Pharmaceutical giant held liable under the Product Liability Directive for the first time

On 9 February 2004, a Danish Court ruled that the producer of Lariam must pay damages to a consumer who suffered psychiatric side effects after taking Lariam to prevent Malaria when visiting Thailand. The Court held that the product was defective under the Danish law implementing the Product Liability Directive (85/374/EEC) because it did not give the consumer information about known risks from the product. Hoffmann-La-Roche, the producer, had omitted to include a patient information leaflet in error. This case is believed to be the first claim that has been successful in a court under the Product Liability Directive against the manufacturer of a pharmaceutical product.

Case details

The case was brought by a Danish patient, Flemming Jay, and his travel companion who were prescribed Lariam on 2 December 1998 for a vacation to Thailand. Both took two pills and Mr Jay became very ill, suffering from psychiatric episodes, including violent nightmares, aggressive behaviour, fear and crying. Lariam was well known at the time for having serious side effects, such as anxiety, restlessness, depression, forgetfulness, confusion, hallucinations and psychotic, paranoid and other psychological reactions but neither patient was alerted to these side effects because the pack of tablets did not contain the patient information leaflet. Hoffmann-La-Roche admitted that the omission of the patient information leaflet was due to an error on its part, the need for such leaflet having been compulsory in Denmark since 1996.

It was not clear why Lariam was prescribed. Though it is the most efficient medication for prevention of malaria, it is mainly used as a prophylactic treatment for travel to destinations with a high risk of infection with malaria, due to its serious side effects. At the time, Lariam was not recommended for travel to Thailand and other alternative medications were available. The court concluded that the plaintiffs did not receive proper guidance about side effects from the prescribing doctor.

The court held that the lack of the patient information leaflet meant that the product was defective according to Section 5, paragraph 1 in the Danish law on producer responsibility (which implemented the Product Liability Directive) since the producer did not give the consumer information on risks known to the producer such that the product did not present the safety which a consumer is entitled to expect of a prophylactic medicine. It was held that it was immaterial that Lariam was an approved medicine, that the producer had given adequate information about the side effects of Lariam to the relevant authorities, that the side effects had long been commonly known by doctors and that Lariam may only be obtained on prescription.

It was considered important that the medicine was given to healthy persons in order to prevent disease rather than to treat an illness and the court thought that some consumers would expect much higher standards of product safety in relation to a medicine taken as a prophylactic in connection with tourist travel than a medicine for treatment of disease. It was also a factor that there are alternatives to taking a prophylactic medicine, such as changing the method of travel or travel destination, and the probability that information on the side effects of the medicine will have an influence on whether the consumer chooses to take the medicine or not is much higher with a product like Lariam than the probability with a medicine used for treating a disease. It was for the defendant to prove that the missing information leaflet had no importance in the patient's decision to take the medicine and that burden had not been discharged. It was, therefore, held that there is a causal connection between the missing patient information leaflet and the plaintiff's decision to take Lariam.

The court found that Mr Jay's symptoms corresponded with possible known side effects of Lariam and held that, under the circumstances and the close connection in time between taking Lariam and the occurrence of the symptoms and in the light of expert testimony that the symptoms were caused by Lariam, it had been proved that Mr Jay's sickness was caused by Lariam. There was, however, insufficient evidence to prove that Mr Jay's travel companion was also caused injury by Lariam.

Hoffmann-La Roche was ordered to pay Mr Jay 10,000 Danish Kroner, which amounted to 50% of the damages claimed, and the costs of the case. It is understood that the remaining 50% of the damages claimed were paid in an out of court settlement by the doctor who prescribed Lariam and failed to advise the claimant of the side effects of the medicine. It is thought that Roche will appeal against the judgment.

Comment

The warnings given in relation to a product are just one of the factors courts will take into account when assessing the defectiveness or otherwise of a product under the Product Liability Directive. The Directive lays down certain circumstances to be taken into account when considering whether a product provides the safety which a person is entitled to expect. These circumstances are:

a) the presentation of the product;

b) the use to which it could reasonably be expected that the product would be put;

c) the time when the product was put into circulation.

Product warnings are relevant to the presentation of the product and the use to which it will be put. It is an important aspect of a product's safety that appropriate warnings should be given in relation to the risks which a product presents and which it is not possible to eliminate. Warnings are given as part of the presentation of the product, and these warnings have an impact on the expectation of the consumer.

In the case of pharmaceuticals, a higher level of risk may be considered acceptable in the light of the potential benefit of the product. In this case, it was argued that the consumers were unable to form a proper view as to whether to use the product because they were provided with no information as to the possible risks presented by the product. The case underlines the significance of the product information leaflet in a legal context and demonstrates how the provision of information directly to the consumer/patient reduces the ability of pharmaceutical companies to rely in their defence entirely on the doctrine of the 'learned intermediary' and the provision of information by doctors to patients.

For further details please contact Christopher Hodges at christopher.hodges@cms-cmck.com or on +44 (0) 207 367 2738, Zelda Pickup at zelda.pickup@cms-cmck.com or on +44 (0)20 7367 2043 or Natalie Wood at natalie.wood@cms-cmck.com or on (0) 20 7367 2523.