product liability in europe

8/13/2019 product liability in europe

1/4

This guide summarises the general approach that has been taken to date across the EU in respect ofinterpreting the Product Liability Directive (85/374/EEC - the Directive). This guide focuses on how thefollowing four issues have been interpreted by national courts and the ECJ: (i) the concept of "defect"; (2)

the burden of proof and causation; (3) the "development risks defence"; and (4) the concept of "to putinto circulation". This guide is not an exhaustive treatment of the subject and does not capture everyrecorded decision on the Directive.

The concept of defect

The definition of defect is contained in Article 6 of the Directive: "A product is defective when it does not provide the safety

which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product; (b)

the use to which it could reasonably be expected that the product would be put; and (c) the time when the product was

put into circulation". The "expectations test" inherent in the above definition gives rise to a subjective element of the

concept of the defect. The lack of clarity in the definition has left it open to national courts to define the term themselves.

The High Court of England & Wales (a court of first instance), in A -v- National Blood Authority1

, considered the concept ofdefect in detail, by reference to the Directive itself.The case involved a group action brought by 114 individuals who had

contracted Hepatitis C as a result of blood transfusions containing that virus. Although blood producers and medical

practitioners had been aware of the potential risk since the 1970s, no screening test was available at the relevant time that

could identify the infected blood.

The court considered that the product was not ipso facto defective because it was unsafe. The safety is not what is actually

expected by the public at large, but what they are entitled to expect. The court needed to consider whether the public in

general knew of and accepted the risk of infection. It was held that there had been no warnings and no material publicity.

The court therefore held that no risk that any percentage of transfused blood would be infected was accepted by the public.

The claimants were therefore legitimately entitled to expect that the blood transfusions were free of infections.The

contaminated blood was therefore defective.

In reaching its decision, the court held that "all circumstances" were limited to relevant circumstances. Accordingly,

avoidability of a defect and impracticality, cost and difficulty of adopting precautionary measures were considered

irrelevant. The conduct of the defendant was therefore considered not to be a relevant consideration to take into account

when considering whether a product was defective. The benefit to society or utility of the product was held to only be a

relevant circumstance in a situation where the public has full information and proper knowledge of the risks.

In X -v- Johnson and Johnson2, a Belgian court considered a claim brought by a 16-year-old girl who had incorrectly inserted

a mini tampon into the urethra and not the vagina.The incorrect insertion involved a lot of effort and pain and, on her

mother's advice, vaseline.The claimant was unable to remove the tampon after insertion and suffered toxic shock

syndrome. The claimant argued that the product was defective because it did not warn against insertion in the wrong

place. The court dismissed the claim, on the basis that the use to which the claimant put the product was not to be

reasonably expected. The court took into consideration the fact that the defendant had never received any prior

notifications of a consumer attempting to insert a tampon into the urethra and that the instructions were clear, even for afirst-time user.

April 2006

Interpretation of theProduct Liability Directive

Brussels Dubai Frankfurt London Madrid Milan Munich New Delhi New York Paris Singapore Tokyo


2/4

In a case before the District Court of Bonn3, the claimant was said to have consumed a 400g bag of liquorice, daily, from

November 2002 to February 2003. In February 2003, she collapsed and underwent hospital treatment for heart rhythm

disturbances. A subsequent letter from the doctor who treated her attributed the heart problems to her prolonged

consumption of liquorice. She sought damages from the manufacturer, on the basis of a failure to warn of the health

consequences of liquorice consumption.The risks, arising from increased blood pressure due to the presence of glycerine,

were said to be well-known in professional circles but not to the general public.

The court dismissed the claim, holding that the claimant could not establish her case either in tort or under the

implementing legislation of the Directive.The court did not need to consider whether the claimant had in fact consumed

the alleged amount of liquorice or whether the liquorice was a cause of the heart rhythm disturbances, because the

product was not defective, either in tort or under the Directive. There was no construction failure and no failure to warn.

Although a manufacturer was obliged to warn of dangers and risks during normal conditions of use, it was not obliged to

warn of possible risks arising from excessive consumption.

The French Supreme Court heard a claim in respect of an alleged side-effect of dermatitis arising as a result of taking a drug

for treatment of gout4. The claimant alleged that the product was necessarily defective as a result. The French Court of First

Instance and the Appeal Court found in the claimant's favour, inferring the defect from the damage suffered. The

defendants appealed to the French Supreme Court. The Supreme Court dismissed the case as the defective nature of the

drug had not been established and held that it was not sufficient to show simply that a feature of the drug was dangerous.

The court held that all the circumstances had to be taken into consideration, including what the public were legitimately

entitled to expect. A drug is not ipso facto defective as a result of a side-effect.

The burden of proof and causation

Article 4 of the Directive provides that:"The injured person shall be required to prove the damage, the defect and the causalrelationship between defect and damage". The Directive gives no guidance as to the standard of proof that the claimant is

required to meet. National courts have adopted different approaches to the standard of proof to be applied.

In Riboux -v- S.A. Schweppes Belgium5, the first case decided in Belgium on the basis of the Directive, the claimant suffered

injuries as a result of an exploding soft drink bottle.The claimant did not provide evidence of a specific defect that led to

the bottle exploding. However, the District Court was prepared to infer a defect from the fact that one would not expect a

bottle to explode.

In Richardson -v- LRC Products6 the claimant alleged that the teat end of a condom became detached during sexual

intercourse, resulting in pregnancy of the claimant, and that the condom was therefore defective.The court held that failure

itself was not enough, even in circumstances where "naturally enough the users' expectation is that a condom will not

fail". The court considered that a user is not legitimately entitled to expect a condom to be 100 per cent effective as the

possibility of a condom failing was common knowledge. As the product had not failed in a way that defeated legitimate

expectations, the claimant had to prove the defect that caused the teat to become detached.

In a French case before the District Court of Aix-en-Provence7, the claimant was injured when the glass screen for a fireplace

exploded.The court was prepared to infer a defect, and a causal link with the damage, without the cause being proven, on

the basis that the product failed in a way that defeated legitimate expectations. The manufacturer had put forward other

possible causes but the court was prepared to give its decision without a full examination of the actual cause of the defect.

The above case was not heard by an appellate court. However, the French Supreme Court did hear a case brought by a

claimant who had undergone a series of vaccinations for Hepatitis B8. A month after her final vaccination, the claimant had

been diagnosed with multiple sclerosis (MS). The claimant alleged that the vaccinations were the cause of her contracting

MS.The Court of Appeal held that the product was defective on the basis that the claimant had been in good health before

receiving the vaccinations, that other patients had also contracted MS subsequent to receiving the vaccinations and thatthe defendant had not put forward any other cause. The court held that the defective nature of the product was proven by

the fact that it did not meet the level of safety to which the claimant was legitimately entitled to expect. The French

Supreme Court overturned the decision of the lower courts on the basis that neither the defect nor the causal link had been


3/4

proven.The French Supreme Court noted that the aetiology of MS was unknown and that there were no scientific studies or

expert reports to support a suggestion that there was a connection between the vaccinations and the MS.

The development risks defence

Pursuant to Article 7(e) of the Directive: "The producer shall not be liable as a result of this Directive if he proves: (e) that

the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to

enable the existence of the defect to be discovered." In particular, two issues have arisen from the wording of Article 7(e): (1)

whether "the state of scientific and technical knowledge" should be given a narrow or broad definition; and (2) whether the

defect to be discovered is a generic defect or a defect in the specific product that causes the damage.

In the first case in which the German Federal Supreme Court considered the Directive, interpretation of the development

risks defence was a central factor9. The claimant, who was nine years old at the time of the incident, suffered severe injuriesto her left eye as a result of a bottle of sparkling mineral water exploding. The mineral water was distributed in reusable

bottles. Upon return from customers, the bottles were extensively checked for defects, in accordance with the latest state-

of-the-art technology, by machines and by employees, before being put back into the market place. The explosion was

either the result of a chipped area, which the court held that the defendant should have noticed, or was the result of a

microscopic defect that it was not technically possible to detect. The court considered that the potential risk of reusable

bottles filled with carbonated drinks exploding had been known by the public for some time. However, the Federal Supreme

Court ruled that the defence only applied to design defects, and did not extend to manufacturing defects.

In Commission -v- UK10, the ECJ considered whether the UK had failed to correctly implement the Directive in respect of the

development risks defence. The implementing legislation, the Consumer Protection Act 1987, stated "in respect of a defect in

a product it shall be a defence for him to showthat the state of scientific and technical knowledge at the relevant time

was not such that a producer of products of the same description as the product in question might be expected to havediscovered the defect if it had existed in his products while they were under his control".

The court did not consider the UK implementing legislation to be manifestly contrary to the Directive but did give guidance

as to how it considered the defence should be interpreted.The court considered that the burden of proof was on the

defendant to show that at the time that the product was put into circulation the objective state of scientific and technical

knowledge was such that, on the basis of a reasonableness test, the products defect could not have been discovered.

In Scholten -v- Sanquin Foundation11, another blood transfusion case, the claimant contracted the HIV virus as a result of

receiving contaminated blood. The infection had not been detected as the donor had only just contracted the HIV virus and

his infection was in the three-month "window period" when detection was not possible by screening. The Dutch Court of

First Instance held that the defence applied as the Sanquin Foundation, which had supplied the blood, had acted in

accordance with the scientific and technical knowledge available at the time when the blood was administered. The risk of

contracting HIV was known by the Sanquin Foundation but not by the general public. The court considered that avoidability

was relevant and that the defence applied as the infection was unavoidable.The decision of the Amsterdam District Court

has received considerable criticism.

In A -v- National Blood Authority, the parties agreed that the relevant state of scientific and technical knowledge was the

most advanced available to anyone (not simply the producer), although the information must be accessible. Certain

information would not be considered accessible such as an unpublished document or unpublished research. The

development risks defence ceases to be available if and when such information becomes reasonably accessible.

The court considered it to be clear that "existence of the defect" referred to knowledge of the generic defect in a product.

Once there was that knowledge there was knowledge of the risk of the defect materialising in a specific product. Once a

producer is on notice of a potential problem, if he continues to supply products it is at his own risk. It would be inconsistent

with the purpose of the Directive if a producer, knowing of that risk, was not responsible for any injuries resulting fromcontinuing to supply that product. The court considered that the development risks defence served only to protect the

producer from unknown risks.


4/4

To put into circulation

The wording "put into circulation" has great significance with regards to interpreting the Directive. As we have seen above,

a person's legitimate expectations (Article 6) and the state of scientific and technical knowledge (Article 7) are to be

assessed at the time the product is put into circulation. Further, pursuant to Article 11: "Member States shall provide in their

legislation that the rights conferred upon the injured person pursuant to this Directive shall be extinguished upon the

expiry of a period of 10 years from the date on which the producer put into circulation the actual product which caused the

damage, unless the injured person has in the meantime instituted proceedings against the producer". However, in spite of

the significance of the wording, it was left to national courts to interpret "put into circulation".

In Veedfald -v- Arhus Amtskommune12, Denmark referred the issue of interpreting "put into circulation" to the ECJ. The

claimant had been in hospital awaiting a kidney transplant. A kidney was removed from the donor, the claimant's brother,

and prepared for transportation through "flushing" with a fluid designed for that purpose. The fluid proved defective andthe kidney was rendered unusable for any transplant. The claimant sought damages. The defendant hospital denied liability

on the grounds, among others, that the product had not been put into circulation. The court held that the definition must

be interpreted in accordance with the aim and purpose of the Directive. The exception that the defendants sought to rely

on had been intended to cover cases where (1) a person other than the producer has caused the product to leave the

process of manufacture; (2) the product is used contrary to the producer's intention; and (3) where the manufacturing

process is not yet complete. Accordingly, the court considered that the kidney had been put into circulation in the instant

case.

In O'Byrne -v- Sanofi Pasteur13, the English courts referred the issue of when a product is "put into circulation" to the ECJ.

The claimant had suffered severe injury following vaccination with an antihaemophilic vaccine. The claimant claimed that

his injuries were caused by a defect in the vaccine. The producer of the vaccine had sent it to a distributor, which

subsequently was sold to the UK Department of Health and delivered to a hospital nominated by the Department ofHealth. In the context of an issue with regards to the ten-year long stop, the question of when the product was put into

circulation became significant. The court held that a product is put into circulation when it leaves the production process

operated by the producer and enters a marketing process in the form in which it is offered to the public in order to be used

or consumed.

Notes

1 [2001] 3 All ER 2892 Rb. Zwolle 24 April 2002, Praktijkgids 2002,59213 19 April 2004,District Courtof Bonn,9 0 603/03 (Haribo)4 Cour de Cassation,Premier Civ.,1 April 20055 21.11.96,Civ.Namur,5e.Ch.6 [2000] Lloyd's Rep. Med.2807 Tribunal de Grande Instance, Aix-en-Provence, 2 October 2001,D.2001.IR.30928 Cour de Cassation,Premier Civ, 23 September 2003, Bull. C.V. 1,no 188

9 BGH,9.5.95,VI ZR 158/9410 Case C-203/9911 RB Amsterdam 3 February 1999,NJ 1999 62112 Case C-203/9913 Case C-127/04

www.ashurst.com 2006 Ashurst Ref:DTP/4270 Apr 06

Contacts

Arundel McDougall, Partner

Tel: +44 (0)20 7859 1095

Email: [email protected]

Andy McGregor, Solicitor

Tel: +44 (0)20 7859 2692

Email: [email protected]

product liability in europe

Documents