The case of Dr Hadiza Bawa-Garba shook the medical profession, and the outcome of a review of the case has implications for the whole of healthcare, according to pharmacy lawyers.

On February 18, 2011, Dr Bawa-Garba, by all accounts a competent and promising junior doctor, was on her first day back at Leicester Royal Infirmary after 11 months on maternity leave. Due to staffing shortages, she was the most senior doctor covering the clinical assessment unit, the emergency department, and a ward.

She failed to diagnose six-year-old Jack Adcock with sepsis, leading to his death later that same day. In the years that followed, Dr Bawa-Garba was convicted of gross negligence manslaughter and given a suspended two-year prison sentence – despite an initial decision by the Crown Prosecution Service not to pursue a conviction. She was also suspended from the General Medical Council (GMC) register for 12 months.

But Dr Bawa-Garba's suspension was later challenged by the GMC, who went to the High Court to seek her permanent removal from the medical register. The judge agreed with the GMC, and ruled that he did not see “that public confidence in the profession and its standards could be maintained by any sanction short of erasure”. Dr Bawa-Garba was struck off – but has won the right to appeal her exclusion from the GMC register, which will be heard later this month (see timeline, below).

Medical backlash

The backlash from the medical profession over the High Court decision was severe, and in February this year secretary of state for health and social care Jeremy Hunt asked former Royal College of Surgeons of England president Professor Sir Norman Williams to “conduct a review into the application of gross negligence manslaughter in healthcare”.

The review was published in June – but Professor Williams had already explicitly ruled out reviewing whether the law relating to gross negligence manslaughter should be changed. Instead, he focused on the application of the legal principles of medical manslaughter, and where the bar is set for pursuing these cases.

Professor Williams concluded that “a clearer understanding” of when manslaughter charges should be brought against healthcare professionals “should lead to fewer criminal investigations”.

He recommended that criminal investigation should be confined “to just those rare cases where an individual's performance is so 'truly exceptionally bad' that it requires a criminal sanction”.

Implications for pharmacy

David Reissner, a consultant at pharmacy lawyers Charles Russell Speechlys and current chairman of the Pharmacy Law and Ethics Association, considers the review “probably worthless”. 

“It was announced to appease the medical profession, which was up in arms about the Bawa-Garba case. [While] it is unrealistic to expect the law of gross negligence manslaughter to be changed, I would have hoped that the sanctions guidance for fitness-to-practise cases involving healthcare professionals could be revised so that if they are convicted of manslaughter, they need not be removed from their professional register…where there was no reason to doubt the practitioner’s competence to practise safely.”

In terms of medical manslaughter law – and how it might relate to pharmacists – Mr Reissner says the Court of Appeal clarified this in the case of optometrist Honey Rose, who failed to spot during a routine eye test that an eight-year-old patient, Vincent Barker, had a condition that would lead to his death.

Ms Rose’s conviction was overturned by the Court of Appeal in July 2017, because although her gross negligence resulted in a patient’s death, she could not reasonably have known at the time of the sight test that there was a serious and obvious risk of death because of her failure to identify the condition.

In that case, the Court of Appeal said that to convict a healthcare professional of gross negligence there must be a duty of care that is breached, and it must be reasonably foreseeable that the breach would give rise to a serious and obvious risk of death – as well as that breach directly causing a patient’s death.

What about inadvertent dispensing errors?

The Bawa-Garba outcry came just two months before the introduction of a long-awaited defence against criminal prosecution for pharmacy professionals who make inadvertent dispensing errors. 

Mr Reissner says the same defence will probably apply to pharmacists in most circumstances in which they might be grossly negligent, because “it will not be reasonably foreseeable from most picking errors or clinical decisions in many pharmacy settings that there would be a serious and obvious risk of death”.

Andrea James, a specialist healthcare partner at law firm Knights 1759, says that many people involved in defending healthcare professionals feel that the bar for a finding of gross negligence manslaughter, while already high, “should be raised further in respect of healthcare professionals” – so that “a healthcare professional can only be convicted...if their actions were intentional, reckless or grossly careless”.

In a C+D poll conducted when the defence became law in April, half of readers said it would not encourage them to report errors – as there are still some significant exceptions when pharmacists would not be able to rely on it.

Glyn Walduck, head of claims at the National Pharmacy Association, says pharmacists who undertake regular CPD will know the reflective process is intended to encourage them to learn from their mistakes, and identify where improvements can be made.

Pharmacists are “on a fairly well-trodden path of reporting adverse incidents and errors, and so overall learning and openness is becoming ingrained”, he adds.

The General Pharmaceutical Council (GPhC)'s stance is that it is “vital for patient safety that errors are reported and discussed”, and that “a key factor considered at each stage of a [fitness-to-practise] case is whether the pharmacy professional has acted with openness and honesty”.

Revalidation and reflective accounts

The Williams Review also considered how “reflective learning, openness and transparency can be properly sustained, to ensure that there is a robust learning process when errors are made”.

As is common for clinicians, Dr Bawa-Garba kept reflective learning material in an e-portfolio as part of her training. Part of the controversy surrounding her situation is speculation that the GMC used this material to build its case against her – something the GMC has always denied.

The GPhC introduced a reflective account into its new process for revalidation, which it launched on March 30 this year. The regulator now requires pharmacists and pharmacy technicians to use the reflective account to describe how they have met one or more of the GPhC’s standards, along with a “peer discussion...with someone who [they] trust and respect”.

Richard Hough, pharmacist and partner in the commercial team at the law firm Brabners LLP, says if records of reflective accounts are used by those who sit in judgment on them in disciplinary or criminal proceedings – something that is still disputed in the Bawa-Garba case – it will “inevitably foster a culture of concealing errors and deficiencies”.

So how will CPD records be used?

GPhC chief executive Duncan Rudkin said at the time of its February statement that Dr Bawa-Garba's case “caused concern among pharmacy professionals … over how these reflections could be used”.

“We want to be clear that we will not ask pharmacy professionals or peers to record what was discussed,” he said. “Instead they will be asked to record how the process of having a peer discussion has benefited their practice. Records should not contain any details which could identify a patient.”

This seems to be in line with the recommendations from the Williams review, that “professional regulators that have a power to require information from registrants for the purposes of fitness-to-practise procedures should have this power modified to exclude reflective material”.

Nonetheless, Ms James acknowledges that in view of the widespread fear and mistrust caused by Dr Bawa-Garba’s case, “a high degree of protection will be required before healthcare professionals feel completely free to engage in meaningful reflective practice”.

If pharmacists are to be encouraged to report and learn from errors, then it's vital that regulators create an environment of supported learning to help prevent these tragic instances from being repeated.