Debendox

Schedule 6 – in the House of Commons at 5:21 am on 25th July 1984.

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Photo of Mr Greville Janner Mr Greville Janner , Leicester West 5:21 am, 25th July 1984

I am happy to have the opportunity to draw the attention of the House to the general picture on product liability and to the tragedy of Debendox in particular. I ask the Government to assist those members of the public who are already struck by tragedy in no way of their making, especially those 70 British families whose children have been disabled because of the drug Debendox.

It has long been the case that the law has been available to those who are wealthy and able to pay for it, and to those who are totally without means and who have a good case and can obtain legal aid. The help of the law is not available to the vast majority of citizens who need it. They have to struggle as best they can to obtain their remedy without the help of legal aid, and they often, therefore, receive no help.

When dealing with the ordinary troubles of a difficult life, it is possible sometimes to stagger along and keep away from courts, but when tragedy strikes a family—for example, when there has been a defect in a product, which has caused illness or disablement — there is a desperate need for intervention by the law. The law is intended to protect people and to provide a system of justice that is open to all. The courts should not be, as a judge once described them, like the Waldorf hotel—open only to those who have the money to pay for them.

In the days of the disaster of the drug Thalidomide, the public became convinced that it was vital to have a system which would enable people to have access to the courts when they need them; that it was vital that people should not be reduced to battles with great drug companies, in which they had to pay for representation and prove negligence—prove positively that the drug companies or other producers had been guilty of carelessness — or otherwise lose their right to compensation for tragedies. It was realised that it was beyond the powers of the courts to provide adequate compensation for such tragedies, but at least compensation could enable sufferers and their families to have the basic amenities of such life as their health left open to them.

As a result, various Law Commissions met, and each in its turn recommended the institution of absolute liability, or "product liability", as it has come to be known. The English and Welsh Law Commissions unanimously recommended that our present system, where negligence has to be proved positively by the plaintiffs, should end, and that we should substitute in its place a system such as that which is already in operation in most of the United States, and is already assisting ordinary people in France and the Federal Republic of Germany, whereby once it is proved that a product is defective and it is shown that the manufacturers, in the proper exercise of their right to earn their living, had improperly put out a product that was defective, the sufferers would have a claim in law which would not depend upon proof of negligence.

Those two reports were followed by the setting up of the Royal Commission on civil liability, headed by that redoubtable and most lovable of judges, Lord Pearson, to whom I wish to pay a warm and affectionate tribute, in his capacity as a judge and especially in the marvelous friendship that he afforded to many people, including those younger than himself, such as me, whom he was always glad to help.

Lord Pearson's Royal Commission on civil liability, always known as the Pearson commission, also recommended that we should introduce into this country the kindly, humane and decent system of strict liability for defective products. As the years went on and the Pearson report moved into a pigeon hole, Lord Pearson himself became more upset, worried and anxious—he expressed that frequently—because the recommendations were not being carried out, and no doubt one would have to wait for another misery such as Thalidomide before the public became enraged, and whichever Government happened to be in power were forced into action. He was deeply concerned at the inevitability of the suffering that would result from lack of action.

In the days when there was a Labour Government—those happy and far-off days when I spoke from behind a Minister, even at strange hours of the night — the Government said with some reasonableness, "Let us wait for Europe to take action. It will because there is already" —that was way back in 1979—"a draft directive on product liability, and we must expect action shortly." They said that in those circumstances it would not be appropriate for the United Kingdom to take action itself.

I have always believed that that was a short-sighted and wrong view, not least because of the difficulties of ensuring that Europe would act, but also because of the hideous possibility that the Labour Government might be replaced by a Conservative Government who would not take the same positive view that product liability law should be introduced, but would instead devote themselves to cushioning the industry against any sort of expenditure which might create problems for their supporters and those who finance them including some drug companies.

However, no action was taken and the draft directive on product liability was turned into a revised draft directive. The Government have done everything in their not inconsiderable power to induce Europe to place its revised draft directive on product liability into another pigeon hole alongside its home effort, which was successful enough to drive Colin Pearson's report and the recommendations of the two Law Commissions into oblivion in this country.

That is the background, which has extended from 1979 to 1984—five years of Government deliberate inaction on product liability—to the Debendox case, which is in many ways precisely the sort of misery which Lord Pearson and the Law Commissions were determined should be avoided by the introduction of product liability legislation.

The Debendox case is not the same as the Thalidomide case. It is one where families both in the United States and in the United Kingdom have suffered tragedy as a result of prescriptions being issued for Debendox, which was taken by individuals. Cases were brought in the United States, some of which failed in spite of legislation of the sort that Lord Pearson wished to see introduced.

Nevertheless, the fact is that mothers who took Debendox gave birth to children who were damaged by that morning sickness drug. In the United Kingdom the manufacturers Merrell Dow decided to pay nothing to those families, nothing to those children and nothing to provide some solace for those who suffered as a result of taking the drug.

In the United States the company took another view. The company's lawyer said that it had offered a settlement because of 678 actions which were before the United States' courts. The families involved will not have been particularly pleased with the sums they received, but at least there was a reasonable effort to provide some decent compensation for this morning sickness drug and for the 450 children who claimed that they were damaged before birth because of it.

The drug was sold without prescription until 1978, but was then put on prescription. All sorts of committees have met to discuss how to prevent this drug being given to those who were expecting children and who should be protected.

I am not an expert in this area of medical science. I leave that to my right hon. Friend the Member for Stoke-on-Trent, South (Mr. Ashley). I wish publicly to pay tribute to him. I have known him for many years. He was my mentor at Cambridge, where he was president of the Cambridge Union, that distinction was also achieved by the Minister who is to reply to the debate—the greatest distinction that he can hope to achieve—and which I was also happy to achieve in the footsteps of my right hon. Friend.

In those days my right hon. Friend and I talked about ways in which life could be improved for the disabled. My right hon. Friend could hear with his ears and not, as has happened, with his eyes and with the help of that marvellous lady, his wife Pauline, to whom I wish also to pay tribute. Since those days my right hon. Friend has led a series of campaigns on behalf of disabled people, for which he has received great honour and distinction, and which he is continuing. In consultation with him, I have been seeking to bring to the attention of the House and the nation the legal aspects that arise from the Debendox case and, in particular, the legal necessity for a change in product liability law, leaving my right hon. Friend to his campaign on behalf of the Debendox families.

I wish to commend to the Government the urgent need to apply the type of pressure that is open to Governments to induce the drug company to do what is decent, right, fair, kind and compassionate for the families in this country who are suffering, and for the children in this country who may not be able to discharge the burden of proving negligence which was laid upon them by the awful law as it stands, but who could, and should, nevertheless, receive minimum and minimal financial solace as compensation for the maximal and incredible hardship which has been imposed upon them for the totality of their lives as a result of the Debendox drug.

I have no doubt that the settlement which has been made in the United States by the manufacturers did not emerge as a result of the deep wish of the manufacturers to pay out shareholders' money to those who had suffered. It came because, as business people, they looked at the reality of the cases which were being brought against them and, in particular, at the possibility of losing those cases because there would be product liability. There would be no need to prove negligence in court. That is to say, there would be no need to show positively that the drug had caused the injury in the cases due to lack of care on the part of the manufacturers.

The manufacturers would not be able to wriggle off the legal hook by showing that they, for example, came up to the standards of testing made necessary by the state of the art — the current state of medical knowledge. That defence was one which Colin Pearson believed should not be open to defendants who had put a defective product on to the market, where that product had caused, death, damage or physical injury. Colin Pearson believed that this would cut the ground from under the recommendations of his committee, and he was backed in that belief by the committee.

In the United States, parents of the Debendox children are to receive compensation, even in the absence of provable scientific evidence that Debendox was the massive cause of the mighty injuries, although the Merrell Drug Company had won a verdict from a jury that freed it from responsibility. That is not the same as the Thalidomide case. The path is not as clear as it was in the days of Thalidomide, and the trail from product to tragedy is not as open and as proven. Nevertheless, it is the path of misery for a large number of British families with children who will grow up in a tough world faced with a disablement that is rare and wretched.

I shall leave it to my right hon. Friend the Member for Stoke-on-Trent, South to explain to the House, with his accustomed eloquence, the case on behalf of those families, and I return, in conclusion of my speech, to the general principle of product liability which the Debendox case has thrown into high and tragic relief.

Many allegations are made against Law Commissions, whether they be English or Scottish, or whether they are set up as a Royal Commission headed by a great lawyer such as Lord Pearson. One allegation that is not made is that they are radical panels, hacking away with enthusiasm at the body of the law and seeking to introduce massive changes in the light of the policies and desires of the far Left. On the contrary, they tend to be the sort of solid, reliable and quietly decent people who maintain the dignity of the law and the inevitability of change by gradual methods. They are not a hot bed of Militant Tendency, nor even of the centre Left. The idea that these bodies would get together on a radical recommendation — the English, the Welsh and the Scottish Law Commissions and the Pearson committee—in the wish to produce a vigorous change, particularly one where France, the Federal Republic of Germany and the United States have been in the lead, was to many of us almost a dream.

However, that dream took place. This committee, made up of people of all political persuasions, came to a unanimous conclusion. It decided that it was necessary, in the interests of decency, kindness and compassion for families such as those of the Thalidomide children, that the law should be made available to all British citizens. Where a manufacturer places a product on the market, he should bear a responsibility for that product and should not be entitled to duck behind the law of negligence. Those who have suffered should not be required positively to prove negligence.

It is a dreadful condemnation of Her Majesty 's Government that they have allowed five years to pass during which help could have been made available to sufferers. They have deliberately, with a determination that has been a disgrace in the circumstances, not only refused to introduce legislation but blocked legislation which European countries have been trying to bring forward for the benefit of those who have no access to the law, although their suffering has been the result of the law as it stands.

In the teeth of the recommendations of two Law Commissions and the Pearson commission, and in the face of suffering, the Government have blocked European legislation in such a way that the revised draft directive on product liability has been left, if not dying, moribund, the only hope for sufferers being that in due course the British electorate will get rid of the present Government so that action on their behalf may be taken by this country by no longer blocking product liability legislation.

The Government stand charged on an indictment of determined opposition to decent change. The Law Commissions, irrespective of political belief, unanimously recommended change. Lord Pearson campaigned for change until his dying moments. That campaign has brought us here in the middle of the night so that we might again prod the Government into compassionate action. The laws on strict liability must not remain in their present state. That fact has been brought into high relief by the Debendox case.

I commend the continual efforts on behalf of the disabled of my right hon. Friend the Member for Stoke-on-Trent, South with the loyal and determined assistance of Pauline, without whom that effort would not be possible. I urge the Government at least to express their determination to take action. I urge them to stop blocking action in Europe and to give some hope to families who are suffering that the law will be changed so that the courts will be open to all and manufacturers which market products which cause death, destruction or misery will be held accountable.

I beg the manufacturers of Debendox to do for the sufferers in this country that which they have done in the United States under the impetus of product liability law there, and make a payment to those sufferers and thereby redeem the company's dreadful image in the eyes of the British public.

Photo of Mr Jack Ashley Mr Jack Ashley , Stoke-on-Trent South 5:49 am, 25th July 1984

I congratulate my hon. and learned Friend the Member for Leicester, West (Mr. Janner) on initiating this debate. He has rendered a valuable service to the House by talking about a subject that is vital to many British people who have suffered damage. He is a great expert in this area, and the House will appreciate his expertise.

The Debendox saga has been drawn out for more than four years, and the families are still waiting for justice. I have been campaigning with them during those years, and I pay tribute to their persistence and dedication. For a change, it was pleasant to hear an hon. Member support this campaign rather than vilify it, as Conservative Members and Ministers tend to do. Vilification appears to be the standard line of the DHSS when faced with a campaign on behalf of drug-damaged people.

The former Secretary of State for Social Services—the right hon. Member for Wanstead and Woodford (Mr. Jenkin)—is known to make ingratiating speeches to the drug industry, but to snarl and snipe at its critics. The former Parliamentary Under-Secretary of State for Social Services—the hon. Member for Ealing, Acton (Sir G. Young)—when I asked him about Debendox, accused those critical of the drug industry of being anti-science, anti-progress and anti-medicine.

Photo of Mr Jack Ashley Mr Jack Ashley , Stoke-on-Trent South

The Minister says, "Quite right", which shows how ignorant he is of the subject. I should have thought that the former Secretary of State and the present Minister for Health would recognise that the £92 million paid by the manufacturer is cause for a slight change of mind away from the blind dogmatism that they have shown all too often.

I am sorry that I had to criticise the Minister for Health for saying, "Quite right", because the only glimmer of hope comes from him. Those previous Ministers showed a regrettable and deplorable lack of understanding, but the present Minister has shown the proper way. He said that we must protect the successes of the drug industry, but added that we must ensure that we do not pay excessive prices for drugs through the National Health Service. Good for him. That was a sagacious comment, and I commend that sort of approach rather than the silly, blind dogmatism of his colleagues.

The Minister for Health and the Government have a specific resonsibility to ensure that British children who claim compensation for the damage caused by Debendox are treated similarly to those in the United States of Amercia. No self-respecting Government can stand aside and support this unfair discrimination against British children. I know all about the excuses made by Merrell Dow—that the drug is fine and that it paid out only because of the excessive cost of defending itself in the United States—but they cut no ice. The truth is that the company made the placatory offer just one week before a consolidated court case was due to be heard. It was a crucial case on the main issues. Had the company won, the battle would probably have been over, with the families' resistance crushed. Had it lost, all 700 plaintiffs would have almost certainly received massive payments. Merrell decided that it could not risk that. It chose to spend £92 million to stop legal processes rather than $1 million to fight the case. One can presume only that it knew that its case was weak.

One group of claimants is being paid in the United States while a similar group of claimants is being spurned in Britain. That is unacceptable discrimination, and I contend that the Minister has a clear obligation to act. I suggest that he supports a voluntary boycott of Merrell pharmaceutical products by the NHS. I know that he wants to respect the clinical judgment of doctors, so the best way of proceeding is for him to advise all doctors to prescribe drugs from companies other than Merrell, where possible. Evidence from the British National Formulary suggests that alternatives are available for nearly all useful Merrell drugs.

I hope that the Minister will not jump to the erroneous conclusion that I am making a blanket attack on the drugs industry. His previous colleagues have fallen into that trap. I am not making such an attack. I readily agree that many parts of the industry have a magnificient record. I also concede that the Minister must respect, though not necessarily defer to, the Committee on Safety of Medicines. No doubt the right hon. and learned Gentleman will reiterate that the CSM has examined Debendox eight of nine times and found no incriminating evidence against it. I hope to open his eyes about Merrell and Debendox.

Debendox is not Merrell's only controversial product. It had the United States rights for Thalidomide and harassed the Food and Drugs Administration to market it. The company gave free samples of Thalidomide to American GPs and, incredibly, continued to do so after Thalidomide was withdrawn in West Germany. Luckily, an FDA pharmacologist, Dr. Frances Kelsey, resisted.

The Minister should not be shy about fighting Merrell or assume that it is a stranger to damages. Merrell paid $200 million in damages for MER 29, the wonder drug which lowered cholesterol. Unfortunately, it caused cataracts as well. Criminal charges were brought against Merrell for lack of accuracy in information given to the FDA". The charges were not contested, the maximum fine of $80,000 was imposed, and three executives of the company were put on probation.

How careful was Merrell with Debendox, a drug for pregnant women? Tests on pregnant animals were carried out by the company only after they were required, following the Thalidomide disaster. The company then gave an inaccurate report of results to the FDA.

In the United States, inquiries to drug companies do not have to be reported to the FDA, whereas adverse reactions do. The charge against Merrell is that it took calculated steps to ensure that every report was termed an inquiry. Therefore, it was able to say that it had no knowledge of reports of abnomalities.

As for the view of the CSM that there is no scientifically acceptable evidence that the drug is dangerous, the committee may speak the truth, but it misses the point. Drug safety is about the safety of people, and the balance of doubt should lie with people's interests, not with the company's. Drug safety has to be considered in relative terms; absolutes are inappropriate.

The most striking feature about Debendox is that there is no scientifically acceptable evidence that it is safe, even though more than 3 million prescriptions have been issued in Britain. A Parliamentary reply to me in 1980 revealed that no tests had been carried out on a sufficiently large scale to identify risks of one in 1,000, one in 500 or even one in 100. Therefore, how can it be said that on balance the drug is safe?

Since the controversy first exploded in the United States, there have been further studies. The FDA has pursued the issue and, unlike the British CSM, it has held public discussions with experts. Like the CSM, it has found no proven causal evidence of damage, but is did not stonewall. The "residual uncertainty" of the experts led the FDA to issue a strong warning that the drug should be used only for "significant" nausea and vomiting that is not responsive to non-prescription measures. That implied a clear "keep away" notice to many of the 25 per cent. of United States pregnant women who would have normally taken Debendox.

Those who, like the Minister, are anxious to defend the drug industry damage their case by defending companies like Merrell Dow. The Minister's Department is at fault because a few weeks ago the Parliamentay Under-Secretary of State for Health and Social Security, in answer to a planted question about Debendox, claimed that the company had decided to cease production for commercial reasons arising from ill-informed criticism of the product, and litigation, particularly in the United States.

In its press handout for the gullible, Merrell Dow used almost the same words. The Minister was uncritically parroting the glib excuse of the company. That was a regrettable lapse by a Minister for whom I have great respect. The truth is that the company ceased production because in August 1983 the Food and Drug Administration planned to press the company to give patients important information, to the effect that two studies had shown an increased risk of stomach defects after using Debendox. The company anticipated the request and withdrew the drug, and 30 years of marketing the drug came to an abrupt end.

The controversy did not end with the withdrawal of the drug, and the legal battle will not end with the £92 million offer that the company is making. Merrell Dow is trying to get away with the absolute minimum and it does not seem to mind who it hurts in the process. It calculates that British families will not win in British courts because we do not have product liability. It knows how difficult it is to prove negligence, which the parents of British children have to do in our courts, as my hon. and learned Friend the Member for Leicester, East has so eloquently explained.

What Merrell Dow should do, and what I would dearly love the Minister to do, is to heed the splendid example of ICI — a drugs firm with a fine record. After the Eraldin affair, ICI argued that it had no legal liability for those who had been damaged by the drug. Yet the company set up a comprehensive compensation scheme, giving equality of treatment to all. I hope that, in particular, the Minister will note that ICI paid those outside the United Kingdom who had been damaged by the drug. ICI showed a proper regard for its customers. By contrast, Merrell's refusal to pay British children, when it is paying children in the United States, is an absolute disgrace to the pharmaceutical industry. I hope that the Minister will give us his view on that situation this morning.

The only good thing to emerge so far from this unhappy state of affairs is that it will advance the day when product liability is the law of this country. As my hon. and learned Friend the Member for Leicester, West has made clear, the present arrangements are hopelessly inadequate and we need the new deal which only product liability can provide.

I believe that the drugs industry and the Minister will be acting foolishly if they oppose product liability — although I have more confidence in the Minister than in the drugs industry. Without product liability, we shall continue to have drug scandal after drug scandal as the black sheep of the industry pursue their nefarious ways.

The arguments that product liability will be costly and hold up research do not bear examination, as a glance at the United States will show. Product liability there has not damaged the drugs industry at all. That argument is quite bogus.

In the report in the Financial Times on Merrell's offer of £92 million to children in the United States, the comment was that it would not affect the earnings of the parent company, Merrell Dow Chemicals, as the payment was covered by insurance and reserves. As for the finances of drugs companies operating over here, with our crazy system of rewarding them, who knows who pays compensation? It may well be the Department of Health and Social Security. The Minister may be able to enlighten us on that point.

Drug damage may be an unfortunate accompaniment of progressive medicine. It is a risk which it is neither easy nor sensible for individuals to insure against. It is a risk that the drug companies should cover. Without product liability, we have an arbitrary system—a crazy battle for compensation. The vast majority of drug-damaged victims receive nothing from this casino approach. Only a handful of cases benefit. The resultant injustice defaces our society. It is time for the House of Commons to initiate a change to a fairer and more just system of compensation. A move towards product liability would be more than a useful start.

Photo of Kenneth Clarke Kenneth Clarke Minister of State (Department of Health) 6:08 am, 25th July 1984

I congratulate the hon. and learned Member for Leicester, West (Mr. Janner) on raising this subject at such an uncivilised hour. He will not be surprised, and neither am I, that his right hon. Friend the Member for Stoke-on-Trent, South (Mr. Ashley) has also taken part in the debate. Both the hon. and learned Gentleman and the right hon. Gentleman are known to be extremely compassionate men, ready to take up the causes of individuals whom they see as suffering from injustice—particularly the disabled and the handicapped. They tend to have the support of many hon. Members in their campaigns, and of the public, and I hope that the Ministers who reply to them are equally compassionate and do their best to respond sympathetically.

The right hon. Member for Stoke-on-Trent, South made attacks—they were not virulent ones but sideways swipes—on at least three of my right hon. and hon. Friends who have answered on these matters from the Dispatch Box. All three of my colleagues to whom he referred are equally compassionate and would not hesitate to use the power of the Government to help disabled or handicapped people who suffer injustice as quickly as any other hon. Member.

The Government defend the success of the pharmaceutical industry. It has produced many enormously beneficial drugs. By scientific advance, it has considerably reduced illness and suffering. The British pharmaceutical industry is in the forefront of development and is an extremely valuable source of employment and earnings. We are right, however, to have an extremely severe and strict regulatory system which governs the safety of drugs. We use it when it is obviously right that the Government should ensure the prompt withdrawal of drugs that cause damage. It is also right that British law should produce compensation for people who have suffered damage and are entitled to compensation.

There is no difference in motive between us. Nobody fails to recognise the suffering that the parents of deformed children have endured. Having said that, however, I must say that the campaign against Debendox is wholly misconceived. The arguments of the hon. and learned Member for Leicester, West and the right hon. Member for Stoke-on-Trent, South are subject to two fundamental defects.

Photo of Mr Jack Ashley Mr Jack Ashley , Stoke-on-Trent South

Can I make it clear that I am not suggesting that the right hon. and hon. Members to whom I referred are not compassionate? I made specific charges against them and gave them notice that I would criticise them. I did not allege that they are not compassionate, for I think they are, but that they were badly mistaken in what they said about people attacking the drug industry.

Photo of Kenneth Clarke Kenneth Clarke Minister of State (Department of Health)

I am grateful to the right hon. Gentleman. He is following his usual practice of not introducing a note of personal animosity into the division of opinion between him and Ministers.

All Ministers, including me, have concluded that the campaign is wholly misconceived and subject to two fundamental flaws. First, there is no scientific evidence to suggest that Debendox caused the deformities in children which are complained of. There is no causal link, if I might use the jargon, between the drug and the injuries for which compensation is sought. Secondly, no system of law will provide compensation for an injured person if he or she cannot demonstrate that the injury was caused by the product against which he or she makes complaint.

For that reason, the Pearson commission, although important, is almost irrelevant to the Debendox case. Even if we had strict product liability, I fail to see how any compensation would be won in the courts if those who brought the actions could not demonstrate that their injuries were caused by the product. No question of negligence would ever arise unless the causal link were established.

We all know that Debendox is used to treat severe morning sickness. It was first licensed in the United Kingdom in 1972 and still is licensed. However, Merrell Dow will not renew the licence next month when it expires at the end of its normal five-year term. The company has told us that it will withdraw the drug for purely commercial reasons. In particular it has decided that it is not justified in marketing the product because of the cost it was incurring in defending the product against a large number of legal suits brought against it in the United States. It has also found that the campaign launched against the drug has resulted in sales falling to such a level that it is not worthwhile to market it any further. The company has never at any stage conceded that the drug is unsafe or has caused injuries to the expectant mother.

I do not rely on the company. I was prepared to be as critical, and even sceptical at times, about the claims of giant companies in this area as the right hon. Member for Stoke-on-Trent, South, but I am persuaded by all the evidence that comes to me from the scientific community. As a result of the campaign, the drug has been closely investigated by the scientific community and the media for at least six years. The claim has been made that the administration of the drug to the mother during pregnancy has caused abnormalities in some children.

In Britain, Ministers look for their advice primarily to the Committee on Safety of Medicines. We endeavour, and I think that we succeed, in attracting to the membership of the CSM the most distinguished medical advisers that we can persuade to give this public service. At the moment we have 19 people, drawn from a wide range of professional disciplines. They do their best to give an objective and fearless appraisal of the safety of drugs that are referred to them.

Such is the concern about any allegation that a drug causes deformities that the committee has repeatedly looked at the drug Debendox. The committee, at the Government's request, investigated the drug in June 1978, February 1979, March 1980, December 1980, February 1982, April 1982, May 1982 and February 1983. On no fewer than eight separate occasions has the CSM examined the evidence relating to the safety of Debendox. It looked at the data drawn from animal and human studies. It considered a swatch of reports which suggested that there were aspects of the drug that bore examination. On each occasion the committee has reached the same conclusion.

That conclusion is that there is no acceptable scientific evidence that Debendox causes abnormalities in children. That remains the position and the right hon. Gentleman knows it. The committee has come to that conclusion for no other reason than that that is its expert appraisal of the scientific evidence placed before it.

That is not only the view of the CSM. It is not unknown for campaigners, even the right hon. Gentleman, to make attacks on the CSM when it will not come to the conclusions that they think it ought to on particular products. In fact, the evidence has been scrutinised by other regulatory authorities in other countries. It has been scrutinised by every major drug regulatory authority in the developed world where the product is marketed, including the United States, Germany and Australia. They have all come to the same conclusions as the CSM. It is not possible to find a reputable drug regulatory agency which has decided that Debendox is unsafe or that it causes abnormalities in children.

That baffles a layman. It baffles me. One finds cases of children being born with deformities and mothers who are absolutely convinced that it is the result of taking the drug for their morning sickness. The fact is that it is one of the tragic risks of life that some children—a small minority—are born with deformities. Sometimes there is a cause—rubella or a virus infection; occasionally a drug, as was tragically the case with Thalidomide. In a minority of cases, however, no one knows the cause of the handicap and it is pointless to blame a particular drug unless one can establish on a sound scientific basis that there is a link between the product and the handicap experienced.

Photo of Mr Jack Ashley Mr Jack Ashley , Stoke-on-Trent South

I am amazed at the Minister's claim that there is no evidence of damage caused by the drug. First, he ignores the warnings expressed by the FDA. Secondly, some American experts have said that Debendox is a low-grade teratogen. Thirdly, I challenge him to tell the House whether it is true that no tests have been carried out to show whether Debendox damages one in 100, one in 500 or one in 1,000. Unless such surveys are carried out, it cannot be claimed that a drug taken by 3 million women here and 33 million throughout the world has not caused damage. Only when that has been done can the Minister make such a statement.

Photo of Kenneth Clarke Kenneth Clarke Minister of State (Department of Health)

With the greatest respect, it is no use the right hon. Gentleman saying that he is amazed by what I say unless he can demonstrate some inaccuracy in it. After the most exhaustive examination of all the evidence, all the major regulatory drug authorities in the western world have failed to find any causal link between this drug and deformities in children. No regulating authority has ever withdrawn the licence, because it is the opinion of the experts in every country that on the scientific evidence available to them there is nothing to show that the drug is unsafe.

In his final point, the right hon. Gentleman was reduced to using an argument that sounds plausible but has no scientific merit. He says that it has never been possible to prove absolutely the safety of the product, but that is true of countless beneficial drugs. He is merely saying eloquently and with heavy emphasis that it has been impossible to prove the negative. Neither he nor anyone else can prove that the drug is unsafe, so he argues that it cannot be exhaustively shown that it is absolutely safe. That argument is ingenious. but it is nothing like enough to support the case that he has made, the strictures that he has made or, I fear, the claim for compensation.

I quite understand the concern of people who have children damaged from birth and who have persuaded themselves that the damage is somehow related to the drug, but unless and until some scientific connection is established, it is not possible to take the steps that the right hon. Gentleman wishes.

The Department must base itself on scientific appraisal of these matters. We cannot be towed off into populism, emotion and political campaigning on a subject as fundamental as drug safety and the health of the population. We must be guided by the best scientific advice we have, which is that, so far as anyone can see, the drug is safe.

The result of the campaign has been somewhat extraordinary in that a product regarded by all the regulatory authorities as one that ought to be licensed has been driven from the market. On 23 January 1982, the British Medical Journal published an article entitled Crying wolf on drug safety which described campaigns of this kind in the following terms: In contrast, associations may prove false alarms which cast an unwarranted blight on a useful drug. One such was the report associating skeletal malformations with Debendox, which has not been confirmed by later large-scale studies but played a part in the loss of public and medical confidence in the use of the drug by pregnant women. Many doctors think that the right hon. Gentleman and those who campaigned with him have driven a useful drug off the market. It is certainly the case that, of its kind, Debendox was the best tested drug that we had for morning sickness. Morning sickness of a mild kind is something that many expectant mothers experience, but acute nausea and severe morning sickness can be very serious. Acute nausea can damage the foetus in extreme cases. Because Debendox, the best tested drug that we had on the market, has now been withdrawn from the market, one can only assume that what the doctors are doing is prescribing another antihistamine which is less well tested and which expectant mothers are now taking when they suffer from severe nausea.

I do not think that it is altogether in the interests of the public that we come to such conclusions unless and until there is some acceptable scientific basis for moving to that position. The fact is that the drug is unmarketable because of the campaigning against it, and the clinical freedom in this country has therefore been restrained to the extent that other less well tested products have to be used for the problem of morning sickness.

I have put my case, about which the right hon. Gentleman is still annoyed, but he knew that I was going to put it, and I think that in his heart of hearts he knows perfectly well that one cannot mount a successful campaign for compensation for an injury from a drug unless one can begin by proving that the injury was caused by the drug against which one is campaigning.

Given the conclusions to which I am driven, I regard his suggestion that we should now go on to boycott every other product made by Merrell and the Dow Chemical Company as ridiculous and irresponsible. It would lead to driving other worthwhile drugs off the market simply because he has convinced himself, in the teeth of the scientific evidence, that there was some connection there if only somebody somewhere would accept his belief in it in the absence of any scientific evidence.

The hon. and learned Member for Leicester, West, with his usual ingenuity, has linked the problem of Debendox, regarding which he has some sympathy with his right hon. Friend's case, with the Pearson commission on civil liability. As he conceded quite fairly, the link in fact is not a terribly good one. As I have said, if we did have strict product liability in the country, I cannot see how anybody would establish any case for compensation unless he could prove a causal connection between the drug and the injury.

As the hon. and learned Gentleman also conceded, cases were lost in America when they were brought. Two cases were fought in America, which has a stricter regime of product reliability, and the company successfully defended them. Nevertheless, Merrell has decided to offer payments from a £92 million fund to the parents who have begun, or might in future begin, legal action against the company on the grounds that Debendox caused birth defects in their children. About 700 of such legal campaigns have been filed in the United States so far. Before one looks to that, as one must, and wonders whether this is some concession of liability, and whether it shows that, under a stricter system of law, damages might have been obtained, one has to look at the background and the reasons that have been given for that payment.

Merrell has never admitted that its drug causes injuries, and has successfully defended itself against that allegation in the American courts. It was facing a huge number of claims being brought against it, and I am informed that the position in America was that the company was highly unlikely to recover any of the legal costs that it incurred in successfully defending action after action. The company says that it faced the possibility of years of campaigning cases being brought against it, and that it could have incurred legal costs of up to £700 million in the United States.

The company had already spent £3 million on defending the first two cases and it decided to pay what would be regarded in English law as a nuisance payment, although it involves substantial sums. The company has paid £92 million to parents to save further legal costs. It has insisted that a condition of the payment is that litigants sign a statement to the effect that Debendox was not responsible for the alleged congenital defects.

It is not for me to put the case for Merrell. It is not for me to go into American legal cases, but no one has demonstrated that the American legal system is superior to ours in this respect, or that the payments made by Merrell prove that compensation should be paid in the absence of a scientifically provable link between a product and the injury complained of.

Photo of Mr Greville Janner Mr Greville Janner , Leicester West

Does the Minister agree that, in the absence of strict liability law in the United States, which is what I am talking about here, the manufacturers of the Debendox drug in the United States would not have made a payment of £92 million to the suffering families?

Photo of Kenneth Clarke Kenneth Clarke Minister of State (Department of Health)

I disagree. I do not act as advocate for Merrell, but I have studied the reasons given by it for paying out. The company had to pay the costs of actions which it successfully defended, because it could not recover costs from the plaintiffs. It faced the prospect of 700 or more successful defences of its product, which could have created a huge bill despite liability not being proven. The company made a financial decision that it was cheaper to pay out £92 million to settle the actions than to pay £700 million to defend them successfully. The calculation that it is cheaper to pay even with a good defence applies whether or not strict liability applies.

The Royal Commission report on "Civil Liability and Compensation for Personal Injury" is known as the Pearson report. It deals in detail with issues relating to legal liability and compensation in cases where products, including drugs, are alleged to cause injury. We have not filed away the report as a whole. It made over 20 recommendations on various aspects of the law. We have acted on one or two of the less important recommendations.

The most important recommendation is that a producer should be strictly liable for personal injury caused by defective products. That would remove the necessity in English law to establish negligence or breach of contract by the producer before compensation can be awarded.

I have never been convinced of the Pearson case. The principal problem is that the insurance costs for some products, particularly drugs, could be considerable. Pearson says happily that the costs of insurance would be passed on to the customer. The right hon. Member for Stoke-on-Trent, South rightly spends much of his time pressing us to keep drug costs to the minimum. We cannot ignore the fact that the price of some products would be raised dramatically by insuring them against liability when there is the risk of a disaster of Thalidomide proportions. The costs and risks of changing must be considered carefully. We must reflect on the possible effect that change would have on technical innovation and research.

However, this Government, like the previous Government, have not rejected Pearson outright. We are waiting for progress on a draft European Community directive. We have decided that it would not be right to make an amendment to United Kingdom law on the issue whilst a draft EC directive on product liability is being discussed in Brussels.

Photo of Mr Greville Janner Mr Greville Janner , Leicester West

The Government are blocking it.

Photo of Kenneth Clarke Kenneth Clarke Minister of State (Department of Health)

I understand that in Brussels there are disagreements on a wide range of issues involving EC directives. One of the principal concerns of many, which I share, is to allow to product liability a state-of-the-art defence. I do not believe that Pearson is relevant to the Debendox case. In so far as the report is relevant, I must confess that I have never agreed with its recommendations. Protracted negotiations go on in Europe, and the Government believe that there are advantages in establishing a common system of liability throughout the Community.

We cannot take a final view of the proposals until certain details have been clarified. We are especially concerned to ensure a proper balance between the interests of the producer and the consumer—for example, by providing producers with a state-of-the-art defence.

Photo of Mr Greville Janner Mr Greville Janner , Leicester West

I fully accept that there is a protracted negotiation in Europe. The protraction is caused mainly by the Government, who are deliberately dragging out the negotiation to avoid any conclusion being reached. I note with great interest that the Minister has now declared himself against the product liability recommendations of the Pearson commission. I am deeply worried about that aspect, because I had always counted the right hon. and learned Gentleman as one of the more progressive members of his Government, and I hope that his view on this matter is not shared.

Will the right hon. and learned Gentleman elucidate some matters for the House? First, is his view that of the Government? Are the Government against this recommendation? Secondly, are the Government blocking European action? If so, will the right hon. and learned Gentleman please come clean and tell the House and the country about that matter? Thirdly——

Photo of Mr Harold Walker Mr Harold Walker , Doncaster Central

Order. The hon. and learned Member has gone far enough. Interventions should be brief. The hon. and learned Member cannot address the House twice in this debate.

Photo of Kenneth Clarke Kenneth Clarke Minister of State (Department of Health)

The hon. and learned Member for Leicester, West was accusing the Government of blocking this directive in Brussels. He knows perfectly well that the Government think that there should be a state-of-the-art defence for producers. I believe that there should be a state-of-the-art defence. I do not think that, because one disagrees with the hon. and learned Gentleman on this occasion, one is necessarily not progressive. Pearson was misconceived in going for absolute product liability. The part of the report dealing with that aspect is not convincingly argued.

The Government believe that there should be a general law of product liability throughout the EC. Obviously, there should be some improvements and we should continue to negotiate constructively on progress towards a common product liability within the EEC.

Pearson has no direct relevance to the Debendox case. The drug was accepted by the scientific and medical community as safe and of considerable value to many women suffering morning sickness during pregnancy. It is no longer commercially worth while for the company to market the drug, and its licence is about to be withdrawn. There is, however, no prospect of compensation being given to everyone unless and until any mother of a deformed child shows that that deformity was caused by the drug about which the complaint is made.

If scientifically acceptable evidence should ever emerge to demonstrate a link between this drug and the birth of deformed children, everyone's view would obviously change dramatically. I hope that, if there were any change in the scientific evidence, we would all be able to ensure that women and children who have suffered are treated seriously. We cannot simply ignore the weight of evidence against this claim. I am afraid that unless and until there is some scientific basis for the claim, this is one of those campaigns that are well-intentioned and arouse understandable emotion but are devoid of any solid basis in fact or in law.