Katharine Muir

The decision to bring criminal charges against ITH Pharma Ltd (“ITH”), the manufacturer of an intravenous nutritional product, is a reminder that manufacturers have duties to the end users of their products and can face criminal as well as civil liability for failures. It also underlines the need for manufacturers to monitor their suppliers to ensure the quality and compliance of component parts.

ITH manufacture and supply total parental nutrition (“TPN”), which is used to feed premature and sick babies. The death of one baby has been linked to contaminated TPN, and several other babies required treatment after contracting septicaemia after receiving TPN. As a result, ITH has been charged with offences under both the Health and Safety at Work Act 1974 and the Medicines Act 1968. ITH have denied the charges, and it has been reported that they have claimed that the contamination came from an unspecified raw ingredient from a supplier.

The offences under the Medicines Act will apply only to the manufacturers of medicinal products. However, offences under the 1974 Act apply to all manufacturers.

Under the 1974 Act employers must ensure, so far as reasonably practicable, that that they do not expose persons who may be affected by their business to risks to their health and safety. A manufacturer cannot pass the blame on to another party and escape criminal liability simply by claiming that the defect came from a component provided by a supplier.

In order to avoid criminal liability, the manufacturer must show that they took all reasonably practicable steps to prevent the risk arising. In the ITH case the steps the company took to monitor their suppliers and ensure that what they were supplying was of the required quality and specification will be examined, as well as the checks within their own manufacturing process to ensure that TPN was safe for use.

Separate to criminal liability, claims for damages may be brought against ITH by individuals (such as the children’s parents) who have been affected by the incident under the Consumer Protection Act 1987 and under common law. Where a product is made up of component parts, a manufacturer may in some cases be able to pass the blame to the supplier of a component if they are entirely responsible for the defect or share the blame with them, depending on the circumstances.

The outcome of this case will be interesting to follow, as it may provide additional guidance for manufacturers and clarify the requirements that must be satisfied by them in ensuring the safety and quality of the components they use.

Katharine Muir is a solicitor at Burness Paull