British man Neil Judge died at the Northern General Hospital in Sheffield, England in 2010 after being treated with pre-filled syringes that turned out not to contain insulin. He suffered a serious episode of diabetic ketoacidosis which triggered multi-organ failure.
The defective syringes were supplied to the hospital by Fresenius Kabi as a licensed wholesaler for manufacturer Calea UK Ltd.
Sheffield Crown Court this month ordered Fresenius Kabi to pay a fine of £500,000 ($778,000) and ordered to pay a further £5,900 ($9,100) in costs after pleading guilty to breaching the UK Medicines Act.
Calea UK was fined £50,000 with £5,900 costs after also pleading guilty to similar breaches.
Second syringe failure
A coroner ruled the failure of the medicine – which resulted in Mr Judge being deprived of insulin for 13 hours – was a “major contributory factor” in his death.
The court was told this was not an isolated incident and that Calea had manufactured and supplied to another faulty batch of pre-filled Tobramycin syringes to a hospital in 2011.
The syringes were administered to a patient with cystic fibrosis, but found to contain three times their labelled dose after the patient reported a fizzing sensation. There were no lasting adverse effects.
During the prosecution by the Medicines and Healthcare products Regulatory Agency, the court heard the incidents followed inspections by the MHRA of Fresenius Kabi and Calea’s shared site in Runcorn, UK. The visits highlighted concerns about reporting protocols for product defects.
Alastair Jeffrey, Head of Enforcement at MHRA, commented on the sentencing:
“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.”
A spokesperson for Fresenius Kabi told us the company expresses its condolences to Mr Judge’s family and that “the issue [was] fixed immediately after the incident occurred” in 2010. The error only affected products supplied to the UK, he added.