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	England and Wales Court of Appeal (Criminal Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Criminal Division) Decisions >> Guy's and St Thomas' NHS Trust, R. v [2008] EWCA Crim 2187 (02 October 2008) URL: http://www.bailii.org/ew/cases/EWCA/Crim/2008/2187.html Cite as: [2009] PTSR 1095, [2008] 4 All ER 1174, [2008] EWCA Crim 2187

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IN THE COURT OF APPEAL
CRIMINAL DIVISION

		Royal Courts of Justice Strand London, WC2A 2LL
		2 October 2008

1. Lord Justice Toulson: This application for permission to appeal has been referred to the Full Court by the registrar. At the outset of the hearing we granted leave to appeal.
2. On 13 March 2008 at the City of Westminster Magistrates' Court the appellant Trust pleaded guilty to supplying a medical product not of a nature or quality specified in a prescription contrary to section 64(1) of the Medicines Act 1968. The case was committed to the Crown Court for sentence. On 23 May 2008 at Southwark Crown Court the appellant was fined £75,000 and ordered to pay costs. The appeal is against the fine.
3. On 24 April 2006 baby twins were born at the Chelsea and Westminster Hospital. The births were very premature and the male twin died shortly after birth. The female twin, Jada, survived initially but was in a poor condition and was transferred to the intensive care unit. In the course of the treatment that followed the Chelsea and Westminster Hospital ordered from the appellant Trust a product called TPN, which is short for "Total Parental Nutrition". The Chelsea and Westminster Trust did not have its own facilities for the production of this solution. The appellant Trust does and it produces such products both for its own use and also for use by other hospital trusts who are charged at cost.
4. It is necessary to describe the way in which the solution is produced. The product is made up by a trained technician acting under supervision and using a machine called Automix. There were three major ingredients: vaminolact, which is a protein, glucose and water. The technician received the specification for the product which was particular to the needs of this child in the form of a computer generated worksheet. The software programme was written in such a way that on the worksheet the specified ingredients were shown in the order mentioned, that is vaminolact, glucose and water. In this instance the specification was for 27.4 mL vaminolact, 24.2 mL glucose and 111 mL water. The control unit on the Automix enables the technician to key in the required quantities and then press a pad which will result in them being dispensed from separate sources into a bag in which they are mixed and which is provided to the requesting hospital for administration to the patient.
5. The columns on the Automix happened to be in a different order from the specification in the worksheet. On the Automix the left-hand column was for the vaminolact, the middle column for water and the right-hand column for glucose. The machine could not dispense less than 30 mL of any ingredient, so if the amount required in a particular case was less it would be inserted by syringe.
6. It can be inferred from the tragic events which happened and from the detailed subsequent investigation of them that in the instant case the technician inserted the required quantities of vaminolact and glucose by syringe, each being less than 30 mL, but instead of adding 111 mL water he must, inadvertently, have keyed that requirement into the glucose column with the result that the solution prepared by him had 27.4 mL vaminolact and 135.2 mL glucose.
7. This error on his part was compounded by error on the part of his supervisor who was responsible for checking the process. The system was such that no product could go out, or should go out, unless its compilation had been observed by the technician and his supervisor. In other words, recognising that where human affairs are concerned there is always a possibility of human error, the Trust's system was such that an off-spec solution, if it may be so described, could not be produced by a single error of one employee. There had to be two employees both at fault for such a default to occur.
8. The solution was administered to Jada on 26 April 2006 at 11.00 pm. It was a massive glucose overdose. The baby died on the following day. The coroner at the inquest found that a number of factors contributed to her death, one of which was hyperglycemia caused by the glucose overdose.
9. Section 64 of the Medicines Act 1968 provides as follows:

"(1) No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.

...

(5) Where a medicinal product is sold or supplied in pursuance of a prescription given by a practitioner, the preceding provisions of this section shall have effect as if --

(a) in those provisions any reference to sale included a reference to supply and (except as provided by the following paragraph) any reference to the purchaser included a reference to the person (if any) for whom the product was prescribed by the practitioner, and

(b) in subsection (1) of this section, for the words 'demanded by the purchaser', there were substituted the words 'specified in the prescription'."

It is for practical purposes a strict liability offence.

10. The background to this tragic event was that the appellant Trust had been producing solutions of this kind and in this way over a period of about 15 years using the same methodology and during that time had produced something in the order of 100,000 bags.
11. There had been one previous occasion on which a similar mistake had been made and in the investigative process attention was properly directed to that previous incident. It has been referred to as the Green incident. It was fully investigated by the Trust at the time because it was recognised that any such incident could be extremely serious.
12. The judge in his sentencing remarks said about it:

"In 2005, there was a similar incident, but one which had been detected before any damage could be caused. I am satisfied from what I have been shown today that that was thoroughly investigated and various options were considered for remedying the problem, but it was decided that the system as it stood should remain because altering it could in itself lead to mistakes being made and I am told that following the incident that I am dealing with here, the system was altered and mistakes were made during the initial period after the change."

13. Although the judge does not say so in explicit terms, the clear implication of that passage is that he was satisfied that the Green incident had not only been thoroughly investigated, but that the Trust's response to it had been reasonable. We were nevertheless concerned to satisfy ourselves that we had fully understood the investigations on that occasion and this court has come to the same conclusion. We add that the prosecution are represented here today by Mr Bird, who, in response to enquiry from the court, has not sought to argue against that conclusion.
14. In brief, after the Green incident an investigator suggested that three steps be taken to prevent such an error occurring again. The suggestions were: (1) change the order of the bulk solutions on the Automix; (2) investigate the purchase of a compounding system that would allow a different print-out of the solution and weights added to a TPN bag; (3) investigate the use of standard TPN bags to reduce the risks from bespoke compound for individual patients.
15. We have seen the contemporaneous documentation which shows how each of these suggestions was evaluated. It was decided not to make the first change because on consulting the staff the point was made that technicians were very well used to the Automix as it was. They had been using it for many years. There had been this one isolated error. To change the Automix would in the view of the staff familiar with it be more likely to lead to error than avoid error, because of the familiarity which users had with the machine as it then was. On consideration those with responsibility for the matter concluded that this point was valid and that the balance of risk favoured not changing the Automix.
16. Obtaining a different form of print-out was explored but proved to be not a viable proposition because the suppliers were not willing to provide a different formulation of print-out. The print-outs came from their software as written and the Trust had to accept the specification sheets as they received them. In truth, it was not a difficult matter for a technician to read down the specification and know what he had to key in.
17. The third possibility of using standard bags would not have been relevant in the present case because standard bags are just that, they are standard bags. In many cases, of which this was one, the product was individually prescribed and a standard bag would have been inappropriate.
18. We are satisfied that the response of the Trust to the previous incident was a reasonable one. Their system essentially depended upon staff being properly trained and properly supervised. As already explained, there had to be dual error for an event of this kind to occur.
19. The judge was faced with a difficult sentencing exercise because there is a lack of case law in this area on which to draw. He said as follows:

"I have sought, but found no previous cases with facts of a similar type to this to assist me, so I have to sentence the Trust for this offence against the background of its excellent reputation, but recognising the awful truth, that their error was a contributing factor in the tragic death of a young baby. No fine can begin to reflect the value of that child's life and any fine that I do impose removes money that would otherwise be put to the Trust's primary purpose of healthcare."

20. Mr Climie on behalf of the appellant makes a number of criticisms of the judge's approach of which the most important in our judgment are two. First, he submits that the judge has failed to give adequate recognition of the fact that this was not a case of a failure in management systems or any form of management negligence. This was a case where work was properly delegated to an employee, who was properly trained, and the Trust did all that it could reasonably be expected to do to provide a proper system of supervision. Nothing can ever wholly prevent the possibility of multiple human error, as occurred in this case, but the liability of the Trust is a purely vicarious liability for a default on the part of its staff without actual negligence on the part of the Trust.
21. Secondly, Mr Climie submits that although the judge referred to the fact that any fine imposed would remove money that would otherwise be available for the Trust's primary purpose of healthcare, he failed to factor that consideration into account when setting the penalty.
22. We accept that, as a matter of principle, where a not-for-profit organisation exists to carry out work for the public benefit and a failing occurs without actual fault on the part of that body, but through an act or default of an employee to whom the task has been properly delegated and who has been properly trained, the court ought not to punish such a body by the imposition of a financial penalty which would materially impact on its ability to discharge its public duty. The reason is that the public interest would not be served by so doing.
23. If an organisation is run on a commercial basis the people who will stand to profit from it are the owners of the business, or shareholders in the case of a limited company. The result of the imposition of a fine may be to reduce the amount of their dividend, and, at least in theory, may cause shareholders to hold to account the managers of the company. But in the case of a body of a kind with which we are concerned there are no such financially interested parties who stand to profit from its gains. The beneficiaries of the trust are the general public for whom the service is provided and to impose a fine which reduces the ability of the trust to serve the beneficiaries in that way is not in the public interest. This is not a novel proposition. It was recognised by this court in Milford Haven Port Authority [2000] 2 Cr App R(S) 423 in substance if not exactly as we have stated it.
24. Mr Climie has referred us also to the decision of this court in the case of Southampton University Hospital NHS Trust [2006] EWCA Crim 2971. In that case a hospital patient died as a result of gross negligence on the part of two doctors who were subsequently convicted of manslaughter and received custodial sentences. The Trust itself pleaded guilty to an offence under section 33(1) of the Health and Safety at Work Act 1974. The charge against the Trust was that it had failed to conduct its undertaking in such a way that, so far as was reasonably practical, it implemented and maintained an adequate system of direction and supervision of senior house officers in the trauma and orthopaedic department of the hospital. There were in that case serious management errors. At first instance the court imposed a fine of £100,000. The sentence was reduced on appeal to £40,000, the court drawing particular attention to the observations of this court in the Milford Haven case.
25. Mr Climie makes the point that if £40,000 was an appropriate level of fine in a case where a hospital trust had been guilty of serious management error, the appropriate fine ought to have been significantly less in a case where there was no such management error. As a result of this latest incident the system has been changed but in ways which were not considered after the Green incident. Nor did the prosecution suggest that the subsequent measures ought to have been undertaken earlier.
26. In our judgment, there is force in these points. We recognise the difficult position in which the judge was placed with a dearth of authorities. Nevertheless, we consider that the criticisms made of the judgment are sound in that the fine failed to give adequate recognition of the fact that this was a case of pure vicarious liability for the acts of two employees to whom work had been properly designated and for which they had been properly trained, and failed to recognise sufficiently the detriment to the public in imposing a fine which would seriously impact on the Trust's ability to serve the public. To put £75,000 into practical terms, we were told that the average staff cost of the hospital is £30,000 per head. That covers an average of the wage costs of all staff from the most junior probationary nurse or medical auxiliary to the most senior consultant. In other words, the fine was equivalent to the average staff costs for a year of two and a half members of staff. To impose a fine of that order is bound to have an adverse impact on the work of such a trust. Of course, the sum could be translated into other comparables, such as costs of medicines, but wage costs is a helpful way of seeing the impact of such a fine.
27. It was suggested in argument below and before this court that the matter could have been appropriately dealt with by some form of discharge. We are not persuaded of that argument. In the first place, for all that the liability of the Trust is purely vicarious, this was still a serious matter and we do not think it would be adequately reflected by an order of discharge. Secondly, a fine may serve a public benefit, even where there has not been prior management negligence, in causing those responsible for running the operation to redouble efforts to ensure that staff recognise the importance of being kept up to the mark. But such theoretical or potential benefit to the public has to be balanced against the actual and immediate impact on the Trust of losing money which it would otherwise be using for medical purposes and a fair balance drawn. In our judgment, the fine of £75,000 was excessive. An appropriate figure would have been £15,000. We therefore quash the fine and substitute a fine of £15,000.