THE TRANQUILLISER ADDICTION SOLICITORS' GROUP
OPINION OF SENIOR COUNSEL
relative to
REPRESENTATIONS
TO
THE SCOTTISH LEGAL AID BOARD
in respect of the continuance of
legal aid for proceedings against
John Wyeth & Brother Limited
MARCH 1997
OPINION OF COUNSEL FOR THE TRANQUILLISER ADDICTION
SOLICITORS' GROUP RE: ATIVAN CASES
1) INTRODUCTION
The actions raised on behalf of those claiming to have suffered loss, injury and damage through their use of the drug Ativan have, in many instances, now languished in the Court of Session since the years 1990 to 1992. Five or more years have passed with little occurring in the litigations to progress them towards resolution. It may be that the reasons for this are complex and, at least in large part, attributable to the approach adopted in England and to the ingenuity of the advisors of the defenders. Nevertheless, one is bound to remark that it cannot reflect well on the legal system of any country that parties have been unable to secure any form of inquiry into their case before a Court within that timescale.
As far back as early 1991 when the hearing on the motion for a commission and diligence in the McInally v Wyeth and Brother Ltd took place before Lord Coulsfield, it was accepted by the defenders that the pursuers had averred a relevant case (1992 SLT 344 at 348 col 2 G-H). It has to be borne in mind therefore that as a generality there are no disputed points of law arising between the parties. It is all a question of fact. In these circumstances, it might be said to be surprising that the system has not yet required the defenders even to lodge defences!
Having regard to the consensus on relevancy, the main issue addressed in this opinion is whether there is sufficient evidence supporting the averments to demonstrate that the pursuers, taken as whole, have reasonable prospects of success. In that regard it is not the purpose of this opinion to explore the detail of the many propositions and counter propositions of fact (but not law) which could be advanced should the causes be explored at a proof The fundamentals of the pursuers' case have already been set out to a large extent and in some detail in the Ativan Master Statement of Claim and there seems little point in repeating them here. Rather this Opinion is designed to set out in short compass the basics of the case for the pursuers having regard to the forthcoming review by the Legal Aid Board.
(2) THE CONTEXT OF RELEVANCY
In most of the cases the basic propositions are, per se, straightforward. The various pursuers were prescribed Ativan and became dependent upon it. No warnings of the risk of dependence were given to the pursuers. It is averred that the defenders knew of the risk but did little or nothing about it. It is also said that the defenders ought to have known about the risk both by reason of the information contained in sundry journals and the fact that proper tests would have revealed the problem.
(3) THE EVIDENCE
There are many adminicles of evidence on both sides and citations from the copious quantities of medical and pharmaceutical literature could no doubt form the beginnings of an attack or defence on the main propositions being advanced by either side. Two areas of evidence do, however, deserve special attention when looking at probabilis causa:
(i) The Testimony of Thomas Harry
This witness was the defenders' associate medical director. He speaks to the general and specific approaches taken by the defenders relative to the testing of Ativan. He speaks to the pressure of the parent company in the United States relative to the manner of research and the resignation, presumably upon ethical grounds, of the German Medical Director because of this. In addition, for example, he says that:
"The trials were carried out for too short a period of time to reveal the side effects...resulting from prolonged repeated administration of this drug...We never considered the drug was going to be provided over a prolonged period of time and, therefore, never tested for the effect of long term prescription. I was not asked to design and control trials to ascertain the extent of the addictiveness of the drug nor to test for problems of withdrawal...
"The paper that de Buck (instructed by Wyeth) published was sent to Wyeth. When the paper arrived we noted the incidence of epileptic fits...and also noted his concern as to abrupt cessation of the drug...
"...trials...designed to check for problems...were never carried out (because) there was nothing to be gained by them but everything to lose in the sense (of) "courting disaster". As a result no-one ever asked me to carry out trials on sudden withdrawal...
"I don't think that any study got off the ground prior to 1986, this was despite the fact that there was a growing awareness of the dependency problem from, at the latest, the late 1970s.
"By the time Ativan was being developed, everyone at Wyeth were (sic) aware that Valium had produced problems for those on long term prescriptions. This was not considered a problem in the development of Ativan since this drug was envisaged for being only for short term use. However, the Company did not wish to commit the product to short term use only, and so no efforts were made...to rule out long-term use or conducting long term trials. Certainly Wyeth had no reason to know that Ativan would be free from long term problems. This possibility was not investigated, neither in the form of trials, nor in the form of ongoing post launch research."
The thrust of Dr. Harry's evidence is simply that the defenders actually knew of the potential difficulties with the drug in medium or long term use but: (i) did nothing to test for those difficulties; and (ii) did not warn the doctors or patients of them. If he is accepted on these points (and no-one has provided a satisfactory answer as to why he should not be) then the pursuers will succeed on the merits irrespective of the more esoteric propositions relative to what the defenders ought to have appreciated and done.
(ii) The evidence of Professor Dukes
Professor Dukes has provided a sound resume of the medical literature and reports in respect of Ativan and related drugs. This literature has, of course, already been canvassed extensively in the English "Master Statement of Claim". Perhaps of more direct importance, Professor Dukes also gives an overview of the many expert medical reports already given. In doing so, he commences by indicating that the experience of dealing with barbiturates ought to have alerted the drug companies at least to the potential hazard of dependence (pp.5-6). He then draws attention to the early reports and surveys and remarks that:
"All in all, experts seem largely in agreement that a manufacturer could have been considered alerted to the potential problem of dependence in normal doses by 1972/73." (p.8)
This was, of course, at or about the time of the first availability of Ativan in the United Kingdom. By 1978 it had become apparent that benzodiazepines were particularly likely to cause dependence in anxious individuals yet these were the very persons to whom Ativan was likely to be prescribed. This, Professor Dukes emphasises (pp.10-11), is one of the situations where "a drug is most problematical" thus imposing a duty on the manufacturer to "exert restraint and balance".
Given the obvious adverse consequences of dependence, the Professor then analyses what the manufacturers should have done but did not do. He makes the point that when Ativan was put onto the market, the prescribers and patients were given no reason to suppose that it was than a short acting version of Valium (p. 18) "offering no particular risk". In such circumstances:
"...it was incumbent on Wyeth to see what was known about the existing products in the field and to assume, until or unless the contrary was proven, that the same applied to its own compound. In 1972 any company with a scientific staff and library should have been fully aware of the emergent risks of dependence and withdrawal..." (p.19).
Yet no specific study and no warnings in the initial data sheets were carried out. "Failure to set an appropriate dosage and a suitable graded range of tablet may be one of the strongest points in the case against Wyeth" (p.19)
There had been a "cascade of clinical complaints" by the early 1980s and this ought to have prompted appropriate research into the dependency issue (p.21) but that was not done and, perhaps as an obvious consequence, no adequate warnings were included in the data sheets.
He concludes (p.27) that
"...where the dependence on benzodiazepines is concerned, the behaviour of the companies concerned was...deficient as regards the interpretation of the literature, the research which was carried out (or not carried out) to delineate emergent risks, and the informations which were given (or not given). The risks of dependency were brought forward too hesitantly or not at all, the picture provided regarding adverse reactions was optimistic, and the general portrait painted of the benzodiazepines was that they were a harmless panacea which could be safely used in a wide range of everyday situations. This behaviour must be considered as inconsistent with standards existing at the time, whether based in statute law, regulation, industrial ethics or common decency. (my emphasis).
Professor Dukes is very eminent in his field. The conclusion which he comes to is a firm one. Once more, if the thrust of Professor Dukes is accepted then success ought to follow.
(iii) Conclusion on the Evidence
The evidence, if accepted, is such that not only ought the defenders to have been aware of the problems yet failed to act upon them but they actually knew of the problems but did nothing about them. In these circumstances, the pursuers ought to succeed. For these reasons alone, and despite the contrary views expressed ex parte on behalf of the defenders, my view must be that there are reasonable prospects of success.
(4) REASONABLENESS
It is difficult for counsel to express any view, as a matter of law, on what factors the Scottish Legal Aid Board ought to place particular stress upon when coming to a decision on this matter. In normal circumstances, it is not the province of counsel to do so. The Board must look at a great number of factors relative to both the public and private interest before reaching a view. No doubt the dicta of Lord Kirkwood in McTear v Scottish Legal Aid Board 1997 SLT 108 will be remembered relative to cost and quantum. In those respects, the financial aspects of the cases will, I understand, be dealt with in the revised representations to the Board.
Presumably also be borne in mind is article 6 of the European Convention for the Protection of Human Rights and Fundamental Freedoms (1950) which provides that:
"1. In the determination of his civil rights and obligations...everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law."
This principle does lie at the heart of the pursuers' contentions about the right to have their cases dealt with by a Court and not to have the merits of the cases effectively determined by the Legal Aid Board. As was said in the case of Golder v United Kingdom (1975) 1 EHRR 525:
"34...in civil matters one can scarcely conceive of the rule of law without there being the possibility of access to the courts."
"35...The principle whereby a civil claim must be capable of being submitted to a judge ranks as one of the universally recognised fundamental principles of law..." (p.535)
The locus classicus is Airey v Ireland (1979-80) 2 EHRR 305 where it was made clear that the provision of legal aid will be a necessary part of the principle in circumstances where the assistance of a lawyer "proves indispensable for an effective access to court...by reason of the complexity of the...case".(p.317 at para 26). One would have thought that the present situation fell neatly into the dicta of the Court in that case since it could not conceivably be maintained that an individual could run a case of this type without the help of a lawyer. Given also that the pursuers cannot conceivably begin to instruct legal assistance without public finance, it becomes reasonably evident that there is a risk of the pursuers' rights under the Convention being denied in the current circumstances were legal aid now to be withdrawn.
THE OPINION OF
C.J.M. Sutherland Q.C.
11th March 1997
Benzodiazepine Litigation
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