Gross Negligence Manslaughter in Healthcare where are we now (how did - - PowerPoint PPT Presentation

Gross Negligence Manslaughter in Healthcare

where are we now (how did we get here) … and where are we going? Leslie Hamilton LLM FRCS Cardiac Surgeon [retired (early), licence to practise

past Council, Royal College of Surgeons England Assistant Coroner, Durham and Darlington Chair, Independent Review of GNM / CH 30 July 2019

Manslaughter – the Law

• Manslaughter is homicide without premeditation (with = murder)
• Two types: voluntary and involuntary
• Voluntary: the unjustifiable, inexcusable, and intentional killing of a

human being without deliberation, premeditation, and malice.

• Involuntary: the unlawful killing of a human being without any

deliberation, which may be involuntary, in the commission of a lawful act without due caution and circumspection

• 4 categories of which GNM is one

NB Scotland: ICH (involuntary culpable homicide) – need mens rea / recklessness

Gross Negligence Manslaughter

Case Law (not Statute) R v Bateman (1925)

The doctor must be proved to have shown such disregard for the life and safety of others as to amount to a crime against the State and conduct deserving of punishment.

Criminal Negligence

GNM: the Law

R v Adomako [1994] UKHL 6

• Anaesthetist: failed to notice oxygen disconnected
• House of Lords (Lord Mackay of Clashfern):
• the defendant owed the victim a duty of care
• the defendant breached that duty
• the breach caused (or significantly contributed to) the victim’s death
• the breach was grossly negligent.

Lord Mackay

• “Grossly negligent”

“The jury will have to consider whether the extent to which the defendant’s conduct departed from the proper standard of care incumbent upon him, involving as it must have done a risk of death to the patient, was such that it should be judged criminal… The essence of the matter…is whether having regard to the risk of death involved, the conduct of the defendant was so bad in all the circumstances as to amount in their judgment to a criminal act.”

David Sellu

MB BCh 1973 Manchester

Consultant Colo-rectal Surgeon, Clementine Churchill, London

2010

The Story begins … David Sellu

• 5 February 2010: James Hughes (from N.I.) had elective knee replacement
• Day 6: abdominal pain – DS asked to review in the evening (Thursday)
• “urgent” CT scan ordered for next morning (abdominal x-ray ? air)
• delays … Mr Hughes rang home …. operation late evening
• died next day
• MCCD: 1a) MOF 1b) faecal peritonitis 1c) perforated diverticulum
• Coroner’s Inquest: ? perjury
• → Police → CPS → prosecution for GNM (experts: c/r surgeon (2nd) + intensivist)
• “ ..conduct was completely uncharacteristic of Mr Sellu, who had had a blameless career of 40

years and was known by colleagues and patients alike as a kind and careful man”.

1 August 2011

David Sellu … whatever happened next?

• convicted 2 October 2013: Jury verdict: guilty (10 to 2 majority)
• “whole series of omissions in your care …”
• “numerous occasions when your care fell far below that

which could reasonably be expected of a consultant colorectal surgeon”.

• “no alteration of medical records

which would have been a significantly aggravating factor”

• October 2013: custodial sentence (2.5 years):
• served 15 months
• > 300 surgeons wrote to RCS: “do something about experts”
• Jenny Vaughan, Consultant Neurologist (Peter McDonald + Roger Kirby: RSM)
• http://www.manslaughterandhealthcare.org.uk/
• Council debate (President: Dame Clare Marx)
• Bertie Leigh (Hempsons): MDU / RCOG
• AoMRC – meeting with Coroners

BMJ 2019;364:l1024 doi: 10.1136/bmj.l1024

David Sellu … the ongoing saga Mail on Sunday 26 July 2015

David Sellu … continued (after release from prison)

• 17 November 2016: Appeal (NB “out of time”) Sellu [2016] EWCA Crim 1716
• 5 clinical grounds (including Dabigatran) – dismissed
• but … conviction quashed …
• ” trial judge did not give the jury adequate legal guidance on what gross negligence meant”.
• The Court allowed the appeal because they held that the jury was given no guidance on

the meaning of ‘gross negligence’ and that juries need to have clear directions as to the very serious nature of the negligence in order for manslaughter to be proved.

• judges must direct juries very tightly: the standard has to be that the defendant

acted in a “truly, exceptionally bad” manner. … there must be foreseeability of death for negligence to be of criminal degree.

David Sellu … enter the GMC (Medical Act 1983)

• A GMC spokesperson said:
• “Although Dr Sellu’s criminal conviction was overturned on appeal there remained a very

serious allegation that he failed to provide good clinical care to his patient.”

• 6 March 2018: MPTS (set up after Dame Janet Smith Shipman Inquiry)
• Tribunal: lay chair + 2 doctors + legal advisor (now legally qualified Chair + lay + doctor)
• Experts: Consultant Colo-rectal Surgeon (different from trial) + others
• allegations and findings of fact: NOT PROVED (note: balance of probabilities)
• NB jury (10 / 2): PROVED at the criminal standard of proof
• reflection on role / function of experts + spectrum of opinion

July 2019

Meanwhile ….. 18 February 2011 (Leicester Royal Infirmary)

Jack Adcock (age 6) Dr Hadiza Bawa-Garba

Jack Adcock

• 6-year old, Down’s syndrome. PMH: heart surgery (CAVSD: on ACE inhibitor)
• frequent URTIs – 1 previous admission with pneumonia
• A+E: admitted with D+V - pale, lethargic, dehydrated – to CAU @ 11am
• responded to fluids – portable chest x-ray (delayed)
• chest infection → sepsis
• delay in antibiotics (3pm: B-G not told x-ray available)
• nurse (Amaro): agency; no obs or fluid balance, did not report deterioration (NMC Tribunal)
• turned off oxygen monitor as “Jack better” (Appeal Court [2018] EWCA Civ 1879: para 14)
• delay in antibiotics
• admitted to ward (SHO / nurse decision)
• to room previously occupied by patient on end-of-life care (DNACPR)
• mother gave ACE inhibitor (hospital policy) – cardiac arrest
• confusion in resuscitation: ? DNACPR
• died 11 hours after admission (sepsis)

Dr Hadiza Bawa-Garba (“in all the circumstances”)

• ST 6 in paediatrics (Judge: above average; Trainers: top 1/3 of cohort)
• 14 months maternity leave (1st weekend on-call):
• Community paediatrics: no Trust induction / return to work plan
• interrupted handover (unit busy)
• only Registrar: CAU (15 beds) Reg off, wards (4 floors) - new, inexperienced SHOs
• 12 hour shift, no break (NB PSV licence: 2h45mins)
• Consultant out of town: saw blood results at handover (4.30pm) but not patient
• “#armchairconsultant: she did not ask me to see the patient
• took her to the canteen and made her write down her mistakes (“reflective practice”)
• in his written statement (now working in Ireland) and uploaded to training portfolio
• radiology delayed
• IT system “down” – blood results not available (abnormal results normally highlighted)
• “ .. By 4 o’clock, the SHO had not got the results I had to ring a different lab …” Inquest transcript
• end of life care in one patient / baby ? meningitis
• made serious errors (including high lactate/Cr/U+E + DNACPR – not causative)

Dr Hadiza Bawa-Garba (“in all the circumstances”)

• Airline: crew shortage, fatigue, aircraft technical problems, radio …
• Sir Ian Kennedy, RCSEd Conference 22 March 2018
• ”In terms of human factors, she was walking into a disaster zone”
• LRI investigation
• 6 “root causes”
• 23 recommendations
• 79 action points (including posters to remind other doctors)

Andrew Furlong, Medical Director: “Best practice shows that when you’re trying to identify learning, the way to do that is in an open culture, where people can give evidence without fear of sanction or blame”

Sepsis

• Definition: an overwhelming response to infection in which the immune

system initiates a potentially damaging systemic inflammatory response syndrome (SIRS).

• spectrum: infection … sepsis …. severe sepsis … septic shock … death

UK Sepsis Trust

• 200,000 cases in UK each year (25,000 children)
• 44,000 deaths
• major cause of “avoidable” deaths
• treatment (especially antibiotics) asap
• “Sepsis 6”: 3 investigations + 3 treatments

2015 “One broad underlying problem is that the recognition of illness often requires more experience than junior members of staff can draw upon.”

• delay in identifying
• sepsis 36%
• severe sepsis 52%
• septic shock 33%
• essential investigations
• delayed 38%
• missed 39%
• sepsis care bundle 40%
• avoidable delay in antibiotics 29%
• affected the outcome 44%

> 16 years of age

Dr Hadiza Bawa-Garba

• Coroner referred case to Police
• 2012 CPS: no further action (compare Scotland)
• July 2013: Coroner’s Inquest – back to Police
• “Expert” said cardiac arrest was “preventable beyond reasonable doubt” (ACE inhibitor)
• December 2013: CPS Special Crime Division: "Having completed our review, we have concluded

there is sufficient evidence and it is in the public interest for Dr Bawa-Garba, Sister Taylor and Staff Nurse Amaro to each face charges of gross negligence manslaughter.“

• 4 November 2015: Nottingham Crown Court (Dr B-G working for 4 years – no concerns)
• Expert Paediatrician: “barn door obvious sepsis”; “any competent doctor ….” (NCEPOD)
• Trust investigation: 23 recommendations, 79 action points (posters for other doctors)
• “You may or may not think that the hospital itself was at fault, but you must set those feelings aside”. Nicol J
• convicted of GNM - 2 year suspended sentence
• 8 December 2016: refused leave to appeal
• R v Bawa-Garba (Hadiza) [2016] EWCA Crim 1841. Sir Brian Leveson P
• 13 June 2017: MPTS: 12 months suspension (GMC asked for erasure)
• insight, remediation, circumstances, no impairment of FTP

Medical Act 1983: the GMC

• (1A) The over-arching objective of the General Council in exercising their

functions is the protection of the public.

• (1B) The pursuit by the General Council of their over-arching objective

involves the pursuit of the following objectives

• (a) to protect, promote and maintain the health, safety and well-being of the public
• (b) to promote and maintain public confidence in the medical profession
• (c) to promote and maintain proper professional standards and conduct for members
• f that profession

Enter the GMC ….

• 8 December 2017: GMC appeals MPTS decision (public confidence …)
• 25 January 2018: Appeal Court upholds GMCs appeal to “strike her off”
• explosion of concern
• toxic fear …
• international interest

Dr Hadiza Bawa-Garba: GMC Appeal Gross LJ and Ouseley J [2018] EWHC 76 (Admin)

• Lord Justice Ouseley: “The Tribunal did not respect the verdict of the jury as it should have.

In fact, it reached its own and less severe view of the degree of Dr Bawa-Garba’s personal culpability”

• Charlie Massey (GMC): the court has confirmed that the tribunal (MPTS) was simply wrong to

conclude that public confidence in the profession could be maintained without removing the doctor from the medical register. The ruling clarifies that tribunals cannot go behind the jury’s verdict when a doctor is convicted in a criminal court.

• we took legal advice and had to take action (? reflection ….)
• GMC commissions review (Dame Clare Marx)
• Jeremy Hunt warns he is “deeply concerned” about the implications of the decision.
• asks Sir Norman Williams (ex PRCSE) to conduct “rapid policy review” of GNM in medicine
• doctors’ fear .. “blame culture” in the NHS. Thousands of doctors sign a letter warning there

will be wide-ranging consequences from the ruling which they say will make doctors working in the overstretched NHS more risk-averse and less likely to admit mistakes (Independent).

Williams Review

• 6 February 2108: Sir Norman Williams (Clinical Advisor to Jeremy Hunt)
• England only

“GNM in Healthcare: rapid policy review” (June 2018)

• GMC to lose right of appeal (only Regulator of 9 to have right of appeal)
• PSA: Professional Standards Authority
• guidance to investigatory and prosecutorial bodies re very high bar for prosecution
• national “virtual” police team
• improving local investigations: systemic and human factors taken into account
• focus on learning not blame
• bereaved families: more involvement and support (NQB July 2018:”Learning from Deaths”)
• GMC and General Optical Council not able to ask for “reflections”
• improving assurance and consistency in the use of experts
• doctor’s “reflections”: GMC / AoMRC guidance
• BME issue (over-representation in GMC and criminal cases)

Dr Hadiza Bawa-Garba: the reaction

• 26 January 2018: £200,000 (later £350,000) “crowd funding” for legal fees to appeal
• Mrs Adcock said: “I’ve a problem with people funding the doctor who killed my son”
• Martin Bromily, James Titcombe …
• 9 March 2018: BMA LMC Conference (GPs): vote of no confidence in GMC
• 28 March 2018: Rt Hon Lord Justice Simon granted leave to appeal
• 14 April 2018: Lancet editorial:
• “To rebuild confidence in the GMC Terence Stephenson and Charlie Massey must resign”.
• June 2018: BMA ARM – vote of no confidence in GMC
• 13 August 2018: Master of the Rolls Sir Terence Etherton: appeal granted
• Charlie Massey, GMC Chief Executive: “It was important to clarify the different roles of

criminal courts and disciplinary tribunals in cases of gross negligence manslaughter, and we will carefully examine the court’s decision to see what lessons can be learnt.”

• Hospital Consultants and Specialists Association: call for Charlie Massey’s resignation

Dr Bawa-Garba appeal [2018] EWCA Civ 1879

THE LORD CHIEF JUSTICE OF ENGLAND AND WALES THE MASTER OF THE ROLLS LADY JUSTICE RAFFERTY

• a specialist adjudicative body, such as the Tribunal in the present case,

usually has greater experience in the field in which it operates than the courts (para 67)

• a fundamental difference between the task and necessary approach of the

jury, on the one hand, and that of the Tribunal, on the other (para 76) NB new sentencing guidelines for GNM (circumstances → mitigation)

GMC commissioned Review of GNM / CH

22 February 2018: GMC commissions Dame Clare Marx Review (past PRCSE)

• Working Group: 6 “medics”, 3 legal (inc CPS), 2 lay / patient reps
• ToR: review process of investigation after an unexpected death
• application of the law (NB: excludes calling for change in the law)
• 4 Home Countries
• written responses (>750)
• workshops (>200 attendees), oral evidence (20 organisations), interviews (40)
• commissioned research (“public confidence in the profession”) + BAME
• Scottish “Task + Finish” group (law is different)

30 July: Privy Council appoints Dame Clare Marx as Chair of GMC Council

• LH takes over as Chair (re-named “Independent Review of GNM / CH”)
• report published 6 June 2019

GMC Sanctions Guidance (used by MPTS)

Maintaining public confidence in the profession

Patients must be able to trust doctors with their lives and health, so doctors must make sure that their conduct justifies their patients’ trust in them and the public's trust in the profession. Although the Tribunal should make sure the sanction it imposes is appropriate and proportionate, the reputation of the profession as a whole is more important than the interests of any individual doctor. Appeal Court [2018] EWCA Civ 1879 para 96: Public confidence in the profession must be assessed by reference to the standard of “the ordinary intelligent citizen” who appreciates the seriousness of the proposed sanction, as well as the other issues involved in the case. NB ? CPS: public interest

Public Expectations (Community Research)

• link to research in report
• GMC
• public had limited knowledge (assumed regulation happened)
• 96% had confidence in the profession
• focus groups: none could remember Dr Bawa-Garba’s name (or even her case)
• stronger action if dishonesty / cover up / falsify records / shift blame
• if conviction, assumption that Court will have thoroughly investigated circumstances
• What makes a doctor’s actions criminal?
• intent to harm / wilfully reckless
• so why GNM for genuine errors?
• but .. contradiction: actions judged by outcome (death of patient)

Is there a problem? Tell doctors to “man up”

• doctors on GMC register?
• >300,000 (250,000 with licence to practice)
• Independent academic lawyers (Danielle Griffiths and Oliver Quick)
• Review of CPS files: 2007 – 2018 (12 years)
• 192 cases referred by police for decision
• 15 to 16 per year (but “ripple effect”)
• 43 Police forces, 88 Coroners
• 53% discontinued at “early investigative advice” stage
• 32% at “Full Code Test”
• 6% proceeded to prosecution (7 doctors, 7 nurses, 1 optometrist)
• 6 convictions
• 2 successful appeals

https://www.gmc-uk.org/

6 June 2019 (D Day celebrations, Donald Trump in London, Tory leadership campaign ..)

• 29 recommendations (each stage of events after an unexpected death): 77 pages
• Local investigations into patient safety incidents
• GMC
• Relationship with the profession
• Equality, diversity and inclusion (BAME concerns)
• Policies and processes
• Families and healthcare staff (NQB)
• System scrutiny and assurance (CQC)
• Expert reports and expert witnesses
• Coroner and Procurator Fiscal (Chief Coroner)
• Police (early independent advice) and CPS (more transparency)
• Reflective practice (? legal protection)
• Support for doctors (including Coroner’s Court; return to work plan; MDO cover)

Independent Review of GNM / CH published 6 June 2019

Local Investigations

Recommendation 15:

• Improvements in patient safety are most likely to come through local

investigations into patient safety incidents which are focused on learning not blame.

• We strongly endorse recent developments in the frameworks for

investigations: HSIB / NHS Improvement

https://improvement.nhs.uk/resources/about-new-patient-safety-incident-response-framework/

• These emphasise the need for the investigation team to have the time and

the appropriate experience, skills and competence (including understanding

• f human factors) to undertake investigations, and the necessary degree of

externality to command confidence in the process.

• We also stress the need to involve and support families and staff.

NHSI: A Just Culture Guide

• Supported by:

“Experts”

• active and relevant clinical practice
• basis on which they are competent to provide an opinion
• where they fit on the spectrum of within their specialty (esp Coroner’s Court)
• calibrate their opinion: met standard, below .., far below .., truly exceptionally bad
• two experts with concurring view to progress FtP / MPTS (clinical competence)
• > 65% of FtP cases discontinued after an expert report
• ? Crown Prosecution Service
• GMC:
• make transparent their process for recruitment and QA
• provide access to panel / register of experts

A “Just Culture”

• not “no blame” (1990s):
• James Reason (2004): culpable and non-culpable unsafe acts
• James Titcombe: conscious disregard of a substantial and unjustified risk
• Alan Merry and Alex McCall-Smith: slips (errors) vs violations (conscious disregard …)
• Berwick report 2013 (post mid Staffs): “A Promise to Learn – a Commitment to Act”
• ? change in the law: Law Commission 1996
• fair to patients / families and fair to staff
• accountability and learning
• Expert Advisory Group (led to HSIB cf AAIB)
• A shared set of values in which healthcare professionals trust the process of patient

safety investigation and are assured that any actions, omissions or decisions that reflect the conduct of a reasonable person under the same circumstances will not be subject to inappropriate or punitive sanctions.

The Challenge for the GMC

• Mission statement
• “We help protect patients and improve UK medical education and practice

by supporting students, doctors, educators and healthcare providers”.

• Doctors’ views of the GMC
• anti-doctor
• fear
• legalistic
• cold, lacking humanity
• adversarial
• lacking understanding of realities of clinical practice
• slow
• resentful of annual fee (£399)
• loss of trust: the Bawa-Garba case was the final straw

The Challenge for the GMC

• Practice Guidance
• excellent, multiple topics
• Regional Liaison Service
• workshops
• Employer Liaison Advisers (Responsible Officers)
• reduce referrals
• Corporate Strategy 2020
• “We want to shift the emphasis of our work from acting when things have gone wrong

to supporting all doctors in delivering the highest standards of care”.

• need doctors to engage
• … but require change in legislation governing regulation (proposals published)

Doctors should not be above the law

• deliberate, reckless, disregard for patient safety, repeated, ignore advice ….
• but genuine errors, especially under pressure ??
• Alan Merry: “slips” vs “violations”
• Which law?
• Medical Act 1983 (1858) → GMC to judge doctor’s conduct / performance
• ? MPTS best placed to judge if conduct is “truly exceptionally bad” (legal roundtable)
• Scotland – doctor’s errors not criminal; ICH (needs mens rea): moral culpability
• GMC FTP or civil law (clinical negligence)
• GNM: circular test (NB Shoreham air crash, Hillsborough / Duckenfield case)
• vast majority of cases are not due to one individual’s actions
• “in all the circumstances”
• focus on harm – the outcome not the act (need to accept that errors occur)
• CPS guidance: emergency services … starting point .. not to prosecute
• many calls for the law to be changed (Sir Robert Francis at HSC)

“These recommendations, if implemented in full, will go a long way to address the climate of fear. We welcome the focus on support for both families and staff, as well as the emphasis on the quality and impartiality of local investigations. An inquiring investigative process that prioritises safety concerns and care of those involved, rather than apportioning blame, is vital for a just culture which addresses everyone’s needs.”

The Lancet June 22, 2019

It is important to identify reckless or deliberate action. However, criminalising errors in a sector with inherent risk and apparent bias is a serious barrier to fostering proportionate, fair, and consistent regulatory and criminal justice systems that are essential to constructively engage the UK medical profession and to maintain patient safety. Although this review is a good first step towards acknowledging ongoing problems, the degree of change required in both the GMC and the criminal justice system to restore trust is not yet evident.

Gross Negligence Manslaughter

The Lancet June 22, 2019

The last word … ?

• Sir Ian Kennedy (Bristol Inquiry, Ian Patterson review): RCSEd Conference 22 March 2018
• “We need to rethink the role of the criminal law and medical manslaughter. Does it have

any place in how we deal with things going wrong . . . because medical manslaughter means that you can pick someone, blame them, and imagine that you’ve solved the problem. And what you have actually done is exacerbated it.”

• Sir Robert Francis (Mid Staffs report) at Commons HSCC on GNM 16 October 2018
• “Gross negligence manslaughter law is flawed. This flaw affected healthcare more then

most because of the complexities of a case.”

• Matt Hancock, Secretary of State (at launch of DAUK “Learn not Blame” campaign)
• “Open to law reform to stop genuine mistakes landing doctors in prison”. 20 October 2018
• Nick Ross (Crimewatch):
• “It is harmful to threaten people with imprisonment when they have no mens rea to do

something wrong. Particularly in clinical care …”

The very last word: Professor Sir Liam Donaldson

• LSHTM and previous CMO, England → Clinical Governance

BMJ Editorial (“In Harm’s Way): 11 May BMJ 2019; 365:I2037

“Nor do the public or the media seem too horrified by the lamentable failure of the NHS to learn from the past.” “ .. investigations invariably show these (patient safety) events are caused by a combination of individual failings, systemic weaknesses, and environmental factors.” “Regulations, legal frameworks, and most statutory inquiries have so far failed to understand the difficulties for conscientious health professionals of keeping patients safe in a flawed and overloaded system.”

A final thought

Criminal justice and a just culture … do not seek the same outcome.

White Park Bay, County Antrim, N Ireland