Estoppel and validated process/SAL
Estoppel and validated process/SAL
While Medpro maintained in closing that the estoppel case extended to validated process to the extent that the validated process argument crosses over with SAL, no estoppel can arise. This is essentially for the same reason outlined above as to Medpro’s case on construction: that it was agreed that the compliance with SAL was satisfied by provision in advance of the partial certification, and photos of gowns with an NB number which was not apt to sterile gowns. Medpro says “Ultimately, it was for the DHSC, through the Technical team, to determine whether the documents provided by PPEM met the necessary technical requirements, and before the gowns were purchased.”
There plainly is no representation which can be spelled out of the circumstances here, as to validated process and SAL – particularly when the complications of the process form part of the backdrop: how could it be understood that DHSC were satisfied that gowns would be sterile if they were as presented? At this level Medpro’s case becomes that DHSC agreed or represented or the parties assumed that the kind of non-sterile gowns which were not needed could be the sterile gowns which were needed.
The estoppel case could therefore only conceivably work if SAL were independent of validated process. Then there might be room for a representation/assumption that all that was needed (in terms of validation of process) to demonstrate compliance with SAL was compliance with ISO 11137. However that case itself would fail for the same reasons as the ETS arguments already considered. There is no clear representation (again see the relevant backdrop of what the process is covering), there is no evidence of assumption, there is no evidence of reliance, and there is no presumption of inducement.
- 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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