Berger v Eli Lilly & Company

JurisdictionEngland & Wales
Judgment Date28 August 1992
Judgment citation (vLex)[1992] EWCA Civ J0828-1
Docket Number92/0780
CourtCourt of Appeal (Civil Division)
Date28 August 1992
Ellen Maude Nash and Others
Appellants (Plaintiffs)
Eli Lilly & Company and Others
Respondents (Defendants)
And Between:
Lois Emily Berger and Others
Appellants (Plaintiffs)
Eli Lilly & Company and Others
Respondents (Defendants)

[1992] EWCA Civ J0828-1


Lord Justice Purchas

Lord Justice Ralph Gibson


Lord Justice Mann (In his absence)


QBENF 91/0664/C






Royal Courts of Justice

MR. D. BRENNAN Q.C., MR. A. ULLSTEIN Q.C. and MISS S. PARKES (instructed by Messrs. Dawbarns, King's Lynn, Norfolk) appeared on behalf of the Appellants (Plaintiffs).

MR. J. PLAYFORD Q.C., MR. A. PRYNNE and MR. C. GIBSON (instructed by Messrs Davies Arnold Cooper) appeared on behalf of the Respondents (Defendants).



This is the judgment of the court.




These consolidated appeals are from two judgments delivered by Hidden J. on 31st January 1991 ("the first judgment") and 2nd March 1992 ("the second judgment"). In both judgments the learned judge was concerned with preliminary issues raised in claims made by selected plaintiffs as to whether they were statute barred under section 11 of the Limitation Act 1980 ("the Act") and, if so, whether it should be directed under section 33 of the Act that the limitation provisions should not apply to any of these actions. The plaintiffs concerned in the first judgment had been selected from a substantial group of patients for whom a drug known as Opren had been prescribed and who had allegedly suffered various ill effects as a result. These "Lead Cases", as they were called, were regarded as typical of various sub-groups which comprise the remaining cases so that the judgments would enable the parties to dispose of the remaining cases by reference to Hidden J.'s judgment. The second judgment dealt with a number of plaintiffs who contended that their cases were not covered by any of the lead cases considered in the first judgment. There are issues raised in the consolidated appeals which are generally relevant in all the appeals but, essentially, the cases must be individually considered.


There were initially seven defendants but the claims against the sixth and seventh defendants, the Committee on Safety of Medicines and the Licensing Authority under the Medicines Act 1968, have been abandoned. The remaining defendants are Eli Lilly & Company Limited (the first defendants) which is a multi-national pharmaceutical company based in Indianapolis, Indiana, U.S.A. Below them in the corporate structure are Lilly Industries Limited (the third defendants) who are a wholly owned subsidiary of Eli Lilly & Co. and the wholly owned subsidiaries of Lilly Industries Limited, namely Dista Products Limited (the second defendants) and Lilly Research Centre Limited (the fourth defendants). The fifth defendant, Dr. Shedden, was the servant of one or more of the first, second and third defendants and was in charge of research and engaged in the development of Opren.


The background


Opren was developed during the 1970s by Lilly Research Limited. It was licensed in March 1980 by the seventh defendant acting on the advice of the sixth defendant. It was originally only available for use by consultant physicians in hospitals, but on 30th October 1980 it was made available for prescription by general practitioners. Although Opren had a beneficial effect in the form of relief of pain in the case of patients suffering from arthritis, both rheumatoid arthritis and osteo-arthritis, it also had serious side effects which proved unacceptable. In the result in this country the seventh defendant, the Licensing Authority, withdrew the product licence during the first week in August 1982. The drug was withdrawn by the Eli Lilly Group throughout the world within the next few days. The drug had been manufactured in this country by Dista Products Limited.


The nature of the side-effects varied widely. The plaintiffs with whom the appeals are concerned were mainly complaining of photosensitivity and onycholysis. Onycholysis is a condition which affects finger and toe nails, causing them to become ridged and loose and even to separate from the nail bed. Other patients had suffered from more serious complications such as liver and kidney failure resulting, in certain cases, in death.


Products liability claims


In the field of product liability litigation pharmaceutical claims present special problems. These were brought to general notice for the first time in the thalidomide litigation. The defendant manufacturer, Distillers Company Limited, whilst denying liability made available a global sum to be distributed amongst a defined class, the claim for membership of which raised one of the issues for determination. The other main issue was the degree of disability of any claimant which determined the size and nature of the settlements made from the global sum in favour of individual sufferers and/or their parents. A substantial part of this global sum was retained in the form of a central trust administered for the benefit of all qualifying sufferers. In all such cases problems arise from the large number of possible claimants and the necessity, for proof of liability, to establish a sufficient connection between the injuries suffered and the drug alleged to have caused them, assuming that the damaging quality of the drug is attributed to some fault on the part of the manufacturer. It is in this context that a distinction has to be drawn between side effects which are acceptable in the context of the relief afforded by the drug, and side effects which amount to unacceptable injury caused by that drug. Defendants and their insurers, in considering how to handle such litigation, must have regard both to the uncertainties of litigation and to the likelihood that, in most cases, even if the defence should be successful, costs will not be recoverable from the plaintiffs.


The Opren claims


After widespread reports had been received of unacceptable side effects caused by taking Opren and of its suspension in August 1982, two bodies were established to assist the sufferers and to facilitate the co-ordination of anticipated claims from patients. In August 1982 the Opren Action Group ("O.A.G.") was formed. This consisted of a group of solicitors who were co-ordinated by Messrs Goldberg Blackburn and Howards (as that firm was then known). In September 1982 a further organisation, the Opren Action Committee ("the O.A.C.") was established. This consisted of lay persons who made their knowledge and advice available to sufferers. In the same month the Law Society set up a register of solicitors acting in these claims.


These bodies, namely the O.A.G. and the O.A.C., did not, of course, have any formal locus standi before the courts under existing United Kingdom legal procedures. Nevertheless, Hirst J. did much to assist and to expedite the determination of the complex issues and the management of the high numbers of potential plaintiffs in the interests of all concerned.


The law in the United States of America has for a considerable time made provision for what is there described as the "class action". Compared with the procedure adopted by Hirst J., the class action procedure has both advantages and disadvantages for the parties involved. It is of no assistance in the task before this court, however, to make further reference to the American procedures. The existence of them may have been one of the reasons for the initial move against Lilly made by the O.A.G., namely, the issuing of proceedings in the courts of the State of Indiana. That took place in 1984. In connection with those proceedings, O.A.G. wrote a letter asserting that they had, at that time, sufficient information about the drug and its effects to bring home liability against the company in the American courts. As was indicated during argument, however, the basis of such a claim may have been, or may have included, a statutory liability.


To what extent, if any, regard should be had to the "Group Action" structure, set up by Hirst J. in exercising discretion in any case under section 33 of the Act, is an issue in these appeals.


The first writ was issued in England by Marlene Preece Betton in the Swansea District Registry on 4th November 1983. That action and other actions commenced in the early stages of this history were part of the activities of the O.A.G. Their first essay was to initiate proceedings before a court in Indianapolis. That action was unsuccessful. It seems that the judge held that the claims should not be pursued in that State on the basis of forum non conveniens.


In the case of those writs already issued and served the matter was dealt with on 23rd July 1986 by Hirst J., who gave directions for a time-table for those actions. This group has become known as "Group A cases". His order provided, inter alia, that all writs had to be issued by 1st October 1986. Further writs, however, were issued after that date and, as a result, on 13th January 1987 Hirst J. laid down a further time-table for the additional claims. This contained a date for the service of writs, namely, 31st January 1987. These became known as "Group B cases".


An agreement was reached between the defendants and O.A.G. under which the defendants made available a sum of money, the distribution of which amongst the claimants in Groups A and B was to be determined by the O.A.G. subject to appeals to Hirst J. as arbitrator. That process has now been completed. It is to be noted, however, that on the dates upon which...

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