Pharmaceutical company admits supplying contaminated feed
A pharmaceutical company has admitted to supplying contaminated feed to premature babies that are believed to have caused the death of a nine-day-old boy.
An investigation was launched after three babies, including Yousef Al-Kharboush, died and another 20 required treatment when they developed Bacillus Cereus bacteremia linked to the delivery of total parenteral nutrition (TPN) from ITH Pharma to 14 in 2014. hospitals.
The infants were fed the liquid because they were unable to eat independently between May 27 and June 2, 2014.
Adrian Darbishire QC, on behalf of ITH Pharma, has today pleaded guilty to three offenses at Southwark Crown Court.
An investigation was launched after three babies, including Yousef Al-Kharboush, (pictured) died and another 20 required treatment when they developed Bacillus Cereus bacteremia
These include failure to make an appropriate and sufficient risk assessment between August 1, 2009 and June 1, 2014 regarding the supply of TPN to patients, under the Health and Safety Regulations at Work of 1999, and two charges of supplying a medicine that was not of the nature or quality stated on the prescription under the Medicines Act of 27 May 2014.
One of the Drugs Act charges concerns Yousef, while the second concerns the other 22 babies, whose names are included in a confidential index.
Yousef and his twin brother, Abdulilah, were born by caesarean section at St Thomas’ Hospital in central London in May 2014 at 32 weeks gestational age.
While in intensive care, they were both fed intravenously, but while Abdulilah was unaffected, Yousef died.
Prosecutors allege that his death was the result of being administered the contaminated TPN, although ITH Pharma denies that his death was caused by the administration of the feed.
Judge Deborah Taylor will rule on the matter at a two-day hearing on April 28.
Mark Heywood, QC, said ITH Pharma’s pleas were “acceptable” to the Crown Prosecution Service (CPS) and “meet the judge in the case.”
Vicki Golden, mother of Tameria Aldrich, who died on June 10 nine days after Yousef after being transferred from Broomfield Hospital in Chelmsford to St Thomas’, and whose twin sister Tia survived, left court in tears.
Mrs Golden’s godmother, Joanne Bartlett, known as Dolly, had already stormed out of court when Mr Darbishire said: ‘These violations took place eight years ago and the company is and remains a trusted supplier of TPN to the NHS.’
ITH Pharma CEO Karen Hamling and her husband Adam Bloom made a statement following the deaths of the children at their Park Royal production plant in West London
Speaking to reporters, she called the case “absolutely disgraceful” and added: “I am disgusted by ITH Pharma and the CPS.
“They should be ashamed of themselves. They threw the police under the bus.’
Yousef’s parents, who now live in Saudi Arabia, had hoped to watch the hearing via video link, but were unable to participate.
His father, Raaid Sakkijha, said in a statement: “We had to change every aspect of our life in London that would remind us of the loss of Yousef – our previous apartment, the area we used to live in, the places we used to live. go to when we were pregnant with the twins.
“Even today, Yousef’s mother Ghada has a panic and crying attack when she sees a mother with a twin pram while she feels the loss of her son over and over again.
“We really hope that justice will finally be done after seven years of endless suffering for our family.”
Arti Shah, a medical negligence attorney at Fieldfisher, the company that represents the families of Yousef, Tameria and Oscar Barker, who died at Rosie Maternity Hospital in Cambridge, said: ‘We believe justice will prevail in civil court and we will carry on. pursuing ITH Pharma on behalf of the families who have suffered the most terrible loss.
“We are confident that 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 about what happened to cause so many babies death and injury.”
Police launched an investigation in 2014 after two babies died at St. Thomas’ Hospital, pictured
ITH Pharma said in a statement: ‘We at ITH Pharma would like to express our deepest condolences to the families of patients affected by the events of eight years ago.
“ITH has been a leading manufacturer of total parenteral nutrition (TPN) and other pharmaceuticals for many years.
“The events of May 27, 2014 were utterly exceptional and on June 5, 2014, the MHRA Inspection Action Group affirmed that, after considering all available information, including the company’s changes in manufacturing practice for parenteral nutrition products, it is not recommending any regulatory action against the company. .
‘Since 2008, parenteral nutrition produced by ITH has helped many tens of thousands of the most vulnerable babies survive preterm and complex births.
“We are proud to support the NHS and, most importantly, patients in this vital work. We know how much our colleagues in hospitals across the UK appreciate the service we provide and the accuracy 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 violation of failing to have an appropriate and satisfactory risk assessment, under the Management of Health and Safety at Work Regulations 1999, and to two regulatory violations under the Medicines Act 1968 of the 27 May 2014 to supply a medicine that is not of the nature or quality stated on the prescription. These pleas have been accepted by the Prosecutor.”*