Scottish Court of Session Decisions

er

Pursuer: Brodie, Q.C.; Balfour + Manson LLP

Defenders: Comiskey; Central Legal Office

24 May 2011

[1] This action arises from the pursuer's participation in a clinical drug trial between 2002 and 2005. The trial was of a new non-ergot dopamine agonist patch medication called Rotigotine CDS ("Rotigotine"). Dopamine agonist drugs are used to treat the symptoms of Parkinson's Disease from which the pursuer was diagnosed as suffering in early 2002. The Sponsor of the trial was Schwarz Pharma AG of Germany, under licence from Aderis Pharmaceuticals Inc, an American company. The purpose of the trial was to determine the effects and safety of Rotigotine transdermal patch administration in comparison with the dopamine agonist Ropinirole and a placebo, in patients with early stage Parkinson's Disease. The first defender was the principal investigator of the trial, which was conducted at the Southern General Hospital in Glasgow, the assets and liabilities of which have now been assumed by the second defender. The first defender's responsibilities included identifying suitable patients for participation in the trial, obtaining informed consent from each patient prior to participation and supervising the research team's management.

[2] The pursuer avers that while the potential physical side effects of participation in the trial were explained to him on 26 June 2002 when he was assessed for suitability as a participant, the potential for developing addictive behaviour was not discussed. He goes on to aver that he was provided with a document entitled "Patient Information Sheet (Version: UK Version 2 (MRECT) 22 October 2001)". That sheet made reference to the terms on which compensation would be provided in the event of him sustaining injury as a result of the trial. The pursuer avers that he participated in the trial between 19 July 2002 and 26 October 2005 and that he was in receipt of Rotigotine as opposed to Ropinirole or a placebo throughout that period. He then avers that Rotigotine causes a small number of those receiving it in treatment to develop serious compulsive behaviour. Amongst the serious and uncontrollable addictions developed is that of gambling. The link was recognised at the latest in 2005. The pursuer claims that in the course of 2003 he developed an uncontrollable urge to gamble, which he hid from his family at first. He avers that he lost £85,000 by spending that sum on gambling. He claims that he raised the issue of his gambling on attending his regular clinical appointments at the Southern General Hospital on 1 December 2004 and at three subsequent appointments during 2005. It is agreed that on 26 October 2005 the first defender advised the pursuer to cease treatment with Rotigotine. The pursuer's claim is, in essence, that the first defender, which failing the second defender, undertook a unilateral obligation in terms of the said Patient Information Sheet that in the event that the pursuer sustained injury as a result of participation in the trial, compensation would be paid. The case is pled in the alternative as a contractual provision. The defenders claim that the action is irrelevant and the case came before me for a Procedure Roll discussion on their first and second pleas-in-law.

Submissions for the defenders
[3] Counsel for the defenders submitted that the pursuer's averments that the Patient Information Sheet ("the PIS 2001") amounted to a unilateral obligation to pay compensation to the pursuer were irrelevant. She argued that where acceptance was a condition, then a statement could not be regarded as a unilateral obligation. Attention was drawn to page 2 of the PIS 2001 which provided as follows:

"Your participation in this trial is entirely voluntary. It is up to you to decide whether or not to take part. If you decide to take part you will be given this information sheet to keep and asked to sign a consent form ...".

As the pursuer avers that the first defender offered the pursuer that he participate in the trial and that the pursuer agreed to participate, the case relating to a unilateral obligation was accordingly irrelevant. As far as the second defenders were concerned there were, in any event, insufficient facts pled from which any unilateral obligation to compensate the pursuer in terms of the PIS 2001 could be held to be incumbent on them. The Patient Information Sheet had been lodged and formed No. 7/2 of process. It was accepted that the address heading the sheet was that of the second defenders. Attention was drawn to page 4 of the sheet, which listed the side effects of which patients were informed. It was accepted that these were effectively all physical side effects. Attention was also drawn to page 6 of the sheet, which records that if any new findings occur with the trial medication the patient would be informed of those and could decide whether or not to continue taking part in the trial. The Sponsor, Schwarz BioSciences Inc, ("Schwarz") was identified on page 6 as the company organising and funding the research. The sheet records that the patient will be refunded for travel costs by the Sponsor. The argument centred on the paragraph in the Patient Information Sheet headed "What if something goes wrong?". That paragraph is in the following terms:

"Compensation for any injury caused by taking part in this study will be in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI). Broadly speaking the ABPI guidelines recommend that the Sponsor without legal commitment, should compensate you without you having to prove that it is at fault. This applies in cases where it is likely that such injury results from giving any new drug or any other procedure carried out in accordance with the protocol for the study. The Sponsor will not compensate you where such injury results from any procedure carried out which is not in accordance with the protocol for the study. Your right at law to claim compensation for injury where you can prove negligence is not affected. Copies of these guidelines are available on request.

If you should suffer any injury arising as a result of your participation in this research trial, you will receive appropriate medical treatment.

In addition, the Sponsor of this trial is also insured through a company called VICTORIA. The extent of this compensation may vary depending on the circumstances involved. Your doctor will be able to provide you with more information."

[4] It was clear from the above paragraph, submitted counsel, that patients were told that any compensation would be subject to the ABPI guidelines. A copy of those guidelines is lodged at No.7/1 of process. Counsel for the defenders submitted that those guidelines do not amount to an obligation to pay, but merely a recommendation to pay in certain circumstances. The first of the basic principles in the ABPI guidelines is in the following terms:

"Notwithstanding the absence of legal commitment, the company should pay compensation to patient-volunteers suffering bodily injury (including death) in accordance with these guidelines."

Counsel noted that at its highest, it was said that there "should" be payment not that there "shall" be payment. It was argued that there was no basis in the guidelines for payment by either of the defenders in the event that the Sponsor refused to pay. It was clear that claims were to be made by the patient to the Sponsor "preferably via the investigator" (ABPI guidelines, paragraph 5.1). Thus the investigator might be a channel for claims being made against the Sponsor, but there was no basis at all for payment by him or by the second defenders. Accordingly, if it was wrong to say that the guidelines provided only a recommendation not an obligation, it was nonetheless clear that it was the company's Sponsor that was liable and not the defenders. Counsel submitted that it was the Sponsor, Schwarz, who should have been sued. She queried why the pursuer had not brought Schwarz into the action. The first defender was simply a point of contact and had no liability to the pursuer.

[5] In light of the above, counsel submitted that neither the first nor the second defender had entered into a unilateral obligation or a contractual obligation to pay compensation to the pursuer. The action was irrelevant and should be dismissed. In support, reference was made to McBryde, The Law of Contract in Scotland (3^rd ed.) Chapter 2, paragraph 2-02. There it is confirmed that a promise is binding in the law of Scotland without consideration and without acceptance. A promise requires the act of only one party, where a contract requires at least two parties. However clear words are required before a statement would be regarded as a unilateral obligation. In Dow v Tayside University Hospitals NHS Trust [2006] SLT (Sh.Ct.) 141 it was said that in relation to medical treatment under the NHS, any obligation additional to the statutory duties imposed on a doctor would require to be expressed in clear terms. Further, there must be an enforceable obligation applying the normal rules of construction for the pursuer to succeed. In Morton's Trustees v The Aged Christian Friend Society of Scotland (1899) 2 F 82, where a series of letters was being construed, it was clear that the person involved intended to bind himself and did in fact do so on a particular condition relating to the establishment of a scheme. The question to be asked was what obligations, if any, have the first or second defenders undertaken. Counsel for the defenders submitted that no enforceable obligations were undertaken by them. Reference was made to Ballast plc v Lauriston Properties [2005] CSOH 16. Counsel for the pursuer submitted (and counsel for the defenders agreed) that the summary laid out by Lady Paton in that decision at paragraph [142] constituted the most relevant recent dicta on the principles of construction. The principles were (1) interpretation is the ascertainment of the meaning which the document would convey to a reasonable person having all the background knowledge which would reasonably have been available to the parties in the situation in which they were at the time of the contract, (2) the enquiry will start and usually finish by asking what is the ordinary meaning of the words used and (3) the relevant factual context is only that which was known or should reasonably have been known to both parties at the time when the document was written. Additionally, in the context of a unilateral document, the appropriate perspective is the meaning which the words would convey to a reasonable person in the position of the recipient. Counsel for the defenders identified one of the issues as whether the PIS 2001 was a unilateral document. Reference was again made to McBryde, The Law of Contract in Scotland where at paragraph 2-12 it is said that a statement may be considered in the context of all the admissible evidence, but sometimes the only evidence is the document and a construction contra proferentum goes against the words being a promise in case of doubt. The case of Scott v Dawson (1862) 24 D 440 was cited in support. Professor McBryde in his text also distinguishes a promise from an offer. Where acceptance is a condition then the statement is not a unilateral obligation. Relevance was made to Stair I, x, 3, 4 and Morton's Trustees v The Aged Christian Friend Society of Scotland (supra).

[6] It was submitted that it was clear from both the Patient Information Sheet and the ABPI guidelines that a patient could still pursue a legal remedy and that the role of the investigator was only to bring any injury to the attention of the Sponsor rather than to be liable himself. It could not be construed as a unilateral obligation on the part of the investigator that he would pay compensation to the pursuer. The patient is clearly told who the Sponsor is and that compensation will be paid by the Sponsor. There are obligations on the patient, although those relate more to the extent of any compensation rather than the obligation. There is nothing in the document to suggest that it is the first defender who would be liable for such compensation. Even if the terms of the Patient Information Sheet relating to compensation could be regarded as a promise, a promise to someone that they would be paid is not enforceable without knowing who would pay. In any event, it was said that no firm obligation to pay is expressed by the document. And neither was it sufficient to put the defenders in the role of guaranteeing payment. By giving the document to the patient the defenders were not saying that they would compensate, or even that the pursuer would be given compensation.

[7] It was noted also that a doctor performing normal duties would not be able to prescribe unlicensed drugs. Clearly informed consent was required before those drugs could be administered to the patient. Accordingly the information contained in the Patient Information Sheet could be described as the conditions on which the pursuer gave consent. To that extent it was accepted that the pursuer's consent was conditional on the provisions in the Patient Information Sheet about compensation, both in terms of payment and who would pay. It was part of the arrangement between the patient and the defenders.

[8] Counsel for the defenders had a number of subsidiary arguments in relation to alleged lack of specification of the pursuer's case. The first main point related to quantum of damages. The ABPI guidelines, at paragraph 4.1, record that the amount of compensation should in general terms be consistent with the quantum of damages commonly awarded for similar injuries by an English court in cases where legal liability is admitted. It was argued that the pursuer failed to relevantly aver facts and circumstances from which evidence regarding the quantum of damages commonly awarded for similar injury from an English court could be led and proved. The second specification matter related to a lack of averments about the pursuer meeting the criteria for any recognised psychological or psychiatric condition as a result of taking Rotigotine in the trial. Reference was made to McTear v Imperial Tobacco 2005 SC 1. It was said that the pursuer had failed to aver sufficient causal connection between his alleged gambling losses and his taking Rotigotine in the trial. Further, the pursuer's averments regarding the alleged losses of £85,000 did not give adequate notice to the defenders as such that they could properly investigate and prepare to deal with the matter at proof. They were entitled to fair notice of the case being made against them in the pleadings. Reference was made to Avery v Hew Park School for Boys 1949 SLT (Notes) 6.

[9] In conclusion, counsel for the defenders acknowledged that the specification points were of a minor nature and that the main thrust of her argument was that the case was irrelevant as the averments were insufficient to offer to prove a case based on either unilateral obligation or contract. She moved for absolvitor, which failing dismissal.

Submissions for the pursuer
[10] Senior counsel for the pursuer confirmed that his principal position was that a proof before answer should be allowed reserving the defenders' preliminary pleas. However, he accepted that there may be different approaches depending on which, if any, of his arguments found favour. He analysed the arguments in relation to the pursuer's pleadings as (1), an attack on whether there could be said to be a unilateral obligation, (2), an attack on whether there could be said to be a consensual agreement and (3), the specification points. Senior counsel accepted that if no relevant obligation was pled in relation to either unilateral obligation or contract, then the action would fall to be dismissed. However, if proof before answer was to be allowed on either a unilateral obligation or consensual agreement, then a By Order might be required.

[11] Senior counsel explained that the case involved an unusual situation where the pursuer had no right of action for any loss through negligence, as it could not be said that there was a sufficient knowledge base on which to establish fault. The side effects of the drug were not known until 2005. Further, it was accepted that there was no agreement or undertaking that the pursuer could enforce directly against Schwarz, who was not a party to the contract. There was no relationship between Schwarz and the pursuer and thus no contractual nexus. The defenders were not agents for a disclosed principal. The basis of the pursuer's case is the Patient Information Sheet, No.7/2 of process, which contained the obligation on which it is sought to rely. The relevance of the ABPI guidelines was that they required to be looked at for the type of injury and on issues of quantum. The guidelines themselves were not the basis of the alleged obligation. It was accepted that the guidelines themselves do not constitute any obligation. The document that constituted an obligation (the PIS 2001) was not framed in a way that disclosed that the defenders were somehow acting for Schwarz. There was no basis for ostensible authority and counsel had been unable to bring Schwarz into the action.

[12] The background was that the defenders invited participation in a drugs trial and they invited the pursuer in particular to do a number of things. It was not being suggested that the defenders said that they would pay compensation. It was a question of the defenders saying to the pursuer that Schwarz would pay. The issue was whether there was an obligation to the pursuer, owed by the defenders in the circumstances, to pay compensation. The source of the obligation was the paragraph in the Patient Information Sheet headed "What if something goes wrong?" already referred to. The nature of a unilateral obligation was that there was no corresponding obligation. Counsel for the defenders waswrong to say that the fact of acceptance meant that it required to be interpreted as a contract with a mutuality of obligations. Senior counsel for the pursuer argued that it could be seen that the obligations were all one way. Where conditions were attached to a promise, it may still be construed as a promise not a contract. Agreeing to participate in the trial did not carry the import of an obligation by the participant, according to senior counsel. He argued that it was the equivalent of a statement such as "I will buy you a car if you pass your exam". There would be no obligation on the candidate to pass the exam, but the promise of a car would be conditional upon the pass mark being obtained. Similarly in this case compensation was to be payable in accordance with the scheme and the guidelines. If the patient did not turn up for the trial, the guidelines would not be applicable to him. Thus, on one view, all of the obligations went one way and were given by the defenders. On that basis it could be said that there was not a contract. If the Patient Information Sheet could be construed as a unilateral obligation, then that could be determined on argument. However, it was accepted that if it was deemed to be a contractual provision, a proof before answer would be required.

[13] If the argument that it was a unilateral obligation failed, senior counsel for the pursuer argued that what the sheet constituted was an agreement to undergo medical treatment with the pursuer's consent being dependent upon performance by the defenders of undertakings made. The Patient Information Sheet constituted the offer and the signed consent form was the acceptance. The form contained a series of obligations where the defenders were binding themselves to do a number of things. While participation was voluntary, the defenders assessed suitability and undertook to provide treatment. Regardless of whether a patient was given Rotigotine, Ropinirole or the placebo, all would constitute treatment. Moreover, the defenders were undertaking to assess the condition of the pursuer during the trial period. They were undertaking to ensure that there was a staggered decrease in dose and a safety follow up. There were various phases in the treatment and different undertakings in each. At page 6 of the Patient Information Sheet there was an undertaking to keep the patient informed of new findings. It was argued that this was very important and constituted part of the care that the defenders were undertaking to provide to the pursuer. Thus the defenders were obliged to do their best to ensure that participants were giving informed consent. There were unequivocal statements in the sheet. For example, if a patient suffered injury they were told that they would receive appropriate medical treatment. It was accepted that the compensation provisions were slightly less clear. The undertakings were to administer a specified form of treatment following a specific methodology and under provision of certain safety measures. The signed consent form and the act of making himself available for participation constituted acceptance by the pursuer such that the Patient Information Sheet and consent form constituted the terms of the contract.

[14] If it was accepted as a contract, then the question of construction had to be in line with the familiar principles of interpretation as neatly summarised by Lady Paton in Ballast plc v Lauriston Properties (supra). The approach is an objective one and the words should be given their ordinary meaning. On one view, evidence was unnecessary if the meaning was clear, as much of the background knowledge was in the written documents.

[15] Turning to the pleadings, Articles 2 and 3 condescendence narrated the happening of the trial, its nature, the purpose of the trial, the defenders' undertaking of the trial in Scotland and the circumstances in which the pursuer came to be on it. The pursuer was in the trial to gather information on the effectiveness and safety of the drug. The Patient Information Sheet narrated the known side effects of the drug being trialled and detailed these. Thus it was representing to the pursuer that treatment would be provided in the case of injury on the trial. The important point was that the relevant paragraph of the Patient Information Sheet referred to compensation and compensation in terms of the guidelines. The fact that the ABPI guidelines referred to were guidelines, did not affect the fact that the PIS created an obligation. In all the circumstances, and construing the documents as a whole, the clear meaning a reasonable person would take from the relevant paragraph was "compensation will be paid in accordance with the guidelines". The paragraph on compensation was a substantial clause appearing in a document placing someone on an unlicensed, unexplored, medicinal product. The provider of the document must have been aware that the invitee would be significantly influenced by what protections exist for their health and safety and significantly influenced in deciding whether to participateby whether compensation was available. The undertakings in the Patient Information Sheet were consistently linked with safety issues. Further, it was significant that the assurance about medical treatment in the event of injury was included in the clause indicating that there would be compensation. The "reasonable recipient" in the particular circumstances described, on being offered all of the undertakings about safety, would read this as an understanding that compensation would be payable, but that the quantum of that might vary. The words "the extent of this compensation ..." would be understood by the patient in that context. The document indicated that the patient was being given something of added value to common law negligence actions. The provision had a purpose and its content was to make provision for compensation. It should be asked what the reasonable participant and participator would think if they read it. It was suggested that what the patient would take from it was comfort that there was a simple and expeditious procedure for compensation. There was a written assurance to the investigator (the first defender) and the Ethics Committee (the second defenders). The preamble to the ABPI guidelines directed the relevant companies to give hospitals an assurance that the scheme would be implemented. The whole scheme was founded upon a promise that compensation will be payable.

[16] Senior counsel for the pursuer argued that it was important to understand the role of the defenders in the matter. While the source of the payment on the face of documents was to be the Sponsor, nonetheless it was the defenders who were incurring an obligation to pay. If that was wrong, then in any even the pursuer had an averment that Schwarz had failed to pay and the defenders would become liable in that instance. As part of the factual matrix the guidelines pointed towards an objective construction of the "What if something goes wrong?" section of the Patient Information Sheet as being that there was prima facie obligation to pay. A dose of commercial reality should be applied to the situation. Any party invited to a drugs trial would want to know what security was available against things going wrong. The investigator would know that such a person is unlikely to come on board the trial without that security. There was no purpose to the clause other than to provide reassurance that compensation was available.

[17] In answer to the specification points, senior counsel for the pursuer argued first that on quantum, the position was no different from any damages action in this court where reference is regularly made to English awards. It would not be difficult to assess quantum on the basis of what was pled. So far as the argument about the condition said to have developed, there were averments at page 20 of the Closed Record, Article 11 of condescendence, that the pursuer had developed an uncontrollable addiction to gambling. The case was distinguishable from McTear where the argument was made after proof and related to criticisms made by the pursuer on the defenders pleadings on addiction. . In any event, in this case it was not the drug that was addictive. However, he accepted that there were no specific references to DSN-1V in relation to the nature of the addiction. Finally, on the issue of the lack of specification of the alleged losses of £85,000, it was open to the defenders to proceed with a specification of documents and the problem would be for the pursuer if he was unable to prove the extent of his loss. Senior counsel had provided as much specification as he had.

Reply for the defenders
[18] In a brief reply, counsel for the defenders submitted that senior counsel for the pursuer had somehow suggested that the motivation of a patient to participate in the trial might be partly the potential for compensation. However, it should not be ignored that the real benefit was of receiving treatment. It was noteworthy that the pursuer avers that even by 2005 he was reluctant to cease treatment as the drug was relieving his symptoms of Parkinson's. When the pursuer saw the first defender on 26 October 2005 he was still indicating that he wanted to continue with the trial despite knowing of the potential side effects which had been intimated in a letter previously.

[19] The nub of the issue was whether the clause "What if something goes wrong?" in the Patient Information Sheet carried with it an implication that compensation would be paid. The correct construction, according to counsel for the defenders, was that while there was a right to seek compensation, there was no right to sue if no payment was made.

Discussion
[20] The first issue for determination in this case is whether the patient information sheet No. 7/2 of process can be characterised as a document containing a unilateral obligation made by either of the defenders to the pursuer, or whether it, taken together with the form of consent signed by the pursuer and attached to it constitute a contract. In my view the relationship between the pursuer and the defenders was a contractual one and the paragraph headed "What if something goes wrong?" should be construed in that context. I have reached this view partly because the sheet itself is expressed as an invitation. At the outset the patient is advised of that and counselled that it is important to read the information provided carefully before deciding whether or not to take part. Accordingly, it seems to me that the patient information sheet constitutes an offer by the defenders and the consent form signed by the pursuer on 26 June 2002 is the acceptance. The form makes clear that the patient is to sign the consent form after deciding on the basis of the information provided, to take part. In any event, the pursuer agreed to take part in the trial of the drug Rotigatine CDS because he had been diagnosed with early stage Parkinson's Disease. I disagree with the submission of senior counsel for the pursuer that the obligations all go one way in the arrangement, which was the primary basis for suggesting the obligation was unilateral. The patient information sheet sets out the five periods involved in the trial. It is clear that the obligations on the patient include attendance at the hospital and taking whichever medication was administered. There are directions in connection with applying patches and taking capsules. There is a direction to return all unused study medications at each clinic visit in the paragraph "Safety follow up period". The whole arrangement is bilateral and involves the co-operation of the patient in the trial to which he has agreed. In my view the relevance or otherwise of the pursuer's case is dependent upon him having pled a case in contract.

[21] The terms of the contract are all contained within the documents at No 7/2 of process, namely the Patient Information Sheet and the consent form. Unlike the situation in Dow v Tayside University Hospitals NHS Trust 2006 SLT (Sh Ct) 141,the pursuer here entered into a contractual relationship additional to and quite separate from the statutory one for NHS treatment. The central question is whether one of the terms of that contract can be interpreted as imposing a legally enforceable obligation to pay compensation, without any requirement to establish fault, for any injury sustained as a result of participation

[22] The principles of construction to be applied are those summarised by Lady Paton in the case of Ballast plc v Lauriston Properties Ltd and Others [2005] CSOH 16. The starting point is to ask what the ordinary meaning is of the words used. The aim is to ascertain the meaning which the relevant part of the contract would convey to a reasonable person having all the background knowledge which would reasonably have been available at the time. The significant words that require interpretation in this case include the following:

"Compensation for any injury caused by taking part in this study will be in accordance with the guidelines of the Association of the British Pharmaceutical Industry (ABPI). Broadly speaking the APBI guidelines recommend that the sponsor without legal commitment, should compensate you without you having to prove that it is at fault."

The question is whether these words constitute a legally enforceable obligation on the part of one or both of the defenders. In my view, giving the words their ordinary meaning, they do not amount to any sort of guarantee that compensation will actually be paid. What they mean is that the issue of compensation will be governed by the guidelines referred to. At its highest, there might be said to be an expectation of compensation in appropriate circumstances but the terms of the Patient Information Sheet do not, in my opinion, go so far as to impose a legally enforceable obligation. That would require too much to be read in to the wording. On the face of it, I consider that the paragraph concerned does no more than assure the recipient that there is an appropriate system for compensation. It does not say that compensation "will be paid". The three caveats contained within the second sentence reinforce this. The words "broadly speaking", "recommend", and "should", all suggest that while the sponsor really ought to pay compensation for any injury caused by taking part in the study, it is not bound to do so. The knowledge available to the pursuer was all that contained in the Patient Information Sheet which runs to some eight pages. A reasonable person having read through the document would not assume that compensation would always be available without proving fault. He would understand that the applicable guidelines contained a recommendation that that would be the case, but no guarantee.

[23] Senior Counsel for the pursuer suggested that the plain meaning of the first line of the relevant paragraph was that the word "paid" could be implied after the words "will be". In my view that goes beyond giving the words used their ordinary meaning. The implication is rather that the question of compensation will be determined, and if payable, assessed and calculated in accordance with the relevant guidelines. Further, it is noteworthy that the "What if something goes wrong?" chapter of the sheet is in fact in three separate paragraphs, reproduced at paragraph [3] above. The paragraph on compensation for injury part of which is narrated above is contained within the first paragraph. The second short paragraph provides an assurance to the patient that he will receive appropriate medical treatment should any injury be suffered as a result of participation in the trial. In contrast with the first paragraph, the second does provide a legally enforceable obligation. The words "you will receive" make that clear. The third paragraph of the section refers to insurance taken out by the sponsors. In circumstances where there is a claim on that insurance the issue is more narrowly focused as the extent of the compensation provided, rather than whether it will be provided at all. Again this contrasts with the first paragraph. Senior counsel for the Pursuer very candidly advised me that the usual routes by which a pursuer might seek a remedy in a case where injury had been sustained were not open to the pursuer in this case. It is unfortunate that the terms of the provisions that governed the arrangement between the pursuer and the defenders named the sponsor as the company who would be responsible for compensation in appropriate circumstances when the pursuer had no contractual relationship with them. However, an obligation to make payment requires to be in clear terms before it can be enforced - Scott v Dawson (1862) 24 D 440. A statement of general intention, or a recommendation, is not enough. Accordingly, this is not a case where any clear obligation arises. I accept in principle that a contract between these parties could create an obligation to pay compensation that would in the circumstances be owed by the defenders, notwithstanding the naming of the sponsor. But I have reached the conclusion that the particular terms of this contract do not amount to the creation of that obligation.

[24] In light of the decision I have reached, there is little that need be said about the specification points. Had I been minded to allow a proof before answer, I would not have regarded the defenders' criticisms as particularly material. The pursuer avers that he has developed a compulsive disorder of the type reported by some patients and included in an addendum to the patient information sheet of 12 August 2005. Any difficulties in quantification would be for him to address.

Decision
[25] Accordingly, I intend to sustain the preliminary pleas for the defenders and dismiss the action. I will have the case called By Order so that issues of expenses can be addressed.