Best v Wellcome Foundation Ltd

CourtHigh Court
Judgethe President of the High Court
Judgment Date01 January 1992
Neutral Citation1991 WJSC-HC 83

1991 WJSC-HC 83


No. 2641P/1978







Medical practitioner

Infant - Vaccination - Vaccine - Danger - Proof - Absence - Pertussis vaccine - Encephalopathy - Onset of symptoms - Conflicting evidence - Onus of proof - Balance of probabilities - (1978/2641 P - Hamilton P. - 11/1/91) - [1993] 3 I.R. 421

|Best v. Wellcome Foundation Ltd.|


Medical practitioner

Infant - Vaccination - Vaccine - Danger - Proof - Absence - Pertussis vaccine - Encephalopathy - Onset of symptoms - Conflicting evidence - Onus of proof - Balance of probabilities - (1978/2641 P - Hamilton P. - 11/1/91) - [1993] 3 I.R. 421

|Best v. Wellcome Foundation Ltd.|


Judgment of the President of the High Court delivered on the 11th day of January 1991.


The Plaintiff in this case, Kenneth James Best, is now aged 21 years and suffers from gross mental retardation and epilepsy.


He is, in the words of Dr. Ronald Gabriel, "profoundly mentally retarded. He is non-socialised which means he has little in the way of social skills" and requires complete and total care from his mother and father.


He was born on the 30th day of April 1969 at the District Hospital in Youghal in the County of Cork after an uneventful pregnancy and delivery.


From an early age he showed signs of eczema in the joints of his arms and elbows, at the back of his knees and on his face. He was treated for this condition by Dr. Gowan.


At the end of August 1969, his parents moved from Youghal to Kinsale as his father had secured employment as a Security Officer at Cork Airport.


On the 17th day of September 1969 he received his first immunisation against Diphteria/Whooping Cough and Tetanus at the Dispensary in Kinsale which was under the control of the third-named Defendant and the supervision of the second-named Defendant.


He received a second injection on the 15th day of October 1969 and the third injection on the 19th day of November 1969.


By letter dated the 9th day of January 1970, he was referred to Dr. Barry at St. Finbar's Hospital by Dr. O'Keeffe, the second-named Defendant herein.


On the 18th day of February 1970, he was seen by Professor Gerard Cussen who was doing duty for Dr. Barry at St. Finbar's Hospital at that time.


Professor Cussen directed that certain investigations be carried out; these related to blood calcium, E.E.G., skull X-ray and urine chromotography. The E.E.G. was abnormal showing epileptic features which were most marked on the left side.


A report was furnished to the second-named Defendant, Dr. O'Keeffe, recommending that Kenneth be treated with a elixir phenobarb to control the seizures which he was having.


Dr. O'Keeffe gave a prescription in accordance with the directions of Professor Cussen.


Subsequently, Kenneth was seen by the District Nurse who thought he was suffering from deafness and recommended that he be brought to the Well Baby Clinic in Kinsale, where he was seen by Dr. Galvin who made an appointment for him to be seen by Dr. O'Sullivan at the Audiologist Clinic at St. Finbar's Hospital.


Kenneth was seen at this Clinic by Dr. O'Sullivan who referred him to Dr. O'Donoghue.


Dr. O'Donoghue saw him on the 23rd day of September 1970 and arranged for him to be admitted for tests on the following day.


Following these tests, Dr. O'Donoghue formed the opinion that Kenneth had infantile spasms, presenting as myoclonic epilepsy with an abnormal E.E.G. and a clinical pattern of fits.


By letter dated the 23rd of October 1970, Dr. O'Donoghue wrote to Dr. O'Keeffe and recommended that diazepam and pyridoxine be prescribed for him.


Kenneth was again referred to Dr. O'Donoghue on the 14th day of April 1971.


He was seen by Dr. O'Donoghue on the 30th day of April 1971 Dr. O'Donoghue on the 30th day of April 1971 Dr. O'Donoghue stated:-

"I think he is pursuing the recognised course of infantile hypsarrhymia. Though one can use various medications to help control his myoclonic episodes which is sometimes resistent to treatment, there is nothing one can do about the inevitable retardation that accompanies this condition. As he is having up to ten attacks a day in addition to his pyridoxine and diazepam, I think it would be worth trying him on phenytoin phenobarbitone.

I have told the mother that these myoclonic episodes will eventually cease but they may well be replaced by major convulsions which would be far less fewer in number by I explained that the child would be mentally handicapped, his developmental quotient amount being approximately 50".


On the 30th day of April 1971, Kenneth's mother learned for the first time that Kenneth was mentally retarded and would continue to be so.


On the 5th day of May 1978 she on behalf of the then infant issued proceedings against Wellcome (Ireland) Limited, Maurice O'Keeffe and the Southern Health Board claiming damages against these Defendants.


By order dated the 10th day of April 1986, it was ordered that Wellcome Foundation Limited be substituted as first-named Defendant in lieu of Wellcome (Ireland) Limited and that the Minister for Health, Ireland and the Attorney General be joined as Defendants in the proceedings already instituted.


In these proceedings, the Plaintiff alleges that his condition was caused by the pertussis vaccine contained in the injection which he received on the 17th day of September 1969 and that the Defendants and each of them were negligent in the manner set out in a letter dated the 17th day of February 1989 a copy of which is annexed to this judgment.


The Defendants and each of them have denied that the Plaintiff's condition was caused by the pertussis vaccine which was contained in the injection which he received on the 17th day of September 1969 and that they were guilty of the negligence alleged against them or any negligence.


It is quite clear from a consideration of the pleadings herein, the oral testimony which I heard over a period of approximately 32 days, the documents and articles referred to in the course of such testimony and the submissions of Counsel for the parties at the conclusion thereof that a number of very important issues have been raised in these proceedings; issues in respect of which opinion in the medical profession has been sharply divided and opinions have changed as further studies have shed light upon the problem and issues involving the constitutional rights of the Plaintiff and the alleged failure to defend and indicate these rights.


These issues are -


(1) Whether a vaccine containing a pertussis component can cause in admittedly rare cases an encephalopathy known as post-pertussis vaccinal encephalopathy;


(2) If so, did it in the instant case;


(3) If it did, were the Defendants or any of them negligent.


(4) Has the State failed to defend and vindicate the rights of the Plaintiff.


The onus of proof is on the Plaintiff to establish that pertussis vaccine can cause permanent brain damage and did so in this case and the standard of proof is the balance of probability.


If that onus is discharged the onus is still on the Plaintiff to establish that the Defendants or one of them was negligent.


It is not sufficient for the Plaintiff to establish negligence on the part of the Defendants or one of them unless the actual negligence caused the Plaintiff's condition.


Consequently, the first issue which I have to determine is the nature of the Plaintiff's condition, whether he is suffering from a post-pertussis vaccinal encephalopathy or infantile spasm unrelated to the pertussis vaccine.


If the Plaintiff is suffering from the latter condition, namely, infantile spasm unrelated to and not caused by pertussis vaccine, then the issue as to whether or not pertussis vaccine can cause post-pertussis vaccinal encephalopathy becomes academic.


An encephalopathy is any disease of the brain.


There is no doubt but that the onset of serious neurological disease which in some cases has led to brain damage and death has occurred in close temporary relationship to vaccination against pertussis.


Chapter 5(3)(2) of the National Childhood Encephalopathy Study contains the following statement:-

"Acute encephalopathic disorders in young children are extremely rare and have many causes. Known aetiological agents and mechanisms include infection, metabolic disorders, chemical poisons, congenital abnormalities and brain infiltrations. Acute encephalopathic illness may be associated with systemic disorders, such as malignant disease, burns and hypertension. An encephalopathy may be mediated either by a direct neurotoxic effect, or, as has been suggested in the case of vaccines, by the induction of of antigen/antibody reactions. The clinical investigation of cases in search of cause both in life and at autopsy may involve the use of a variety of sophisticated techniques, facilites for which are available only in the main neurological units. Even when such techniques are fully implied the cause shown frequently remains obscure. In recently immunised children, therefore, the absence of any alternative explanation does not prove that the illness is due to pertussis vaccine".


While, as I have said, the onus is on the Plaintiff to establish that the Plaintiff is suffering from post-pertussis vaccinal encephalopathy caused by pertussis vaccine, the Defendants allege that he is suffering from infantile spasm and that provides an alternative explanation for his condition.


There was considerable conflict between the evidence of the...

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