UK police have charged drug compounding company ITH Pharma with multiple offences following the deaths of babies who consumed its baby feed at hospitals around the country four years ago.
The Metropolitan Police released a statement last week revealing that ITH has been charged with “seven counts of supplying a medicinal product which was not of the nature or quality specified in the prescription on 27 May 2014.”
ITH also allegedly violated the Health and Safety at Work Act, having failed to “take all reasonably practicable steps to ensure that patients were not infected by contaminants.”
The investigation was originally launched in 2014 after three babies died and another 20 were treated for septicaemia in hospitals across central England.
It was found that nine-day-old Yousef Al-Kharboush was the only fatality possibly linked to ITH’s product Total Parental Nutrition, which was contaminated with the bacteria bacillus cereus. The other babies all fell ill after receiving the feed as well, but the product was not said to be the direct cause.
Two lawyers from Fieldfisher law firm, Paul McNeil and Arti Shah, are acting as legal advisors for Yousef’s family.
“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,” Shah said in a statement. “Their lives have been devastated.”
Responding to the charges, ITH said it has “every sympathy for all the families affected, regardless of the cause.” However, the company said it was “disappointed” by the charges and that it would “vigorously defend this case.”
“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,” the ITH statement continued. “This product has helped thousands of extremely vulnerable infants survive premature and complex births.”
ITH added that it “has always had a strong relationship with the Medicines and Healthcare products Regulatory Agency and continues to receive exemplary ratings for quality and safety.”
A team from Hickman & Rose is due to represent ITH Pharma in the proceedings, made up of founding parter Ben Rose and head of general crime Jenny Wiltshire.
The case is due before Westminster Magistrates’ Court on 17 December 2018.