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Case:
BGHZ 51, 91 VI. Civil Senate (VI ZR 212/66) Hühnerpest -decision = NJW 1969, 269 See JZ 1969, 387 for an approving note by Diederichsen and VersR 1969, 155 for an approving note by Deutsch
Date:
26 November 1968
Note:
(with approving notes by Diederichsen = JZ 1969, 387 and E. Deutsch = VersR 1969, 155)
Translated by:
F.H. Lawson and B.S. Markesinis
Copyright:
Professor B.S. Markesinis

On 19 November 1963 the plaintiff, who ran a chicken-farm, had her chickens inoculated against fowl pest by the vet, Dr H. A few days later fowl pest broke out. More than 4000 chickens died and over 100 had to be slaughtered.

The plaintiff claimed compensation for the damage from the defendants, vaccine manufacturers, whose vaccine XY had been used by the vet. This he (the vet) acquired from the defendants in 500 cm bottles at the beginning of November 1963. The bottles came from batch ALD 210, which the defendant company had had inspected on 18 October 1963 at the public Paul-Ehrlich Institute in Frankfurt-am-Main; and the batch had been released by them for public use. The defendant had subsequently and in the course of its business poured the contents into receptacles normally used in commerce. As regards receptacles with lower than 500 cm capacity that is done by airtight closure under negative pressure; larger bottles were filled by the defendants ‘openly’ but in a closed room under ultraviolet radiation.

When a few days later, on 22 November 1963, Dr H inoculated the chickens at R’s farm, fowl pest broke out there. At about this time fowl pest also broke out in three other poultry farms in Württemberg which had had their chickens inoculated with the defendant company’s vaccine from batch ALD 210. When the Stuttgart Veterinary Inspection Officer had several bottles of that batch inspected by the Federal Research Institute for virus diseases in animals, there were found in some bottles bacterial impurities and still active ND (Newcastle Disease) viruses, which had not been sufficiently immunized. Moreover, the Paul-Ehrlich Institute established that some of the bottles sent to it for inspection were not sterile and ND virus could be detected in them.

The defendant company disputed the claim that the outbreak of fowl pest was to be traced to the use of its vaccine; and in any case the defective sterility of the bottles was not the cause. For this it invoked the opinion supplied to it by Dr E of the Federal Research Institute for Virus Diseases. It put forward evidence exonerating it from liability for its workers in and the director of its virus section.

The Landgericht and the Oberlandesgericht declared the claim well founded. The defendant company’s appeal was unsuccessful for the following

Reasons

The Court of Appeal started by finding that the vaccine supplied to Dr H was contaminated by bacteria, and that the outbreak of fowl pest was to be traced to it. Even the defendant company’s expert, Professor Dr E, could not exclude the possibility that the contamination had arisen through carelessness on the part of persons employed by the defendant company in the bottling. For their fault the defendant company must be liable under § 278 BGB to the vet, the buyer of the vaccine. He, however, was entitled to be compensated for the damage done to the plaintiff. Since he had assigned his claim for compensation to the plaintiff, the action was well founded.

I. The principles governing the claims for damage suffered by a third person (Drittschadensliquidation) cannot be applied to the present case.

1. In principle, the only person who can claim compensation for damage under a contract is the one to whom the damage occurred in fact and who, in law, has to bear it. If the damage occurs to a third party, the doer of it is liable to him—apart from certain exceptions—only in delict. This distinction between the more favourable liability in contract and the more restricted liability for delict is imbedded in the existing system of liability law and is not a mere theoretical dogma. Only in special cases have the courts admitted exceptions, namely where special legal relations between the creditor under the contract and the beneficiary of the protected interest cause the interest to be ‘shifted’ on to the third party, so that as a matter of law the damage is done to him, and not to the creditor. From it the doer can derive no benefit to the third party’s detriment: he must make good to the creditor the damage to the third party. That applies—apart from the rare cases of responsibility for risks (BGHZ 40, 91, 100)—where the creditor has contracted for the third party’s account (BGHZ 25, 250, 258), or where the thing that the debtor promised to take care of belonged not to the creditor but to the third party (BGHZ 15, 224).

(a) This is no such exceptional case. No ‘union of interests’ between the vet (who made the contract) and the third party (i.e. the plaintiff) is created by indirect agency. Dr H had not bought the vaccine to the order or for the benefit of the plaintiff. When he ordered and obtained it from the defendant company he did not yet know for which farmer he would use it. A vet invariably buys his medicines for himself like a contractor in respect of his materials and not for his patients or employers, even if he requires them to perform an order already given to him.

Moreover, this is not one of the cases where the thing placed in the debtor’s care belonged not to the creditor but to a third party. Of course Dr H may have had imposed on him a ‘duty of care’ (Obhutspflicht) concerning the plaintiff’s chickens. But it is a condition for claiming for damage suffered by a third party (Drittschadensliquidation) that the duty of care exists between creditor and debtor (BGHZ 40, 101). That was not the case here.

(b) The Court of Appeal also acts on these principles. It is also aware that in principle the manufacturer and supplier of a thing which has been sold again to a third party does not need, merely on the basis of the contract of sale, to make good damage occurring to a third party (BGHZ 40, 104, 105). All the same it believed that in the present case it could permit the claim in respect of the damage suffered by the third party. Here the faultless condition of the vaccine was of special interest to the plaintiff, on whose chickens it was to be used. The vet could not check the condition of the vaccine, but had to rely on careful manufacture by the defendant company. The latter must therefore have proceeded on the assumption that a duty of faultless delivery rested on it in favour not merely of the vet but also of whomever happened to keep chickens.

(c) These considerations do not justify treating this as a case for claiming damage as suffered by a third party (Drittschadensliquidation). Already in its judgment (BGHZ 40, 90) the Bundesgerichtshof has emphasized that a contract of sale cannot be interpreted in accordance with the requirement of good faith so as to afford a basis for compensation to a third party injured through defects in the thing bought. In that decision it departed from the judgment of the Reichsgericht in RGZ 170, 246. The Court of Appeal has also established no concrete basis for holding that the defendant company had been ready and willing to afford to the other party to the contract (namely the vet) claims to compensation more extensive than under the statutory law of sale. Moreover, it is a condition of claiming for damage suffered by a third party that only one damage shall have taken place, which would have been suffered by the creditor unless the protected legal interest was that of a third party. There can be no question here of ‘shifting’ the damage. It occurred here to the plaintiff in fact as well as in law, whereas in a genuine ‘shifting’ of damage it occurs to the creditor in fact, though not in law. It could not occur either to the vet or to the chicken-farmer, but only the latter, and not—which is the decisive point—to him instead of the vet.

The cases of claims for damage suffered by a third party (Drittschadensliquidation), so far admitted by the courts, cannot be extended to cover a case like the present. Otherwise the manufacturer and supplier of necessaries and luxuries, of toiletries and medicines, etc. would have to make good damage to the ultimate user not only in delict but also on the contract of sale. For he also knows, like this buyer, the wholesaler, intermediate, and retail dealers, that any damage would show itself in the hands not of the dealer, but of the ultimate recipient. This does not lead to the conclusion, however, that the producer is liable in contract to the ultimate recipient. The question how these interests are to be protected cannot, therefore, be solved by allowing a claim for damage suffered by a third party (Drittschadensliquidation).

2. The Court of Appeal also based its opinion on the principle that a duty of care on the part of the manufacturer towards the third party arises from the meaning and purpose of the contract. This might be interpreted in the sense that the Court of Appeal is willing to allow the plaintiff a claim to compensation on a contract with protective effects for third parties. That consequence also cannot be approved.

(a) The Bundesgerichtshof has, indeed, allowed claims to compensation on this legal theory and under specified circumstances to a third person not a party to a contract (BGHZ 33, 247, 249 and 49, 350, 351 with references). Those principles, however, cannot be called in aid here.

In no way can everyone who has suffered damage through a failure of care on the part of a debtor derive his own claim to compensation from the contract between creditor and debtor (Senate judgment of 30 April 1968—VI ZR 29/67 NJW 1968, 1323). The Senate in its judgment of 18 June 1968 (VI ZR 120/67 NJW 1968, 1929) indicated afresh that the law distinguishes between persons suffering direct and indirect damage and that liability under a contract is, on principle, bound up with the bond that binds debtor to creditor (cf. also BGH judgment of 9 October 1968—VIII ZR 173/66). Otherwise there is a danger that the debtor can no longer calculate the risk that he undertakes in making a contract. Hence it would no longer accord with the principle of good faith, out of which the contract with protective effect for third parties has been developed, for the debtor to be liable for such extensive consequences of his breach of contract. That can be admitted only if the creditor shares, so to say, in the responsibility for the welfare of the third party, because damage to the latter affects him also, since he is under a duty to afford him care and protection. It is this internal relation between creditor and the third party, ordinarily marked by legal relations of a personal character, and not the relation between the parties to the contract, that is the reason for the protection of the third party. Such a relation does not, as a rule, exist in a contract of sale or a contract for doing a job.

(b) Moreover, in the present case there are no such close relations between the creditor (the vet) and his clients.

II. If therefore the judgment under attack cannot be supported by the foregoing reasoning, we must enquire whether it can be upheld on other grounds. The plaintiff not only based her action on claims derived from the contract made by Dr H with the defendant company, but also invoked §§ 823 ff. BGB. In addition, she prayed in aid the question exhaustively argued in recent times, above all at the Deutscher Juristentag of 1968, concerning the direct liability of the manufacturer of goods to the ultimate user (‘product liability’).

1. Even the advocates of an extensive liability of the producer start as a rule from the proposition that it can be based neither on a claim for damage suffered by a third party (Drittschadensliquidation) nor on a contract with protective effects for third parties. They prefer to provide the user with his own claim for damages, not one dependent on the contract between the manufacturer and buyer, and not brought against the manufacturer as an ‘action directe’—like the claim for damages based on §§ 823 ff. BGB. But they consider this claim in delict no longer satisfactory or appropriate, because it does not, as a rule, cover purely economic damage and, above all, because it leaves open to the producer the possibility of exonerating himself, especially where there is a mere slip in the productive process.

The case to be considered here affords no occasion for examining the question whether we should adhere to the rule developed by the courts that the producer can invoke § 831 BGB when there are defects in the actual production . . . and that such defects raise no presumption of fault against the manufacturer (Senate judgment of 21 April 1956—VI ZR 36/55). For it is not established here that it was because the defendant company’s staff had made a mistake that the vaccine contained reactivated viruses. That may also be due to causes that are inherent in the company’s methods of production, and in particular in the method of bottling. In the present case there is no need to adopt a comprehensive attitude to the problems of products liability. Here, only the following considerations apply.

(a) The claim in the action could be granted without further discussion if the view of Diederichsen in his Die Haftung des Warenherstellers (1967) could be followed, that the manufacturer must be liable for every kind of defects in the product without reference to fault, as in the liability for risks or results (‘strict liability’). He believes that this can be derived from the existing law by ‘considerations of legal sociology or legal theory’. It is however doubtful whether his standpoint can be supported on grounds of legal policy and, at any rate, liability without fault is incompatible with the present law of (civil) liability. To extend the liability for risks regulated in particular enactments—mostly subject to different ceilings—to products liability is forbidden to judges. It is rather for the legislator to decide whether or how far a stronger objective liability should be imposed on the manufacturer.

(b) Nor is it legally possible—apart from special cases—to afford to the ultimate recipient a direct claim for damages on the assumption that contract of warranty was concluded directly, albeit tacitly, between him and the producer. The fact that the producer allows his goods to be distributed as his invention, that is to say with his label, in original packaging, with his trade name or trademark, and so on, cannot, as a rule, be considered as a declaration that he intends to make himself responsible to users for careful manufacture (cf. RGZ 81, 1). Normally, even the advertisement of branded goods which are advertised with particular emphasis on the ultimate user, contains no indication of any willingness to be liable for any defects in the goods (BGHZ 48, 118, 122–3). Moreover, that cannot be assumed even when the appreciably wider question is asked whether the manufacturer is willing to be directly liable to the ultimate user of his product.

(c) There is also no question of a claim for damages being accorded for a breach of alleged duties of protection consequent on a ‘social contract’. No business relations exist between manufacturer and recipient nor are they intended to be started and, eventually, to be concluded. The relations which certainly exist on the sociological plane have not enough legal weight for claims for liability to be made from a special legal relation. That applies also to Weimer’s attempt to derive a producer’s liability from the general rule in § 242 BGB.

2. Special consideration is merited by the idea that recognition should be given to a special quasi-contractual relation between manufacturer and user, resting on statute and developed from the notion of confidence. In fact the relations that have come into existence between the buyer of a dangerous product and its manufacturer, before the occurrence of the damage, would seem to be closer than those that bring the latter into relations with ‘everyman’ when—and not before—he is actually injured. As regards the claims for compensation of a buyer, on the other hand, it should be considered whether they also arise from contract law if he bought the goods not directly from the manufacturer but through a dealer.

(a) Starting from the special legal relationship between manufacturer and acquirer of goods, Lorenz at the Karlsruher Forum 1963 was the first to state the opinion that the manufacturer must be liable under § 122 BGB to answer for the confidence in his product, strengthened by advertising, that he has awakened in its users. Those ideas were mentioned by the Eighth Civil Senate of the Bundesgerichtshof at the close of its judgment of 13 July 1963 (BGHZ 40, 91, 108), but without committing itself to any position. In its judgment BGHZ 48, 118, it declined to accept advertisement as a possible source of liability. In the struggles for the all-important customer (König Kunde), advertisements have become more and more extensive and more and more significant from a business point of view. This, however, does not yet mean that they have acquired the meaning of a promise of legal liability. Moreover, no reasonable user understands it to be so: and Lorenz has not followed up his idea.

(b) Lorenz’s basic idea provided the foundation for the attempts to derive the manufacturer’s liability from a duty to satisfy the confidence placed by the user and made the basis for a claim corresponding to the legal principles developed for culpa in contrahendo.

It is however doubtful whether these considerations can hold water, so as to afford the user a claim for damages which, like the claim in delict, cannot be excluded automatically, but on the other hand would not be threatened by exoneration under § 831 BGB. The Senate has already, in its judgment of 21 March 1967 (VI ZR 164/65) reacted against the attempts to base the liability of a third person, not a party to a supposed contract, on the fact that his confidence was sought; and it emphasized that they would break, with dire consequences, through the boundary drawn between liability based on a contractual obligation and that arising from delict. Whether the doubt there expressed against an extension of liability for ‘positive breach of contract’ (‘positive Vertragsverletzung’) tells also against a subjection of the producer to a liability on the analogy of contractual liability need not be finally decided in this case. Nor need the question be gone into of how such a quasi-contractual claim should be afforded to a person injured by the product if he did not buy it but damage occurred through its use by himself or another person. In the case now to be decided there is no question of a number of legally successive sale contracts in which the seller, in fact, is often the mere ‘distributor’ of the manufacturer in which case a breaking of the veil suggests itself. Here between the plaintiff and the defendant company stood a vet, who had alone to decide which vaccine to use. The plaintiff had placed confidence in him and not in any advertisement. She was not, herself, in a position to buy the vaccine directly or in the market: the defendant company could deliver it only to the vet and only he might use it . . . That, of itself, excludes the idea that a quasi-contractual relation existed between the parties. The plaintiff was not a ‘consumer’ of the vaccine, nor even a ‘user’ of it, but, from a legal point of view, ‘only’ a sufferer of damage. As such she is limited to her claim in delict.

III. According to the Court of Appeal’s finding of fact the conditions of liability under § 823 BGB are fulfilled. The vaccine supplied by the defendant company was defective and the cause of the disease to the chickens. Even if, as explained above, the rules of contract law are not applicable, nevertheless the starting-point must be that the defendant company has committed a fault. If anyone when using an industrial product for its declared purpose suffers injury in one of the legal interests protected by § 823 I BGB, through the defective manufacture of the product, it is for the manufacturer to explain the antecedents that caused the defect and thereby to show that he was not to blame for it.

1. It is not in question that even in ‘product liability’ the injured party must prove that the damage was caused by a defect in the product. The plaintiff had therefore to show that the fowl pest broke out among her chickens because the vaccine originated with the defendant company and contained active viruses when delivered.

That proof was considered by the Court of Appeal to have been furnished. [An explanation followed.]

2. The Court of Appeal, having to ascertain why the vaccine contained live viruses, started from the fact that both the Paul-Ehrlich Institute and the Federal Research Institute found bacteria in the bottles examined by them. It based its conclusions in essence on Professor Dr E’s opinion. He declared it highly probable that the bacteria had found their way into the bottles at the manual pouring of the vaccine from the large containers into the bottles. It has been observed on various occasions that viruses which—as here—have been killed by the addition of formaldehyde can, under certain conditions, become reactivated. It was therefore possible that the bacteria here had reactivated the virus. On the basis of these explanations of the expert, the Court of Appeal believed it could find that the contamination of the bottles by bacteria was the cause of reactivation. It pointed out also that no damage arose from the part of the batch that was not contaminated by bacteria, whereas that was the case with the bottles used by Dr H and in the district of Heilbronn, and in which the bacteria were found. Even Dr E held it possible that the contamination of the vaccine was caused by ‘human error’ on the part of one of the persons employed by the defendant company in bottling the vaccine.

3. The appellant attacked this conclusion of the Court of Appeal, but without success.

It is indeed correct that the Court of Appeal considered no fault of the defendant company itself as proved. It accepted that it was probably only an employee that was to blame for the damage. A liability of the defendant company, cannot, as we have seen, be established by applying the law of contract, as set out in § 278 BGB. That does not, however, necessitate sending the dispute back to the judge of fact. For it would still be for the defendant company to exonerate itself even if the plaintiff can rely on § 823 BGB.

(aa) This results from the fact that the plaintiff’s claim for compensation is also based on § 823 II BGB. For the defendant company, by delivering the dangerous bottles of vaccine infringed a protective enactment. This vaccine, a medicine in the sense of the Medicines Act of 16 May 1961 (§ 3 III AMG), was capable of producing in the chickens injurious, even fatal, effects. § 6 AMG prohibits the putting of such vaccines into circulation. That provision—like § 3 LebMG (cf. RGZ 170, 155, 156 on § 4 LebMG) which applies to foods dangerous to health—constitutes an enactment for the protection of endangered human beings or animals. If, however, an infringement of a protective enactment is proved, it is presumed to be the result of fault. The infringer therefore must produce facts sufficient to disprove his fault (Senate judgment of 12 March 1968—VI ZR 178/66). The owner of the business did not produce that proof so long as a possible cause, falling within the scope of his responsibility and which might point to fault remained unelucidated (Senate judgments of 3 January 1961—VI ZR 67/60 and 4 April 1967—VI ZR 98/65).

(bb) This rule governing the burden of proof would, however, also apply if the plaintiff could here base a claim for damages only on § 823 I BGB. In that case also it would be for the defendant to exonerate itself. It is true that the injured party who relies on § 823 I BGB will have to allege and if necessary prove not only the causal connection between his damage and the conduct of the doer, but also his fault (BGHZ 24, 21, 29). However, the possibility of proving the subjective conditions depends appreciably on how far the injured party can elucidate the detailed course of events. That is however especially difficult when it relates to antecedents which played a part in the business of manufacturing the products. The courts for a long time came to the help of the injured party by contenting themselves with proof of a chain of causation, which, according to human experience, indicates an organizational fault in the manufacturer. All the same, one cannot stop at this point in considering claims for damages for ‘product liability’. All too often the owner of a business can show that the defect in the product might have been caused in a way that does not point to his fault—evidence which generally relies on activities in his business and which is difficult for the injured party to disprove. In consequence, when damage has arisen within the range of the manufacturer’s business risks, he cannot be regarded as exonerated merely because he points out that the defect in the product might have arisen without any organizational fault of his. This is required in the area of ‘product liability’ in order to protect the interests of the injured party—whether ultimate acquirer, user, or third party; on the other hand, the interests of the producer allow him to demand that he may prove his lack of fault.

This rule of evidence indeed only operates as soon as the injured party has proved that his damage falls within the scope of the manufacturer’s organization and risks, and indeed is satisfied by the existence of an objective defect or of unbusiness like conduct. This proof is required of the injured party even when he sues the doer of damage for breach of protective and subsidiary duties arising from a contract or the negotiations for one (Senate judgments of 16 September 1961—VI ZR 92/61 and 18 January 1966—VI ZR 184/64). It is the same if he claims against the producer for breach of his duty of care. However, once he has provided this evidence, the producer is better able to explain the facts or to bear the consequences of being unable to offer an explanation. He surveys the field of production, determines and organizes the manufacturing process and the control of delivering the finished products. The size of the business, its complicated, departmentalized organization, its involved technical, chemical, or biological processes and the like make it practically impossible for the injured party to ascertain the cause of the defect. He is therefore unable to lay the facts before the judge in such a way that he can decide with certainty whether the management is to be blamed for neglect or whether it is a case of a mistake in manufacture for which a workman is at fault, or a single breakdown that may happen at any time, or defect in development that was unforeseeable in the existing state of technology or science. But if the unknown cause lies within the scope of the producer, it is also within the scope of his risks. In that case it is appropriate and expected of him that the risk of not being able to prove his innocence should lie with him.

Such rules of evidence have always been applied to contractual or quasi-contractual relations of a special legal character between injured party (creditor) and doer of damage (debtor) (BGHZ 48, 310, 313). No obvious reason can be given why they should not also apply to delict, if the reasons for them apply. In certain connections § 831 BGB already imposes on the employer the proof of exoneration—the same applies to liability cases under §§ 832, 833, 834 BGB, and above all to §§ 836 ff. Here, indeed, the law requires a person damaged through the collapse of a building to prove that the damage was ‘the consequence of defective erection or defective maintenance’, but lays on the possessor etc. the burden of proving that he had done everything to avoid the dangers that could attach to his building. The reversal of the burden of allegation and proof ordered in these provisions does not always proceed from a presumption of fault in the doer of damage. It rests in the main on the thought that the doer is in a better position than the injured party to throw light on the events relevant to the charge of negligence, so that it is just to impose on him the risk of being unable to do so. The Senate has already in its judgment of 1 April 1953 (VI ZR 77/52) indicated that the plaintiff cannot be required to prove—as a rule an almost impossible task—that the thing that caused the damage came into circulation through the fault of the owner of the business or his agents. Above all, the Senate has already in its judgment of 17 October 1967 (VI ZR 70/66) declared that it is for the producer to exonerate himself, if the injured party can give no detailed information about the management’s blameable breaches of duty. The modern development of production, which is distributed among persons or machines that are hard to identify at a subsequent stage and rests on finishing processes capable of being inspected and controlled only by specialists, demands a development of the law of evidence in the direction already indicated in § 836 BGB . . .

In any case—as with the recognized shifting of the burden of proof for ‘positive breach of contract’—it always depends on the interests at stake in the groups of cases from time to time under consideration. The question whether the assumption of the risk of proof can be imputed in the case of the owner of a small business, where the manufacturing processes can be easily surveyed and examined (family and one-man businesses, agricultural producers, and the like), need not be considered here. In cases of the present kind it is in any case for the manufacturer to exonerate himself.

4. The defendant company has not furnished that proof of exoneration.

(a) According to Professor Dr E’s opinion submitted by the defendant company, it is possible that carelessness on the part of someone concerned with the bottling led to the contamination of the bottles. He considered the process of filling containers over 500 ccm by manual pouring and not, as happens with the smaller containers, by means of an apparatus as an ‘older method’ which was indeed ‘tolerable’, but needing improvement. For this manual pouring there must at least be constructed a correspondingly superior ‘clean work bench’ with UV radiation. In addition the ‘modest apparatus outfit’ of the business must be increased by installing dry sterilizers, so that the larger containers could be better sterilized, above all without long interruption. He also pointed out that in the process of autoclave without a temperature and pressure gauge no control could be exercised over whether the high temperature needed for the sterilization under pressure was really attained. Moreover, he recommended the use of tubes showing changes of colour. He also advised that the filling-room be examined for its germ content from time to time by exposing dishes of agar or blood.

The expert then was of opinion that in spite of these suggestions for improvement, the manufacturing methods of the defendant company were ‘not unsatisfactory’ and fulfilled the ‘normal requirements’. Moreover, the method of bottling guaranteed a sufficient degree of security, even though it needed to be improved. Finally, he was of opinion that the defendant company had not carelessly neglected any of the necessary precautions. The bacterial contamination could indeed have been caused by defective observance of the required precautions, but could have occurred even if they had been observed.

(b) The expert’s view of the required degree of care cannot be approved. Even he starts by saying that in the manufacture of vaccines in which the effect of living viruses must be immunized ‘the highest possible security’ must be required. For that very reason vaccine works are subjected to strict public supervision (§ 10 AMG together with the provisions of Land law still operative under § 5). The defects mentioned by him in the equipment of the defendant company’s business, above all as regards manual bottling, are in conflict with a finding that the management were not guilty of careless conduct. The improvements recommended by him were not at all far-fetched and imposed on the company requirements that were neither technically nor financially excessive. The possibility cannot be excluded that those additional precautions would have averted the bottling of dangerous vaccine.

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