UK firms fined for supplying defective pre-filled syringes

Published: 9-Jul-2015

One syringe contained no insulin and another three times the prescribed dose of Tobramycin

A healthcare company and its sister firm have been fined for supplying hospitals with defective pre-filled syringes, which contributed to the death of a diabetic patient.

Neil Judge, from Barnsley, died at the Northern General Hospital in Sheffield, South Yorkshire, UK in November 2010 after being treated with a batch of intravenous insulin syringes that contained no insulin.

He suffered multi-organ failure because his body was deprived of insulin for more than 13 hours.

The faulty syringes were supplied to Sheffield Teaching Hospitals NHS Foundation Trust by Fresenius Kabi, a licenced wholesaler for Calea UK, which manufactured the product.

Both companies, based in Runcorn, Cheshire, were fined at Sheffield Crown Court today (9 July) after being prosecuted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Fresenius Kabi was convicted for its role in a ‘medicinal failure’ that a coroner had earlier ruled was a ‘major contributory factor’ in Judge’s death.

The two incidents followed a series of inspections by MHRA officials that highlighted deficiencies at the Runcorn site

The Court heard that supplying faulty syringes was not an isolated incident and that Calea also manufactured a batch of pre-prepared Tobramycin syringes – used to treat infections – that were administered to a patient with cystic fibrosis at the Royal Shrewsbury Hospital in August 2011.

The syringes were each found to contain three times the prescribed daily dose. The over medication came to light after the patient reported an adverse reaction described as a fizzing sensation.

The court was told the two incidents followed a series of inspections by MHRA officials that highlighted deficiencies at the Runcorn site where Calea and Fresenius Kabi operated.

Fresenius Kabi Ltd, of Eastgate Way, Manor Park, Runcorn, was fined a total of £500,000 and ordered to pay a further £5,900 in costs after pleading guilty to breaching Sections 64(1) and 67(2) of the Medicines Act 1968.

Calea UK Ltd, of the same address, was fined £50,000 with £5,900 costs after also pleading guilty to similar breaches.

After sentencing, Alastair Jeffrey, MHRA Head of Enforcement, said: 'Fresenius Kabi Ltd and Calea UK Ltd are equally responsible for the medicinal failure that was a major contributing factor in the tragic death of Neil Judge, who was deprived of the vital insulin his body needed because of a serious manufacturing error.

'Thankfully the patient who was administered an overdose of tobramycin was relatively unharmed, but the consequences could have been more serious had hospital staff not responded to his complaints.

'The two companies are very closely linked, and the onus is on them both to produce and supply products that are fit for purpose and that conform to precise specifications for each and every batch.

'I hope this case serves as a clear reminder to others, that the MHRA will not hesitate to take enforcement action when serious failings occur.'

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