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Country:

Germany

Court:

OLG Hamm, 18 June 2003, NJW-RR 2003, 1382 (Hepatitis-B Vaccination) (This case note is based on my article in the 14 (2004) European Product Liability Review)

Topics:

Liability for vaccines, design defect, instruction/warning defect, causation

Facts:

On 13 August 1996 the two-year old claimant got vaccinated against Hepatitis-B. Another vaccination followed on 18 September 1996. Shortly after the vaccination, the claimant experienced a severe eye-disorder which subsequently led to her losing sight. The instruction leaflet of the vaccine indicated the possibility of an infection of the optic nerve. It did not, however, indicate the possibility of losing sight. The pension office, after obtaining an expert report which found that there was uncertainty about whether or not there was causal link between the vaccine and an infection of the optic nerve, provided the claimant with a compensatory payment for her material losses. The decision to compensate the claimant was based on a provision which allows for compensation of damages due to a possible link between a vaccination and a medical disorder. With her law suit against the manufacturer the claimant sought compensation for pain and suffering.

Legal issues:

1. Test for design defect in drug cases under the German Drug Act

2. Requirements of instruction defects under the German Drug Act

3. Causation under the old and new rules of the German Drug Act

Background:

The claim was brought on the basis of the German Drug Act, which applies instead of the Product Liability Directive, for example, in case of prescription drugs, certain non-prescription drugs and vaccines (§ 15 Produkthaftungsgesetz (German Product Liability Act) and Article 13 of the Product Liability Directive (85/374/EEC). The German Drug Act is practically the only "special regime" which exists alongside the Product Liability Directive). A distributor of drugs is liable under the Drug Act if a "drug, at correct use, has harmful effects which, considering the state of medical knowledge, exceed a tolerable level" (This follows from § 5 Drug Act as well as § 84 (1) no. 1 Drug Act. § 5 is a statutory duty, whose breach leads to liability in negligence; § 84 is an original strict liability rule. The present law suit was brought on the basis of a breach of § 5 as German law, until 1 August 2002, did not allow for compensation for pain and suffering under strict liability rules). That is, the distributor of the drug is liable if the risks of the drug outweigh its benefits. Alternatively, the distributor is liable "if the injury is caused by an instruction which does not adequately represent the state of medical knowledge" (§ 84 (1) no. 2 Drug Act).

Decision

1. According to these standards, the vaccine did not contain a design defect, the Court of Appeal held. Referring mainly to the experts reports, the Court found that the vaccine did not have a negative risk/benefit analysis. The Court considered it relevant in this context that the Commission for Vaccination at the Robert-Koch-Institute had recommended the use of the vaccine. It also had to be taken into account, the Court said, that there was no reasonable alternative to a general Hepatitis-B vaccination. The prior practice in Germany, to vaccinate only special risk groups such as doctors and nurses, had led to a decrease in Hepatitis-B infections among people working in the medical sector but not to a decrease of Hepatitis-B in the overall population.

2. The instruction leaflet, indicating that one possible side-effect of the vaccine was an infection of the optic nerve, adequately represented the state of medical knowledge at the time of vaccination and was therefore sufficient. It was not necessary, said the Court, to mention the loss of sight as this consequence, according to the experts, had not been known at the time of the vaccination. Even though there had been a prior case where a patient developed an infection of the optic nerve, there had been no suggestion in scientific circles that this vaccination could lead to a loss of sight. The present case was the first case where this had been alleged.

3. The Court of Appeal then pointed out that, over and above the fact that the state of medical knowledge did not recognise a causal link between the vaccination and a loss of sight, the claimant herself did not in actual fact prove any such causal link. Only the fact that the claimant had lost sight shortly after the vaccination spoke in favour of a causal link. Other possible causes such as a viral or bacterial infection of the optical nerve, which for itself could lead to a loss of sight, could not be ruled out (The burden of proof under German procedural law requires a high possibility, not merely a standard of "more likely than not" (although even this standard would hardly be met in the present case).

The Court finally made some additional remarks as to the new causation rules under the revised Drug Act, which apply to cases after 1 August 2002. According to the new rules, actual causation between the application of the drug and the damage in the concrete case is presumed if the drug in question is, in the concrete circumstances, generally capable of causing such damage (§ 84 (2) 1st sentence). This rule does not, however, apply "if, in the concrete circumstances, a different instance could have caused the damage" (§ 84 (2) 3rd sentence). Even if, the Court concluded, it was possible that the vaccine was generally capable of causing a loss of sight, which was not established, causation in fact could not be presumed as it was possible that the loss of sight was caused by an independent viral or bacterial infection.

Comment

The case demonstrates typical issues arising in vaccine litigation cases. Even though the claimant sued on the basis of the German Drug Act, the situation would have been little different under the Product Liability Directive. According to Article 6 of the Directive, a product "is defective when it does not provide the safety which a person is entitled to expect". There is some academic discussion as to whether the concept of legitimate expectancy allows for a risk/benefit analysis (See Lovells Product Liability in the European Union - A Report for the European Commission < http://europa.eu.int/comm/internal_market/en/goods/liability/lovells-study_en.pdf >). At least as far as drugs and vaccines are concerned, however, a trade off between risks and benefits is inevitable and also compatible with legitimate public expectation. The public does not expect drugs and vaccines to be completely safe, let alone are they entitled to expect this. People do and are entitled to expect that the medical knowledge at the time speaks in favour of the application of the drug or vaccine. With respect to product information, people do and are entitled to expect that a drug carries warnings which represent the state of medical knowledge at the time when the drug is put into circulation (The foresight perspective in warning cases follows from Article 6 (1) (c) of the PLD. The development risks defence in Article 7 (e) is at least in so far redundant).

As to the causation aspect, the claimant would have faced the same problems under the Product Liability Directive as she did under the German Drug Act. The German legislator intervened and introduced new rules which are supposed to make proof of causation easier for claimants. Whether or not these amendments are legitimate remains to be seen. There are sound reasons why the novel causation rules may contravene Article 13 of the Product Liability Directive. Article 13 allows special product liability systems to remain applicable if they existed at the moment when the Directive was notified, i.e. on 25 July 1985. The European Court of Justice recently made clear that the Product Liability Directive seeks to achieve maximum harmonisation within its scope (Case C-52/00, Commission v France [2002] ECR I-2553; Case C-154/00, Commission v Greece [2002] ECR I-3879; Case C-183/00, González Sánchez v Medicina Asturiana [2002] ECR I-3901). That suggests a narrow reading of Article 13, one that does not allow the German legislator to go it alone in Europe and change the only co-existing product liability regime in a way that would indeed make a real difference to the Directive.

Stefan Lenze

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