England and Wales High Court (Queen's Bench Division) Decisions

IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION

		Royal Courts of Justice Strand. London. WC2A 2LL
		31/07/2007

MR JUSTICE ANDREW SMITH :

1. The claimants seek an order to the effect that there should be a trial of certain preliminary issues on the basis (or largely on the basis) of assumed facts. The purpose of their applications is "to substitute for the full trial of this multi-party action a trial of dispositive preliminary issues". The defendants oppose the applications on the grounds that the court should not change the directions for the trial of these proceedings given by Master Leslie on 25 April 2006, and that the preliminary issues suggested by the claimants are impractical and inappropriate and the proposed trial of preliminary issues would be "futile".
2. This litigation (sometimes called the "FAC litigation") is subject to a group litigation order made with the approval of the Lord Chief Justice on 25 August 2006. It is complicated litigation giving rise to apparently difficult legal and scientific questions. It was observed during the hearing before me that it would assist to have a High Court Judge assigned to it. I agree, and it has now been arranged that the litigation be assigned to Mr. Justice Underhill. All future applications are to be heard by him unless otherwise ordered.
3. The claimants are all children of mothers who suffered from epilepsy and during their pregnancy, it is said, took an anti-epileptic drug (or anti-convulsant drug) called sodium valproate, which the defendants marketed Under the name Epilim. The claimants say that Epilim is a known teratogen, which crosses the placenta during pregnancy and is recognised to cause various deformities, and that therefore it is unsafe for all pregnant women whose fetuses are exposed to it. However, some epileptic women of child-bearing age (and others suffering from epilepsy) need to take Epilim in order to prevent, or at least to reduce, seizures. There is no alternative safe drug for pregnant women with epilepsy, and for some forms of epilepsy Epilim remains an appropriate treatment during pregnancy.
4. Accordingly, the claimants say, a pregnant woman with epilepsy which can be managed by Epilim is placed in the impossible dilemma whether to take the drug in order to protect both herself and to her fetus from the risks associated with her epilepsy or to stop taking Epilim in order to avoid the risk to the fetus caused by its teratogenic properties. It is likely that the nature of the risk to the fetus depends upon genetic makeup, which cannot be known in advance. Epilim (or its metabolites) spreads through the placenta to the embryo and the fetus and so affects development and organogenesis, and causes damage to the fetus and therefore to the child when he or she is born. Although gross teratogenic damage caused by exposure to Epilim can be detected ante-natally, not all forms of teratogenic damage can be.
5. The claimants say that Epilim is a product in which there was a "defect" within the meaning of the Consumer Protection Act 1987. That Act was passed in order to give effect to the Product Liability Directive 85//374/EEC ("the Directive") and is to be interpreted in light of the Directive. It provides that prima facie "there is a defect in a product... if the safety of the product is not such as persons generally are entitled to expect": section 3(1). It also provides that in determining:

"what persons generally are entitled to expect in relation to a product all the circumstances shall be taken into account, including -(a) the manner in which, and purposes for which, the product has been marketed, its get-up, ... and any instructions for or warnings with respect to, doing or refraining from doing anything with or in relation to product;...."

6. Under the 1987 Act where any damage is caused wholly or partly by a defect in the product, among others a producer of the product shall be liable for the damage. There are statutory defences against liability including (at section 4(1)(e)) if the defendant shows:

"that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products when they were under his control."

The burden of proving this (and other statutory defences) is upon the defendant.

7. The claimants bring their action in reliance upon the Congenital Disabilities (Civil Liability) Act 1976 because their claims are for pre-natal injuries and such claims are now governed by the 1976 Act and not the common law. The Act provides that if a child is born disabled as a result of an "occurrence" before birth and a person other than the mother is answerable to the child in respect of the occurrence under the statute, the child's disabilities are to be regarded as damage resulting from the wrongful act of that person, and the child can claim damages. Section 1(2) provides as follows:

"An occurrence to which this section applies is one which - (a) affected either parent of the child in his or her ability to have a normal healthy child; or (b) affected the mother during her pregnancy or affected her or the child in the course of its birth so that the child is born with disabilities which would not otherwise have been present."

8. The claimants say that in this case liability arises under section l(2)(b). The 1976 Act provides at section 1 (4) that "In the case of an occurrence preceding the time of conception, the defendant is not answerable to the child if at that time either or both of the parents know the risk of their child being born disabled (that is to say, the particular risk created by the occurrence)...".
9. Section 1(5) of the 1976 Act that provides that "the defendant is not answerable to the child for anything he did or omitted to do when responsible in a professional capacity for treating or advising the parent, if he took reasonable care having due regard to then received professional opinion applicable to the particular class of case; but this does not mean that he is answerable only because he departed from received opinion".
10. Section 6(3) of the 1987 Act deals with how the 1976 Act is to be given effect in relation to product liability. It provides, so far as is material, that section 1 of the 1976 Act shall have effect as if "a person were answerable to a child in respect to an occurrence caused wholly or partly by a defect in a product if he is or has been liable [under the 1987 Act] in respect of any effect of the occurrence on a parent of the child, or would be so liable if the occurrence caused a parent of the child to suffer damage".
11. The claimants' pleaded case is that they were born disabled as a result of an occurrence within the meaning of section l(2)(b) of the 1976 Act and section 6(3) of the 1987 Act, and that the "occurrence" was "the transplacental spread of Sodium Valproate or its metabolites to the embryo/fetus, which then affected the embryonic and fetal development and organogenesis...".
12. The defendants respond to this pleading as follows:

i) First, it is said that there was no "occurrence" in the statutory sense because the regime that the claimants' mothers required to control their epilepsy was such that they were unable to have a "normal healthy child" (terminology derived from section l(2)(a) of the 1976 Act).

ii) It is said that the only "occurrence" that affected the mothers' ability to have a normal healthy baby was their epilepsy that required treatment with anti-epilepsy drugs, including sodium valproate.

iii) Thirdly, it is denied that any transplacental spread of sodium valproate or its metabolites constituted an "occurrence".

13. The defect that caused the occurrence is said by the claimants to be the teratogenic capacity of the sodium valproate. Their primary case is that information supplied with the drug to a user is not a relevant circumstance for the purpose of assessing the "legitimate expectation of safety of persons generally" for the purposes of the 1987 Act and the Directive. They also say that the information provided by the defendants was inadequate.
14. The defendants for their part say that all anti-epileptic drugs ("AED's") have unwanted side effects and "The current state of scientific knowledge does not permit any of the AED's currently on the market to be deemed free of teratogenic potential". They deny that "a pharmaceutical product such as Epilim is defective within the meaning of the Directive or the CPA where, by its very nature, its use carries a potential risk of adverse events and those potential risks are generally known to treating practitioners and/or specifically warned about by the marketing authorisation holder", that is to say the person authorised to supply the product under domestic and European regulations. They plead "The Claimants' primary case on defect is bad in law. The Directive and the Act cannot properly be construed so as to require a Court to have no regard to the essential factual context of the guidance provided to treating practitioners and/or specific warnings provided by marketing authorisation holders as to adverse events or "harmful characteristics" inherent in the use of a pharmaceutical product". Having referred to section 3 of the 1987 Act, the defendants go on to plead that "the Claimants' primary case would require the Court not only to ignore the express words of the statute, but to implement the statute in a manner that is precisely contrary to the express words of the statute".
15. The defendants also rely upon section 1(5) of the 1976 Act, pleading that to the extent that they were responsible for issuing information and advice for the treatment of patients with Epilim, they took reasonable care in relation to providing such information and advice.
16. The nature of the claimants' case is reflected in the assumptions upon which they propose that preliminary issues be tried. Those assumptions are the following:

"1. Epilim is a known human teratogen.

2. As such it is unsafe for all pregnant women whose fetuses are exposed to it.

3. Epilim forms part of a class of anti-epileptic drugs which it is necessary for epileptic women of child bearing age to take to prevent or reduce seizure activity (where treatable).

4. There is no safe alternative for pregnant women with epilepsy and for some forms of epilepsy Epilim remains appropriate therapy notwithstanding the fact that it is a teratogen.

5. The teratogenic properties of Epilim place a pregnant woman with epilepsy who is required to take the drug in an impossible dilemma to have regard to the requirement to take the drug to reduce the risk to herself and her fetus because of her epilepsy and the risk to any fetus caused by its teratogenic properties.

6. The nature of the true risk to the fetus is probably dependent on genetic make-up, which cannot be known in advance, rendering the risk a random one for any pregnant epileptic woman taking Epilim and her fetus.

7. Only gross teratogenic damage caused by exposure to Epilim, such as neural tube defects, can be detected antenatally, not all teratogenic damage.

8. Any fetus damaged as a result of Epilim's teratogenic properties can only be born in a damaged state.

9. The transplacental spread of Epilim or its metabolites to the embryo/fetus affects embryonic and/or fetal development and organogenesis, causing damage to the embryo/fetus and causing each claimant to be born disable.

10. And having regard to the information at the material times set out supplied by the defendant to -

10.1 Users...

10.2 Prescribes..."

17. It is necessary to explain something of the procedural history of this litigation. The first set of proceedings was served in August 2003. There was a Case Management Conference on 2 March 2005, at which time the litigation was directed against a number of companies who produced, or were said to have produced, different anti-epileptic drugs. A group litigation order was made by Master Turner on 27 July 2005, limited to claims relating to sodium valproate. Master Leslie held further case management conferences on 8 December 2005 and on 25 April 2005. At the latter he ordered that the parties should apply to the Clerk of the Lists to fix a trial date for a trial "of all matter (sic) relating to liability and causation in the FAC litigation", and made orders directed to a trial taking place in October 2008.
18. At that time the claimants had what Mr. Body, a partner of Messrs Irwin Mitchell who act for the claimants, described in his evidence as "public funding for the generic part of the case". Lord Brennan QC, who appeared for the claimants before me, told me that the funding that had been granted by the Legal Services Commission was to pursue to trial the claimants' cases as to liability and what he called "generic causation", subject to an annual "affordability review".
19. On 8 August 2006 the Legal Services Commission notified the claimants of a decision that effectively brought that funding to an end. It was not, I am told, taken under an "affordability review". Judicial review proceedings were brought against it by one of the claimants (presumably a representative claimant), and the case was heard by Mr. Justice Paul Walker in January 2007. In order to protect legal confidentiality only a summary of the judgment dated 15 March 2007 is available to the public, including the defendants, and therefore, of course, only that summary is available to me. It states that the decision of the Legal Services Commission that withdrew funding was quashed and the reasons were summarised as follows:

"The reasons for the decision of the court may be summarised as follows:

(1) The FRC [Funding Review Committee of the Legal Services Commission] failed to give reasons for rejecting one of the submissions advanced before the FRC by the FAC Claimants, namely a submission based upon the principle of fair apportionment of risk.

(2) There was insufficient evidence before the FRC to entitle it to reach the view that it did as to the FAC Claimants' prospects of successfully showing in the FAC Litigation that the quality of information and its transmission to the relevant recipients were insufficient.

(3) The FRC failed to give reasons for rejecting another of the FAC Claimants' arguments, namely that the pre-conception information was irrelevant."

20. Accordingly the Multi-Party Action Committee of the Legal Services Commission held a further hearing on 10 May 2007, and decided to provide some limited funding. Hence these applications.
21. There are currently 39 claims on the group register. There are a further 29 claims where claim forms have been issued and served but claims have not yet been put on the register. There are something like 100 further claims where there has not yet been investigation.
22. The claimants have put before me a witness statement of Mr. David Keegan who is director of the Special Cases Unit of the Legal Services Commission. He says that,

"Ensuring that high cost civil cases are subject to appropriate financial controls requires case managers to ensure funded cases comply with the spirit of the Woolf reforms in particular the overriding objectives of saving expense and dealing with the case in ways which are proportionate given the amount of money involved, the importance of the case and the complexity of the issues".

Thus, he refers to certain of the matters that the Civil Procedure Rules (at l.l(2)(b) and (c)(i)-(iii)) identify as aspects of dealing with a case justly. He does not refer to the other matters referred to in CPR 1.1(2): "ensuring that the parties are on an equal footing" (CPRl.l(2)(a)); "dealing with the case in ways which are proportionate to the financial position of each party" (CPRl.l(2)(c)(iv)); "ensuring that [the case] is dealt with expeditiously and fairly" (CPRl.l(2)(d)); and "allotting to it an appropriate share of the courts resources, while taking into account the need to allot resources to other cases" (CPRl.l(2)(e). The Civil Procedure Rules state a single overriding objective, namely "dealing] with cases justly", and to my mind it is not helpful to elevate the various elements (or some of the elements) that the CPR identify as contributing to it into distinct overriding objectives in their own right, as, according to Mr. Keegan, the Commission has done. Certainly the Court must seek to give effect to the overriding objective as a whole.

23. Mr. Keegan goes on to explain that, in the face of funding restraints, he reviews annually all current and potential multi-party litigation. He says that, as far as this litigation is concerned, the Commission's Funding Review Committee, following the decision in the judicial review proceedings, concluded that the case "had sufficient merits to meet the merits test contained within the Funding Code as long as the case proceeded on the basis that the preliminary issue on defect, which was alone capable of derailing the litigation, was decided first...". He continues as follows: "The Commission entirely respects the Court's role in managing litigation and we regret the late change in which the basis on which funding can be provided. However if the case is to continue to receive public funding that funding must be based on the scope provided by the Funding Review Committee alone. It follows that the case will have to be sent back to them for review if the case cannot proceed by way of a trial on a preliminary issue".
24. My understanding of this evidence is as follows: when Mr. Keegan refers to "the preliminary issue on defect", he is referring to a proposed preliminary issue, but I cannot tell whether he had a specific proposed issue in mind or whether the Commission's thinking had not developed beyond the general notion of some preliminary issue relating to "defect". I do not think it likely that the Commission specifically decided that the preliminary determination should be directed to whether there was a defect within the meaning of section 3 of the 1987 Act rather than an occurrence within the meaning of section 6(3) of that Act and of the 1976 Act. Certainly the claimants have proceeded on the basis that the Commission was not distinguishing between a defect and an occurrence. As Lord Brennan has explained, they have put forward three preliminary issues directed to whether there was an occurrence in the statutory sense and three directed to whether there was' a defect giving rise to the occurrence, and it has not been suggested that their proposal is other than in accordance with what the Commission had in mind. When Mr. Keegan refers to the case proceeding "by way of a trial on a preliminary issue" he is referring, I take it, to the case proceeding by way of the trial of the preliminary issue which he and the Commission contemplate. In the event, the claimants have suggested not one preliminary issue but six, but, as' I understand it, the Commission is content that they should do so.
25. Lord Brennan submitted, indeed he expressed his opinion, that unless the court accedes to the views of the Legal Services Commission as to how this litigation should proceed, it is likely that funding will be discontinued. This submission, I think, goes further than the evidence of Mr. Keegan, and, not knowing what Paul Walker J decided beyond the public summary, I do not know whether such a decision would be in accordance with his judgment.
26. In these circumstances the claimants apply by a notice dated 21 June 2007 to have the following issues determined before other issues:

"1. Does the occurrence in this case for the purposes of section 1(2) of the CDCLA fall within section l(2)(b) and not section l(2)(a) of the CDCLA?

2. Is the determination of notional liability to the claimant's mother for the purposes of section 1(3) of the CDCLA and section 6(3) of the CPA limited to the same factual matrix as that which is relevant for the claim by the claimant for injury sustained in utero?

3. If not, what facts and matters may the Court have regard to in determining such notional liability which would not be relevant to the claim by claimant for injury sustained in utero?

4. In particular, is any particular knowledge acquired in the given case as to the teratogenetic [sic] properties of Epilim by:

4.1 the prescriber of Epilim and or other treating clinicians imparted to the claimant's mother; and

4.2 the claimant's mother; relevant to the determination of whether Epilim as supplied was defective within the meaning of section 3 of the CPA and article 6 of the directive?

5. As a matter of law:

5.1 Is the determination of whether Epilim is or is not defective a generic one based on the expectation of safety of persons generally?

5.2 Is it necessary for a finding that Epilim is defective that it should have to be or should have been withdrawn from the market?

6. In the light of the answers to the foregoing questions and on the factual assumptions the court is invited to make, was Epilim defective as supplied within the meaning of section 3 of the CPA and article 6 of the Directive?"

27. The claimants also suggest that it would be helpful for two test cases to be selected "to illustrate factual matters", and that to this end there should be "fresh statements of case relating directly to the questions posed to the court so that any further issues capable of being dealt with on a preliminary issue basis are identified and so that there is clarity as to the parties' positions". The thinking is that this will be a "further safeguard against any failure to properly identify the relevant issues for the court". The claimants envisage that the court would revisit the definition of the preliminary issues in light of such pleadings. They contemplate that some evidence might be needed upon the hearing of the preliminary issues, but it would be limited.
28. On 14 June 2007 the matter came before Master Leslie on an application that his order be revoked. His preliminary view was that it might very well be outside his jurisdiction to revoke or to vary an order in which he had determined how this litigation should be tried and that it may be necessary for the proposal to be pursued by way of appeal. He directed that the applications be heard by a judge. He also expressed concern about whether the Legal Services Commission were inappropriately seeking to influence the course of the proceedings, saying "one of the things that occurs to me ... is this nasty feeling that the Legal Services Commission is dictating to me what my case management functions are, and for my part I will not stand for it".
29. The claimants say that since Master Leslie made his directions on 25 April 2006 there has been a change of circumstance, in that the claimants have no funding to have the whole of liability and generic causation tried. The essential questions in these circumstances, they say, are whether a trial of preliminary issues would be dispositive, whether it would be workable, whether it would save costs, time and use of court resources, and whether it is just to make the order having regard to the position of the parties, including importantly their economic ability to litigate the issues.
30. The defendants argue against the claimants' proposals. Their first contention is that the court should not reopen the decision taken by Master Leslie on 25 April 2005 either by way of a granting an application under CPR 3.1(7) or by way of allowing an appeal. They rightly observe that in order to appeal the claimants would need permission to apply for permission to appeal out of time and then permission to appeal, and remind me that, when considering whether to grant permission to apply out of time, I should have regard to the considerations identified in CPR3.9(1). As for the application under CPR 3.1(7), they submit that there has not been a change of circumstances that would justify this.
31. The power to revoke or to vary an order made under the CPR is expressed (at CPR 3.1(7)) in unqualified terms. However, in Collier v Williams. [2006] EWCA Civ 20 , [2007] 1 All ER 991, the Court of Appeal referred at paragraph 39 to the judgment of Mr. Justice Patten in Lloyds Investment (Scandinavia) Ltd v Ager-Hanssen, [2003] EWHC 1740 (Ch), [2003] All ER(D) 258 (Jul), in which he said:

"Although this is not intended to be an exhaustive definition of the circumstances in which the power under CPR Pt 3.1(7) is exercisable, it seems to me that, for the High Court to revisit one of its earlier orders, the applicant must either show some material change of circumstances or that the judge who made the earlier order was misled in some way, whether innocently or otherwise, as to the correct factual position before him. The latter type of case would include, for example, a case of material non-disclosure on an application for an injunction. If all that is sought is a reconsideration of the order on the basis of the same material, then that can only be done, in my judgment, in the context of an appeal. Similarly it is not, I think, open to a party to the earlier application to seek in effect to re-argue that application by relying on submissions and evidence which were available to him at the time of the earlier hearing, but which, for whatever reason, he or his legal representatives chose not to employ".

The Court of Appeal continued at paragraph 40:

"We endorse that approach. We agree that the power given by CPR3.1(7) cannot be used simply as an equivalent to an appeal against an order with which the applicant is dissatisfied. The circumstances outlined by Patten J are the only ones in which the power to revoke or vary an order already made should be exercised under CPR 3.1(7)".

32. The defendant argues that here there is no material change of circumstance that would permit the court of exercise its power under CPR 3.1(7) to vary the order of 25 April 2006. They say that nothing has changed except that the Legal Services Commission has changed its position with regard to funding this litigation, and that this is not a legitimate matter for the court to take into account. They rely upon section 22 to the Access to Justice Act 1999:

"... any rights conferred by or by virtue of this Part on an individual for whom services are funded by the Commission as part of the Community Legal Service or Criminal Defence Service in relation to any proceedings shall not affect - (a) the rights or liberties of other parties to the proceedings, or (b) the principles on which the discretion of any court or tribunal is normally exercised".

The relevant Part of the 1999 Act provides for the establishment of a Legal Services Commission and (at section 7) that the Commission may fund services for an individual litigant. The claimants described the section as conferring "a contingent entitlement to legal aid". The defendants say that for similar reasons the court should not give permission to appeal or even extend time to seek such permission.

33. I am not persuaded by these arguments, to which I shall refer as the "defendants' procedural arguments".
34. There are three parts to the notices of application: the claimants seek:

i) First, that the order made on 25 April 2006 be set aside (or in the terminology of CPR 3.1(7), revoked);

ii) Secondly, to appeal against the order made on 25 April 2006, and that the necessary permissions to do so be granted;

iii) Thirdly, a trial of preliminary issues in lieu of a trial of all matters relating to liability and causation.

35. The position with regard to what Master Leslie ordered on 25 April 2006 is not as clear as it might have been. I understand it to be as follows. It was contemplated that there should first be a trial of test cases. The order accordingly recorded that the parties' solicitors should seek to agree appropriate test cases as soon as possible. No number of test cases was specified, and I understand that test cases have not yet been identified.
36. It was common ground that that trial should not be concerned with quantum. There was an issue as to whether the trial should deal with all questions of liability and causation (as the defendants argued) or whether (as the claimants submitted) there should be a separate and subsequent determination of what has been called the DRD issue (or the development risk defence issue), that is to say whether the defendants have a defence under section 4(l)(e) of the 1987 Act. The Master ruled that the DRD issue should not be tried separately.

"There will be a great overlap between the issue of development risk defence and what the defect was. There will be common witnesses of fact... on behalf of the defendants, but much more importantly there will be inevitably a huge exercise in trawling through documentation. It seems to me to have to go through that twice potentially is simply too onerous for the defendants. I am conscious of the fact that the trial of the DRD issue may prolong the trial and may even double its length, I suppose, but it seems to me that that is answered in two ways. First of all balancing that effect against the onerousness of the disclosure exercise, it seems to me that they are fairly finely balanced, but, on the other hand, it does seem that what apparently happened before Mr. Justice Mackay in the earlier litigation ... is something that may find favour with the trial judge in due course. That is to say, hearing the evidence and trying the issue of liability or existence of defect and/or causation before proceeding to hear the development risk defence evidence and/or submissions. It seems to me that the balance falls clearly on having all issues connected with liability dealt with at the same time but I remain, as I have said at the outset, satisfied that the claimants should know what it is that the defendants say in response to their reply, the burden lying on the defendants to make out their development risk defence".

37. To my mind the Master's thinking was sound and in accordance with the overriding objective. He was properly anxious about imposing upon the trial a programme which involved duplication of evidence. This consideration is particularly important in a case of this complexity. It often proves unsatisfactory for complex evidence (whether factual or expert) to be divided into what appear to lawyers to be convenient divisions, which might well not accord with how a scientific or expert witness would naturally present and explain his testimony. The decision of the Master was, as I see it, rightly directed to saving expense, dealing with the case expeditiously and fairly and allotting to it an appropriate share of the court's resources,
38. However, the order that was drawn up after the hearing (dated 31 May 2006) recorded neither Master Leslie's decision about the DRD issue nor that there should be a separate trial of quantum (except in so far as the latter was reflected in the direction to the parties about applying to the clerk of the lists). There was no application before him (on 25 April 2006 or at any time) that there should be preliminary issues along the lines now proposed, and, as far as I am aware, no consideration of whether the trial might be managed along such lines. Admittedly the Master explained his decision in terms that might be interpreted as rejecting any preliminary issue involving splitting the determination of liability, but his words must be read in light of what he was being asked to decide. (There was an order for preliminary issues relating to limitation periods, but that does not bear upon what I have to decide.)
39. The first answer to the defendants' procedural arguments is that the claimants do not need to revoke or vary the order of 25 April 2006 or to appeal against it in order to apply for these preliminary issues. Indeed it is clear that they do not seek to revoke the whole of the order drawn up on 31 May 2006 and it is impossible to identify any provision in the order that they need to have varied or reversed on appeal in order to achieve their purpose. The claimants' real application is no more than that there be a trial of preliminary issues in lieu of a trial of all matters relating to liability and • causation. Of course, it is open to the defendant to argue that this application should not be granted because it should have been made earlier, and such arguments are properly to be weighed in deciding whether the application should be granted, but that is very different from the defendants' procedural arguments objecting to an order under CPR 3.1(7) or to permission being given for an appeal. I mention in this context that there has not yet been disclosure or any exchange of evidence.
40. Secondly, I do consider that there has been a material change of circumstance since 25 April 2006 in that there has been a significant change in the claimants' funding position. The evidence of Mr. Body is that "generic funding" was withdrawn from the claimants after the hearing in April 2006. As I have said, I am told that that funding was to have been provided for the trial of questions of liability and so called generic questions of causation (in contradistinction to questions of causation relating to individual cases) subject only to "affordability reviews". It is clear that the funding presently available is much more limited. As Mr. Keegan apparently acknowledges, it might be that in the future the original funding will be restored (although I do not overlook Lord Brennan's doubts about that), but the fact remains that as things stand the funding available to the claimants has been significantly curtailed from what they understood in April 2006 to be available to them. I do not find the evidence about the precise funding position in April 2006 and at present as clear as might be wished. However, it is clear to me that there has been a significant change adverse to the claimants. I find support for this conclusion in what Mr. Justice Paul Walker (who knew more of the history of the funding in 2006 than I do) said in the summary of his judgment.
41. I reject the submission that section 22 of the Access to Justice Act 1999 precludes me from having any regard to this change in the claimants' funding position when exercising my discretion about how this litigation should be managed. The change of position that the claimants identify does not depend upon the source of the funding of the litigation being public funding under the 1999 Act. The position would be the same if the claimants were reliant upon limited funding provided by, say, a bank. Even assuming (because the claimants did not argue otherwise) that the possibility of funding under part I of the 1999 Act amounts to "rights" within the meaning of section 22, I am unable to see why by accepting the claimants' proposals I would be allowing those rights to affect the principles on which I exercise my discretion in case management, still less how this would impinge upon any question of how the discretion of the court is normally exercised. It would perhaps be surprising if it did do so, given that the overriding objective recognises that dealing with a case justly involves (among other things) dealing with it in ways proportionate to the financial position of each party.
42. I therefore come to the substance of the claimants' application and proposals for preliminary issues. I say at the outset that I have a good deal of sympathy for the purpose lying behind them, and would have much sympathy quite apart from their funding problems. The litigation presents the prospect of a protracted trial: the estimate of the trial contemplated by Master Leslie in April 2006 was 18 weeks, and that, inevitably, was an uncertain estimate made before disclosure and witness statements were exchanged. I see real force in Lord Brennan's submission that "There really has to be some kind of solution to these pharmaceutical claims ... and the court should be ... not just astute to finding an appropriate solution but where appropriate being radical in finding one, provided it is within the context of the overriding objective".
43. In saying this, I do not overlook the many warnings in the authorities of snares in alluring preliminary issues designed to save time and costs. Product liability under the 1987 Act is an area of law which is uncertain and developing (as a mere glance at the judgment of Burton J in A and others v National Blood Authority and others (2001) 65 BMLR 1 demonstrates). In Barrett v Enfield LBC. [2001] 2 AC 550 at p.557E/G, Lord Browne- Wilkinson said: -

"In my speech in the Bedfordshire case [1995] 2 AC 633, 740-741 with which the other members of the House agreed, I pointed out that unless it was possible to give a certain answer to the question whether the plaintiff's claim would succeed, the case was inappropriate for striking out. I further said that in an area of the law which was uncertain and developing (such as the circumstances in which a person can be held liable in negligence for the exercise of a statutory duty or power) it is not normally appropriate to strike out. In my judgment it is of great importance that such development should be on the basis of actual facts found at trial not on hypothetical facts assumed (possibly wrongly) to be true for the purpose of the strike out."

44. Undoubtedly proposed preliminary issues need to be rigorously scrutinised in light of warnings such as these and in light of experience, but that is not to say that they should be routinely eschewed, and it might be that an application specifically directed to questions of preliminary issues affords an opportunity for such scrutiny more readily than an application to strike out proceedings.
45. I therefore examine both the proposed issues and the assumptions upon the basis of which (whether or not supplemented by evidence) it is suggested the court should try them. I make it clear that in doing so I do not intend to seize upon infelicities of drafting which might be remedied. My purpose is to examine whether they reveal the essence of a case management proposal which make practical sense and accords with the overriding objective. The thinking behind the proposal was explained by Mr. Body thus:

"The proposal would not require the court to hear any expert evidence and possibly not any factual evidence because it would be based on assumed facts. It would require the court to answer critical questions which will either dispose of the claims such that the claims would be brought to an end, or if the claimants are successful, limit the evidential enquiry later required."

It is the claimant's case that the assumptions that are proposed are either uncontroversial or essential for the claimant's to succeed in the litigation.

46. I have set out above the six issues that the claimants proposed. In the course of the hearing before me, their proposal was refined. They no longer suggest that the following be determined as preliminary issues: those numbered 2 (Is the determination of notional liability to the claimant's mother for the purposes of section 1(3) of the CDCLA and section 6(3) of the CPA limited to the same factual matrix as that which is relevant for the claim by the claimant for injury sustained in utero?); 3 (If not, what facts and matters may the Court have regard to in determining such notional liability which would not be relevant to the claim by claimant for injury sustained in utero?); 4 (In particular, is any particular knowledge acquired in the given case as to the teratogenic properties of Epilim by: 4.1 the prescriber of Epilim and or other treating clinicians imparted to the claimant's mother; and 4.2 the claimant's mother; relevant to the determination of whether Epilim as supplied was defective within the meaning of section 3 of the CPA and article 6 of the directive?); and 5.2 (As a matter of law: ...Is it necessary for a finding that Epilim is defective that it should have to be or should have been withdrawn from the market).
47. It is not, I think necessary generally to explain why these proposed issues were not pursued by the claimants, but I agree that they are not appropriate preliminary issues. However, I shall refer further to proposed issue (4) later.
48. Particularly in a case of such complexity as this, it is necessary that the assumptions are precise and unambiguous. Otherwise, the assumptions provide no adequate foundation for the enquiry, they need to be expanded and explained by evidence and much of the purpose of having preliminary issues is lost. Of course, it is recognised that it might be necessary to supplement the assumptions with some limited evidence, but the more that is required, particularly if it is necessary to have complicated scientific and pharmacological evidence, the less the attraction of the proposal for preliminary issues.
49. I do not propose to go through each assumption and test it against these considerations and the purpose of the proposal identified by Mr. Body. It is sufficient to illustrate my concerns.
50. The second assumption is that Epilim "is unsafe for all pregnant women whose fetuses are exposed to it". Lord Brennan told me that it was not intended that the description of Epilim as "unsafe" for all such women should mean that "the safety of the product is not such as persons generally are entitled to expect" within the meaning of section 3 of the 1987 Act. In that case, what does it mean? What degree of risk and what potential damage or disabilities would be sufficient for the drug to be described as "unsafe for all pregnant women whose fetuses are exposed to it"? Does the assumption direct the judge to proceed on the basis that the fetuses of all pregnant women who take Epilim are "exposed" to it? Is it to be assumed that a single dose, however small, taken at any stage during pregnancy, is unsafe? Is the judge to assume that there is a risk for any woman whatever her genetic makeup and whatever the genetic makeup of the fetus, or is he to assume simply that no woman can know that she is not at risk given the present state of medical and scientific knowledge? The latter interpretation might be indicated by the sixth assumption but the former seems to me closer to the wording of the second assumption. The second assumption illustrates why I am concerned that the assumptions do not, and however drafted cannot, provide a clear and precise factual basics for the determination of the issues. It is said that this assumption follows from the first assumption that Epilim is a known teratogen, and that the issue for the court is whether this combined with other circumstances renders Epilim a product which has a defect within the meaning of the 1987 Act, and that there is no legitimate expectation of absolute safety. This may be so, but in that case I find it difficult to understand how this assumption will assist the resolution of any issue.
51. The seventh assumption is that "only gross teratogenic damage caused by exposure to Epilim, such as neural tube defects, can be detected antenatally, not all teratogenic damage". The claimants present this as a largely uncontroversial matter. This does not seem to me to be the case. It is admitted in the defence that gross abnormalities such as neural tube defects can be detected antenatally (howsoever caused). As I understand it, there is an issue as to whether other abnormalities can or cannot be detected, and I can readily foresee that in any event questions will arise as to the stage of pregnancy at which abnormalities can be detected.
52. The eighth assumption (that "any fetus damaged as a result of Epilim's teratergenic properties can only be born in a damaged state") is again said by the claimants to be one that should be "entirely uncontentious". It is said that "if it is established by the claimant that he or she was damaged in utero by exposure to Epilim, it follows as a matter of basic logic that he or she can only be born in that state". This ignores the pleaded issue in the defence that some abnormalities may resolve spontaneously. I am simply unable at this stage in the proceedings to dismiss this as fanciful. In any case the assumption is again couched in unqualified terms and upon close consideration of the issues and in light of greater understanding of the facts a more refined approach might well be required. For example, even if the defendants do not show that any defects entirely resolve spontaneously, it might be that some are much ameliorated in the course of development in utero.
53. The ninth assumption is an important one. It is that "the transplacental spread of Epilim or its metabolites to the embryo/fetus affects embryonic and/or fetal development and organogenesis...". Again it seems to me probable that, if the judge were to be faced with deciding this proposed issue, he will need a clearer understanding of the "transplacental spread" that the assumption requires him to make. He might well need to know whether he is to suppose a gradual spread throughout the pregnancy or a spread on one defined occasion. And, of course, if he hears evidence of this kind, the judge might conclude that the assumption of transplacental spread that he is required to make is unsound, and this would belie an assumption that he is required to make.
54. Other examples could be given, but these suffice to indicate the difficulties that will probably, indeed almost inevitably, result from asking a judge to make assumptions of this kind.
55. I come to the first of the questions which the claimants invite the court to direct be determined as a preliminary issue: "Does the occurrence in this case for the purposes of section 1(2) of the [1976 Act] fall within section 1(2) (b) and not section l(2)(a) of the [1976 Act]?" Two major difficulties, to my mind, are immediately apparent. First the formulation of the issue tacitly assumes that there was an "occurrence". As I have explained, that is in dispute. Secondly the formulation of the issue appears to suppose that there is a single relevant "occurrence" which falls either within section l(2)(b) or within section l(2)(a), that is to say that it occurred either before conception or after conception. It does not allow for the possibility that the "occurrence" was by way of an accumulation of the drug within the mother, and a judge trying this preliminary issue might well be embarrassed to be asked to place the occurrence exclusively under one sub-section rather than the other.
56. These are not mere drafting points. At one stage during the hearing, I was attracted to the possibility of a preliminary issue whether on the assumption of the matters pleaded by the claimants the "transplacental spread of sodium valproate or its metabolites to the embryo/fetus" is an occurrence in the relevant statutory sense. This appeared attractive because this is the only basis upon which the claimants plead that there was a relevant occurrence. If they fail to show that this can be an "occurrence" as a matter of law, their case would fail. A decision adverse to the claimants would be dispositive of the litigation.
57. Mr. Michael Spencer QC, representing the defendants, expressed concern that this question could not be decided without evidence. Upon reflection I think that he is right, or at least that it would be wrong for the parties not to be permitted to adduce evidence if such an issue were to be determined. After all, in other contexts, it has been recognised that the word "occurrence" connotes a "degree of unity in relation of cause, locality, time, and, if initiated by human action, the circumstances and purposes of the persons responsible": I cite from the award of Mr. Michael Kerr QC in the Dawson's Airfield Arbitration dated 29 March 1972, which has informed much consideration of the meaning of the term "occurrence" in the context of insurance policies. On such a view, the question whether the claimants' pleaded case as to "occurrence" is right is likely to require evidence about the nature of the transplacental spread which is alleged: that is to say, expert evidence and possibly factual evidence, for example if the nature of the spread might be affected by the mother's genetic makeup or her activities during pregnancy.
58. I am not, of course, in a position to form a firm view about the sort of issues which would arise. I have said enough, I hope, to explain why I do not consider the first proposed issue to be suitable for determination upon hypothetical facts.
59. As I have explained, the fourth issue is no longer put forward by the claimants as suitable for a preliminary hearing in its present form. This was because, in the course of the exchanges during the hearing, Mr. Spencer made it clear that the defendants do not argue that knowledge (whether of the particular claimant's mother or of others who imparted information to her) bears upon the question whether Epilim had a "defect" in the statutory sense. In doing so he observed first that knowledge might be relevant to causation in any particular case, and secondly, that evidence of knowledge might inform a decision as to the adequacy or otherwise of information supplied with Epilim. However on this basis knowledge per se is not relevant to a preliminary issue on "defect". This raises the question as to whether, in place of the fourth issue, an issue might be formulated as to the relevance or otherwise of information supplied by the defendants to the question whether Epilim had a "defect".
60. Mr. Spencer accepted, as I understand it, that this might be decided without evidence and as a matter of law. However it does not seem to me that by itself it would be a useful question for determination. After all, the starting point would, I suppose, be section 3 of the 1987 Act which expressly states that account shall be taken of "all the circumstances" including "any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product". I am unable to understand how a preliminary question of law along these lines could develop the position significantly beyond the simple words of the statute, and I am unable to see how this issue might be dispositive of the litigation, however it was determined.
61. I come to the question in issue 5.1: here the court is asked to determine as a matter of law whether the question whether Epilim is or is not defective is "a generic one based on the expectation of safety of persons generally". As I understand it, the thinking behind this formulation is that there is apparently a difference between the parties as to how the court is to approach the statutory test of "defect" by reference to the safety of the product being such as "persons generally" are entitled to expect. In this case, the question arises in relation to a product of which, I might suppose, many persons are simply unaware. Might an issue be formulated in terms of what knowledge is to be attributed to "persons generally"? In my judgment, it would not be satisfactory to decide that question on the basis of assumptions and without a firm factual and evidential basis. After all, before it can be said that any knowledge should be attributed to "persons generally", it would have to be considered whether that supposed knowledge is scientifically established.
62. The final issue is a general one as to "defect". It is formulated in the following terms:

"In the light of the answers to the foregoing questions and on the factual assumptions the court is invited to make, was Epilim defective as supplied within the meaning of section 3 of the [1987 Act] and article 6 of the Directive".

63. I do not understand that it is suggested that this question is suitable for a preliminary issue by itself. As the formulation indicates, it was designed to present a conclusion from earlier questions. I have indicated enough of my concerns to explain why it does not seem to me suitable as a preliminary issue.
64. I am therefore driven to reject the claimants' applications for an order for the trial of any of these six questions as preliminary issues. I deliberately put my decision in these narrow terms because I do not want to restrict the freedom of Mr. Justice Underhill to manage the litigation as he sees fit. For the same reason I direct that there be liberty to apply to Mr. Justice Underhill in respect of my ruling. I hope that this will mean that should he, in the course of his responsibilities for the litigation, wish to revisit what I have decided, he will be free to do so whether or not there is a change of circumstances such as would normally be required for a judge of parallel jurisdiction to reverse or vary my decision. Mr. Spencer rightly observed that sometimes bolder case management decision can appropriately be made by a judge assigned to a case than by others.