A pharmaceutical company has admitted supplying contaminated feed for premature babies that allegedly caused the death of a nine-day-old boy.
An investigation was launched after three babies, including Yousef Al-Kharboush, died and another 20 needed treatment when they developed Bacillus Cereus bacteraemia linked to ITH Pharma’s supply of total parenteral nutrition (TPN) to 14 hospitals in 2014.
The infants were given the fluid as nutrition because they were unable to feed on their own between May 27 and June 2, 2014.
Adrian Darbishire QC, on behalf of ITH Pharma, entered guilty pleas to three offences at Southwark Crown Court on Friday.
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 other 22 babies, whose names are contained in a confidential index.
Yousef and his twin brother, Abdulilah, were born by emergency Caesarean section at St Thomas’ Hospital in central London at 32 weeks gestation in May 2014.
While in intensive care they were both fed intravenously, but while Abdulilah was not affected, Yousef died.
Prosecutors allege his death resulted from him being fed the contaminated TPN, although ITH Pharma denies his death was caused by the administration of the feed.
Judge Deborah Taylor will decide the issue over a two-day sentencing hearing on April 28.
Mark Heywood QC said ITH Pharma’s pleas were “acceptable” to the Crown Prosecution Service (CPS) and “meet the justice in the case”.
Debbie Jeffrey, a Senior Specialist Prosecutor in the CPS Special Crime Division, said: “This is a truly tragic case that has impacted the lives of many. The company’s failure to conduct a sufficient risk assessment exposed already vulnerable babies to risks that should have been avoided.
“It is right that ITH Pharma have admitted their criminal liability in providing a product that was not of the nature and quality suitable for distribution to hospitals across the country. The contamination in the nutritional medicine caused 19 vulnerable babies to be infected with a dangerous bacteria.
“I hope today’s convictions will bring some semblance of closure to the many families who have been affected by this tragedy.”
A CPS spokesperson said: “The pleas we have accepted from ITH Pharma provide the court with sentencing powers to address this serious offence to the full extent of the law. Our thoughts remain with all the families affected by this tragic case.”
However, Vicki Golden, the mother of Tameria Aldrich, who died nine days after Yousef on June 10 after being transferred to St Thomas’ from Broomfield hospital in Chelmsford, and whose twin sister Tia survived, left the court in tears.
Ms Golden’s godmother Joanne Bartlett, who is known as Dolly, had already stormed out of court as Mr Darbishire said: “These offences occurred eight years ago and the company has been and continues to be a trusted supplier of TPN for the NHS.”
Speaking to reporters, she branded the case “absolutely disgraceful”, adding: “I’m disgusted with ITH Pharma and the CPS.
“They ought to be ashamed of themselves. They threw the police under the bus.”
Yousef’s parents, who now live in Saudi Arabia, had hoped to follow the hearing by video-link but were not able to join.
His father, Raaid Sakkijha, said in a statement: “We had to change every aspect of our life in London that would remind us of Yousef’s loss – our previous apartment, the area that we used to live in, the places that we used to go to when we were pregnant with the twins.
“Even today, Yousef’s mother Ghada has a panic and crying attack whenever she sees a mother with a twin stroller as she feels the loss of her son over and over again.
“We really hope that justice would finally prevail after seven years of endless suffering to our family.”
Arti Shah, a medical negligence solicitor at Fieldfisher, the firm representing the families of Yousef, Tameria and Oscar Barker, who died at Rosie Maternity Hospital in Cambridge, said: “We believe justice will prevail in the civil court and we will continue to pursue ITH Pharma on behalf of the families who suffered the most terrible loss.
“We are confident the company will be found negligent in civil proceedings for providing contaminated feed.
“We will also be working closely with the coroner to provide much needed clarity on what happened to cause death and injury to so many babies.”
ITH Pharma said in a statement: “We at ITH Pharma wish to extend our deepest sympathies to the families of the patients affected by the events of eight years ago.
“ITH has been a leading manufacturer of total parenteral nutrition (TPN) and other medicinal products for many years.
“The events of May 27 2014 were wholly exceptional and, on June 5 2014, the MHRA Inspection Action Group confirmed that having considered all the information available, including the company’s changes to manufacturing practice for parenteral nutrition products, it did not recommend regulatory action against the company.
“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 support the NHS and, importantly, patients in this vital work. We know how much our colleagues in hospitals across the UK value the service we provide and the rigour we deliver in our processes, and we are grateful for the work they all do.
“On January 28, 2022, ITH Pharma 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 May 27 2014 not of the nature or quality specified in the prescription. These pleas have been accepted by the prosecution.”
