LONDON (Reuters) – Police said on Wednesday they had charged pharmaceutical company ITH Pharma with a number of offences as part of an investigation into the deaths and illnesses of seven babies at several hospitals.
London’s Metropolitan Police said the company had been charged with seven counts of supplying a medicinal product which was not of the nature or quality specified in the prescription.
It was also accused of failing to take all reasonably practicable steps to ensure that patients were not infected by contaminants.
The north London company said in a statement: “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.”
The police investigation was launched in September 2014 following the death of a baby three months earlier at London’s Guy’s and St Thomas’ hospital.
The death of a second baby at the same hospital and a third at the Rosie Maternity Hospital in Cambridge, central England, in June 2014 were then also investigated.
The inquiry followed an outbreak of a bacterial infection that affected some babies receiving Total Parental Nutrition (TPN), an intravenous feed. The seven babies involved in the investigation, including the three who died, had all received the feed.
The investigation established that the cause of death of the first baby could be linked to TPN, although the deaths of the other two were not found to be linked.
Five hospitals in total were involved in the investigation, the other three being Russells Hall Hospital in Dudley, Luton and Dunstable Hospital and Lister Hospital in Stevenage, all in central England.
ITH Pharma, which was founded in 2008, said it had manufactured more than 1.4-million components of TPN since its launch and was the sole commercial supplier of reactive feeding solutions to the National Health Service.
“This product has helped thousands of extremely vulnerable infants survive premature and complex births,” it said.
The case is due to start at Westminster Magistrates’ Court in London on Dec. 17.
(Reporting by Michael Holden; editing by Stephen Addison)