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Anaesthesia, 2010, 65, pages 443–452 doi:10.1111/j.1365-2044.2010.06248.

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ORIGINAL ARTICLE
Litigation related to regional anaesthesia: an analysis of
claims against the NHS in England 1995–2007*
K. Szypula,1 K. J. Ashpole,2 D. Bogod,3 S. M. Yentis,4 R. Mihai,5 S. Scott5
and T. M. Cook6
1 Specialist Trainee and 3 Consultant, City Hospital Campus, Nottingham University Hospitals NHS Trust,
Nottingham, UK
2 Locum Consultant and 4 Consultant, Magill Department of Anaesthesia, Chelsea and Westminster Hospital NHS
Foundation Trust, London, UK
5 Consultant, Department of Anaesthesia, John Radcliffe Hospital, Oxford, UK
6 Consultant, Department of Anaesthesia, Royal United Bath Hospital, Bath, UK

Summary
We analysed 366 claims related to regional anaesthesia and analgesia from the 841 anaesthesia-
related claims handled by the National Health Service Litigation Authority between 1995 and
2007. The majority of claims (281 ⁄ 366, 77%) were closed at the time of analysis. The total cost of
closed claims was £12 724 017 (34% of the cost of the anaesthesia dataset) with a median (IQR
[range]) of £4772 (£0–28 907 [£0–2 070 092]). Approximately half of the claims (186 ⁄ 366; 51%)
were related to obstetric anaesthesia and analgesia and of the non-obstetric claims, the majority
(148 ⁄ 180; 82%) were related to neuraxial block. The total cost for obstetric closed claims was
£5 433 920 (median (IQR [range]) £5678 (£0–27 690 [£0–1 597 565]) while that for non-
obstetric closed claims was £7 290 097 (£3337 (£0–31 405 [£0–2 070 062]). Non-obstetric
claims were more likely to relate to severe outcomes than obstetric ones. The maximum values
of claims were higher for claims related to neuraxial blocks and eye blocks than for peripheral
nerve blocks. Despite many limitations, including lack of clinical detail for each case, the dataset
provides a useful overview of the extent, patterns and cost associated with the claims.

. ......................................................................................................
Correspondence to: Dr K. Szypula
E-mail: kasia_szypula@hotmail.com
*Presented in part at the Regional Anaesthesia Great Britain and
Ireland Annual Meeting, London, May 2008; the Obstetric
Anaesthetists’ Association Annual Meeting, Belfast, May 2008; and
the European Society of Regional Anaesthesia Annual Meeting,
Genoa, September 2008.
Accepted: 28 December 2009

The use of regional anaesthesia and analgesia (both central claims related to regional anaesthesia in Canada, Finland
neuraxial and peripheral techniques) has become routine and the USA have been published, with detailed analysis
practice, both for surgical and obstetric procedures. Such of specific patterns of injury and legal liability [10–13].
techniques may be associated with multiple benefits Similar information regarding UK practice is lacking, and
whether used as an alternative or in addition to general to the best of our knowledge the pattern of litigation
anaesthesia, including superior postoperative analgesia and related to regional anaesthesia and analgesia in the UK has
potentially reduced morbidity and mortality [1–5]. not been reported before.
Complications resulting from various regional techniques The National Health Service Litigation Authority
have been well described [6–9], and studies of insurance (NHSLA) is a Special Health Authority responsible for

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K. Szypula et al. Æ Litigation related to regional anaesthesia Anaesthesia, 2010, 65, pages 443–452
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handling both clinical and non-clinical negligence claims settlements in different years could be directly compared
on behalf of the NHS bodies in England. Their Clinical with each other [15].
Negligence Scheme for Trusts (CNST) is a voluntary risk Each claim was initially analysed independently by
pooling scheme to which all NHS Trusts in England three investigators (TC, RM, and SS), in order to classify
currently belong. The NHSLA database contains details cases according to clinical category and severity. Claims
of clinical claims where the allegedly negligent incident that were clearly not related to anaesthesia, and those
took place on or after 1 April 1995, although before 2002 that were related purely to intensive care or management
some minor claims were managed by hospitals locally in a pain clinic, were excluded from further analysis.
without notification to the NHSLA. Claims with too little clinical detail for any useful
This study analyses all claims from the NHSLA database interpretation were also excluded. The remaining
related to regional anaesthesia and analgesia that occurred claims were subdivided into a number of non-exclusive
between 1995 and March 2007. The aims of the analysis categories including obstetric anaesthesia (including
were to highlight areas of high litigation risk and to report analgesia), regional anaesthesia, inadequate anaesthesia,
the financial impact of the claims. We also briefly drug-related excluding allergy, drug allergy, central
compare the differences between neuraxial blocks placed venous cannulation, peripheral venous cannulation,
for obstetric and non-obstetric indications. consent problems, positioning problems and miscella-
neous. Each case was also assigned a severity score, based
on the NPSA tool for grading severity of patient
Methods
incidents (Appendix 1) [16]. Due to lack of detail in
Data on negligence claims related to anaesthesia were clinical descriptions, two intermediate severity categories
requested and obtained from the NHSLA in May 2007, were added: mild ⁄ moderate and moderate ⁄ severe. The
via their ‘freedom of information’ portal. These included results of the independent assessments by the three
all clinical negligence claims notified to the CNST that investigators were then combined. If there was disagree-
occurred between April 1995 and March 2007 filed under ment regarding inclusion, category or severity score, the
‘anaesthesia’. A detailed description of the data review and case was discussed further until agreement was reached.
classification process has been previously reported [14]. In Further investigators were recruited to analyse individual
brief, the data returned were in the form of an clinical categories, and a final dataset was agreed in April
anonymous spreadsheet that included information on 2008.
the financial year of the incident and the claim, whether It is important to appreciate that the NHSLA database
the case was open (ongoing) or closed (settled or is not a clinical or risk database, but was set up for claim
withdrawn), a brief clinical description of the case, the and financial management, with very limited clinical
cost to the NHS of the claim, and the specialties involved detail available. The detailed examination of each claim
in the claim. The dataset also contained a classification of and exclusions as described aimed to improve the quality
the cause of the incidents, the injury type and the location and robustness of the data available to us.
of the incident, but these were found to be inconsistent The type of regional block involved and the basis of the
and therefore unreliable so were not used in sorting or claim were obtained from the brief description of the
subsequent analyses. The clinical details available for each incident. The authors sorted the claims into clinical
claim were very limited. Further clinical information was categories according to the major ‘damaging event’ as
requested from the NHSLA, but was not available for any described in the clinical description (Appendix 2). In
claim. cases where two or more ‘damaging events’ were evident,
The cost associated with a closed claim as described in the claim was categorised under the most serious
the NHSLA database is the cost of defending a claim, complaint.
including legal fees (both claimant and defence) and the Claims in the regional anaesthesia category, obstetric
cost of any settlement, but excluding the cost of the and non-obstetric, were analysed both quantitatively and
NHSLA itself. The dataset did not contain the informa- qualitatively. The quantitative analysis was performed to
tion required to determine the proportions of claims determine the cost associated with regional anaesthesia
successfully defended, or settled in or out of court. claims. The qualitative assessment was performed in an
Neither were the proportions of claim cost allocated to attempt to highlight areas of clinical practice that might be
legal fees and patient settlement available. All financial considered of high medicolegal risk. MICROSOFT EXCEL
settlements, unless stated otherwise, were adjusted using (Version 5.0; Microsoft Corporation, Redmond, WA,
the Retail Price Index to 2006 monetary values (the year USA) was used throughout the project, and data were
of the most recent closed claim in the dataset) so that analysed using simple descriptive statistical tests.

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444 Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland
Anaesthesia, 2010, 65, pages 443–452 K. Szypula et al. Æ Litigation related to regional anaesthesia
. ....................................................................................................................................................................................................................

(£0–28 907 [£0–2 070 092]). Fatal outcome was asso-


Results
ciated with the highest median cost, but the maximum
The NHSLA database contained 1067 reports. In total cost of a claim relating to a severe outcome was more than
226 cases were removed from further analysis, because 10 times the highest cost of a fatal outcome (Table 1).
they were clearly not anaesthesia-related or contained Closed claims associated with a severe outcome ac-
inadequate information (n = 196), or were related purely counted for fewer than 20% of closed claims but almost
to intensive care (n = 13) or pain clinics (n = 17). The half their cost. There were 28 claims with an associated
final dataset contained 841 anaesthetic claims. Regional cost above £100 000 (Table 3); 26 followed neuraxial
anaesthesia was the single largest clinical category in the blockade, of which 9 (35%) were obstetric and 17 (64%)
dataset with 366 (44%) claims, of which 186 (51%) were non-obstetric. Table 4 demonstrates trends in the cost of
obstetric and 180 (49%) non-obstetric. Of the 366 cases claims per year. Ninety-two percent of cases (338) were
included in this analysis, 281 ⁄ 366 (77%) were closed at notified to the NHSLA within 3 years of the incident and
the time when the data were provided. 99% (362) within 4 years.
The severity of claimed outcome and cost of the claims Table 5 shows the frequency of the ‘damaging events’
is reported in Table 1. Compared to the whole anaes- for the 366 regional anaesthesia claims. Of the 326
thesia dataset regional anaesthesia contains a somewhat neuraxial claims, 264 (81%) were related to epidurals.
higher percentage of claims of severe outcome, but fewer Overall, the most frequent ‘damaging event’ was nerve
claims of a fatal outcome [14]. damage (76 claims), followed by inadequate block with
Table 2 shows the types of regional block cited in resulting pain (24 claims), and back pain (24 claims).
claims relating to regional anaesthesia and analgesia. The Other ‘damaging events’ included: injury related to
maximum cost of claims was higher for those related to sensory block, such as burns and pressure sores (23 claims);
neuraxial and eye blocks compared with peripheral nerve dural tap (18 claims); epidural haematoma (eight claims);
blocks. drug error (eight claims); and high block ⁄ hypotension
The total cost associated with regional anaesthesia was (eight claims). There were 17 claims related to infection,
£12 724 017, with a median (IQR [range]) of £4772 including epidural abscess (seven claims), spinal abscess

Table 1 Distribution of severity in claims reported to the NHSLA (1995–2007) relating to regional anaesthesia or analgesia. Values are
number (proportion) or median (IQR [range]).

Closed Claims leading Total


Severity of outcome Claims claims to cost cost; £000 Cost per case; £000

Death 8 (2%) 7 (88%) 6 (86%) 420 42 (3–99 [0–178])


Severe 68 (19%) 50 (74%) 37 (74%) 6313 6 (0–73 [0–2070])
Moderate ⁄ severe 17 (5%) 9 (53%) 7 (78%) 651 3 (1–149 [0–337])
Moderate 83 (23%) 61 (73%) 46 (75%) 2190 8 (0–60 [0–184])
Mild ⁄ Moderate 74 (20%) 60 (81%) 41 (68%) 1262 2 (0–21 [0–376])
Mild 102 (28%) 85 (83%) 45 (53%) 1015 1 (0–15 [0–171])
Unclassified 14 (4%) 9 (64%) 6 (67%) 873 8 (0–31 [0–782])
Total 366 (100%) 281 (77%) 188 (67%) 12 724 5 (0– 29 [0–2070])

Table 2 Claims reported to the NHSLA (1995–2007) relating to regional anaesthesia or analgesia, according to the type of block.
Values are number (proportion) or median (IQR [range]).

Closed claims
Type of block Claims Closed claims leading to cost Total cost; £000 Cost per claim; £000

Epidural 264 (72%) 206 (78%) 131 (64%) 8074 2 (0–23 [0–2070])
Spinal 54 (15%) 38 (70%) 26 (68%) 3016 14 (0–41 [0–1598])
CSE 8 (2%) 8 (100%) 7 (88%) 958 82 (6–269 [0–376])
Eye 12 (3%) 10 (83%) 8 (80%) 361 24 (7–33 [0–184])
Upper limb 6 (2%) 2 (33%) 2 (100%) 1 0.5 [0–1]
Lower limb 4 (1%) 4 (100%) 2 (50%) 116 6 (0–58 [0–105])
Paravertebral 1 0 N⁄A N⁄A N⁄A
Splanchnic 1 0 N⁄A N⁄A N⁄A
Unspecified 16 (4%) 13 (81%) 12 (92%) 199 7 (3–21 [0–78])

CSE, combined spinal-epidural anaesthesia

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Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland 445
K. Szypula et al. Æ Litigation related to regional anaesthesia Anaesthesia, 2010, 65, pages 443–452
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Table 3 Closed claims with cost exceeding £100 000 in 366 claims reported to the NHSLA (1995–2007) relating to regional
anaesthesia or analgesia. Values are actual amounts. Obstetric cases are indicated by *.

Year of claim Cost; £000 Clinical details

1999 ⁄ 2000 2070 Spinal haematoma in relation to epidural analgesia for bowel surgery, leading to paraplegia
2000 ⁄ 2001 1598 Needle inserted into wrong position during spinal anaesthesia for removal of retained placenta*
2000 ⁄ 2001 782 Neurological damage following epidural for knee replacement
2000 ⁄ 2001 597 Cardiac arrest and brain damage following epidural local anaesthetic overdose
2001 ⁄ 2002 398 Paraplegia following labour epidural analgesia*
1998 ⁄ 1999 376 Neurological damage following CSE*
2001 ⁄ 2002 337 Neurological damage following spinal anaesthesia
1999 ⁄ 2000 269 Pain and weakness in leg and back following damage to nerve roots during epidural via ‘needle
through needle technique’*
2002 ⁄ 2003 269 Epidural morphine overdose
1997 ⁄ 1998 251 Spinal cord damage following cervical epidural
2004 ⁄ 2005 184 Globe perforation during peribulbar block
2000 ⁄ 2001 178 Epidural haematoma leading to paraplegia
1999 ⁄ 2000 171 Difficult ⁄ failed spinal
1999 ⁄ 2000 166 Spinal infarct after prophylactic saline infusion for dural puncture following labour epidural*
2001 ⁄ 2002 165 Epidural haematoma leading to paraplegia
1998 ⁄ 1999 159 Epidural analgesia for laparotomy. Pressure sore on heel and permanent nerve lesion
1997 ⁄ 1998 143 Spinal anaesthetic complicated by cord damage, leading to permanent disability*
2002 ⁄ 2003 142 Delay in diagnosis of epidural ‘ulcer’
2002 ⁄ 2003 139 Pain during hysterectomy under spinal anaesthesia
1997 ⁄ 1998 133 Spinal abscess complicating epidural insertion, leading to permanent disability
2001 ⁄ 2002 130 Labour epidural complicated by dural puncture, leading to ongoing backache and hearing problems*
1999 ⁄ 2000 130 Nerve damage following spinal anaesthetic for elective caesarean section*
1999 ⁄ 2000 129 Temporary paralysis in relation to epidural anaesthesia for hiatus hernia repair
2000 ⁄ 2001 120 Nerve damage during CSE*
2000 ⁄ 2001 108 Nerve root trauma during CSE, resulting in persistent pain and hypersensitivity
1999 ⁄ 2000 105 Nerve damage after femoral ⁄ sciatic block for knee replacement, leading to permanent disability
2001 ⁄ 2002 101 Cervical epidural complicated by dural puncture and cord damage
2002 ⁄ 2003 100 Neurological damage following epidural for arterial bypass

CSE, combined spinal-epidural anaesthesia

Table 4 Claims reported to the NHSLA (1995–2007) relating to regional anaesthesia or analgesia, according to the year of the
incident. Values are number (proportion) or median (IQR [range]).

Closed Closed claims


Year Claims claims leading to cost Total cost; £000 Cost per claim; £000

1995 ⁄ 1996 18 17 (94%) 13 (76%) 925 6 (0–38 [0–376])


1996 ⁄ 1997 20 19 (95%) 17 (89%) 1563 44 (2–142 [0–269])
1997 ⁄ 1998 20 19 (95%) 16 (84%) 660 9 (0–47 [0–178])
1998 ⁄ 1999 34 33 (97%) 24 (73%) 2823 14 (0–40 [0–2070])
1999 ⁄ 2000 39 38 (97%) 30 (79%) 3534 5 (0–32 [0–1598])
2000 ⁄ 2001 37 33 (89%) 19 (58%) 1306 2 (0–27 [0–597])
2001 ⁄ 2002 54 45 (83%) 28 (62%) 1091 5 (0–15 [0–337])
2002 ⁄ 2003 48 36 (75%) 23 (64%) 413 3 (0–14 [0–75])
2003 ⁄ 2004 51 28 (55%) 15 (54%) 338 1 (0–13 [0–184])
2004 ⁄ 2005 27 11 (41%) 2 (18%) 58 0 (0–0 [0–42])
2005 ⁄ 2006 16 2 (13%) 2 (100%) 15 8 ([2–14])

(two claims), meningitis (two claims) and other infection Of the 12 (3%) claims arising from ophthalmic regional
(five claims). Of the 54 (17%) claims related to spinal anaesthesia, globe perforation was the ‘damaging event’ in
anaesthesia, the three most frequent ‘damaging events’ 10 cases, with resultant loss of vision and ⁄ or need for
were inadequate block (21 claims), nerve damage (13 further surgery.
claims), and drug error (three claims). Seven out of the The six (2%) claims arising from upper limb regional
eight claims related to combined spinal-epidural anaes- anaesthesia comprised intravenous injection (two claims),
thesia (CSE) were of alleged nerve damage. pneumothorax (two claims), neurological damage (one

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446 Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland
Anaesthesia, 2010, 65, pages 443–452 K. Szypula et al. Æ Litigation related to regional anaesthesia
. ....................................................................................................................................................................................................................

claim) and infection from an indwelling axillary catheter Table 5 Damaging events (proportion) in 366 claims reported
(one claim). The four (1%) claims arising from lower limb to the NHSLA (1995–2007) relating to regional anaesthesia or
analgesia.
blocks all related to neurological damage.
There were 12 claims in which fatality was recorded as
All claims Non-obstetric Obstetric
the coded injury sustained. This equates to approximately n = 366 n = 180 n = 186
one claim related to death in this group, each year. Eleven
claims cited an epidural and one an eye block. All deaths Nerve damage 105 (29%) 66 (37%) 39 (21%)
were related to non-obstetric regional anaesthesia. After Pain* 63 (17%) 6 (3%) 57 (31%)
Back pain 26 (7%) 7 (4%) 19 (10%)
consideration of the limited description of the incidents, Injury related to 23 (6%) 7 (4%) 16 (9%)
outcome was classified as ‘death’ only if the investigators sensory block
considered that the death was a direct consequence of the Dural tap 20 (5%) 9 (5%) 11 (6%)
Infection† 18 (5%) 17 (9%) 1
incident. This resulted in eight of these 12 outcomes Drug error 13 (4%) 10 (6%) 3 (2%)
classified as ‘death’, three as ‘severe’, and one as Globe perforation 10 (3%) 10 (6%) N⁄A
‘mild ⁄ moderate’. Epidural haematoma 8 (2%) 8 (4%) 0
Injury related to 7 (2%) 3 (2%) 4 (2%)
The number (proportion) of claims leading to cost was motor block
similar for obstetric (103 ⁄ 186; 55%) and non-obstetric Indeterminate 25 (7%) 7 (4%) 18 (10%)
(85 ⁄ 180; 47%) claims, respectively. The total cost for Other 48 (13%) 30 (17%) 18 (10%)

obstetric closed claims was £5 433 920 (median (IQR


*Including intra-operative pain, pain during labour, and postopera-
[range]) £5678 (£0–27 690 [£0–1 597 565]) and for tive.
non-obstetric closed claims, £7 290 097 (£3337 (£0–31 †Including epidural abscess, spinal abscess, meningitis, sepsis, wound
405 [£0–2 070 062]). Neuraxial block accounted for all infection and other.
of the obstetric claims and 148 ⁄ 180 (82%) non-obstetric
claims of claims. In 8 ⁄ 186 (4%) of the obstetric claims the
exact type of block involved was indeterminate. Non- Table 6 Severity of outcome in 334 claims reported to the
NHSLA (1995–2007) relating to neuraxial regional anaesthesia
obstetric neuraxial claims were more likely to relate to or analgesia. Values are number (proportion).
severe outcomes than obstetric ones. Tables 5–7 provide
an overview of the differences between the obstetric and Obstetric Non-obstetric
non-obstetric claims. n = 186 n = 148
The most frequent damaging events for the obstetric
neuraxial claims were inadequate block (pain during Death 0 8 (5%)
Severe 19 (10%) 37 (25%)
caesarean section or labour) (57 claims), nerve damage (39 Moderate ⁄ severe 5 (3%) 11 (7%)
claims) and back pain (19 claims); for the non-obstetric Moderate 41 (22%) 31 (21%)
claims these were nerve damage (58 claims), infection Mild ⁄ Moderate 49 (26%) 23 (16%)
Mild 67 (36%) 30 (20%)
(16 claims) and drug error (10 claims). Unclassified 5 (3%) 8 (5%)

Discussion
The principal finding of this analysis of claims in the events are accurate. We found the NHSLA coding of type
NHSLA dataset relating to regional anaesthesia and of injury, location and speciality to be of little value; in
analgesia is that they are responsible for 44% of claims many cases it did not correlate with the clinical descrip-
and a similar proportion of the cost of the overall tion. More than 10% of cases were misclassified as
anaesthesia dataset. Eighty-nine per cent of the claims ‘anaesthesia’, which raises the question of how many
involve neuraxial blocks, predominantly epidurals. claims actually related to anaesthesia were also misclassi-
Our analysis has a number of limitations. A detailed fied and therefore not included in the dataset provided to
account of these limitations is provided elsewhere [14]. As us. The data available on the cost of claims included the
previously noted, the function of the NHSLA database is cost of claimant as well as defence legal services, but not
to allow financial management of claims, and the clinical the cost of the NHSLA itself, and we were unable to
information available for each case is therefore severely obtain the breakdown of cost into legal fees and patient
limited. The clinical information is a very brief account of awards, nor determine the proportion of cases which
the alleged incident and lacks verification of actual clinical were settled out of court. The NHSLA database does not
details and outcome, as well as characteristics of the contain any denominator data, nor any details of adverse
patient and their ASA and CEPOD status. Inclusion in events that did not lead to initiation of a claim. As a result,
the database does not mean that the described clinical estimates of risk of litigation for regional anaesthesia in

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Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland 447
K. Szypula et al. Æ Litigation related to regional anaesthesia Anaesthesia, 2010, 65, pages 443–452
. ....................................................................................................................................................................................................................

Table 7 Claims reported to the NHSLA (1995–2007) relating to neuraxial anaesthesia or analgesia, according to the type of block.
Values are number (proportion) or median (IQR [range]). Claims with indeterminate type of block (n = 16) have been excluded.

Closed claims
Type of block Claims Closed claims leading to cost Total cost; £000 Cost per claim; £000

Obstetric Epidural 139 (78%) 115 (83%) 75 (65%) 2198 3 (0–28 [0–398])
Spinal 35 (20%) 23 (66%) 17 (74%) 2322 20 (0–45 [0–1598])
CSE 4 (2%) 4 (100%) 4 (100%) 822 195 (104-322 [56–376])
Total 178 (100%) 142 (80%) 96 (68%) 5342 5 (0–28 [0–1598])
Non-obstetric Epidural 125 (84%) 91 (73%) 56 (62%) 5876 2 (0–35 [0–2070])
Spinal 19 (13%) 15 (79%) 9 (60%) 694 2 (0–37 [0–337])
CSE 4 (3%) 4 (100%) 3 (75%) 136 14 (14-18 [0–108])
Total 148 (100%) 110 (74%) 68 (62%) 6706 2 (0–35 [0–2070])

general or for specific regional anaesthesia procedures spends slightly more on legal fees (51% in 2007) than on
cannot be made directly from these data. Our analysis is patient settlements (49%) [18].
likely to underestimate the number of regional anaesthesia Regional anaesthesia accounts for the largest number of
cases in the dataset since, unless there was clear evidence claims in the full ‘anaesthesia’ dataset (44%), and, of these
that a case was related to regional anaesthesia, it was claims, approximately half are obstetric. Regional anaes-
excluded from our analysis. Finally, over the 11-year thesia is also the group with the highest overall cost.
database period, there have been changes in anaesthetic However, it does not have the highest cost per claim; the
practice and standards. groups with the highest mean cost per claim are
Despite the above limitations, analysis of the NHSLA respiratory, central venous cannulation and drug error
claims related to regional anaesthesia or analgesia is excluding allergy [14]. These data cannot provide an
valuable, by disclosing the type of regional block estimate of risk of litigation due to the lack of denom-
involved, the severity and the financial risk of such claims inator data. While it is not known how many anaesthetics
in the NHS in England. It is potentially useful at various are administered in the UK or in England per year it has
organisational levels. Firstly, by highlighting areas of been estimated that 7.2–8 million surgical procedures are
apparently high medicolegal risk, it may help professional carried out in England each year (http://www.npsa.nhs.
organisations, including trusts and those who advise them, uk/corporate/news/safe-surgery-saves-lives/ (accessed
to direct development of guidelines regarding safe 22 ⁄ 04 ⁄ 2009)) [19], and the 3rd National Audit Project
practice and risk avoidance. Secondly, it is potentially of the Royal College of Anaesthetists (NAP3) has
very useful to individual clinicians, by demonstrating the established that approximately 700 000 neuraxial blocks
type of cases that lead to medicolegal claims, and the are performed in the NHS in the UK each year [6]. These
nature of those claims. For example, the fact that almost data strongly suggest that the number of claims related to
10% of claims included allegations of lack of consent may regional anaesthesia is disproportionately high.
act as an impetus to anaesthetists to consider how best to The results may be taken to suggest that there is a
deliver and document information about the risks and decrease in the number of claims for the years 2003
benefits of regional blocks [17]. onwards. However, the time from the incident occurring
In general terms, there was a tendency for cost to rise to claim notification was up to 10 years. Only 10% of
with increased severity. This is in keeping with expec- claims were registered within 1 year of the incident, and
tations, and suggests that our assessment of severity was 8% were registered more than 3 years after the incident.
not grossly inaccurate for the regional anaesthesia claims Therefore data for the years 2003 onwards are almost
[14]. However, caution is needed when assuming a close certainly incomplete, and very unlikely to reflect a true
correlation between cost and severity of damage. While downward trend. Indeed, the broader NHSLA data
the award to the patient might reasonably be expected to suggest that the number of claims is probably increasing
reflect the harm that they have experienced, the far from [18].
trivial legal cost component of the overall sum is often The review of the Canadian Medical Protective
related to whether the negligence claim proceeds to a full Association claims for the period 1990–1997, by Peng
hearing or is settled out of court. This is more likely to and Smedstad, identified 310 cases involving anaesthetists,
depend on the merits of the claim, specifically whether of which 61 cases (20%) were related to (obstetric and
there is clear failure of duty of care and causation, rather non-obstetric) regional anaesthesia [10]. The authors
than being related to degree of harm. Overall the NHSLA reported that approximately two thirds of closed claims

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448 Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland
Anaesthesia, 2010, 65, pages 443–452 K. Szypula et al. Æ Litigation related to regional anaesthesia
. ....................................................................................................................................................................................................................

were related to neuraxial blockade (n = 42), with eye Claims arising from obstetric neuraxial regional anaes-
blocks the most commonly cited peripheral nerve block thesia were associated with a lower proportion of severe
(n = 7 ⁄ 19), accounting for 12% of all regional claims. injuries and death than non-obstetric claims and more
There were no deaths in the regional anaesthesia group. mild-moderate injuries (Table 6). Despite similar num-
In a review from the American Society of Anesthesi- bers of claims in the two subsets, the total cost was lower
ologists Closed Claims Project (ASACCP), Lee et al. [12] in the obstetric group, due to a larger number of claims
reviewed injuries associated with regional anaesthesia for related to lower severity harm. A similar picture is seen in
the period 1980–1999. Of 5047 claims in that period, just the obstetric claims in the ASACCP, where the majority
under 20% (n = 1005) were related to regional anaesthe- of claims were also less severe [13]. This highlights the
sia and analgesia, including obstetrics. Of the neuraxial importance of tackling relatively small events ⁄ incidents as
anaesthesia claims, 368 (45%) cases were obstetric and 453 well as major ones in order to reduce the financial burden
(55%) non-obstetric. Of the 453 non-obstetric neuraxial of obstetric anaesthetic claims on the NHS. The distri-
anaesthesia claims, 143 (32%) led to death ⁄ brain damage, bution of the type of regional anaesthesia involved was
117 (26%) to permanent nerve injury and 172 (38%) to similar in the obstetric and non-obstetric groups. Inad-
temporary nerve injury. Peripheral nerve blocks equate regional anaesthesia leading to pain during surgery
accounted for 13% of all regional anaesthesia claims, and or labour was the most common ‘damaging event’ in the
21% of the non-obstetric claims, while regional anaes- obstetric group with 57 (31%) claims; in comparison there
thesia of the eye (45 ⁄ 1005) accounted for 4% of all were only two cases with intra-operative pain as the main
regional anaesthesia claims. ‘damaging event’ in the non-obstetric group. Pain during
In the NHSLA dataset, claims relating to eye blocks caesarean section under regional anaesthesia was classified
represented 3% (12 ⁄ 366) of regional anaesthesia claims, as ‘mild’ or ‘moderate’ (where post-traumatic stress
comparable to the ASACCP data, but significantly less disorder was cited) harm and these cases in particular
than in the Canadian dataset. In the North American contribute to the high frequency of low severity claims
reviews retrobulbar and peribulbar blocks had been used seen with obstetric anaesthesia. The relatively large
in the majority cases. During the period of the NHSLA proportion of claims relating to pain during caesarean
dataset it is likely that such blocks have decreased with a section suggests a need to improve intra-operative
commensurate increase in sub-Tenon’s blocks and topical management of regional anaesthesia for these. The cost
(eye-drop) anaesthesia. While these techniques might be (and, we speculate, the settlements) associated with the
anticipated to lead to a reduction in the number of second most frequent damaging event, nerve injury, was
complications and negligence claims [20], with seven of considerably greater than the cost associated with inad-
12 claims occurring in the second half of the dataset there equate anaesthesia. There was a wide spectrum of claimed
is no evidence of such an effect to date. injury, from paraesthesia and mild injuries to cases of
Compared to these two North American anaesthesia paraplegia. Nerve injury (most being temporary and ⁄ or
datasets the data presented here have approximately twice non-disabling) is now the most frequent damaging event
the proportion of claims relating to regional anaesthesia. in the ASACCP for obstetric anaesthesia [13], having
This may reflect a greater reliance on regional blocks in previously been the third commonest cause [24]. Notably
UK practice. Of note, the North American analyses cover only a third of ASACCP claims relating to nerve injury
an earlier period than the NHSLA data and the use of received payments, compared with over three-quarters of
regional anaesthetic and analgesic techniques has probably similar NHSLA closed claims.
increased in the early years of the 21st century, due to In the ASACCP, the most frequent cause of maternal
greater appreciation of the benefits of these techniques death between 1990 and 2003 was high neuraxial block,
[21] and the development of new techniques for accounting for 22% of maternal deaths in the obstetric
successful siting of regional blocks [22]. The different dataset overall and 37% of deaths related to regional
legal systems might also contribute to this discrepancy: in anaesthesia [11]. The majority (80%) were epidural related
the USA litigation with low value claims (e.g. < $50 000) (10 accidental intrathecal catheters and two high blocks).
is less likely to be encouraged in the ‘no-win no fee’ The NHSLA dataset included no deaths associated with
system, while in England, where all legal costs are high obstetric regional anaesthetic blocks, though in the
sometimes provided by the state, the likelihood of low last four Confidential Enquiries into Maternal Deaths
value claims is perhaps increased [23]. As the regional triennial reports there were two direct anaesthetic deaths
anaesthesia group contains a relative excess of low related to high neuraxial blocks: one following a CSE in
severity, low value claims, this group would be most the 1994–1996 report and one epidural in the 1997–1999
affected by such a trend. report [25–28].

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K. Szypula et al. Æ Litigation related to regional anaesthesia Anaesthesia, 2010, 65, pages 443–452
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Recently, NAP3 has helped to define the risks of neur- is evident there are potential solutions to reduce risk of
axial blockade and has also provided robust denominator patient harm and litigation. Examples include: appropriate
data on the number of neuraxial blocks performed in the informed consent for regional anaesthesia with docu-
NHS in the UK [6]. The results of NAP3 have been mentation of the risks discussed; improved intra-operative
described, by its authors (one also an author of this paper), care to eliminate pain from inadequate regional anaes-
as ‘largely reassuring’. Out of the 700 000 cases, the thesia (particularly in obstetric practice); and perhaps
‘pessimistic’ point estimate of incidence of permanent improved postoperative surveillance to prevent, or allow
injury was 1 in 24 000 and of paraplegia or death was 1 in early active management of, sequelae. Drug errors may be
55 000. Of note, peri-operative epidurals were associated reduced by improvements both in design of delivery
with the highest incidence of adverse sequelae (with point systems and systems for drug checking.
estimates of between 1 in 6000 and 1 in 12 000). In the While analysis of the present data has enabled docu-
NHSLA dataset, epidural block was responsible for more mentation of the broad patterns of litigation in this area,
than two-thirds of all claims; but, due to limited clinical the quality of the data on which the analysis is based
data, we were unable to determine the proportion of prevents both genuine closed claim analysis and root
claims related to permanent nerve damage or paraplegia. It cause analysis. A communication pathway between the
is also possible that the term ‘epidural’ has been used NHSLA (and other UK-based bodies) and anaesthetists
generically for other procedures such as spinal, caudal or that improved the extent and quality of review of these
CSE techniques: this would artificially increase the cases would enable detailed analysis of claims and better
proportion of claims filed under ‘epidural’. Spinals identification of patterns resulting from system error, and
accounted for over 40% of neuraxial blocks in NAP3, enable resultant change in practice to minimise patient
and yet there were only 54 (15%) claims related to spinal harm and litigation. This would logically be beneficial for
anaesthesia in the current dataset. This suggests that spinal clinicians, the NHSLA itself and ultimately for patients.
anaesthesia is a procedure associated with a relatively low In conclusion, we have examined the existing data held
risk of litigation. by the NHSLA on claims related to regional anaesthesia
There is much current interest in wrong-route errors in in England. The dataset provides an overview of the
neuraxial block and their potential solutions. NAP3 extent, patterns and cost associated with the claims. The
highlighted nine cases (six in obstetrics) of wrong-route data suggest that claims associated with regional anaes-
injection errors, where a drug planned for neuraxial thesia are proportionately more likely in England than
administration was accidentally injected intravenously, or North America. Non-obstetric claims appear to be of
vice versa. There was one clear wrong-route error greater severity and are associated with higher cost than
involving the wrong drug administered into an epidural obstetric claims. Factors frequently associated with litiga-
catheter (in obstetric theatre recovery) and three others tion include epidurals, nerve injury, inadequate anaes-
that may have been wrong-dose or wrong-route errors thesia, obstetrics and, to a lesser extent, ophthalmic
(one theatre based and two ward-based, all non-obstetric) blocks. However, the data analysed have considerable
[29]. There were no claims relating to accidental limitations and the potential lessons that might be learnt
intravenous administration of epidural drugs, nor of the from a genuine closed claims analysis are not achievable
wrong drug given intrathecally. This small number of from these data. Introduction of a UK-wide closed claims
wrong-route claims contrasts markedly with recent analysis system would overcome many of the limitations
reports [6, 30]. Surveys of lead obstetric anaesthetists in of the NHSLA dataset, and would be beneficial to the
the UK suggest that drug errors are relatively common NHS, anaesthetists and patients.
[30, 31], with almost one in four UK obstetric units
surveyed in September 2006 having knowledge of a
Acknowledgement
recent wrong-route error in their department [30]. This
mismatch between errors and litigation may be explained We are grateful to Ms Ruth Symons of the National
by incorrect classification of claims but, if this is not so, Health Service Litigation Authority for assistance with the
other possibilities are that few patients involved in such dataset.
incidents are harmed or that disproportionately few
proceed to litigation. Recent events make this unlikely
References
to be sustained.
The current dataset highlights some high medicolegal 1 Ballantyne JC, Carr DB, deFerranti S, et al. The compar-
risk areas where claims may be avoidable, but, with the ative effects of postoperative analgesic therapies on pul-
limited clinical data, a detailed analysis of system and monary outcome: cumulative meta-analysis of randomised
human factors is not possible. However, in many areas it controlled trials. Anesthesia and Analgesia 1998; 86: 598–612.

 2010 The Authors


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Anaesthesia, 2010, 65, pages 443–452 K. Szypula et al. Æ Litigation related to regional anaesthesia
. ....................................................................................................................................................................................................................

2 Liu SS, Wu CL. The effects of analgesic technique on post- tient-safety-tools-and-guidance/7steps/ (accessed
operative patient reported outcomes including analgesia: a 22 ⁄ 04 ⁄ 2009).
systematic review. Anesthesia and Analgesia 2007; 105: 789– 17 Association of Anaesthetists of Great Britain & Ireland.
808. Consent for Anaesthesia, revised edition. London: AAGBI,
3 Richman JM, Liu SS, Courpas G, et al. Does continuous 2006.
peripheral nerve block provide superior pain control to 18 NHSLA annual report and accounts HMSO London 2007.
opioids? A meta-analysis. Anesthesia and Analgesia 2006; http://www.nhsla.com (accessed 22 ⁄ 04 ⁄ 2009).
102: 248–57. 19 Hospital episode statistics http://www.hesonline.nhs.uk/
4 Jenkins JG, Khan MM. Anaesthesia for Caesarean section: a Ease/servlet/ContentServer?siteID=1937&categoryID=
survey in a UK region from 1992 to 2002. Anaesthesia 2003; 204 (accessed 22 ⁄ 04 ⁄ 2009).
58: 1114–8. 20 Davison M, Padroni S, Bunce C, Rüschen H. Sub-Tenon’s
5 Hawkins JL, Koonin LM, Palmer SK, Gibbs CP. anaesthesia versus topical anaesthesia for cataract surgery.
Anesthesia-related deaths during obstetric delivery in the Cochrane Database of Systematic Reviews 2007; 3: CD006291.
United States, 1979–1990. Anesthesiology 1997; 86: 277– DOI: 10.1002/14651858.CD006291.pub2.
84. 21 Marret E, Remy C, Bonnet F, et al. Meta-analysis of
6 Cook TM, Counsell D, Wildsmith JAW. Major compli- epidural analgesia versus parenteral opioid analgesia after
cations of central neuraxial block: report on the Third colorectal surgery. British Journal of Surgery 2007; 94:
National Audit Project of the Royal College of Anaesthe- 665–73.
tists. British Journal of Anaesthesia 2009; 102: 179–90. 22 Chin KJ, Chan V. Ultrasound guided peripheral nerve
7 Christie IW, McCabe S. Major complications of epidural blockade. Current Opinion in Anesthesiology 2008; 21:
analgesia after surgery; results of a six-year survey. Anaes- 624–31.
thesia 2007; 62: 335–41. 23 Huycke JJ, Huycke MM. Characteristics of potential
8 Moen V, Dahlgren N, Irestedt L. Severe neurological plaintiffs in malpractice litigation. Annals of Internal Medicine
complications after central neuraxial blockades in Sweden 1994; 120: 792–8.
1990–1999. Anesthesiology 2004; 101: 950–9. 24 Chadwick HS. An analysis of obstetric anesthesia cases from
9 Auroy Y, Narchl P, Messiah A, Litt L, Rouvier B, Samii K. the American Society of Anesthesiologists Closed Claims
Serious complications related to regional anaesthesia. Re- Project database. International Journal of Obstetric Anesthesia
sults of a prospective survey in France. Anesthesiology 1997; 1996; 5: 258–63.
87: 479–86. 25 Why Mothers Die 1994–96. Report on Confidential Enquiries
10 Peng PWH, Smedstad KG. Litigation in Canada against into Maternal Deaths in the United Kingdom. London: HMSO,
anesthesiologists practicing regional anesthesia. A review of 1998.
closed claims. Canadian Journal of Anesthesia 2000; 47: 105– 26 Why Mothers Die 1997–99. Report on Confidential Enquiries
12. into Maternal Deaths in the United Kingdom. London: RCOG,
11 Aromaa U, Lahdensuu M, Cozanitis DA. Severe compli- 2001.
cations associated with epidural and spinal anaesthesia in 27 Saving mothers’ lives (2000–2002). Report on Confidential
Finland 1987–1993. A study based on patient insurance Enquiries into Maternal and Child Health. London: RCOG,
claims. Acta Anaesthesiologica Scandinavica 1997; 41: 445–52. 2004.
12 Lee LA, Posner KL, Domino KB, Caplan RA, Cheney 28 Lewis G (ed.). The confidential Enquiry into Maternal and
FW. Injuries Associated with Regional Anesthesia in the Child Health (CEMACH). Saving Mothers’ Lives: Reviewing
1980s and 1990s. A Closed Claims Analysis. Anesthesiology Maternal Deaths to Make Motherhood Safer 2003–2005. The
2004; 101: 143–52. seventh report on Confidential Enquiries into Maternal
13 Davies JM, Posner KL, Lee LA, Cheney FW, Domino KB. Deaths in the United Kingdom. London: CEMACH, 2007.
Liability associated with obstetric anesthesia. Anesthesiology 29 Cranshaw J, Gupta J, Cook TM. Litigation related to drug
2009; 110: 131–9. errors in anaesthesia: an analysis of financial and clinical
14 Cook T, Bland L, Mihai R, Scott S. Litigation related to impact of claims against the NHS in England 1995–2007.
anaesthesia: an analysis of claims against the NHS in Anaesthesia 2009; 64: 1317–23.
England 1995–2007. Anaesthesia 2009; 64: 706–18. 30 Jones R, Swales HA, Lyons GR. A national survey of
15 National Statistics. http://www.statistics.gov.uk/down safe practice with epidural analgesia in obstetric units.
loads/theme_economy/RP02.pdf (accessed 22 ⁄ 04 ⁄ 2009). Anaesthesia 2008; 63: 516–19.
16 Seven steps to patient safety – The full reference guide 31 Yentis SM, Randall K. Drug errors in obstetric anaesthesia:
National Patient Safety Agency, London. August 2004. a national survey. International Journal of Obstetric Anesthesia
http://www.npsa.nhs.uk/nrls/improvingpatientsafety/pa 2003; 12: 246–9.

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Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland 451
K. Szypula et al. Æ Litigation related to regional anaesthesia Anaesthesia, 2010, 65, pages 443–452
. ....................................................................................................................................................................................................................

Appendix 1
Appendix 2
National Patient Safety Agency severity of outcome scale,
Types of ‘damaging events’ in the regional anaesthesia
for patient safety incidents.
claims.

Severity grade Description


Allergy Infection (other)

None No harm (whether lack of harm was due to


prevention or not) Awareness Injury related to failure of block*
Low Minimal harm necessitating extra observation Back pain Injury related to motor block
or minor treatment* Bladder damage Injury related to sensory block
Moderate Significant, but not permanent harm, or mod- Cardiac arrest Iv injection
erate increase in treatment† Child injury Meningitis
Severe Permanent harm due to the incident‡ Consent Nerve damage
Death Death due to the incident Drug error Pain
Dural tap Pain during CS
Epidural abscess Pain with EFL
Epidural haematoma Pain intra-operative
*First aid, additional therapy or additional medication.
Foreign body Pneumothorax
Excludes extra stay in hospital, return to surgery or Globe perforation Psychological
readmission. Headache Spinal abscess
High block with EFL Spinal cord ischaemia
†Return to surgery, unplanned re-admission, prolonged
Hypotension Total spinal
episode of care as in or out patient or transfer to another Inappropriate block Wrong site of block
area such as intensive care unit. Indeterminate
‡Permanent lessening of bodily functions, sensory,
motor, physiologic or intellectual. *Injury related to general anaesthesia following failed
regional anaesthesia.
CS, caesarean section; EFL, epidural for labour.

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452 Journal compilation  2010 The Association of Anaesthetists of Great Britain and Ireland

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