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

Medical responsability

when there is an operative

endoscopy complication.

F. PIERRE

Gynaecologist Obstetrician

POITIERS University hospital

General remarks

General remarks

concerning litigation

Although there has been no “explosion”in

the number of complaints made in the

context of laparoscopic surgery,

that it is justified by: that it is justified by:

-- an efficient procedure,an efficient procedure,pp ,,

-- with minimal anatomical invasion and with minimal anatomical invasion and functional repercussions,

functional repercussions,

-- and a considerable reduction in hospital and a considerable reduction in hospital stays and temporary disability;

stays and temporary disability; In other words, real progress in terms of In other words, real progress in terms of

medical care and quality of life. medical care and quality of life.

There is a time lag between current

medicolegal affairs and the current

medical situation.

surgery and its application in the surgery and its application in the management of most gynaecological management of most gynaecological pathologies are realities

pathologies are realities pathologies are realities, pathologies are realities,

….cases with respect to legal ….cases with respect to legal responsibility mostly concern adnexal responsibility mostly concern adnexal laparoscopic surgery

laparoscopic surgery(minimal and major (minimal and major investigational laparoscopic procedures, investigational laparoscopic procedures,

≠≠advanced laparoscopic surgery)advanced laparoscopic surgery)

The data in the “Europa Medica” study

(6 European insurance groups)

surgery (1993 surgery (1993--97):97):

• young patients "in good health",

• late diagnosis of complications (75 %),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 Properly established indication, …rarely

questioned questioned

•• information that is information that is full, clear, and adapted to the full, clear, and adapted to the pathology concerned and the operation pathology concerned and the operation

p gy p

p gy p

proposed

proposed, without forgetting to discuss , without forgetting to discuss alternative, non

alternative, non--surgical techniques surgical techniques •• a competent operator (wella competent operator (well--trained and trained and

practised), i.e. with real experience practised), i.e. with real experience

•• (a well(a well--equipped operating theatre: staff and equipped operating theatre: staff and equipment) and post

The jurisdictions

j

potentially concerned

"Medical" responsibility

•

Penal

involuntary homicide / bodily harmif there is a fault, and/or

non application of laws and/or regulationso app cat o o a s a d/o egu at o s [ textile foreign bodies +++]

"Medical" responsibility

•

Civil (private practice)

contractual responsibility

(obligation of means or even results) (obligation of means, or even …results)

•

Administrative (State hospital)

"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 to claim compensation on the grounds of national solidarity from the French National Office for Compensation of Medical Accidents (ONIAM)

•

Not "judiciarised":

[decree n° 2003-314 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

i d f 12 th

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

Accidents Commission

(“CNAM”)

(ONIAM) Socal Security

Regional Commissions for Conciliation and Compensation

(CRCI)

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 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)

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 222.19, 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…

»

Sophisticated equipment (3)

Prevention

training to match the magnitude of investments

ªknow assembly operation operation safety features operating theatre organisation

ª protocol for checks

for maintenance / disinfection (ÎThe problem of single use items …re-used!)

The surgeon's responsibility does not

stop at the sole act of operating

Consequence of anaesthesia without any particular precautions

ªCostly post anaesthesia care and sequelae Initial judgement was "anaesthetist's fault" Initial judgement was anaesthetist s fault …

but on appeal (Paris Appeal Court, 1st chamber, 19/2/1993)

ª "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

to laparoscopic surgery.

The medicolegal risks specific to

laparoscopic surgery

1 - Complications due to the approach (trocars)

ª- agreement between experimental studies / surveys and registers ("there is no safety trocar")

whatever the surgeon's training / type of procedure - 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

… at a time when a trocar accident is

ft

(

l

)

id

d

often (… or always) considered 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

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 aorta means that the existence can be deduced, although it cannot be clearly distinguished, of a fault, negligence or imprudence

”

…and above all !

“

and, even if the trocar is inserted blind, the practitioner's familiarity with anatomy allows

p y y

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

with / information and consent)

ª i f ti i t (" " i ª information prior to surgery ++("covers" in addition the risk of managing a per-operative complication by laparotomy … if the post-operative information is appropriate ++)

3 - when a complication is overlooked (late diagnosis)

The need for information /

informed consent

Î multi-centre, multi-surgeon survey (Dognon 1993)

EP: conversion (11.4 %) complications (3.7 %)

Î 15.1 % laparotomies Ovarian cyst : conversion (6 %) complications (2 %) Ovarian cyst : conversion (6 %) complications (2 %)

Î 6.2 % laparotomies

Î developer centre survey (Chapron ..)

Î"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

ª

This is not a complication but can

ª

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)

ª1/3 of serious complications diagnosed on ≥ 3rd post operative day (Chapron, Querleu, Dognon, Pierre, SFEG surveys and registers)

Surgical monitoring

standard, however …

Delay in diagnosis

ÎThe first cases concerning responsibility

ÎThe first cases concerning responsibility late bowel peritonitis

secondary haematoceles

Î Over 1/3 of digestive (and urinary) complications discovered after D3 (Dognon 1993, Chapron)

Visceral complications diagnosed late

[Besançon Appeal Court 14/9/1993]

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)

( pp , , )

• 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)

Even without fully comprehensive

information concerning possible - but

exceptional - complications, provided the

treatments were justified!

• Digestive lesion secondary to electrical burn

d i ti " hi h th l

during an operation "which 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

ª"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 Ô

small intestine: examination+tracking,±flow digestive juices colon: examination (trocar/dissection), ±transanal

insufflation after pelvic immersion / –colouring (if any doubt about trajectory of trocar Îsupra pubic optics)

Post-operative prevention

Surgical monitoring - in the ward

- and above all outside …!

ª- 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)

While it seems fairly easy

to comply with the

above conditions,

…..certain points

deserve to be clarified:

Points to make clearer:

procedure; procedure;

•• 22-- The ways for effective assessment of the The ways for effective assessment of the competence and experience of an operator / type of competence and experience of an operator / type of procedure

procedure

•• 33-- The organisation of continuous updating of data The organisation of continuous updating of data (both national and local) concerning practice / (both national and local) concerning practice / complications.

complications.

New operations /

techniques already assessed

… or currently being

assessed

What is a validated operating

technique?

Difference between: 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 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 Current evidence on safety and efficacy of LTH does not appear adequate to support the use of this procedure appear adequate to support the use of this procedure without

without

-- special arrangement for consent,special arrangement for consent, dit h

dit h””

-- audit or researchaudit or research” ”

[[≠≠LAVH, uncertainty / efficiency, urinary lesions +++, LAVH, uncertainty / efficiency, urinary lesions +++, training]

training]

The consultation period closed in October 2003, The consultation period closed in October 2003,

recommendations in April 2004…, recommendations in April 2004…,

……but this standpoint has considerable influence ……but this standpoint has considerable influence from the point of view of medical responsibility from the point of view of medical responsibility..

What are the grounds for these

conclusions concerning LTH ?

• the “evidence” published

:: series by

series by

experienced teams; registers recording

experienced teams; registers recording

accidents (national, insurance

accidents (national, insurance

companies,..); declarations of

companies,..); declarations of

complications.

complications.

•• + experts' opinions

+ experts' opinions

(the same as in a

(the same as in a

context of legal expert reports!)

context of legal expert reports!)

••

Since 2004, a more favourable review

Since 2004, a more favourable review

(but serious complications x 2 / laparotomy (but serious complications x 2 / laparotomy))

Acquisition of

these new techniques

Surgeon during training

/ recently trained

y

… or established surgeon

Assessing the experience of an operator

effective experience of a surgeon? effective experience of a surgeon?

•• European Board and College of Obstetrics European Board and College of Obstetrics and Gynaecology Log Book, comprising an and Gynaecology Log Book, comprising an inevitable phase "of training on

inevitable phase "of training on inevitable phase …. of training on inevitable phase …. of training on humans", which needs to be controlled humans", which needs to be controlled •• …and continuous collection of details on …and continuous collection of details on

individual practice (a sort of "accreditation" individual practice (a sort of "accreditation" process)

process)

Common points,

more acute for laparoscopic

surgery

training

/ technique chosen

/ equipment used

/ equipment used

assessment

Laparoscopic surgery is a means of

surgery like the others …

….but under a different light.

OTHER TIMES

[scalpel

Î

technological progress

(multiple complex devices)]

OTHER ATTITUDES

[video, media coverage (cosmetic

[

g (

aspect)]

…. OTHER RISKS

[with respect to society …

Î

medico-legal risks]