Product Liability 2009 - Arnold & Porter LLP

Muscat Azzopardi & Associates Malta
consumers. It is merely through an order in writing that the Director
can request the immediate withdrawal of unsafe products from the
market and, whenever he deems it necessary, to order the destruction
of such products under such conditions as he may deem fit.
Upon receipt of a notice in writing ordering the producer to
withdraw the product in question, until such time as the notice is
withdrawn, the product shall not be used, sold, offered for sale or
traded or shall not be removed except to such place as the notice
may specify. Breaching such written notice will result in a criminal
offence.
1.5 Do criminal sanctions apply to the supply of defective
products?
The Product Safety Act, Chapter 427 of the Laws of Malta, imposes
upon distributors, and that is upon any person in the supply chain
whose activity does not affect the safety properties of a product,
including wholesalers, retailers, commission agents and other
intermediaries, the requirement to act with due care in ensuring that
compliance with general safety requirements is held. Distributors
may not supply products they know, or should reasonably know, not
to be compliant with such safety requirements.
Distributors supplying products known to them not to be in
conformity with the established safety requirements shall be
prosecuted in a Court of Magistrates sitting as a Court of Criminal
Judicature. Upon being found guilty the criminal sanctions
applicable in this regard range from a minimum fine of €1,164.69
to a maximum fine of €23,293.73 and imprisonment not exceeding
four years.
Furthermore the Court may order the suspension or cancellation of
any licence or licences issued in favour of the person charged or
convicted or in respect of the premises involved in the proceedings.
2 Causation
2.1 Who has the burden of proving fault/defect and damage?
The onus of proving any defect and any possible damage that has
resulted from the said defect shall rest upon the claimant. It is the
causal relationship between the defect and the resulting damage that
must be shown by the injured party.
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?
It is enough for the claimant to show that his association with the
product resulted in the injury. There shall not lie upon the injured
person the burden of proving the fault of the producer. A product
will be considered to be defective if it does not provide the safety
which a person is entitled to expect. In this regard consideration
shall be given to the presentation of the product, how it was
marketed and any directions and warnings that may have been
provided and to the use to which the product could reasonably be
expected to have been put. Whilst a product shall be considered
defective if it does not provide for the safety which is usually
provided for by other models of the same type a product shall not
be considered defective only because a better product is
subsequently put on the market.
ICLG TO: PRODUCT LIABILITY 2009
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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?
Whilst there are no provisions for market share liability the law
states that whenever two or more persons are liable for the same
damage (liability must thus first be established) they shall be liable
jointly and severally.
2.4 Does a failure to warn give rise to liability and, if so, in
what circumstances? What information, advice and
warnings are taken into account: only information provided
directly to the injured party, or also information supplied to
an intermediary in the chain of supply between the
manufacturer and consumer? Does it make any difference
to the answer if the product can only be obtained through
the intermediary who owes a separate obligation to assess
the suitability of the product for the particular consumer,
e.g. a surgeon using a temporary or permanent medical
device, a doctor prescribing a medicine or a pharmacist
recommending a medicine? Is there any principle of
“learned intermediary” under your law pursuant to which
the supply of information to the learned intermediary
discharges the duty owed by the manufacturer to the
ultimate consumer to make available appropriate product
information?
When considering whether or not a product is defective
consideration is given to, amongst other things, the product
information and warning supplied with or for the product, the
product’s labelling information and data sheet, marketing material
and any statements that may have been made in relation to the
product throughout the marketing process and by sales
representatives.
Article 77 of the Consumer Affairs Act, Chapter 378 of the Laws of
Malta, provides that where the trader as a final seller of goods is
liable to the consumer because of a lack of conformity resulting
from an act or omission by the producer, by a previous seller in the
same chain of contracts or by any other intermediary, the final seller
shall be entitled to pursue remedies against the person or persons
liable in the contractual chain.
3 Defences and Estoppel
3.1 What defences, if any, are available?
In relation to liability for defective products the Producer shall not
be liable if he brings as proof one of the following defences:
(a) that he was not the person to have put the product into
circulation;
(b) that it is probable that the defect which caused the damage
did not exist at the time when the product was put into
circulation by him or that the defect came into being
afterwards;
(c) that the product was neither manufactured by him for sale or
for any form of distribution for an economic purpose nor
manufactured or distributed by him in the course of his
business or trade;
(d) that the defect in question is due to compliance with a
mandatory requirement imposed by law or by a public
authority;
(e) that the state of scientific and technical knowledge at the
time when the producer put the product into circulation was
not such as to enable the existence of the defect to be
discovered; or
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