“The Court, dismissing an appeal by the defendant drug company, held that two actions brought on behalf of children born with physical deformities allegedly as a result of their mothers taking the defendant’s drug Primodos while pregnant should proceed as set down for trial, and that three further actions against the same defendant and relating to the same drug but involving different deformities should be stayed pending the outcome of the first two. The Court also refused to split the issue of causation off for trial as a preliminary issue, holding that the questions of causation and of negligence were so intertwined as to require examination in the same proceedings.”
“It seems to me that justice can well be done if the two heart cases are tried first. They have no doubt been selected by the Association and their advisers as being the strongest cases they can bring. If they fail, all the others will fail too. If they succeed, it is true that it does not follow that the others will succeed … But I cannot help thinking that at the trial of the first two cases (the heart cases, as I have called them) the evidence and the findings of the judge will give a good guide as to the outcome of all the remaining actions. It seems to me that the evidence on causation will cover not only the causation of the heart defects, but also the other defects – the hare lip, the limb reduction, and so forth. In considering the teratogenic capability of this drug, it will be necessary for the court to consider the whole range of effects it might have in causing the congenital malformations in other cases …”
“The effect of that order is not to shut out the Plaintiffs absolutely. It is open to them to apply in the future in the event of a scientific revolution or a marked change in the circumstances. I should, however, make it clear that for leave to be given on any future occasion a very strong case indeed would have to be made out by the Plaintiffs to show that it was just for the matter to be re-opened, and the Court would have to be satisfied that no unreasonable prejudice to the Defendants would accrue. I think it very unlikely that leave to the Plaintiffs would be given, but I think that it is in all the circumstances just that the door should be kept open to that very limited extent.”
“The epidemiological evidence showing a clear association between HPTs and birth defects which in the absence of any other plausible explanation can only be considered causal and which is consistent in its results with the proposed causal mechanism.”
“148.1. Whether epidemiological evidence establishes a casual association between HPTs and congenital malformations. 148.2. If it does, whether a plausible mechanism for the occurrence of such congenital malformations by HPTs can be demonstrated. 148.3. If so, whether any other possible cause of the relevant congenital malformation can be excluded with confidence.”
“In conclusion, it is my opinion to a reasonable degree of medical and scientific certainty, that observed human teratogenicity after the use of Primodos is causally related to Primodos induced embryonic hypoxia and re-oxygenation damage following an unsuccessful abortion process.”
“But the Court can’t proceed on the assumption that those deficiencies exist, when the Court has not seen the substantive expert evidence.”
“The totality of the available evidence from pharmacology, non-clinical, epidemiological and adverse event reporting data was very limited and did not, on balance, support a causal association between the use of HPTs, such as Primodos, by the mother during early pregnancy and congenital anomalies in the child.”
“In order to succeed in their present claims it would be essential for the Plaintiffs to establish as a matter of probability that Primodos, when given to a pregnant woman, materially increases the risk that her offspring will be born with a congenital malformation. The proof of that proposition depends essentially on the evaluation of expert evidence. The expert evidence is concerned with three main areas of enquiry, but the primary field of investigation on which proof of the Plaintiffs’ case must ultimately depend is in the discipline of epidemiology ….. There have been many studies published concerned with the relative incidence of congenital malformations, among those exposed to various synthetic or exogenous sex hormones …. Those studies have to be evaluated to assess the reliability of the data incorporated in them …. That evaluation can only be made with the help of expert evidence. Indeed, as your Lordship ruled … the published studies can only ever be received in evidence as part of the material on which the opinions of the expert witnesses are based. This whole area of enquiry has been the subject of reports from a considerable number of expert witnesses, whose reports have been exchanged between the parties. At the outset of the case the expert evidence available to the Plaintiffs’ advisers appeared to indicate that there was a reasonable prospect of establishing as probable the existence of a causal association between Primodos and congenital malformations …. However, as the expert evidence has accumulated we have been driven to the conclusion that the totality of that evidence does not afford any real possibility that we can establish that there is such an association.”
“… it is clear that scientists of distinction are not agreed whether or not the mechanisms proposed afford a possible explanation of how Primodos might cause congenital malformations. But we have been driven to the conclusion on the whole of the biomechanical evidence before us, and in the absence of the requisite epidemiological evidence the hypothesised biochemical mechanisms are not capable of establishing that Primodos does cause malformations.”
“… we cannot exclude the possibility that within the next few years scientific advances may throw a new light on the problem.”
“The Claimants’ position will be that in respect of a birth defect shown to have had a significantly increased risk from taking of an HPT in the absence of any identifiable genetic cause on testing, the court should conclude on the balance of probabilities that the HPT was the cause.”
“If a statistically significant relationship is found between an agent and a health outcome, one of the methods subsequently used to determine whether that relationship is indicative of a biologically causal relationship is the Bradford Hill guidelines.”
“But if the disease materialises, the existence of a statistically significant association between factor X and disease Y does not prove in the individual case it is more likely than not that factor X caused disease Y.”
“a broad merits-based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court by seeking to raise before it the issue which could have been raised before.”
“A finding of abuse of process does not lead automatically to a striking out of the claim. The court then retains a discretion as to the appropriate response, which must always be proportionate”
“Litigants are not without scrupulous examination of all the circumstances to be denied the right to bring a genuine subject of litigation before the court.”
“…the inherent power which any court of justice must possess to prevent misuse of its procedure in a way which, although not inconsistent with the literal application of its procedural rules, would nevertheless be manifestly unfair to a party to the litigation before it or would otherwise bring the administration of justice into disrepute among right-thinking people.”