“5. … what is sought to be alleged in these proceedings is that [Seroxat] 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." 6. That is the essential (and primary) nature of the case advanced. If that allegation is established as a matter of fact, it is alleged that it gives rise to the conclusion that the drug is "defective" withinsection 3 of the Consumer Protection Act 1987 ('the 1987 Act'). 7. The alternative (and secondary) allegation is that Seroxat is defective because it is "marketed and sold without warnings that it [causes] more or greater symptoms on discontinuation than all other SSRIs".”
“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. 41. Further, if, which is denied, a defect in a prescription-only medicine can be assessed by comparing such medicine against another prescription-only medicine, it is denied that the proper range of medicines against which Seroxat should be compared should be limited to the other SSRIs. By way of example, the Claimant was prescribed a range of antidepressant medication for the treatment of her conditions. Each of these medications, and others, would have been considered or capable of being considered by the prescribing doctor as treatment for the Claimants’ conditions.”
“Request 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? 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? (c) Please explain why, if it is, the “comparator” group is limited to other SSRIs. If it is not so limited, please identify the other pharmaceutical or other products or treatments which form part of the “comparator” group.” “Replies 6. No. 7. (a) 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 Claimant denies that the Product had or has any or any greater effectiveness or other substantial benefit when compared with other SSRIs. (b) No answer required, given the answer to 6. (c) Strictly, the answer to 6, an answer is not required. However, the comparators are limited to SSRIs because i. other anti-depressants (such as tricyclics and SNRIs) are not comparators as they have a different profile of action; ii. The Product was marketed alongside other SSRIs and promoted as a safer alternative to older anti-depressants, with fewer side effects.”
“The Claimants do not admit the Defendant’s case that it complied with all legal requirements imposed upon it. That is a subjective opinion within the knowledge of the Defendant and the relevant licensing authorities. It is noted for example that the Defendant was the subject of a lengthy criminal investigation in relation to alleged breaches of the Medicines Act in relation to its regulatory obligations. The decision not to prosecute does not necessarily mean that there was compliance as asserted by the Defendant. However, it is not and never has been part of the [Claimants’] case that the [Defendant] failed to comply with legal requirements imposed upon it. As such the Claimants decline to expend resources attempting to prove a negative when the compliance or otherwise with legal requirements does not form part of their case.”