(C) Contractual liability and medical products

There is, moreover, a further way in which English law (apart from the Consumer Protection Act 1987) in practice distinguishes between liability for the provision of public and private health care and this relates specifically to the supply of products. For the House of Lords has held that NHS patients are not treated or supplied with drugs under contracts, as the statutory provisions which underpin the NHS are inconsistent with the existence of contracts between the service providers (hospitals and general practitioners) and their patients, even where the patient contributes some payment to the cost of the provision.¹⁹⁵ When treated under the NHS a patient has a statutory right to the medicine and the hospital or pharmacist has a statutory duty to supply it and this is inconsistent with the existence of a contract which rests on the parties’ express or implied agreement.¹⁹⁶ The courts have consistently upheld this position and have applied it to the relationship between general practitioners and their NHS patients.¹⁹⁷ The logical consequence of this denial of contract is that a NHS patient supplied with a product in a hospital or by a general practitioner, or even a prescribed drug by a commercial pharmacist must claim on the basis of the tort of negligence and not on the basis of the strict statutory terms implied in any contract for services which includes the transfer of goods,¹⁹⁸ even where a charge is made. By contrast, where a private patient is supplied with a product in the course of his or her treatment, (p.292) their provider will be liable where they were not reasonably fit for their purpose or of satisfactory quality.¹⁹⁹ So too will a pharmacist or a supermarket who supplies non-prescription medicines. In the result, where products are supplied under the public health service their supplier will liable only for negligence, whereas where they are supplied by way of private health care liability will be strict.

So, in common with the position which applies to the liability of public utilities, while the liability rules themselves distinguish liability for negligence in tort and strict liability in contract, the courts’ view that contracts are incompatible with relationships shaped by statutory rights and duties leaves public liability for products to negligence and private liability as strict.

(D) The liability in negligence of manufacturers and suppliers

There are few English decisions imposing liability on manufacturers of medical products in general and none in the area of pharmaceuticals.²⁰⁰ Given the absence of privity of contract between manufacturers and those who suffer personal injury and death as the alleged result of use of a product, the basis of liability remained the tort of negligence until the passing of the Consumer Protection Act. This means that a description of the application of the tort of negligence to manufacturers of medicinal products generally consists of extrapolation from decisions in other contexts. And while generally Donoghue v Stevenson established the existence of a duty of care,²⁰¹ claimants have found it difficult to establish a causal link between use of a medicinal product and their own harm, even before the question of negligence in their manufacturer is argued.²⁰²

Nevertheless, it is clear that a manufacturers duty to take reasonable care has a number of elements. Some relate to the state of the product itself: its design, instructions or warnings for use; the range of tests carried out before it is released onto the market (for example, whether it is reasonable to rely on testing on animals or on limited numbers of human subjects).²⁰³ In this respect, compliance with the terms of a product licence or even particular legal requirements (for example, as to package inserts accompanying pharmaceuticals) is not conclusive of the issue of reasonable care, following the general position.²⁰⁴ Where a manufacturer of a product already marketed later discovers some risk relating to its use, it must take reasonable care in deciding whether or not to issue public warnings, to suspend or to terminate production and order its withdrawal from use:²⁰⁵ in the pharmaceutical context withdrawals (p.293) are common and sometimes controversial.²⁰⁶ However, there are two particular features in assessing negligence in relation to medical products.

First, use of a particular medical product may be a better or even the only way to treat a particular condition which is itself painful, distressing, disabling or even life-threatening and so the ‘cost/benefit’ analysis required in assessing the requirements of reasonable care must include the human cost of withdrawal of a product from use.²⁰⁷ Secondly, there are difficult questions as to the relative responsibilities of the manufacturer of a medical product and the medical practitioner who prescribes its use.²⁰⁸ Clearly, it is for a physician to diagnose and to assess whether an individual patient requires a particular medicine and, sometimes, in what quantities and combined with what other medicines. To this end, a manufacturer must put medical practitioners in a position to make a proper assessment, but on the understanding that the practitioner is trained, has recourse to published pharmacological guides and can take specialist advice if need be. In the case of medicines available only on prescription, it is this combination of information and expertise which allows a medicine to be put to its effective and safe use. From this perspective, it may be thought enough for a manufacturer to furnish information only to prescribing professionals, rather than requiring information to be brought directly to a patient.²⁰⁹ On the other hand, manufacturers of medicines are required by specific laws to provide some information about their products direct to their users.²¹⁰ Given this practice, the law of negligence would require that any information is accurate, clear and enough to inform and warn non-specialist users of any particular risks. For example, where a medicine has serious risks when taken by a pregnant woman, a manufacturer should not be able to rely merely on prescribing doctors asking their female patients about their present or intended condition, given that a simple direct warning accompanying the product may avert serious harm caused by a doctors own inadvertance.

As I earlier explained, the law of negligence is typically much less demanding of those in the chain of distribution other than manufacturers.²¹¹ So, generally the care expected of a mere supplier or distributor, such as a wholesaler will not usually extend to the design of the products in which they deal, whether this consists of their composition or the information which accompanies them. Mere distributors may reasonably rely on the reputable manufacturer of a product in respect of these matters and do not have to undertake research for themselves, though they must use care in ensuring that no damaged or out-of-date product is supplied.²¹² This liability in tort is of greater significance in the context of provision under the NHS, since those who supply medical products to patients will not owe them strict contractual obligations. On the other hand, pharmacists purchase prescription medicines from wholesalers under contracts, (p.294) the wholesalers in turn purchasing from manufacturers or importers and then the pharmacist charges the NHS the cost of the medicine supported by the prescription; and hospitals buy medicines in large amounts, requiring manufacturers to tender for contracts to supply at discounted rates directly.²¹³ This leads to the rather odd position that while an NHS supplier of a medicine is liable only on the basis of negligence (apart from liability under the Consumer Protection Act 1987), they can themselves claim under the strict implied terms in the Sale of Goods Act.