Pharmaceutical company fined £1.2 million after supplying contaminated baby feed
Three premature babies died after receiving the company’s feed
A pharmaceutical company has been fined more than £1.2 million after supplying contaminated feed for premature babies, three babies later died.
In England, some 19 infants were infected with Bacillus Cereus bacteraemia at nine hospitals, after receiving a contaminated batch of ITH Pharma's total parenteral nutrition (TPN).
The babies were all given the fluid as nutrition directly into their bloodstream between May 27 and June 2 2014, because they were unable to feed on their own.
Contaminated baby feed given to premature babies
Nine-day-old Yousef Al-Kharboush died at St Thomas' Hospital in central London on June 1 2014 after he developed sepsis.
He and his twin brother, Abdulilah, were fed intravenously in intensive care after they were born by emergency Caesarean section at 32 weeks gestation in May 2014.
While Abdulilah was not affected, Yousef died.
Tameria Aldrich, whose twin sister Tia also survived, died nine days later on June 10 after being transferred to St Thomas' from Broomfield hospital in Chelmsford.
Oscar Barker died at Rosie Maternity Hospital in Cambridge.
ITH Pharma prosecuted for baby feed supply
Prosecutors said ITH Pharma's failure to carry out a proper risk assessment resulted in the death of Yousef, while TPN was not alleged to have caused the deaths of the other two babies.
However, Judge Deborah Taylor said: "I did not find the causation of Yousef's death is proved to the criminal standard."
She said that for legal purposes the bacteraemia had not necessarily caused actual harm, but the company's processes risked "serious harm and or death".
The judge fined the company £1.215 million and ordered the firm to pay £291,000 in costs on Friday, after they previously pleaded guilty to three offences.
One of which was failing to make a suitable and sufficient risk assessment over the supply of TPN to patients, under the Management of Health and Safety at Work Regulations 1999.
The other two offences were for supplying a medicinal product which was not of the nature or quality stated in the prescription, under the Medicines Act 1968, on May 27, 2014.
One of the Medicines Act charges relates to Yousef, while the second covers the 18 other babies who were infected, alongside four more who were prescribed TPN but never given it.
“The terrible memories still haunt us"
Tameria's mother, Vicki Golden, and Oscar's mother, Holly Barker, wept as the sentence was passed.
Yousef's father, Raaid Sakkijha, and mother, Ghada Sakkijha, now live in Saudi Arabia and could not attend the hearing by videolink.
Mr Sakkijha said in a statement: "The terrible memories still haunt us and will do forever.
"Every time Ghada looks at Yousef's twin brother, she feels the weight of the loss of her son.
"This company that did this to us won't even feel the fine. It's business as usual for them. Is that justice?"
Arti Shah, a medical negligence solicitor at Fieldfisher, the firm representing the families of Yousef, Tameria and Oscar in civil proceedings, said: "For eight years, ITH Pharma has continued operating as normal.
“For eight years, Yousef's parents have lived in hell, and still the company has not admitted causing Yousef's death."
Families continue to fight for justice
Ms Golden, 39, who is from Essex, said ITH Pharma had been "playing Russian roulette with people's lives, and it was only a matter of time before something bad did happen".
She adds, "For eight years we have been fighting for justice for my daughter and I just feel that in itself was not justice."
"I have been through eight years of hell; I’ve always felt that feed contributed to my daughter's death."
An ITH Pharma spokesman said: "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, having pleaded guilty to a single regulatory offence of failing to have a suitable and sufficient risk assessment, and to two regulatory offences of supplying a medicinal product not of the nature or quality specified in the prescription.
"ITH Pharma has been a leading manufacturer of total parenteral nutrition (TPN) and other medicinal products for many years and the events of 27 May 2014 were wholly exceptional.
"Since 2008, parenteral nutrition produced by ITH has helped many tens of thousands of the most vulnerable babies survive premature and complex births, we’re proud to be trusted by the NHS and importantly support patients in this vital work."
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