What is TPN?

Total Parenteral Nutrition (TPN) is the administering of vital nutrients via the bloodstream through a central venous catheter (CVC).

TPN will be a patient’s only source of nutrition as the nature of their condition means they cannot absorb nutrients from food in the usual way. TPN can be administered at home or in hospital.

Parenteral Nutrition (PN) is also administered into the bloodstream through a CVC. However, this is administered as a supplement to a patient taking food normally.

The specific types of CVC devices that medical professionals may use to administer TPN are a PICC line (peripherally inserted central catheter) or a Hickman line. The device used will depend on the how long the TPN is required. Through this, a patient can be provided with a balance of nutrients quickly by bypassing the gastrointestinal tract to prevent malnutrition and sustain a life when a person is unable to eat or absorb nutrients.

The basic ingredients of TPN are fluids, sugars, electrolytes, lipids, amino acids, minerals, and vitamins. The TPN solutions will vary depending on an individual patients’ other medical conditions and the patient’s age.

TPN may be required for patients suffering with the following conditions:

  • an abnormal connection between two organs (fistula)
  • some stages of ulcerative colitis
  • certain paediatric GI disorders (e.g congenital GI anomalies, prolonged diarrhoea)
  • bowel obstruction
  • Crohn’s disease (in severe cases)
  • Gastrointestinal cancer
  • Intestinal failure
  • Malnutrition
  • Gastrectomy
  • Short bowel syndrome
  • Severe pancreatitis
  • Some cases of cancer

 

We couldn’t have had a better solicitor. So knowledgeable and efficient, yet the most kind, caring and understanding friend all rolled into one, at a time when few people could really understand what my injury had done to me. – Client

Disruption in supply of TPN from Calea

Calea is a specialised homecare company that aims to work with healthcare professionals to provide care and treatment packages that meet their tailored requirements and patients’ needs. Specifically, Calea formulates and supplies Total Parenteral Nutrition (TPN) to patients who cannot absorb nutrients on their own. Calea, based in Runcorn, is one of only a handful of firms that supply TPN in the UK.

Following a routine inspection on 24-26 June 2019 by the Medicine and Healthcare Regulatory Agency (MHRA), it was found that Calea’s Runcorn site failed to meet the requirements of guidance for manufacturing sites published by MHRA in 2015. This inspection resulted in the MHRA having “serious concerns” about Calea’s procedures and found a “significant risk to product safety”.

Due to the critical and major deficiencies identified by the MHRA in Calea’s manufacturing processes, Calea was forced to change their manufacturing processes resulting in an immediate and significant reduction in supply of TPN. The reduction in supply led to very limited availability of TPN, with many patients having their prescription TPN bags substituted for multi-chamber bags (MCB), also known as ‘off the shelf’ bags which are not tailored towards the needs of individual patients.

On the 13 August 2019, the NHS has declared this situation as an emergency incident “at the highest level” along with setting up a National Action Group run by the UK Government’s Department of Health and Social Care. Dr Aidan Fowler, the National Patient Safety Director, outlined a strategy to work with other TPN suppliers, monitor patients affected by the reduction in supply, ensure an adequate supply of MCBs and access stock from abroad.

Alongside these efforts, an incident management team was also created to allocate the limited supplies of prescription TPN to each Trust for future allocation to patients assessed to be at highest risk. Nonetheless, these measures have still left patients who are in desperate need of prescription TPN without the treatment they need.

Given Calea is “one of only a handful of firms” supplying TPN, this disruption has had significant impact on their current patients and has already started having a knock-on effect on patients awaiting treatment . A report by the BBC has stated that more than 500 patients have had their regular supplies halted and it is still unclear exactly how many people the shortage has affected. Initially, Calea was determined to resolve their supply issues within four weeks. However, the disruption has far surpassed this timescale and has still not been resolved.

We couldn’t have had a better solicitor. So knowledgeable and efficient, yet the most kind, caring and understanding friend all rolled into one, at a time when few people could really understand what my injury had done to me. – Client

Consequences for TPN patients of Calea’s supply issues

As a result in the disruption of supply from Calea of prescription TPN bags, many patients were required to substitute their prescription TPN for multichambered bags (MCB), also known as ‘off the shelf’ bags. However, these do not provide adequate nourishment and hydration to the individual patient.

This sudden increase in the demand for MCBs led to a shortage of MCBs nationally causing further difficulties for patients who rely on this treatment to supply life-sustaining nourishment. Patients were left worrying if they will end up being admitted to hospital with malnutrition after having to wait for days without nutrition.

Calea initially considered that four weeks would be sufficient to restore the supply issues. However, the period of disruption has extended far beyond this and has led to many patients who rely on TPN to suffer from a wide variety of symptoms which have included:

  • Malnourishment
  • Malnutrition
  • Dehydration
  • Fatigue/exhaustion
  • Anxiety/stress
  • Reduced mobility
  • Weight loss
  • Muscle mass loss
  • Muscle cramps

Calea is one of the country’s largest manufacturers of TPN bags. Hugh James is acting on behalf of a number of patients that have been adversely affected by the disruption in supply of TPN bags from Calea. If you or a member of your family has been adversely affected by a disruption in supply of their TPN supply, then please get in touch with our specialist lawyers at Hugh James by clicking on the “Start Your Claim” button at the top of this page.


Your questions answered

We can offer you a free no obligation consultation with one of our specialist lawyers to discuss whether you can make a claim.  We can provide a clear explanation of the claims process and the various options open to you.

There are a number of ways you can get in touch and a member of our team will contact you to discuss further:

A group action is a means of individual claims being brought together. It will allow all claims to be managed collectively where multiple individual claims are brought against the same defendant(s) for the same cause of action. We typically split the group action into two elements of work; these being generic work (sometimes referred to as “common costs work”) and individual work. The generic aspects of the claim will deal with those issues common to all the claimants in the group. The individual aspects of the claim are specific to each individual claimant.

A group action also involves claimants agreeing to share the costs of the case that are generic or common with other cases within the group including a share of costs that have already been incurred when they join the group.

The vast majority of cases are funded on a no win, no fee basis, also known as Conditional Fee Agreements (CFAs). This means that if your case is unsuccessful you will not have to pay anything. We will only take on your case if, after assessing your claim, we decide that there is a reasonable chance of success. Our initial consultation is free, so you won’t pay a penny if we don’t accept your case.

Yes. The sooner you instruct solicitors the better. There are strict time limits for individuals wishing to pursue claims for personal injury. Court proceedings must be issued within three years of the date you suffered your injury or your date of knowledge i.e. the date that you knew, or ought to have known, that the injury was significant and that the injury was attributable to the acts or omissions of the defendant. Failure to issue court proceedings is likely to result in your claim being statute barred (out of time) which means you will not recover any damages.

Each claimant, even in a group litigation like this, is unlikely to have the same limitation date. However, we know that the MHRA’s inspection of Calea’s Runcorn facility took place on 24 June 2019. The critical and major failures identified by the MHRA were communicated to Calea in a letter dated 28 June 2019. Consequently, the disruption to the supply of HPN bags to patients appears to have started in around June/July/August 2019 for most patients.

Therefore, setting a conservative date that would apply to all claimants within the group, we have calculated the limitation date to be 28 June 2022 as being the date by which Court proceedings must be issued.

We will need to issue court proceedings before the end of June this year. Any new enquiries that we receive after this date will run the significant risk of being out of time to join the group. Any new enquiries that come to us after May 2022 will need to be carefully assessed as to whether there is sufficient time to prepare the case for issuing. Therefore, if you think you may have a claim, do not hesitate in contacting us.

If you were/are reliant on receiving your prescription parenteral nutrition (PN/TPN/HPN) from Calea and that supply was interrupted or substituted, then you may be able to join the group action. Please contact us to discuss your specific case for us to advise you appropriately. There is no charge for us discussing this with you.

We act for clients from across England and Wales that have been affected by this disruption.

In the vast majority of cases the person we will deal with on a day-to-day basis will be the individual who has suffered as a result of the disruption.

In certain, restricted circumstances, an official litigation friend will need to be appointed to make decisions on behalf of the injured party. This will include cases where the injured party is under the age of 18 or lacks the mental capacity to carry out the litigation.

More commonly we are asked whether someone else can deal with the day-to-day running and correspondence of the case, often because of persistent illness or the demands of ongoing treatment of the injured person. This is not a problem and something that can be easily accommodated. We will still need to take instructions from the injured person but day-to-day correspondence can be handled by someone else, usually the partner/parent/child of the injured person.

Sadly, we also have a number of cases where the injured party has passed away and we are continuing the claim on behalf of the deceased’s estate.

It is possible that your case may ultimately be decided in court. Whilst the majority of personal injury claims are settled out of court, we always need to consider what a judge would decide if your case did go to court.  In group action cases it is usual for a small number of individual cases to be chosen to illustrate the types and severity of the injuries suffered.

We will need to issue court proceedings to prevent the claim being time barred. This will start the court process. The court will look to set a timetable to manage the case through various aspects including the exchange of relevant documents, witness statements and expert evidence. Ultimately, the court will look to set a date for a formal trial to take place.

Every case is prepared for trial. However, both sides are encouraged to engage in Alternative Dispute Resolution (ADR) whereby matters are resolved outside of the court process.

It is difficult to provide a precise timescale for the claim at this stage. Group actions tend to take longer to resolve than individual claims.

An expert gastroenterologist will be instructed to provide their expert opinion and write a report in each individual case. It is likely that you will have to meet with an expert to discuss your medical history, although in these cases, the expert is likely going to be satisfied doing this remotely without the need for a physical examination.

No. The medical legal expert needs to be independent of your treatment to avoid any potential for a conflict of interest. Their duty is to provide an impartial report for the benefit of the Court. Therefore, the expert needs to have had no prior involvement in your treatment.

The overriding aim of personal injury litigation is to place a claimant in the position they would have been in if the negligence (in this case the disruption in supply of HPN) had never occurred. Of course, in the majority of cases, this is not possible due to the physical or mental injury caused which is why compensation is sought for the pain, suffering and loss of amenity (PSLA) in addition to pure financial loss.

You can claim compensation for any financial losses you have sustained as a result of the disruption in supply of your HPN. It is for the claimant to prove they have suffered a financial loss and that the loss was caused as a result of the consequences of the disruption in the supply of HPN. This will often be proven through witness evidence, expert evidence and receipts. Types of losses that can be claimed include:

  • general damages for the pain, suffering and loss of amenity (PSLA) you have sustained;
  • expenses and other losses incurred as a result of your injury. These might include the costs of additional medical treatment or travel expenses incurred;
  • the cost or value of additional care and assistance you have received. This can be either paid professional assistance or assistance from family and friends;
  • the cost of making any changes or adaptations to your home;
  • loss of income or earnings;
  • interest on all of the above; and
  • future losses and expenses where there are anticipated ongoing losses

A claim is made up of general damages (for pain, suffering and loss of amenity) and special damages (out of pocket expenses and financial loss). We can only properly assess general damages after we have received the expert medical reports that are specific to each case so it is not possible to provide a valuation to you at the outset of the matter.


Your Obligations

You will be asked to co-operate with us to assist with the preparation of your case. You may be asked to provide us with witness statement evidence, complete questionnaires detailing your specific issues from time to time, provide us with authority to obtain your medical records and attend an appointment(s) with our medical experts. However, everything will be explained to you in writing.


Why Hugh James?

Our team has many years’ experience of bringing successful harmful product claims.

Our expert advice has helped us to be ranked first as a representative of claimants in these types of cases by Chambers and Partners and the Legal 500, the independent guides to Law firms.

Compensation has been recovered for many victims of harmful products such as ordinary household products as well as medical and pharmaceutical devices.

Most recently the firm:

  • is pursuing further claims of defective intraocular lenses manufactured by Oculentis and supplied by Optical Express or by private hospitals;
  • represents victims of vaginal mesh implants against the manufacturers and the health authorities responsible for implanting the mesh;
  • is investigating injuries caused by NutriBullet blenders, retractable dog leads and other consumer products;
  • is investigating a defective knee implant;
  • representing claimants where PEEK, a medical compound was used in upper limb joint implants;
  • investigating failed heart assist and defibrillator devices;
  • investigating injuries caused by Essure contraception device and failed Gastric bands; and
  • investigating long-term damage caused by Gadolinium contrast agent.

In the past Hugh James has negotiated:

  • a settlement protocol for patients who alleged visual problems from their HOYA cataract remedial intraocular lenses;
  • various confidential settlements arising out of failed hip and spinal devices; and
  • settlement of claims arising from aircraft and helicopter crashes and for victims of the South Wales E Coli outbreak.

Our product liability lawyers

  • assist some of the 700,000 or so people who are injured each year and wish to seek compensation for their losses – and we can assist those who have been injured and who could claim but feel unable to;
  • investigate each potential claim thoroughly and offer early and ongoing assessments as to the prospects of success in your claim and the likely level of compensation and other remedies you may be entitled to;
  • help clients who have suffered relatively minor injuries and those who have had the misfortune to suffer catastrophic and life-changing injuries;
  • work to the highest service standards so that we conclude your case as quickly as possible with the right remedy; and
  • work on conditional fee agreements (no win, no fee) so that if we don’t win your case there is no bill to pay.

Amongst us Deputy District Judges, Recorders, Queens Counsel, Solicitors Regulation Authority specialist panel members, Fellows of the Association of Personal Injury Lawyers (APIL), members of Action for the Victims of Medical Accidents, published authors of legal texts, frequent contributors of legal journal articles and some of the country’s most renowned trainers of other lawyers on all aspects of personal injury law.

Can I once again say how appreciative I am of all the hard work you and all your team at Hugh James put in on my behalf. I have no doubt that without your perseverance and attention to detail we would not have achieved anything near the outcome. — Client


She is great with clients, and her analysis and work product is great. She has many years of experience and a very good understanding of cases and the technical medical issues involved.

Chambers & Partners

He’s great with the big-picture level but gets into the detail too.

Chambers & Partners

They have the depth and breadth across all areas of expertise in these cases, with plenty of support to cover all the eventualities that might arise in group litigation.

Chambers & Partners

Pauline Roberts, very experienced PL litigator, who has been involved in many of the largest medical devices/products claims. Able to balance the ‘big picture’ element of working in large pieces of litigation with the need for the fine eye for detail to identify the winning points. Like Mark, she is an utter pleasure to work with.

The Legal 500

Mark Harvey. Top drawer. Exceptional breadth of knowledge. Brings an internal focus to the work through his European and wider links. Creative product liability lawyer who is prepared to take risks to try and push the law onwards. A genuine pleasure to work with.

The Legal 500

The team is willing to take a risk and push ‘challenging’ cases forward with consistently impressive results. They are also internationally aware and liaise well with other firms across the world in this field, which gives them a real edge, especially in claims involving multi-nationals with enormous financial resources.

The Legal 500

Mark Harvey is a stand-out practitioner. He has a phenomenal work ethic, is a fantastic team player and has huge experience as a litigator in complex healthcare related litigation, in particular complex product liability group litigation. He has been at the centre of most of the leading group actions in this field for many years and is widely regarded as the go-to solicitor in this field. He also has an international reputation and is often called upon to address overseas conferences in the product liability field.

The Legal 500

The firm is unique in its unrivalled approach to managing complex litigation, in particular group litigation. It has unrivalled case management skills and resources. The firm is able to produce extremely sophisticated comprehensive bundles of papers at very short notice. It has an impressive track record in product liability and has justifiably earned its reputation in this field.

The Legal 500

Mark Harvey is a real star in this field. Has worked on multiple pieces of group litigation. Knows the area inside out.

The Legal 500

Vast experience of claimant product liability work. The firm covers work from individual cases to very large group litigation. The team is well resourced and knowledgable.

The Legal 500

I would like to take this opportunity to thank you and your team for all the hard work in achieving this positive outcome. I really am very grateful. Best wishes for the future and sincere thanks once again.

Client

I just wanted to say how much I appreciated your hard work and professionalism dealing with my claim against the hip manufacturers with a satisfactory outcome.

Client

Pauline Roberts is hardworking and very knowledgeable. She has superb client skills and the talent to find ‘the something’ that can make the difference in the mass of disclosure that often accompanies major litigation in this field’.

The Legal 500

Thank you for the compensation that you recovered for me and also your help and guidance that you gave me throughout the case

Client

Thank you so much for your help throughout the case, you’ve been excellent keeping me updated and answering any queries I’ve had in a prompt and professional manner. If I ever need the services of a solicitor in the future I shall know where to come.

Client

Thank you for all the work you have all put in on my behalf – please convey my thanks to Mark Harvey and all who have been involved in this matter. It has been a pleasure having the occasional conversation with you and meeting Mark when he visited me in 2017

Client

Thank you so very much for everything you have done for me.

Client

The extremely experienced Mark Harvey garners praise from market sources for his “very good understanding of the claimant market.” His practice demonstrates considerable prowess in the co-ordination of multiparty proceedings and large group actions, particularly those relating to defective medical devices. Another source describes him as “an excellent cross-border litigator.”

Chambers & Partners

Mark Harvey is excellent and the person you would want running your product case’.

The Legal 500

Mark Harvey is a complete master in the field; he combines legal knowledge, sound tactical skills and good judgement’.

The Legal 500

The team at Hugh James undertakes work of the utmost complexity in this field. They have the strength-in-depth to be able to take on litigation of any size, from single claims to complex, multi-party medical product litigation’.

The Legal 500

Department co-head Mark Harvey offers a well-regarded personal injury practice, with particular expertise in product liability claims. One source says: “He has a very strong reputation in Cardiff for being a technically good and tough litigator.”

Chambers & Partners

Equally as capable when assisting individual clients as when providing robust support during complex group litigation.

Chambers & Partners

Mark Harvey is a leading practitioner and is the object of praise with regard to his expertise in handling headline product liability claims. One source says: “He’s really at the forefront of claimant class and group actions in terms of how to strategically run them. Very few people have as much experience as him.”

Chambers & Partners

an excellent cross-border litigator.

Chambers & Partners


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