High Court finds PPE supplier breached sterility requirements in £122m gown contract

The High Court has ruled in favour of the Secretary of State for Health and Social Care in a significant pandemic procurement dispute, finding that PPE Medpro Limited breached its contract to supply 25 million sterile surgical gowns during the COVID-19 crisis.

Mrs Justice Cockerill DBE delivered judgement on 1 October 2025, concluding that whilst DHSC had lost its right to reject the goods due to delayed inspection, Medpro remained liable for the full contract price of £121,999,219.20 as damages. The claim for £8.6m storage costs failed due to insufficient evidence.

The contractual requirements

The case centred on complex technical questions concerning sterility assurance levels (SAL) and validated processes. The contract required gowns to be sterile with a SAL of 10⁻⁶, meaning no more than one viable micro-organism per million gowns. Crucially, the court found this requirement necessarily implied compliance with a validated sterilisation process, despite Medpro's arguments to the contrary.

Medpro accepted the SAL obligation but contended there was no independent requirement to demonstrate a validated process. The court rejected this position, finding that SAL cannot be meaningfully tested post-delivery and can only be established through documented validation of the sterilisation process itself, including bioburden testing and proper dose-setting.

Critical evidential gaps

The evidence revealed significant deficiencies in Medpro's sterilisation documentation. Whilst gowns were irradiated at seven facilities in China, no proper dose-setting exercise was undertaken. The irradiators relied on customers to specify doses rather than conducting the microbiological qualification required by ISO 11137-2. Critically, there was no bioburden assessment as part of any dose-setting exercise.

Expert evidence suggested the irradiation doses applied (18.2-20.3 kGy) were likely insufficient given the probable bioburden levels on the gowns (potentially 6,000-9,000 colony-forming units), which would have required doses approaching 28 kGy to achieve the requisite SAL.

The construction battle

Medpro advanced an extensive estoppel defence, arguing that DHSC's technical approval statements during procurement created representations that its equivalent technical solution was accepted. The court found these arguments unpersuasive, noting the absence of clear representations and Medpro's failure to adduce evidence of actual reliance—no witness from Medpro testified at trial.

The contractual estoppel arguments similarly failed. Non-reliance and entire agreement clauses within Schedule 2 of the contract precluded reliance on extra-contractual statements, absent fraud.

Rejection and mitigation

DHSC's rejection notice (served 23 December 2020) came too late. Under the ex-works contract, delivery occurred when goods were made available in China. DHSC's logistics agent Uniserve could have inspected packaging for CE marking compliance upon collection, but failed to do so within a reasonable timeframe.

However, this did not save Medpro. The court found the gowns had nil value as they could not lawfully be used as sterile gowns in the NHS or elsewhere. Medpro's mitigation arguments—that gowns could have been repurposed or sold internationally—failed for lack of evidence demonstrating realistic alternative markets or viable relabelling processes.