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

There are therefore pieces of evidence both statistical and as to sterility which the sides pray in aid. The question is whether on that basis it would have been possible to conclude that the cause of the sterility findings ex post facto was manufacturing contamination or contamination in transit – or whether neither conclusion can be drawn and the matter must rest with the burden of proof.

Here the time which had elapsed and the very sketchy (to put it politely) chain of custody evidence meant that there were huge hurdles to concluding that any robust conclusions could be drawn from the Swann Morton samples. In terms of assessing the evidential picture there is a large gap whose significance cannot be ignored or (as DHSC would seek to do) treated as an irrelevance. For clarity the reasons are as follows.

Testing occurred more than 1 ½ years after delivery. While Medpro overstates matters somewhat in its closing, I accept that, in order to draw proper and meaningful conclusions about the state of the gowns at the point of delivery, part of the key evidential base is material which would show or enable a conclusion to be drawn on the balance of probabilities that the gowns when tested were in precisely the same condition and state as they were when delivered and that any of the contamination that was discovered on testing could not or was unlikely to have occurred by reason of anything that took place between delivery and testing;

DHSC had the knowledge of what happened to the gowns in the crucial intervening period between delivery and testing. The evidence served by DHSC did not come close to evidencing the journey of the gowns generally or the tested gowns in particular. DHSC had the option and ability to test on delivery. It did not do so. It chose to test later. That being the case the evidential burden falls on it to establish there was no change of condition in the intervening period.

To do this the court would expect to have heard from witnesses in relation to the delivery, loading, transport, transhipment, storage and selection of the Medpro gowns, DHSC called two witnesses of fact, Mr Parkes and Mr Reid who, by their own admission, could give no relevant evidence regarding the specifics of the Medpro gowns. Mr Reid thought Mr Parkes should know about it, but he apparently did not.

While it might be argued that, so long as the gowns were visibly in intact packaging at the time of testing there could have been no contamination, this would be an overreach. Dr Richards’ evidence was that the plastic packaging was in his opinion capable of withstanding normal conditions of use within the distribution chain for handling and routine transportation. He did not deal with the possibility of contamination from something outside routine conditions, and there was no evidence that the life journey of the gowns – taking in transportation, handling on discharge, destuffing, restuffing, further transportation and storage – was entirely within normal or routine conditions. He accepted that he proceeded on that assumption. Although one of the expert issues was the “relevance and significance of transportation and storage conditions in relation to the sterility of the gowns supplied by [Medpro]” he was not provided with and did not ask for material on this.

Both Dr Richards and Prof Hutton (in the absence of full evidence) proceeded in their analysis on the assumption that containerised goods were effectively safe from contamination. This is, of course, not a safe assumption (explosions, faulty gaskets, handling damage, rust are all possible vectors for damage to containerised cargo). While they were criticised for their assumptions by Medpro, the reality is that they were doing their best to assist the court and were not aware, outside their expertise, of the factors which might come into play. However the court cannot make those assumptions.

While there is no positive evidence which indicates a particular factor which would have caused contamination, there are facets of the partial picture which emerges which indicate at least some non-normal conditions. These include the length of time the gowns were in containers (at least six months- obviously less of a factor than if they were cocoa beans (Footnote: ³), but still an abnormality) many of them in open air conditions rather than in controlled or even covered ambient conditions; and that fact that some at least of the containers appear to have been stored in an open field for at least 3 months. That, Dr Richards agreed, was not a suitable environment.

Further while it may be that the positive evidence on contamination from extraordinary events was vague or speculative, that was in essence a product of the evidential vacuum created by DHSC. If the events post delivery had been known and evidenced, the parties could have determined what issues might or might not arise which could compromise biosecurity of the gowns and deal with the precise risks.

Ultimately it is simply not possible to say with any confidence that the gowns as tested were in the condition they were in on delivery.