Product Liability 2009 - Arnold & Porter LLP

Lovells LLP Germany
statutory or regulatory duty falls on the person to whom the
relevant provision assigns the duty (e.g. on producers and suppliers
under sections 4 and 5 of the Product Safety Act).
1.4 In what circumstances is there an obligation to recall
products, and in what way may a claim for failure to recall
be brought?
Where a producer becomes aware of risks emanating from a
product that is already on the market, he is under a duty of care to
take appropriate measures to avoid or minimise the risks. Often, it
will be sufficient to issue warnings, but the producer can be under
a duty to recall the product where other measures are inadequate.
An obligation to recall products can also follow from an order by
the relevant authority. Under the Product Safety Act, as amended in
2004, authorities can issue a recall order if they have reason to
assume that a product is not in conformity with the safety
requirements under the Act, provided a recall is the most
appropriate form of action.
The failure to issue warnings or to recall the product gives the
injured person a claim in negligence or for breach of
statutory/regulatory duty. Furthermore, some courts also accept a
claim for mandatory injunction for warnings and even recalls.
1.5 Do criminal sanctions apply to the supply of defective
products?
There are criminal sanctions for the supply of defective products.
Relevant provisions exist, for example, in the Criminal Code in the
Food Act and in the Drug Act.
2 Causation
2.1 Who has the burden of proving fault/defect and damage?
Section 1 (4) PLA puts the burden of proving defect on the injured
person, who has to show that the product did not provide the safety
a person is entitled to expect (section 3 PLA). As to the proof of
manufacturing defects, this means the higher the expectations of
safety to which the typical consumer is entitled, the lower the extent
to which the claimant has to investigate the exact nature of events
leading to the product’s failure - and vice versa. As far as design
defects and warning defects are concerned, proof of defect
effectively comes close to establishing corporate negligence.
Under section 84 of the Drug Act, the claimant must prove (i) that
the risks of the product in question outweigh its benefits, or (ii) that
the information in the product labelling (e.g. on potential adverse
events) did not accurately reflect the state of scientific knowledge
at the time when the product was put into circulation. As a result,
in practice, the standard under the PLA and under the Drug Act will
be very similar.
While in tort the burden to prove fault is usually on the claimant,
this rule is modified in product liability cases. Where a breach of a
duty of care is in question, it suffices that the consumer proves that
the product was defective. The producer must then show that he did
everything necessary and reasonable to discover and avoid the
defect. Finally, it is for the claimant to prove damage, i.e. his injury
and any consequential damages resulting from the injury.
ICLG TO: PRODUCT LIABILITY 2009
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2.2 What test is applied for proof of causation? Is it enough
for the claimant to show that the defendant wrongly
exposed the claimant to an increased risk of a type of
injury known to be associated with the product, even if it
cannot be proved by the claimant that the injury would
not have arisen without such exposure?
In order to prove causation, the claimant has to show that the
damage would not have occurred but for the defect, or the breach of
duty, respectively (condition sine qua non test). The claimant does,
as a rule, not satisfy this test by demonstrating that the product
created an increased risk.
According to the rules of prima facie evidence, the claimant can
prove causation by establishing a typical course of events. This
does not mean, however, that the claimant only needs to
demonstrate an increased risk or a certain probability of causation.
It means that the court can infer causation from the circumstances
of the case if it is an established fact that those circumstances
typically indicate a causal link.
Following a reform of the Drug Act in 2002, the claimant no longer
needs to prove that the drug he used did in fact cause his injury. He
only needs to prove that, considering all the circumstances of the
individual case, the drug was “capable” of causing the damage.
Causation will then be presumed, and it is for the defendant to prove
the absence of a causal link. However, this rule does not apply
where other factors were (also) capable of causing the damage,
which is often the case in practice. For example, the courts have
confirmed that this rule does not apply where the claimant’s injury
could also have been caused by individual risk factors.
2.3 What is the legal position if it cannot be established which
of several possible producers manufactured the defective
product? Does any form of market-share liability apply?
The theory of market share liability does not apply in Germany.
Instead, according to section 830 (1) of the Civil Code, joint and
several liability applies “if it cannot be ascertained which of several
participants caused the damage through his conduct”. This
provision may apply where the claimant can prove that several
manufacturers breached their duty of care towards the consumer
and that each breach of duty could have caused the damage, as long
as other causes can be ruled out.
It has been argued that this provision also applies in cases where the
claimant cannot prove which of several defective products he used
caused the damage, provided he can demonstrate that each
defective product could have caused the injury. Whether this theory
has a basis in the statute is the subject of some controversy. What
is clear is that this provision does not apply where the claimant
cannot prove: (i) exactly which products he used; (ii) that all
products he used were defective; (iii) that each of these defective
products could have caused the damage; and (iv) that no other
factors could have caused the damage.
As mentioned above, under the Drug Act, the claimant only needs
to prove that the relevant product was capable of causing the
damage. It is then for the defendant to demonstrate that other
factors were also capable of causing the damage. Significantly, the
defendant cannot point to the application of other drugs as an
alternative factor unless liability for the other drugs would be
excluded for other reasons than the lack of a causal link (section 84
(2) 4). This will be the case, in particular, where the other drugs are
not defective, for example because the alleged event is labelled in
the product information.
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