¹ See Council Directive of 25 July 1985 on the approximation of the laws, regulatioins and administrative provisions of the Member States concerning liability for defective products (No. 85/374/EEC).

² Article 6(1) of the Directive.

³ The phrase “development risk” is preferable to “state of the art.” The first refers to undiscoverable defects, whereas the second is usually associated with the most up to date technological learning in a particular industry. Such an issue is relevant to the issue of “defectiveness,” but not development risks.

⁴ Article 15 of the Directive permits derogation from the defence at the discretion of member states. It was only with this latitude that agreement on its provisions became possible. As of September 1988, only Italy, Greece and the U.K. have implemented the Directive. All have adopted the defence. Germany proposes to do so, except with respect to pharmaceutical products.

⁵ See H. L. Deb. Vol. 485, cols. 848–855 (9 March 1987).

⁶ See H. L. Deb. Vol. 487, col. 784 (14 March 1987). The change was agreed with much reluctance, in order to pass the Act in that session of Parliament.

⁷ A number of jurisdictions in America have rejected the defence: see e.g. Beshada v. Johns-Manville Corp. 447 A. 2d 539 (N.J. Sup. 1982)Google Scholar, in which the reasons for doing so are discussed. The large majority, however, have adopted a development risk defence: see Hulsen, H. “Design Liability and State of the Art. The United States and Europe at a Crossroads” 55 St. Johns Law Review 450 (1981)Google Scholar. The American Model Uniform Product Liability Act also contains the defence: see section 106.

⁸ Paris v. Stepney B.C. [1951] A.C. 367Google Scholar, The Wagon Mound (No. 2) [1967] 1 A.C. 617Google Scholar, Wright v. Dunlop (1972) 14 K.I.R. 255Google Scholar.

⁹ Bolton v. Stone [1951] A.C. 850Google Scholar, Independent Broadcasting Authority v. E.M.I. Electronics Ltd. and B.I.C.C. Construction Ltd. (1980) 14 B.L.R. 1Google Scholar.

¹⁰ Darvill v. C. J. Hampton Ltd (1972) 13 K.I.R. 275Google Scholar, Latimer v. A.E.C. [1953] A.C. 643Google Scholar.

¹¹ Stokes v. G.K.N. (Bolts and Nuts) Ltd [1968] 1 W.L.R. 1778, 1783Google Scholar. It may be said that the wording of section 4(1)(e) is to the contrary. It requires only that producers know as much as “a producer of products of the same description as the product in question” and, therefore, that if a particular producer has additional knowledge, it must be disregarded. Such an interpretation would introduce a standard lower than that established in Negligence and is clearly contrary to the intention of the Act.

¹² Lambert v. Lewis [1978] 1 Lloyd's Rep. 610Google Scholar, aff. [1982] A.C. 225.

¹³ Stokes v. G.K.N. (Bolts and Nuts) Ltd. (supra). A lapse of six months after date of publication was excused on behalf of a doctor in Crawford v. Board of Governors of Charing Cross Hospital (1953) The Times, 8 12 1953, , C.A.Google Scholar

¹⁴ Thompson v. Smith Shiprepairers (North Shields) Ltd. [1984] Q.B. 405Google Scholar.

¹⁵ Vacwell v. B.D.H. Chemicals Ltd. [1971] 1 Q.B. 88Google Scholar.

¹⁶ Brown v. Rolls Royce [1960] 1 W.L.R. 210Google Scholar.

¹⁷ See Re The Herald of Free Enterprise, The Independent, 18 December 1987.

¹⁸ Stokes v. G.K.N. (Bolts and Nuts) Ltd. (supra). In Winward v. T.V.R. Engineering Ltd. [1986] B.T.L.C. 366 (C.A.)Google Scholar the defendant sports car manufacturers fitted engines supplied by Ford. In doing so they incorporated a carburettor which had been in use by Ford for about twelve years. It was judged to be defective for causing a fire in a vehicle owned by the plaintiff. The defendants contended they had fulfilled their duty of care to the plaintiff by acquiring supplies that were considered safe from well established, reputable manufacturers on whose judgment they were entitled substantially to rely. The contention was rejected. They ought to have conducted their own tests, to have become aware of the design fault and to have rectified it because the cost of avoiding a substantial risk was small.

¹⁹ Thompson v. Smith Shiprepairers Ltd., note 14 (supra).

²⁰ See Walton and Walton v. British Leyland U.K. Ltd. (1978), unreported, reproduced in Miller, and Harvey, , Consumer and Trading Law (1985) p. 159Google Scholar, Wright v. Dunlop Rubber Co. Ltd. (1972) 14 K.I.R. 255Google Scholar.

²¹ Implementation of E.C. Directive on Product Liability—An Explanatory and Consultative Document (1985) Department of Trade and Industry, p. 5, (emphasis added). The matter may be referred to the European Court of Justice for determination under Article 177 of the E.E.C. Treaty; or the United Kingdom may, after Commission investigation, be arraigned before the Court under the Article 169 procedure.

²² See 5 05 1987, H. C. Deb. Standing Committee D, p. 33Google Scholar. The Consumers' Association has received a strong opinion to the contrary from counsel. For a possible indication of the potential of the distinction see Philips v. William Whiteley Ltd. [1938] 1 All E.R. 566Google Scholar, Caminer v. Northern & London Investment Trust Ltd. [1951] A.C. 88Google Scholar.

²³ In support of this general approach see Funston, C. Eric, “The Failure to Warn Defect in Strict Products Liability: A Paradigmatic Approach to State of the Art Evidence and Scientific Knowability” (1984) Ins. Counsel, J.39Google Scholar. The European Commission is in informal discussion with the government about the matter. In any event, s.1(1) of the 1987 Act provides that “This Part shall have effect for the purpose of making such provision as is necessary to comply with the product liability Directive and shall be construed accordingly.”

²⁴ See C.B.I. Parliamentary Brief: Consumer Protection Bill, 21 April 1987, and the endorsement of the view by MrHoward, , Under Secretary of State for Trade and Industry, 5 05 1987, HC Deb. Standing Committee D, p. 31Google Scholar.

²⁵ The drug Practolol gave rise to eye and skin damage but “None of the recognised laboratory procedures gave warning of the serious clinical syndrome nor, even with hindsight, has a procedure been discovered which would have predictive value.” Weatherall, M., “An end to the search for new drugs?” Nature, 296 p. 387, 388 (1982)Google Scholar. Equally, on the other hand, products may possess unforeseen benefits. Aspirin helps to reduce the likelihood of heart attacks. See “A Milestone for Myocardial Infarction” Julian, D. J. et al. Brit. Med. J. 297, 497 (1988)Google Scholar.

²⁶ The government does not consider the small number to suffer from the effects of food additives to be a problem. See H. C. Deb. Vol. 112, col. 301 (W.A.). For concern as to pesticides, see The Effects of Pesticides on Human Health (1985–1986) H.C. 268Google Scholar. A domestic shampoo has recently been identified as being responsible for an attack by a swarm of bees. See: “Washed hair sparked attack by 4,000 bees.” The Daily Telegraph, 12 06 1987, p. 3Google Scholar.

²⁷ For such an example see Doughty v. Turner Manufacturing Co. Ltd. [1964] 1 Q.B. 58Google Scholar. See also Human Health and Environmental Toxicants, (ed.) Clive Wood, and A. Hay, The Chemical Scythe, on the effects of the chemicals 2, 4, 5–T and Dioxin.

²⁸ Independent Broadcasting Authority v. E.M.I. Electronics Ltd. and B.I.C.C. Construction Ltd. (1980) 14 B.L.R. 1, 36per Fraser, LordGoogle Scholar. The case concerned the effects of wind on an aerial mast known as vortex shedding, which caused the mast to oscillate and collapse. As this case demonstrates, there may be many instances in which a failure of this nature will be criticised as negligent.

²⁹ Discussed by Diamond, A. in Comparative Product Liability, (ed.) Miller, C. J. (1986), p. 42Google Scholar. See also the Bunk Beds (Entrapment Hazards) (Safety) Regulations 1987, S. I. 1987 no. 1337, introduced after a number of children were killed by wriggling between the safety rails of the upper tier of a bunk bed and being suspended by their necks.

³⁰ “…there is a defect in a product … if the safety of the product is not such as persons generally are entitled to expect…” see s.3(1) of the Consumer Protection Act 1987. Note, however, subs. (2): “In determining … what persons generally are entitled to expect … all the circumstances shall be taken into account, including … (b) what might reasonably be expected to be done with or in relation to the product.”

³¹ [1946] A.C. 401.

³² Ibid., p. 445

³³ See below: (iii) Defect foreseeable in principle but undiscoverable in practice, (b) State of the art of quality control.

³⁴ See, e.g., note 18 (supra).

³⁵ Examples of similar defects unforeseen by general rather than scientific and technical knowledge are available from the Home Accident Surveillance Unit of the Department of Trade and Industry. Studies have been commissioned on the causes of serious product-related accidents. Their findings suggest that perfect knowledge about the way a product will be put to use and cause injury is impossible, and design defects may come to light only after a consistent pattern of injuries have been reported. See, e.g., the studies on kitchen equipment, bouncing baby cradles, carrycots, circular saws. In the case of one tin-opener it was estimated “if the can being opened is of the corned beef type then the probability of an accident occurring is some 100 times higher than if it is not.” See Tins H.A.S.S. (D.T.I.).

³⁶ For example, an increase in the number of deaths from asthma has been attributed to the very effectiveness of treatment. Such treatment may tend to mask the severity of the illness and may serve to delay the sufferer in calling for help on those occasions when the usual treatment will be inadequate. Hence an increase in asthma fatalities. See The Independent, 4 11 1986, p. 15 “The unexplained deaths of asthma sufferers.”Google Scholar

³⁷ Note that Negligence is already prepared to impose liability for some categories of defect unforeseen by scientific and technical knowledge, viz., (i) when injury has arisen in circumstances the precise details of which were unforeseeable but which are of a class or type, or within a general risk, that ought to have been anticipated and guarded against: Hughes v. Lord Advocate [1961] A.C. 388Google Scholar, Roe v. Minister of Health [1954] 2 Q.B. 66, 85Google Scholar, Haynes v. Harwood [1935] 1 K. B. 156Google Scholar; and (ii) when injury of some kind is foreseeable but current knowledge is unable to reveal the full extent of the damage: Vacwell v. B.D.H. Chemicals [1971] 1 Q.B. 88Google Scholar, Bradford v. Robinson Rentals Ltd. [1967] 1 W.L.R. 337Google Scholar, Smith v. Leech, Brain & Co. [1962] 2 Q.B. 405Google Scholar.

³⁸ See Stokes v. Guest, Keen and Nettlefold (Bolts and Nuts Ltd.) [1968] 1 W.L.R. 1776Google Scholar.

³⁹ See note 27 (supra). See also H. Teff and C. Munro, Thalidomide: the Legal Aftermath, ch. 1 for a discussion of the accretion of information in that example, and Weatherall, note 25 (supra).

⁴⁰ “Aluminosilicates and Senile Plaque Formation in Alzheimer's Disease,” Candy, et al. The Lancet, 15 02 1986, p. 354Google Scholar; “Aluminosilicates at the centre of dementia,” New Scientist 27 02 1986, p. 23Google Scholar.

⁴¹ In McColl v. Strathclyde Regional Council 1983 S.L.T. 616Google Scholar, an allegation was made as to the carcinogenic potential of the fluoridation of the public water supply.

⁴² Wells v. Ortho Pharmaceutical Corp, 615 F. Supp. 262, 294. (D.C. Ga. 1985) affirmed 788 F. 2d 741 (11th Cir. 1986).

⁴³ Ibid.

⁴⁴ See Limitation Act 1980, ss. 11 and 14, and Davies v. Ministry of Defence, The Times, 7 August 1985. See also S. Todd: Limitation Periods in Personal Injury Cases, pp. 16–30.

⁴⁵ Wells v. Ortho Pharmaceutical Corp. 788 F. 2d. 741, 745 (11th Cir. 1986)Google Scholar.

⁴⁶ Devilez v. Boots Pure Drug Co. (1962) 106 Sol. Jo. 552Google Scholar.

⁴⁷ Wright v. Dunlop Rubber Co. Ltd. (1972) 14 K.I.R. 255Google Scholar, Rivtow Marine Ltd. v. Washington Iron Works (1973) 40 D.L.R. (2d) 530Google Scholar.

⁴⁸ Wells v. Ortho Pharmaceutical Corp., note 45 (supra). See also the case of the pregnancy testing drug Primodos, Hudd v. Schering Chemicals Ltd. (1980) Court of Appreal, unreported.

⁴⁹ The highly subjective nature of risk assessment and of suitable responses to it is discussed in Fischhoff, Lichstenstein et al., Acceptable Risk (C.U.P. 1981).

⁵⁰ Note that the burden of proof on the issue rests with the producer: see below.

⁵¹ See s.4(1)(e).

⁵² See Watt v. Hertfordshire C.C. [1954] 1 W.L.R. 835Google Scholar, Quinn v. Scott [1965] 1 W.L.R. 1004Google Scholar.

³³ Compare, for example, Bolton v. Stone [1951] A.C. 850Google Scholar with The Wagon Mound (No. 2) [1967] A.C. 617Google Scholar. See also the guidelines relating to the relative safety to which employees are entitled under the Health and Safety at Work Act 1974 in Occupational Exposure Limits 1984, Guidance Note EH40 (H.S.E.)

⁵⁴ See Devilez v. Boots Pure Drug Co. (1962) 106 Sol. J. 552Google Scholar, Holmes v. Ashford [1950] 2 All E.R. 76Google Scholar.

⁵⁵ Watt v. Hertfordshire C.C. (supra). The case concerns the effectiveness of safety procedures, rather than the quality of products, but the same principle would seem to apply.

⁵⁶ See Newdick, Christopher, “The Future of Negligence in Product Liability” (1987) 103 L.Q.R. 288, 300–309Google Scholar and the decision in contract of Griffiths v. Peter Conway [1939] 1 All E.R. 685Google Scholar.

⁵⁷ I.e., that “the safety of the product is not such as persons generally are entitled to expect”: see s.3 of the 1987 Act.

⁵⁸ See, e.g., Ortho Pharmaceutical Corp. v. Heath 722 P. 2d 410 (Colo. 1986)Google Scholar.

⁵⁹ See art. 6 of the Directive: “A product is defective when it does not provide the safety which a person is entitled to expect…” (emphasis added). Here, too, note the difference between the provision in the Directive and in s.3(1) of the 1987 Act.

⁶⁰ British Standard Institution guidelines for the provision of adequate systems of quality control are contained in B.S. 5750, 1981, Quality Systems. See in particular Part 5, para. 4.12.2: “when sampling procedures are used they have to provide adequate protection to the purchaser, it being recognized that any sampling procedure has limitations.”

⁶¹ “…no system of mass production can ever be perfect: mistakes and troubles of one sort or another, generally minor, are bound to occur from time to time…” per Rougier, J. in Bernstein v. Pamsons Motors Ltd. [1987] 2 All E.R. 220, 228Google Scholar. The example of a tyre manufacturer with a failure rate of 0.05% is discussed by H. Taschner in Comparative Product Liability (ed.) C. J. Miller, p. 5, who takes the view that the policy of the Directive is to impose liability in such cases irrespective of fault.

⁶² [1974] A.C. 839. For a contrary view, however, see Daniels and Daniels v. R. White and Sons Ltd. and Tabard [1938] 4 All E.R. 258Google Scholar.

⁶³ [1974] A.C. 839, 848, per Lord Hailsham.

⁶⁴ [1974] A.C. 839, 842, 845, per E. F. Jowitt Q.C. arguendo.

⁶⁵ [1974] A.C. 839, 850.

⁶⁶ [1974] A.C. 839, 851, per Lord Hailsham.

⁶⁷ [1936] A.C. 85 (P.C.).

⁶⁸ Ibid., p. 101. A similar approach was adopted in Ward v. Tesco Stores Ltd. [1976] 1 All E.R. 219Google Scholar and McMorran v. Dominion Stores (1977) 14 D.L.R. (3d) 186Google Scholar (Ont. HC).

⁶⁹ [1974] A.C. 839, 855 per Viscount Dilhorae.

⁷⁰ Grant v. Australian Knitting Mills [1936] A.C. 85, 101Google Scholar.

⁷¹ In Smedleys the producers were subjected to a fine of £25 and not expected to make alterations to their inspection process.

⁷² For a pace-maker case, see Dreilling v. General Electric Co. 511 F. 2d 768 (La. 1975)Google Scholar. See also Braithwaite, J., Corporate Crime in the Pharmaceutical Industry (R.K.P., 1983) pp. 119–129Google Scholar for evidence of defective pace-makers.

⁷³ See Hines v. St. Joseph's Hospital 527 P. 2d 1075 (N.M. 1974)Google Scholar, (blood contaminated with hepatitis virus); Mills v. United States 764 F. 2d 373 (5th Cir. 1985)Google Scholar (allergic reaction to vaccine). The American Model Uniform Product Liability Act would impose liability for unavoidable failures of quality control, see section 106: analysis.

⁷⁴ See Frost v. Aylesbury Dairy Co. [1905] 1 K.B. 608Google Scholar, Dodd v. Wilson [1946] 2 All E.R. 691Google Scholar, Ashington Piggeries v. Christopher Hill Ltd. [1972] A.C. 441Google Scholar.

⁷⁵ See also Part II of the 1987 Act, where section 10(2)(c) expressly raises the issue of reasonable means of production as one of the factors to be taken into account in determining criminal liability. The omission of this consideration from the description of the word “defect” in s.3 may be significant for the issue of civil liability. The majority of American jurisdictions accept the existence of an implied warranty of fitness between the manufacturer of goods and the ultimate consumer, irrespective of privity of contract. See Henningsen v. Bloomfield Motors Inc. 161 A. 2d 69 (N.J. 1960)Google Scholar.

⁷⁶ See, e.g., in criminal law the Weights and Measures Act 1963, s.26; Weights and Measures Act 1979, s.3; Trade Descriptions Act 1968, s.24; Consumer Credit Act 1974, s.168; Consumer Protection Act 1987, s.39; Food Act 1984, s.3.

⁷⁷ See note 25 (supra).

⁷⁸ Bolam v. Friern Hospital Management Committee [1957] 1 W.L.R. 582Google Scholar.

⁷⁹ By way of analogy, in Roe v. Minister of Health [1954] 2 Q.B. 66Google Scholar, the plaintiff was unable to prove that a prudent anaesthetist, in 1947, ought to have recognised the need to guard against the risk that ampoules might contain invisible cracks. Nevertheless, in the previous year, two American publications had advised of such a need, and at least one research laboratory had adopted precautions against the possibility (see [1954] 1 W.L.R. 128, 135 and [1954] 2 Q.B. 66, 77). With this information and the burden of proof reversed, would the defendant still be able to show that “knowledge was not such that a producer of products of the same description might be expected to have discovered the defect”?

⁸⁰ See Implementation of E.C. Directive on Product Liability- An explanatory and consultative note (D.T.I. 1985), p.5Google Scholar.

* The author would like to thank Professors John G. Fleming and A.T.H. Smith and Mr. Steve Weatherill for their comments during the preparation of this article.