A British pharmaceutical company has been charged with a number of offences related to the deaths and illnesses of seven premature babies.
Guy's & St Thomas'
London-based ITH Pharma has been accused of supplying a medicinal product which does not match up to the quality specified in its product’s prescription.
The charges come following a four-year investigation by London's Metropolitan Police into the deaths and illnesses of seven premature babies whom had received Total Parental Nutrition (TPN) via an intravenous feed.
Launched in 2014, the investigation found a death of a baby at London’s Guy’s and St Thomas’ hospital could be linked to ITH Pharma’s TPN feed.
The death of a second baby at Guy’s and St Thomas’ and another at the Rosie Maternity Hospital in Cambridge were also investigated.
The investigation looked into the outbreak of a bacterial infection that had affected the seven babies receiving the intravenous feed. In total, five hospitals were investigated, including Russells Hall Hospital in Dudley, Luton and Dunstable Hospital and Lister Hospital in Stevenage.
ITH Pharma is now set to appear at Westminster Magistrates’ Court on 17 December.
In response to the decision, the company issued a press statement, saying: “As founders of ITH we have every sympathy for all the families affected, regardless of the cause. However, we are disappointed by the decision to charge the company and will vigorously defend this case. It would not be appropriate to comment further at this stage.”
“Since 2008, ITH has manufactured more than 1.4-million components of total parenteral nutrition and is the sole commercial supplier of reactive feeding solutions to the NHS. This product has helped thousands of extremely vulnerable infants survive premature and complex births. ITH imposes rigorous environmental monitoring on its manufacturing process. The company has always had a strong relationship with the MHRA and continues to receive exemplary ratings for quality and safety.”