Wholesaler Fresenius Kabi and drug manufacturer Calea UK have been fined for supplying defective pre-filled syringes that contributed to the death of diabetic man Neil Judge at the Northern General Hospital in Sheffield in November 2010. The syringes contained no insulin, which led Judge to go into diabetic ketoacidosis, leading to multi-organ failure.
The Medicines and Healthcare products Regulatory Agency (MHRA) prosecuted the companies. 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. Sheffield Crown Court fined Fresenius Kabi £500,000 and Calea £50,000. The companies were also ordered to pay £5,900 each in costs.
This isn’t the first manufacturing error for Calea. In August 2011, a patient with cystic fibrosis was dosed with tobramycin from syringes specifically prepared for the individual, and each contained three times the daily dose. The overmedication was only spotted when the patient reported a “fizzing sensation”. Fortunately, the patient had no permanent after effects.
According to Alastair Jeffrey, head of enforcement at the MHRA, the two companies, which are ”very closely linked” (they share a site in Runcorn, Cheshire), were equally responsible for the errors, and the onus was on both to produce and supply products that are fit for purpose.
“I hope this case serves as a clear reminder to others, as the MHRA will not hesitate to take enforcement action when serious failings occur,” Jeffrey adds.