The High Court trial between PPE Medpro and the Department of Health and Social Care (DHSC) resumed on day eight with a forensic focus on the statistical credibility of the government’s gown sterility tests — tests that underpin its £122 million claim that PPE Medpro breached contract by supplying non-sterile surgical gowns.
In a day that further undermined the DHSC’s central argument, cross-examination of the government’s statistics expert Professor Anne Hutton revealed significant flaws in the design and reliability of the gown testing programme — including the startling admission that no formal sampling approach was used and that critical questions about the storage of the gowns remained unanswered.
The government’s testing, conducted by Swann-Morton in 2022, was based on a sample of just 60 gowns out of a total delivery of 25 million — all of which had been sterilised by just one of seven facilities. Furthermore, only two shipping containers were sampled from an estimated 544. The testing took place 18 months after the gowns were handed over to the government’s logistics agents in China, with no detailed record of how the sampled gowns were stored or handled in the interim.
‘No formal sampling approach’
Under questioning from PPE Medpro’s lead counsel Charles Samek KC, Professor Hutton admitted that the government’s sampling method failed to follow recognised statistical protocols.
Samek KC: “You’re very clear: ‘the sample of gowns did not use a formal approach…’ Do you stand by those words?”
Professor Hutton: “Yes, they did not use a formal approach.”
Pressed further, she acknowledged that the sample selection appeared to be little more than a manual grab from a warehouse shelf.
Samek KC: “Someone went into the Bis Bardon warehouse and took down boxes of different sizes of the gowns, isn’t it?”
Professor Hutton: “That’s roughly what I remember being told.”
No knowledge of how gowns were stored
Crucially, Professor Hutton admitted she had no knowledge of how the sampled gowns had been transported or stored — a central issue in the case. PPE Medpro maintains that any contamination likely occurred after the gowns were delivered to DHSC’s agents, and that the testing was therefore not reflective of their condition at the point of delivery.
Samek KC: “You have no knowledge whether the containers may have been kept in a container park or in an open field?”
Professor Hutton: “I have no knowledge of that.”
She further admitted that her analysis was conducted on the assumption of normal storage conditions, and had not accounted for the chaotic handling and undocumented storage environments previously described in court.
“I should have asked further questions,” she said, echoing admissions made by the DHSC’s sterility expert Dr Richards earlier in the trial.
‘Probative of nothing’
Samek KC summarised PPE Medpro’s argument that the test results were ultimately meaningless without any assurance of how the gowns were handled over the previous 18 months.
“Unless one can properly exclude anything that happens to the gowns after delivery and prior to testing, the value of the testing after the event… is nil and probative of nothing,” he said.
Professor Hutton agreed that the tests had limited value under such circumstances, and acknowledged in her report that “not normal conditions” would require a completely different set of questions and controls.
PPE Medpro’s expert: testing process ‘entirely flawed’
Later in the day, DHSC counsel Paul Stanley KC cross-examined Dr Chris Williams, PPE Medpro’s expert on statistics, who gave his assessment of the government’s sampling method.
Dr Williams described the testing process as “entirely flawed”, pointing out that testing 60 gowns from such a vast and complex delivery — involving 544 shipping containers and 14 separate UK storage sites — could not reliably represent the condition of the entire batch.
“Clearly there has been time that has passed,” he said. “Across that time these gowns have come from being delivered in China, to being stored in China, to being pushed across the sea… then they were stored in 14 different storage facilities. All of this creates uncertainty… or a risk.”
Williams added that such uncertainty fundamentally undermined the integrity of the testing and made it unsuitable to support DHSC’s claim.
Day 8 adds to the growing list of challenges facing the government’s case. From questionable gown storage in open-air container parks to flawed sterility testing protocols and inconsistent timelines, PPE Medpro continues to argue that DHSC’s rejection of the gowns is not grounded in reliable evidence — but rather in a post-hoc attempt to recover public funds.
The trial continues, with further expert evidence expected.
Read more:
Sterility test sample flawed, admits DHSC statistics expert in ppe medpro trial