PPE Medpro has attempted to sell medical devices in the UK with a safety report allegedly produced by a company that has refused to produce the document, the government has found in a £133million lawsuit.
PPE Medpro, which was formed just weeks before signing its first contract with the Department of Health and Social Care, submitted a test report from Intertek, an accreditation company. However, according to the department’s lawsuit against PPE Medpro, Intertek refused to issue the document.
The department’s complaint, filed in the High Court in December and recently obtained by the Financial Times, also alleges that PPE supplied Medpro 72 batches of gowns bearing a CE mark, confirming a product has been assessed by an accredited body would. It is also a legal requirement for products to be “sterile”.
However, PPE Medpro did not include a number indicating which body had performed the accreditation, the lawsuit says. PPE Medpro has not yet responded to the lawsuit.
PPE Medpro has been embroiled in a scandal for months after it was reported that lingerie entrepreneur Baroness Michelle Mone used her personal email addresses to trick ministers into ensuring the company secured lucrative government contracts totaling more than received £200 million. She has consistently denied having any relationship with the company.
Bank documents reported by the Guardian and FT late last year outlined how at least $65m
The new lawsuit alleges that PPE provided Medpro with “invalid” information about the health and safety of the products themselves during the height of the pandemic.
When a government representative contacted the company to inquire about the origin of the CE marking on the gowns, PPE Medpro director Anthony Page – a business partner of Barrowman – confirmed that the medical equipment “did not have the required accreditation ordered by a notified body”. according to the legal documents.
During a second and separate tendering process for PPE, PPE provided Medpro with a test report it said had been prepared by Intertek with code SHAT06648491, according to the statutory filing, which Intertek “denied having issued”.
Intertek did not respond to a request for comment.
The lawsuit states that 92 percent of the 60 PPE-Medpro gowns tested by the government were found to be non-sterile. It also stated that the gowns were single, not double-bagged, in breach of requirements, and that they “could not be used for any purpose within the NHS”.
On December 23, the government wrote to PPE Medpro rejecting the gowns because “they did not comply with relevant medical device laws and because PPE Medpro had not provided a certificate proving that the gowns had been reliably sterilized for medical use, thereby they were restored unusable in the NHS”.
The government is seeking a refund of £122m for the dresses and £11.6m for costs incurred in connection with the case.
PPE Medpro did not respond to a request for comment. It previously told the FT that the gowns were “manufactured to the quality standards and specifications set out in the contract, delivered on time and at a price that was 50 per cent of what DHSC was paying at the time”.
It claimed that DHSC rejected the gowns because it “severely overordered” PPE and realized it could not use the items, adding: “DHSC’s cynical attempt to reclaim money from suppliers like PPE Medpro who acted in good faith contract specifications will be discovered through the civil court proceeding”.
DHSC said, “We do not comment on matters that are the subject of ongoing legal proceedings.”
https://www.ft.com/content/7a2093f8-55f8-400f-9176-2225b9193e05 PPE Medpro granted ‘invalid’ accreditation for gowns, UK government claims