Commentary: International Comparison of Jurisprudential Influences on Biologicals

Commentary: International Comparison of Jurisprudential Influences on Biologicals LORD KILBRANDON INTRODUCTION I propose to follow up Professor Curran's luminous presentation by examining the impact which has been made on international attitudes to the problem of patient-damage resulting from biologicals. I shall, like him, treat this part of the subject, looked on from broad principle, as largely an aspect of product-liability. I consider the problem to be of topical inter- national interest because it is at present under examination both by the Council of Europe and by the Commission of the European Com- munities. I shall look at the draft convention of the former (the Strasbourg Convention) and the draft Directive of the latter, together with the Memorandum and Explanations which ac- company them. This will involve considering, very briefly, the laws of certain member states and others. My object is to supplement, in a minor way, Professor Curran's comparative re- searches. The progress of international agree- ment on topics such as this, where attention has to be paid to so many conflicting legitimate interests, is shown by past experience to be far from swift. But I think there is movement. I have one other word in introduction. I would hke to touch on the juridical aspect of an essential factor in the research, development and use of biologLcals, namely, the experi- mental work which must precede the introduc- tion upon the market or into the pharma- copoeia of any new substance. That work must in most cases involve the experimental medica- tion of patients suffering from complaLnts which the new substance has been designed to relieve. How far does the law control in the interest of the patient, such necessary experi- ments? And if the experiment takes the normal course of introducing the new remedy to only a percentage of the patients, for the purpose of making a statistical comparison with controls from whom the drug has been withheld, what does the law say about depriving the controls of a potentially advantageous treatment? THE UNREFORMED LAW We begin by supposing that a person or cor- poration, concerned with the manufacture of biologicals for gain, has placed upon the mar- ket, through whatsoever mercantile or consulta- tive channels, a product which, on being con- sumed in the widest sense, caused loss and damage to the consumer. Is that supplier required by law to restore, so far as money can do so. the consumer to the position he was in before he was exposed to the product? A classical lawyer will have no diffi- culty in identifying parameters which, in his view, will contain any possible answer to that question. He will ask two questions: (l) How far v ;',s ere a contraL:ual relationship between the supplier and the consumer. and was there a breach of the agreement between them? (2) Was the supplier Ln a relationship with the con- sumer which obliged him to take reasonable care for the safety of the latter? These two legal concepts, contract and tort, (we would say "delict" in Scotland, resting A Lord ofAppeal in Ordinary. Late Chairman, Scottish Law Commission 67 Lord Kilbrandon originally on the lex AquMlia and the actio iniuriarum) can be rationalised very simply. As for contract, people are free to enter into such legally enforceable agreements as they please, or to refrain from doing so if they think that the terms offered are unacceptable. The older authorities, at least, tend to emphasize that the contractor is a be gent-equity will step in to protect him if he can show he was not-and that, in short, he who made his bed must lie upon it. Liability in tort or delict is founded on the generally accepted proposition that he who is guilty of negligence is morally to blame. He has done a legal wrong, and the law should be active in enforcing the duty of that man to re- spect at least the personal safety of his neigh- bour. It is perhaps significant that while "delict" in Scotland means the commission of a civil wrong, in France "delit" means the com- mission of a crime. One finds in the French Criminal Code, for example, the "delit de non- assistance a une personne en peril" in the corn- mon-law jurisdiotions; so far as I am aware, the conduct therein condemned as criminal is not even actionable civilly. And unless there is moral obliquity, in Ithe sense of knowingly or carelessly neglecting one's duty to one's neigh- bour, the injured neighbour has no cause of ac- tion to recover damages. If there be a neigh- bourhood relationship, accordingly, between the supplier and the Consumer of a product, the consumer who is injured through a defect in the product can succeed in his action against the producer if, and only if, he can show that the producer was quasi-morally to blame for failing to take reasonable care to avoid the oc- currence of the damage. tifferent systems have different rules as to the burden of proof; but, in principle, liability depends on a failure of the duty to take reasonable care, whether it be for the consumer to prove that failure or for the producer to disprove it. CRITICS OF THE LAW Critics of the law are to be found not only among persons concemed with social problems but also among lawyers who are not satisfied that the development of the principles of the law is keeping up with changes in technological and mercantile methods. One sees this clearly in the international fiIeld. The Draft Explanatory Report, for example, attached to the Strasbourg Convention, takes paTticular note (a) that there is an absence, in all countries, of special rules governing the liability of pro- ducers; (b) that case-law solutions in some jurisdictions-and I would add that these are by no means confined to the common-law countries-being based on the general principles of legal liability, had recourse to fiction to ensure the better protection of consumers and were highly complex. Ihe Strasbourg draftsmen considered it important to introduce special rules on the liability of producers worked out at European level, since the question could no longer be confined within national frontiers. One may be permitted to make an obvious suggestion, namely, that ideally a pan-European convention might form a basis for world-wide negotiation. There will also, I suppose, be gen- eral agreement with the proposition that while in each of several jurisdictions the law is far too technical and confusing, the divergences be- tween the remedies available in the various jurisdictions themselves even more clearly justify dissatisfaction with the existing state of consurmer protection. The Memorandum attached to the EEC Draft Directive takes basically the same line, though naturally emphasizing political and commercial factors arising from the variety of different legal attitudes. In the first place, it is said that differences between national laws ad- versely affect competition within the common market by imposing unequal burdens on in- dustry as between one state and another. For example, in a country in which a drug manu- facturer may be found liable in damages with- out proof of fault, he can manufacture and sell less cheaply than in countries where negligence must be proved against him, since he must in- clude the cost of this extra or non-comparable burden in his selling price. Secondly, it is pointed out that the present differences in the law may inhibit the free 68 Commentary: International Comparisn of Jursprudential Influences on Biologicals6 movement of goods across frontiers withm the market, which is of course one of the raisons d'8tre of the Treaty. This is to some extent another way of describing the consequences which have already been noted. Thirdly, and looking more to the interests of the individual than to those of states or cor- porations, the inadequacy of the protection to the consumer which some state laws seem to afford is commented upon. One may perhaps fairly say that the juridical doctrines which Professor Curran has described for us have made an impact on international opinion, which because of their variety, amounts to dis- satisfaction and distrust. THE STRASBOURG DRAFT CONVENTION This Convention makes proposals of a radi- cal character. The fundamental principle upon which the Convention is constructed is seen in the brief Article 3 (1):--"The producer shall be liable to pay compensation for death or per- sonal injuries caused by a defect in his pro- duct." The product is defined in Article 2 suf- ficiently widely to include biologicals. The pro- ducer means the manufacturer, or the importer, or anyone who presents by causing to appear on the product, his name, trademark or dis- tinguishing feature, the product as his product. If information as to origins is not disclosed to a claimant, the suppher is deemed to be the pro- ducer. A product has a defect when it does not provide the safety which a person is entitled to expect, having regard to all the circumstances, including the presentation of the product. It is explained in the Commentary on the Provisions that "presentation" is intended to include not only warnings or directions which are incorrect or incomplete, but also the absence of direc- tions for use or of any warnings. This last definition seems to me to be of imporatnce as being relevant to some of the U.S. cases cited by Professor Curran. It appears to be in line with the Cutter decision, which went on breach of warranty. Warranty implies that the purchaser is entitled to expect safety, since that is what the seller promises. But war- ranty is relevant only in the context of con- tract. and, as we shall see, the Strasbourg solu- tion is independent of contract. In the Wyeth Laboratories case, the Court held, rightly or wrongly, that the necessary warning had not been given. That would also import liability, if it could be established, under the Convention. Tinnerholm seems also to have been decided on its facts. In Griffin, it is not possible to detect, so far as I can see, any failure in the application of principles of substantive law, although the application of adjective law-i.e. the weighing of evidence-leaves one with some misgivings of miscarriage. The radical-or to the old common lawyer, revolutionary-feature of the Convention is its overthrow of fault liability; thus, to that ex- tent, the whole law of tort has become redun- dant. This is no new feature of "westem" juris- prudence. It has been gradually creeping in. It can be justified in many ways. Socially, there are forrnidable and unfair difficulties in the way of the ordinary citizen who has to bring fault home to a powerful corporation, or, even if the burden of proof be reversed, in sufficiently identifying causation to infer negligence. As the Explanatory Report put it, "the notion of 'fault'...no longer constituted a satisfactory basis..in an era of mass production, where tech- nical developments, advertising and sales meth- ods had created special nsks, which the con- sumer could not be expected to accept." More simply, he who advantages himself by operating a potentially dangerous agent, whether it be an automobile or a drug factory, should include in his overhead costs the price of compensating those who are even accidentally damaged by his activity. It will have been noticed that one of the effects of the Strasbourg proposals would be to move the remedy of a consumer aganst a pro- ducer out of the region of the law of contract. This would mean sweeping alterations to the laws of several member states. However, the re- tention of the contract remedy becomes un- necessary if a more general ground of action is laid down. That ground would cover what may be common instances of a consumer being in- 69 0LArd Kibrando jured by a faulty product where no contractual relationship exists between him and the manu- facturer or any member of the mercantile chain from the manufacturer up to, and including, the retailer. An xanmple is the case of the man who buys a product which is consumed by a member of his household or even an acquaint- ance. It is po.sble to construct sophisticated doctrines based upon a &s quaesitum tertio which may or may not be effective, but they are uncertain and clumsy in comparison with a straight imposition of absolute liability. There is one important feature of legal liabi- lity arising from the use of biologicals, dealt with by Profesor Curran, on which the pro- posal of no-fault products liability would ap- pear to have no effect That is the situation which arises when mass-imunisation is recom- mended by a health authority and claims arise ftom the operation of it. They may take two forms. One is a claim against the medical practi- tioner concerned in respect of some kind of malpractice, whether technical, or in failure to warn or advise, but not relying on any defect in the vaccine as sucb. Presumably these claims would be regulated by existing negligence codes. But the recent experiences, especially in the United States, of the distrous medico- legal consequences of the proliferation and exaggeration of such suits have already been the subject of international comment. The most hopeful solution so far adopted, I believe, is that of the consortium arranged in Sweden be- tween the public health authorities and certain private insurance corporations, by which funds are made available for the relief, on an in- surance and not a judicial basis, of patient- accidents, however caused. This scheme may perhaps be added to those described by Profes- sor Curran. The second respect in which strict product- liability is not effective is where it is desired to bring suit for personal injury against the public authority whJici ordered or recommended the immnunisation programme. There are strong grounds, one would have thought, for sug- gesting that such is a case, not so much for the assertion of legal liability on any particular ground, but rather for acknowledging that the costs of community action, undertaken at least in part for the general community welfare as well as for the health of individuals, should fall on the community. This would apply specially, but not I would submit only, where the im- munisation was compulsory. I will add, in passing, that there would in Britain be no con- stitutional legal obstacle to suing a govern- mental agency in any capacity, whether as manufacturer or administrator. EEC DRAFT DIRECTIVE This has the same basic principle as has the Strasbourg draft, namely, liability without fault. It goes much further inasmuch as it pro- vides for liability to property as well as to per- sons, and may for that reason not be readily agreed to by the member states. On the other hand, the definition of "defect," as it is at pre- sent under discussion, contains nothing which would cover the absence of proper directions or warnings. I will not take time to exhibit the differences between the EEC and the Stras- bourg proposals but wil observe that if the EEC proposals were adopted legislatively, by the Council and the Assembly, it would then become an obligation on member states to alter their own laws. EXAMPLES OF PRESENT LAW At a late stage in my minor contribution, I have to consider how to handle this extensive topic in order to rationalise what precedes. I have decided that economy points to my sup- plementing the data given in Professor Curran's presentation by adding a brief and totally un- scientific, being over-simplified, appendix. It will not satisfy lawyers but may be enough for discussion purposes. EXPERIMENTAL WORK Probably enough has been said about pre- licensure research and testing to introduce the discussion. To the lawyer, the problem is pri- manly one of consent. Treatment which is still 70 Commenty: Intemaional Compario of Juiprdential Influences on Biologicals 71 in the experimental stage of its development, the efficacy of which requires further proof, should not be gven without the consent of the patient. In law, the consenter must have the juridical status which enables him to give or withhold consent. Tbis may be absent, for example, in the mentally sick and the very young. For them, consent to any treatment must be given on their behalf by parent or guardian. But can it be given for treatment which is for the benefit not of the patient but of scientific research? Furthermore, many people think that a prisioner can never validly consent to such treatment. These are difficult questions, but well worth discussing. How many have heard of James Phipps, a hero of medical research? On 14 May 1796, at the age of 8 years, he was vaccinated with cow- pox lymph by Dr. Jenner. He duly contracted cow-pox. On 1 July 1796, Dr. Jenner innocu- lated him from a case of smallpox. He did not get smallpox, and that disease thereby received its death-warrant. James cannot, in the legal sense, have consented to the experiment. We do not know whether his parents purported to do so. It would not surprise me-this being 18th century London-that no one know who his parents were. I will close my commentary with a tnbute of gratitude, not without misgivings, to young James Phipps. Sources The Law Commissions: Joint Worldng Paper No. 64120. Travaux Preparatoires of Scottish Law Commission. Hon. Lord Hunter. Paper read to Law Society of Scotland, 29 January 1976. Harvey Teff: Products Liability in the Pharmaceutical Industry at Common Law, 20 McGil L.J. 102. D.N.B. sub. nom. Edward Jenner. Amos and Walton: Introduction to French Law. 3 Ed. Lord Xilbiandon APPENDIX COMPARATIVE TABLE OF LAW RELATING TO LIABILITY OF PRODUCTS MANUFACTURER France Contract. Much relied on. Existence of intermediate dealer, e.g. retailer, between buyer and seller is no obstacle. Manufacturer warrants against vices caches. In case of vices apparents vendor is liable if he knew of defect.But if he is vendeurprofessionel, his knowledge is irrebuttably presumed. Exemp- tion clause will not avoid this. Delict. Action available only to those not in contractual relationship. Claimant must prove fault. But manufacturer's liability is strict if he is gardien de la structure, e.g. in case of structual defect as opposed to fault in user, when gardien du comportement is responsible. Seller liable for insufficient warning or instruction. Belgium Contract. Very similar to France. But presumption of knowledge on part of seller is rebuttable. Exemption clause available to seller unless he was negligent. But court will be unwilling to enforce. Delict. Distinction between two classes ofgardien not accepted. Federal Republic of Gemany Contract. Plays small part. Exemption clauses effective. No presumption that seller is aware of defect. Jus quaesitum tertio allowed, as in Scotland, i.e. contract entered into between A & B for benefit of C is enforceable by C against A. Delict. Courts have handed down decisions more favourable to tonsumer than would be expected from BGB. For example, employer is not liable for negligence of employee if he took proper care in appointing him. This is unique, but recent cases get round the rule. Seller not liable for defect he was not aware of. But he will fail if he cannot establish exact cause of damage. Switzerland Not necessary to distinguish from Germany. But civil code embodies provisions in favour of consumer which are to be found only in German decisions, not in BGB. Netherlands Both contractual and delictual remedies are available. Implied warranty against hidden defects protects buyer. A new civil code, which may take account of proposed reforms, is in course of preparation. South Africa A Civil (i.e. Roman) Law country. Contracting out much same as in Belgium. Otherwise no marked distinction in forms of remedy, although civil law origins render these mostly less advanta- geous to consumer. Quebec Another Civil Law country. Naturally comparable with France, though origins of law pre-date Code Napoleon. like South Africa. Roman origins make it more interested in the contractual reme- dies, especially the actio redhibitoria and the actio quanti minor Australia: Common-law Provinces of Canada Contract. Tbere is no fundamental difference from British law of sale and warranties arising thereunder. Delict. Courts have gone further in willingness to infer negligence from mere condition of the product, but have stopped short of erecting a presumption of law. 72