Conclusion
Conclusion
Ultimately as indicated I am left with the following difficulties (i) large unaccounted for gaps in the gowns’ history, which could have led to contamination (ii) puzzling testing results which do not point squarely to manufacturing contamination (iii) lack of positive evidence of contamination in transit. In essence a concatenation of uncertainties.
Had the history of the gowns’ peregrinations been more clear, and had that disclosed that there was no obvious environmental cause of contamination I would – just - have formed the view that the evidence of manufacturing contamination was more probable than not.
As it is the other uncertainties – and in particular the lack of any proper chain of custody evidence - mean that I conclude that it is not possible to say that it is more probable than not that the contamination was caused on manufacturing. Essentially there are weak cases for both outcomes.
Although DHSC attempted to persuade me that the authorities (in particular the Popi M) favour a positive conclusion, I agree with Mr Samek that where there is a combination of weak evidence and massive evidential gaps (caused by a failure on the part of one party to provide relevant evidence) it is wrong to say that one should simply opt for the more probable of the two weak cases. Here one might say that there is a 40% case for DHSC, a 30% case for Medpro and an evidential gap of 30%. One cannot simply cancel out the 30% which would tell us whether (for example) there were the kinds of conditions which might engage Mr Atchia’s speculative theory, or conversely show that nothing particularly risky happened.
Because the missing evidence is evidence legally within DHSC’s control that absence must lie at its door. This is in essence a case where an adverse inference is entirely sensible and permissible on the basis of the authorities (such as Wiszniewski v Central Manchester Health Authority [1998] PIQR 324, 340; Magdeev v Tsvetkov [2020] EWHC 887 (Comm), [147]-[154] and Efobi v Royal Mail Group [2021] UKSC 33, [41]). On the basis of the evidence I conclude that (i) had sterility been capable of being tested for this way and (ii) had the case not already been decided on other bases I would have concluded that taking the absence of evidence and the evidence favouring in transit contamination together the claim failed, alternatively that DHSC had not discharged the burden of proof upon it.
- Heading
- This judgment was handed down by the court in person and by circulation to the parties’ representatives by email and released to The National Archives. The date and time for hand-down is deemed to be
- Sterility 101: An Introduction to sterility and Medical Device Law
- ISO 11137: Requirements of a Sterilisation Process
- Sterility level: EN 556
- Medical devices: MD Directive and MDR 2002
- Other relevant standards
- Summary
- Factual Background
- The PPE Cell
- The Recommendation
- The Essential Technical Requirements Document (“ETRD”)
- Precontractual Negotiations
- Closing
- Final Approval and Contract
- Manufacturing, delivery and inspection
- Rejection of the Gowns
- Testing of Gowns
- The Trial and issues
- The Contractual Claim
- The parties’ cases on construction
- The significance of the accepted obligation to deliver gowns with an SAL of 10 -6
- Was there breach of a requirement for a formally validated process in this case?
- Did the Contract require EN 556 or an Equivalent Technical Solution?
- Did the Contract require CE marking?
- The original case: Statistics, Physical Testing and Sterility
- Estoppel and related concepts
- Representation/assumption: clear?
- Approval of an ETS in place of EN 556
- Meeting the technical requirements/ No requirement to have a CE mark with an NB number
- Reliance
- Estoppel and validated process/SAL
- Non-Reliance and Entire Understanding Clauses
- Remedies
- Was the right to reject lost?
- Damages: The value of the Gowns and Mitigation
- Damages: The Claim for Storage Costs and Gown Disposal
- The Counterclaim
- Common mistake and rectification
- Negligent misstatement
- Conclusion
- Annex 1: Statistics, Physical testing and Sterility
- The testing
- Statistics
- The evidence and its implications
- The evidence gap
- Conclusion
- Annex 2: Relevant provisions of the Contract The Contract between DHSC and Medpro consists of a front page and several documents
- Order Form Section 5 of the Order Form “ The Supplier shall supply the deliverable described below on the terms set out in this Order Form and the Schedules and Annex A. Unless the Contract otherwise requires, c
- Section 7 of the Order Form is headed “Specification” and states: “The specification of the Deliverables is as set out in Annex A.1 – A.9 [26.06.2020]. Not as embedded/attached documents. Please confi
- Schedule 1
- Clause 2.2 of Schedule 1 states that the Order Form is to “ include, without limitation, the Authority’s requirements in the form of its specification and other statements and requirements, the Suppli
- Clause 3 of Schedule 1 is headed “ Quality assurance standards ” and states: “The following quality assurance standards shall apply, as appropriate, to the manufacture, supply, and/or installation of
- Conclusions
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