Clinical negligence, consent, and hospital prescribing

The recent judgment of HH Judge Richard Roberts, sitting as a Deputy High Court Judge, in Alexander v (1) HCA International Limited and (2) Dr David Reffitt [2026] EWHC 1284 (KB) deals with the need for consent when administering diclofenac, and with compliance with the requirements of the Human Medicines Regulations when supplying diclofenac, a Prescription Only Medicine, in a hospital setting. The judgment also has lessons for expert witnesses. 

The claim 

HCA, the First Defendant, is the owner of London Bridge Hospital, a private hospital. Dr David Reffitt, Second Defendant, is a Consultant Gastroenterologist under whose care the Claimant was. 

Mr Andrew Alexander brought a claim for damages for clinical negligence arising out of an endoscopic investigation of the biliary tract performed on 16 July 2019 by Dr Reffitt at the hospital where Mr Alexander was a private patient. The procedure carried a 3% risk of developing pancreatitis. To reduce the risk of developing pancreatitis, Dr Reffitt’s usual practice was for diclofenac to be administered to the patient rectally. After the procedure, Mr Alexander developed pancreatitis, leading to life-changing injuries.  

The hospital was responsible for clinical, nursing and other staff at the hospital and is vicariously liable for the negligent acts and omissions of staff committed within the course of their employment. Dr Reffitt and the staff of the First Defendant owed the Claimant a duty to treat him with reasonable professional skill and care. Both defendants also owed the claimant a duty in contract. 

It was the responsibility of the Dr Reffitt alone to decide what medication the Claimant required prior to, during or after the procedure. It was the responsibility of the First Defendant’s nursing staff to administer medication as prescribed by Dr Reffitt. 

Key questions that arose during the trial included whether Mr Alexander had consented to the administration of diclofenac and, crucially, whether diclofenac had, in fact, been administered. The judge criticised some of the expert evidence and had trenchant comments to make about the lack of compliance with the Human Medicines Regulations. 

Consent 

It was not in dispute that 15 or 20 minutes before the procedure, Dr Reffitt had taken Mr Alexander through the consent form. The consent form included a box alongside the words “The procedure will involve rectal administration of drugs”. This box was not ticked, and nor were the boxes stating that the procedure “will involve general and/or regional anaesthesia or sedation”. The patient signed the consent form, and Dr Reffitt signed it immediately beneath the unticked section “rectal administration of drugs”; indeed, his signature overlapped the words “rectal administration of drugs”. 

An expert witness for Dr Reffitt said in his report that he would not expect any discussion about the use of a diclofenac suppository. The judge found that this position was untenable and said it would constitute substandard and negligent practice. The judge took such a serious view of what the expert had said that the evidence of the witness on this point diminished his credibility as an independent expert and resulted in the judge placing less weight on his evidence. 

Diclofenac – HMR requirements 

Diclofenac is a Prescription Only Medicine (POM) and regulation 214 of the Human Medicines Regulations 2012 prohibits a sale or supply except in accordance with a prescription. Regulation 227 of the Human Medicines Regulations gives an exemption from the requirement for a prescription in the case of the sale or supply in the course of the business of a hospital in accordance with directions that are given in writing by an appropriate practitioner (a doctor, nurse or dentist). 

Had diclofenac been administered? 

Dr Reffitt said it was his usual practice to prescribe Diclofenac either before or during this procedure in all cases – to be administered rectally – in order to reduce the risk of post-procedure pancreatitis. 

If Diclofenac had been prescribed, it would have had to have been brought from the ward or pharmacy, as it is not stored in theatre. 

The box on the consent form next to the words “The procedure will involve rectal administration of drugs” was not ticked. 

The Endoscopy Department Drug Prescription and Administration Chart did not record diclofenac as having been prescribed or administered, and the hospital electronic Medication Discharge Summary did not mention diclofenac. 

Dr Reffitt’s case was that it was routine practice to sign for all medication at the end of the procedure when he and the nursing staff knew the exact doses that had been required.  

Dr Reffitt said that a prescription was not given in advance of the operation. Instead, the prescribing was done orally and then the drug would be signed for it at the end of the procedure “because you don’t, until the end of the procedure, know what medications have been given.” The judge was unimpressed by this evidence. He noted that it was known from the very outset that diclofenac would be administered pre-procedure. The judge pointed out that Dr Reffitt “did not even acknowledge in his witness statement or his oral evidence the existence of regulation 227 of the Human Medicines Regulations, let alone acknowledge that it should be complied with. The judge found that this reflected detrimentally on his credibility”. 

Two theatre nurses said that it was usual practice for verbal instructions to be given by the surgeon for the administration of diclofenac suppositories. 

An expert witness for Dr Reffitt had agreed in a written report that diclofenac should have been recorded in the Drug Prescription and Administration Chart, but in his oral evidence said that in his experience it was common for rectal NSAIDs to be prescribed ‘on word of mouth’ by the endoscopist. The judge took a dim view of this evidence, describing it as “seeking to walk the admission back and to reduce a legal requirement to an ideal to be aspired to”.  

Outcome 

The judge concluded that there had been no prescription or direction for diclofenac, nor were there any oral instructions to the nurses to administer it. He concluded that diclofenac had not been given to the patient. If it had been given, it would have had a material effect in reducing the patient’s inflammation. 

The theatre nurses were not found to be negligent, so the claim against the hospital was dismissed. Dr Reffitt was found to have been negligent in not prescribing or directing the administration of diclofenac. Judgment against him was given in the agreed sum of £550,000. 

The judge’s “Final thoughts” 

An unusual feature of the judgment is what happened next. Judgments usually end when the judge records the outcome. However, after recording the outcome in this case, the judge added “Final thoughts” because of his concerns about the apparent ignorance of the hospital and Dr Reffitt of the requirements of the Human Medicines Regulations. (In doing so, the judge did not distinguish between a prescription and directions in writing, using the word “prescription” to cover directions that may be given under regulation 227 of the Human Medicines Regulations.)  

Extracts from the judge’s Final thoughts are quoted below. 

“This is a very serious case. As a result of diclofenac not being administered, the Claimant suffered life-threatening severe acute necrotising … pancreatitis. After the [procedure], the Claimant was in hospital for nearly four months, during which time he underwent multiple operations. He has been left with life-changing consequences …, which has reduced his life expectancy. 

Firstly, it is concerning that the First Defendant seemed wholly unaware of regulation 214 of the Human Medicines Regulations, which mandates that a prescription must be in writing. From their witness statements, it would appear that [nurses and other hospital staff] were wholly unaware of this requirement. … 

… What was conspicuous was [the] failure to explain why [hospital staff] had allowed it to become commonplace for a verbal direction to be given for prescription drugs which it was known from the outset would be administered…. 

[Dr Reffitt] showed no awareness that this was in breach of regulation 227 of the Human Medicines Regulations. 

[A hospital witness said in evidence] that the failure to record a prescription for diclofenac in the Drug Prescription and Administration Chart or Short Stay Drug Chart was a “minor recording omission”. Nothing could be further from the truth. If a prescription for Diclofenac had been recorded in the Drug Prescription and Administration Chart, it is likely that diclofenac would have been administered and on the balance of probabilities, the Claimant would not have suffered pancreatitis. 

In this case there were far too many errors in the record keeping, which were wrongly characterised as minor clerical errors or minor recording omissions. They are not minor, they are serious. There was no explanation for them, and the impression given was that the [hospital] considered them to be of no consequence. 

I am concerned that, notwithstanding the very serious consequences for the Claimant, lessons have not been learned from this case by the First and Second Defendants.”