Case details
Summary
In medical negligence, the relevant question is whether the defendant followed a reasonable and acceptable practice, not whether it adopted the preferred or best practice. A responsible body of expert opinion must withstand logical analysis, although judges should rarely reject genuinely held expert views. The standard may include relevant evidence from outside the United Kingdom where domestic practice is limited. A claimant must prove causation on the balance of probabilities. The Control of Substances Hazardous to Health Regulations 1999 exclude risks to hospital patients arising where a substance is administered in medical treatment, including transplantation.
Factual background
The claimant received a corneal graft at Moorfields Eye Hospital in 2001. Donor tissue infected with Pseudomonas aeruginosa caused endophthalmitis and loss of sight. She alleged negligent decontamination and breach of statutory duty under the Control of Substances Hazardous to Health Regulations 1999.
The issues were whether the hospital’s use of Framycetin rather than Povidone-Iodine fell below the applicable standard, whether Povidone-Iodine would probably have prevented the infection, and whether the Regulations applied to contaminated transplant tissue.
Held
- The claim failed. The hospital’s decontamination process was reasonable and acceptable. Applying Bolam v Friern Hospital Management Committee [1957] 1WLR 52, as approved and qualified by Bolitho v City of Hackney Health Authority [1998] AC 232, negligence depended on whether the practice was reasonable and acceptable, not whether it was preferred or best. Supporting expert opinion had to withstand logical analysis (para [28]).
- The appropriate standard was that of a comparable United Kingdom eye bank. Given the small number of domestic institutions, European and American evidence was relevant. The duty was to follow an acceptable standard, not merely to copy other United Kingdom eye banks (paras [30]–[32]).
- The judge preferred the evidence of Professors Gould and Dua and rejected Professor Goodwin’s evidence. The Moorfields process was acceptable, having been used without earlier incidents and reflecting varied international practice (paras [31]–[37]).
- Causation was not proved. The claimant had to show that Povidone-Iodine would have eradicated the organism, which required proof that contamination was probably on the corneal surface. Internal contamination remained a credible possibility (para [36]).
- The statutory claim also failed. Regulation 3 extended duties beyond employees, and a micro-organism fell within the Regulations. However, regulation 5(1)(c) excluded risks to a person to whom a substance was administered in medical treatment. That exclusion covered transplantation and excluded hospital patients in these circumstances. The Regulations did not impose absolute liability (paras [39]–[43]).
- There was judgment for the defendant (para [44]).
The court’s approach to earlier authorities
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