(file photo)
(Picture: PA Wire)A pharmaceutical company has pleaded guilty over the supply of contaminated feed for premature babies.
ITH Pharma has admitted supplying substandard medicine Total Parenteral Nutrition (TPN) on May 27, 2014, which was given to a series of babies receiving hospital care because they were unable to feed on their own.
One of the babies, nine-day-old Yousef Al-Kharboush, received contaminated TPN after being born by emergency Caesarean section at St Thomas’ Hospital in central London along with twin brother Abdulilah. Yousef subsequently contracted septicaemia and died.
At Southwark crown court on Friday, the pharmaceutical firm entered guilty pleas to three charges and is now due to be sentenced in late-April.
The company admitted supplying a medicinal product not of a nature or quality specified in the prescription to Yousef, and an identical charge involving other babies who have not been publicly identified.
It also pleaded guilty to failing to make a suitable and sufficient risk assessment - in breach of health and safety laws - for TPN between August 2009 and June 2014.
Prosecutor Mark Heywood QC asked for a further seven charges on the indictment to be left on file when sentencing takes place on April 28 and 29.
He said the other charges which have not been admitted “cover a significant part of the same ground” as those that have been admitted.
The barrister representing ITH Pharma told the court the company continues to be the main supplier of TPN to the NHS, with no concerns raised in the eight years since 2014.
“Families of those currently receiving TPN may read press coverage with some interest”, he said.
“Any person whose child is receiving TPN will be undergoing an extremely distressing period. In no way should anyone in that position experience unnecessary anxiety.
“These offences occurred eight years ago, the company has and continues to be a trusted supplier of TPN to the NHS. It has fulfilled that role for the past eight years, been regulated throughout that period, and the offences it has pleaded guilty to relate solely to the supply in 2014 and the risk assessments up to that date.”
The criminal investigation was launched after three babies died and another 20 needed treatment in 2014. Two of the fatalities were found not to be linked to TPN.
When charges were brought, ITH Pharma issued a statement saying it was “disappointed” by the move and vowed to “vigorously defend this case”.
In a statement on Friday, a spokesperson for the company said: “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 27 May 2014 were wholly exceptional and, on 5 June 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 28 January 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 27 May 2014 not of the nature or quality specified in the prescription. These pleas have been accepted by the prosecution.”
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 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.”
