Andrew Alexander v HCA International Limited & Anor

In clinical negligence claims, a prescription-only medicine administered in hospital must be directed in writing where the statutory hospital exemption applies. A patient should be informed before sedation if treatment involves rectal administration of medication. Causation is determined on the civil balance of probabilities, not by requiring a 95% scientific confidence interval. Statistical evidence should be selected for its closeness to the claimant’s circumstances, including the particular drug and route of administration. Where the evidence establishes that the breach probably caused the injury, the claimant succeeds. A failure to prescribe or administer appropriate prophylactic medication may constitute a breach of duty, and inaccurate medication records may substantially undermine the defendants’ factual case.

The claimant underwent an ERCP at the first defendant’s hospital, performed by the second defendant. He subsequently developed severe acute necrotising post-ERCP pancreatitis and claimed damages for clinical negligence.

The issues included whether the second defendant prescribed 100mg rectal Diclofenac, whether the claimant was informed that it would be administered, whether it was administered, whether the first defendant’s nurses acted negligently, and whether the failure to administer Diclofenac caused or materially contributed to the pancreatitis.

The parties agreed quantum at £550,000, subject to liability. The central questions were whether the second defendant breached his duty by failing to instruct the nurses to administer Diclofenac and whether causation was established on the balance of probabilities.

1. Consent and prescription. The claimant should have been informed during the consenting process, and before sedation, that Diclofenac would be administered rectally. He was not so informed. The consent form did not record rectal administration. That omission constituted substandard practice.
2. Under regulation 227 of the Human Medicines Regulations 2012/1916, directions for administering a prescription-only medicine to a particular patient in hospital must be in writing. This was a legal requirement, not merely a matter of convention or good practice. Diclofenac should have been recorded on the Drug Prescription and Administration Chart.
3. The court rejected the second defendant’s late-emerging recollection that he had orally instructed the nurses to administer Diclofenac. The absence of a written prescription, the absence of Diclofenac from the relevant medication records, the inaccurate recording of Ciprofloxacin and Buscopan, and the witnesses’ evidence undermined the defendants’ case. Diclofenac was not prescribed or administered.
4. The second defendant intended to prescribe Diclofenac but failed to communicate the instruction to the nurses. He thereby breached his tortious and contractual duties. The claim against the first defendant was dismissed because there was no written or oral prescription for its nurses to administer.
5. For causation, the applicable standard was the balance of probabilities. A 95% confidence interval was not required. Following Gregg v Scott and Sienkiewicz v Greif (UK) Ltd, the court considered all the evidence and gave weight to statistics closely matching the claimant’s position. Studies involving rectal Diclofenac were preferred over studies involving other drugs or ineffective routes of administration. The claimant proved that, more probably than not, pre-operative rectal Diclofenac would have prevented the pancreatitis.
6. It was unnecessary to decide material contribution, but the court held that the evidence would alternatively have established a more-than-negligible contribution by Diclofenac to reducing the inflammatory process, with the resulting damage unamenable to apportionment.
7. There was judgment for the claimant against the second defendant for £550,000. The claim against the first defendant was dismissed.