State Consumer Disputes Redressal Commission
Sarita Singh vs Globe Meducare on 29 November, 2023
Cause Title/Judgement-Entry STATE CONSUMER DISPUTES REDRESSAL COMMISSION, UP C-1 Vikrant Khand 1 (Near Shaheed Path), Gomti Nagar Lucknow-226010 Complaint Case No. CC/32/2018 ( Date of Filing : 24 Jan 2018 ) 1. Sarita Singh Lucknow ...........Complainant(s) Versus 1. Globe Meducare Lucknow ............Opp.Party(s) BEFORE: HON'BLE MR. Rajendra Singh PRESIDING MEMBER HON'BLE MR. Vikas Saxena JUDICIAL MEMBER PRESENT: Dated : 29 Nov 2023 Final Order / Judgement राज्य उपभोक्ता विवाद प्रतितोष आयोग , उत्तर प्रदेश , लखनऊ। सुरक्षित परिवाद सं0-32/2018 1.
श्रीमती सरिता सिंह आयु लगभग 38 वर्ष पत्नी स्वर्गीय श्री योगेश सिंह (मृतक मरीज/उपभोक्ता की विधवा पत्नी)
2. श्रीमती सम्पता देवी आयु लगभग 87 वर्ष पत्नी स्वर्गीय श्री रघुबीर सिंह (मृतक मरीज/उपभोक्ता की विधवा माता)
3. कुमारी यशिता सिंह आयु लगभग 14 वर्ष पुत्री स्वर्गीय श्री योगेश सिंह (मृतक मरीज/उपभोक्ता की अवयस्क पुत्री)
4. यतेन्द्र प्रताप सिंह आयु लगभग 11 वर्ष पुत्र स्वर्गीय श्री योगेश सिंह (मृतक मरीज/उपभोक्ता का अवयस्क पुत्र)
5. कुमारी ताशु सिंह आयु लगभग 03 वर्ष पुत्री स्वर्गीय श्री योगेश सिंह (मृतक मरीज/उपभोक्ता की अवयस्क पुत्री) निवासीगण-भवन संख्या-09-301, न्यू मल्हार, सहारा स्टेट, मोहल्ला व पोस्ट-जानकीपुरम, थाना गुडम्बा, जिला-लखनऊ।
........... परिवादीगण । बनाम
1. ग्लोब मेडिकेयर द्वारा प्रबन्धक, स्थित-ए0-03, विवेकानन्द पालीक्लीनिक के सामने, मोहल्ला व पोस्ट-निराला नगर, थाना-हुसैनगंज, जिला-लखनऊ, पिन-226020. (मृतक मरीज/उपभोक्ता को गुणवत्ता विहीन चिकित्सकीय सेवा उपलब्ध कराने वाला चिकित्सकीय संस्थान)
2. न्यू इण्डिया ऐश्योरेंस कम्पनी लिमिटेड द्वारा उप प्रबन्धक, तृतीय पक्ष दावा प्रकोष्ठ, 94-महात्मा गांधी मार्ग, राजभवन के सामने, मो0 पोस्ट व थाना-हजरतगंज, जिला-लखनऊ (विपक्षी चिकित्सकीय संस्थान को बीमित करने वाली बीमा कम्पनी) .............. विपक्षीगण।
समक्ष:-
1. मा0 श्री राजेन्द्र सिंह, सदस्य।
2. मा0 श्री विकास सक्सेना, सदस्य।
परिवादीगण की ओर से उपस्थित : श्री प्रकाश चन्द्रा विद्वान अधिवक्ता।
विपक्षी सं0-1 की ओर से उपस्थित: श्री मनीष मेहरोत्रा विद्वान अधिवक्ता।
विपक्षी सं0-2 की ओर से उपस्थित: कोई नहीं।
दिनांक :- 01-01-2024.
मा0 श्री राजेन्द्र सिंह , सदस्य द्वारा उदघोषित निर्णय परिवादिनी श्रीमती सरिता सिंह के पति स्व0 योगेश सिंह अपनी मृत्यु के समय 37 वर्षीय एक स्वस्थ युवा थे, जिनका अपना दैनिक जीवन बेहद नियमित एवं संयमित था। वे शारीरिक रूप से स्वस्थ थे और धार्मिक पृवृत्ति के थे। वे एक सफल उद्यमी थे। उन्होंने अपने मूल निवास स्थान ग्राम-बदरिया बुजुर्ग, पोस्ट-हथियागढ़, जिला-बस्ती, उत्तर प्रदेश में मैसर्स बोरोलॉग बायो टेक्नोलॉजीज प्राइवेट लिमिटेड के नाम से एक कम्पनी पंजीकृत कराई थी और खाद कारखाना लगाया था, जिसमें स्थानीय और बाहरी लोगों को रोजगार का अवसर प्रदान किया गया था। परिवादिनी के पति की आय पर परिवादिनी स्वयं तथा उनकी विधवा माता, अवयस्क पुत्र और पुत्रियॉं आश्रित थे। परिवादिनी के पति को दिनांक 05/06-01-2016 की रात को पेट के ऊपरी हिस्से में दर्द की शिकायत हुई, जिस पर उन्होंने दिनांक 06-01-2016 को सुबह ही हनुमन्त इण्डोसर्जरी सेण्टर, गोमती नगर, लखनऊ में डॉक्टर योगेश मिश्रा से चिकित्सीय परामर्श लिया और उनकी सलाह पर दिनांक 07-01-2016 को ठुकराल डायग्नोस्टिक सेण्टर प्राइवेट लिमिटेड से अल्ट्रासोनोग्राफी परीक्षण तथा चिकित्सीय परामर्श के अनुसार ही दिनांक 07-01-2016 को ही निदान डायग्नोस्टिक सेण्टर से विभिन्न प्रकार के रक्त व मूत्र परीक्षण कराये। इन परीक्षण रिपोर्ट को दिनांक 08-01-2016 को पुन: हनुमन्त इण्डोसर्जरी सेण्टर में डॉक्टर विनायक मिश्रा को दिखाया गया, जिनकी सलाह पर कुछ दवाईयॉं अगले 05 दिन तक ली गईं।
इसके पश्चात् एक दूसरे चिकित्सक की सलाह लेने के लिए परिवादिनी के पति ने विपक्षी ग्लोब मेडिकेयर के प्रमुख चिकित्सक डॉक्टर दीपक कुमार अग्रवाल से चिकित्सीय सलाह लेने का निर्णय लिया और उन्हें दिनांक 08-01-2016 को दिखाया। उनके द्वारा कुछ प्राथमिक परीक्षण किया गया और कुछ चिकित्सीय परीक्षण ग्लोब मेडिकेयर से और कुछ परीक्षण बाहर से कराने की सलाह दी गयी। इस सलाह के अनुसार दिनांक 08-01-2016 को एम0डी0एस0 डायग्नोस्टिक प्राइवेट लिमिटेड से कुछ परीक्षण कराये। परीक्षण रिपोर्ट प्राप्त होने के पश्चात् उससे ग्लोब मेडिकेयर को तत्काल अवगत कराया लेकिन वहॉं के चिकित्सक इस रिपोर्ट से सन्तुष्ट नहीं हुए और उन्होंने ऐसी जांच स्वयं कराने का निर्णय लिया और पुन: रक्त परीक्षण किया गया, जिसकी रिपोर्ट दिनांक 12-01-2016 को प्राप्त हुई। रिपोर्ट प्राप्त होने पर ग्लोब मेडिकेयर के प्रधान चिकित्सक डॉ0 दीपक कुमार अग्रवाल को परिवादिनी के पति ने दिखाया, जिन्होंने अल्ट्रासोनोग्राफी होल एब्डामिन कराने का निर्देश दिया और यह ग्लोब मेडिकेयर में ही किया गया। इन सारी रिपोर्टों को देखने के बाद परिवादिनी के पति को दिनांक 13-01-2016 को ई0आर0सी0पी0 कराये जाने की सलाह दी गयी। दिनांक 14-01-2015 (लिपिकीय त्रुटि, जबकि इसे 2016 होना चाहिए) को परिवादिनी के पति ग्लोब मेडिकेयर पहुँचे, जहॉ पर 20,000/- रू0 जमा कराये गये और फिर चिकित्सक द्वारा दी गयी सूचना के अनुसार परिवादिनी के पति का ई0आर0सी0पी0 सफलतापूर्वक सम्पन्न हुआ। आपरेशन थिएटर से बाहर अपने पर परिवादिनी के पति बेहद तकलीफ में थे और उनको अत्यधिक पीड़ा हो रही थी। विपक्षी ने बताया कि यह पीड़ा कुछ समय के लिए है। मारीज को दर्द निवारक दवाऐं और नींद के इंजेक्शन दिये गये, जिससे उनका दर्द धीरे-धीरे कम होगा। बाद में उनके साथ परिवादिनी को भी रहने की अनुमति प्रदान की गयी।
ई0आर0सी0पी0 होने के तीन-चार घण्टे बाद परिवादिनी के पति की शारीरिक अवस्था तेजी से बिगड़ने लगी और उन्हें होने वाला दर्द असहनीय होता चला गया, जिस पर अस्पताल प्रशासन ने उन्हें कुछ अन्य दवाऐं व दर्द निवारक इंजेक्शन लगाये और मरीज की स्थिति ठीक है ऐसा कहते हुए प्रयास करते रहे। ई0आर0सी0पी0 होने के पांच-छ: घण्टे बाद परिवादिनी के पति लगभग कोमा की स्थिति में आय गये, जिससे अस्पताल प्रशासन में हड़कम्प मच गया और फिर परिवादिनी के पति को आई0सी0यू0 में भर्ती किया गया। आई0सी0यू0 में परिवादिनी के पति दिनांक 14-01-2016 से 16-01-2016 तक भर्ती रहे और इस बीच परिवादिनी के पति का पुन: अल्ट्रासोनोग्राफी होल एब्डामिन तथा रक्त परीक्षण कराया गया।
जब विपक्षी ग्लोब मेडिकेयर का अस्पताल प्रशासन एवं उसके प्रधान चिकित्सक डॉ0 दीपक कुमार अग्रवाल परिवादिनी के पति की स्थिति सम्भाल पाने में असफल दिखे तब परिवादिनी के पति के जीवन पर संकट के बादल मंडराने लगे। ऐसी स्थिति में परिवादिनी ने चिकित्सीय लापरवाही के कारण गम्भीर रूप से अपने पति का जीवन बचाने के आशय से उन्हें नई दिल्ली ले जाने का निर्णय लिया और दिनांक 16-01-2016 को उपरोक्त चिकित्सक से अनुरोध करके अपने बीमार पति को डिस्चार्ज करा लिया। दिनांक 16-01-2016 को ही परिवादिनी अपने पति को एयर एम्बुलेंस से दिल्ली ले गई और जिसका व्यय 3,10,000/- रू0 उसके द्वारा दिया गया। दिल्ली पहुँच कर उसने अपने पति को मेदान्ता द मेडिसिटी, सेक्टर-38, गुड़गॉंव, हरियाणा में दिनांक 17-01-2016 को रात्रि 01.07 बजे भती कराया और तुरन्त उनका इलाज शुरू किया गया। अच्छे से अच्छा इलाज करने के बाद भी परिवादिनी के पति का देहान्त दिनांक 25-01-2016 को रात्रि के 08.09 बजे हो गया और मेदान्ता द मेडिसिटी द्वारा परिवादिनी को डेथ समरी प्रदान की गयी।
मेदान्ता द मेडिसिटी में परिवादिनी द्वारा एयर एम्बुलेंस को किये गये भुगतान 3,10,000/- रू0 के अितिरिक्त 10,46,969/- रू0 का भुगतान किया गया और दिनांक 16-01-2016 से दिनांक 26-01-2016 के मध्य अस्पताल प्रशासन उपरोक्त को किये गये भुगतान के अतिरिक्त परिवादिनी द्वारा लगभग 1,00,000/- रू0 का भुगतान अन्य मदों में किया गया।
ग्लोब मेडिकेयर के प्रधान चिकित्सक डॉ0 दीपक कुमार अग्रवाल द्वारा अपनी निगरानी में परिवादिनी के पति का ई0आर0सी0पी0 दिनांक 14-01-2016 को कराया गया था, जिसमें अपेक्षित सावधानी न बरते जाने और उपरोक्त चिकित्सीय पद्धति को अपनाने में लापरवाही दिखाने और अनुभवहीन होने तथा उसकी पूरी जानकारी रखने में असमर्थ होने के कारण परिवादिनी के पति की ई0आर0सी0पी0 पूर्णतया असफल हो गयी और इसके कारण परिवादिनी के पति के शरीर में गम्भीर रूप से संक्रमण हो गया, जिसको विपक्षी समझ नहीं नहीं पाये और परिस्थितियों को सम्भाल न सके।
विपक्षी ने पहले ग्लोब मेडिकेयर में स्टोन होने की बात कही और छोटा आपरेशन का हवाला देते हुए उसे दिनांक 14-01-2016 को बुलाया गया, जहॉं कथित ई0आर0सी0पी0 किया गया और ई0आर0सी0पी होने के बाद भी परिवादिनी के पति कभी अपने पैरों पर खड़े नहीं हो सके और अन्तत: उन्हें अपने जीवन से हाथ धोना पड़ा। ग्लोब मेडिकेयर द्वारा की गयी लापरवाही के कारण परिवादिनी के पति की मृत्यु होना उसके द्वारा सेवा में कमी और उपेक्षा का परिणाम है, जिसके लिए यह परिवाद प्रस्तुत किया गया है।
जिस अवधि के बीच परिवादिनी के पति के साथ चिकित्सीय लापरवाही की गई थी उस समय चिकित्सीय संस्थान और उसके प्रमुख चिकित्सक डॉ0 दीपक कुमार अग्रवाल का बीमा न्यू इण्डिया ऐश्योरेंस कं0लि0 से प्रोफेशनल इण्डेमिनिटी इन्श्योरेंस (डॉक्टर) नामक पालिसी के अन्तर्गत बीमा था। अत: विपक्षी द्वारा की गयी चिकित्सीय लापरवाही और उपेक्षा के कारण परिवादिनी अपने पति की हुई मृत्यु के सम्बन्ध में निम्नलिखित अनुतोष की मांग करती है :-
1. विपक्षी सं0-1 द्वारा प्रदर्शित घोर लापरवाही और त्रुटिपूर्ण चिकित्सीय सेवाओं के मद में विपक्षी सं0-1 से परिवादिनी गण को 50,00,000/- रू0 प्रतिकर के रूप में दिलाये जाने का आदेश दिया जाये।
2. परिवादिनी द्वारा विपक्षी सं0-1 संस्थान को भुगतान की गयी धनराशि में से 43,031/- रू0 का भुगतान वापस दिलाया जाये।
3. परिवादिनी को अपने स्वर्गीय पति को एयर एम्बुलेंस से दिल्ली ले जाने में किये गये भुगतान 3,10,000/- रू0 भी विपक्षी सं0-1 से दिलाये जायें।
4. परिवादिनी मेदान्ता द मेडिसिटी में किये गये इलाज सम्बन्धी भुगतान 10,46,969/- रू0 को भी विपक्षी सं0-1 से पाने की अधिकारी है।
5. परिवादिनी मेदान्ता द मेडिसिटी में रहने के दौरान् खाने-पीने व अन्य मदों में किये गये खर्च के रूप में 1,00,000/- रू0 भी विपक्षी सं0-1 से पाने की अधिकारी है।
6. इसके अतिरिक्त परिवादिनी विपक्षी से मानसिक क्लेश, दु:ख, पुत्र व पुत्रियों को अपने पिता के स्नेह से वंचित होने के मद में 5,00,000/- रू0 पाने की अधिकारी है।
7. परिवादिनी, विपक्षी से वाद व्यय के रूप में 1,00,000/- रू0 भी पाने की अधिकारी है।
आदेश पत्र दिनांकित 11-01-2022 को देखने यह स्पष्ट होता है कि विपक्षी के विद्वान अधिवक्ता द्वारा यह कहा गया कि वह लिखित कथन प्रस्तुत नहीं करेंगे और यह कहा गया कि दिनांक 13-03-2018 को प्रस्तुत की गयी प्रारम्भिक आपत्ति को ही विपक्षी की ओर से लिखित कथन माना जाये।
उपभोक्ता संरक्षण अधिनियम 1986 के अन्तर्गत लिखित कथन प्रस्तुत करना प्रारम्भिक अवस्था है और लिखित कथन प्रस्तुत करने के पश्चात् ही साक्ष्य प्रस्तुत किया जा सकता है, क्योंकि साक्ष्य का आधार लिखित कथन होता है।
इस सम्बन्ध में माननीय सर्वोच्च न्यायालय द्वारा दिये गये निम्नलिखित दिये गये निर्णय को देखना आवश्यक है :-
A Constitutional Bench (5 JJ) of the Hon'ble Supreme Court In the Case of New India Assurance Complainant Vs Hilli Multipurpose Cold Storage Private Limited, Civil Appeal no.10941-10942 of 2013 along with other many related Civil Appeals ( judgment 04.03.2020) held ;
"The reference made to this Constitution Bench relates to the grant of time for filing response to a complaint under the provisions of the Consumer Protection Act, 1986 (for short 'the Act").
The first question referred is as to whether Section 13(2) (a) of the Consumer Protection Act, which provides for the respondent/opposite party filing its response to the complaint within 30 days or such extended period not exceeding 15 days,should be read as mandatory or directory ; i.e., whether the District Forum has power to extend the time for filing the response beyond the period of 15 days, in addition to 30 days.
The second question which is referred is as to what would be the commencing point of limitation of 30 days stipulated under the aforesaid Section.
The first question was referred by a two Judges bench of this Court vide an order dated 11.02.2016 passed in Civil Appeal No (s) 10831084 of 2016, M/S Bhasin Infotech and Infrastructure Pvt Ltd Vs M/S Grand Venezia Buyers Association ( Reg), the relevant portion of which is as under :
"there is an apparent conflict between the decision of this Court in Topline Shoes Limited vs Corporation Bank [(2002)6 SCC 33], Kailash vs Nankhu [(2005)4 SCC 480] , Salem advocate Bar Association VS Union of India [(2005) 6 SCC 344] on the one hand and J J Merchan &Ors vs Shrinath Chaturvedi [(2002) 6 SCC 635)] and NIA Vs Hilli Multipurpose Cold Storage [ 2014 AIOL 4615] on the other in so far as the power of the courts to extend time for filing of Written Statement/reply to a complaint is concerned. The earlier mentioned line of decision take the view that the relevant provisions including those of Order 8 Rule 1 of the Civil Procedure Code 1908 are directory in nature and the Courts concerned have the power to extend time for filing the written statement. The second line of decisions which are also of coordinate Benches however takes a contrary view and hold that when it comes to power of the Consumer Fora to extend the time for filing a reply there is no such power. Since the question that falls for determination here often arises before the Consumer Fora and Commissions all over the country it will be more appropriate if the conflict is resolved by an authoritative judgement. Further since the conflict is between Benches comprising three Judges we deem it fit to refer these appeals to a five - Judge Bench to resolve the conflict once and for all. While we do so we are mindful of the fact that in the ordinary course a two - Judge Bench ought to make a reference to a three - Judge Bench in the first place but in the facts and circumstances of the case and keeping in view the fact that the conflict is between coordinate benches That comprising three Judges a reference to 3 Judges may not suffice"
The Hon'ble Supreme Court in para 41 of the judgement has held " To conclude, we hold that our answer to the first question is that The District Forum has no power to extend the time for filing the response to the complainant beyond the period of 15 days in addition to 30 days as envisaged under section 13 of the Consumer Protection Act ; and the answer to the second question is that the commencing point of limitation of 30 days under Section 13 of the Consumer Protection Act would be from the date of receipt of the notice accompanied with the complainant by the opposite party and not mere receipt of the notice of the complainant. "
The Hon'ble Supreme Court in para 40 of the judgment has held ".............. we may, however, clarified that the objection of not having received a copy of the complaint along with the notice should be raised on the first date itself and not thereafter, otherwise permitted to be raised at any point later on defeat the very purpose of the Act, which is to provide simple and speedy Redressal of consumer disputes."
[Section 38 of the Consumer Protection Act 2019 has also the same time limit to file written statement. It is quoted hereinbelow ;
38. Procedure on admission of complaint -(1) the District Commission shall , on admission of a complaint, or in respect of cases referred for mediation on failure of the agreement by mediation proceed with such complaint.
(2) were the complainant relates to any goods, the discussion That shall -
(a) referral copy of the admitted complaint, within 21 days from the date of its admission to the opposite party mentioned in the complaint directing him to give his version of the case within a period of 30 days or such extended period not exceeding 15 days as may be granted by it ; ] According to section 49 of The Consumer Protection Act 2019, the provisions relating to complainants under section 35, 36, 37, 38 and 39 shall, with such modifications as may be necessary, be applicable to the disposal of complaint by the State Commission.
So in this case the written statement has been filed beyond the prescribed period as mentioned in section 49 of the Consumer Protection Act 2019. As per the act and as per the judgment of the only Supreme Court (Constitutional Bench) this written statement is not liable to be taken on record so it will be not the part of the record.
In the case of Arn Infrastructure India Limited Vs Hara Prasad Ghosh , SC (civil appeal diary no 31182/2023 ,Jtdtd 04.09.2023) the facts are as follows :
A complaint under original jurisdiction was filed before the NCDRC seeking return of deposit from the Opposite Parties. In the said case, the Opposite Parties did not file their Written Version within the statutory timeline prescribed. While so, at the time of hearing final arguments, the Opposite Parties entered appearance through an advocate and sought an adjournment to make final arguments in the case.
The NCDRC rejected the said request on the ground that the Written Version was not filed within the statutory period. The NCDRC allowed the complaint by hearing only the Complainant on merits. An application was filed by the Opposite Parties to recall the aforesaid order. The said application was also dismissed by the NCDRC against which a civil appeal was filed before the Hon'ble Supreme Court which is under discussion here.
The issue before the Hon'ble Supreme Court was whether the Opposite Parties are entitled to make final arguments even when the Written Version was not filed. The Hon'ble Supreme Court held that the Opposite Parties have a right to make final arguments even if the Written Version was not filed. The Apex Court observed that hearing only the Complainant on merits when the Opposite Parties intended to make submissions is violative of the principles of natural justice.
इससे स्पष्ट होता है कि जहॉं पर लिखित कथन प्रस्तुत नहीं किया जाता है, वहॉं पर पक्षकार को तर्क प्रस्तुत करने का अवसर दिया जाता है।
अत: हमारे द्वारा परिवादीगण की ओर से विद्वान अधिवक्ता श्री प्रकाश चन्द्रा एवं विपक्षी सं0-1 की ओर से विद्वान अधिवक्ता श्री मनीष मेहरोत्रा को विस्तार से सुना गया तथा पत्रावली पर उपलब्ध समस्त अभिलेखों/प्रपत्रों व साक्ष्यों का सम्यक् रूप से परिशीलन किया गया। विपक्षी सं0-2 की ओर से बहस करने हेतु कोई उपस्थित नहीं हुआ।
विपक्षी की ओर से बहस करते हुए कहा गया कि इस मामले में मरीज का आपरेशन ई0आर0सी0पी0 बायल डक्ट स्टोन को हटाने के लिए किया गया था। उसका ई0आर0सी0पी0 दिनांक 14-01-2016 को किया गया और सी0बी0डी0 स्टोन सफलतापूर्वक हटाया गया। इसके पश्चात् उसको दर्द हुआ, जिसकी पहचान पेनक्रियाटाइटिस के रूप में की गयी, जो ई0आर0सी0पी0 के अन्तर्गत एक जटिल क्रिया के रूप में जानी जाती है। इसको शीघ्र ही पहचान कर इसका प्रबन्धन किया गया। मेडिकल प्रोटोकाल के अनुसार मरीज का इलाज किया गया, लेकिन रोगी के परिवारीजन उसे मेदान्ता द मेडिसिटी हास्पिटल गुड़गॉव ले जाना चाहते थे, इसलिए उनको जाने की अनुमति दी गयी। विपक्षी डॉक्टर 25 वर्षों से ई0आर0सी0पी0 कर रहे थे और इसे सफलतापूर्वक किया गया। पेनक्रियाटाइटिस के बारे में रोगी के सहयोगियों को भलीभांति बता दिया गया था।
परिवादिनी की ओर से कहा गया कि इस मामले में विपक्षी ने लापरवाही बरती है और उनकी लापरवाही के कारण ई0आर0सी0पी0 सफल नहीं हो सका और इस कारण मरीज को मेदान्ता हास्पिटल ले जाया गया, किन्तु वहॉं पर मरीज की मृत्यु हो गयी। इससे स्पष्ट होता है कि विपक्षी की लापरवाही के कारण रोगी की जान चली गयी।
सर्वप्रथम हम चिकित्सीय क्षेत्र में प्रवेश लेने वाले डॉक्टर द्वारा ली गयी शपथ का अवलोकन करते हैं, जो इस क्षेत्र में प्रवेश करने से पहले प्रत्येक डॉक्टर को लेना अनिवार्य होती है :-
Now let us see the oath taken be a doctor before entering the nobel profession of the Medical World. As per guidelines of MCI, Every member should get it framed in his or her office it should never be violated in its letter and spirit.
"I solemnly pledge myself to consecrate my life to service of humanity.
Even under threat, I will not use my medical knowledge contrary to the laws of Humanity.
I will maintain the utmost respect for human life from the time of conception.
I will not permit considerations of religion, nationality, race, party politics or social standing to intervene between my duty and my patient.
I will practice my profession with conscience and dignity.
The health of my patient will be my first consideration.
I will respect the secrets which are confined in me.
I will give to my teachers the respect and gratitude which is their due.
I will maintain by all means in my power, the honour and noble traditions of medical profession.
I will treat my colleagues with all respect and dignity.
I shall abide by the code of medical ethics as enunciated in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002.
I make these promises solemnly, freely and upon my honour."
The complexity of the human body and the uncertainty involved in the medical procedure are of such great magnitude that it is impossible for a Doctor to guarantee a successful result; and the only assurance that he can give, or can be understood to have given by implication is that he is possessed of requisite skill in that branch of profession which he is practising and while undertaking the performance of the task entrusted to him, he would be exercising his skills with reasonable competence. An ordinary physician or surgeon is not expected to be either a clodhopper or feckless practitioner of profession, as much as, he is not expected to be a paragon, combining qualities of polymath or prophet as in the realm of diagnosis and treatment, there is ample scope for genuine difference of opinion; and a Doctor cannot be treated as negligent merely because his conclusion differs from that of other persons in the profession, or because he has displayed less skill or knowledge than others would have shown. The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of, if acting with ordinary care. Furthermore, a golden principle of law has been laid down by the Hon'ble Apex Court in Jacob Mathew Vs. State of Punjab, (AIR 2005 SC 3180) that no sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient as the professional reputation of the person is at stake. A single failure may cost him dear in his career. Even in civil jurisdiction, the rule of res ipsa loquitor is not an universal application and has to be applied with extreme care and caution to the cases of professional negligence and in particular that of the doctors, else it would be counter productive. Simply because a patient has not favourably responded to a treatment given by a physician or a surgery has failed, the doctor cannot be held liable per-se by applying the doctrine of res ipsa loquitor. Yet, another golden principle of law has been laid down by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha's III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, it has been observed in Malay Kumar Ganguli's case (AIR 2010 SC 1162) that" charge of professional negligence on a medical person is a serious one as it affects his professional statusand reputation and as such, the burden of proof would be more onerous. A doctor cannot be held negligent only because something has gone wrong. He also cannot be held liable for mischance or misadventure or for an error in judgment in making a choice when two options are available. The mistake in diagnosis is not necessarily a negligent diagnosis." In the instant matter, thus a simple test, in the light of aforesaid observations, needs to be conducted in order to ascertain whether the Doctor is guilty of any tortious act of negligence/battery amounting to deficiency in conducting a surgery in the delivery of child and not properly attending the patient, the complainant and consequently, liable to pay damages for leaving cotton mass in the abdomen / stomach due to failure in surgery and deteriorating condition of the patient.
Now, it is required to be seen whether an expert report is necessary in each and every case relating to medical negligence or not ? It has been observed by the Hon'ble Apex Court in Indian Medical Association Vs. V.P. Santha III (1995) CPJ 1 (SC) at para 37 that "it is no doubt true that sometimes complicated questions requiring recording of evidence of experts may arise in a complaint about deficiency in service based on the ground of negligence in rendering medical services by a medical practitioner; but this would not be so in all complaints about deficiency rendering services by a medical practitioner. There may be cases which do not raise such complicated questions and the deficiency in service may be due to obvious faults which can be easily established such as removal of the wrong limb or the performance of an operation on the wrong patient or giving injection of a drug to which the patient is allergic without looking into the out patient card containing the warning or use of wrong gas during the course of an anaesthetic or leaving inside the patient swabs or other items of operating equipment after surgery. Furthermore, in B. Krishna Rao Vs. Nikhil Super Speciality Hospital 2010 (V) SCC513 at para 40 the Hon'ble Apex Court was pleased to hold that it is not necessary to have opinion of the expert in each and every case of medical negligence. The Hon'ble Apex Court was pleased to further hold in Nizam Institute of Medical Sciences Vs. Prashant S. Dhananka and others 2009 (VI) SCC 1 that "in a case of medical negligence, once initial burden has been discharged by the complainant by making of a case of negligence on the part of the hospital or the doctor concerned, the owner then shifts on the hospital or to the attending doctors and it is for the hospital to satisfy the court that there was no lack of care or diligence".
A doctrine or rule of evidence in tort law that permits an inference or presumption that a defendant was negligent in an accident injuring the plaintiff on the basis of circumstantial evidence if the accident was of a kind that does not ordinarily occur in the absence of negligencea plaintiff who establishes the elements of res ipsa loquitur can withstand a motion for summary judgment and reach the jury without direct proof of negligence-- Cox v. May Dept. Store Co., 903 P.2d 1119 (1995).
In Byrne vs Boadle, this maxim was used for the first time where the complainant was injured by a barrel that dropped from the window of the defendant. In the abovementioned case, Pollock, C. B., said "here are many incidents from which no presumption of negligence can arise, but this is not true in every case. It is the duty of persons who keep barrels in a warehouse to take care that they do not roll out and I think that such a case will, beyond all doubt, afford prima facie proof of negligence."
This doctrine intends to help direct the court proceedings to a conclusion, especially if it is established through the implication of this doctrine's rule that the injury caused to the claimant would not have occurred or taken place if the defendant wasn't negligent. This also gives enough cause and evidence to hold the defendant liable for his negligent actions.
DOCTRINE OF RES IPSA LOQUITAR The thing speaks for itselfis the gist of the maxim Res Ipsa Loquitur Maxim. What are the essentials of this maxim.
The injury caused to the plaintiff shall be a result of an act of negligence.
There is a lack of evidence, or the evidence presented before the court is insufficient to establish the possibilities of the fault of the plaintiff or third party.
The defendant owes a duty of care towards the plaintiff, which he has breached.
There is a significant degree of injury caused to the plaintiff.
Applicability of Doctrine of Res Ipsa Loquitur.
The maxim of res ipsa loquitur came into force to benefit the plaintiff as he can use circumstantial evidence to establish negligence.
Consequently, it shifts the burden of proof on the defendant, logic being, where there is an event of unexplained cause, usually, the one that does not occur without the defendant's negligence in controlling the action which has caused the injury to the claimant or destroyed his goods.
In this scenario, the court shall presume negligence on the part of the defendant in such a case unless it includes an appropriate explanation compatible with his taking reasonable care.
In Achutrao Haribhau Khodwa and Others vs. State of Maharashtra and Others, it was considered that the maxim should not be applied in the case of general incidences of neglect and shall only be reflected when there is a significant degree of injury caused.
Section 106 of the Indian Evidence Act Section 106 of the Act provides that when any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Res ipsa loquitur is a Latin phrase that means "the thing speaks for itself." In personal injury law, the concept of res ipsa loquitur (or just "res ipsa" for short) operates as an evidentiary rule that allows plaintiffs to establish a rebuttable presumption of negligence on the part of the defendant through the use of circumstantial evidence.
This means that while plaintiffs typically have to prove that the defendant acted with a negligent state of mind, through res ipsa loquitur, if the plaintiff puts forth certain circumstantial facts, it becomes the defendant's burden to prove he or she was not negligent.
Res Ipsa Loquitur and Evidence Law Accidents happen all the time, and the mere fact that an accident has occurred doesn't necessarily mean that someone's negligence caused it. In order to prove negligence in a personal injury lawsuit, a plaintiff must present evidence to demonstrate that the defendant's negligence resulted in the plaintiff's injury. Sometimes, direct evidence of the defendant's negligence doesn't exist, but plaintiffs can still use circumstantial evidence in order to establish negligence.
Circumstantial evidence consists of facts that point to negligence as a logical conclusion rather than demonstrating it outright. This allows judges and juries to infer negligence based on the totality of the circumstances and the shared knowledge that arises out of human experience. Res ipsa is one type of circumstantial evidence that allows a reasonable fact finder to determine that the defendant's negligence caused an unusual event that subsequently caused injury to the plaintiff.
This doctrine arose out of a case where the plaintiff suffered injuries from a falling barrel of flour while walking by a warehouse. At the trial, the plaintiff's attorney argued that the facts spoke for themselves and demonstrated the warehouse's negligence since no other explanation could account for the cause of the plaintiff's injuries.
As it has developed since then, res ipsa allows judges and juries to apply common sense to a situation in order to determine whether or not the defendant acted negligently.
Since the laws of personal injury and evidence are determined at the state level, the law regarding res ipsa loquitur varies slightly between states. That said, a general consensus has emerged, and most states follow one basic formulation of res ipsa.
Under this model for res ipsa, there are three requirements that the plaintiff must meet before a jury can infer that the defendant's negligence caused the harm in question:
The event doesn't normally occur unless someone has acted negligently;
The evidence rules out the possibility that the actions of the plaintiff or a third party caused the injury; and The type of negligence in question falls with the scope of the defendant's duty to the plaintiff.
As mentioned above, not all accidents occur because of someone else's negligence. Some accidents, on the other hand, almost never occur unless someone has acted negligently.
Going back to the old case of the falling flour-barrel, it's a piece of shared human knowledge that things don't generally fall out of warehouse windows unless someone hasn't taken care to block the window or hasn't ensured that items on the warehouse floor are properly stored. When something does fall out of a warehouse window, the law will assume that it happened because someone was negligent.The second component of a res ipsa case hinges on whether the defendant carries sole responsibility for the injury. If the plaintiff can't prove by a preponderance of the evidence that the defendant's negligence cause the injury, then they will not be able to recover under res ipsa.
States sometimes examine whether the defendant had exclusive control over the specific instrumentality that caused the accident in order to determine if the defendant's negligence caused the injury. For example, if a surgeon leaves a sponge inside the body of a patient, a jury can infer that the surgeon's negligence caused the injury since he had exclusive control over the sponges during the operation.
In addition to the first two elements, the defendant must also owe a duty of care to protect the plaintiff from the type of injury at issue in the suit. If the defendant does not have such a duty, or if the type of injury doesn't fall within the scope of that duty, then there is no liability.
For example, in many states, landowners don't owe trespassers any duty to protect them against certain types of dangers on their property. Thus, even if a trespasser suffers an injury that was caused by the defendant's action or inaction and that wouldn't normally occur in the absence of negligence, res ipsa loquitur won't establish negligence since the landowner never had any responsibility to prevent injury to the trespasser in the first place.
Res ipsa only allows plaintiffs to establish the inference of the defendant's negligence, not to prove the negligence completely. Defendants can still rebut the presumption of negligence that res ipsa creates by refuting one of the elements listed above.
For example, the defendant could prove by a preponderance of the evidence that the injury could occur even if reasonable care took place to prevent it. An earthquake could shake an item loose and it could fall out of the warehouse window, for instance.
A defendant could also demonstrate that the plaintiff's own negligence contributed to the injury. To go back to the flour-barrel example, if the defendant shows that the plaintiff was standing in an area marked as dangerous it could rebut the presumption of negligence created by res ipsa.
Finally, the defendant could establish that he did not owe the plaintiff a duty of care under the law, or that the injury did not fall within the scope of the duty owed. For example, if the law only imposes a limited duty on the defendant not to behave recklessly, then res ipsa will not help the plaintiff by creating an inference of negligence since a negligent action would not violate the duty owed to the plaintiff.
According to the Blacks Law Dictionary the maxim is defined as the doctrine providing that, in some circumstances, the mere fact of accidents occurrence raises an inference of negligence so as to establish a prima facie (at first sight) case. It is a symbol for that rule that the fact of the occurrence of an injury taken with the surrounding circumstances may permit an inference or recipes omission of negligence, or make out a plaintiff's prima facie case and present a question of fact for defendant to meet with and explanation. It is merely a short way of saying that the circumstances attendant on the accident are of such a nature to justify a jury in light of common sense and past experience in inferring that the accident was probably the result of the defendant's negligence, in the absence of explanation or other evidence which the jury believes.
Its use in clinical negligence gained some traction before Bolam and Bolitho. Mahon v Osborne [1939] 1 All ER 535, is an early example of the application of res ipsa loquitur in a case where a surgical swab had been left inside a patient's body.
In Clarke v Worboys (1952) Times, 18 March, CA, a patient noticed burns on her buttock shortly after surgical excision of a breast tumour. The surgery involved cauterisation. The Court of Appeal held that this was a case where res ipsa loquitur applied. The outcome was not one that would ordinarily occur in the absence of negligence, and the surgical team were unable to explain how the injury was caused.
In Cassidy v Ministry of Health [1951] 2 KB 343, Denning LJ succinctly summarised the maxim's application to clinical negligence cases: "I went into hospital to be cured of two stiff fingers. I have come out with four stiff fingers and my hand is useless. That should not happen if due care had been used. Explain it if you can."
Ng Chun Pui Vs Lee Chuen Tat, the first defendant was driving a coach owned by the second defendant westwards in the outer lane of dual carriageway in Hong Kong. Suddenly the course across the central reservation and collided with a public bus travelling in the inner lane of the other carriageway, killing one passenger in the bus and injuring the driver and three others on the bus. The plaintiff could not prove that the defendants were negligent and had caused the accident. They however proceeded on the basis of Res Ipsa Loquitur and shifted the onus on the defendants to prove that they were not negligent. However, they failed to do so. And the judicial committee of the Privy Council held the defendants liable for the plaintiffs injuries. { MarkLuney and Ken Opliphant, Tort Law Text And Materials (Oxford University Press, New York, 2000) pp 173-175 } In A.S. Mittal & Anr Vs State Of UP &Ors , AIR 1979 SC 1570 , the defendants had organised an eye camp at Khurja along with the Lions Club. 88 low risk cataract operations were undertaken during the period of the camp. It was however, disastrous as many of those who had been operated upon lost their eyesight due to post medical treatment. Proceedings against the government initiated for negligence of the doctors. Damages worth Rs.12,500/- were paid as interim belief to each of the aggrieved. The decision was on the basis of Res Ipsa Loquitur as the injury would not ave occurred had the doctors not been negligent in not having followed up with post-operation treatment. Res Ipsa Loquitur can be applied in matters where are the procedures have not been followed and is not just limited to the commission of an act.
We can define 'Medical negligence' as the improper or unskilled treatment of a patient by a medical practitioner. This includes negligence in taking care from a nurse, physician, surgeon, pharmacist, or any other medical practitioner. Medical negligenceleads to 'Medical malpractices' where the victims suffer some sort of injury from the treatment given by a doctor or any other medical practitioner or health care professional.
Medical negligence can occur in different ways. Generally, it occurs when a medical professional deviates from the standard of care that is required.
So, we can say that any kind of deviation from the accepted standards of medication and care is considered to be medical negligence and if it causes injury to a patient then the doctor who operated on him, other staff and/or hospital may be held liable for this.
Some of the common categories of medical negligence are as follows:
Wrong diagnosis - When someone goes to a hospital, clinic or medical room, etc. the first step after admittance is the diagnosis. Diagnosing symptoms correctly is critical and important to provide medical care to any patient. However, if a patient is not treated properly due to any mistake in diagnosis, the doctor can be made liable for any further injury or damages caused as a result of the wrong diagnosis.
Delay in diagnosis - A delayed diagnosis is treated as medical negligence if another doctor would have reasonably diagnosed the same condition in a timely fashion. A delay in diagnosis can cause undue injury to the patient if the illness or injury is left to worsen with time rather than being treated. Obviously, any delay in the identification and treatment of an injury can reduce the chance of recovery for the patient.
Error in surgery - Surgical operations require an enormous level of skill and it should be done with due care and caution because even the slightest mistakes can have profound effects on the patient. The wrong-site surgery, lacerations of any internal organ, severe blood loss, or a foreign object being left in the body of the patients, all this comes under Surgical error.
Unnecessary surgery - Unnecessary surgery is usually associated with the misdiagnosis of patient symptoms or a medical decision without proper consideration of other options or risks. Alternatively, sometimes surgery is chosen over conventional treatments for their expediency and ease compared to other alternatives.
Errors in the administration of anesthesia - Anesthesia is a risky part of any major medical operation and requires a specialist (anesthesiologist) to administer and monitor its effect on the patient. Prior to any medical procedure requiring anesthesia, the anesthesiologist has to review the patient's condition, history, medications, etc. to determine the most suitable of all the medicine to use. Anesthesia malpractice can happen even during the pre-operation medical review or during the procedure itself.
Childbirth and labor malpractice - Childbirth is a difficult event for a woman and it becomes worse if not handled properly by the doctors and nurses. There are many instances of medical negligence during childbirth including the mishandling of a difficult birth, complications with induced labor, misdiagnosis of a newborn medical condition, etc. Long-Term negligent treatment - Medical negligence can also occur in subtle ways over the course of a long treatment period. Usually, the negligence can take the shape of a failure to follow up with treatment, or a doctor's failure to monitor the effects of the treatment properly.
A standard of care specifies the appropriate treatment and medication procedure as per the requirements that should be taken into account by a doctor while providing the treatment to his patients. The care should not be of the highest degree nor the lowest.Here, the degree means the level of care an ordinary health care professional, with the same training and experience, would render in similar circumstances in the same community. This is the critical question in medical malpractice cases and if the answer is "no," and you suffered injury as a result of the poor treatment, you may file a suit for medical malpractice.
In the case of Dr. Laxman Balkrishna Joshi Vs. Dr. TrimbakBapu Godbole and Anr.[ 1969 AIR 128], the Supreme Court held that a doctor has certain aforesaid duties and a breach of any of those duties can make him liable for medical negligence. A doctor is required to exercise a reasonable degree of care that is set for this profession.
Dr. Kunal Saha vs Dr. Sukumar Mukherjee on 21 October, 2011 ( NC) original petition number 240 OF 1999 is one of the most important case regarding medical negligence. The brief facts of the case are-
Toxic Epidermal Necrolysis ( TEN ) is a rare and deadly disease. It is an extoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a larze, superficial, partial-thickness burn wound. The incidence of TEN has been reported at 1 to 1.3 per million per year. The female-male ratio is 3:2. TEN accounts for nearly 1% of drug reactions that require hospitalization. TEN has a mortality rate of 25 to 70%.
Smt. Anuradha Saha (in short Anuradha), aged about 36 years wife of Dr. Kunal Saha (complainant) became the unfortunate victim of TEN when she alongwith the complainant was in India for a holiday during April-May 1998. She and the complainant although of Indian original were settled in the United States of America. The complainant is a doctor by profession and was engaged in research on HIV / AIDS for the past fifteen years. Anuradha after acquiring her Graduation and Masters Degree was pursuing a Ph.D. programme in a university of U.S.A. She was a Child Psychologist by profession. Anuradha showed certain symptoms of rashes over her body and received treatment at the hands of Opposite Parties and some other doctors as outdoor patient uptil 10.05.1998 and she was admitted in Advanced Medicare and Research Institute Limited, Calcutta (for short, AMRI), on 11.05.1998, where she was treated by the above-named Opposite Parties and other doctors uptil 16.05.1998. As there was no improvement in her condition, she was shifted to Breach Candy Hospital, Mumbai, on 17.05.1998 by an air ambulance. She was treated in Breach Candy Hospital from 17.05.1998 evening till she breathed her last on 28.05.1998.
Our Complainant as husband of Anuradha felt that the doctors who treated Anuradha and the hospitals where she was treated were grossly negligent in her treatment and her death was occasioned due to gross negligence of the treating doctors and hospitals. Complainant, accordingly, got issued a legal notice to as many as 26 persons i.e. various doctors who treated Anuradha between end of April to the date of her death alleging negligence and deficiency in service on their part and claiming a total compensation exceeding Rs.55 crores from them. Complainant, thereafter filed the present complaint on 09.03.1999 before this Commission claiming a total compensation of Rs. Rs.77,07,45,000/- ( Seventy Seven Crores Seven Lakhs Fourty Five Thousand only). Later he also filed another complaint no. 179 of 2000 in this Commission against Breach Candy Hospital, its doctors and functionaries claiming a further compensation of Rs.25.30 crore ( though the said complaint was later on withdrawn), thereby making claim of compensation exceeding Rs.102 crores, perhaps the highest ever claimed by any complainant for medical negligence before any consumer fora established under the provisions of Consumer Protection Act, 1986 (in short, the Act). These are some of the facts which make the present case extra ordinary.
The present complaint was filed by the complainant against the above-named opposite parties, namely, Dr. Sukumar Mukherjee, Dr. B. Haldar (Baidyanath Halder), Advanced Medicare and Research Institute Limited ( in short the AMRI Hospital ) and Dr. Balram Prasad and Dr.Abani Roy Chowdhury (physician) and Dr.KaushikNandy (plastic surgeon), the Directors of the AMRI Hospital and others claiming a total compensation of Rs. Rs.77,07,45,000/- under different heads alleging various acts of commission and omission on the part of the doctors and hospital amounting to negligence and deficiency in service. Complainant through his brother-in-law Malay Kumar Ganguly also filed criminal complaint against some of the doctors and the hospital under section 304A IPC.
The complaint was resisted by the doctors and the hospital on a variety of grounds thereby denying any medical negligence or deficiency in service on their part. Parties led voluminous documentary and oral evidence and testimonies of some of the witness were even recorded through video conferencing through a Local Commissioner. After a protracted trial and hearing and on consideration of the evidence and material so produced on record and taking note of the legal position governing the question of medical negligence, this Commission ( by a three Member Bench presided over by the then President) dismissed the complaint by an order dated 01.06.2006 holding as under:
In the result, we reiterate that Doctors or Surgeons do not undertake that they will positively cure a patient. There may be occasions beyond the control of the medical practitioner to cure the patients. From the record, it would be difficult to arrive at the conclusion that the injection Depo-Medrol prescribed by Dr. Mukherjee was of such excessive dose that it would amount to deficiency in service by him which was his clinical assessment.
Thereafter, with regard to the alleged deficiency in the treatment given to Mrs. Anuradha by Opposite Party Doctors 2, 3, 5 and 6, there is no substance. The contention against the hospital that it was not having Burns-Ward, and therefore, the deceased suffered is also without substance. Hence, this complaint is dismissed. There shall be no order as to costs.
Aggrieved by the dismissal of his complaint, the complainant filed Civil Appeal (No.1727 of 2007) in the Honble Supreme Court. It would appear that even before the said appeal was filed before the Hon'ble Supreme Court, the Supreme Court was seized of the matter in Criminal Appeal Nos.1191-94 of 2005 filed by Malay Kumar Ganguly, the complainant in the criminal complaint, against the Orders passed by the Calcutta High Court. Since the Criminal Appeals and the Civil Appeal filed by the complainant in the present complaint raised the same questions of fact and law, the Hon'ble Supreme Court heard all the appeals together and decided the same by means of a detailed judgment dated 07.8.2009. By the said order, the Apex Court dismissed the Criminal Appeals filed by Shri Malay Kumar Ganguly but allowed the Civil Appeal No. 1727 of 2007 filed by the complainant and set aside the order dated 01.6.2006 passed by this Commission dismissing the complaint and remanded the matter to this Commission for the limited purpose of determining the adequate compensation, which the complainant is entitled to receive from the subsisting opposite parties by observing as under:
So far as the judgment of the Commission is concerned, it was clearly wrong in opining that there was no negligence on the part of the Hospital or the doctors. We, are, however, of the opinion, keeping in view the fact that Dr.KaushikNandy has done whatever was possible to be done and his line of treatment meets with the treatment protocol of one of the experts viz.. Prof. Jean Claude Roujeau although there may be otherwise difference of opinion, that he cannot be held to be guilty of negligence.
We remit the case back to the Commission only for the purpose of determination of the quantum of compensation. We, keeping in view the stand taken and conduct of AMRI and Dr. Mukherjee, direct that costs of Rs.5,00,000 and Rs.1,00,000 would be payable by AMRI and Dr. Mukherjee respectively.
We further direct that if any foreign experts are to be examined it shall be done only through video conferencing and at the cost of the respondents.
Summary In view of the foregoing discussion, we conclude as under:
The facts of this case viz., residence of the complainant and Anuradha (deceased) in USA and they working for gain in that country; Anuradha having been a victim of a rare and deadly disease Toxic Epidermal Necrolysis (TEN) when she was in India during April-May 1998 and could not be cured of the said disease despite her treatment at two superspeciality medical centres of Kolkata and Mumbai and the huge claim of compensation exceeding Rs.77 crores made by the complainant for the medical negligence in the treatment of Anuradha makes the present case somewhat extraordinary.
The findings given and observations made by the Supreme Court in its judgment dated 07.08.2009 are absolutely binding on this Commission not only as ratio decidendi but also as obiter dicta also, the judgment having been rendered by the Supreme Court in appeal against the earlier order passed by a three Member Bench of this Commission and, therefore, no attempt can be allowed to read down / dilute the findings and observations made by the Supreme Court because the Supreme Court has remitted the complaint to this Commission only for the purpose of determination of the quantum of compensation after recording the finding of medical negligence against the opposite parties and others.
The task entrusted to the Commission may appear to be simple but the facts of the present case and the voluminous evidence led on behalf of the complainant has made it somewhat arduous. Still difficult was the task of apprortionment of the liability to pay the awarded amount by the different opposite parties and perhaps it was for this reason that the Supreme Court has remitted the matter to this Commission.
Multiplier method provided under the Motor Vehicles Act for calculating the compensation is the only proper and scientific method for determination of compensation even in the cases where death of the patient has been occasioned due to medical negligence / deficiency in service in the treatment of the patient, as there is no difference in legal theory between a patient dying through medical negligence and the victim dying in industrial or motor accident. The award of lumpsum compensation in cases of medical negligence has a great element of arbitrariness and subjectivity.
The foreign residence of the complainant or the patient and the income of the deceased patient in a foreign country are relevant factors but the compensation awarded by Indian Fora cannot be at par which are ordinarily granted by foreign courts in such cases. Socio economic conditions prevalent in this country and that of the opposite parties / defendants are relevant and must be taken into consideration so as to modulate the relief. A complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune. The theoretical opinion / assessment made by a Foreign Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court.
There exists no straight jacket formula for apportionment of the awarded compensation amongst various doctors and hospitals when there are so many actors who are responsible for negligence and the apportionment has to be made by evolving a criteria / formula which is just going by the nature and extent of medical negligence and deficiency in service established on the part of different doctors and hospitals.
On a consideration of the entirety of the facts and circumstances, evidence and material brought on record, we hold that overall compensation on account of pecuniary and non pecuniary damages works out to Rs.1,72,87,500/- in the present case, out of which we must deduct 10% amount on account of the contributory negligence / interference of the complainant in the treatment of Anuradha. That will make the net payable amount of compensation to Rs.1,55,58,750/- (rounded of to Rs.1,55,60,000/-). From this amount, we must further deduct a sum of Rs.25,93,000/- which was payable by Dr. Abani Roy Chowdhury (deceased) or his Legal Representative as the complainant has forgone the claim against them.
In view of the peculiar facts and circumstances of the case and as a special case, we have awarded a sum of Rs. 5,00,000/- as cost of litigation in the present proceedings.
The above amount shall be paid by opposite parties no.1 to 4 to the complainant in the following manner:
(i) Dr. Sukumar Mukherjee-opposite party no.1 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation].
(ii) Dr. B. Haldar (Baidyanth Halder)-opposite party no.2 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation]
(iii) AMRI hospital-opposite party no.3 shall pay a sum of Rs.40,40,000/- (Rupees Forty Lakh Forty Thousand only ) i.e. [Rs.38,90,000/- towards compensation and Rs.1,50,000/- as cost of litigation .
(iv) Dr. Balram Prasad-opposite party no.4 shall pay a sum of Rs.26,93,000/- (Rupees Twenty Six Lakh Ninety Three Thousand only) i.e. [Rs.25,93,000/- towards compensation and Rs.1,00,000/- as cost of litigation] The opposite parties are directed to pay the aforesaid amounts to the complainant within a period of eight weeks from the date of this order, failing which the amount shall carry interest @ 12% p.a. w.e.f. the date of default."
अब हम इस तथ्य को देखते हैं कि ई0आर0सी0पी0 क्या होती है और इसका क्या प्रभाव या दुष्प्रभाव शरीर पर पड़ता है ?
What is an ERCP procedure?
Definition Purpose Procedure Recovery Efficacy Complications Summary Endoscopic retrograde cholangiopancreatography (ERCP) procedures help diagnose and treat pancreatic or bile duct blockages. ERCP combines the benefits of gastrointestinal endoscopy and X-rays.
Developed in the late 1960s, doctors once primarily used the procedure to diagnose duct disorders. Nowadays, doctors use the ERCP procedure to both diagnose and treat these health issues.
Read on for more about ERCP, including how it works, recovery time, effectiveness, and possible complications.
Definition Share on The ERCP procedure diagnoses and treatsTrusted Source narrowed or blocked pancreatic or bile ducts. It combines endoscopy and fluoroscopy.
In a GI endoscopic procedure, a doctor inserts a long, thin, hollow tube called an endoscope down a person's throat and into their duodenum, or small intestine. The endoscope has a light and a viewing lens.
Once the doctor positions the hollow endoscope correctly, they pass another long narrow tube called a catheter into the endoscope. They use the catheter to deliver dye to the affected area to develop X-ray images.
With fluoroscopy, doctors get a continuous flow of X-ray images which helps themTrusted Source:
guide catheters through a person's ducts assess the condition of a person's bile and pancreatic ducts, and gallbladder remove stones and other blockages place devices called stents in ducts to keep them open Purpose Doctors use ERCP for both diagnosis and treatment. They may use it to observe the drainage ducts from the liver and the pancreas, also known as the bile or pancreatic ducts. It can also help doctors examine the gallbladder.
Treatments doctors may conduct during an ERCP procedure include:
making a small incision called a sphincterotomy, which enlarges the openings of the ducts removing stones from the bile duct placing stents in the bile or pancreatic ducts using balloons to stretch out narrowed passages in the ducts collecting a tissue sample to search for signs of cancer An ERCP procedure can also help doctors determine if a person needs surgery.
According to the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the reasons for conducting an ERCP procedure include:
a blocked bile ductTop of Form abnormal ultrasound, CT scans, or blood tests stones in the pancreatic or bile ducts pre- or post-gallbladder surgery concerns Bottom of Form Procedure The ERCP procedure takes roughly 30-60 minutes. It involves the following steps:
numbing the throat to prevent gagging and promote comfort intravenous sedative administration for relaxation or total anesthesia using air to inflate the duodenum inserting the endoscope into the duodenum inserting the catheter through the endoscope injecting dye for the X-rays through the catheter studying the X-ray images to analyze the condition of a person's ducts, collect a tissue sample for a biopsy, remove stones, or place a stent, depending on a person's condition Recovery The recovery period after an ERCP procedure is typically short. A person rests in the outpatient facility or clinic until the sedatives wear off, which usually takes 1-2 hoursTrusted Source. They should not drive themselves home.
A person can eat their regular diet after the procedure, but doctors recommend relaxing for the rest of the day. Some people may have a sore throat for a few days. Some people may also need to stay in the hospital overnight after an ERCP procedure.
Effectiveness Research shows that the ERCP procedure is generally effective and safe for people of all ages.
A relatively small 2021 study of 126 people in their 90s found that the ERCP procedure was effective. Additionally, these older participants did not have more complications than people between the ages of 65 and 89.
A study conducted in a high volume interdisciplinary endoscopy department studied the effectiveness of ERCPs on children ranging in age from 3 weeks to just under 18 years. The researchers found the success rate of these procedures was 90.7%. They also found a low rate of side effects.
Doctors are more likely to use the ERCP procedure for diagnostic purposes with younger people. In older adults, physicians are more likely to use ERCP for treatment.
Complications Compared with the complication rate of other endoscopic procedures, the complication rate for the ERCP procedure is fairly high. The most common complication is pancreatitis.
Pancreatitis is inflammation of the pancreas. It can beTrusted Source a very serious condition and requires medical care. According to a 2020 retrospective study, 16.5% of people who had the ERCP procedure developed pancreatitis in 2016.
If a person develops pancreatitis after an ERCP procedure, the resulting irritation is often due to the dye or the endoscope doctors use to perform the procedure.
After an ERCP, a person should seek immediate medical help if they notice the following:
severe pain in the belly that worsens bloody bowel movements fever chills nausea Other potential complications include:
bleeding infection piercing the bowel wall There is a slight riskTrusted Source of burns, tissue damage, and later cancer due to fluoroscopy-related radiation.
Summary ERCP is a procedure that combines endoscopy and X-ray technology. Doctors use it to diagnose and treat issues with the pancreatic ducts, bile ducts, and gallbladder.
Doctors can conduct the procedure on people of all ages. They typically perform ERCP on an outpatient basis, often with the person only partially sedated. The recovery period is generally short and does not require more than a day away from regular activities.
The ERCP procedure has a reputation for being generally safe and effective. However, it has a higher risk of complications than other endoscopic procedures. Pancreatitis is the most common complication.
अब हम pancreatitis के बारे में विस्तृत रूप से विचार करते हैं ।
Pancreatitis Overview Pancreatitis caused by gallstonesEnlarge image Pancreatitis is inflammation of the pancreas. Inflammation is immune system activity that can cause swelling, pain, and changes in how an organ or tissues work.
The pancreas is a long, flat gland that's tucked behind the stomach. The pancreas helps the body digest food and regulates blood sugars.
Pancreatitis can be an acute condition. This means it appears suddenly and generally lasts a short time. Chronic pancreatitis is a long-term condition. The damage to the pancreas can get worse over time.
Acute pancreatitis may improve on its own. More-serious disease requires treatment in a hospital and can cause life-threatening complications.
Products & Services A Book: Mayo Clinic Family Health Book, 5th Edition Show more products from Mayo Clinic Symptoms Symptoms of pancreatitis may vary. Acute pancreatitis symptoms may include:
Pain in the upper belly.
Pain in the upper belly that radiates to the back.
Tenderness when touching the belly.
Fever.
Rapid pulse.
Upset stomach.
Vomiting.
Chronic pancreatitis signs and symptoms include:
Pain in the upper belly.
Belly pain that feels worse after eating.
Losing weight without trying.
Oily, smelly stools.
Some people with chronic pancreatitis only develop symptoms after they get complications of the disease.
When to see a doctor Make an appointment with your doctor if you have sudden belly pain or belly pain that doesn't improve. Seek immediate medical help if your pain is so severe that you can't sit still or find a position that makes you more comfortable.
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Causes The pancreas has two major roles. It produces insulin, which helps the body manage and use sugars.
The pancreas also produces dietary juices, called enzymes, that help with digestion. The pancreas makes and stores "turned off" versions of the enzymes. After the pancreas sends the enzymes into the small intestine, they are "turned on" and break down proteins in the small intestine.
If the enzymes are turned on too soon, they can start acting like digestive juices inside the pancreas. The action can irritate, damage or destroy cells. This problem, in turn, leads to immune system responses that cause swelling and other events that affect how the pancreas works.
Several conditions can lead to acute pancreatitis, including:
Blockage in the bile duct caused by gallstones.
Heavy alcohol use.
Certain medicines.
High triglyceride levels in the blood.
High calcium levels in the blood.
Pancreas cancer.
Injuries from trauma or surgery.
Conditions that can lead to chronic pancreatitis include:
Damage from repeated acute pancreatitis.
Heavy alcohol use.
Inherited genes linked to pancreatitis.
High triglyceride levels in the blood.
High calcium levels in the blood.
Sometimes, a cause for pancreatitis is never found. This is known as idiopathic pancreatitis.
Risk factors Factors that increase your risk of pancreatitis include:
Excessive alcohol use. Research shows that having four or five drinks a day increases the risk of pancreatitis.
Cigarette smoking. Compared with nonsmokers, smokers are on average three times more likely to develop chronic pancreatitis. Quitting smoking can decrease the risk.
Obesity. People with a body mass index of 30 or higher are at increased risk of pancreatitis.
Diabetes. Having diabetes increases the risk of pancreatitis.
Family history of pancreatitis. A number of genes have been linked to chronic pancreatitis. A family history of the disease is linked to an increased risk, especially when combined with other risk factors.
Complications Pancreatitis can cause serious complications, including:
Kidney failure. Acute pancreatitis may result in the kidneys not filtering waste from the blood. Artificial filtering, called dialysis, may be needed for short-term or long-term treatment.
Breathing problems. Acute pancreatitis can cause changes in how the lungs work, causing the level of oxygen in the blood to fall to dangerously low levels.
Infection. Acute pancreatitis can make the pancreas vulnerable to infections. Pancreatic infections are serious and require intensive treatment, such as surgery or other procedures to remove the infected tissue.
Pseudocyst. Acute and chronic pancreatitis can cause fluid and debris to collect in a "pocket" in the pancreas, called a pseudocyst. A large pseudocyst that ruptures can cause complications such as internal bleeding and infection.
Malnutrition. With both acute and chronic pancreatitis, the pancreas may not produce enough enzymes for the digestive system. This can lead to malnutrition, diarrhea and weight loss.
Diabetes. Diabetes can develop when chronic pancreatitis damages cells that produce insulin.
Pancreatic cancer. Long-standing inflammation in the pancreas is a risk factor for cancer of the pancreas.
Abstract Endoscopic retrograde cholangiopancreatography (ERCP) carries a post-ERCP pancreatitis (PEP) rate of 2-10%, which could be as high as 30-50% in high-risk cases. PEP is severe in up to 5% of cases, with potential for life-threatening complications, including multi-organ failure, peripancreatic fluid collections, and death in up to 1% of cases. The risk of PEP is potentially predictable and may be modified with pharmacological measures and endoscopist technique. This review covers the definition, epidemiology and risk factors for PEP, with a focus on the latest evidence-based medical and endoscopic strategies to prevent and manage PEP.
1. Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is the primary therapeutic approach for disorders affecting the pancreatobiliary tree, including stone clearance and relief of benign and malignant biliary obstruction. Of all the mainstay endoscopic modalities, ERCP carries the highest risk of complications and mortality, with post-ERCP pancreatitis (PEP) being the most frequent complication after sedation-related adverse events, even after a seemingly straightforward procedure [1]. Although most patients with PEP take an inconspicuous or mild clinical course, some develop severe complications, such as multi-organ failure, pancreatic and/or peripancreatic fat necrosis, collections and even death. This review focuses on the diagnosis and medical management of PEP and evidence-based measures to prevent PEP.
2. Diagnosis of PEP A consensus paper in 1991 defined PEP as "clinical evidence of pancreatitis" after ERCP associated with a three-fold increase of serum amylase at ≥24 h and necessitating hospital admission or prolonged hospital stay [2]. Thereafter, in 1996, Freeman added pain (i.e., new or worsening abdominal pain) as a further criterion to the PEP definition [3]. The 2020 ESGE guideline on ERCP-related adverse events defines PEP as a condition that is associated with new or worsened abdominal pain combined with elevated pancreatic enzymes (amylase or lipase ≥ 3 times upper limit of normal), thus prolonging a planned hospital admission or necessitating hospitalization after an ERCP [1].
In terms of diagnosing PEP, abdominal discomfort is common after ERCP; thus, clinical assessment, in combination with serum amylase and/or lipase, is essential to differentiate between transient post-procedural bloating; PEP; and other complications, e.g., perforation, cholangitis and unresolved biliary obstruction (such as from retained CBD stones). Early cross-sectional imaging can be helpful for diagnosis and to exclude a structural cause for PEP, e.g., retained stone, which may necessitate early repeat ERCP. The management of PEP (discussed below) is similar to that of acute pancreatitis. Endoscopists should be encouraged to clearly document the difficulty level of ERCP, type of ampulla, number of attempts required to achieve selective biliary cannulation, biliary cannulation technique, use of air vs. carbon dioxide and time required to complete the procedure, because these factors are predictors of difficult ERCP and possible PEP.
PEP can be classified by severity. The consensus paper initially defined mild and moderate PEP solely on the duration of the hospitalization (i.e., hospital stay to 2-3 days or 4-10 days, respectively). Severe PEP was defined as hospitalization > 10 days or hemorrhagic pancreatitis or pseudocyst requiring intervention (percutaneous drainage or surgery). The revised Atlanta classification sees local complications, systemic complications and organ failure and its duration or the absence thereof at 48 h as factors to stratify the severity of acute pancreatitis [4]. Severe pancreatitis occurs in approximately 5% of PEP cases [5] and is defined by the presence of persistent (>48 h) organ failure, moderate as transient (≤48 h) organ failure or local or systemic complications and mild as the absence of complications [4]. The revised Atlanta classification appears to better predict the severity and mortality of PEP compared to the consensus criteria [6].
2.1. Pathophysiology of PEP PEP is thought to result from an interplay of mechanical obstruction and/or hydrostatic injury, which causes early activation of pancreatic enzymes, leading to local and potentially systemic inflammation [7]. Obstruction can be caused by oedema or trauma to the papilla most often through over-manipulation. Thus, it is crucial to recognize this and to consider alternative cannulation techniques when standard attempts fail. Hydrostatic injuries can be induced by pancreatic duct (PD) injection with the use of contrast agents or water, especially in the case of acinarization. Further causes for injuries include perforation of the pancreatic duct side branch with guidewire, use of electrocautery and possibly allergic reaction to the contrast agent [8].
2.2. Incidence and Mortality of PEP Cotton and colleagues (1991) analyzing the complications of biliary sphincterotomy (EST) in over 11,400 ERCP reported a PEP rate of 2.1% and a mortality rate of 0.2% [2]. Freeman and colleagues (1996) analyzing over 2300 ERCP showed a PEP rate of 5.4% with a mortality rate of <0.1% [3]. A systematic review of RCTs in 2015 with almost 13,300 patients revealed a PEP rate of 9.7% and an overall mortality rate of 0.7% with an interestingly differing PEP and mortality rate according to geographic locations with 8.4% and 0.2% in Europe, 9.9% and 0% in Asia, and 13% and 0.1% in North America, respectively [5]. Another systematic survey of prospective studies with almost 17,000 patients reported a lower PEP incidence of 3.47% [9]. A large American retrospective study comprising over 1.2 million patients between 2011 and 2017 concluded that the mortality rate increased from 2.8% of PEP patients to 4.4% at the end of study period, despite the PEP rate being 4.5% and thus comparable to previous publications. In patients with Sphincter of Oddi dysfunction (SOD), the reported PEP rate was as high as 15% [10,11]. A recent Japanese RCT with 370 patients undergoing biliary stenting revealed that patients without biliary sphincterotomy conveyed a PEP rate of 20.6% compared to 3.9% in patients with prior sphincterotomy [12] 2.3. Risk Factors Associated with PEP Because of the potentially severe but modifiable nature of PEP, it is important to recognize its risk factors, most of which can be patient-related or procedure-related (Table 2).
Table 2. Excerpt of patient and ERCP-related risk factors for PEP (adapted from Dumonceau 2020 and * Mutneja 2020). OR: Odds Ratio; PEP: post-ERCP pancreatitis; SOD: Sphincter of Oddi Dysfunction.
3. Patient-Associated Factors Patient-related factors include female gender, previous pancreatitis, previous PEP and suspicion of SOD, younger age, non-dilated common bile duct, normal bilirubin and end stage renal disease [1]. Other modifiable factors, such as alcohol and cocaine use, and non-modifiable factors, including race, obesity and congestive heart failure, may also be implicated [13]. A comparison of ESGE and ASGE guidelines in ERCP-related adverse events showed similar patient- and procedure-related factors [1,14]. ESGE further classifies patient- and procedural-related factors into "definite" and "likely" groups. An ERCP can be considered as high-risk for PEP if one definite factor (either patient- or procedure-related) or two likely factors are fulfilled .
4. Endoscopist-Associated Factors It is plausible that less experienced endoscopists would incur higher rates of PEP and other adverse events (AEs). Lee et al. [15] found that endoscopist with lesser experience, possibly due to difficulty in bile duct cannulation, had a higher PEP rate compared to more experienced endoscopists (OR 1.63; 95% CI, 1.05-2.53). This could partially be explained that lesser experience leads to prolonged cannulation time, which is associated with a higher PEP rate [16]. A meta-analysis by Keswani et al. found that high-annual volume endoscopists had a 60% higher ERCP success rate than low-annual-volume endoscopist and 30% less overall chance of an AE, but there was no difference in PEP when stratified by high-volume endoscopists or centers [17]. However, there was considerable heterogeneity in the definition of high-volume vs. low-volume endoscopists amongst the included studies, with cutoffs ranging from 25 to 156 annual procedures.
Several studies have explored whether trainee involvement in ERCPs may increase the risk of PEP. Using the national inpatient sample with over 480,000 ERCP in the USA, a study looked into the so-called "July effect" and post-ERCP sepsis [18]. The "July effect" is an academic period between July and September which marks the enrollment of new fellows. The study found a higher PEP and post ERCP-sepsis rate compared to a period of October-June (1.2% vs. 1.1%, p = 0.004 and 9.4% vs. 8.8%, p < 0.001, respectively). However, a multicenter study from Europe showed that ERCP success and AE was similar in both trainee and non-trainee groups [19]. This was also replicated in a recent Chinese study involving 4000 ERCPs [20]. With adequate trainer supervision and taking over the procedure as required, it is possible to maintain patient safety while delivering hands-on training until trainees are deemed to be competent for independent practice [21].
5. Procedure-Associated Factors Since overmanipulating the papilla is a risk factor for PEP, it is important to study the papilla and optimize conditions before attempting cannulation. Haraldsson and colleagues (2017) proposed a visual system to classify the papilla (Figure 1). Using this classification, two recent studies indeed showed a higher rate of difficult cannulation and PEP for a protruding-type and small-type papilla [22,23], but on multivariable analysis, papilla morphology was not a significant risk for any complication [22]. An earlier German study classifying the papilla according to size and roof concluded that these had no effect on successful biliary cannulation, whereas stable scope position and visualization of the papilla were predictive [24].
Figure 1. A proposed classification of the papilla morphology and the associated difficulty during bile duct cannulation. * Significantly higher risk vs. Type 1 papillae.
Biliary cannulation can be technically challenging. ESGE defines difficult cannulation as cannulation time > 5 min, >5 contacts with the papilla or ≥1 accidental PD cannulation (the so-called "5-5-1" rule) [25]. An analysis of 1067 patients found that PEP rate was 3.9% for cannulation times between 3 and 5 min and as high as 11.9% after 5 min of cannulation attempts. PEP rate was as high as 16% in patients with > 5 min cannulation attempts and a PD cannulation [16]. Therefore, early adoption of a rescue cannulation technique (mostly precut fistulotomy) and/or change of operator should be considered according to local expertise available [15]. In trainees' hands-on procedures, a recent study proposed a "15-10-2" rule (i.e., 15 min of cannulation attempts, 10 contacts with the papilla and ≥2 accidental PD cannulations), as rates of successful biliary cannulation, PEP and overall AE were similar to experienced endoscopists, using the "5-5-1" rule [20].
The degree of PD manipulation directly correlates with PEP rates. In patients with a small CBD (<9 mm), PEP rates range from 4.6% without any PD manipulation to 8.3% with contrast material alone to 16.9% with guidewire alone to 22.1% with both contrast material and guidewire [26].
6. Prevention of PEP 6.1. Patient Selection The best way of preventing PEP is by avoiding unnecessary ERCP. There should be measures in place to ensure appropriate referrals and case selection, with access to multidisciplinary team review, to ensure that ERCP is absolutely indicated for strategic planning of complex cases and to ensure that cases are appropriate for the endoscopist's skill set [21]. Safer alternatives to ERCP, such as EUS or MRCP for confirming choledocholithiasis, should be considered if available and accessible [27]. A Japanese study reported that, in patients with a negative MRCP, EUS found stones in ~35% of the cases, and on the contrary, no stone was found in MRCP after a negative EUS [28]. Despite this, single session EUS/ERCP sessions for low-risk bile duct stones are limited by availability, expertise, reimbursement and logistical planning. Surgery may be an alternative to ERCP for CBD stones and malignant strictures. Laparoscopic CBD exploration in conjunction with cholecystectomy for the intraoperative removal of CBD stones can be performed [1]. For surgically fit patients with resectable malignant strictures, those with lower levels of bilirubin may benefit from early surgery, leaving ERCP for patients who have to wait longer until surgery or with complications e.g., cholangitis, severe pruritus or have a very high level of bilirubins prone to cholangitis and/or acute kidney failure [29]. A Dutch RCT of patients with resectable pancreatic carcinoma, which compared preoperative ERCP with fully covered biliary metal stents (FC-SEMS) vs. plastic stent (PS) vs. early surgery found that the early surgery group had an overall lower risk of AEs compared to patients assigned to FC-SEMS and PS, respectively [29].
Endoscopists should know the case in advance, study the relevant imaging, plan the team and necessary accessories and prepare a procedural roadmap. Patients requiring general anesthesia or at high ASA risk should undergo anesthetic review to ensure patient safety and comfort. Risk factors for PEP should be considered to provide an approximate estimate of risk which helps for counselling and consenting the patient and scheduling post-procedure aftercare. Performing a team timeout before the procedure could help ensure that everything needed is in place or within a short reach and align the team's mind to reach the goal of the ERCP.
6.2. Medical Prophylaxis of PEP 6.2.1. Non-Steroidal Anti-Inflammatory Drugs The use of non-steroidal anti-inflammatory drugs (NSAIDs) for PEP prophylaxis has been enshrined into ERCP practice. The recent ESGE guidelines cited as many as 27 meta-analyses showing reduced PEP with NSAID prophylaxis, with an NNT to prevent PEP of 8 to 21 [1].
In addition to rectal suppositories, other routes of administration have also been studied. Oral diclofenac [30,31], celecoxib [32] or a combination of udenafil and aceclofenac [33] have not been found to reduce PEP compared to a placebo or saline infusion. Placebo-controlled studies have also found no significant difference in PEP rates with intravenous valdecoxib [34], or with the combination of intramuscular diclofenac and isotonic saline [35]. Geraci and colleagues performed a five-arm study (n = 20 per arm) comparing diclofenac given orally, intramuscular, intravenous, rectal and placebo and found PEP to be lowest (i.e., 0%) in the rectal diclofenac group [36].
The optimal timing of NSAID has also been debated; a Lancet RCT of 2600 patients demonstrated an overall PEP rate of 4% vs. 8% in patients receiving pre-ERCP and post-ERCP NSAIDs, respectively (OR, 0.47; 95% CI, 0.36-0.66) [37]. A sub-analysis of 346 patients from the FLUYT trial showed a PEP rate of 8% in the pre-ERCP NSAID group vs. 18% in the post-ERCP NSAID group [38]. The dose of rectal suppositories used was 100 mg for both diclofenac and indomethacin. A recent large RCT (n = 1037) comparing 100 mg and 200 mg post-ERCP indomethacin in high-risk patients found no difference in PEP rates [39]. Retrospective studies from Japan on the effect of low-dose rectal diclofenac (25-50 mg) have not shown this to be effective for PEP prophylaxis [40,41,42,43].
The combination of NSAID and aggressive hydration has shown a lower OR of PEP in two recent meta-analyses [44,45]. The result of the FLUYT RCT dispelled this idea; FLUYT enrolled 826 patients with moderate-to-high-risk PEP and found no difference in PEP rates between patients randomized to rectal NSAID (8%) versus the combination of rectal NSAID and aggressive fluid therapy (9%) [46].
NSAIDs are not recommended in pregnancy >30 weeks of gestation, patients with a history of allergic or pseudoallergic reaction to NSAID such as a NSAID-exacerbated respiratory syndrome or history of severe reaction such as Lyell's Syndrome or Stevens-Johnsons-Syndrome attributed to NSAID. In these patients and their first-degree relatives NSAID should be avoided [1]. Despite this, it is worth emphasizing that AEs from a single dose NSAIDs in our clinical experience are rare.
6.2.2. Intravenous Fluids Intravenous fluids should be considered when NSAIDs are contraindicated [1]. Two meta-analyses support the role of fluid therapy for PEP prophylaxis [47,48]. Despite no significant differences in adverse events between aggressive and standard hydration in one meta-analysis [47] and in the FLUYT-trial [46], caution should be exercised in patients with significant fluid overload, e.g., congestive heart failure, decompensated cirrhosis and severe chronic kidney disease. ESGE recommends applying 3 mL kg/h during ERCP and 20 mL/kg as a bolus after ERCP, followed afterward by 3 mL/kg/h over 8 h [1].
6.2.3. Glyceryl Trinitrate Topical GTN appears to reduce the contractility of the sphincter of Oddi [49] and may reduce PEP. A meta-analysis of 12 RCTs found GTN to lower the overall incidence of PEP but not significantly lower the rate of moderate and severe PEP [50], with sublingual application (albeit only in 2 out of 12 RCTs) being more effective than intravenous or transdermal routes. Due to its proposed mechanism of lowering sphincter of Oddi pressure, an incremental benefit in cases of pancreatic stenting is not clear. A United States Cooperative for Outcomes Research in Endoscopy (USCORE) evaluation of pharmacologic prevention for PEP recommended the use of sublingual nitroglycerin in patients with NSAID allergy or in cases where pancreatic stenting is not possible, as well as additive prophylaxis to NSAIDs in high-risk patients, who do not receive pancreatic stenting [51]. GTN can lead to hypotension and headache; thus, it should be used with caution in these contexts, especially with intravenous and sublingual formulations [50].
6.2.4. Other Agents There are further pharmacological agents that were studied regarding PEP, such as somatostatin and octreotide (an inhibitor of exocrine pancreas function). The largest study in somatostatin to reduce PEP was a multicenter, open-label RCT with over 900 patients, which showed a 4% PEP rate in the somatostatin group vs. 7.5% in the control group [52]. In the study, somatostatin was given as a 250 μg bolus injection before ERCP and as a 250 μg/hour intravenous infusion for 11 h after ERCP [52]. A meta-analysis regarding somatostatin in PEP prophylaxis revealed an overall risk reduction with somatostatin (OR, 0.6; 95% CI, 0.41-0.89), but this was only significant in high-risk patients and not in low-risk patients [53]. Despite this, the ESGE currently does not recommend somatostatin due to the uncertainty of the estimates (upper-bound CI of the meta-analysis was close to 1) [1]. Aligning with this recommendation, a recent Iranian RCT (n = 376) reported no difference in rates of PEP in patients receiving intravenous somatostatin (250 ug bolus and 500 ug infusion over 2 h) and rectal indomethacin (11.4%) versus 100 mg rectal indomethacin alone (15.2%; p = 0.666) [54]. Protease inhibitors such as gabexate [55], ulinastatin [56] and nafamostat [57] and topical epinephrine (which reduces papillary oedema) [58] have also been studied but are not recommended by ESGE due to uncertain efficacy [1].
7. Procedural Factors to Prevent PEP 7.1. Approaches for Difficult Biliary Cannulation The ESGE recommends wire-guided biliary cannulation because of higher success rate and avoidance of pancreatic duct contrast injection [1]. Before cannulation, it is crucial to have a stable scope position, study the papilla's morphology, identify the orifice and plan the trajectory of cannulation to avoid excessive papillary trauma. Depending on access and ampullary morphology, it may be reasonable to start with an alternate sphincterotome or with a slimmer (0.025″) hydrophilic guidewire [59].
It is prudent to define difficult cannulation using the "5-5-1" or "15-10-2" rule in the presence of a trainee, which then should prompt second-line access strategies. In these cases, early precut-papillotomy or needle-knife fistulotomy (NKF) was shown to reduce PEP [60,61], but this requires a higher level of training and expertise. A comparison of different expertise levels in primary NKF for bulging papillae (i.e., Haraldsson Type 3) and conventional sphincterotomy has shown a higher PEP rate after conventional sphincterotomy in the low-expertise group but, interestingly, no difference in outcomes with primary NKF [62]. Repeating ERCP on another day, typically after 2-4 days, is another viable consideration. Deng [63] and Colan-Hernandez [64] reported successful biliary cannulation in approximately 80% on repeat procedures after failed index ERCP with a biliary precut papillotomy. It is recommended to stop the procedure after a prespecified time (e.g., 45 min) if cannulation does not succeed and reattempt another day.
7.2. Inadvertent PD Cannulation In the case of inadvertent pancreatic duct (PD) cannulation, it is advisable to adopt an early pancreatic guidewire-assisted technique, such as double-guidewire technique (DGW) or transpancreatic biliary septotomy (TPS). For the DGW technique, the guidewire is left in the PD as a reference point, and biliary cannulation is then performed by using a second guidewire [65]. This offers several advantages, including (1) estimation of the location of the bile duct (often at the upper left side) relative to the PD orifice, (2) straightening the angle of the bile duct and (3) partially occluding the PD orifice to redirect the second wire into the CBD. A recent RCT showed that early DGW after one inadvertent PD cannulation led to higher rates (84%) of successful biliary cannulation in 10 min compared with repeated single-wire cannulation (50%) without affecting PEP rates [66].
TPS is a technique in which papillotomy is performed from the PD toward the direction of the bile duct. This is thought to cut the septum between the two sphincters and open the bile duct orifice, facilitating easier cannulation. In an RCT comparing TPS with DGW in difficult cannulation, higher rates of biliary cannulation were achieved with TPS (84.6% vs. 69.7%) with comparable rates of PEP (13.5% vs. 16.2%) [67]. A recent meta-analysis (comprising four RCTs with 260 patients) showed a higher successful biliary cannulation rate in the TPS vs. DGW (93% vs. 79%), with lower PEP rates (8.9% vs. 22.2%). Of note, the use of prophylactic PD stenting and/or NSAID was not clearly mentioned in the cited studies. In the RCT in which all patients received PD stenting, the risk of PEP was low (approximately 2.9%) in both groups [68].
In order to perform TPS or DGW successfully, the guidewire must first be secured in the PD. After completing the procedure, it is reasonable to place a pancreatic stent for PEP prophylaxis [25]. A European multicenter study comparing pancreatic stent placement vs. no stent placement after inadvertent PD cannulation showed a reduced PEP rate of 12% to 25%, although it is unclear if NSAIDs were administered [69]. Another RCT studied the combination of pharmacological prophylaxis and pancreatic stenting vs. pharmacological prophylaxis alone in over 400 high-risk patients and showed a comparable PEP rate of 14.3% vs. 15.9% [70]. In this study, all patients received pharmacological prophylaxis with 100 mg rectal indomethacin and 5 mg sublingual isosorbide dinitrate pre-ERCP. Both groups also had fluid therapy consisting of Ringer's lactate 6 mL/kg/h during ERCP, followed by a 20 mL/kg bolus after the procedure and 3 mL/kg for 8 additional hours. Thus, it is unclear if PD stenting would provide incremental benefit in addition to extensive pharmacological and fluid prophylaxis.
7.3. Prophylactic PD Stenting PD stents are currently the mainstay prophylactic measure for high-risk patients and nearly eliminates the risk of severe PEP [1]. In the study by Philip et al. [69], the number needed to treat (NNT) for PD stenting to prevent one case of PEP was 8.1. Despite their efficacy, variation in practice exists. A 2012 survey found that only half of UK endoscopists had ever considered prophylactic PD stenting [71]. Retained PD stents must be extracted within 2 weeks, as stent retention beyond this can result in stent-induced PD fibrosis and a 5.2-fold higher risk of PEP [72,73]. The ESGE recommends assessing for spontaneous migration of the PD stent by 5-10 days post-ERCP (with plain abdominal radiography) and for urgent extraction if retained. In the RCT by Chahal et al. [73], the placement of an unflanged short (3 cm) 5 Fr stent was found to be easier to deploy than a longer (8 cm+) 3 Fr stent and led to higher rates of stent dislodgement at 14 days (98% vs. 88%, p < 0.001), thus reducing the need for endoscopic extraction. The advent of biodegradable PD stents allows for rapidly degrading stents (within 12 days), thus obviating the need for abdominal radiography +/− stent extraction [74].
In cases where the guidewire did not inadvertently cannulate the PD, repeated attempts at PD cannulation solely for the purpose of PD stent placement is not advisable, as failed attempts at PD stenting can lead to an extremely high risk of PEP (up to 65%) [75].
7.4. Other Intraprocedural Modifiers In patients requiring endoscopic papillary balloon dilation (EPBD, aka balloon sphincteroplasty), the duration of dilation appears relevant. An RCT showed that, in EPBD with a 10 mm balloon, dilation of <1 min was associated with a higher rate of PEP (15%) compared to 5 min with a PEP of 4.8% and with higher success of stone extraction in the 5 min group [76]. Another study found that dilation of <3 min had an increased PEP rate of 13% vs. 3% in the 3-5 min group [77]. A large RCT combining small sphincterotomy (3-5 mm), followed by balloon dilation with four different durations (0 s, 30 s, 60 s, 180 s and 300 s) found that 30 s balloon dilatation time after sphincterotomy had lower PEP incidence than the 300 s group (7% vs. 15%) [78]. Thus, in patients needing a combination of EPBD and EST a dilation duration of 30 s could lead to less PEP.
For biliary strictures, self-expandable metallic stents (SEMSs) may be deployed without sphincterotomy, especially in patients who are at a high bleeding risk. From retrospective studies, the rates of PEP appear to be higher with SEMS (8.0%) vs. plastic stents (4.8%) [79] but similar for covered vs. uncovered SEMS (6.9% vs. 7.5%, p = 0.82) [80]. In a recent RCT, sphincterotomy before stent deployment was associated with lower rates of PEP (3.9%) versus those without sphincterotomy (20.6%, p < 0.001) [12].
8. Management of PEP The therapy for PEP is similar to that of acute pancreatitis. Analgesia and supportive care with fluids are often sufficient in most patients with PEP [81]. PEP severity should be assessed according to the revised Atlanta classification to identify patients with moderate or severe cases and channel them to the appropriate level of care, e.g., high-dependency or intensive care unit with organ support where necessary. Because of the criteria currently applied (local complications or persistent organ dysfunction > 48 h), classifying PEP's severity correctly could only be performed in retrospect. Nonetheless, early identification of predicted severe pancreatitis is theoretically lifesaving. A plethora of other scores for estimating severity, e.g., APACHE-II and Ranson Score or Pancreatitis Outcome Prediction score [82], can also be used to predict severe PEP.
Fluid therapy should be started after the diagnosis is confirmed. Some evidence points toward a benefit for Lactated Ringer Solution instead of normal saline, but this is controversial [83]. An analysis of three RCTs and five retrospective studies found that, on the first day, a starting infusion rate of >300 mL/h or <200 mL/h could be harmful to the patients and recommend an infusion rate of 200-300 mL/h, which means a total volume of ca. 4800-7200 mL of fluid on the first day [84]. A multicenter trial (Waterfall trial-NCT04381169) studying fluid therapy with Ringer's lactate compared aggressive vs. moderate fluid therapy in acute pancreatitis. The aggressive arm received 20 mL/kg bolus--administered over 2 h, followed by 3 mL/kg/h for 12 h--vs. a moderate arm receiving a bolus 10 mL/kg--administered over 2 h in case of hypovolemia or no bolus in patients with normovolemia, followed by 1.5 mL/kg/h for 12 h; afterward, all patients with normovolemia received 1.5 mL/kg/h. The final results of this trial will be available in the following weeks (accepted, under press embargo) [85].
9. Duty of Candor The United Kingdom General Medical Council defines candor as openness and honesty when things go wrong. In its duty-of-candor guidelines [86], it states that every healthcare professional must be open and honest with patients in their care when something goes wrong or if it causes, or has the potential to cause, harm or distress. It stresses that it is always right to say "sorry" and gives information about things that perhaps went wrong and that this is not an admission of liability. A lot of factors leading to PEP are sometimes outside of the hand of the endoscopist and are not due to error, but the endoscopist still holds a major active role in the process. Thus, in the advent of PEP, saying sorry to the patient and his/her family and explaining the situation and the treatment of PEP with an outlook of what to come should always be considered, along with any shared learning.
10. Summary PEP is a potentially life-threatening complication of ERCP which can be mitigated through a combination of pharmacological and intraprocedural measures, prompt diagnosis and early management. Efforts to reduce PEP risk has led to the publication of a plethora of high-quality RCTs in recent years, along with the release of international guidelines on PEP (Table 4). Implementation of evidence-based best practices, quality assurance and ERCP training will help to further minimize PEP risk and improve patient safety in ERCP.
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अब हमें यह भी देखना होगा कि ई0आर0सी0पी0 और एम0आर0सी0पी0 की क्या प्रक्रिया है और क्या फायदे हैं ?
Endoscopic retrograde cholangiopancreatography (ERCP) and magnetic resonance cholangiopancreatography (MRCP) are medical tests. They're used to diagnose problems in the bile and pancreatic ducts, such as:
gallstones acute or chronic pancreatitis tumors cancers infection ERCP involves an endoscope and X-ray to create images of your ducts. It's a gold-standard method for diagnosing bile and pancreatic issues. However, it's invasive and associated with various complications.
MRCP is a type of magnetic resonance imaging (MRI) technique. It uses magnets and radio waves to produce images of the ducts. The procedure is noninvasive and doesn't use radiation, unlike ERCP.
How is preparation for the procedures different?
Before you get either procedure, your doctor will consider any allergies or medical conditions you have.
These factors might increase your risk of complications related to contrast dye, which is used to produce better images. It's used in ERCP and some MRCP tests.
Depending on your risk factors, your doctor might take extra precautions when planning your procedure.
Preparation also depends on the test.
ERCP preparation ERCP involves sedatives. Therefore, here's what preparation will involve:
You might need to stop taking your medications for a short time if they interact with sedatives. You may also need to temporarily stop taking medications that control blood clotting.
Ask a trusted friend or relative to help you get home. You'll be asked to avoid driving for 24 hours after the procedure.
Avoid eating, drinking, smoking, or chewing gum 8 hours before ERCP. This will let your doctor view your intestinal tract properly.
MRCP preparation Since MRCP is less invasive, the preparation process is less strict. It may involve the following:
Wear comfortable clothing.
Take off all your jewelry.
Let your doctor know if you have an implanted device.
You might need to avoid eating or drinking for a few hours before the procedure.
Comparing ERCP and MRCP procedures Here's how ERCP and MRCP compare.
Equipment ERCP uses an endoscope, which is a long tube with a tiny camera at the end, and a catheter. Both tools are inserted into your small intestine. ERCP also involves X-ray, which uses radiation to create images of the ducts.
MRCP involves an MRI machine. It uses magnets and radio waves to take images.
Purpose Both techniques are used to detect pancreatic and bile duct problems. They produce similar images that can be used for diagnosis.
ERCP also allows your doctor to complete certain treatments, such as:
sphincterotomy stent placement stone removal If you're unable to get ERCP, MRCP can be used as a substitute. MRCP can also determine if you need ERCP as a pre-surgery procedure.
Location Both tests may be done at a hospital or outpatient center. You can also receive either test as part of a hospital stay.
Process During both procedures, you'll be lying down on a table.
ERCP takes 1 to 2 hours. It generally involves the following:
Your doctor will give you an intravenous (IV) line of sedatives to help you relax.
They will also give you a local or general anesthetic.
Your doctor will insert an endoscope into your mouth until it reaches your small intestine.
They'll locate the ducts and insert a catheter into the endoscope until it reaches the ducts.
Your doctor will inject a contrast dye into the ducts and take an X-ray.
The process of getting MRCP takes 45 to 60 minutes. It involves:
You'll lie flat on your back on a table, which will slide into the MRI machine.
If you're also getting a standard MRI, a contrast dye will be injected into your arm.
You'll be asked to stay still during the entire test. You'll also be asked to hold your breath for 12 to 18 seconds several times.
The MRI machine will take multiple images of your ducts.
Recovery from ERCP and MRCP After ERCP, you'll need to wait for the sedative or anesthesia to wear off. You'll likely need to stay at the hospital or outpatient center for 1 or 2 hours.
You may also experience the following after ERCP:
bloating nausea sore throat It's recommended to rest when you're back home. You can return to your usual diet when your sore throat goes away.
MRCP requires little to no recovery. You can go home after the procedure. If you took a sedative, you'll need a ride home.
Difference between ERCP and MRCP risks Since ERCP is invasive, the procedure is associated with more risks than MRCP. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), complications occur in 5 to 10 percent Trusted Source of ERCP tests.
Potential ERCP complications include:
pancreatitis, which is the most common complication infection of the gallbladder or bile ducts gastrointestinal bleeding puncture of ducts or small intestine atypical reaction to the sedative or dye tissue damage from the X-ray MRCP is non invasive, so there are fewer risks. They include:
kidney scarring from the dye allergic reaction to the dye issues relating to implanted devices Which procedure is right for you?
If you're allergic to iodine, it's best to avoid ERCP. That's because the contrast dye used in ERCP contains iodine. In this case, MRCP is the safer choice.
But if you need another treatment, like a stone removal, ERCP is the better choice. MRCP won't allow your doctor to complete other treatments.
What about hepatobiliary iminodiacetic acid (HIDA) scan?
A hepatobiliary iminodiacetic acid (HIDA) scan is used to take images of the bile ducts, gallbladder, liver, and small intestine. It involves a radioactive tracer that's injected into your vein.
It's also called:
hepatobiliary scan cholescintigraphy hepatobiliary scintigraphy A HIDA scan might diagnose a condition that can be treated with ERCP. It might also be used after MRCP to confirm the results.
What about the cost?
The cost of ERCP and MRCP can vary greatly. It depends on many factors, like your insurance provider and where you live.
According to MDsave.com, the average cost for ERCP is $11,234.
The average cost for MRCP is $4,656, according to a 2015 articleTrusted Source.
Both ERCP and MRCP are only used to diagnose medical conditions. If you have health insurance, this means your provider should cover some or all of the costs.
Takeaway ERCP and MRCP are used to diagnose problems with the bile and pancreatic ducts. ERCP is more invasive, but it can be used as a treatment for certain conditions. MRCP is noninvasive and is ideal if you're unable to get ERCP.
Your doctor can determine which test is best for you. They'll consider factors like your medical history and symptoms. In some cases, they might use MRCP to determine if you need ERCP.
What is ERCP? (Endoscopic Retrograde Cholangio-Pancreatography) ERCP is a procedure that allows your doctor to see the small tubes inside your body called the pancreatic and bile ducts. These tubes are near your stomach. They carry digestive juices from your liver and pancreas to the intestines.
For ERCP, your doctor uses a flexible lighted tube called an "endoscope." The endoscope, or scope, is about as thick as your index finger. It goes through your mouth into your stomach and the first part of the small intestine, called the "duodenum." Then the doctor puts a very small, flexible plastic tube through the scope and injects some dye that shows up on X-rays. This procedure allows your doctor to see the ducts and how well they are working.
About ERCP Why is ERCP done?
Doctors do ERCP to find and treat problems in the pancreatic duct and bile duct. For example, you might have ERCP if your doctor suspects a disease of the pancreas or liver or a problem in the bile ducts. You might also have ERCP to find the cause of abnormal results from a blood test, ultrasound, or CT scan or to fix a problem that was identified on one of these tests. Finally, ERCP can help your doctor decide if you need surgery and if so, which surgery is best.
The most common reasons for ERCP include:
Yellow skin or eyes (jaundice), light stool and dark urine Stones in the bile or pancreas duct A lesion or tumor in the pancreas, gallbladder, or liver Your doctor might do ERCP before or after gallbladder surgery in specific situations. For example, they can find and remove gallstones from the bile duct and sometimes from the pancreas. ERCP can also help find cancer or non-cancerous lesions. If your bile duct is blocked, your doctor can use ERCP to put in a small plastic tube called a "stent". This keeps the duct open and digestive juices flowing. Finally, ERCP can help find and treat problems following gallbladder surgery.
Before the Procedure / Getting Ready for ERCP ERCP is done in a doctor's office, clinic, or hospital. It is often done with sedation. You are not asleep during the procedure, but you take medicines called "sedatives" that make you relaxed and sleepy.
Sometimes ERCP must be done under general anesthesia, with you completely asleep. If you need general anesthesia, your doctor will discuss it with you. You might need a full physical examination. You might also need some tests to make sure you are healthy enough for surgery.
The surgeon who will do your ERCP will talk with you about the risks and benefits of the procedure. Then you will sign a form saying you understand and agree to the procedure. Your surgeon's office will tell you what to do and avoid before surgery. The exact instructions depend on your surgeon, but here are some common things to do.
Stop eating and drinking at the time your doctor tells you before surgery The morning of your surgery, you may take medications your doctor told you are allowed. Take them with just a sip of water only You might need to stop taking certain medicines before surgery. These include blood thinners, supplements, and medicines that affect your immune system. Talk to your surgeon when you schedule your medications Tell your surgeon if you have a shellfish or iodine allergy You will need someone to drive you home from the procedure. You may also need someone to stay with you overnight. Ask your doctor or nurse how much help you might need.
Are there any alternatives to ERCP?
Occasionally, these problems can be addressed by radiology procedures or more advanced surgical procedures using cameras and tools by open or laparoscopic surgery, but ERCP is more commonly used because it is less invasive than surgery and it has a high rate of success.
What to Expect During the ERCP A nurse may spray your throat with a local anesthetic before the test begins. This will numb your throat to keep you from gagging (choking) and make you more comfortable. You will receive sedative medicine through an IV. If you need general anesthesia for an ERCP, you will be completely asleep for the procedure.
You will be lying on a table for the procedure which allows x-rays to be taken. Your doctor puts the endoscope into your mouth. Then they pass it down your throat (esophagus) to the stomach and the first part of your small intestine, the duodenum. The endoscope does not affect your breathing, and you might even fall asleep during the procedure. If you do feel discomfort, it will probably be minor. For example, you might feel slightly bloated from the air your doctor uses to inflate the duodenum. You might also feel minor discomfort when your doctor injects dye for the x-rays.
ERCP usually lasts thirty minutes to an hour. Your procedure might take more or less time depending on what your doctor needs to learn and do. You can talk with your doctor ahead of time about how long it might take.
After the Procedure What Happens after ERCP?
You stay in the procedure area for one (1) or 2 hours after your ERCP, until the sedatives wear off. Then you can have someone drive you home. You will probably want to spend the rest of the day relaxing at home. You may eat normally and take your regular medicines after the procedure, unless your doctor tells you not to. You might have a sore throat for a day or two. You might need to spend the night in the hospital after the procedure. If so, your doctor will discuss it with you.
When will I learn my ERCP results?
Your doctor will usually tell you the ERCP results on the day of the procedure. It might take several days to get all the information if your doctor took a small sample of tissue, called a biopsy. These results take longer because a laboratory needs to examine and test the tissue. Ask your doctor about the best way to learn your biopsy results.
What if I have questions?
Sedative medicines can make you forget what your doctor told you to do after the procedure. You might even forget the results. Call your doctor's office if you have any questions or want more information.
Possible ERCP complications:
ERCP is safe when your doctor has had specific training and is experienced at doing this specialized procedure. Problems, also called complications, can happen with any medical procedure. They are rare with ERCP, but they may include the problems listed in this section.
The most common problem after ERCP is a condition called "pancreatitis." This happens when the duct to the pancreas is irritated by the X-ray dye or small plastic tube used in ERCP. This can cause abdominal pain that gets worse instead of better after the procedure.
Other problems are possible if your doctor did any treatment during your ERCP, such as removing stones or putting in a small drain called a stent. These treatments have a small risk of causing bleeding or making a hole in the intestine or bile duct. Rarely, people who have bleeding after the procedure may need a blood transfusion to replace the lost blood, but this is rare. Another very rare risk is the risk of infection transmission from scopes.
It is important for you to know the early signs of possible complications. Call your doctor's office immediately if you have any of the problems below after ERCP.
Severe belly pain Fever Chills Vomiting Blood in your stool तर्क के मध्य विपक्षी सं0-1 के विद्वान अधिवक्ता ने यह कहा कि ईआरसीपी में पेनक्रियाटाइटिस एक साधारण तत्व है, परन्तु प्रश्न यह उठता है कि जब ईआरसीपी के दौरान् पेनक्रियाटाइटिस एक साधारण तत्व है तब आपने ईआरसीपी क्यों किया और सुरक्षित साधन एमआरसीपी का प्रयोग क्यों नहीं किया ? हमने देखा है कि ईआरसीपी तभी सुरक्षित है जब सम्बन्धित डॉक्टर को ईआरसीपी करने के सम्बन्ध में विशिष्ट प्रशिक्षण दिया गया हो और वह इसको करने में दक्ष हो। हमने ऊपर देखा है कि एमआरसीपी में स्वस्थ होने में अल्प समय लगता है और इस प्रक्रिया के बाद आप घर जा सकते हैं।
Difference between ERCP and MRCP risks Since ERCP is invasive, the procedure is associated with more risks than MRCP. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), complications occur in 5 to 10 percent Trusted Source of ERCP tests.
Potential ERCP complications include:
pancreatitis, which is the most common complication infection of the gallbladder or bile ducts gastrointestinal bleeding puncture of ducts or small intestine atypical reaction to the sedative or dye tissue damage from the X-ray MRCP is non invasive, so there are fewer risks. They include:
kidney scarring from the dye allergic reaction to the dye issues relating to implanted devices It is on the doctor to know that this procedure will be adopted in regard to a patient. It is your duty to communicate the patient all the things before going for operation. When you know that the side effect of ERCP is pancreatitis, don't need to go for ERCP when there is MRCP.
डॉक्टर और मरीज का सम्बन्ध विश्वास का होता है। डॉक्टर को अपने मरीज को सारे तथ्य सत्य बताने चाहिए।
The relationship between doctor and patient is very delicate and it is the duty of the doctor to let his patient know everything about the procedure and side effects of the treatment. we have to see the doctor - patient relationship (DPR). This relationship is very important for all types of treatment of a patient by a doctor.
"Medicine is an art whose magic and creative ability have long been recognized as residing in the interpersonal aspects of patient-physician relationship."
Hall et al.,1981 A doctor-patient relationship (DPR) is considered to be the core element in the ethical principles of medicine. DPR is usually developed when a physician tends to a patient's medical needs via check-up, diagnosis, and treatment in an agreeable manner. Due to the relationship, the doctor owes a responsibility to the patient to proceed toward the ailment or conclude the relationship successfully. In particular, it is essential that primary care physicians develop a satisfactory DPR in order to deliver prime health care to patients.
The physician-patient relationship is a foundation of clinical care. Physician-patient relationships can have profound positive and negative implications on clinical care. Ultimately, the overarching goal of the physician-patient relationship is to improve patient health outcomes and their medical care. Stronger physician-patient relationships are correlated with improved patient outcomes. As the relationship between physicians and patients becomes more important, it is essential to understand the factors that influence this relationship.
Frameworks for Physician-Patient Relationships Throughout history there has been much debate regarding the "ideal" physician-patient relationship. In 1992, Ezekiel and Linda Emanuel proposed four models for the physician-patient relationship: the paternalistic model, the interpretive model, the deliberative model, and the informative model. These models differ based on their understanding of four key principles: the goals of physician-patient interactions, the physician's obligations, the role of patient values, and the concept of patient autonomy.
Factors that Influence the Physician-Patient Relationship Although there are several factors that influence physician-patient relationships, the dynamic shared and sense of trust between physicians and patients are two critical components to their overall relationship.
Dynamic Between Physicians and Patients The dynamic between physicians and patients refers to the communication patterns and the extent to which decision making is shared between both parties. Effective physician-patient communication is an integral part of clinical practice and serves as the keystone of physician-patient relationships. Studies have shown the approach taken by physicians to communicate information is equally important as the actual information that is being communicated. This type of communication incorporates both verbal and nonverbal interactionsbetween physicians and patients.iEffective communication has been shown to influence a wide array of outcomesincluding: emotional health, symptoms resolution, function, pain control, and physiologic measures such as blood pressure levels. When miscommunication occurs, it can have severe negative implications in clinical caresuch as impeding patient understanding, expectations of treatment, treatment planning, decreasing patient satisfaction of medical care, and reducing levels of patient hopefulness.
In addition to having effective communication, it is important that medical decisions stem from a collaborative process between physicians and patients. Decision makingis a process in which patients should be involved from the very beginning, and the result is a decision which reflects the physician's medical knowledge as well as the patient's values and beliefs.ivCollaborative communication and decision making have been correlated with greater patient satisfaction and loyalty. Working from a collaborative framework along with effective physician-patient communication can also strengthen a physician's ability to utilize a personalized health care model through patient empowerment.v Trust Between Physician and Patients "....'patients must be able to trust doctors with their lives and health,' and that maintaining trust is one core guidance for physicians..."
Birkhäuer et al, 2017 Trust is a fundamental characteristic of the physician-patient relationship. Patients must trust that their physicians will work in their best interests to achieve optimal health outcomes. Patients' trust in their physicians has been demonstrated to be more important than treatment satisfactionin predictions of patient adherence to recommendations and their overall satisfaction with care.iStudies have also shown that trust is additionally a strong predictor of a patient continuing with their provider.iiTrust extends to many different aspects of the physician-relationships including, but not limited to: physicians' willingness to listen to patients, patients' believing that physicians value patient autonomy and ability to make informed decisions, and patients feeling comfortable enough to express and engage in dialogue related to their health concerns.
Physician-Patient Relationships Influence on the Future of Healthcare The idea of viewing physician-patient relationships as a core element of quality health care is not something new, however understanding and assessing the factors that influence this relationship is just beginning. Effective physician-patient communication has been shown to positively influence health outcomes by increasing patient satisfaction, leading to greater patient understanding of health problems and treatments available, contributing to better adherence to treatment plans, and providing support and reassurance to patients. Collaborative decision making enables physicians and patients to work as partners in order to achieve a mutual health goal. Trust within all areas of the physician-patient relationship is a critical factor that influences communication between both parties. As health care transforms into a more personalized and patient-centered model, the physician-patient relationship will significantly shape health outcomes. The personalized health care model encourages collaboration among physicians and patients in order to create shared health goals and the cultivation of a health plan to address identified problems. By understanding the factors that influence patient-physician relationships, in the future, health care providers will be able to address some of the barriers that prevent the adoption of more personalized approaches to health care.
ईआरसीपी होने के तीन से चार घण्टे के अन्दर रोगी की तबियत तेजी से बिगड़ने लगी। विपक्षी सं0-1 ने उसे कुछ दवाऐं दीं, किन्तु उनका कोई असर नहीं हुआ और रोगी कोमा में चला गया, जिसे तुरन्त सघन गहन चिकित्सा में भर्ती किया गया, जहॉं पर व दिनांक 14-01-2016 से 16-01-2016 तक रहा। इस अवधि के दौरान् उसके सम्पूर्ण एब्डामिन की अल्ट्रासोनोग्राफी हुई और रक्त परीक्षण किया गया। रोगी की हालत अच्छी नहीं थी। तब परिवादिनी ने यह उचित समझा कि वह अपने पति को वहॉं से हटाकर किसी अन्य अस्पताल में दिखाये। उसने विपक्षी सं0-1 से दिनांक 16-01-2016 को अनुरोध किया कि वह उसके पति को डिस्चार्ज कर दे। इसके पश्चात् वह अपने पति को एयर एम्बुलेंस से दिल्ली ले गयी, जिसका खर्च 3,10,000/- रू0 आया। उसने अपने पति को मेदान्ता द मेडिसिटी, गुड़गॉंव में दिनांक17-01-2016 को भर्ती कराया और पर्याप्त चिकित्सकीय सुविधाओं के बाबजूद वे उसे बचा नहीं पाये और दिनांक 25-01-2016 को उसकी मृत्यु हो गयी।
विपक्षी सं0-1 ने रोगी पर ईआरसीपी का प्रयोग किया जो पूर्णरूप से असफल हुआ, क्योंकि इससे कई अन्य जटिलताऐं उत्पन्न हो गयीं, जिन्हें विपक्षी सं0-1 सम्भाल नहीं सका, भले ही उसने रोगी को सघन चिकित्सा कक्ष में भर्ती कर दिया हो। डॉक्टर को रोगी के बारे में और उसकी हालत के बारे में सब कुछ पता था और उसके शरीर की भौतिक स्थिति मालूम थी और उसी के अनुसार रोगी का उपचार किया जाना चाहिए था। विपक्षी सं0-1 रोगी का उपचार सही ढंग से नहीं कर सका, जिससे परिवादी के पति की मृत्यु हो गयी। यहॉं पर रेस इप्सा लाक्यूटर का सिद्धान्त पूर्णरूप से लागू होता है और विपक्षी सं0-1 द्वारा परिवादिनी के प्रति सेवा में कमी किया जाना परिलक्षित है।
इस प्रकार उपरोक्त परिस्थितियों से यह स्पष्ट होता है कि इस मामले में परिस्थितियॉं स्वयं बोलती हैं, का सिद्धान्त लागू होता है और विपक्षी सं0-1 की लापरवाही से रोगी की मृत्यु हो गयी। अत: मामले के समस्त तथ्य एवं परिस्थितियों को देखते हुए वर्तमान परिवाद निम्नलिखित अनुतोष के लिए स्वीकार किये जाने योग्य है :-
1. परिवादीगण, चिकित्सीय लापरवाही एवं सेवा में कमी के मद में विपक्षी सं0-1 से 30.00 लाख रू0 और इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक ब्याज पाने के अधिकारी हैं, यदि यह धनराशि इस निर्णय के 30 दिन के अन्दर अदा की जाती है अन्यथा ब्याज की दर 15 प्रतिशत वार्षिक होगी, जो दिनांक 25-01-2016 से वास्तविक भुगतान की तिथि तक देय होगी।
2. परिवादीगण, विपक्षी सं0-1 से एयर एम्बुलेंस का किराया 3,10,000/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर पाने के अधिकारी हैं और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
3. परिवादीगण, विपक्षी सं0-1 से रोगी के उपचार के मद में खर्च किये गये 43,031/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर पाने के अधिकारी हैं और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
4. परिवादीगण, विपक्षी सं0-1 से मेदान्ता द मेडिसिटी हास्पिटल गुड़गॉव में रोगी के इलाज के मद में खर्च किये गये 10,46,969/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर पाने के अधिकारी हैं और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
5. परिवादीगण, विपक्षी सं0-1 से दिल्ली में रूकने और ठहरने और भोजन आदि के मद में खर्च के रूप में 01.00 लाख रू0 एवं वाद व्यय के रूप में 50,000/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर पाने के अधिकारी हैं और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
6. परिवादीगण, विपक्षी सं0-1 से मानसिक यन्त्रणा, शारीरिक क्लेश एवं अवसाद के मद में 05.00 लाख रू0 एवं दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी पाने का अधिकारी हैं और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब ब्याज की धनराशि 15 प्रतिशत वार्षिक की दर से दिनांक 25-01-2016 से वास्तविक भुगतान की तिथि तक देय होगी।
7. विपक्षी सं0-1, विपक्षी सं0-2 से बीमित धनराशि के सापेक्ष प्रतिपूर्ति पाने का अधिकारी होगा।
वर्तमान परिवाद तदनुसार आंशिक रूप से स्वीकार किए जाने योग्य है।
आदेश वर्तमान परिवाद निम्नवत् आंशिक रूप से स्वीकार किया जाता है।
1. विपक्षी सं0-1 को आदेश दिया जाता है कि वह परिवादिनी सं0-1 को चिकित्सीय लापरवाही एवं सेवा में कमी के मद में 30.00 लाख रू0 और इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक ब्याज का भुगतान करे, यदि यह धनराशि इस निर्णय के 30 दिन के अन्दर अदा की जाती है अन्यथा ब्याज की दर 15 प्रतिशत वार्षिक होगी, जो दिनांक 25-01-2016 से वास्तविक भुगतान की तिथि तक देय होगी। उक्त धनराशि में से परिवादी सं0-3, 4 व 5 के नाम से पॉंच-पॉंच लाख रू0 किसी राष्ट्रीयकृत बैंक की फिक्स डिपोजिट योजना के अन्तर्गत जमा किये जायेंगे, जो उनके बालिग (21 वर्ष) होने पर उन्हें देय होंगे। इसके अतिरिक्त 05.00 लाख रू0 परिवादी सं0-2 के बचत खाते में किसी राष्ट्रीयकृत बैंक के मासिक आय योजना में जमा किये जायेंगे, जिसमें प्रत्येक माह ब्याज का भुगतान परिवादी सं0-2 को किया जायेगा।
2. विपक्षी सं0-1 को आदेश दिया जाता है कि वह परिवादीगण को एयर एम्बुलेंस का किराया 3,10,000/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर भुगतान करे और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
3. विपक्षी सं0-1 को आदेश दिया जाता है कि वह परिवादीगण को रोगी के उपचार के मद में खर्च किये गये 43,031/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर भुगतान करे और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
4. विपक्षी सं0-1 को आदेश दिया जाता है कि वह परिवादीगण को मेदान्ता द मेडिसिटी हास्पिटल गुड़गॉव में रोगी के इलाज के मद में खर्च किये गये 10,46,969/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर भुगतान करे और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
5. विपक्षी सं0-1 को आदेश दिया जाता है कि वह परिवादीगण को दिल्ली में रूकने और ठहरने और भोजन आदि के मद में खर्च के रूप में 01.00 लाख रू0 एवं वाद व्यय के रूप में 50,000/- रू0 इस परिवाद के निर्णय के दिनांक से 30 दिन के अन्दर भुगतान करे और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब इस पर दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज भी देना होगा।
6. विपक्षी सं0-1 को आदेश दिया जाता है कि वह परिवादीगण को मानसिक यन्त्रणा, शारीरिक क्लेश एवं अवसाद के मद में 05.00 लाख रू0 एवं दिनांक 25-01-2016 (परिवादिनी के पति की मृत्यु का दिनांक) से 12 प्रतिशत वार्षिक की दर से वास्तविक भुगतान की तिथि तक ब्याज का भुगतान करे और यदि इस निर्णय के 30 दिन के अन्दर भुगतान नहीं किया जाता है तब ब्याज की धनराशि 15 प्रतिशत वार्षिक की दर से दिनांक 25-01-2016 से वास्तविक भुगतान की तिथि तक देय होगी।
7. विपक्षी सं0-1, विपक्षी सं0-2 से बीमित धनराशि के सापेक्ष प्रतिपूर्ति पाने का अधिकारी होगा।
यदि विपक्षी सं0-1 इस निर्णय के 30 दिन के अन्दर इस आदेश का पालन नहीं करता है तब परिवादीगण को अधिकार होगा कि वे विपक्षी सं0-1 के व्यय पर इस न्यायालय के समक्ष उसके विरूद्ध निष्पादन वाद प्रस्तुत करें।
उभय पक्ष को इस निर्णय की प्रमाणित प्रति नियमानुसार उपलब्ध करायी जाय।
वैयक्तिक सहायक से अपेक्षा की जाती है कि वह इस निर्णय को आयोग की वेबसाइट पर नियमानुसार यथाशीघ्र अपलोड कर दें।
(विकास सक्सेना) (राजेन्द्र सिंह) सदस्य सदस्य
निर्णय आज खुले न्यायालय में हस्ताक्षरित, दिनांकित होकर उद्घोषित किया गया।
(विकास सक्सेना) (राजेन्द्र सिंह) सदस्य सदस्य दिनांक :- 01-01-2024. प्रमोद कुमार, वैय0सहा0ग्रेड-1, कोर्ट नं.-2. [HON'BLE MR. Rajendra Singh] PRESIDING MEMBER [HON'BLE MR. Vikas Saxena] JUDICIAL MEMBER