Clinical guidelines: Litigation, Patient Safety and the Law

This paper was originally delivered by Laurence Vick, Legal Director at Enable Law, to the legal and medical delegates attending a conference held at Friends Meeting House, London 27 September 2018 for the joint de Montfort University – Staffordshire University research project funded by the British Academy and the Leverhulme Trust.

THE ROLE OF GUIDELINES AND PROTOCOLS IN CLINICAL NEGLIGENCE LITIGATION

In recent years there has been a proliferation of guidelines and protocols issued at local, national and international level by NICE, Royal Colleges, Department of Health, NHS Trusts and other organisations. Their aim is to facilitate best practice in a standardised way, ensuring consistency of care, ultimately leading to improvements in patient safety and in turn driving down the cost of negligence claims against the NHS.

The issue over the legal implications of guidelines isn’t new. John Tingle in his 2002 article ‘Do guidelines have legal implications?’ was commenting on their legal ramifications in response to the increased use of guidelines at that time. 20 years ago guidelines were already described as a ‘flood’ in general practice in a BMJ article from 1998 (‘Guidelines in general practice: the new Tower of Babel’) to reflect what was already becoming a bewildering range of voices and languages.

I have over 30 years’ experience of acting for Claimants in clinical negligence litigation, specialising for nearly 20 years in paediatric cardiac surgery and cardiology cases following my involvement in the Bristol Public Inquiry which led to the Kennedy report of 2001.

This is a field in which we still remain heavily reliant on expert evidence in its traditional forms: written reports and oral evidence referring to the expert’s clinical experience of treatment standards at the time, supported by relevant published sources in the form of text books and journals.

Guidelines and protocols still play a relatively minor role in these cases, for reasons I’ll explain. I have, though, taken soundings from colleagues across my firm who carry out a wide range of cases and from Counsel and experts we use including a Consultant in Emergency Medicine who was involved in formulating the Sepsis 6 guidelines.

Guidelines and protocols have become increasingly important in clinical negligence litigation but their impact on the litigation process is difficult to assess, not least because it can still take up to 5 years for a complex, contested case to come to trial.

The three year limitation period is extended for children who are able to bring a claim at any time before their 21st birthday, or beyond if they lack mental capacity. Birth and other serious brain injury cases may not therefore get to court until many years after the alleged negligent event.

Data published in January 2018 revealed that in the past five years the Department of Health had paid out £152 million, including legal fees, to victims of negligence which had occurred before April 1995. As the number of reported cases increases, though, there should be less uncertainty over how guidelines are interpreted, the force they carry, and the weight given to them by a court.

This may change but there seems to be little evidence of the use of guidelines resulting in a reduction in cases coming forward or of cases being settled or abandoned after pre-action protocol correspondence in which guidelines have been relevant. Neither do we know yet if the application of guidelines has resulted in improvements in patient safety and a reduction in avoidable harm.

WHAT PRACTICE AREAS DO THEY COVER?

Key areas where guidelines and local protocols have an important medico-legal role include:

• Obstetrics: national guidelines on monitoring and interpretation of CTG traces and how to act upon them; RCOG guidelines going back 20 years, most of which are adopted as local protocols, covering twin pregnancy, diabetic pregnancy, major haemorrhage, pre-term labour and more recently placenta praevia, placenta accreta, and vasa praevia.

• Delay in cancer diagnosis: NICE guidelines on referral for suspected cancers will be central to any case on breach of duty (and possibly relevant to causation).

• General medicine: guidelines and protocols for prevention and management of venous thromboembolic (VTE) disease and major haemorrhage.

• Diabetes: guidelines and protocols for diabetic ketoacidosis (DKA).

• Chest disease – guidelines and protocols for the prevention and treatment of asthma in adults and children.

• Stroke – thrombolysis guidelines & protocols.

• Age-rated wet macular degeneration (wet AMD) – NICE treatment guidelines

• Antibiotic prophylaxis and treatment, in particular for high risk surgical patients; also MRSA screening and treatment.

THE SEPSIS SIX PROTOCOL

The Sepsis Six protocol and NICE Guideline 51 are perhaps the best examples of guidelines and protocols which the Courts certainly do follow and which play an important part in clinical negligence claims.

Sepsis can be life threatening if not treated appropriately. 123,000 cases of sepsis occur in England annually with approximately 37,000 deaths each year. Timely recognition and treatment of sepsis is crucial to outcome. The Sepsis Six was developed by the UK Sepsis Trust in 2006 as a practical tool to help healthcare professionals deliver the basics of care rapidly and reliably. The protocol consists of six interventions – three diagnostic investigations and three initial therapies – all of which can be delivered by any healthcare worker within one hour of the initial recognition of sepsis.

It seems clear that the introduction of the Sepsis Six care bundle endorsed by NICE in their comprehensive Guideline 51 of 2016 has resulted in encouraging improvements in mortality and morbidity. Although the Professor Brian Jarman data published in August 2018 showed that sepsis hospital deaths had risen by over a third in 2 years this was believed to be due to increased awareness, detection and improved recording of sepsis: a sign that more cases are being identified rather than an increase in sepsis cases per se.

No two cases are the same and each turns on its own facts. To succeed in a clinical negligence claim involving injury resulting from sepsis the Claimant still has to demonstrate that with an appropriate standard of care the outcome for the claimant was avoidable. Expert evidence will be needed to establish causation. Sepsis can progress rapidly with a limited window of opportunity for treatment which makes causation problematic.

Diagnosis can be difficult with no obvious focus of infection and the presenting symptoms can be non-specific. The physical signs may be wide-ranging and difficult to unite in a single diagnosis, with sepsis affecting many of the body’s systems.

Patients require early recognition, prompt treatment with fluids and antibiotics and close monitoring in order to detect what can be a swift deterioration. Patients who don’t respond or who only respond transiently will need urgent critical care. The standard of care for these patients is then set out in the Sepsis 6.

Links to The legal implications of NICE guidance and NICE Guideline 51 2016

CRITICISM OF GUIDELINES AND WHY THEY MAY NOT BE ACCEPTED AS AUTHORITATIVE

Guidelines may be vulnerable to challenge in court cases if not shown to be the product of an unquestionable decision-making process or if the process of dissemination, awareness and publication of a guideline is inadequate. At one time the medical profession appeared to have a sceptical view and guidelines were seen as ‘one-size-fits-all’ too prescriptive, restricting clinical discretion and autonomy and inflexible in the face of real patients. As Professor of Cardiology John Hampton put it in a 2003 article: ‘Guidelines—for the obedience of fools and the guidance of wise men‘

Clin Med. 2003; 3: 279–284.

Quoting from this article

‘The fundamental aim of a guideline is to get away from individualised treatment. The enthusiast will claim ‘levelling up’ and the cynic will – as always – fear ‘levelling down. A guideline intends to play down the role of clinical expertise and emphasise the importance of systematic research, but the results of the systematic research – which at the moment means clinical trials – are far from certain and always open to interpretation by Opinion’.

‘The wise man will know the limits of the evidence, and also the limits of his own expertise. The wise clinician will treat his patient as an individual, even if his therapy is derived from a statistical analysis of the treatment of many patients. But what if his advice to a particular patient differs from a guideline?’

Some guidelines appear to be aspirational in nature. Experts sometimes feel that NICE and other guidance reflects a committee compromise. Ultimately the profusion of guidelines may compromise their authority and validity. Even the most authoritative guidelines may also be subject to change in the face of new evidence which is now becoming available at an unprecedented rate via digital media and the internet, as I’ll cover later.

WHAT IS THE STATUS OF GUIDELINES AND WHAT PART DO THEY PLAY IN A CLINICAL NEGLIGENCE CLAIM?

Guidelines are not regarded as having the force of law – they are guidelines designed to promote best practice with the intention of assisting clinicians in making decisions about the diagnosis and management of specific conditions. They help set a recognised standard but do not dictate it in all circumstances. They won’t cover every situation and there will be occasions when a responsible body of practitioners may be justified in not following a particular guideline.

The GMC instructs doctors to be ‘familiar with guidelines and developments that affect your work’ ‘to keep up to date with and follow the law, our guidance and other regulations relevant to your work’ and to ‘provide effective treatments, based on the best available evidence.’

Competent practitioners should therefore be aware of evidence-based guidelines relevant to their specialisms and these should be followed unless there is good reason not to do so. A departure from a Trust’s own local protocol without good reason will be difficult to justify and practitioners employed by that Trust will find it difficult to argue that they were unaware of that protocol.

We are still some way, though, from having to engage in trial by protocol.

In a clinical negligence case the Claimant has to establish negligence (‘breach of duty’) and causation: a Claimant will be compensated for an injury if he proves a breach of duty and that but for that breach of duty he would not have suffered that injury – as I simplify it for clients, ‘avoidable harm resulting from that negligence’.

The Court remains the final arbiter and it is for the Judge to determine the standard of care on the basis of the evidence before him. What constitutes the appropriate standard of care; how is the appropriate standard of care measured and how is this affected by guidelines?

The 1957 case of Bolam remains good law – ‘a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in their particular art.’

A clinician is judged in accordance with the standard of the reasonably competent practitioner in his or her field. A Court must be satisfied that no responsible body of doctors would support the standard of care that was provided.

A Bolam defence may be available and a claim can be defeated even if there has been a departure from a guideline if the Defendant can call an expert who testifies that a particular practice was followed by and considered acceptable at the time of the treatment by a responsible body of doctors – the ‘reputable minority’ defence.

In establishing the appropriate standard of care to be applied to a particular course of treatment guidelines provide the Court with objective benchmarks of practice and may limit but not usurp the traditional reliance on expert opinion supported by authoritative textbooks and other relevant contemporaneous published sources.

Where a guideline relevant to the particular form of treatment is endorsed as authoritative by an expert the Court will usually give significant weight to that evidence, but only as part of the overall evidence.

Bolam is not definitive though. Since the 1997 Bolitho case the court will examine the expert evidence and may subject a form of treatment and any relevant guidelines to logical scrutiny and decide that negligence has been established even if a body of medical opinion suggests otherwise.

The experts must direct their minds to the comparative risks and benefits and reach a defensible conclusion on the matter. A Defendant must still demonstrate that a practice is responsible and reasonable. A departure from a guideline doesn’t of itself amount to evidence of substandard care if the procedure followed by the doctor or surgeon is Bolam defensible.

As guidelines become increasingly widespread and more authoritative and are regularly reviewed and updated it seems inevitable that they will be considered the “standard of care” – and there will be a heavy onus on the clinician to justify why he or she deviated from a recognised guideline, particularly if it applies to the patient’s clinical presentation.

CASE LAW

There has been debate as to whether guidelines can be used as a sword or a shield in a clinical negligence claim. Will a deviation from a guideline amount to prima facie evidence of negligence and be used as a sword against doctors or will a guideline be regarded as a shield to protect doctors if a guideline has been followed? The answer is that neither is conclusive – whether there has been reliance on or deviation from a guideline doesn’t mean it’s game over for either side in a clinical negligence claim.

The first instance Winchester District Court case of Adshead v Tottle reported on Lawtel in 2007 involving delayed diagnosis of breast cancer is instructive.

A widower successfully sued a GP – a recently qualified locum – for failing to diagnose his late wife Sharon Adshead, then aged 32, with breast cancer and failure to refer her to a breast cancer specialist after she had complained of a lump and tenderness in her left breast in May 2000. The GP Dr Tottle examined her and – noting a ‘tender lump 2 cms in diameter’ – told her the lump was benign.

There was an issue at the trial over the advice given by the GP at that visit. Sharon became pregnant and attended the surgery on a number of occasions when there was no mention of the lump in her breast. She attended the surgery in September 2001 complaining of difficulties breast-feeding.

On this occasion a different GP found masses in the left breast and left axilla and Sharon was urgently referred to the breast clinic. An aggressive cancer was diagnosed. Despite a mastectomy, radiotherapy and chemotherapy she tragically died in January 2003 aged only 35 leaving her husband and baby Logan.

The case was defended by the GPs indemnity insurers. During the trial in 2007 the GP expert for the Defence Dr Budd supported Dr Tottle’s actions and told the court that the chances of a GP seeing a woman under 35 with breast cancer was rare and likely to happen only once in 50 years. It was agreed that if Sharon had been referred to the breast clinic in May 2000 she would have been seen by a specialist within 2 weeks and treatment could have commenced within a month: by mid-July.

An issue arose as to the relevant Department of Health guidelines at the time of Mrs Adshead’s treatment seven years before the trial. The 2000 guidelines required an urgent referral in the case of ‘patients with a discrete lump in the appropriate age group eg age (greater than) 30’ and those requiring referral but not necessarily an urgent referral.

The latter included ‘women eg age (less than) 30’ with a discrete lump and patients with ‘asymmetrical nodularity persisting after menstruation.’ The GP expert called by Sharon’s family Dr Adrian Rogers argued that Dr Tottle’s note of her May 200 examination suggested there had been a discrete lump which mandated an urgent referral. This evidence was accepted by the Judge.

This is how Mr Justice Gray dealt with this issue:

“I reject the suggestion that in 2000 there existed the body of opinion in general practice to which Dr Budd referred. I accept the evidence of Dr Rogers that, if Mrs Adshead had presented with a discrete lump in her breast, responsible practitioners in 2000 would have referred her urgently under the 2 week guideline laid down in the Department of Health Guidelines in force at the time.

“It is in my opinion nothing to the point that the guidelines may have altered at a later date. This is not a case where there is room for the application of the Bolam principle.

In the case of a patient who presents with a potentially life-threatening symptom, I do not accept that a responsible general practitioner would delay referring her, even for a short period, in circumstances where the recommendation made unambiguously in the guidelines is to refer immediately.”

CARDIAC CLAIMS

In my main field of children’s heart surgery claims the role of guidelines and protocols in establishing standard of care appears to have been relatively limited. We rarely encounter NICE guidelines when looking at standards of care and the treatment issues and clinical decisions and judgments that have been made. We rely heavily on expert testimony and, where relevant, written texts as to contemporaneous practice.

Cardiac surgery is a ‘team sport’ involving the skills of medical as well as surgical staff. The liability issues tend to be multifactorial depending on the age of the child, type of congenital heart defect, the complexity of each individual child’s medical condition and any co-existing defects or co-morbidities, the form of surgery involved, the accuracy of diagnosis and timing of surgery, the experience of the surgeon and the unit in a particular procedure, the post-operative care and the way in which the unit or surgeon was able to cope with the complications inherent in paediatric cardiac surgery.

Placing children on cardio pulmonary bypass (CPB) via the heart-lung machine operated by the clinical perfusionist which takes over when the heart and lungs are stopped and maintains blood oxygenation and circulation while the heart and lungs are stopped carries an ever-present risk of neurological harm. There are neuroprotection protocols intended to minimise the duration of CPB which recommend how the blood gases are administered and anaesthesia monitored by the perfusionist.

Achieving the appropriate level of scientific significance in paediatric surgery and cardiology is problematic due to the lack of large enough cohorts of comparable cases. Single centre studies may not deal with adequate numbers to enable proper classification and comparison, making it difficult to establish standards of care and form robust conclusions.

With low patient numbers there may be a tendency to lump similar but technically different conditions together because the necessary granularity of the data isn’t there. A paediatric cardiology expert I spoke to said this isn’t just a case of comparing apples with apples but actually comparing a “granny smith’ with a “cox’s orange pippin!”.

Adult cardiology seems a different matter. A number of guidelines and methodologies have been introduced by the European Society of Cardiology (ESC) and more have been added recently following their meeting in Munich in August 2018 for which I have provided links, including the 2014 guidelines on the management of patients with hypertrophic cardiomyopathy (HCM), another area of interest.

The American Heart Association (AHA) has also been active in publishing guidelines which include a number relevant to paediatric procedures. The ESC noted that the application of guidelines had improved the quality of clinical practice but in spite of well-defined standards for issuing good quality guidelines, recent surveys of guidelines published in peer-reviewed journals had shown that methodological standards were not always complied with – demonstrating the importance of the guidelines development process itself.

Children’s heart surgery is still not free of controversy since the scandal of the 90s which led to the Bristol Heart Inquiry and Kennedy report of 2001. A bone of contention for me on behalf of parents of children who have survived surgery but suffered brain damage and other injury, success in an operation – statistically – is still confined to 30 day mortality/survival.

The New (national) Congenital Heart Disease Review (NHSE July 2015) set out a long list of recommendations, underpinned by the Report into Children’s Services at Bristol in 2016 but the focus was very much on data collection and recording of outcomes rather than standards of care.

Adult heart surgery has led the way in the publication of data but there has been evidence that some heart surgeons demonstrate risk-averse behaviour and are reluctant to perform difficult operations to avoid attracting poor mortality ratings.

OPEN ACCESS, SOCIAL MEDIA and #FOAMed

High quality evidenced-based research and peer-reviewed guidelines are now easily accessible via the internet. Knowledge stored in textbooks, journals and other printed media is increasingly being digitised. The GMC’s 2013 guidance ‘Doctors’ use of social media’ was already talking in terms of and advocating the use of blogs and microblogs, internet forums and social networking sites.

One of the clinicians I spoke to commented on the fears amongst the research community that obtaining funding and demonstrating the benefits of funding research in a particular practice area may become more difficult if there if there is already a well-regarded guideline in place.

Textbooks can be several years out of date – delays of up to 3 years from drafting to publication are not uncommon. Once published, textbooks and printed articles can soon become out of date. With the move towards open access publishers may be less inclined to fund expensive textbooks, leading to fears that they may eventually become obsolete.

This clinician also commented on the increasing influence in the medical research field of FOAMed:. Free, Open Access Medical Education. Not a new phenomenon but an international, rapidly expanding movement given this name in 2012; describing itself as a continuously expanding database of up to date, high level material in the form of blogs, podcasts, tweets and Facebook groups.

As Dr Joe Lex, known in the US as the Godfather of #FOAMed, put it on the naming of the movement in 2012:

• If you want to know how we practised medicine 5 years ago, read a textbook.
• If you want to know how we practised medicine 2 years ago, read a journal.
• If you want to know how we practise medicine now, go to a (good) conference.
• If you want to know how we will practise medicine in the future, listen in the hallways and use FOAM.

– from International EM Education Efforts and E-Learning by Joe Lex 2012

This process will evolve in the coming years and can’t be ignored. These developments are bound to have an effect on both the conventional reliance on what is taken to be contemporaneous expert testimony and any challenge to the validity and authority of a guideline that may have become out of date or the subject of debate in professional circles.

The conclusion is that although clinical guidelines and protocols continue to penetrate all areas of medical and surgical practice they have not yet become a proxy for the standard of care in clinical negligence litigation.

For references used in this article, please click here.