglobin had come down from 11 grams to 9.8 grams. At about 1.30 p.m., on 30.09.1997, the Patient was shifted to the Intensive Care Unit (ICU). There too, the Patient's condition kept on deteriorating and on 03.10.1997 he was put on a ventilator. The treating Doctor informed the relatives of the Patient that the Patient was not responding to the antibiotics. Ultimately, on 06.10.1997 at 7.10 p.m., the Patient breathed his last, due to Cardio Respiratory Failure secondary to Gram Negative Septicaemia and Right Basal Consolidation with Cholecystectomy for Gall Stones and Obstructive Jaundice with Cholecystitis as associated causes.
2.3 Being convinced that the patient had died due to the negligence on the part of the treating Doctor, the Complainant filed a Complaint before the State Commission, praying for a direction to the treating Doctor and the Hospital to jointly and severally pay to her a total sum of ₹7,70,000/- (i.e. ₹5,00,000/- towards the loss of life of the Patient; ₹2,00,000/- towards the mental trauma caused to the family and ₹70,000/- paid as charges for the surgery, hospitalization etc.). The main allegations, against the treating Doctor, in the Complaint were: (i) though the Patient was suffering from infection in the gallbladder, the treating Doctor conducted the Laparoscopic Cholecystectomy, which led to Septicaemia and his death; (ii) no antibiotic was prescribed to the Patient and surgery was conducted without controlling the infection, though Dr. Maydeo had stressed on the need for controlling the same before conducting the surgery; (iii) before the surgery, no investigations, like Sonography, X-ray or any other procedures were conducted to find out the condition of the gallbladder prior to the surgery; (iv) since the Patient did not require an emergency surgery and was in reasonably good health, there was no need for the treating Doctor to conduct the surgery within 30 days after the first admission and that too without conducting necessary investigations, which were essential in order to prevent post-operative complications; (v) though a blood vessel was damaged during the surgery and an Open Surgery was required to be conducted on the Patient, to control the same, but the treating Doctor did not do anything in this regard, jeopardizing his life; and (vi) open surgery for repair of Hernia was not urgent, which was also responsible for the disastrous consequence of death of the Patient.
3. As expected, the Complaint was contested by both the Opposite Parties. In their written versions, while denying any medical negligence on their part in the treatment of the Patient, it was pleaded by the treating Doctor that utmost care was taken in the treatment of the Patient and both the surgeries were advisable and therefore, with the written consent of the Patient, the same were performed successfully; all the pre-operative tests were conducted and before conducting the surgeries, Jaundice was controlled. It was asserted that in spite of due care, skill and caution exercised by him, he was being unnecessarily dragged into litigation on frivolous grounds. The Hospital pleaded that since no charges were levelled against it, it may be discharged.
4. Upon appraisal of the evidence adduced by the parties before it, including the opinion of Dr. Sanjay Nagral, placed on record by the Complainant and the affidavits of Dr. Vinay G. Mehandale and Dr. Roy Patankar as also the other medical records of the deceased Patient and relying on the decision of the Hon'ble Supreme Court in Martin F. D'Souza Vs. Mohd. Ishfaq, (2009) 3 SCC 1, the State Commission has observed that though serious charges of medical negligence were levelled against the treating Doctor, but the Complainant had failed to place on record any expert opinion to substantiate the same; the Complainant had made up her mind on the basis of her own ideas, notions and perceptions about the medical negligence; from the case papers, it was clear that utmost care had been taken by the treating Doctor in the treatment of the Patient; every attempt was made to control the Jaundice and the infection, including administration of antibiotic injections for a period of 10 days, and before conducting the surgery on the Patient, Jaundice was brought under control. Referring to the affidavits filed by way of evidence by both sides and the medical literature on the point, the State Commission has arrived at the conclusion that removing the gallbladder through incisions in the abdomen was the best way to treat Gall Stones and that risks and complications attached thereto include excessive bleeding or infection and therefore, in the absence of any cogent and reliable evidence, neither the treating Doctor nor the Hospital could be held guilty of medical negligence. Consequently, the State Commission has dismissed the Complaint with costs of ₹5000/- to be paid by the Complainant to the treating Doctor. Hence, the present First Appeal.
5. During the pendency of the Appeal, the Complainant passed away on 27.05.2010. Vide order dated 11.01.2013, her legal heirs were brought on record and impleaded as the Appellants.
6. We have heard Ms. Manisha Ambwani, Learned Counsel appearing for the Appellants and Mr. Santosh Paul who appeared on behalf of the treating Doctor and the Hospital. We have meticulously re-appraised the entire material on record.
7. The question as to what constitutes medical negligence, based on the touchstone of Bolam Vs. Friern Hospital Management Committee, (1957), 1 WLR, 582 (the Bolam's test), is well settled through a catena of decisions of the Hon'ble Supreme Court, including in Jacob Mathew Vs. State of Punjab & Anr. - (2005) 6 SCC 1 Indian Medical Association Vs. V.P. Shantha and Ors., (1995) 6 SCC 651 and Kusum Sharma & Ors. Vs. Batra Hospital and Medical Research Centre & Ors. (2010) 3 SCC 480. Gleaned from these judgments, broad principles to determine what constitutes medical negligence, inter alia, are: (i) Whether the doctor in question possessed the medical skills expected of an ordinary skilled practitioner in the field at that point of time; and (ii) Whether the doctor adopted the practice (of clinical observation diagnosis - including diagnostic tests and treatment) in the case that is accepted as proper by a responsible body of professional practitioners in the field. In this connection, in Jacob Mathew's case (supra), a three Judge Bench of the Hon'ble Supreme Court, elaborating on the degree of skill and care required from a medical practitioner, quoted Halsbury's Laws of England (4th Edn., Vol.30, para 35), as follows:-
"35. The practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence, judged in the light of the particular circumstances of each case, is what the law requires, and a person is not liable in negligence because someone else of greater skill and knowledge would have prescribed different treatment or operation in a different way..."
8. The Hon'ble Supreme Court stated in unequivocal terms that a simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long a doctor follows a practice, acceptable to the medical profession by that day, he cannot be held liable for negligence, merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure, which the accused doctor followed.
9. We shall, therefore, examine the allegations of medical negligence on the touchstone of the aforenoted broad principles.
10. In the present case, as noted above, the allegations of medical negligence against the treating doctor are culled out in paragraph 2.3 supra. As per the operation sheets, signed by the treating doctor, the following procedures/operations were conducted on the patient:-
"Operation:-
Lap. Chole, conversion to Open Cholecystectomy and repair of L inguinal hernia under GA Findings:-
The gallbladder was shrunken. Pneumo created with Veres needle. There were adhesions? Infective. The adhesions were separated. The cystic duct was dissected, clipped and cut. The cystic artery was dissected, clipped and cut. The GB was dissected from the bed after doing the LapChole there was a bit of bleeding around the pancreatic duodenal area which required a mini Lap to control the bleeding with a stich. The hernia was repaired with a Prolene mesh. It was a direct hernia.
The GB fossa was clear. The clips on the cystic duct were intact. The stent was felt in the CBD. The bleeder was in the supraduodenal part of the pancreas probably due to the separation of the adhesions. The cystic artery was intact. The wash fluid was sucked out. There was no bleeding at the time of closure and hence no drain was put for the patient as the patient had a stent as well.
Wound closed with 2.0 Vicryl in layers. Hernia repair done with Prolene mesh since it was direct hernia (L). Post operative blood loss calculated at 250cc."
11. Similarly, as per the Nurses' notes, recorded at 7.45 a.m. on 27.09.97, the following procedure was performed in the operation theatre:-
"OT 7.45 AM Lap Cholecystectomy and left inguinal hernia repair meshplasty with mini laprotomy done to control the bleeding from the duodenum with a stitch. GA done by Dr. Anil Pinto asst by Dr Lawrence and Dr. B Sodder. Anaesthetist Dr. Salyankar."
12. These notes suggest that during the Laparoscopic Cholecystectomy, there was bleeding in the supraduodenal part of the pancreas and to control the bleeding the procedure had to be converted into open laparotomy technique. The version of the treating doctor is that the bleeding could be due to separation of adhesions and it was controlled with a stitch; there was no bleeding at the time of closure of the wound and hence there was no need for drain.
13. As noted above, to drive home her allegation that before conducting the surgery, the treating doctor had not conducted the requisite investigations, like sonography etc., the Complainant had relied on the opinion of one Dr. Sanjay Nagral, M.S., Gastrointestinal & Hepatopancreatobiliary Surgeon of Jaslok Hospital, Mumbai, which reads as follows:-
"Dr. MS Kamath Medico Legal Consultant Dear Dr. Kamath, This is in response to your query dated Fab. 19th. I presume when you refer to a stent in the gall bladder you actually mean a stent in the bile duct. If a sonography examination is performed in the presence of a stent in the bile duct the surrounding organs are still seen quite well. As for the bile duct itself the details may be partially obscured by the stent but information like the size of the duct & the presence or absence of stones can still be obtained. As for the usefulness to the operating surgeon it would be entirely depend on the clinical context."
14. Although the said opinion was general in nature and did not record any specific finding on the point as to whether in the present case what kind of pre-operative investigation was required, yet the Opposite Parties got the said opinion analysed from one Dr. Roy Patankar, Assistant Professor of Surgery at Somaiya Medical College, Mumbai and a faculty member at the Ethicon Institute of Surgical Education at Mumbai, who in his opinion, in the form of an affidavit, opined thus:-
"A repeat Ultrasonography is not mandatory prior to a laparoscopic cholecystectomy in a patient who has had a CBD stone removed and a stent placed at ERCP if patient's jaundice has normalised and WBC counts have returned to normal. A plastic stent often masks a stone in a collapsed CBD after ERCP and stenting and hence a routine ultrasonography is not routinely performed prior to a laparoscopic cholecystectomy. Hence ultrasonography is performed only at the discretion of the surgeon depending on the clinical pictures of the patient."
15. Additionally, in support of his stand that there was no negligence in the conduct of surgeries on the patient, the treating doctor filed an affidavit of one Dr. Vinay G. Mehendale, M.S., M.N.A.M.S., Hon. Surgeon Rajawadi Mun. Hospital, Hon. Prof. of Surgery D.Y. Patil Medical College, which reads as under:-
" I Dr. Vinay G. Mehendale would like to state that I have done over 2500 laparoscopic surgeries all over India. I have gone through the case papers of Mr. Alfred Pais, age 62 years, who was operated on by Dr. Anil Pinto at the Holy Family Hospital, Bandra, for a laparoscopic cholecystectomy which was converted to open surgery. He also had a left inguinal hernia at the same time. I find no negligence on part of Dr. Anil Pinto in the above said procedures. I also find no negligence in the fact that the surgery was done 3 weeks after ERCP. There was also no negligence in repairing the hernia at the same time."
16. In the light of the afore-extracted medical experts' opinion and other documents on record, the allegations of negligence based on grounds (i) to (iv) above, do not merit consideration, as we also find from the record, examination note, dated 27.09.1997, the Bilirubin Level had come down to 1.09 from 14: Temperature was normal; pulse rate was 78 p.m. and the Patient had been on IV antibiotics etc. After removal of stones by ERCP, his jaundice had normalised. Further, even as per the opinion of Dr. Roy Patankar, ultra-sonography is not routinely performed prior to a Laparoscopic Cholecystectomy. It is discretionary depending on the clinical picture of the patient. Thus, the question surviving for consideration, and which seems to be at the core of the Complainant's case, is whether the treating Doctor had failed to do what he ought to have done when there was bleeding due to a cut around the pancreatic duodenal area, while performing cholecystectomy, which allegedly was the cause of septicaemia leading to the death of the patient. At the outset, we may note that except for the treating doctor's aforesaid version that the bleeding was in the supraduodenal part of the pancreas there is no other material on record to even remotely indicate the exact spot/area of the cut, resulting in bleeding and therefore, we have to examine the issue only on the premise that the statement of the treating doctor is correct, more so, when the said stand remained uncontroverted.
17. At this juncture, it would be beneficial to refer to some medical literature, indicating the benefits and risks involved in Laparoscopic Cholecystectomy, which has now become most common technique for removal of the diseased gallbladder. According to the American College of Surgeons, Division of Education, in patients; who have Laparoscopic procedures, infections occur in less than 1 of 1000 patients and bleeding is rare and occurs in 1 to 5 of 1000 cases. In the Journal of the American Society of Abdominal Surgeons, it is also opined that:-
" Complications after abdominal surgery, including bile leak, intra-abdominal bleeding, anastigmatic leak, intra abdominal abscess, small bowel obstruction, bowel necrosis, inadvertent bowel injury, and hollow viscous perforation, may necessitate reoperation and can be associated with significant morbidity and mortality. Re-laparotomy is considered beneficial in patients developing intraperitonealsepsis after abdominal procedures. Abdominal re-exploration by laparotomy is associated with an increased risk of abdominal infection, pain, ileus, would complications, and prolonged admission."
18. In other journals, including Bailey & Love's Short Practice of Surgery, British Journal of Surgery 1989, Vol. 76, British Journal of Surgery 1999, Vol. 86, Maingot's Abdominal Operation, 8th and 10th Editions and Bailey and Love's Short Practice of Surgery, 26th Edition etc., the common complication during and after Laparoscopic Cholecystectomy is stated to be bile leakage, which could be due to iatrogenic; injuries to the common bile duct or any of the preceding biliary ducts; slipping of the ligature of or injuries to the cystic duct; Cystic stump leaks because of faulty clip application; Etc. It is opined that a major risk factor for bile duct injury is the experience of the surgeon, which are much more common, early in a surgeon's experience with the technique.
19. It appears from the medical literature that complications during Laparoscopy could also be on account of Intra-abdominal hematoma, abscess and free fluid; tears of colon, stomach and small bowel; anastigmatic leak; adhesions small bowel and stomach necrosis, identified during mesh detachment from the abdominal wall; and small bowel obstruction, but the major life risk factor is attributed to injury to bile duct which in turn is relatable to the experience of the Surgeon. In the instant case, nothing had been brought on record by the Complainant to controvert the stand of the treating Doctor that the bleeding was around the pancreatic duodenal area, which was controlled with a stich. The expert opinions of the three Doctors, extracted above, do not even suggest the probable cause of septicaemia, the ultimate cause of death of the patient, let alone an indication of injury to the bile duct. On the contrary, Dr. Vinay G. Mehendale, has given a clean chit to the treating Doctor, opining that there was no negligence in the performance of all the three surgeries/procedures, viz. laparoscopic Cholecystectomy, Laparotomy and open surgery for repair of left inguinal hernia. This expert opinion also remains unrebutted. As a matter of fact, noticing the bleeding, the treating Doctor rightly switched over to an open laparotomy technique, a recommended protocol in the medical science. Similarly, no material was brought on record in support of the plea that simultaneous open surgery for repair of left inguinal hernia aggravated the complications, leading to the death of the patient.
20. In view of the aforegoing discussion, we are of the opinion that the aforestated allegations against the treating Doctor and the Hospital are not sufficient to hold that there was deficiency in pre-operative diagnosis or any kind of negligence at the hands of the treating Doctor while performing any one of the aforenoted surgeries/procedures. Hence, no fault can be found with the decision of the State Commission, dismissing the Complaint. In the result, the Appeal is dismissed but with no order as to costs.
......................J D.K. JAIN PRESIDENT ...................... M. SHREESHA MEMBER