One of the babies was nine-day-old Yousef Al-Kharboush, who died at St Thomas’ Hospital in central London on June 1, 2014.
ITH, a major pharmaceutical firm, pleaded guilty to failing to conduct a suitable and sufficient risk assessment on TPN between August 2009 and June 2014, 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 May 27, 2014.
At Southwark crown court on Friday, Judge Deborah Taylor, the Recorder of Westminster, imposed a £1,215,000 fine on the company, saying the contaminated TPN product was a “significant shortfall from the required standard”.
“The loss of a child in tragic circumstances such as these is a devastating experience for a family”, she said.
But the judge said it had not been proven that Yousef’s death was caused by the contaminated feed, or that the babies had contracted sepsis as a direct result of being administered TPN.
She sentenced the company for administering bacteria into the babies’ bloodstreams and risking serious harm with the contaminated feed.
The judge added that the company had not put profit before safety, nor deliberately created the risk in its product.
The court heard the 19 infants who fell ill from the contaminated TPN were at nine hospitals across England, and received the fluid directly into their bloodstream because they were unable to feed on their own between May 27 and June 2, 2014.
Outlining the case on Thursday, 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.
Mr Heywood said: “The defendant company, which was then, and still is, involved in the manufacture and supply of medical nutritional products to hospitals, including for administration to infants who were unwell, supplied one large batch of such products, which was contaminated with a pathogen, a bacterium which was dangerous to health and life particularly if allowed to enter the bloodstream.”
The prosecutor said of the victims: “Some became ill, some very ill, and the prosecution case is that among that number, one of the babies who died, died, says the prosecution, as a result of the infection that followed the administration.”
Yousef and his twin brother, Abdulilah, were born by emergency Caesarean section at St Thomas’ Hospital at 32 weeks gestation in May 2014.
While in intensive care they were both fed intravenously, but while Abdulilah was not affected, Yousef died.
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 on June 10 after being transferred to St Thomas’ from Broomfield hospital in Chelmsford, while her twin sister Tia survived. Oscar died at Rosie Maternity Hospital in Cambridge.
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.”
Karen Hamling, the managing director of ITH Pharma, which had a £66 million annual turnover up to March 2020, sat in the public gallery during the hearing. In a statement, she said she had felt “mixed” emotions since 2014, including “desperate anxiety for the babies who received contaminated TPN and their parents” as well as “anger and sadness” at the way “the company was attacked”.
“I am genuinely sorry a product we manufactured might have caused or risked causing anyone harm,” she added.
ITH Pharma has also agreed to pay £291,000 in prosecution costs, and has been given six weeks to settle the legal bills. Civil proceedings for compensation are also underway by some of the families involved.
A spokesperson for ITH Pharma: “We at ITH Pharma first and foremost offer our deepest sympathies to the families of the patients affected by the events of eight years ago.
“We accept the fine imposed by the Court.”
It called the incident “wholly exceptional”, adding: “Since 2008, parenteral nutrition produced by ITH has helped many tens of thousands of the most vulnerable babies survive premature and complex births. We are proud to be trusted by the NHS and importantly support patients in this vital work.”