Pharmaceutical firm fined £1.2m after premature babies given contaminated feed

A pharmaceutical company has been fined £1.2m after supplying contaminated feed for premature babies, three of whom 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.

Yousef Al-Kharboush died at St Thomas’ Hospital in central London on June 1, 2014, at just nine-days-old, after he developed sepsis.

He and twin brother, Abdulilah, were born by emergency C-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.

While 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.

And 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.”

The Brent-based pharmaceutical company received their fine at Southwark Crown Court today (Friday April 29) after previously pleading guilty to one count of failing to make a suitable and sufficient risk assessment and two counts of supplying a medicinal product not of the nature or quality specified in the prescription.

Yousef’s parents, Raaid and Ghada Sakkijha, now live in Saudi Arabia and could not attend the hearing.

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.”

While Arti Shah, a lawyer representing the families of Yousef, Tameria and Oscar in the civil proceedings, said: “For eight years, Yousef’s parents have lived in hell.”

Tameria’s mother, Vicki Golden, from Essex, 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. I have always felt that feed contributed to my daughter’s death.”

DCI Richard Leonard, who led the investigation, said: “This has been a lengthy and complex investigation and our thoughts today remain with the families of all those affected.

“We commend their bravery and dignity in coming to court and reliving their most difficult moments. We hope they can take some comfort in the fact the criminal proceedings have now concluded.

“This outcome was only possible thanks to the tireless work of a dedicated team of officers, particularly DS Simon Dawes who must be commended for his efforts.”

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.”