Nine-day old baby's sepsis death caused by firm's risk assessment failure, court hears

A nine-day-old boy’s death was the result of a pharmaceutical company’s failure to carry out a proper risk assessment, leading to the firm giving contaminated feed for premature babies, a court has heard.

Yousef Al-Kharboush died on 1 June 2014 after developing sepsis, having been given ITH Pharma’s total parenteral nutrition (TPN) at St Thomas’ Hospital in London.

Yousef was one of 19 infants at nine hospitals in England who fell ill after being infected with Bacillus Cereus bacteraemia from a contaminated batch of the fluid, Southwark Crown Court heard.

The TPN was administered directly into their bloodstream because they were unable to feed on their own between 27 May and 2 June 2014.

ITH Pharma is facing a fine on Friday when a judge will sentence the firm, which has previously entered guilty pleas to three offences.

Yousef and his twin brother, Abdulilah, were born prematurely by emergency caesarean section and while in intensive care they were both fed intravenously – Abdulilah was not affected.

Firm previously pleaded guilty to three offences

Prosecutor Mark Heywood QC said: “The prosecution case is very firmly that Yousef’s death was the result of the way this company was carrying out the manufacturing activity and in particular the lack of a risk assessment.”

He said that despite the fact the manufacturing process carried an obvious risk, the company did not have a “suitable and sufficient risk assessment” as required by law.

ITH Pharma’s previous guilty pleas to three offences, include failing to make suitable risk assessment between August 2009 and June 2014 over the supply of TPN to patients and two charges of supplying a medicinal product which was not of the nature or quality specified in the prescription, under the Medicines Act on 27 May 2014.

One of the Medicines Act charges relates to Yousef, while the second covers the 18 other babies who fell ill, as well as four more who were prescribed TPN but never given it.

Other babies affected

Tameria Aldrich and Oscar Barker also became ill after being given contaminated TPN, although this is not alleged to have caused their deaths.

Tameria died nine days after Yousef after being transferred to St Thomas’ from a Chelmsford hospital, while her twin sister Tia survived.

Oscar died at Rosie Maternity Hospital in Cambridge.

Firm’s head: ‘I am genuinely sorry’

Adrian Darbishire QC, defending, said that “there is no dispute… that a possible consequence of infected TPN is death,” but added: “It is not possible to determine a cause of death to the criminal standard.”

Managing director of ITH Pharma, Karen Hamling, which had a £66m annual turnover up to March 2020, sat in the public gallery during the hearing.

In a statement, she said she had “mixed” emotions since 2014, including “desperate anxiety” for babies who received the contaminated feed and “anger and sadness” at the way the firm was “attacked”.

“I am genuinely sorry a product we manufactured might have caused or risked causing anyone harm,” she added.

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