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Case:
BGH NJW 2000, 1784 VI ZR 48/99 (Karlsruhe)
Date:
15 February 2000
Judges:
Professor B. S. Markesinis
Copyright:
Mr Raymond Youngs, Southampton Institute

Facts:

The claimant, who was born on the 8th February 1994, seeks compensation from the defendant paediatrician for harm caused by vaccination. The claimant was brought by her mother to the defendant on the 11th May 1994 for a routine child care investigation. She gave her a primary immunisation against a number of diseases and a threefold live oral vaccine against poliomyelitis, with the agreement of her mother. The defendant's receptionist gave the mother beforehand a leaflet about the vaccinations which she looked at in the waiting room and gave back again without signing it. The side effects of the vaccination against poliomyelitis were stated in the leaflet, amongst others, to be that: "Feverish reactions seldom arise, and paralyses extremely rarely (one case in five million vaccinations)". The defendant asked her if she had read the leaflet and she said she had. After examining the claimant, the defendant said a vaccination was now possible if the mother wanted it. On the 13th June 1994 the mother came to the defendant again because the child had a skin rash, and the second vaccination against poliomyelitis was then carried out. On the 18th June 1994 she was found to have fever and on the 25th June restraint in the use of her left leg. Investigations revealed that she was suffering from poliomyelitis. The social security office at F found harm caused by vaccination with a reduction in ability to work of 80%, and awarded a vaccination benefit. The claimant claimed defective treatment and insufficient explanation resulting in no effective consent; and that there was no consent by the father either. She claimed damages for pain and suffering of at least 100,000 DM and a declaration that the defendant was under a duty to compensate for all consequential harm.

The Landgericht rejected the claim. The Oberlandesgericht allowed it in substance, awarding damages for pain and suffering of 80,000 DM.

The appeal in law by the defendant was successful.

Grounds:

I...

II. These statements do not stand up to legal examination in the end result. The claimant is not entitled to a claim to compensation against the defendant for unlawful harm to her health. The appeal in law is right in objecting to the fact that the assumption by the appeal court that the claimant's mother did not effectively consent to the vaccination because of the lack of sufficient explanation by the defendant was based on requirements which were too strict.

1. The appeal court has admittedly correctly stated that an effective consent was not lacking simply because the claimant's father had not agreed to the vaccination. It is true that in cases in which, as here, parental care belongs to both parents jointly (§§ 1626 ff. of the BGB), the consent of both parents is needed for a medical operation, which also includes a medical vaccination. But it will in general be possible to proceed on the basis that the parent appearing at the doctors with the child has the power to give consent to the medical treatment on behalf of the absent parent as well; and the doctor may rely on this within limits, as long as no circumstances which would indicate the contrary are known to him. This applies, as the Senate has already stated in its judgment of the 28th June 1988 (reference omitted), and it adheres to this, at any rate in routine cases, which include routine injections.

The oral vaccination against poliomyelitis with live attenuated polio pathogens carried out in the first half year of 1994 is a routine vaccination, as the appeal court has stated without legal error. It was recommended a long time ago by the Standing Vaccination Committee of the Federal Health Office (references omitted) and was also publicly recommended in Baden-Württemberg by the relevant health authority in accordance with § 14 (3) of the BSeuchG, in particular in 1994 (reference omitted). It had been carried out millions of times since the introduction of oral polio vaccine in 1962. The question of undertaking of such vaccinations arises for everyone having custody of children in the first months of a child's life (reference omitted) and usually on the occasion of the routine child care investigations of babies and small children, and this was generally known. On a vaccination recommended in this way, which a large number of parents let their children receive, the defendant might therefore rely on the fact, in the absence of concrete indications to the contrary, that the claimant's mother made her decision in favour of vaccination with the father's authority, especially as the mother - as the appeal court correctly observes - always (and this included previous occasions) appeared alone with the claimant at the surgery.

2. The appeal court further correctly assumes that the consent given by the claimant's mother to the vaccination was only effective if the risks associated with it had been previously explained to her. Such an explanation of the risks is also necessary for a voluntary vaccination and even when the vaccination is publicly recommended (references omitted). The necessity for an explanation about the danger that a person who has been vaccinated might contract spinal poliomyelitis because of vaccination with living polio viruses did not - contrary to the view of the appeal in law - cease to apply simply because it was an extremely rare consequence of vaccination. The appeal court, referring to C. Braemer (reference omitted) took as a basis a frequency of harm of 1 : 4.4 million. In the leaflet given by the defendant to the claimant's mother a risk of 1 : 5 million is given. Although the reply to the appeal in law claims that these figures are incorrect, and that on first vaccinations the risk in fact rises to 1 : 750,000 vaccinations, no more precise clarification of the frequency of harm is necessary as statistical risk figures have a comparatively low value (references omitted). The decisive factor for determining whether there is a medical duty to advise is not a particular degree of risk, and especially not a particular statistic; it is whether the risk concerned is specifically attached to the operation and on the realisation of the risk it would be especially burdensome to the patient's lifestyle (references omitted). The Senate therefore adheres to the view that in principle even extremely uncommon risks of this kind must be explained. Contrary to the view of the appeal in law and statements to the same effect in the academic literature (reference omitted) this applies also for publicly recommended vaccinations, for which the primary immunisation of the whole population is in the public interest in order to prevent an epidemic spread of a disease. In cases of public recommendation of vaccination, it is true that the health authorities have already balanced the risks of vaccination for the individual and his environment on the one hand, and the dangers threatening the general public and the individual in the case of non-vaccination on the other hand. But that does not change the fact that the vaccination is nevertheless voluntary, and the individual person receiving the vaccination can therefore also decide against it. This person must therefore not only be aware of the voluntariness of the vaccination (reference omitted), which, in relation to the claimant's mother, is not questioned here. He must also make a decision about whether to take the risks associated with the vaccination or not. This presupposes knowledge of these risks, even if they are only realised extremely rarely; they must therefore be communicated to him by medical explanation.

3. The Senate also agrees with the appeal court that the written advice on vaccination against poliomyelitis in the leaflet which was given to the claimant's mother is not open to objection as to its content.

b)...

aa)...According to the case law of the Senate, the patient only needs explanation about the chances and risks of the treatment "by and large". Exact medical description of the risks coming into consideration is not necessary...

Although the reply to the appeal in law mentions other risks (meningo-encephalitis, convulsions etc., see (reference omitted)) which had not been explained, this does not justify any different conclusion. If, as in the present case, the precise risk which had to be explained, and actually was explained, has in fact been realised, it does not as a rule matter whether other risks needed to be mentioned as well in the explanation. The patient has given his consent in the knowledge of the risk which was realised, so for this reason no liability can arise from the operation. Considerations as to whether he would possibly have refused approval on being advised of another risk are necessarily speculative and can therefore not be the basis of a claim for compensation...

4. However there are serious reservations about the view of the appeal court that the explanation could not be regarded as having been given in time, having regard to the manner in which it was made...

b) The appeal court is exaggerating the requirements for an explanation to be given in time in connection with a routine vaccination, as the appeal in law correctly argues. According to the established case law, an explanation on the day of the operation in principle suffices in the case of outpatient operations (references omitted). The only case when that does not apply is if the explanation only occurs so immediately before the operation that the patient is under the impression that he can no longer extricate himself from a course of events already set in motion (e.g. an explanation at the door to the operating theatre).

The multiple vaccination undertaken here did not require an explanation at some earlier point in time, separated from the vaccination. In particular, no requirement can be made (as the appeal court thought was necessary) for the leaflet to be given to the mother to take home, so that she could read and consider it there in peace, and for the vaccination then to be carried out on a separate date. This places excessive requirements on the doctor.

The oral vaccination, even if it was not completely free from risk, did not present the parents with difficult decisions which would first have needed thorough weighing up and careful consideration. It was a question, as has been observed, of a routine vaccination in connection with which the element of conflict in the decision was to a large extent removed from the parents by the balancing of the advantages and disadvantages undertaken by the health authorities and the recommendation for vaccination made by them. The necessity for vaccination had been generally recognised for a long time amongst the population and parents everywhere saw to it that it was done to their children, in order to avoid the feared disease of poliomyelitis. In this situation the defendant could assume that the claimant's mother was familiar with the vaccination and was in the picture about the generally accepted need for it. If a person having custody of a child should in such a case exceptionally want a period for reflection, then he could be expected to state this to the doctor and to decline an immediate vaccination.

c) The explanation which had been given to the claimant's mother was also not insufficient simply because the defendant did not make it in a personal conversation about the vaccination and its risks. According to the case law of the Senate "conversation based on trust between the doctor and the patient" is admittedly necessary for the purpose of making an explanation (reference omitted). That however does not in any way exclude the use of leaflets in which the necessary information about the operation, including its risks, is set out in writing. Written advice of this kind is normal today to a large extent and has the advantage of giving a precise and comprehensive description of the subject of the explanation, as well as providing the doctor with substantial means of proof. It is in particular appropriate for routine treatments and therefore also for publicly recommended protective vaccinations.

Such leaflets can admittedly not replace the necessary discussion with the doctor (reference omitted), in which the doctor must satisfy himself as to whether the patient has read and understood the written advice, and which gives him the opportunity to go into the individual interests of the patient and answer possible questions. But this requirement of an explanatory conversation, which must be adhered to in principle, does not require an oral explanation of the risks in every case. In certain circumstances, as with the present facts, having regard to the routine character of the publicly recommended vaccination, the doctor can by way of exception proceed on the basis that the patient does not attach any importance to an additional presentation of the risks in discussion. For such routine treatment, it can suffice if, after a written explanation, opportunity is given to the patient for further information by a conversation with the doctor...

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