Best v Wellcome Foundation Ltd

• Jurisdiction: Ireland
• Judge: O'FLAHERTY J.,FINLAY C.J.
• Judgment Date: 01 January 1993
• Neutral Citation: 1992 WJSC-SC 1422
• Court: Supreme Court
• Docket Number: [1978 No. 2641P]
• Date: 01 January 1993

BEST v. WELLCOME FOUNDATION LTD

BETWEEN

KENNETH JAMES BEST, AN INFANT, SUING BY HIS MOTHER AND NEXTFRIEND MARGARET BEST

Plaintiff

Appellant

and

WELLCOME FOUNDATION LIMITED, MAURICE O'KEEFFE, THE SOUTHERNHEALTH BOARD, THE MINISTER FOR HEALTH, IRELAND AND THE ATTORNEYGENERAL

Defendants/

Respondents

1992 WJSC-SC 1422

Finlay C.J.

O'Flaherty J.

Egan J.

151, 152, 153/91

THE SUPREME COURT

Synopsis:

SUPREME COURT

Appeal

Facts - Assessment - Trial judge - Findings - Basis - Circumstantial evidence - Inferences drawn by judge - Opposite inferences drawn by appellate court - (151-3/91 - Supreme Court - 3/6/92)

|Best v. Wellcome Foundation Ltd.|

NEGLIGENCE

Medical practitioner

Infant - Vaccination - Vaccine - Danger - Proof - Pertussis vaccine - Encepahlopathy - Onset of symptoms - Conflicting evidence - Facts - Circumstantial evidence - Inferences drawn by trial judge - Appellate court - Opposite inferences drawn - (151- 3/91 - Supreme Court - 3/6/92) - [1993] 3 I.R. 441 - [1992] ILRM 609

|Best v. Wellcome Foundation Ltd.|

Citations:

DONOGHUE V STEVENSON 1932 AC 562

KIRBY V BURKE & HOLLOWAY 1944 IR 207

G (D), IN RE 1991 1 IR 491

G (O) V P (S) 1991 1 IR 491

M (J) & M (J) V BORD UCHTALA 1988 ILRM 203

HANRAHAN V MERCK SHARP & DOHME 1988 ILRM 629

NORTHERN BANK FINANCE CORPORATION LTD V CHARLTON 1979 IR 149

HAY V O'GRADY UNREP SUPREME 4.2.92

SS GAIRLOCH, IN RE 1899 1 IR 1

PEOPLE V MADDEN 1977 IR 336

CLARK V MACLENNAN 1983 I AER 416

DUNNE V NATIONAL MATERNITY HOSPITAL 1989 IR 91

MCGHEE V NATIONAL COAL BOARD 1972 3 AER 1008

WILSHER V ESSEX AREA HEALTH AUTHORITY 1988 1 AC 1074 1988 2 WLR 557

BONNINGTON CASTINGS LTD V WARDLAW 1956 AC 613

FLEMING, LAW OF TORTS 7TH ED 175

R V COLL 24 LR IR 522

1 JUDGMENT delivered on the 3rd day of June 1992by FINLAY C.J.[EGAN CONC.]

2 This is an appeal brought by the Plaintiff from the judgment and orders of the High Court made herein by Hamilton P. on the 4th May 1989 and on the 11th January 1991, in so far as the said orders granted the third named Defendant's (the Southern Health Board) application for a non-suit, and in so far as the saidorders dismissed the Plaintiff's claim against the first, second, fourth, fifth and sixth named Defendants with costs. The Plaintiff who was born on the 30th April 1969 instituted these proceedings by plenary summons issued on the 5th May 1978 against Wellcome (Ireland) Limited, Maurice O'Keeffe and the Southern Health Board, claiming damages for personal injuries alleged to have been sustained by him by reason of the negligence of the Defendants in and about and concerning the administration of a triple vaccine against diphtheria, tetanus and pertussis (also known as the DTP vaccine), on the 17th September 1969, as a result of which it was alleged that the Plaintiff suffered severe personal injuries and became grossly mentally retarded.

3 By subsequent amendment, Wellcome Foundation Limited was substituted for Wellcome (Ireland) Limited as the first named Defendant, and there were added as Defendants the Minister for Health, Ireland and the AttorneyGeneral.

4 The case made against the Minister for Health, Ireland and the Attorney General was that the Plaintiff had suffered injuries as a result of a breach by the State of its constitutional obligation to protect and vindicate his personal right to bodily integrity and that he was entitled to compensation as a result thereof.

5 In the course of this judgment I will refer to the first named Defendant as Wellcome; to the second named Defendant as Dr. O'Keeffe; to the third named Defendant as the Health Board; and to the fourth, fifth and sixth named Defendants as the State.

6 The action in the High Court was tried on oral evidence before the President sitting without a jury on a total of thirty-five days, between the 18th April 1989 and the 30th June 1989. Judgment was then reserved and was delivered on the 11th day of January 1991. Prior to the hearing of the action in the High Court, discovery had been made as between the parties and, in particular, Wellcome had made the most ample discovery of a verylarge mass of documentary evidence concerning the manufacture and testing of this triple vaccine, as well as evidence in documentary form of scientific papers, documents and research, in which the employees of Wellcome were involved and which was known to them.

7 As a result, in the course of the trial in the High Court over thirty large books of documents were admitted into evidence and formed part of the material of examination and cross-examination.

8 The Defendants Wellcome had agreed prior to the hearing to the admission of documents without formal proof which had been discovered by them and were relevant to the questions at issue.

The Plaintiff's case as presented against the Defendants in the HighCourt

9 The Plaintiff was born as the first child of his parents in the Youghal District Hospital, his parents at that time living in Youghal. His birth was uncomplicated, and his mother had no prenatalcomplications. He was a fully normal, healthy child, though bearing from his early life some signs of eczema.

10 In August his parents moved from Youghal to Kinsale, and at the end of August or beginning of September his mother, with the child, called to a chemist to inquire if she could obtain the advice of a doctor concerning the eczema. She was brought by that chemist to meet Dr. O'Keeffe, who met her in the street, made an examination of the child and gave her an ointment for the eczema without a prescription. At that time, it was alleged, Dr. O'Keeffe asked her whether the child had been vaccinated, and on being told that it had not, suggested she should attend at the dispensary where he attended, for vaccination.

11 Subsequently, on the 17th September the mother brought the child to the dispensary in Kinsale to be vaccinated. Dr. O'Keeffe was present and the vaccination was carried out by the nurse. The child still had eczema but no inquiry was made of the motherwith regard to eczema or any other condition, either by the nurse or by the doctor, and no examination of the child was made by the doctor.

12 Within eight hours the child suffered a fit or convulsion in which his eyes rolled and his hands were clenched to his breast, and he screamed. This was witnessed by both the mother and the father. The mother rang Dr. O'Keeffe to inform him of this and he reassured her, telling her that children often had a reaction to the vaccine and that there was nothing to worry about. Subsequently the mother, having continued regularly to complain of these fits and convulsions which continued, though they changed somewhat in character in November, eventually obtained from Dr. O'Keeffe, on the 9th January 1970, a letter of reference to Dr. Barry in Cork. She was subsequently seen in February by Professor Cussen who was doing duty for Dr. Barry. The child has been from that time grossly mentally retarded, and for sustained periodssufferedfrom serious convulsions and fits as well as other physicalconditions.

13 On these facts the case presented by the Plaintiff against each of the Defendants can thus be very briefly summarised.

Against Wellcome

14 The documentary evidence surrounding the particular batch out of which the vaccine given to the Plaintiff was taken indicates that it was excessively high in both potency and toxicity and that these two features in the DTP vaccine are, as a matter of scientific proof, linked. In particular, it was alleged that the batch having failed the mouse weight gain test which was routinely done by Wellcome at that time, and having done so by a wide margin, should not have been released without at least a further test which it passed and, if it did not pass on re-testing, should never have been released. To release it without further testing and without any possible warning eitherto health authorities or to individual doctors administering the vaccine, was an act of negligence. It was further contended against Wellcome that the tests carried out on the Plaintiff and the evidence given by the experts on his behalf clearly and uncontestably outruled any other known cause for the infantile spasms which he suffered other than post-pertussis vaccinal encephalopathy (PPVE).

Against Dr. O'Keeffe

15 Against Dr. O'Keeffe it was asserted that at the time (1969) both the literature, a pamphlet, enclosed by the manufacturers with the vaccine, and the instructions emanating from the Southern Health Board to general practitioners, indicated that the existence of eczema in a child was a contra-indication to vaccination with a triple vaccine and that, accordingly, Dr. O'Keeffe was negligent in failing to have regard to the fact that he had been informed that the child was suffering from eczema, and in failing to inquire or examine, by himselfor through the nurse, the child for eczema before permitting a vaccination. Eczema, it was alleged, was an indication of an altered immune system and persons with altered immune systems are particularly vulnerable to a serious reaction from the triple vaccine.

Against Southern Health Board

16 Against the Southern Health Board the case was simply made that the Southern Health Board was vicariously liable for the nurse, and that the nurse was herself, though under the direction of Dr. O'Keeffe, guilty of negligence in failing to make the inquiry about eczema and presenting the child to the doctor and asking for his decision before giving it avaccination.

Against the State

17 Against the State the case was made that even if the vaccine was of normal strength and toxicity once it was established that the giving of it to very young children, who had no choice in the matter and who could not defend themselves concerning it, could, in even veryrare cases indeed, to a particular child with a particular altered immune system cause serious consequences such as occured in this case,...