(E) The State as manufacturer and supplier of medical products

However, the dominance of the NHS in the provision of the health care for the last half century has led public bodies themselves on occasion to take on the role of manufacturer as well as supplier of certain medical products. I shall give two very different examples, the first concerning the use in NHS hospitals of a generic spray for burns which caused deafness; the second the production and supply of human growth hormone (HGH) which was found to be infected with Creutzfeldt-Jakob disease (CJD).

(I) The nhs as commissioner of the manufacture of generic medical products

In Mann v Wellcome Foundation Ltd²¹⁴ the two plaintiffs had been treated as children in 1968 and August 1969 in two NHS hospitals for serious burns with a polybactrin spray; both later suffered deafness. The unpatented product in question, whose active agent was neomycin, had been marketed in the UK from 1952 by a small pharmaceutical company and had been sold to many hospitals through wholesalers. In 1963 in the interests of cutting costs the regional health authority in which the two hospitals were situated engaged another company to make up the spray to their specification and supply it to their hospitals. The plaintiffs were unsure which spray had been used in their own treatment and so sued the health authority and both manufacturers, though the manufacturers both fell out of the picture, the first owing to the lack of evidence that their product had been used and the latter on the basis that they had no role in determining the spray’s chemical formulation.²¹⁵

This left the health authority in the firing line, it being found that there was a strong probability that the plaintiffs had been treated with the generic spray and it being admitted that the plaintiffs’ deafness had been caused by their treatment with the spray. Waterhouse J had no doubt that the health authority owed the plaintiffs a duty of care ‘having taken over the role of the original manufacturer of the spray as supplier…and being responsible for managing, in effect, the use of the drug in their hospitals’. The plaintiffs argued that the health authority failed to carry out clinical (p.295) tests, failed to consider the optimum balance of the chemicals, failed to warn of the risk of ototoxicity (poisoning of the ear) and failed to establish any safe regime for administration of the spray, for example, with maximum limits for applications. The defendants countered, inter alia, that at the relevant time reasonably informed medical opinion believed that neomycin was not absorbed to any significant extent by the body and had been established as a safe and satisfactory treatment of burns: the health authority could not reasonably have been expected to carry out further tests when it switched to a virtually identical generic substitute for a product which had been in use for about six years and was considered appropriate by the medical profession.

Waterhouse J decided that the ‘overwhelming weight of the evidence’ was in favour of a finding that until the autumn of 1969 the health authority could not reasonably have foreseen that neomycin might be absorbed to a significant extent when applied by spray to a burn: the health authority ‘cannot reasonably be expected to be wiser or to have greater prophetic vision than the doctors and scientists who advise it, subject only to consideration of what was available additionally in medical and scientific literature and the state of knowledge in the relevant expert branches of those professions’. Waterhouse J rejected all the plaintiffs’ allegations of negligence and their claims failed.

Here, therefore, we can see that the special position of the NHS in commissioning the manufacture of a generic product and then arranging for its use in its own hospitals owes duties which extend beyond those of the ‘mere supplier’. By undertaking responsibility for the composition, supply and administration of the product the NHS authorities thereby owed a combination of the practical duties normally associated with manufacturers, suppliers and the supervisors of medical practice. While in Mann there was the special feature that the NHS authority specified the composition of the product, Waterhouse J’s judgment also indicates that the standard of care expected of the bodies responsible for the supply of products within the NHS owe a duty of care whose content is anyway more akin to a manufacturer’s than a commercial distributor’s, a more onerous duty justifiable given the importance of their decision and their access to expertise and advice. In this respect, the tort of negligence is able to accommodate this range of duty by the flexibility of the requirements of reasonable care. As we shall see, though, this marks a striking contrast with the Product Liability Directive which distinguishes sharply between ‘producers’ and mere suppliers.²¹⁶