A pharmaceutical company has been fined more than £1.2 million after supplying contaminated feed for premature babies – three of whom later died.
Some 19 infants were infected with Bacillus Cereus bacteraemia at nine hospitals in England after receiving a contaminated batch of ITH Pharma’s total parenteral nutrition (TPN).
They were all given the fluid between May 27 and June 2 2014 as nutrition directly into their bloodstream because they were unable to feed on their own.
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 born by emergency Caesarean section at St Thomas’ 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, whose twin sister Tia also survived, died nine days after Yousef on June 10 after being transferred to St Thomas’ from Broomfield hospital in Chelmsford, while Oscar Barker died at Rosie Maternity Hospital in Cambridge.
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 ITH Pharma, which had a £66.8 million annual turnover up to September 2020, £1.215 million and ordered the firm to pay £291,000 in costs on Friday after the company previously pleaded guilty to three offences.
They include failing to make a suitable and sufficient risk assessment between August 1, 2009 and June 1, 2014 over the supply of TPN to patients, under the 1999 Health and Safety at Work Regulations, 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.
One of the Medicines Act charges relates to Yousef, while the second covers the 18 other babies who were infected, as well as four more who were prescribed TPN but never given it.
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.”
Ms Golden, 39, who is from Essex, said ITH Pharma had been “playing Russian roulette with people’s lives”.
“It was only a matter of time before something bad did happen,” she said.
“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,” Ms Golden continued.
“I have 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 by the court, having pleaded guilty to a single regulatory offence of failing to have a suitable and sufficient risk assessment, under the Management of Health and Safety at Work Regulations 1999, and to two regulatory offences under the Medicines Act 1968 of supplying a medicinal product on 27 May 2014 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 are proud to be trusted by the NHS and importantly support patients in this vital work.”