Defective Medicinal Products

If a patient is harmed by a defective Medicinal Product it may be easier to bring a claim against the producer than any Medical Practitioner.

The attraction of this is that there then may be no need to prove fault. The Consumer Protection Act 1987 (CPA) imposes strict liability. Simply put, the test is whether the Product is as safe as people (the UK public) are entitled to expect and whether it caused the damage in question. Devices, medicines and human blood are “Products”, for this purpose, and probably even organs for transplantation.

The Court will want to consider the time when the Product was put into circulation, its presentation to the general public and its expected use. The relevance of labelling is a tricky issue because a Producer is forbidden from limiting liability under the CPA. However, once a defect is established, what is certainly not relevant is the Producer’s conduct or any cost benefit considerations. It then matters not if the Product was only available upon medical advice, nor that the Product complied with the prevailing licensing regime.

Comparing products

A useful tool is to compare the offending Product against other Products in the same series or against other similar Products on the market. Again, a Product should not be considered defective purely by reason of a better Product being subsequently put into circulation.

The problem generally in determining whether a Product is defective is that the body is a complex organism and at the time of treatment is already subject to adverse pathology. Therefore, in order to avoid an adverse reaction a medicine would have to be able to cope with faulty organs, disease and almost infinite variations in individual susceptibility. The greater the beneficial potential of the medicine, the more extensive its effect is likely to be and the greater the chances of an adverse effect.

Side effects

Hence Cancer treating drugs are known to have serious adverse effects yet generally their use is justified. However, is one entitled to expect no side effects, minimal risk or simply that use of the medicine will not present a greater risk than no treatment at all? Should the methods employed by the Producer for avoiding side effects be considered in making this determination?

A Product defect may be a design, manufacturing or marketing one. A split of fractured condom might be considered an obvious defect. However, although the user’s expectation is that a condom will not fail, the Producer successfully contested the legal claim on the basis that there was never any assertion that none would ever fail, ie no method of contraception intended to defeat nature will be 100% effective.

In other cases, such as with blood products for transfusion, persons might be entitled to expect 100% safety.

Could the defects have been expected

Space precludes consideration of all the different potential legal defences, defined under the CPA, but one of the more challenging, particularly with Medicinal Products, is that the Producer can escape liability by showing that scientific or technical knowledge at the relevant time were such that discovery of the defect by the Producer would have been expected. The relevant time is when that particular Product is supplied.

This does not interpret as meaning that practical implications must be tested by every Producer on the strength of every, and any, speculative account say in an obscure academic journal which just might bear upon the effect of a given product. No – the test is what a reasonable person would do and the accessibility of the information is an important consideration.

Interestingly, whilst the general risk of Hepatitis C in blood was well known, until 1989 there was no method of detecting it in a particular blood product. So could this Defence be run – known colloquially as the “State of the Art” Defence? Or, was the defect discoverable? The Court held that it was discoverable. The defect was a generic one; there was a known risk and the Producer continued to supply the Product with this knowledge of such risk.

The intention of the CPA is not to discourage innovation. So it protects Producers in respect of the unknown, but the purpose of the Act is to prevent injury and to facilitate compensation for it.

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