3. The Context of the Safety of Products

There are four recognisably different types of failure of response by a public authority to a product risk:

1. (i) a failure to enact appropriate rules to regulate the manufacture, distribution or access to market of a particular category of product;

2. (ii) a failure in respect of the enforcement of rules affecting the safety of products, whether these are general rules (such as the general safety requirement⁸⁹) or special to a particular type of product;

3. (iii) a failure in the provision of information concerning the safety or risks of particular products;

4. (iv) a failure to control access to the market of a particular class of product or a particular individual product where it has the power to do so.

Of course, in a particular case a claimant may allege that more than one of these types of failure in the administration have contributed to his harm. And in some cases, of which Smith v Secretary of State for Health is a striking example,⁹⁰ a defendant public authority may argue that its approach to one type of response (for example, an order of recall of a product from the market) is related to its view as to another type of response (for example, the provision of public warnings): here, therefore, the public authority’s defence to an allegation of negligence is in part that it made a reasonable choice as between a number of possible regulatory responses.

In the following discussion, I shall look at these four types of failure in turn, both from the point of view of the existence of a duty of care and the issue of negligence.

(a) A failure to enact appropriate rules

While English law possesses general requirements for the safety of consumer products,⁹¹ it also possesses very considerable sets of regulations for the control of particular categories of product, such as in the case of food or medical products (including pharmaceuticals).⁹² These rules may specify the necessary characteristics of a particular product (for example, providing that motor vehicles are manufactured with seat belts for their passengers), or may make special provision for the licensing of new products before they are marketed (as in the case of pharmaceuticals),⁹³ or the (p.345) inspection of old products before they can continue to be used (as in the case of the requirement of motor vehicles to be tested annually under the MOT scheme).

Let us take by way of example a case where a claimant is injured in a road accident while being driven in a coach and it is accepted that her injuries are attributable to the absence of any seat belt in the coach in question. She alleges, inter alia, that the coach should have been fitted with seat belts and that the defendant public authority should have issued regulations which required that a coach of the type in question should be used for the transport of passengers only if it has been certified by a responsible body as fitted with appropriate seat belts. How would an English court approach the questions of duty of care and breach of duty in this sort of circumstance?

In my view, even within a set of facts such as this, a number of distinctions could be drawn. First, there is a distinction between the situation where no regulations have been made to govern the aspect of passenger restraint in the category of vehicle in question (a ‘pure omission’) and the situation where regulations have been made to govern this issue, but where their observance could not (and did not) prevent injury of the type suffered by the claimant (where the defendants conduct could be thought of more in terms of inadequate action).⁹⁴ Secondly, where a body has not taken any action in relation to the risk of injury of the sort suffered by the claimant, a distinction could be drawn between cases where a competent public authority considers whether or not to intervene and chooses not to do so, and cases where it fails to consider the question of intervention, perhaps owing to some administrative oversight or delay. Thirdly, a distinction could be drawn between the question whether some protective measures should be required of those running passenger coaches, perhaps in relation to the cost of the safety measures as against other considerations, such as the cost of public transport (this question appearing to be one of ‘policy’) and issues relating to the technical details of the measures, given what is known about the nature of accidents in question, their incidence and their likely effects (this appearing to be more ‘operational’ in its nature).

In all these different variables, the courts are likely to be concerned with two main considerations in determining whether to impose a duty of care. The first is a concern to protect the legitimate exercise of the public authority’s discretion in deciding whether or not or how to regulate passenger safety in coaches. In this respect, it may be thought of as peculiarly a matter of policy for a body to determine the appropriateness of enacting secondary legislation. Indeed, unlike French law, English law does not furnish any example of a successful challenge to a public body in respect of the failure to make a relevant bye-law or issue delegated legislation by way of judicial review nor any claim for damages against a public body in respect of the same type of failure, although the latter would clearly be possible if it consisted of the non-implementation of an EC Directive.⁹⁵ This is not to say that a court would never interfere in such a decision, if, for example, a body with rule-making power adopted a policy for its exercise which was irrational or inconsistent with higher constitutional principle. On the other hand, (p.346) while enacted subordinate legislation may be challenged on the ground of its substantive ultra vires (on the ground that it falls outside the powers of the enabling legislation, conflicts with a persons primary legislative rights, or with constitutional principle or is otherwise unreasonable), this last criterion has not been used as a ground for declaring subordinate legislation invalid where the court considers it unnecessary or inconvenient.⁹⁶

However, while judicial concern to protect a public body’s law-making discretion will be a strong one, situations may be envisaged where other considerations would pull strongly in the opposite direction. So, where a competent public body was aware of the very serious nature of a risk to health or safety and the enactment of a rule or rules (such as requiring seat belts in my example) was relatively straightforward and uncontroversial and yet failed to intervene as a result of administrative incompetence (such as a breakdown in communications within the public body⁹⁷) or for an improper reason (such as a desire not to impose a burden on the coach-building industry based in a marginal parliamentary constituency⁹⁸), then the courts may well consider both that the considerations to be taken into account were ‘justiciable’ and that the imposition of a duty of care was ‘fair, just and reasonable’. Again, it can be seen that the questions traditionally associated with determining the existence of a breach of duty (the magnitude of risk and the cost of precautions and more generally the nature of the negligence on the facts) would figure as factors in deciding whether or not to impose a duty of care, but with the difference that the courts would be swayed by evidence of obvious negligence. It is not merely, therefore, that the courts are not willing to determine the issue of duty of care in this developing area without looking at the facts of any alleged negligence (and so not usually on an application of striking out), but rather that once established, the nature and degree of the defendant’s negligence becomes relevant to whether or not a duty of care should be recognised. Here, therefore, English law does seem to be moving towards an approach which imposes liability only for serious fault at the same moment when French law appears to be abandoning this approach, but the two systems are moving in the same direction, that is, toward more liberal approaches to liability than they formerly possessed.

(b) The enforcement of rules

In this situation, a claimant does not impugn the content of rules governing the safety of a product on the market, but rather the policing of those rules by the appropriate public authority. In other contexts, English courts have held that there are good reasons for refusing to impose a duty of care in respect of the investigation and prosecution of criminal offences. So, the House of Lords has held that as a matter of public policy the ordinary police are not liable in negligence in respect of their activities in the investigation and suppression of crime.⁹⁹ The Court of Appeal took a (p.347) similar approach to the liability of the Crown Prosecution Service to a defendant in relation to the conduct of a prosecution, on the basis that the prosecution service should not have to spend time and use scarce resources in dealing with threatened litigation which should be concentrated on their prime function of prosecuting offenders, even though its actions could lead to the imprisonment of people subsequently not prosecuted.¹⁰⁰

However, in 2002 in Thames Trains Ltd v The Health and Safety Executive the existence of a duty of care in relation to the policing of requirements of safety arose in a context not dissimilar to product safety.¹⁰¹ This case concerned the Ladbroke Grove Junction railway crash, in which 31 people were killed and 259 injured when a westbound Thames train passed through a signal at danger and collided with an eastbound high speed train. The accident was probably caused partly by the failure of the driver of a train operated by Thames Trains and partly by a failure in Railtrack, the private company which controlled the infrastructure and which was primarily responsible for the signalling system at the junction which was confusing and to a degree obscure.¹⁰² Thames Trains and Railtrack agreed to settle the claims of those injured or the dependants of those killed,¹⁰³ but Thames Trains then claimed contribution from the Health and Safety Executive (HSE), alleging breaches of a number of its statutory duties in relation to the supervision of safety on the railway and of a duty of care at common law. On an application by HSE for the claim against them to be struck out, Morland J accepted that there was no reasonably arguable case that the HSE owed a statutory duty giving rise to a private right to passengers on trains, a decision confirmed on appeal.¹⁰⁴ Morland J also recognised a number of considerations arguing against such a common law duty of care in the HSE: notably that there was no indication in the legislation that Parliament intended that it should be liable for any failure in its supervisory role; that the rail companies were primarily responsible for safety of the railways; that its position could be seen as analogous to prosecuting authorities who were not liable to the persons primarily responsible and that there was no ‘policy imperative’ to impose liability on the HSE given the accident’s victims’ claims against the companies; that the HSE’s powers of intervention were discretionary; and that any liability in the HSE would be borne by the taxpayer.¹⁰⁵ Nevertheless, Morland J refused to strike out the claim in the circumstances. For he noted that it was alleged that Railtrack had undertaken a major remodelling of the railway infrastructure in the area of the crash and had sought approval of these changes from the HSE, which nevertheless neither gave its approval nor prevented trains from running through the altered scheme and that the HSE had known through inspection that the sighting of the signals in question ‘was inadequate and created a risk of collision’.¹⁰⁶ Therefore, although the HSE is a ‘regulatory supervisory, licensing body’ and therefore unable to carry out or to duplicate the primary duties of Railtrack and the train operators to (p.348) manage the railways safely, nevertheless it does have a specific, long-stop purpose of safety from personal injury.¹⁰⁷ In Morland J’s view, therefore, the case differed both from Yuen Kun Yeu v A-G of Hong Kong¹⁰⁸ (which concerned a regulator’s liability for pure economic loss) and Marc Rich¹⁰⁹ (which concerned a classification society’s liability for loss of property). The learned judge cited with evident attraction the Canadian decision in Swanson v The Queen in right of Canada¹¹⁰ which upheld a duty of care in the Canadian regulatory of air safety to family members of those killed in an air crash in respect of its failures in supervision of air safety on the basis that its decisions had not involved any considerations of policy.¹¹¹ He concluded that, even with the state of the authorities as they were,¹¹² it could reasonably be argued that ‘the Executive should be made liable not for failing to use statutory powers involving expenditure of money but for failing negligently to use, as the public would expect, their statutory powers through the Railway Inspectorate in carrying out routine duties of inspection and supervision’.¹¹³ Moreover, the possibility of a duty of care being recognised was more likely given the Railway Inspectorate’s ‘alleged close involvement in and knowledge of the dangerous situation at Ladbroke Grove junction with inaction over a period of three years’.¹¹⁴

The Court of Appeal also upheld Morland J’s decision as to the reasonably arguable existence of a common law duty, noting, inter alia, the fact that the HSE’s behaviour may well be found at trial to have gone beyond ‘pure omissions’ and so outside the impact of the denial of a duty of care in Stovin v Wise,¹¹⁵ in an arguable reliance of the public or of passengers in the role of the HSE in relation to rail safety, and in the possible existence of exceptional factors which would apply on the facts once revealed.¹¹⁶ Given the ‘strong tide of modern authority’ against striking out claims before full trial of the facts,¹¹⁷ the application to strike out this claim should be denied without any more elaborate review of the authorities.¹¹⁸

Here, then, we can see two of the more general themes in the case law of the last decade (in the concern with the protection of the exercise of discretion involving consideration of policy and the lack of need for liability in a public regulatory body where there is another body who is primarily responsible), but these themes are capable of being counterbalanced by the nature of the harm in respect of which liability is sought (personal injuries and death as opposed to damage to property or pure economic loss) and the degree of involvement of the public body in the circumstances leading to the harm. And Morland J saw the facts allegedly constituting breach of any duty to be imposed as significant to the question of duty of care, for, according to the claimant’s allegations, the defendant had actual knowledge of the grave risk and the length of time during which it took no action and it permitted the risk to be run.¹¹⁹

(p.349) (c) Supplying information about products

A failure in the provision of information about the risks to health or person of a product already in circulation may itself take a number of forms: a total failure to inform people of the risk associated with use of a particular category of product or individual product; a failure to inform people adequately of such a risk, whether this relates to the content of any information or the way in which it is conveyed; or the positive promotion of a product for use where this involves risks which are not specified or not explained to its users.

In 1984, the position as to liability for advice as to the use of a product by central government by way of exercise of a statutory power appeared to be fairly clear, for in that year a claim by children harmed allegedly by ‘whooping cough vaccine’ against the Department of Health for its alleged negligence in promoting the use of the vaccine was struck out by Stuart-Smith J.¹²⁰ There, the Department relied on its Ministers general powers and duties for the promotion of physical and mental health under the National Health Service Act 1946 and a specific power to make arrangements with local health authorities for vaccination or immunisation of diseases.¹²¹ Applying the then current distinction between the policy and operational spheres, Stuart-Smith J held that the Department’s allegedly negligent action in failing to warn the public of the risks was plainly within the limits of a discretion bona fide exercised under these statutory powers and was therefore protected, though he accepted that it could be argued that the advice given by NHS doctors as to how or in what circumstances the vaccine should be administered fell within the operational sphere.

Danns v Department of Health is a more recent and particularly good example of the courts’ approach to liability for the provision of information by central government, though not in the context of products.¹²² In that case, the male plaintiff had undergone a vasectomy operation in 1983 and, following current practice, had been advised by his doctor that its effect would be to render him sterile. In 1991, however, his wife, the second plaintiff, gave birth to his son. The plaintiffs claimed damages for pain, distress and the financial costs of this unwanted child against the Department of Health, alleging that from the publication of a particular survey in 1984, it had become known that after vasectomy a man had a 1 in 2,000 chance of later becoming fertile. As a result, the Minister should have disseminated this information directly via newspapers to the some three quarters of a million men affected and not merely have left it to doctors to warn their patients.

The Court of Appeal affirmed the decision at trial holding the Department not liable in the tort of negligence in these circumstances.¹²³ Leggatt LJ considered that (p.350) the judge below was right to hold that as regards future patients the Department was ‘fully entitled to leave it to the [medical] profession to decide what advice or counselling it should give’.¹²⁴ As to their own position, the plaintiffs had alleged that the Department had not considered the 1984 survey which had escaped the attention of those dealing with such matters there; the Department contended that they had considered it and decided to do nothing. Here, Leggatt LJ considered that even if the plaintiffs’ case had been accepted, they would still have had to show that, ‘if the Department had exercised its discretion, it would have been bound to decide to disseminate the information’, which it was clear was not the case.¹²⁵ However, the Court of Appeal accepted the Department’s contention that it had considered whether or not to disseminate this information and that this decision, bona fide made could not be challenged (as was indeed accepted by the plaintiffs themselves), applying the approach of Lord Browne-Wilkinson in X v Bedfordshire CC in this respect which tied the possibility of liability in negligence in respect of the exercise of a statutory discretion to a condition of illegality.¹²⁶ Given that this view has itself been overtaken by subsequent decisions in the House of Lords,¹²⁷ it may be thought that the Court of Appeal’s approach in Danns is to this extent vitiated. However, the Court of Appeal was clearly influenced by its view of the substance of the Department’s decision making, it being ‘sensible’ in 1984 for it to refrain from disseminating the information about the risk of fertility:¹²⁸ confining one’s attention to the single subject of ‘the remote possibility’ of the risk of fertility in determining what information to provide ‘is to ignore the scope and volume of medical research’.¹²⁹

In Harris v Evans in 1998 the question of liability for the public provision of information concerning the safety of a product arose in very different circumstances, but it also resulted in denial of the existence of a duty of care.¹³⁰ There the plaintiff ran a business of ‘bungee jumping’ from a mobile telescopic crane in an area whose local authority was advised by an HSE inspector that it should not be used for this purpose until certified as fit by some competent person or the manufacturer of the crane. The plaintiff failed to fulfill these conditions and so was ordered not to use the crane by the local authority, but this was later withdrawn. The plaintiff claimed damages for lost business against the inspector personally and against the HSE in negligence arguing that they were liable for his allegedly negligent misstatement under Hedley Byrne, but this claim was struck out by the Court of Appeal. In its view, in such a context appeal to authorities governing ‘assumption of responsibility’ in respect of pure economic loss¹³¹ (as suffered by the plaintiff) could not take place outside the context of the statutory framework. Here, statute created extensive powers in the inspectors in the interest of safety and also provided a system of appeals against any act taken by the statutory enforcing authority (which the (p.351) plaintiffs had not chosen to exercise).¹³² In these circumstances, no duty of care should be imposed in respect of the economic consequences of any decision made unless it created a new risk or danger.¹³³

This decision makes an interesting contrast with Danns v Department of Health.¹³⁴ The two decisions have in common a concern with the protection of the purposes of the two sets of statutory powers whose exercise or non-exercise is impugned, but whereas in Danns the plaintiffs claimed that the Department had not done enough to protect their personal interests, in Harris v Evans the plaintiff claimed that the HSE had done too much in a mistaken belief that it was in the interests of safety and that this had prejudiced his economic interests. Whereas in Danns, it could be said that the parties were not ‘proximate’ (the male plaintiff being a member of a class of three-quarters of a million),¹³⁵ in Harris the HSE could clearly see that its advice would principally affect the plaintiff’s business. Nevertheless, in both cases the courts were concerned to give room to the defendant public bodies to advise or not to advise on matters of safety as they thought fit, as had been provided by statute. As I shall explain in relation to Smith v Department of Health,¹³⁶ this concern is likely to remain one which the courts will see as all but conclusive of the issue of duty of care in negligence in this sort of case, even after the degree of liberalisation in approach to the liability of public authorities after Barrett and Phelps.¹³⁷

(d) Controlling access to or continuance on the market of a particular product

Perhaps the most important supervisory control which public authorities possess in relation to product safety is found in their control over access to or continuance on the market of a category of a product or, indeed, an individual product. This takes two main forms: pre-circulation control (licensing, inspection or certification) and post-circulation control (exercising powers to order a product’s recall).

Two contrasting decisions in the context of the certification of aircraft reflect the changing focus of judicial concerns. In Philcox v Civil Aviation Authority in 1995 the plaintiff owned a light aircraft which had been repaired by his club, a limited company, and then inspected and certified for airworthiness by the Civil Aviation Authority (‘CAA’) under statutory powers: without such a certificate, the aircraft could not lawfully fly.¹³⁸ A month later the aircraft crashed and while neither the plaintiff nor his passenger were seriously injured, the plaintiff claimed damages from his club, an action later settled. The plaintiff then brought an action for damages for the necessary repairs to the aircraft for the loss he suffered owing to the air crash, that is, damage to the aircraft not recompensed by his insurer and for loss of revenue from hire of the aircraft while it was unable to fly. While the Court of Appeal was not altogether clear as to the nature of the plaintiff’s harm (whether damage to property, (p.352) economic loss, or economic loss ‘associated with physical damage to the aircraft’¹³⁹), all the judges agreed that no duty of care arose in the CAA in respect of its certification, on the basis that it was not ‘fair, just and reasonable’ to impose a duty in the circumstances, principally on the ground that a person such as the plaintiff whose action is supervised by a public regulator should not be able recover damages against that regulator¹⁴⁰ or, put another way, the statutory scheme of control in question was constructed for the protection of people other than the aircraft’s owner, such as passengers, cargo-owners or other members of the public.¹⁴¹ The primary responsibility for the maintenance of the aircraft rested on the plaintiff as owner.

In Perrett v Collins, decided just three years later, the Court of Appeal took a rather different approach.¹⁴² There the first defendant had purchased a kit aircraft and in the course of its construction had decided to substitute a different gearbox without making the necessary alteration to the aircraft’s propeller. This construction was carried out under the occasional supervision of an inspector (the second defendant) generally employed by a flying club (the third defendant) of which the first defendant was a member but who was paid a small fee by him for this purpose. On completion of the aircraft, the second defendant signed a permit to allow the aircraft to fly as provided for under rules made under statutory powers contained in the Civil Aviation Act. However, the aircraft crashed on its test flight and injured the plaintiff, the first defendant’s passenger.

On these facts, the Court of Appeal upheld the trial judge’s decision below and held that both the second defendant inspector and the flying club owed the plaintiff duties of care in respect of his inspection and certification, despite the presence of the construction fault: the plaintiff’s harm was physical (personal injury) which was a ‘potent factor’ pointing to the existence of a duty of care, whereas the harm in Philcox was treated as ‘purely economic’;¹⁴³ there was no concern with either the foreseeability of the plaintiff’s harm (which the defendants had conceded¹⁴⁴); the statutory scheme of control was constructed for the safety of aircraft and persons, that is, with the view to avoid the type of harm which in fact occurred;¹⁴⁵ and the role of the surveyor was not ‘secondary’ but was ‘independent’ of the role of the owner/builder who was merely an amateur.¹⁴⁶ In this respect, it clearly weighed with the court that the inspector was very closely involved in the construction of the plane and the flying club was very closely involved ‘in organisational terms’ with the owner/builder;¹⁴⁷ that the inspector was paid by the owner and that, while the flying club might not be profit-making, its purposes were both recreational and potentially extremely dangerous to third parties.¹⁴⁸ Finally, Buxton LJ was unimpressed by the policy reasons against liability put forward by the defendants, whether in terms of an increase in their insurance premiums, the danger of ‘defensive surveying’ or that the withdrawal of the flying club would put a burden on the CAA, ‘with greater expense to small aircraft operators or the taxpayer or both’.¹⁴⁹ These assertions were unsupported by evidence and the increase of costs to (p.353) defendants from liability should not be seen as a reason for denying relief where a person had been negligently injured.¹⁵⁰

In this case, therefore, the defendant inspector was held liable for failing to take reasonable care before giving a permission necessary for the lawful use of a particular example of a product of a type whose use entails a high risk of injury or death. The safety defect in the aircraft was one of manufacture (by an amateur builder/owner), the inspector’s negligence a failure to discover and/or act reasonably in response to that defect. Quite apart, though, from the special features of the case (notably, that the defendant inspector was a private person acting professionally and for reward even if within a statutory framework and the ‘close involvement’ in the product’s construction¹⁵¹), the central thesis of the case which distinguishes on the one hand between liability for physical damage (and in particular personal injury) in which a duty is more likely to be imposed and pure economic loss on the other reveals a striking paradox in the law more generally.

For if held liable the first defendant, the owner/builder whose negligence contributed to the plaintiff’s personal injuries, could claim contribution from either or both of the two other defendants, the inspector and the club under the law governing joint and several tortfeasors. This may not seem objectionable on the facts as the owner/builder had engaged the inspector and joined the club in part to prevent himself from building an unsafe aircraft, but behind the parties present in Perrett v Collins one could see other possible defendants, notably, the seller and the manufacturer of the kit of the aircraft. While the facts necessary to take a view on the potential liabilities of these parties are not available in the judgments (notably, as regards the person from whom the owner/builder bought the substitute gearbox) one could imagine a situation where one or other of such persons should have warned the amateur owner/builder of the aircraft of the risk of changing the gearbox but not the propeller. Even at common law, if negligence could be made out in either seller or manufacturer, they could be liable to the passenger injured when the aircraft crashed and could, therefore, also claim contribution from the inspector and flying club in respect of any liability incurred. In this way, a decision imposing liability on a certifier of a product to a victim of personal injuries can lead to a claim for contribution by the person controlled by the process of certification in respect of the economic loss caused by his own civil liability for personal injuries.

Perrett v Collins, therefore, shows that the distinction between compensating the primary victims of personal injuries from regulatory failures by a public body and compensating a person regulated by such a body which suffers economic loss breaks down when juxtaposed with the law of contribution between tortfeasors. For where liability is imposed in a regulator to a primary victim of this kind, then the regulated party stands to benefit by way of contribution towards any liability for which he is ‘primarily responsible’ (as indeed was the situation in Thames Trains v HSE).¹⁵² Of course, such a claim for contribution by a regulated person may not lead to a very large (p.354) actual award against a regulator in the regulated person’s favour, as the court possesses a discretion under the Civil Liability (Contribution) Act 1978 to award what is just and reasonable taking into account the relative fault and causal significance of the fault in the production of the primary victims harm.¹⁵³ But a claim for contribution will exist.

(e) Choosing between regulatory responses

Perhaps, however, the most rewarding discussion in the area of the liability of regulators of products in the interests of their safety may be found in Smith v Secretary of State for Health,¹⁵⁴ particularly in relation to the issue of breach of duty. There in late May 1986 the plaintiff when four years old suffered from chicken pox, had been given aspirin by her mother and as a result of this medicine developed Reyes syndrome, and became grievously permanently disabled. On 10 and 11 June 1986, the Committee on the Safety of Medicines (‘CSM’) issued warnings against the use of aspirin in children under the age of 12 which were reported in a national newspaper. The plaintiff’s basic case was that this warning should have been given earlier, and in particular within a week or two of a meeting of the CSM in March 1986 when it had been advised of the risk of death or serious injury from Reye’s syndrome in children on taking aspirin, for if a warning had been given, the plaintiff’s mother would not have given her aspirin and she would not have been injured.

A number of preliminary issues came for trial before Morland J, including both the existence of a duty of care and of breach of duty, which he set in the statutory framework in which the Department and CSM worked. In law, it was for the Secretary of State for Health to determine the granting, renewal and revocation of licenses for all medical products in the UK, including ‘proprietary medicines’, that is, those available over the counter without prescription,¹⁵⁵ though his power to revoke or vary a medicine’s licence once granted was ‘circumscribed and [could] involve very lengthy consultation and appeal processes’.¹⁵⁶ The CSM was established by statutory instrument to advise the Secretary of State as to the ‘safety quality and efficacy’ of medicines for human use,¹⁵⁷ and in reality laid down the policy which the Department implemented.¹⁵⁸

In the larger part of his judgment, Morland J addressed the question whether the Secretary of State had been negligent in failing to issue public warnings about aspirin earlier. In this respect, he contrasted the approach of the UK authorities to the US experience, where in 1982 the authorities had issued warnings as to the use of aspirin by children even though at the time its validity was disputed by the pharmaceutical industry and their action opposed:¹⁵⁹ it was only in 1985 that the US industry started to cooperate with the authorities’ concerns.¹⁶⁰ In Morland J’s view, the US experience formed an object lesson to the CSM on how the problem should not be dealt with:

The lesson was that clear informative warnings fully supported by the whole pharmaceutical industry were required. Otherwise a mixed and confused message would come across not (p.355) stopping aspirin being given to febrile children but at the same time causing loss of confidence in aspirin when it should be taken by children and adults.¹⁶¹

For while aspirin in children possessed the risk of Reyes syndrome, aspirin remained an effective antipyretic and analgesic.¹⁶²

In March 1986 the CSM accepted the possible causal link of aspirin to Reyes syndrome in children and it recommended that warnings should be issued, possibly to include letters to prescribing doctors, pharmacists, advertisements and product labelling, but did not recommend that paediatric preparations should be withdrawn from the market.¹⁶³ However, once the CSM’s secretariat met industry representatives (which they quickly did), the difficulty and scale of the problem became apparent, for aspirin had been ‘a panacea in every medicine cupboard of every home since Edwardian times’ and there were some 40 million packs already in circulation.¹⁶⁴ In response to this, the Department decided to postpone further discussion of the issue by the CSM until May in the ‘reasonable belief and expectation that there was the likelihood of the full cooperation of the industry thus circumventing the cumbersome statutory procedures [of withdrawal of its licence] and achieving a more effective result’,¹⁶⁵ in particular so as to avoid the US route which led to a complete loss of public confidence in aspirin. In Morland J’s view, this positive cooperation by the industry was crucial to the success of any decision relating to aspirin and children,¹⁶⁶ but establishing unanimity among producers required effort.¹⁶⁷ When the CSM met in late May it endorsed the strategy proposed by the industry, that is, to amend dosage instructions on adult products, to warn against use by children under 12 without medical advice and to run a public education campaign funded by the Aspirin Association and developed in conjunction with the Department: this advice was followed by the Department.¹⁶⁸ In the result, there was a ‘concerted and successful campaign’ to stop children under 12 being given aspirin except on doctor’s orders,¹⁶⁹ with ‘excellent results but tragically too late to save [the plaintiff] from catastrophic disability’.¹⁷⁰ In Morland J’s judgment, there was, therefore, no fault in either the Department or the CSM in dealing with the risk caused by aspirin: the delay of an extra month ‘created a window of opportunity for a far better overall result’,¹⁷¹ and the risk that two or three children might die or be gravely disabled had to be balanced against the ‘undoubted benefit of a coherent coordinated comprehensive campaign including the withdrawal of paedriatric aspirin with the full weight of the Department of Health, the CSM and the industry behind it thus giving a clear definitive unambiguous message to both professionals and the general public’.¹⁷²

This is a very important illustration of the way in which an English court applies the ‘cost/benefit’ analysis in assessing the existence of negligence,¹⁷³ even when balancing the cost in terms of death and disability against a benefit of other possible death or disability. In coming to his view, Morland J looked extremely carefully at the development of the public authority’s view as to how to proceed and how it changed once the (p.356) difficulty of achieving an effective result in the particular context was appreciated. In the context, the Department was right not to issue public warnings nor to start the process by which the product’s licence would be revoked, but rather to come to an agreed joint solution in partnership with industry. In these circumstances, even though those responsible knew of the risk that a child may suffer as a result of the necessary delay, this risk was worth taking; therefore, they were not negligent. This decision makes an interesting factual contrast with Morland J’s earlier imposition of liability for negligence in the Department and the Medical Research Council in relation to Human Growth Hormone and CJD, though there these public bodies both produced and supplied as well as regulated the product in question.¹⁷⁴

Having come to this view as to the absence of negligence, Morland J’s decision in Smith v Department of Health on the existence of a duty of care became hypothetical and he treated it briefly. His conclusion was that no duty was owed as the decisions to postpone the CSM’s final decision on action in relation to aspirin and the content of any warning were ‘well on the “discretionary/policy” side’ of the line between discretionary/policy decisions and operational decisions and were not justiciable,¹⁷⁵ though Morland J added that he was not saying that the public bodies before him could never be liable for a failure to exercise or an improper exercise of their statutory powers, for example if the Secretary of State had delayed implementation of a decision until after a bye-election in a marginal constituency where there was a large aspirin factory or the CSM had postponed its meeting to avoid the Epsom Derby meeting: special circumstances clearly demand a remedy, as the House of Lords in Phelps had acknowledged.¹⁷⁶