A pharmaceutical company facing prosecution over the supply of contaminated feed for premature babies has pledged to “vigorously defend” the case.
ITH Pharma is facing seven counts of supplying a medicinal product which was not of the nature or quality specified in the prescription, and with failing to take all reasonably practicable steps to ensure that patients were not infected by contaminants.
An investigation was launched after three babies died and another 20 needed treatment when they contracted septicaemia in 2014.
The charges announced by the Metropolitan Police on Wednesday are linked to seven babies, including three who died, who were given the fluid as nutrition because they were unable to feed on their own between May 27 and June 2 2014.
This includes nine-day-old Yousef Al-Kharboush, who died at St Thomas’ Hospital in central London after contracting fatal blood poisoning from the feed which was contaminated with the bacteria bacillus cereus.
The deaths of the other two infants – one at the same hospital and another at Rosie Maternity Hospital in Cambridge – were found not to be linked to the product.
Yousef’s parents said they have been living “with an open wound that will not close” and have found it “impossible to move on while the case is ongoing”.
He and his twin brother Abdulilah were born by emergency Caesarean section at the hospital at 32 weeks’ gestation in May 2014.
While in intensive care they were both fed intravenously, and while Abdulilah was not affected, Yousef contracted septicaemia.
Their father Raaid Sakkijha said: “It has been like living with an open wound that will not close. We have found it impossible to move on while the case is ongoing, I am not sure that we will ever come to terms with what happened.
“We never celebrate events such as Yousef’s brother’s birthday because it is too painful a reminder of what we’ve lost.”
Their lawyer Arti Shah, from Fieldfisher, said: “It has been incredibly hard for Yousef’s parents to have to wait so long for a charging decision while the company has simply been allowed to continue to trade.
“Yousef’s family has suffered the worst grief imaginable, knowing that Yousef’s death was avoidable.”
Representatives of ITH Pharma are due to appear at Westminster Magistrates’ Court on December 17.
The 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. 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 (Medicines and Healthcare products Regulatory Agency) and continues to receive exemplary ratings for quality and safety.”