CL-2022-000676 - [2025] EWHC 2486 (Comm)

Fecha: 01-Oct-2025

The evidence and its implications

The evidence and its implications

339.

There is nonetheless a need for a view to be taken as to whether the micro-organisms fond are explicable or more likely to be explicable by reason of the contamination of the gowns after they had been sterilised. On this difficult question it is unfortunate that it cannot be said that the expert evidence on either side was of the highest quality.

340.

Dr Richards, called for DHSC, did not perform particularly well as a witness. While he plainly, from his expert report, had the relevant expertise (albeit not necessarily particularly recent, with his last audit engagements being in the 1990s) he gave the impression of not having engaged particularly rigorously with the exercise he was being asked to perform. A good example was his response when asked about the Joint Report – a key document for the Court’s purposes. He said “I think you need to ask that question of your expert because he wrote the report. I was just reviewing and signing off on the report..” This gave the impression that he had not engaged with care in signing off on a critical document and that he had not prepared carefully to give his evidence orally. Elsewhere Mr Samek mercilessly exposed examples of generalisations, loose assumptions and failures to dig into the relevant evidence. Dr Richards also occasionally lost the train of his thoughts or did not accurately recall the questions.

341.

Mr Atchia for Medpro was certainly no better. He was, despite the making of a succession of fairly major mistakes in his report (such as his misleading equation of a SAL with a log reduction in micro-organisms, or his equally misleading presentation of Dasheng’s dosimetry setting)., extremely dogmatic, and unwilling to make proper concessions for example when refusing repeatedly to concede that the Dasheng exercise was not about establishing the sterilisation dose, and then having had to concede it, refusing to delete the words which were, given the concession plainly inaccurate. His evidence was on occasion plainly overstated – his description of the relevant micro-organisms as “bilge water specialists” is a good example, as is his trumpeting of lactobacillus yapensis as a “Rosetta Stone species” which existed only in one trench in the Pacific. There was a distinct impression that he sought to overbear both Mr Stanley and the court with a document dump of citations (numbers of which on probing proved not to exist or not to be relevant to the proposition cited) and with fluent and dogmatic answers. He left the distinct impression of a lack of neutrality.

342.

It is probably sufficient to summarise the position on the evidence thus:

The testing results were puzzling to the experts. Both experts would have expected different species of micro-organisms to have been recovered as adventitious bioburden on the gowns, with this adventitious bioburden being derived from various sources, for example, raw materials, the manufacturing environment, process contamination and from personnel;

The isolates recovered were ones which typically would be recovered from environmental habitats;

There were no expected adventitious contaminants such as skin commensals;

Some environmental contaminants – but not necessarily the ones found -might be transferred in the manufacturing process;

This left a question as to whether that was because there was later environmental contamination, or whether contamination with both human and environmental micro-organisms had occurred in manufacturing, with only those organisms connected with human contamination being destroyed by the irradiation;

343.

There were also some puzzles deriving from the facts that:

One of the contaminants Lysinibacillus yapensis, was a species which was not isolated until 2017, when it was recovered from the deep sea Yap Trench;

another Ornithinibacillus contaminans is documented in a blood sample in Sweden;

a third Bacillus mojavensis was (as its name suggests) first isolated in the Mojave desert;

others found in one or more of the samples (or their close relatives) have been associated with marine environments.

344.

It was hard to assess what weight should be given to these facts. Although Dr Richards said that these might have occurred from a number of environmental sources, there was no detailed explanation of what that meant or where other samples of these contaminants had since been found.

345.

In addition the effect of a radiation dose of 18 kGys on the particular micro-organisms was unclear. While Dr Richards accepted that some of these prima facie marine or marine associated micro-organisms might have been introduced via a shipping container which was never cleaned.

346.

There were however a number of indications which provided a real case for DHSC’s preferred analysis of contamination during manufacturer.

The first – and most significant - is that the tested gowns showed no signs of the wrappings having been soaked (cardboard) or pierced (plastic). There was no material testing of the packaging, but both experts had agreed that it was suitable for the purpose, implying that it should not be permeable, and the testing facilities noted no problems with it at the time of testing of the sample gowns.

While Dr Richards agreed that permeability would not necessarily be visually apparent, there were, even in theory limited ways in which permeability could happen – the expectation (agreed to by both experts) is that in the normal run of events this packaging should keep micro-organisims (and other contaminants) out.

The permability theories of Mr Atchia were predicated on the potentially abnormal conditions which could not be excluded from having happened. Mr Atchia posited the possibility of bacilli penetrating plastic pores but on the evidence that theory was not supported by any research. He cited two pieces of literature to support the notion that plastic may be permeable or porous to gas or water vapour—but that takes matters no further, since bacilli, while tiny, are vastly larger than gas or water molecules. He also cited one theoretical experiment that showed that bacilli could move through deliberately created small channels in a silicon chip but that does not advance matters, as he accepted. Ultimately his theory was a speculative one based on a combination of heat and pressure creating an aerosol which could permeate plastic. It was not particularly convincing, particularly given the other weaknesses in his evidence.

The irradiation dose seems on the evidence – see [ref**] above – not to have been sufficient that one would expect gowns with a high bioburden to be sterilised. A sterilisation dose of 18KGy would be sufficient for a bioburden per item of 13 cfu; the evidence suggests that the bioburden on these gowns may well have been higher. One cannot be sure because (i) the tests carried out by GTTC and Intertek were done as part of the manufacturing process and Dr Richards considered that they did not permit conclusions about bioburden, and (ii) the calculation used is one designed to establish bioburden for dose setting. However if that approach is robust (which is logical, if not supported by the experts – Dr Richards not having grappled with it and Mr Atchia predictably fighting the suggestion) figures given in the tests carried out by GTTC and Intertek are for between 14 and 77 cfu per 100cm, the bioburden on the gowns was between 6,000 and 9,000 cfu and would have required a dose of nearly double that applied.

There is some evidence of sub-standard practices at the manufacturing sites. Medpro’s disclosure contained inspection reports produced variously by Medpro, Eric Beare and Testcoo. These reports included photographs of the manufacturing environment in the factories which led Dr Richards to conclude that they indicated a “poor level of compliance with established quality systems standards and Good Manufacturing Practices in terms of clothing, personnel cleanliness and environmental controls.”. Even Mr Atchia accepted that workers wearing short sleeves within the factory setting is not best practice and that that the photographs of gowns trailing on the floor, personnel wearing street shoes and operating without hair protection were not ideal. Mr Atchia attempted to dismiss the significance of these photographs as typical of such manufacturing environments because different departments would operate different levels of control, but that did not seem to deal with the evidence that there appear to have been opportunities for a high bioburden to have been acquired via the manufacturing process.