Nurofen product recall

At the end of August 2011 all packs of Nurofen Plus painkillers were recalled from the UK market by its manufacturer, Reckitt Benckiser, after several were found to contain the wrong medicine. It is not known whether all packs are affected, but all have been recalled as a precautionary measure.

Nurofen Plus is used for short-term relief of acute or moderate pain; it is not a prescription medication, but consumers must ask for it from a pharmacist. Four affected packs in South London contained 50 milligram tablets of Seroquel XL, a prescription-only anti-psychotic medicine used to treat schizophrenia, mania and bipolar depression. Another pack in Northern Ireland was found to contain an epilepsy and peripheral neuropathic pain treatment.

It is understood that the only likely effect of a single ingestion of a Seroquel tablet would be sedation. However, in people taking antihistamines and other sedatives, the potential additional effects have been described as "quite extreme".

The recall decision was taken in full consultation with the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) as a precautionary measure. The MHRA has issued a Class 1 drug alert to healthcare professionals and has advised people to return all packets of Nurofen Plus to a pharmacy.

Sabotage is suspected and Reckitt Benckiser is working with the police on a formal investigation to find the person or persons responsible. Reckitt Benckiser has ruled out a manufacturing error and it is thought that the company may have been targeted because it tests products on animals, although it states that it has a firm policy of not testing on animals unless legally required to do so by the UK government. Seroquel is manufactured by AstraZeneca, and Reckitt Benckiser has stated that it is trying to establish how a rival company's product could have found its way into packs of Nurofen Plus. A source close to the company has reportedly suggested that the anti-psychotic drugs must have got into the boxes "somewhere between factory and the shops, or in the shops themselves".

Potential implications

Part 1 of the Consumer Protection Act 1987 renders a producer strictly liable for personal injury, death or damage to a consumer's property caused by a defective product. Although fault is not a requirement, the consumer must prove the defect, the injury and a causal link between them. However, under Section 4 of the act a producer or importer can avoid liability if it can prove that:

  • it did not supply the product to another party (eg, the product was stolen or a fake);
  • the defect did not exist in the product when it was supplied (eg, the product became defective as a result of careless handling by the retailer or user);
  • the product was not supplied in the course of business (eg, it was supplied for charity purposes or sold at a car boot sale);
  • the defect was caused by the defendant's compliance with the law (in which case the defendant must show that the defect was the inevitable result of such compliance);
  • it is a producer of a component and the defect was due to the design of the finished product or to defective specifications provided by the producer of the finished product; or
  • the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might have been expected to discover the defect if it had existed in its products while they were under its control.

Therefore, under the act, if a consumer were to suffer personal injury as a result of taking a 'defective' tablet, in the event of sabotage the manufacturer would have only one defence available - it would have to prove that it did not supply the counterfeit product that caused the consumer's injury.

Lessons for manufacturers and suppliers

Malicious acts, such as product sabotage and intentional product contamination, can be extremely damaging to a company's reputation, its brand and its employees - and, most of all, consumers of its products. It is vital that product manufacturers and suppliers assess the vulnerability of their products to the risk of intentional contamination or harm in their production facilities and in the warehouses where the products are stored. It is equally important to ensure that adequate mechanisms are in place to prevent or limit such harm. These may include:

  • clear identification and monitoring of employees and visitors to such premises;
  • security measures, such as closed-circuit television, fences and adequate lighting;
  • regular checks on whether product packaging makes signs of tampering obvious;
  • product recall procedures to deal efficiently with intentional contamination;
  • product recall and contamination insurance, including accidental contamination and malicious product tamper/product extortion covers; and
  • measures to protect proprietary information from falling into the wrong hands.
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.