Pharmacovigilance And Product Liability

Consumers who claim to have been injured by medicinal products have various remedies in law against those who manufactured or supplied the products in question. Until 1988 patients in the United Kingdom who wished to bring civil claims for compensation in the absence of a contractual relationship with the supplier, were generally restricted to any claim they might have in negligence.

In 1985, Directive 85/374/EEC (the Directive) introduced the principle of strict liability for defective products, including pharmaceuticals, in the EU. The Directive has now been implemented by national legislation in all the Member States. In the United Kingdom it was incorporated in the Consumer Protection Act 1987 (the 1987 Act), Part 1 of which adds, in theory, a strict liability remedy to those which may be available at common law in contract and tort. Liability is strict in the sense that it is not necessary to prove that a manufacturer or other defendant failed to take reasonable care to avoid injury to those likely to use the product. A claimant still has to prove that the product was defective and that that defect caused his injury or other loss.

The 1987 Act defines those against whom proceedings under Part 1 can be brought. These are a producer (manufacturer), own brander, importer of a product from outside the EU or the supplier (retailer or distributor) if he fails upon request to identify the producer, own brander or importer. Such a person may be liable for injuries caused by a defective medicinal product put into circulation in the United Kingdom after 1 March 1988.

Clearly, a medicinal product is not defective simply because it is capable of producing adverse reactions. Unavoidable side-effects and those in respect of which warnings are given do not render a medicine defective under the 1987 Act. The claimant must prove that the product was defective in that its safety was ''not such as persons generally are entitled to expect'' (section 3(1); Directive 85/374/EEC, Article 6.1). In determining what persons generally are entitled to expect, all the circumstances should be taken into account including the marketing, packaging, labelling, instructions for use and warnings, foreseeable use or misuse and the time when a product was supplied (see section 3(2)).

Section 3(2) concludes ''and nothing in this section shall require a defect to be inferred from the fact alone that the safety of a product which is supplied after that time is greater than the safety of the product in question'' (Article 6.2). Thus the mere fact that an improved, lower risk formulation of a medicine has been put on the market since the date the product complained of was supplied, is not enough to render that product defective. However, pharmacovigilance will often bring to light new information about a medicine, rendering certain risks to patients avoidable. Since ''persons generally'' are entitled to expect that a less risky formulation or presentation of a product will replace an earlier version with riskier characteristics, a product that could not be proved to have been defective under the 1987 Act in 1990 might have been rendered defective by 1995 through the accumulation of information resulting from postmarketing surveillance. It is not enough for a manufacturer to show that a marketing authorisation has been properly obtained in respect of any given product. The 1987 Act does not apply to medicinal products supplied in the course of clinical trials.

The Directive provides for a number of statutory defences. The most important for the pharmaceutical industry is the ''development risks'' defence, set out in Article 7(e), which provides that a producer is not liable if he proves ''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''. Article 15(1)(b) of the Directive makes its inclusion in implementing legislation optional for each Member State. In the United Kingdom it is enacted in Section 4(1)(e) of the 1987 Act, the wording of which is to be construed to bring it in line with that of Article 7(e). (See European Commission v. United Kingdom [1997] AER (EC) 481; paragraph 21.)

The circumstances in which a medicinal product may be rendered defective by reason of information acquired through pharmacovigilance have yet to be explored fully in any reported cases under Part 1 of the UK 1987 Act of which there are currently fewer than 10. Across the EU, there is a general paucity of reported cases under the national legislation implementing the Directive. The provisions of the Directive were, however, reviewed in depth by the English High Court in the Hepatitis C case (A and others v. The National Blood Authority and others [2001] All ER (D) 298 (MAR)), in which 114 claimants sought damages under the 1987 Act after being infected with Hepatitis C virus through blood transfusions. Mr Justice Burton held that the unavoidability of the harmful characteristic of the product was irrelevant to whether it was defective. He also held that the medical profession's knowledge of the risk of infection, which was not shared by the public at large, did not assist the Defendants. If the ''learned intermediary'' doctrine is to be rejected in strict liability cases, it will be necessary for pharmaceutical companies to warn the actual product users of risks, including those detected through pharmacovigilance, and not to rely on warnings given by the doctor or pharmacists, even where the product is only available from a health care professional.

Failure to meet post-marketing obligations may of course render a pharmaceutical manufacturer liable to a claim in negligence brought by a patient whose injuries can be attributed to that failure.

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