Pharmaceutical giant is fined £1.2million after it supplied contaminated drip feeds linked to deaths of three babies including a nine-day-old boy

• ITH Pharma Ltd has been fined £1.2million after the death of three babies 
• The company supplied contaminated drip feeds to premature, vulnerable infants
• Yousef Al-Kharboush died on June 1 2014 at nine days old after having sepsis 
• The child was one of 19 infants at nine hospitals who fell ill after being infected

A pharmaceutical company has been fined £1.2m after supplying contaminated drip feeds linked to the death of three babies.

ITH Pharma Ltd, based in Wembley, was charged with multiple offences after the children died and around 20 others needed treatment at nine hospitals across the UK.

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. 

Legal representatives for the company, a supplier of specialist drip feeds for premature and vulnerable babies, accept that the feed was contaminated and admitted to failing to make a suitable risk assessment between 1 August 2009 and 1 June 2014.

Nine-day-old Yousef Al-Kharboush died at St Thomas’ Hospital in central London on June 1 2014 after he developed sepsis

The company also admitted supplying a medical product not of the nature and quality specified in the prescription in relation to drip feed given to baby Yousef Al-Kharboush at St Thomas’ Hospital on 27 May 2014.

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.

ITH Pharma disputes that its parental nutrition product caused his death, but pleaded guilty to supplying a medical product not of the nature and quality specified in the prescription in relation to the other 22 babies involved.

Four of these babies were prescribed but did not actually receive the drip feed.

The contaminated feed has previously been linked to the deaths of two other babies, Tameria Aldrich and Oscar Barker.

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. 

Prosecutor Mark Heywood, QC, told Southwark Crown Court: ‘The prosecution’s case is very firmly Yousef’s death was the result of the way in which this company was carrying out the manufacturing activity and in particular the lack of the risk assessment.’

Lawyers representing ITH pharma dispute this.

Judge Deborah Taylor said: ‘Outbreaks of infection have previously been linked to TPN manufacture by others.

‘It is not possible to remove any of those risks entirely.

‘ITH accepts that TPN supplied on the 27th of May 2014 was contaminated.

‘Overall I accept the prosecution’s submission that…the absence of a suitable and sufficient risk assessment for an extended period of time with a failure to review points of significant change…was a significant shortfall from the required standard.’

Addressing Yousef’s death, judge Taylor said: ‘I do not find that the causation of Yousef’s death was proved to the criminal standard.’

She went on: ‘I also find that the introduction of bacteremia…is not harm in itself.’

The contaminated feed has previously been linked to the deaths of two other babies, Tameria Aldrich and Oscar Barker (pictured)

The judge said that there was not sufficient medical evidence that the presence of bacteremia in the babies’ blood led to sepsis.

However, she concluded that the presence of that bacteria did expose the infants to ‘the risk of serious harm 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 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. 

Oscar and Tameria’s mothers, Hollie Barker and Vicky Golden, wept as the judge gave her decision on Friday.

Previously, Mr Heywood said: ‘The essential case for the prosecution is that the defendant company, which was then involved, and still is, of the manufacture and supply of medicinal nutrition products for hospitals including for administration to infants who were unwell, supplied one large batch of such products which were contaminated by a pathogen.

‘That is to say, a contamination that is dangerous to health and life particularly if allowed to enter the bloodstream.’

The court heard there were 23 supplies of contaminated Total Parenteral Nutrition (TPN) to hospitals, 19 of which were administered to babies.

‘Some became ill, some very ill,’ Mr Heywood said.

‘Among that number, one of the babies died as a result of the infection that followed the administration.’

This baby was Yousef. Born on 23 May 2014 at St Thomas’ hospital in central London, he was was premature.

‘On the 27th of May, parenteral nutrition feed bag was ordered for Yousef,’ Mr Heywood said.

‘His pre administration condition although he, as in the state he was having been delivered in a moderately premature state and being underweight, there were no other medical conditions from which he was suffering at the time.

‘But on the 30th his condition deteriorated considerably.’

The court heard that he had a fever, his blood sugar levels were high and a cranial scan suggested the presence of abscesses in his brain.

A blood test revealed the presence of bacteria Bacillus Cereus.

‘[On] 1 June, his breathing tube was removed after consultation with his family and death was certified,’ Mr Heywood said.

Yousef died after developing sepsis, the court was told.

His father, Raaid 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?’

Subsequent investigation, the prosecutor continued, showed that ITH Pharma did not have in place suitable and sufficient risk assessment of its activities.

Mr Heywood alleges that had risk assessments been properly performed, the ‘obvious risk’ would have been addressed.

The prosecutor continued: ‘It was in May and June of 2014 when there was, at the time, an unusual outbreak of illness and bacterial infection which occurred among premature children.

‘Nineteen cases were identified, that involved children in nine different hospitals.

‘Each of the 19 was found to have been affected by some bacteria.’

The bacteria is Bacillus Cereus, a BC44 strand.

‘All of the affected babies received TPN products that were supplied by the defendant company,’ Mr Heywood said.

‘Of those, all of the TPN products had been manufactured by the company at their premises on the 27th May 2014.

‘To summarise, that batch was recalled. Some hospitals still held unused quantities and some of those when recovered and tested were found to be contaminated.’

It is said the batch was contaminated during manufacture.

Babies were first reported to be septic at the Chelsea and Westminster Hospital on 31 May 2014, the court heard.

These infants had been born premature and were being fed TPN intravenously, it is said.

On 2 June, a second hospital reported two babies who had developed symptoms of sepsis who were, again, premature and receiving TPN drip feed.

The issue was linked to ITH and a recall was issued for 81 batches, the prosecutor said.

‘Tameria is never forgotten in our house’ 

Tameria Aldrich died nine days after Yousef on June 10 after being transferred to St Thomas’ from Broomfield hospital in Chelmsford

Tameria Aldrich’s mother, Vicki Golden, 39, said her daughter was three weeks old when she died.

A twin born premature, Tameria had been ‘the healthy one,’ Ms Golden said.

The baby was kept in the same hospital room as Yousef.

Ms Golden, from Essex, said: ‘I watched Yousef going through that then I watched my daughter going through the same thing.’

Tameria’s twin will be eight years old in May.

‘She’s perfectly fine,’ Ms Golden said, ‘She runs around like a little nutter.

‘Tameria is never forgotten in our house.

‘We go to her grave on any special occasion.

‘She knows that she has a sister in heaven.’

The mother also has twin boys coming up to 21, a seven-year-old daughter, a nine and an eight-year-old.

Asked about ITH Pharma, Ms Golden said: ‘I think they were playing Russian Roulette from 2009-2014.

‘Playing Russian Roulette with people’s lives.’

She added: ‘It’s like someone stabbing you in an open wound and every so often throwing salt in it.’ 

Family members of the dead babies listened as lawyers for the pharmaceutical giant argued that their product did not cause Yousef’s death.

Arti Shah, a medical negligence solicitor at Fieldfisher who represents three families who believe their babies died from receiving contaminated feed 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.’

Yousef’s twin survived, the court heard.

Mr Sakkijha has said previously: ‘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 hoped that justice would finally prevail after seven years of endless suffering to our family.’

Adrian Darbishire, QC, defending, disputed on behalf of ITH Pharma that the drip feed is proved to have caused Yousef’s death.

‘The reality is…it is not possible to determine a cause of death to the criminal standard,’ Mr Darbishire said.

He went on to say that although the company has pleaded guilty to failing to make a suitable risk assessment, that does not mean a proper risk assessment would have entirely prevented the whole issue.

‘It is very, very difficult to rid oneself of hindsight.

‘It is because you cannot unknow what we now know that makes it so difficult to judge what the risk assessment would have contained.

‘Complaint that is accepted is insufficient risk assessment, that is not to say if you had had [one] consequence A and consequence B would not have happened.’

Mr Darbishire also said that the company accepted that TPN was contaminated but that the bacteria was ‘a clinical sign’.

‘It cannot be regarded as actual harm for sentencing purposes.’

Director and founder of ITH Pharma Karen Hamling said in a statement: ‘I am genuinely sorry that a product we have manufactured may have caused or risked causing anyone harm.’

Ms Hamling’s statement explained that ITH Pharma was started in 2008 and grew exponentially.

The court heard previously that its turnover in 2020 was £66m.

‘The success of the company has been built on…a reputation for the highest quality products and service.

‘The company has accepted that it fell short of its obligation.’

An ITH Pharma spokesperson 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 was fined £1,215,000. The pharmaceutical giant was also ordered to pay costs of £291,000.

Detective Chief Inspector 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.’ 

Source: Read Full Article