Following the outcome of the national election on 4 July 2024, on 17 July 2024, King Charles III gave a speech to the UK Parliament in which, as directed by the new Government, he outlined the key points of its legislative and policy agenda.

The agenda includes a Product Safety and Metrology Bill.  Some form of legislation to address UK product regulation was expected in order to take account of market developments and new technologies, such as online selling and AI.  We set out below a brief summary of the Bill.Continue Reading The King’s Speech: Product Safety and Metrology Bill

Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Continue Reading Implications of the New EU Product Liability Directive

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.Continue Reading Medical Devices and Compulsory Insurance in the EU

On 12 November 2018 the EU Commission announced that its rapid alert system formerly known as ‘RAPEX’ is being updated and rebranded as ‘Safety Gate’.  Aside from the rebranding, the main new features of the Safety Gate platform are that it is more accessible to consumers, being now available in 25 languages, and it is capable of being shared by consumers via social media.

With certain exceptions, this online product safety database covers dangerous non-food products.  It includes cosmetic products, but not medicines or medical devices.  It is populated by alerts of potentially serious risks posed by such products.  In line with applicable EU legislation, economic operators are required to notify risks presented by products that they have placed on the market in the EU to the competent national authorities in the Member States in which the affected products have been sold.  The legislation requiring such notification is the General Product Safety Directive, or sector-specific legislation with similar effect, such as the legislation applicable to toys and electrical goods, as implemented in each Member State.  The legislation also obliges operators to take corrective actions, such as product recall, if appropriate.Continue Reading EU Safety Gate

Judgment was handed down on 21 May in the DePuy Pinnacle Metal on Metal Hip group litigation: Gee & Others v DePuy International Limited [2018] EWHC 1208 (QB)

312 claimants in the group litigation brought claims against DePuy, alleging that the hip prostheses with which they had been implanted were defective for the purposes of the Consumer Protection Act 1987 (the Act) and the Product Liability Directive 85/374/EC (the Directive). The judgement followed a trial at first instance of a common preliminary issue, namely “whether or not the defendant is liable to the claimant, subject to any development risk defence.” The preliminary issue encompassed questions of causation.Continue Reading England & Wales High Court Judgment in metal on metal hip group litigation

Many things have changed since 1985, in particular in the world of technology.  The Commission’s 10 page report and evaluation of 7 May 2018 questions whether the Product Liability Directive of 1985 (“the Directive”) is still fit for purpose.  The Directive was implemented to protect consumer safety and imposes strict liability (i.e. no requirement for the injured party to prove fault) on a producer of defective products for personal injury or damage to property caused by the defect.

The Commission’s Report

Although, historically, the Commission has reported on the implementation of the Directive to the Council and Parliament every 5 years, this is the first time that the report has been accompanied by an evaluation of the relevance of the Directive in the EU today, owing to widespread concerns regarding the invention and everyday use of “products” that were not even imagined back in 1985.  The report recognises the urgent need to consider whether the Directive, in its current form, adequately deals with the challenges posed by “digitisation, the Internet of Things, artificial intelligence and cybersecurity” now and in the future, and, if it does not, what changes would be required to address the shortcomings.Continue Reading Is the EU Product Liability Directive still fit for purpose?

What does “defect” mean?

Rarely has the Court of Appeal been required to examine the meaning of “defect” within Section 3(1) of the Consumer Protection Act 1987 (the Act). In Baker v KTM Sportmotorcycle UK Ltd and another [2017] EWCA Civ 378, the Claimant, a maxillofacial surgeon, had suffered severe personal injuries when the front brakes of the second-hand motorbike he was riding seized without warning and he was thrown off. The motorbike had been well-maintained, had low mileage and was only two years old. The Claimant sued the motorbike manufacturers (KTM) under the Act and in negligence, and won (under the Act) at first instance. KTM appealed, on the basis that the Recorder was wrong to conclude that the corrosion which led to the brakes failing was a “defect” within section 3 of the Act. The Appeal was unsuccessful—the Court of Appeal found that the brakes failed because they were defective. The Court explained that the Claimant did not have to prove the existence of a specific design or manufacturing defect for there to be a finding of defect within the meaning of section 3, nor did he have to show how the defect was caused. The Claimant merely had to show that a defect existed at the relevant time and that this caused the accident. The Court found on the expert evidence that there must have been a defect in the brakes of this particular motorbike, which Hamblen LJ described as “a susceptibility for galvanic corrosion to develop in the front brake system when it should not have done i.e. after limited and normal use and notwithstanding proper servicing, cleaning and maintenance”. This susceptibility was not present in other bikes of the same type, and therefore the Court was entitled to infer that these particular brakes were defective, and the Claimant had proved his case.Continue Reading Meaning of defect? Court of Appeal clarifies s3 Consumer Protection Act 1987