“(1) Subject to the following provisions of this section, there is a defect in a product for the purposes of this Part if the safety of the product is not such as persons generally are entitled to expect; and for those purposes “safety”, in relation to a product, shall include safety with respect to products comprised in that product and safety in the context of risks of damage to property, as well as in the context of risks of death or personal injury. (2) In determining for the purposes of subsection (1) above 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, the use of any mark in relation to the product and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product; (b) what might reasonably be expected to be done with or in relation to the product; and (c) the time when the product was supplied by its producer to another; and nothing in this section shall require a defect to be inferred from the fact alone that the safety of a product which is supplied after that time is greater than the safety of the product in question.”
“5.1 - The product was defective as defined in the Directive and the Act because the safety of the Product was not such as persons generally were entitled to expect in that the capacity of the Product to cause adverse effects consequent upon or following discontinuance (withdrawal) was such as to prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking the product, to an extent greater than other SSRIs (emphasis added); 5.2 - (a) the adverse effects, and (b) the need to continue taking the product, amount to a personal injury.”
“Question 6: In contending that Seroxat was defective for the reasons alleged in paragraph 5.1 of the Particulars of Claim, is it the Claimant’s case that the benefits of Seroxat against other SSRIs for a particular Claimant are material or to be taken into account?”
“No.” “Question 7: If so: (a) is it contended that Seroxat had lesser benefits for every Claimant than other SSRIs?; (b) please identify each benefit and each SSRI being referred to?”
“Strictly, given the answer to 6, an answer is not required. However, in the event that potential benefit is determined to be of relevance, the Claimants denies (sic) that the Product had or has any or any greater effectiveness or other substantial benefit when compared with other SSRIs.”
“No answer required, given the answer to 6” (emphases added) To this question 6, the Claimants answered: “No.”
“No answer required, given the answer to 6”
“Is it the Claimants’ contention that even if there were therapeutic benefits available from Seroxat not available from any other SSRI, Seroxat should have carried the warnings identified at paragraphs 12.3.4.1 to 12.3.4.3? A: This is irrelevant but the answer is yes.”
“39. For the avoidance of doubt, it is denied that a defect, within the meaning of the 1987 Act, in a prescription-only medicine can be established by comparing the incidence and/or severity of a particular adverse reaction associated with that medicine against the incidence and/or severity of that adverse reaction associated with another prescription-only medicine. The producer of a prescription-only medicine cannot properly compare its medicine with all other “comparator” medicines either at the stage of development, post marketing or in its product literature.”
“40. Without prejudice to the foregoing denial, it is averred that any proper comparison between medicines would have to include a comparison of the relative risk/benefit profiles of the medicines being compared, both generally and for the particular Claimant in question. Such an analysis would include consideration of: (a) The relative efficacies of the medicines being compared. (b) The time likely to be taken to achieve steady state and, therefore, to achieve therapeutic efficacy. (c) The indications and contra-indications of the medicines being compared. (d) The available formulations of the medicines being compared. (e) The risks associated with the medicines being compared, including those associated with a longer half-life, for example, in overdose and when switching from one medication to another; and (f) The adverse reactions associated with the medicines being compared.”
“(c) Yet further and in any event, as explained above there was no basis for distinguishing between Seroxat and other SSRIs in relation to efficacy or nature of adverse reactions…”
“a) Does Seroxat have a “capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as to prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking”
“4. The first question confronting Foskett J was whether the claim should be allowed to proceed given the reason for the trial in 2011 having been vacated and the prolonged interval before it had been restored before the Court. In his judgments of February 2016 and March 2017 Foskett J determined that the fair course was to allow the litigation to go forward, but only on the basis that the Claimants’ case should remain as pleaded at the date of the vacated trial. I will return to those judgments later but pause here to note that Foskett J set out his analysis of the pleadings and the parties’ respective cases in some detail in those two judgments as it was the necessary context for his handling of the case management issues which arose. He recorded in March 2017 that the accuracy of his earlier summary (in February 2016) of the essential nature of the case advanced on behalf of the Claimants was common ground between the parties. Neither ruling was the subject of appeal.”
“The issue which arises is whether in considering whether the safety of the product, Seroxat, is such as persons generally are entitled to expect, the Claimant is entitled on the pleadings to advance the case that Seroxat has no particular benefits relative to other drugs in the appropriate comparator group. The Claimant is not entitled to do so. As recorded in judgment of February 2019, the relative risks and benefits of Seroxat and its comparators do not form one of the issues at trial, other than in respect of discontinuation symptoms; and they do not form one of the issues at trial because of the Claimant’s pleaded case. It does not follow from the Defendant’s pleadings and, in particular, from the absence of a positive pleaded case on the benefits of Seroxat compared with other drugs in the comparator group (save in respect of the number of conditions for which Seroxat is licenced) that the Defendant has conceded that Seroxat has no particular relative benefits and/or that the Claimant is entitled to advance the case that Seroxat has no particular relative benefits.”
“35. ...the issue which is addressed in this ruling (and which has taken considerable court time to ventilate) has already been covered, centrally, by Foskett J in March 2017 and also by myself in my ruling in February 2019. As I have already said, there has been no appeal from either of those rulings. What the Claimants have sought to do by opening the case in the way they have, is to seek to justify the limited approach (said to be flawed by the Defendant) on defect on the basis of an asserted concession by the Defendant that if a wider risk/benefits analysis were to be undertaken it would reveal a level playing field across the class of drugs. This case simply does not square with the Claimants’ pleaded claim nor with Foskett J’s analysis, nor mine. If either Foskett J or I were thought to be wrong in our analysis, then the proper course would have been to have appealed the relevant rulings. It is now too late to do so.”
“….what is sought to be alleged in these proceedings is that it is worse than other drugs of a similar nature in relation to symptoms following discontinuation of its use. It is pleaded on behalf of the Claimants that “the capacity of [Seroxat] to cause adverse effects consequent upon or following discontinuance (withdrawal) [is] such as to prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking [it], to an extent greater than with other SSRIs.”
“…I wish to proceed on a step-by-step basis with a careful eye on the costs of each step. I do not intend to “micro-manage” this litigation, but I need to see to what extent certain crucial stages are capable of being achieved and at what cost before I can obtain a sense of how realistic it is that it can proceed.”
“a. at [11] it was common ground that he had summarised the essential nature of the case advanced on behalf of the Claimants accurately in his first judgment; b. at [12] that the Claimants’ primary and secondary case were translated into the agreed issues set out in the GLO; c. at [13] that Mr Gibson QC (for the Defendant) had characterised the primary allegation as being that Seroxat was “worst in class”, in other words that Seroxat was the worst in the class of SSRIs because of the greater difficulty relative to other SSRIs of a user of Seroxat discontinuing his/her use of the drug and the consequent prolongation of discontinuation symptoms. Foskett J approved this characterisation of the Claimants’ case, stating that it was accurate; d. at [15] the Defendant’s case throughout the litigation had been that the approach to the primary issue adopted on behalf of the Claimants was fundamentally misconceived and that the Defendant’s case was that it was necessary to look at a prescription only drug of this type “in the round” before deciding that it is defective, taking into consideration amongst other things, a risk/benefit analysis of its features. This case had been advanced in the Defence served in September 2008 at paragraph 40 and then put in issue in the Amended Reply. Foskett J then set out the Request for Further Information served by the Defendant concerning the need to address the relative benefits of Seroxat (against other SSRIs) in considering whether the drug was defective and the Claimants’ negative response to this Request; e. at [20] the Defendant’s assertion that, since the close of pleadings, the Claimants’ case had proceeded only on the basis of the “worst in class for discontinuation symptoms for SSRIs” allegation and the associated allegation of failure to warn that Seroxat was “worst in class” in this respect was justified; f. at [23] since the action had been before him, it had been the consistent position of the Claimants’ team led by Ms Perry QC that the case would continue (if permitted to do so) only on the basis of the pleaded case and the issues defined in the way in which he had described them. There had been no application to amend the Particulars of Claim nor to expand upon the issues identified in the GLO; g. at [23] his case management of the claim had been intended “purely to enable the effective resurrection of the issues that came to rest in 2011” (Foskett J’s emphasis); h. at [24] any attempt on behalf of the Claimants (or the Defendants) to expand the case “outside those well-defined parameters” would not have his approval. This is the “unequivocal starting point” for the issue in hand (which was the scope of the report by Professor Healy); i. at [27] the issues for his determination of the litigation have been clearly and closely defined over a period of years and subject to the updating of the disclosure exercise and the expert evidence, the parameters for the forthcoming trial have not changed. The new legal team has not sought to change things although there has been “a hint in some of Mr Lambert’s submissions that there is now a desire to engage, at least to some extent, in a risk/benefit analysis, something which had previously been expressly disavowed. If there is any such a desire or intention, then the short answer to it is that it is now too late to do so.””
“(1) Is it appropriate in principle to assess whether the prescription-only medicine Seroxat is defective pursuant tos. 3 of the Consumer Protection Act 1987 (“the Act”) by seeking to establish whether it is “worst in class” in that: (1)(a) It causes adverse effects on discontinuation which are (i) of a greater incidence; (ii) a greater severity; and (iii) a longer duration than the other medicines in the class; and that (1)(b) Such adverse effects prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from Seroxat than is the case with the other medicines in the case?” (1)(a) It causes adverse effects on discontinuation which are (i) of a greater incidence; (ii) a greater severity; and (iii) a longer duration than the other medicines in the class; and that (1)(b) Such adverse effects prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from Seroxat than is the case with the other medicines in the case?”
“24. I also cleared the decks of a pleading issue which had arisen during the course of Mr Kent’s submissions. It concerned the extent to which the relative risks and benefits of Seroxat (as compared with other drugs in the appropriate comparator class) were in issue at the trial and, if not, why not. At [15] of the judgment I ruled that the relative benefits of Seroxat would not form an issue at trial, noting that neither party submitted that the topic was in scope...”
“If either Foskett J or I were thought to be wrong in our analysis, then the proper course would have been to have appealed the relevant rulings. It is now too late to do so.”