On 12 October 1961 the plaintiff, a farmer’s wife born in 1920, went to a hospital for a minor gynaecological operation to be carried out by its director. Dr M, his assistant, injected the plaintiff with an anaesthetic called Estil to be employed for a short narcosis, which was produced by the defendant. Dr M injected it in the bend of the plaintiff’s left arm. By accident, the anaesthetic, which was to be administered intravenously only, was injected into an artery. This led to a serious disturbance of the plaintiff’s circulation and necessitated, finally, the amputation of her upper arm.

Beginning in August 1960 Estil had been subject to clinical tests, first in one and then in several hospitals. As early as 8 December 1960 an accidental injection into a patient’s artery had resulted in the amputation of an arm. Estil was registered with the Senator for Health in Berlin on 23 January 1961 and was put on sale on 1 April 1961. Instructions attached to each package contained the sentence in bold type: ‘Intra-arterial injection must be avoided with certainty’. After the accident involving the plaintiff, the warning attached to the package was increased twice. On 9 February 1962 the defendant withdrew Estil from sale.

Meanwhile a number of such accidents had occurred, most of them involving the loss of an arm, but also some affecting the kidneys, in one case with lethal effect. The plaintiff claimed damages from the defendant. The Court of First Instance rejected the claim, but the Court of Appeal of Stuttgart allowed it. A second appeal by the defendant was unsuccessful for the following

Reasons

I. The Court of Appeal holds the defendant to be liable in tort (§ 823 I BGB) because he has caused the loss of the plaintiff’s arm by having culpably violated in his capacity of producer of medicines his public duty of care. The appeal against this decision fails in the result.

1. (a) The Court of Appeal reaches this view primarily because it holds that thorough clinical tests had not been carried out before Estil was put on the market. Such tests were required in order fully to recognize the dangerous nature of Estil, i.e. its arterial intolerance and the fact that an intra-arterial injection could not be avoided with certainty. If these tests had been carried out, so the Court of Appeal believes, the incident suffered by the plaintiff would not have happened.

(b) This Division agrees with the appellant that the arguments of the Court of Appeal cannot be accepted in their entirety. It may be true that further clinical tests were indicated. It is also clear that if the tests had not yet come to an end, the medicament would not yet have been in free circulation and would not have been administered to the plaintiff. Nevertheless, it seems doubtful whether, regarded from this point of view, the incident which affected the plaintiff can be attributed in law to the defendant as a breach of duty. The incident suffered by the plaintiff was caused exclusively by the arterial intolerance of the medicament, as the Court of Appeal found without committing a mistake of law. In order to obtain further certainty further clinical tests with human beings would hardly have been the most suitable means, especially since incorrect injections are less likely to occur among medical specialists and since greater care is applied in an experimental situation than in general practice, for which the medicament was meant at least as much. However, at the time when it was put on the market, the defendant was not at all in doubt, as the Court of Appeal itself stated in another connection and, as he states, he decided for this reason to include a warning in the notice attached to the package, an unusual measure from his point of view. The general danger of intra-arterial injections by accident, especially in the arterial area, was not to form the object of experiments with human beings, least of all by a medicament which would cause necessarily most severe damage in such circumstances. Moreover, applying that degree of care which must be expected absolutely of a manufacturer of such a medicament, this danger could be gleaned already at that time from the medical literature, as the expert opinions show upon which the Court of Appeal relied in another connection.

2. It is unnecessary to enlarge on this point, since the decision of the Court of Appeal is well founded in law on the ground of insufficient information concerning the dangerous nature of the medicament.

(a) The Court of Appeal holds it against the defendant, above all, that he was content to include a general warning in a notice included in the package and in the prospectus sent to medical men without having indicated in any way the serious, possibly irreparable, consequences of a misdirection of the injection into the artery, although he was well aware of them.

In the opinion of the Court of Appeal, there was all the more reason to do so since according to the unanimous opinion expressed in specialist medical circles an accidental intra-arterial injection could not be avoided with certainty, especially if administered in the bend of the arm; the danger inherent in particular in the bend of the arm in this respect could not have escaped the attention of the research department, directed by a medically qualified person, of the defendant’s enterprise. Instead the defendant had recommended for the first time only in the notices dispatched after 16 October 1961—i.e. after the incident involving the plaintiff—to make injections in the lower arm for preference and, moreover, at first only 0.5 ccm as an experimental dose; even then he had not mentioned the nature of the possible danger. He had done so only in the third version of the notice—when called upon by the authorities—from January 1962 onwards, i.e. shortly before the product was withdrawn.

The Court of Appeal found further: If the defendant had, as was his duty, drawn the attention of every medical person to the existing risk in such a forcible manner from the beginning or at least after the Congress of Anaesthetists held on 8 October 1961 (where the Estil incidents were discussed) Dr M would have avoided the bend of the arm, and if he had approached the artery nevertheless, he would have noticed it at any rate while making an experimental preliminary injection. Thus the incident would have been avoided.

(b) These arguments cannot be invalidated by the appellant. The opinion of the Court of Appeal cannot be faulted in law that the defendant had violated his public duty of care (duty to inform) as a manufacturer of medicaments [references] inasmuch as he failed to indicate openly in the notice included in the package and in the medical prospectus the absolute arterial intolerance of Estil known to him.

It has been recognized for a long time by the practice of the courts that it is the duty of a manufacturer, the violation of which may render him liable to third parties for any ensuing damages, to give an effective warning of specific dangers emanating from a product brought on the market [references].

The requirements are especially strict for providing information about possible danger connected with medicaments. The Court of Appeal is correct in holding that in the face of this principle any consideration of the interest of the manufacturer to promote sales is excluded. The Court of Appeal was therefore right in requiring as information sufficient for the practising medical profession that the consequences of intra-arterial injections (almost certain total loss of the extremity) should be set out clearly together with the advice that the well-known practice of injecting Estil in the bend of the arm must be abandoned, because in the opinion of all the expert advice at the disposal of the Court of Appeal the danger of a misdirected injection is much increased, given the special nature of the anatomical situation. The Court of Appeal, in so holding, agrees in the essential point with numerous decisions which in deciding claims for damages against medical practitioners have found as a fact that an injection of Estil in the bend of the arm is altogether inappropriate. Several of these decisions have been upheld on appeal to this Division [references].

According to the findings of the Court of Appeal, especially in so far as they are based on expert testimony called for by the court and on its foundations, the arterial intolerance to Estil—which could have been proved easily by experiments carried out on the ear of a rabbit—exceeded by far the dangers which accompany generally an accidental intra-arterial injection with other medicaments. The fact that the same may have been true for a few other medicaments which had to be injected intravenously, such as Presuren, which was no longer advertised for sale later on, makes no difference; in the present case a special source of danger existed which the doctor using the medicament did not expect unless his attention was specifically drawn to it. This is all the more valid since according to its purpose as indicated by the advertisements of the manufacturer (the defendant), the medicament was to be used above all in general practice, i.e. by doctors without special qualifications in anaesthetics. This danger was further increased because Estil, intended for brief narcosis, is subject to a quick breakdown in the body and must be injected quickly in one move by a wide-bore needle and under heavy pressure.

No legal objections can be raised if the Court of Appeal holds in the light of these considerations that medical practitioners ought to have been informed of the full extent of the risk in selecting this medicament because only thus would they have been warned particularly to use the utmost care and not to use it at all in case of doubt.

(aa) The appellant fails inasmuch as he wishes to show with reference to the statistical material, previously presented to the judge, but not so found in detail by the latter that on the average other anaesthetic methods disclose for other reasons an even higher quota of incidents. The old medical maxim above all not to create more harm (primum nil nocere) militates against the acceptance a priori of a certain quota of incidents. Instead every recognizable source of danger—especially, however, one which is already well known—must be eliminated in dealings with patients, be they diagnostic, anaesthetic, or therapeutic, if and in so far as it can be reasonably avoided; this applies even if actual danger is only to be expected to materialize in relatively few instances. The duty to avoid danger is primarily incumbent upon the doctor, for subject to agreement with the patient, he determines the treatment. However, to impose this duty upon him alone would not correspond to the peculiarities of modern pharmaceutical specialization. Here the responsibility, and with it the duty of care, of the manufacturer increases to the extent in which the production of the medicament is based on development which cannot be repeated easily by the medical practitioner or even understood; also the manufacturer himself, through intensive advertising among the medical profession, seeks and achieves to influence a choice in favour of his medicament and no other.

This Division need not decide whether—as the Court of Appeal finds in the alternative—already at the time of the incident involving the plaintiff it was improper to put Estil on the market because it was known that the danger connected therewith was disproportionately high (see now § 6 I of the Medicaments Act which in this respect merely gives statutory authority to a previously recognized duty of care towards the public). The decision under appeal is already supported by the conclusion that the defendant has not complied sufficiently with his clear duty of care towards the public to inform freely medical practitioners who wish to use the medicament of the specific danger and to warn them against it. Especially if it were conceded in favour of the defendant that the continuing marketing of Estil could still be justified having regard to its special narcotic advantages, it was necessary to acquaint the medical profession clearly and explicitly. Only thus could a medical practitioner balance correctly the risk which is connected to a greater or lesser degree with the use of every medicament against the benefit for the patient hoped for in the individual case, and could, if necessary, give proper advice to the patient in making up his mind. The conditions required for such weighing to take place were not provided by the defendant when he drew attention in bold type for the need to avoid intra-arterial injections with certainty. This is particularly valid because, as the defendant has stressed constantly, this requirement is a matter of course where narcotic medicaments are being used. This notice did not bring home that a special danger was to be avoided or had to be accepted for special reasons.

(b) Contrary to the view of the appellant, the Court of Appeal is also not wrong in not conceding to the appellant that he could rely on the publications in medical journals to provide the medical profession with information about Estil. Leaving aside the Court of Appeal’s apposite consideration that those general medical practitioners who are mainly concerned with using the medicament do not all read specialized publications regularly, the court could deduce from the files to which it referred that those publications did not justify the defendant to treat them as being of unlimited objectivity, for in accordance with an alleged custom he had inspired these reports himself and had paid for them . . .

(c) As regards the question whether the insufficient information was the cause of the damage, the Court of Appeal concluded that a warning of the kind which it regarded as indicated would have prevented the incident involving the plaintiff.

(aa) This, too, cannot be faulted in law as far as the result is concerned. It could be expected that, as a typical and intended consequence of an adequate notice, no conscientious doctor would have made an injection in the bend of the elbow, but would on finding another suitable vein, have applied the highest possible attention commensurate with the highly dangerous nature of the remedy and would, in appropriate cases have abandoned the use of the medicament altogether. The latter was particularly appropriate in the present case as the appellant emphasizes since . . . the chief medical officer had expected in any case that the well-tried anaesthetic Evipan would be applied.

If this had happened, the typical increase in danger resulting from the failure to give a warning would have been excluded. It was for the defendant to prove that exceptionally, despite the application of extreme care, a misdirected injection would have taken place which according to prevailing medical opinion could never be avoided with absolute certainty . . .

(cc) Finally the appellant argues, though unsuccessfully, that a manufacturer of medicaments can only be held liable for the application of his product in accordance with its prescribed use; to inject a medicament intended for intravenous application in an artery was to apply it contrary to its prescribed use, the consequences of which could not be attributed to the manufacturer.

This is only correct in so far as an intentional misapplication (e.g. oral, instead of external as prescribed) is in issue. In such circumstances the occurrence of unforeseen acts may break the chain of causation. However, even to that extent the manufacturer is not exempt from giving appropriate warning, as the case may be, against likely wrong use, e.g. by a clear notice ‘for external use’ (see now § 10 VI 3 of the Medicaments Act). Such a duty to give notice is precisely in issue here. It is all the more important where it is necessary to prevent not an intentional but a negligent misapplication (‘missing it’) if, as found in the present case, this possibility is not totally remote and must have surprisingly severe consequences. The question as to whether the medical practitioner also acted negligently remains irrelevant as long as the manufacturer is to be blamed specifically for not having forestalled such mistakes of the medical attendant which are not beyond all expectation. According to general opinion, which is also supported by the provision of § 840 I BGB, the fact that another person has also caused the illegal act does not exonerate the tortfeasor either altogether or in part. Thus in the result the Court of Appeal has rightly held that the defendant is liable in tort for the incident involving the plaintiff.

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This page last updated Thursday, 01-Dec-2005 11:04:42 CST. Copyright 2007. All rights reserved.