Patients left without vital IV nutrition threaten to drag the NHS and manufacturer to court over delivery delays
Patients hit by a shortage of tube-feeding liquid are planning to take the NHS to court, according to their lawyer.
More than 40 people have ended up in hospital after a delay to the supplies of feeds for people who are unable to eat solid food.
After an inspection earlier in the year a manufacturer, Calea, was told to change its manufacturing process overnight and its supply chain was disrupted as a result.
Patients waiting for the liquid food are now considering suing the NHS, Calea, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA).
Lauren Mitchell, 21, from Stansted, said she has been feeling sick, tired and dizzy since her liquid food was suspended and replaced with a generic one which isn’t tailored to her needs. It is not known if Miss Mitchell is one of the patients considering legal action
‘These people feel abandoned,’ solicitor Dominic Thompson told the Health Service Journal.
Mr Thompson said he is talking with around 160 of the more than 500 patients affected by the shortage.
‘Many have been left too weak to speak out so we’re hoping to act as a spearhead to ensure maximum pressure is applied so this desperate situation is resolved as quickly as possible,’ he added.
‘What is terrifying for people is that there is no end in sight.
‘They were told the issue would be resolved in four weeks but now they are being told it may not be until the end of the year.
‘This is creating nightmare scenarios for hundreds of people and their families and answers are needed now.’
The feeds, known as total parenteral nutrition (TPN), are used by patients whose digestive systems don’t work well enough for them to eat normal food.
Laura Mitchell, a 21-year-old from Stansted in Essex, has been using TPN since she was seven years old and has had to switch to a generic alternative after Calea’s manufacturing slowdown.
WHAT IS PARENTERAL NUTRITION?
Parenteral nutrition, also known as intravenous nutrition, is feed which people have injected directly into their veins.
It comes in the form of a fluid which contains water, protein, carbohydrates, vitamins and minerals, fats and other vital nutrients.
Parenteral nutrition is given to bypass the digestive system in patients who cannot properly absorb nutrients from gut.
Conditions which may cause this include short bowel syndrome, a bowel obstruction, pancreatitis or a gastrointestinal fistula – a hole in an organ.
Parenteral nutrition may be given to people of any age, and some people only need it for a short time to get over an illness, while others may have to keep using it for years.
She was born with chronic intestinal pseudo-obstruction, which means her digestive muscles are unable to push food through her stomach.
The new feed Miss Mitchell has to use is not tailored to her specific needs and has left her feeling sick, exhausted and dizzy.
‘If diabetics’ insulin was taken away there would be uproar,’ she told the BBC.
‘But because no-one knows what TPN is, no-one’s bothered and no-one knows how serious this is.
‘This is our lives on the line here and we need answers and something to be done about it.’
The disruption to Calea’s products began in June after an inspection by the MHRA – the British drugs regulator – found the manufacturing process didn’t meet its guidelines.
Calea was told to change the way it makes the products, which provide people with nutrients by injecting them into their veins, overnight.
As a result it has since stopped supplying the bags to 511 patients who were deemed to need them the least.
Dominic Thompson & Co Solicitors said it will now investigate whether the MHRA was too rash to demand a process change overnight.
And it would look into why Calea’s process was below standard, and whether the NHS and Department of Health had an adequate backup supply.
The NHS this month declared the issue was an emergency and began importing feeds from Germany and Norway.
Mr Thompson claimed around 18 patients want to take legal action and a further 24 were considering it.
He added: ‘Our clients are angry about the lack of communication, and the whole system seems chaotic with TPN either failing to be delivered, being delivered at extremely irregular times including in the middle of the night, and often in insufficient amounts.
‘Some patients have reported receiving TPN bags and ancillary kits meant for other patients.’
Calea declined to comment.
An MHRA spokesperson said: ‘We are not aware of any correspondence of this kind, but we fully appreciate the difficulties and disruption that many patients have experienced.
‘At all times our priority has been patient and product safety. We are very clear, that the decisions we have taken were both urgent and necessary to protect patients.’
And a Department of Health spokesperson told the HSJ: ‘We have yet to receive the letter, but will consider any correspondence once it has been received.
‘We continue to work closely with the NHS, the supplier and national experts to resolve this supply issue as quickly as possible and to ensure affected patients continue to receive the nutrition they need.’
NHS England told MailOnline it had not been contacted by the patients’ solicitor.
WHY IS THERE A SHORTAGE OF TPN?
In June, Calea, a firm based in Runcorn in Cheshire, was told it wasn’t meeting standards set by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA found the way the company was adding vitamins and elements to the bags was not in line with national requirements.
As a result, Calea had to immediately change the way it makes the feeding bags, which delayed the deliveries to ‘several hundred’ patients in England and Wales.
Intravenous nutrition, also known as parenteral nutrition, is used by patients whose digestive systems don’t work properly.
The MRHA, which regulates all devices used by doctors in the UK, said no defective items had been found so far and that the move was a precaution.
A spokesperson said: ‘MHRA performed a routine inspection of the Calea UK site in Runcorn.
‘Problems were identified with the design of the manufacturing process that did not meet the requirements of guidance previously published by MHRA.
‘Calea have reduced their output while they make necessary changes to the manufacturing process.
‘The MHRA are supervising these changes through regular correspondence and weekly inspection visits.
‘The changes to production are a precautionary, but necessary, measure to ensure product safety is maintained.’