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
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 1 October 2025 at 10:30am.
Mrs Justice Cockerill:
Introduction
In mid May 2020 England was still in the first phase of the COVID lockdown, though COVID numbers and deaths were dropping. Discussions were ongoing as to the easing of lockdown measures. But many people were still getting very ill with COVID; and the Department of Health and Social Care (“DHSC”) was looking to maintain supplies of appropriate medical devices – such as sterile gowns, non-sterile (“isolation”) gowns, masks and gloves.
Against this background the Defendant (“Medpro”), a relatively new company which had access to the so-called “VIP lane” of PPE supply, offered to source and supply sterile gowns. After discussion, during the course of which one of the relevant teams in DHSC said that the submission in respect of the gowns was “technically approved”, a draft contract was sent out and was later concluded.
The gowns were delivered ex works in China between July and early September. DHSC paid a few pence less than £122 million for them.
They arrived in tranches between mid August and mid October. They were not inspected until some time after they had arrived in the UK. On inspection it was concluded that the gowns were not appropriately marked and the DHSC was not satisfied that the gowns were contractually compliant. Just before Christmas 2020 DHSC served a notice rejecting the goods and seeking its money back. Still later a selection of gowns was tested, and it was found that a number of them were not sterile.
Overall DHSC claims the following (capped under the contract at £128,099,180):
Repayment of the Contract price: £121,999,219.20;
Storage Costs of £8,648,691 for the period between February 2021 and June 2024.
That claim raises issues of the terms of the contract, representations said to have been made at the time, and (perhaps more interestingly) of the nature of sterility, statistical probability and the significance of organisms isolated from a deep trench in the Pacific. Then there are issues as to the right to reject the goods, and whether DHSC can claim the full value of the gowns in damages.
Those issues and issues as to the extent of the claim are considered further below under broad headings as follows:
Sterility 101: an introduction to sterility and medical device law
Factual background
The Contractual Claim
Estoppel and related concepts
Remedies
The Counterclaim.
- 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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