HC Deb 20 November 1973 vol 864 cc1293-304

10.50 p.m.

Mr. John Fraser (Norwood)

I rise to raise the rather sad case of Mr. Frank Wakerell, aged 53, a constituent of mine who lives at Loughborough Park.

Early in 1954 Mr. Wakerell consulted King's College Hospital, which is quite close to my constituency, as a National Health Service patient, because he had a skin ailment. He was given different treatments and underwent various tests and finally a substance called Nivaquine, was prescribed for him from 1954 until 1956. He was discharged from the hospital in 1956 and was told that further supplies of Nivaquine would be prescribed by his general practitioner. I emphasise that his general practitioner was advised to continue with the hospital treatment. This is important because of the state of knowledge of medical pracitioners about the use of Nivaquine at that time. I emphasise that he did so on the advice of specialist hospital staff.

Mr. Wakerell's general practitioner treated him with this drug for his skin complaint until September 1962 when trouble developed with his eyesight.

In January 1963 Mr. Wakerell returned to King's College Hospital, and I can best describe accurately what then happened and what was to happen in extracts from a letter addressed by his general practitioner to the medical adviser to May & Baker, the makers of the drug.

On 14th January 1963, after Mr. Wakerell had returned to the hospital with failing eyesight, the consultant ophthalmic surgeon wrote: This patient appears to have both corneal and retinal changes characteristic of Chloroquine intoxication. I have suggested that he discontinues Chloroquine straight away and advised that he attends the Skin Clinic as soon as possible for advice on alternative methods of treatment. On 15th January 1963 the consultant dermatologist at King's College Hospital wrote: The eye department asked me to see this patient in the hope that I might be able to suggest treatment for his recurrent erythema multiforme other than by Nivaquine, which is probably the cause of his disorder of vision. In September 1963 Dr. Wells, a physician at St. Thomas' Hospital, wrote: As you know, he has got a retinopathy, and we think that this has been caused by prolonged treatment with Chloroquine. Obviously it is extremely important that he should have no more of the anti-malarial drugs. In 1965 a consultant physician in Wimpole Street wrote: As you no doubt know, he has Lupus erythematosus of 14 years' duration, with raised, roughly discoid, patches over his temples and cheeks. He told me about the previous treatment he has had, including tab. Mepacrine and later tab. Nivaquine t.d.s. for nine years: until two and a half years ago, which unfortunately has left him with opaque corneae. I have read those extracts because it is important to get on the record what is wrong. It really means that by 1965 Mr. Wakerell was losing his sight. Until 1965 there had been no suggestion that there was any permanent loss of sight. Indeed, even in that last report there was no such suggestion.

I think that I can best illustrate the situation by Mr. Wakerell's own words. He said: I asked the doctor concerned"— the doctor at the hospital to which he had returned in 1963— how long it would be before my eyes got better. He said that he did not know, but as it took a long time to come it would take a long time to go away. That was in 1963, after he had been treated for almost 10 years with Nivaquine.

He continues: In 1968 I paid a visit to the house governor of the hospital"— that is King's College— only to find out that the damage to my eyes was permanent. Not until 1968 did he realise that. He"— that is the house governor— told me that nothing legal could be done as time had expired. Mr. Wakerell then wrote to the hospital to ask for an ex-gratia payment, but that was refused on the ground that the hospital was not morally or legally responsible. He now earns half what he earned in 1962 as a skilled fitter and, tragically, the damage to his eyesight appears to be permanent.

It is indisputable that Nivaquine, which is manufactured by May & Baker, was the cause of what, in 1969, the house governor called the dreadful consequences of causing his eyesight to fail. The question really is whether, to use the house governor's words, the National Health Service is under any legal or moral responsibility. That responsibility has so far been denied, but I hope that at some time it will be admitted.

I shall say little about Mr. Wakerell's legal rights to claim compensation for loss of his eyesight due to wrong treatment, because I should not wish to prejudice any legal claim that he may have. The point at issue is whether there is a moral responsibility to pay compensation to this man for the tragic consequences that he suffered. In my view, there is a moral obligation towards my constituent.

First, Mr. Wakerell trusted the doctors. Had he been a suspicious man he might have taken legal action many years ago. But he was a trusting man who invested a good deal of faith in the specialist hospital to which he had been sent. He trusted the hospital up to 1962, and so did his doctor who prescribed on its advice.

I do not think that it is possible to shrug off responsibility by saying that the deleterious and dangerous effects of Nivaquine could not have been known to the general practitioner, but that is the answer that I have had so far from the Minister. In writing to me on 18th July 1973 the hon. Gentleman said: Whilst I agree that some Papers upon the possible side-effects of the use of Chloroquine were published prior to the treatment of Mr. Wakerell with Nivaquine, I am advised that these Papers are not those which an average General Practitioner would be expected to study. The drug was initially prescribed for Mr. Wakerell not by an average general practitioner but by a well-known, respected and teaching hospital. This was not the responsibility of his general practitioner. This was the responsibility of a hospital which enjoys a very high reputation not just in this country but throughout the world.

There may be some responsibility with the manufacturers—indeed, I have had correspondence with them—but it surely is the case that a responsibility also rests with the teaching hospital. I do not want to blame any particular person. Doctors at King's College—many members of my family have been treated there—work under a good deal of stress, and it is a busy hospital, but I still believe that there is a collective responsibility towards my constituent.

In my view, there was adequate—not abundant—evidence that the drug with which Mr. Wakerell was being treated was likely to cause damage to his eyesight. The evidence for that is contained in papers that have been supplied to me by the manufacturers of the drug. I am sorry to quote technical details but it is important to do so. As long ago as 1954, in a study by Harvey and Cochrane, it was found that as a result of the use of this drug on a number of patients one or more had difficulty in focusing for near vision. That was perhaps only a cloud as big as a man's hand, but the evidence began to accumulate.

In 1958 another study showed the appearance of corneal opacities in patients receiving prolonged chloroquine therapy … This condition is insidious in onset and the opacities are not necessarily associated with symptoms". That was in 1958, four years before my constituent's treatment ceased.

In 1959 a further study by Hobbs, Sorsby and Freedman described retinal changes in three subjects who had received chloroquine in a daily dosage of up to 600 mg. for two and three-quarter years for the same skin disease from which my constituent suffered. The report said: It is therefore desirable that regular ophthalmological examination should be made wherever the use of 'Nivaquine' or other synthetic antimalarials in high dosage over a long period is envisaged. In 1959 a similar case was reported among 100 patients who had been given large doses for more than 18 months.

The evidence after that accumulated more quickly, but the burden of the case is that there was a number of studies, not known to the average general practitioner but which should have been known in a teaching hospital, which provided evidence that this drug was likely to affect Mr. Wakerell's eyesight. All the studies and all the cases that I have quoted took place while he was receiving this drug under administration and before 1962, when the administration stopped.

From 1962 until 1969, Mr. Wakerell was not informed of the diagnosis of his loss of eyesight and its permanent nature until it was too late for him to take any action. I wonder whether it would have been the same had he been a private patient. I am concerned that as recently as August, at the same hospital, I had brought to my notice the case of a patient who was critically ill being denied the use of the main theatre because it was wanted for a private patient who was about to have his teeth extracted. That kind of priority is indefensible.

Mr. Wakerell's case is surely one for re-examination by the Minister of his decision not to award ex-gratia compensation. If he said tonight that he had chanced his mind about the case and that the request for an ex-gratia payment would be granted, I should be delighted and my constituent would be very grateful. If he cannot say "Yes", I ask the Minister not to say "No". I ask him to do no more than undertake a searching examination of what is a real human and pharmaceutical tragedy, something which has denied my constituent his livelihood and his eyesight.

If Mr. Wakerell had been a querulous man, this tragedy might have led to claims taking place within the statutory limitation period, but he trusted his doctors and learned too late that he might have had some cause for action. In the light of the medical evidence now being supplied I believe that this is a proper case, at the very least, for the Minister to have a searching re-examination to see whether some ex-gratia compensation can be made for something which can never now be replaced—the most precious gift of eyesight.

11.3 p.m.

The Under-Secretary of State for Health and Social Security (Mr. Michael Alison)

I am sure that the whole House will feel deep sympathy for Mr. Wakerell. His experience, expounded with his customary clarity and command of the details by the hon. Member for Norwood (Mr. John Fraser), has certainly been an unfortunate one. Before I come to the details of Mr. Wakerell's loss of eyesight, I must sketch in what I am advised is the general position with regard to ex-gratia payments.

In the case of hospital treatment under the National Health Service, if negligence can be proved, an action would lie against the doctor, the hospital authority by whom he is employed, or, ultimately, my right hon. Friend the Secretary of State for Social Services. If there is evidence of negligence, including evidence that the damage suffered flows from that negligence, but the claim has not been pursued within the time limits laid down by the Limitation Acts, an ex-gratia payment can be considered—against the background, that is, of damage by negligence but outside the time limits. It is only where a normal remedy of legal redress is, for one reason or another, not available that we are able to consider an ex-gratia payment, given negligence.

The position is rather different in the case of treatment by a general practitioner. A general practitioner who has undertaken to provide general medical services under the National Health Service, and is included in the medical list of an executive council, is not an employee of that executive council, nor of my right hon. Friend the Secretary of State. He is a self-employed person, in law and in fact.

It follows that a patient who has a claim for negligence against his family doctor can take the necessary legal action himself direct, but it also follows that neither the executive council nor my right hon. Friend the Secretary of State has any—to use the technical term—vicarious liability for the actions of the general practitioner in this case. If action is not taken within the period, six years, laid down by the Limitation Acts, there can thus be no question of an ex-gratia payment being given by my right hon. Friend. This is in the case of a general practitioner.

Turning now to the particular circumstances of Mr. Wakerell's loss of sight, the facts are very much, as far as I can see, as recounted by the hon. Gentleman, but I want to study carefully what the hon. Gentleman has now put on record in his presentation of the case.

Mr. Wakerell attended the dermatology clinic of King's College Hospital outpatients department in 1953, 1954 and 1955, each time for a period of about six weeks. He attended again in May 1956 and was for the first time, I understand, prescribed the drug Chloroquine, a proprietary name for one salt of which is Nivaquine—to adopt the pronunciation of the hon. Gentleman, which I take to be correct. The use of this drug was continued until August 1956, when Mr. Wakerell's skin was clear and he was discharged from hospital.

In 1962 Mr. Wakerell attended the ophthalmic clinic at King's College Hospital for an eye complaint. In 1968, after a short illness, Mr. Wakerell's eyesight deteriorated and he was informed that the damage to his eyes was permanent. Mr. Wakerell then wrote to King's College Hospital about his eye condition. The hon. Gentleman has referred to the contents of this correspondence, and I want to ponder carefully on that.

In a letter dated 9th September 1969 from King's College Hospital, Mr. Wakerell was advised that the proper course would be for him to take legal advice from solicitors independent of the hospital. Mr. Wakerell subsequently took legal advice but as a considerable time, some 13 years, had passed since he had been treated at the hospital for his skin complaint, the limitation period for a legal claim based upon personal injury had elapsed. Mr. Wakerell then raised the question of an ex-gratia payment from King's College Hospital. He was informed that the whole matter had been thoroughly examined and, although the hospital board were extremely sympathetic, there was nothing more that could be done, precisely because no negligence could be seen to have existed in this case.

In June 1972 the hon. Gentleman himself wrote to me about the possibility of an ex-gratia payment being made by the Department. After careful consideration I took the view, for reasons I shall explain shortly, that the request for such a payment must be refused.

When the matter was again raised by the hon. Gentleman in December 1972, he stated that, when Mr. Wakerell had been discharged by the hospital, the hospital had advised the general practitioner to continue to prescribe Nivaquine and that this treatment continued until 1962, when his eyesight began to deteriorate. In these circumstances my Department was asked to reconsider the matter. Two further points were also raised: first, whether tests were carried out upon the drug before it was released on to the market for conditions such as Mr. Wakerell's and, second, when it was first realised that the drug could possibly have serious consequences of causing loss of sight.

Nivaquine was first marketed in 1955. At that time the Committee on Safety of Drugs, the predecessor of the present Committee on Safety of Medicines, had not been set up. It was set up the year after, in 1956. Therefore, there were no arrangements for independent checks to be made on the safety of the drug before it was put on the market. As the responsibility for the safety of Nivaquine rested upon the manufacturer, the hon. Gentleman was invited to approach Messrs. May & Baker Limited of Dagenham for the information on what tests had been made and he has furnished us with some background information about that approach and exchange.

As to the question of the possible side-effects of Chloroquine, the position is more complex. I am advised that the articles quoted in the standard reference book—Martindale—vary in date from 1958 to 1969 but that the overwhelming majority of these are journals which a general practitioner would not normally read. In the view of the Department's medical advisers, it was not until about the mid-1960s that a general practitioner could reasonably be expected to know about the possible toxic effects of Chloroquine on the eye.

In these circumstances I do not believe that there can be any question of negligence on the part of either the hospital doctor who originally treated Mr. Wakerell between 1953 and 1956 or upon his general practitioner who treated him from that date until 1962. In any event, as I said earlier, I regret that my right hon. Friend could not accept responsibility for the actions of an independent contractor, such as Mr. Wakerell's general practitioner.

I should say in passing that we now have the Committee on Safety of Medicines to collect and assess information about adverse reactions to all medicines. This committee, which has a membership of eminent doctors and pharmacists, keeps a constant watch and reports on the side-effects of drugs. The House will appreciate that all effective medicines may cause some side-effects. It is for the Committee on Safety of Medicines to assess whether the benefits which may be achieved with a particular medicine outweigh the possible hazards, whether known or merely suspected. It is, of course, for a doctor to decide as to the drugs with which his patient should be treated, having regard to all the factors of the particular case and relying upon his professional judgment.

In conclusion, we are here faced with the case of a man who lost his eyesight, possibly but not proven as the result of medical treatment he received during the period 1956–62. And I must here point out that although Mr. Wakerell's blindness may be related to the taking of Chloroquine it is quite possible that some other factor may have been the cause. Mr. Wakerell is time-barred from taking action for negligence against either the hospital or his general practitioner.

Prima facie this is a case where my right hon. Friend the Secretary of State could consider making an ex-gratia payment because of the hospital element but I am bound to conclude that the established state of medical knowledge at the time that Mr. Wakerell was being treated was not such as to mean that doctors could be expected to know of the possible side-effects of Chloroquine. I therefore regret that I cannot recomment my right hon. Friend to agree an ex-gratia payment in this case.

As the House will no doubt be aware, there are other people in circumstances similar to those of Mr. Wakerell where some disability has developed but there is no proof of medical negligence or entitlement therefore to compensation. I am advised that this general question falls within the terms of the Royal Commission on Civil Liability and Compensation for Personal Injury, under the chairmanship of Lord Pearson which is currently sitting. Alas, my right hon. Friend the Prime Minister has already made clear that the recommendations of this commission will not be retrospective. This means, I am afraid, that its findings can have no possible effect on Mr. Wakerell's case.

I listened carefully to what the hon. Member for Norwood said. He has put on record facts which I shall want to ponder in the light of the background information we have on the case. I shall weigh carefully what he said to see whether there is any reason to reconsider what I have told him tonight. I guarantee, therefore, that I shall look long and sympathetically at the case he has expounded. However, I must say that I see no grounds, as far as I can judge at present, for reaching a conclusion that it would ever have been possible to establish negligence against the hospital in the matter of the treatment it prescribed and delivered for Mr. Wakerell.

The hon. Gentleman will understand that, if we really could not judge whether negligence had arisen, to give a disbursement of an ex-gratia payment simply out of the profound sympathy which we feel would open an almost uncontrollable floodgate of claims against the Department for side-effects which are invariably associated with new medicines in cases where no negligence has arisen. We should be faced with an impossible situation. We must therefore stick by the principle of establishing negligence, even if not formally established in a legal case because of the time bar, before considering an ex-gratia payment.

It is in that light that, although I have not had a chance to study closely and in a detached way what the hon. Gentleman has said, he has not furnished me with any more information to make me feel that negligence arose. I therefore do not want to be too optimistic but I can promise him that, especially in response to the tone of his appeal, we shall continue to look hard at the facts he has given. I shall certainly have another look at the report of this debate, but I do not want unduly to raise the hon. Member's hopes or those of Mr. Wakerell.

Question put and agreed to.

Adjourned accordingly at sixteen minutes past Eleven o'clock.