Clinical negligence, litigation and healthcareassociated

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Clinical negligence, litigation and

healthcare-associated infections

S.D. Goldenberg

a,b,*

, H. Volpe

´

c

, G.L. French

a,b

aCentre for Clinical Infection and Diagnostics Research, Guy’s & St Thomas’ NHS Foundation Trust, London, UK bDepartment of Infectious Diseases, King’s College, London, UK

cDAC Beachcroft Limited Liability Partnership, Bristol, UK

A R T I C L E I N F O Article history:

Received 3 October 2011 Accepted 20 April 2012 Available online 1 June 2012 Keywords: Clostridium difficile Healthcare-associated infection Medico-legal Meticillin-resistant Staphylococcus aureus S U M M A R Y

Background: Litigation costs resulting from clinical negligence claims involving healthcare-associated infections are a significant but underappreciated cost to healthcare organizations. In England these claims are handled on behalf of the National Health Service (NHS) organizations by the NHS Litigation Authority (NHSLA). The total number of claims and the amounts awarded have increased significantly in recent years.

Aim: To determine whether the recent significant reductions in meticillin-resistant Staphylococcus aureus (MRSA) bloodstream infection (BSI) and Clostridium difficile infections in England have had an effect on the number and value of NHSLA claims relating to these infections.

Methods:Data obtained from the NHSLA relating to claims mentioningC. difficileor MRSA from 2003 to 2010 were correlated with mandatory surveillance data from the Health Protection Agency for these infections.

Findings:The rate of NHSLA claims for MRSA has decreased in line with reductions in BSI for this infection (0.007 per BSI between 2003/4e2006/7 to 0.0017 per BSI between 2007/8 and 2010/11), but there was no significant change in claims relating toC. difficileinfection. Overall the amounts awarded for successful claims have decreased significantly from a total of £76,846 for the period 1997/8e2006/7 to £24,821 for the period 2007/8e2010/11. Conclusions: The number of litigation claims involving MRSA has recently decreased significantly in line with surveillance data. There was no observed effect on claims involvingC. difficile. The amounts awarded for successful claims for both infections have also fallen, although the reasons for this are not clear.

Crown CopyrightÓ2012 Published by Elsevier Ltd on behalf of the Healthcare Infection Society. All rights reserved.

Introduction

Healthcare organizations and healthcare workers (HCWs) have a duty of care to those they treat, and patients (or their representatives) may pursue legal claims for compensation if they believe they have suffered injury, loss or damage resulting from a negligent breach of this duty. In order for a claim to succeed, the claimant must prove four things: that they were owed a duty of care; that the duty was breached; that the * Corresponding author. Address: Directorate of Infection, 5th Floor

North Wing, St Thomas’ Hospital, Westminster Bridge Road, London SE1 7EH, UK. Tel.:þ44 (0) 20 7188 8515; fax:þ44 (0) 20 7188 8341.

E-mail address:Simon.goldenberg@gstt.nhs.uk(S.D. Goldenberg).

Available online atwww.sciencedirect.com

Journal of Hospital Infection

j o u r n a l h o m e p a g e : w w w . e l s e v i e r h e a l t h . c o m / j o u r n a l s / j h i n

0195-6701/$esee front matter Crown CopyrightÓ2012 Published by Elsevier Ltd on behalf of the Healthcare Infection Society. All rights reserved. doi:10.1016/j.jhin.2012.04.020

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breach caused or contributed to damage; and that there has been loss or damage as a consequence. Healthcare providers are vicariously liable for those actions of their HCWs which are deemed to be below the standard expected of a reasonable, responsible and logical body of their professional peers.

It is estimated that 10% of hospital inpatients suffer an adverse event and that 50% of these are avoidable.1Although patients and relatives may complain about their treatment for a variety of reasons, only a minority of them pursue legal claims.2 In the UK the National Health Service Litigation

Authority (NHSLA) handles negligence claims for the NHS under several schemes, including, since 1 April 1995, the Clinical Negligence Scheme for Trusts (CNST). NHS hospital trusts fund the CNST by paying the equivalent of insurance premiums.

One important area which has seen a rising number of clinical negligence claims comprises healthcare-associated infections (HCAIs) which are recognized to be largely, though not completely, avoidable.3 They have been the subject of extensive medical, social and political discussion and numerous media reports. The Health Act was published in England in 2006 and includes a legal requirement for Chief Executives of healthcare organizations to provide an effective system of infection prevention and control for patients, staff and visitors that accords with a national Code of Practice.4There has been

particular focus on HCAIs caused by meticillin-resistant Staphylococcus aureus(MRSA) andClostridium difficile infec-tion (CDI), and there are patient support and advocacy groups for both these infections, together with centrally administered targets with financial penalties for their reduction. All these actions have contributed to a rapid reduction in the incidence of MRSA and CDI in England over the past decade.

The extent and costs of HCAI-related legal claims are poorly appreciated by patients and healthcare professionals alike. Here new data are presented from NHSLA summarizing the volume and value of claims brought under its Clinical Negli-gence Scheme for Trusts (CNST) that mention HCAIs. Finally, the possible impact of the recent fall in MRSA and CDI on clinical negligence claims in England is assessed.

Methods

We collected publicly available data from the following sources.

Formal complaints to the NHS

The NHS Information Centre has collected data relating to written complaints against the NHS in England since 1997. Data are obtained from all NHS organizations, collected voluntarily from NHS Foundation Hospital Trusts.

Reports of safety incidents in the NHS

The UK National Patient Safety Agency manages a National Reporting and Learning Service (NRLS) which receives volun-tary (and since 2010, mandatory) confidential reports of patient safety incidents from HCWs in England and Wales.5

Examples of infection control incidents may include: inappro-priate isolation or cohorting of patients; failure to screen/test for HCAIs; inappropriate use of antibiotics; failure to decon-taminate patients’ skin prior to insertion of an invasive device;

failure to adequately decontaminate equipment (e.g. flexible endoscope, surgical instruments); re-use of a single-use-only device; failure to use personal protective equipment (e.g. apron, gloves) when caring for patients with infections.6

Surveillance data for MRSA and CDI

It has been mandatory for English Acute NHS Trusts to report episodes of MRSA bloodstream infection (BSI) to the UK Health Protection Agency (HPA) since April 2001 and for CDI in indi-viduals aged>65 years since April 2007 (later extended to all those aged>2 years). Although it has not been demonstrated that MRSA BSI or rates of CDI (defined as the detection of toxigenicC. difficilein diarrhoeal stool) are a valid measure of effectiveness of infection control practice, these data are used to compare the success of different healthcare organizations in achieving control of these infections.

Claims for clinical negligence in the NHS

The CNST provided us with information on how many of the clinical negligence claims they received from the English NHS mentioned MRSA or CDI. No further detail was available, so the data do not indicate to what extent these HCAIs formed the focus of the claims or were merely incidental. Details were collected separately for MRSA- and CDI-related claims in England for each financial year since 1995 including the total numbers of claims closed and settled and the total costs awarded. The amounts paid for each claim were separated into defence legal costs, claimant legal costs and damages. This information was correlated with the numbers of episodes of CDI and MRSA BSI in England reported by the HPA mandatory surveillance schemes.7

Results

All time periods refer to financial years (April to May). Formal complaints to the NHS

The number of written complaints about NHS hospital and community health services has increased annually by an average of 1.1% since 1997/8. However, the largest yearly increase of 13.4% occurred recently, rising from 89,139 in 2008/ 9 to 101,077 in 2009/10. There was an apparent decrease in the total number of complaints for the most recent year falling to 97,463 in 2010/11. However, this was accompanied by a decrease in the number of NHS Foundation Trusts returning data (who are exempt from disclosing these data). For organ-izations providing data in both of the last two years, the number of complaints has actually risen slightly by 0.5% from 94,200 in 2009/10 to 94,700 in 2010/11.8

Reports of safety incidents in the NHS

There was an increasing number of infection control inci-dents reported to the NPSA between 2008 and 2010, rising from about 15,000 to about 19,000 (Figure 1). The majority of these incidents resulted in no or very little harm. However, these are voluntary data and there has also been an increase in the number of organizations reporting. Therefore this increase

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does not necessarily mean that more incidents are occurring. Instead, there may be a greater awareness of patient safety and openness among staff.

General clinical negligence claims under CNST

The NHSLA paid a total of £911 million in all compensation claims (clinical and non-clinical) in 2010/11. This represented 0.88% of the estimated total NHS budget for that financial year (£103 billion). However, the NHSLA has an estimated £16.08 billion in potential liabilities, which is more than 16% of the NHS spend in 2010/11. This has increased from 11% of total budget in 2004, when the total estimated outstanding liabilities totalled £7.78 billion.9,10

In 2009/10, the NHSLA received a total of 6652 clinical claims (and potential claims) under CNST and made total payments of £651 million; this included £106 million in claimant costs and £34 million in defence costs. Both the number of claims and amounts awarded have been increasing since 2002/ 3. In 2010/11 these figures increased to a total of 8655 clinical claims (and potential claims) under CNST with total payments of £729 million, which included £181 million in claimant costs, and £54 million in defence costs.9,10

Surveillance data for MRSA and CDI

In 2003/4 there were 7700 MRSA BSI episodes in England, with a rate of 1.83 per 1000 occupied bed-days (OBDs). This declined significantly to 1481 episodes (a rate of 0.39/1000 OBDs) in 2010/2011.7The greatest decline in MRSA BSI occurred between 2003/4 and 2006/7 (a total of 28,412 with a mean of 7103 per year) and 2007/8 and 2010/11 (a total of 10,768 with a mean of 2691 per year) (P<0.01) (Figure 2).

Episodes of CDI are also reported mandatorily. There has been a similar significant decrease in the number of episodes of CDI in the>65-year age group from a peak of 55,635 (a rate of 2.45/1000 OBDs) in 2005/2006 to 16,869 (a rate of 0.75/1000 OBDs) in 2010/2011.7 There were 202,492 infections with a mean of 50,623 per year between 2003/4 and 2006/7. This reduced to 111,284 infections with a mean of 27,821 per year between 2007/8 and 2010/11 (P<0.01).

Figure 2shows the annual numbers of MRSA BSI in all age groups and CDI episodes in those aged >65 years reported under the HPA Reporting Scheme from 2003/4 to 2010/11.

Claims made under CNST relating to HCAIs

Between 1996 and 2010, 971 claims were registered under CNST mentioning MRSA or CDI. Twenty-eight percent were still open at January 2011, but of the remainder, successful claims resulted in total payments of £35.2 million, comprising £20.5 in damages, £5 million in defence costs and £9.7 million in claimant costs (NHS Litigation Authority, personal communication).

Clostridium difficile infection

Between 2001 and 2010 there were 252 claims in total with mentions of CDI, of which 172 have been closed. Of these 172 closed claims, 130 (76%) were successful with costs awarded and 42 (24%) were unsuccessful. Eighty claims were still open at the time of data analysis. Ninety-one cases (52%) resulted (directly or indirectly) in the death of the patient. Median damages paid for these claims were £6,407 with a mean of £15,659 (95% CI: 10,933e20,385). Median defence costs were £3,126 with a mean of £4,699 (95% CI: 3397e6002). Median 12,000 10,000 8,000 6,000 4,000 2,000 0 Jan - Dec 2008 T

otal no. of infection control reports received

Jan - Dec 2009 Jan - Dec 2010

No harm Low harm Moderate harm Severe harm Death

Figure 1. Total number of infection control reports categorized according to harm received by the UK National Patient Safety Agency, 2008e2010.

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claimant costs were £5,425 with a mean of £9,290 (95% CI: 6824e11,756). Median total legal costs were £16,868 with a mean of £29,649 (95% CI: 22,249e37,048) (NHS Litigation Authority, personal communication). Mean costs did not significantly differ for claims between the periods 2003/ 4e2006/7 and 2007/8e2010/11 (data not shown). Overall there were 0.00054 closed claims and 0.00041 closed successful claims for every CDI in those aged>65 years between 2003/4 and 2010/11 (data not shown). There was no significant difference in either annual number of claims between the periods 2003/4e2006/7 and 2007/8e2010/11 (0.00037 and 0.00032 respectively).Table Ishows the total number of closed and successful claims in these two periods.Figure 3shows the total number of clinical negligence claims per CDI from 2003/4 to 2010/11.

MRSA infections

Between 1996 and 2010 there were a total of 734 claims that mentioned MRSA infection, of which 606 have been closed. Of the 606 closed claims, 388 (64%) were successful with costs

awarded and 218 (36%) were unsuccessful; 129 claims were still open at the time of analysis. Ninety-three cases (15%) resulted (directly or indirectly) in the death of the patient.

The mean number of closed successful claims per MRSA BSI has decreased from a peak of 0.0070 in the period 2003/ 4e2006/7 to 0.0017 in the period 2007/8e2010/11 and was statistically significant (P < 0.01) (NHS Litigation Authority, personal communication).Table Ishows total number of closed and successful claims mentioning MRSA.

Median damages paid for these claims were £7,609 with a mean of £48,441 (95% CI: 36,336e60,546). Median defence costs were £5,689 with a mean of £11,701 (95% CI: 10,062e13,340). Median claimant costs were £6,491 with a mean of £22,326 (95% CI: 18,158e26,494). Median total legal costs were £22,445 with a mean of £82,469 (95% CI: 65,981e98,956). Mean values did not significantly differ for claims between the periods 2003/4e2006/7 and 2007/8e2010/ 11 (data not shown).Table Ishows total number of closed and successful claims in these two periods.Figure 3shows the total number of clinical negligence claims per MRSA BSI from 2003/4 to 2010/11. 60,000 12,000 10,000 8000 6000 4000 2000 0 50,000 40,000 30,000 C. dif ficile infections MRSA bacteraemia 20,000 10,000 2003/2004 2004/2005 2005/2006 2006/2007 2007/2008 2008/2009 2009/2010 2010/2011 0

Figure 2. UK Health Protection Agency mandatory reporting schemes 2003/4e2010/11. Dashed curve: total number ofC. difficile infections in those aged>65 years; solid curve: total number of meticillin-resistantStaphylococcus aureus(MRSA) bloodstream infec-tions. Horizontal lines represent mean numbers for the periods 2003/4e2006/7 and 2007/8e2010/11.

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Trend in amounts awarded for MRSA and CDI and overall infections

Between the period 1997/8e2006/7 and 2007/8e2010/11 there has been a significant decrease in amounts awarded for claims mentioning CDI and/or MRSA. Mean damages awarded in the first period were £44,838 per case and £13,324 in the second period. (P<0.001). Mean defence and claimant costs also fell significantly in the second period contributing to an overall decrease in total costs from a mean of £76,848 per case in the first period to £24,821 per case in the second period (P<0.001).Table IIshows the number of successful claims with the amounts awarded during the periods 1997/8e2006/7 and 2007/8e2010/1.

Discussion

Clinical negligence may arise from a variety of actions or inactions, including failure or delay to diagnose or treat a condition, failure to obtain proper consent, incorrect or inappropriate treatment or the failure to prevent the acquisi-tion of an avoidable HCAI. Complainants often pursue legal redress for non-financial reasons, including seeking an inves-tigation or explanation, an admission of fault, an apology, to prevent a recurrence, or to simply voice their grievances.11e13

Legal action is usually a last resort when all other avenues of reconciliation have been exhausted.

As described previously, since 2005, NHS organizations in England have seen decreases in episodes of both MRSA BSI and

0.018 0.0012

0.001

0.0008

0.0006

T

otal no. of claims

p er CDI (a g e >65 y ears) 0.0004 0.0002 0 0.016 0.014 0.012 0.01 T

otal no. of claims per MRSA

bloodstream infection 0.008 0.006 0.004 0.002 2003/4 2004/5 2005/6 2006/7 2007/8 2008/9 2009/10 2010/11 0

Figure 3. Total number ofC. difficileinfection (CDI) claims registered with the National Health Service Litigation Authority (NHSLA) per C. difficileinfection in those aged>65 years (dashed line) and total number of meticillin-resistantStaphylococcus aureus(MRSA) claims registered with NHSLA per MRSA bloodstream infection (solid line).

Table I

Numbers of closed and successful claims forClostridium difficileinfections in patients aged>65 years and for MRSA bloodstream infections for the periods 2003/4e2006/7 and 2007/8e2010/11

Closed claims Successful claims

Mean annual no. 95% CI for the mean P-value Median annual no. Mean annual no. 95% CI for the mean P-value Median annual no. Clostridium difficileinfections in patients aged>65 years

2003/4e2006/7 0.00048 0.00028 to 0.00123 NS 0.00046 0.00037 0.00023 to 0.00097 NS 0.00032 2007/8e2010/11 0.00050 0.00013 to 0.0011 0.00041 0.00032 0.00031 to 0.00095 0.00022 MRSA bloodstream infections

2003/4e2006/7 0.0147 0.0129 to 0.0165 P¼0.02 0.0150 0.0070 0.00042 to 0.0098 P¼0.005 0.0078

2007/8e2010/11 0.0063 0.0023 to 0.0149 0.0055 0.0017 0.0011 to 0.0048 0.0015

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CDI.7Conversely this has been accompanied by an increase in

the number of general formal written complaints to the NHS, in incidents relating to infection control being reported to the NPSA and in the total number and amounts awarded under the NHSLA CNST.

We found that the rate of litigation for cases involving MRSA infection have significantly decreased; the same cannot be said of CDI, but the reasons for this difference are unclear. Mandatory reporting and NHS targets for reductions in CDI were introduced several years after those for MRSA. It is possible that this, together with the suggestion that C. difficilemay feature less in the public eye, could have resulted in this observation. There is also evidence that the amounts awarded to successful claimants are decreasing both in terms of damages awarded and overall legal costs. This change was observed for claims involving MRSA or CDI overall but the difference was not observed for either of these infections individually.

These data must be interpreted with caution, since they include all instances where C. difficile or MRSA were mentioned as part of a claim rather than being the sole basis of the claim. Thus, for example, a patient may have brought a claim relating to alleged negligence resulting from a pros-thetic hip replacement with subsequent MRSA surgical site infection. The claim may have been settled on the basis of negligence related to the surgical procedure rather than to the infection, orvice versa. The data do not allow us to separate out the awards made for each failing. Additionally, there may be a long time lag between the negligent event and the case being closed. Claimants have three years from the date of the alleged negligent incident, or the date when they become aware of it, to bring a claim. Claims may then take a year or more to reach a conclusion. The average time between noti-fication and conclusion of claims under the CNST in 2010/11 was 1.28 years.14Therefore, from the past three or four years there will have been cases that are still running and cases that have not yet been notified to CNST, and this effect may skew the dataset.

These data are in contrast to those observed overall for clinical negligence, which show an increase in the number of claims and amounts awarded. Clinical negligence claims may have increased for a number of reasons: patients have rising

expectations of the quality of care they receive; they show increasing unwillingness to accept any risk associated with medical treatment, despite being warned about these risks during consent; recently there has been a proliferation of ‘conditional fee agreements’, commonly known as ‘win no-fee’, meaning that there is no personal cost risk to a patient in trying to pursue a claim against the NHS, even if that claim subsequently fails and which may encourage individuals to pursue claims; there is increased reporting and publicity in the media about clinical negligence claims, both generally and relating to specific cases; and various patient advocate groups have highlighted negligent care in relation to specific diseases. It is well recognized that HCAIs are associated with signifi-cant costs to society, the individual patient and their families and to healthcare organizations. These include ‘costs’ related to increased length of stay (‘hotel costs’), increased treatment (drugs, surgery, other therapies), increased laboratory tests and imaging studies, increased human resources (doctors, nurses, infection control professionals), patient suffering and absence from work/education.15e19 To this can be added the societal costs of ill health and death and the consequences to healthcare organizations of loss of reputation. The Ministry of Justice estimates that success fees account for 34% of claimant legal costs and 17% of ‘after the event’ insurance premiums paid by the NHS. The Legal Aid, Sentencing and Punishment of Offenders Bill proposes that the NHS will no longer be liable for success fees leaving claimants to fund these costs themselves. However, damages for pain, suffering and loss of amenity will be increased by 10%.20

Litigation is another significant cost of HCAI but is often overlooked. This paper has shown that between 1996 and 2010, claims involving MRSA or CDI resulted in total litigation payments of £35.2 million in England. These figures do not include the costs of abandoned claims. Whatever the legal outcome, healthcare organizations incur additional internal litigation costs due to staff time involved in the investigation and management of claims. The recent significant reduction in HCAIs due to MRSA and CDI in England has been associated with a potential reduction in HCAI litigation claims and costs for MRSA but not for CDI. However, further work is needed to confirm that this is a true causal association and to monitor future trends.

Table II

Numbers of successful claims and amounts awarded for MRSA andClostridium difficileinfections combined for the periods 1997/8e2006/7 and 2007/8e2010/11

Period/costs Mean (95% CI) annual successful claims Median annual successful claims Mean amount awarded (95% CI) (£) Median amount awarded (£) 1997/8e2006/7 44 (23e65) 44 Damages 44,838a(34,134e55,542) 8,000 Defence costs 11,115a(9,628e12,601) 4,962 Claimant costs 20,893a(17,174e24,612) 6,168 Total award 76,846a(62,210e91,481) 22,185 2007/8e2010/11 19 (22 to 60) 10 Damages 13,324a(7,684e18,964) 5,431 Defence costs 3,134a(2,384e3884) 2,103 Claimant costs 8,363a(5,827e10,899) 4,875 Total award 24,821a(17,314e32,328) 15,340

MRSA, meticillin-resistantStaphylococcus aureus; CI, confidence interval. a P<0.001.

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The prevention and control of HCAIs is part of the duty of care to patients to prevent avoidable morbidity and mortality. Because of the significant costs of HCAIs, including litigation, investment in infection prevention and control is highly cost effective as well as good practice.

Acknowledgements

We are grateful to the NHSLA for providing data on CNST claims mentioning HCAIs.

Conflict of interest statement None declared.

Funding sources None.

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