The Contractual Claim
The Contractual Claim
Introduction
The basic principles of construction do not need extensive discussion. As is to be expected, reference was made to the current core trinity of cases: Rainy Sky SA v Kookmin Bank[2011] UKSC 50 at [21] (per Lord Clarke), Arnold v Britton [2015] UKSC 36; [2015] 2 WLR 1593 at [15]-[23] (Lord Neuberger) & [76]-[77] (Lord Hodge) and Wood v Capita Insurance Services Limited[2017] UKSC 24 at [9]-[15]. A little variety was offered by reference to useful summaries by HHJ Pelling KC and approved by the Vos C in Lamesa Investments Ltd v Cynergy Bank Ltd [2020] EWCA Civ 821, 2021 2 All ER (Comm) 573 at [18] and ABC Electrification Limited v Network Rail Infrastructure Limited [2020] EWCA Civ 1645, at [18 (ii)].
However the issues between the parties did not require reference to these principles, but were more about how the specific contractual structure worked and which bits, if any, required to be read down.
There are a number of points of construction which are in dispute. These can be summarised thus:
Did the Contract require Medpro to follow a validated process demonstrating that the gowns when delivered should be sterile to a sterility assurance level (SAL) of 10-6;
Did the Contract require Medpro to follow a process, consisting either of the application of BS EN 556-1:2001 or an “equivalent technical solution” to the manufacture and sterilisation of the gowns?
Did the Contract require Medpro either to apply a valid CE mark to the gowns, or to have obtained a derogation pursuant to Regulation 12(5) of the Medical Devices Regulations 2002 (“MDR 2002”) for the gowns?
It is fair to say that the first of these issues has only taken full form during the course of trial. However it was not, at least initially, suggested that this question was not capable of being fairly decided based on the evidence which was before the Court. While Medpro in closing somewhat resiled from its earlier acceptance of the issue as live, it is, though unpleaded, a point which was squarely raised by the start of trial and would have been explicitly pleaded had Medpro objected earlier. In addition (and as reflected by Medpro’s initial reaction to it) it is not an issue which would have caused prejudice such as to make it appropriate to shut the issue out. Accordingly that issue is considered below.
- 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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