Medical responsability when there is an operative endoscopy complication. concerning litigation F. PIERRE

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1 Medical responsability when there is an operative endoscopy complication. F. PIERRE Gynaecologist Obstetrician POITIERS University hospital General remarks concerning litigation Although there has been no explosion in the number of complaints made in the context of laparoscopic surgery, vigilance is still necessary,.bearing in mind that it is justified by: - an efficient procedure, - with minimal anatomical invasion and functional repercussions, - and a considerable reduction in hospital stays and temporary disability; In other words, real progress in terms of medical care and quality of life.

2 There is a time lag between current medicolegal affairs and the current medical situation. While the spread in use of laparoscopic surgery and its application in the management of most gynaecological pathologies are realities,.cases with respect to legal responsibility mostly concern adnexal laparoscopic surgery(minimal and major investigational laparoscopic procedures, advanced laparoscopic surgery) The data in the Europa Medica study (6 European insurance groups) Main findings concerning litigation in laparoscopic surgery ( ): 97): young patients "in good health", late diagnosis of complications (75 %), 80 % of cases concern diagnostic laparoscopy (time lag...!), 72 % in direct relationship with the management of a complication, 21.5 % with the information, 43 % of cases concern considerable permanent disability, and in 40 % of case, a fault is found to exist. In the context of this surgical practice, the following conditions must apply: Properly established indication, rarely questioned information that is full, clear, and adapted to the pathology concerned and the operation proposed,, without forgetting to discuss alternative, non-surgical techniques a competent operator (well-trained and practised), i.e. with real experience (a well-equipped equipped operating theatre: staff and equipment) and post-operative operative monitoring

3 The jurisdictions potentially concerned "Medical" responsibility Penal death / serious injury involuntary homicide / bodily harm if there is a fault, and/or non application of laws and/or regulations [ textile foreign bodies +++] "Medical" responsibility Civil (private practice) more or less serious sequelae (compensation sought) contractual responsibility (obligation of means, or even results) Administrative (State hospital) compensation sought

4 "Medical" responsibility Implies a definition of the "severity conditions" in order for the victim of a medical accident, an iatrogenic affection, a nosocomial infection to be able to claim compensation on the grounds of national solidarity from the French National Office for Compensation of Medical Accidents (ONIAM) Not "judiciarised": medical accidents compensation commissions [decree n dated 4 April 2003] 4 severity conditions % permanent partial disability [> 24 %] scale appended ("Concours Médical" scale), in process of being revised. duration of temporary inability to work 6 consecutive months, or non-consecutive but within a period of 12 months Permanent inability to work in the professional capacity previously occupied particularly serious problems including of an economic nature, under the person's working conditions National Medical Socal Security Accidents Commission ( CNAM ) National Medical Accidents Compensation Office (ONIAM) Regional Commissions for Conciliation and Compensation (CRCI) Patients

5 A unique factor: sophisticated equipment Sophisticated equipment (1) Its failings "negligence and lack of vigilance he showed by not noticing the omission at the end of the surgical procedure " «negligence that engages the surgeon's responsibility..." Sophisticated equipment (2) The surgeon is responsible for all the equipment and staff he uses during the operation (even if this responsibility is shared if he can prove that there were precise instructions for inspection and/or maintenance)

6 Maintenance: - disinfection - assembly / dismantling - "servicing" the texts and their consequences. Materiovigilance Endoloop jurisprudence: (dressings nurse may be responsible, or share responsibility for a fragment of equipment being overlooked) shared responsibility for checks after use Article , New Penal Code «be the cause by clumsiness, imprudence, lack of attention, negligence or failure with respect to an obligation concerning safety or prudence required by law or regulations, of a third party suffering temporary total disability > 3 months» if the "act" is deliberate, aggravation

7 Sophisticated equipment (3) Prevention training to match the magnitude of investments know assembly operation safety features operating theatre organisation protocol for checks for maintenance / disinfection ( The problem of single use items re-used!) The surgeon's responsibility does not stop at the sole act of operating Laparoscopic surgery anaesthesia accident Consequence of anaesthesia without any particular precautions Costly post anaesthesia care and sequelae Initial judgement was "anaesthetist's s fault" but on appeal (Paris Appeal Court, 1st chamber, 19/2/1993) "The ruling is that responsibility is joint, with 2/3 for the anaesthetist and 1/3 for the gynaecologist" The medicolegal risks specific to laparoscopic surgery.

8 The medicolegal risks specific to laparoscopic surgery 1 - Complications due to the approach (trocars) - agreement between experimental studies / surveys and registers ("there is no safety trocar") - whatever the surgeon's training / type of procedure - various solutions to assess ("open" methods under visual control, micro-trocars, etc)?? 2 - The risk of conversion 3 - When a complication is overlooked (late diagnosis) Survey of the methods of approach for gynaecological laparoscopic surgery (SFEG - 5/1998, then 12/1999) at a time when a trocar accident is often ( or always) considered d as a fault by the co-expert surgeon " due to the fact open laparoscopy insertion of the trocar was not used..." A moderate position to be defended +++ (Consensus Conference - SFEG, 1999).until a better assessment has been made

9 But above all a change in the jurisprudence which will eliminate controversy, if not at scientific level, at least from the legal point of view: Toulouse Appeal Court (14 October 1996), confirming the initial ruling: the fact that insertion of the trocar injured the aorta means that the existence can be deduced, although it cannot be clearly distinguished, of a fault, negligence or imprudence and above all! the existence of an unanticipated fact cannot explain a vascular injury. and, even if the trocar is inserted blind, the practitioner's familiarity with anatomy allows him to avoid a lesion by being sufficiently vigilant The medicolegal risks specific to laparoscopic surgery 1 - complications due to the approach (trocar) 2 -the risks of conversion (to be familiar with / information and consent) information prior to surgery ++ ("covers"" in addition the risk of managing a per-operative complication by laparotomy if the postoperative information is appropriate ++) 3 - when a complication is overlooked (late diagnosis)

10 The need for information / informed consent multi-centre, multi-surgeon survey (Dognon 1993) EP: conversion (11.4 %) complications (3.7 %) 15.1 % laparotomies Ovarian cyst : conversion (6 %) complications (2 %) 6.2 % laparotomies developer centre survey (Chapron..) "gynaecological laparoscopic surgery in France, 1999" survey EP: 4 % Ovarian cyst : 2.3 % The non negligible rate of laparotomy, or conversion during the same anaesthesia does not correspond with the "idealised image" that patients have of laparoscopic surgery This is not a complication, but can become a medicolegal complication due to lack of information for the patients (informed consent) [written support for an oral communication / CNGOF)] The medicolegal risks specific to laparoscopic surgery 1 - complications due to the approach 2 - The risk of conversion 3 - when a complication is overlooked (late diagnosis) 1/3 of serious complications diagnosed on 3rd post operative day (Chapron, Querleu, Dognon, Pierre, SFEG surveys and registers)

11 Surgical monitoring standard, however Delay in diagnosis The first cases concerning responsibility late bowel peritonitis secondary haematoceles Over 1/3 of digestive (and urinary) complications discovered after D3 (Dognon 1993, Chapron) Visceral complications diagnosed late [Besançon Appeal Court 14/9/1993] In spite of the experts' opinions, the judges did not retain a link of cause and effect between laparoscopic surgery and visceral injury ( inherent) but condemned - insufficient vigilance - absence of rapid post-operative diagnosis However, when there is no failing, or fault of technical / expertise type no condemnation Ureteral lesions during laparoscopic surgery for EP / electrocoagulation (Appeal Court, 1st Civil Chamber, 15 June 2004) Peritonitis secondary to a digestive lesion due to burning by an electric scalpel (electrical arcing), although an expert report noted "conscientious, careful care in accordance with current data" (Appeal Court, 1st Civil Chamber, 10 May 2005)

12 Even without fully comprehensive information concerning possible - but exceptional - complications, provided the treatments were justified! Digestive lesion secondary to electrical burn during an operation "which h was the only one suitable given the other treatments already carried out", the lack of information did not therefore result in a loss of opportunity (Nancy Administrative Appeal Court, 17 June 2003) Immediate (per-operative) diagnosis of complications "check-list" (SFEG safety - complications commission) bladder: visual exploration+trocar orifices, catheter pouch ± Blue ureter: trajectory+reptation, appearance of urine, dissection, ± indigo IV, ± fluorescent probe veins: check on haemostasis, sub peritoneal haematoma? blood pressure figures, check after pneumoperitoneum P small intestine: examination+tracking, ± flow digestive juices colon: examination (trocar/dissection), ± transanal insufflation after pelvic immersion / colouring (if any doubt about trajectory of trocar supra pubic optics) Post-operative prevention Surgical monitoring -intheward - and above all outside! - Transfer of information (liaison document) to a responsible contact when the patient leaves the hospital - Document to be handed to the patient ++ (SFEG 1995 / CNGOF)

13 While it seems fairly easy to comply with the above conditions,..certain points deserve to be clarified: Points to make clearer: 1- The definition of a validated operational procedure; 2- The ways for effective assessment of the competence and experience of an operator / type of procedure 3- The organisation of continuous updating of data (both national and local) concerning practice / complications. New operations / techniques already assessed or currently being assessed

14 What is a validated operating technique? Difference between: the general idea: - of a new technique (described for the first time) ; - of the modification of a technique (..with or without the use of new equipment?) protection of individuals and the way it can be applied / introduced.. in a department for treatment (staffing and equipment resources, existence and perspective concerning similar procedures,..) Laparoscopic total hysterectomy (LTH) was proscribed by the National Institute for Clinical Excellence (NICE) in November 2002: Current evidence on safety and efficacy of LTH does not appear adequate to support the use of this procedure without - special arrangement for consent, - audit or research [ LAVH, uncertainty / efficiency, urinary lesions +++, training] The consultation period closed in October 2003, recommendations in April 2004, but this standpoint has considerable influence from the point of view of medical responsibility. What are the grounds for these conclusions concerning LTH? the evidence published: series by experienced teams; registers recording accidents (national, insurance companies,..); declarations of complications. + experts' opinions (the same as in a context of legal expert reports!) Since 2004, a more favourable review (but serious complications x 2 / laparotomy)

15 Acquisition of these new techniques Surgeon during training / recently trained or established surgeon Assessing the experience of an operator What means to use to assess training and effective experience of a surgeon? European Board and College of Obstetrics and Gynaecology Log Book, comprising an inevitable phase. "of training on humans", which needs to be controlled and continuous collection of details on individual practice (a sort of "accreditation" process) Common points, more acute for laparoscopic surgery training assessment / technique chosen / equipment used

16 Laparoscopic surgery is a means of surgery like the others.but under a different light. OTHER TIMES [scalpel technological progress (multiple complex devices)] OTHER ATTITUDES [video, media coverage (cosmetic aspect)]. OTHER RISKS [with respect to society medicolegal risks]