Introduction
There is rarely a dull moment in global product liability litigation. The US continues to dominate discussion of mass torts, with products ranging from pharmaceuticals to automotives to chemicals continuing to generate class actions. The other side of the Pacific has also seen a growth in litigation, with Australian courts in particular, having dealt with an increasing number of substantial product liability related class actions in recent years. Closer to home, the UK and certain European jurisdictions have also seen an increase in product liability class action or group claims brought in respect of medical devices and pharmaceutical products, driven in part by the growth of litigation funders who see the promise of large returns.
In the UK, recent years have seen high-profile group litigation including Colin Gee v DePuy International Ltd [2018] and the UK Supreme Court decision in Hastings v Finsbury Orthopaedics Ltd & Stryker (UK) Ltd [2022]. These cases considered the assessment of defect under the Consumer Protection Act 1987 (CPA) and culminated in landmark rulings which have clarified and shaped the law on product liability, largely in ways that have reassured producers/manufacturers. These cases may for now at least have tempered the enthusiasm of funders for pursuing product liability claims before the UK courts.
By comparison, product liability in the EU is on the cusp of major change. As AI and digital technologies play an increasingly fundamental role in our daily lives, including their integration in products used personally and professionally, the potential for both consumers and businesses to suffer harm as a result of their use continues to grow. The new EU Product Liability Directive (EU) 2024/2853 (PLD), which imposes strict (‘no-fault’) liability on manufacturers, suppliers and other entities for defective products, came into force on 8 December 2024 and replaces its nearly 40-year old predecessor. Member States have until 9 December 2026 to implement the new PLD into national laws after which products placed on the EU market will be subject to the new PLD. Products placed on the market prior to this date are still subject to the existing PLD. It is expected to make it easier for claimants who suffer injury or loss from a defective product, successfully to bring claims (including group actions) against a range of entities, including manufacturers, suppliers and online platforms, due to the wider definitions of products and the expansion of the potential target defendants, among other things.
On 5 November 2024, the UK government published its long-awaited response to its ongoing Product Safety Review (PSR), led by the Office for Product Safety and Standards (OPSS). The response outlines the government’s proposals to modernise the existing product safety framework with a view to ensuring that it can respond to new products and future risks, including those posed by advanced technologies and online marketplaces.
This article discusses trends in group litigation, product safety and risks that may give rise to product liability claims.
Product Liability Class Actions
Dieselgate
Product liability class actions remain front-and-centre in the High Court with the ongoing Dieselgate litigation, ‘Pan-NOx’ emissions group litigation, stretching the capabilities of the courts. The group action is comprised of over 1 million claimants bringing claims against multiple car manufacturer defendants under 13 separate Group Litigation Orders. Cockerill and Jacobs JJ have taken a proactive approach towards case and costs management throughout the litigation to date. As such group litigation cases develop, this approach will likely affect all other parties involved in group actions as an example of the type of case management which the High Court is increasingly likely to adopt in complex litigation.
Per- and polyfluoroalkyl substances (PFAS)
PFAS (also known as ‘forever chemicals’) continue to remain under heavy scrutiny in the UK and EU. On 27 February 2025, France enacted a law to prohibit PFAS in several product groups including clothing and cosmetics. Separately, the EU plans to move forward with proposals to ban PFAS in consumer products with exemptions for “essential” industrial uses. The EU’s environment Commissioner has said that the ban is unlikely to be imposed until 2026 so that they can establish which uses are considered “essential”. While waiting for this clarification, manufacturers may need to start preparing for the possibility of a ban and take steps to remove PFAS from their supply chains and find alternatives to minimise the disruption insofar as is possible.
PFAS litigation continues to gain pace in Europe. In the Netherlands, US chemical company Chemours (previously known as DuPont) was found liable for environmental damage caused by PFAS chemicals on 27 September 2023. On its website, Chemours says it is investing €75 million towards reducing PFAS emissions by more than 99% compared to 2017 baseline levels at the Dutch facility in Dordrecht.
In May 2024, the Veneto Regional Administrative Court ruled that the owners of the now-closed Miteni factory in northeastern Italy, including Mitsubishi, , will bear the clean-up costs arising from the pollution of the river Agno and surrounding water system and soil, which exposed over 350,000 residents to perfluorooctanoic acid. Thirteen managers from Miteni and its main shareholders, namely the International Chemical Investors Group and Mitsubishi Corporation, are now facing criminal charges for pollution and environmental disaster. If convicted, they risk imprisonment and multi-million Euro fines.
In April 2023, the UK’s Health and Safety Executive published its Risk Management Option Analysis report on PFAS, with recommendations regarding limitations on the use of PFAS in various products. It launched a public consultation on 4 April 2024 that sought to gather information and evidence relating to firefighting foams containing PFAS. The consultation closed on 24 June 2024.
Social Media Litigation
In the US, there are new lawsuits being filed against major social media platforms every day across multiple states, including Instagram, Snapchat, YouTube and Facebook. Most plaintiffs allege that minors have suffered physical, mental and emotional harm from the addictive nature of the defendants’ social media platforms. They allege that the companies make their platforms deliberately addictive by using algorithms to generate addictive content similar to the users’ interests to keep them engaged and viewing longer, and in doing so, these online platforms are exploiting minors. The families allege that these platforms’ algorithms and engagement-driven designs foster excessive use, negatively affecting the child user’s mental health.
Product Safety
Online Marketplaces
Following the Labour government taking office in the UK in July 2024, its new legislative agenda includes a proposal for a Product Regulation and Metrology Bill. This Bill would widen regulation making powers to replace, amend or update product safety legislation in the UK, and provides the UK with the ability to be able to pick and choose whether to harmonise or diverge from the EU product safety regimes. The Bill would enable UK ministers to align unilaterally with EU regulations related to the environmental impact of products and will enable the UK to address safety challenges and technological advances. The new Bill will give the OPSS greater regulatory powers to hold manufacturers, importers and online marketplaces accountable for the safety of the products being sold, allowing necessary enforcement action to ensure safety.
Lithium-Ion Batteries
Lithium-ion batteries have become a staple in numerous consumer products thanks to their portability, long lifespan and fast charging times and this has resulted in a rapid increase in global demand. In December 2024, the Department for Business and Trade published guidance on lithium-ion battery safety for use in e-bikes to tackle fires caused by unsafe e-bikes. According to the guidelines, there were at least ten fire-related fatalities in the UK involving lithium-ion batteries in 2023 due to poorly designed or manufactured, or misused, lithium-ion batteries in e-bikes and e-scooters resulting in a serious fire or explosion. The guidance sets out responsibilities for the producer and distributor, to demonstrate that the e-bikes possess adequate and effective safety protections to mitigate the risk of thermal runaways to prevent fires, before reaching market.
In the UK, under the Consumer Protection Act 1987, manufacturers and importers are strictly liable for defective lithium-ion batteries that have caused personal injury, death or damage to private property. Producers may also be strictly liable for defective lithium-ion batteries which they have sourced and incorporated into their products. Compliance with relevant safety guidelines and regulations will be a factor that the Court will take into account when considering liability.
CE and UKCA Marks
To demonstrate that a product complies with the relevant essential requirements of EU product legislation, a manufacturer places a CE mark on its products. Since Brexit, the UK adopted its own UKCA marking to replace the CE mark for goods sold within Great Britain (GB). On 3 February 2025, the Department for Business and Trade published guidance on using European harmonised standards to place CE-marked products in GB. The guidance provides that if the harmonised standard used for CE-marked products does not have an identical GB designated standard, manufacturers may have to undertake additional action or follow different conformity assessment procedures to be able to sell their product in GB.
Environmental, Social, and Governance (ESG) Trends
Environmental and sustainability concerns are at the forefront of public consciousness and so, consumers, investors and governments are paying closer attention to the environmental and sustainability credentials of organisations. To win over customers who want to support environmentally-friendly businesses, companies may be inclined to exaggerate or falsely represent their environmental efforts, creating a misleading image of their practices, known as ‘greenwashing’. UK regulators including the Competition Markets Authority (CMA), Advertising Standards Agency (ASA) and Financial Conduct Authority (FCA) have been taking steps to combat greenwashing. Notably, the CMA launched an investigation over sustainability claims by fashion companies ASOS, Boohoo and George at Asda. On 27 March 2024, the CMA announced that those companies have signed undertakings to ensure that the environmental claims that they are making are accurate, which means millions of customers can expect to see clear and accurate green claims.
In May 2024, the FCA’s anti-greenwashing rules came into force, which aim to enforce industry standards concerning the communication of sustainability-related claims within the financial sector. From 6 April 2025, the CMA will be able to take more robust enforcement action against non-compliant companies including imposing fines of up to 10% of a businesses’ global turnover and up to £300,000 on individuals for breaches of consumer law, through provisions made under the Digital Markets, Competition and Consumers (DMCC) Act. While this Act does not explicitly mention ‘greenwashing’, it targets businesses which engage in misleading commercial practices such as fake reviews and drip pricing, and the list of “misleading” commercial practices may be expanded to add ‘greenwashing’. Therefore any unsubstantiated and misleading environmental claims may garner greater scrutiny once the DMCC Act comes into force.
On the other hand, the EU have taken stronger actions against greenwashing. In January 2024, the European Parliament approved its new Greenwashing Directive, introducing stricter rules surrounding the use of environmental claims by companies. The Directive’s aim is to limit unfair commercial practices and restore transparency and credibility to labelling. The Directive provides that only sustainability labels based on official certification schemes or those provided by public authorities are permitted in the EU, and it intends to harmonise the rules on sustainability claims operating across the EU.
From 5 January 2023, the EU Corporate Sustainability Reporting Directive (CSRD) requires companies to report on the impact of corporate activities on the environment and society. The aim was to provide clarity that will help investors, consumers and other stakeholders to evaluate a companies’ ESG performance. However, on 26 February 2025, the European Commission announced its adoption of the Omnibus package to introduce changes to the CSRD and simplify EU rules on sustainability and EU investments to boost competitiveness. The package proposes applying the CSRD only to the largest companies (those with more than 1,000 employees), ensuring that they can focus on the sustainability reports of the companies that have the biggest impacts on people and environment. The EU is likely to continue to introduce more rules as part of the European Green Deal and its aim is to be the first climate-neutral continent.
Artificial Intelligence (AI)
The capabilities and use of AI software are increasing rapidly and are having a corresponding effect on the litigation landscape. Both the UK and EU are in the process of updating their regulations to address these changes.
The EU AI Act came into force across all 27 EU Member States on 1 August 2024 as the first comprehensive regulation that establishes a unified framework for AI. The Act’s primary goals are to promote safe and trustworthy AI, safeguard fundamental rights and foster innovation, while mitigating the potential risks associated with AI. The Act adopts a risk based approach to AI regulation, prohibiting certain AI systems deemed to pose harmful risks that could deceive or exploit vulnerabilities. It categorises AI systems into high-risk, limited-risk, minimal-risk or no-risk categories. The potential fines for non-compliance are substantial at up to EUR €35,000,000 or 7% of a firm’s total worldwide annual turnover for the previous financial year, whichever is higher, not to mention the potential reputational risk. Most provisions of the AI Act will apply after a two-year implementation period (from 1 August 2026) and during this period, guidance and standards will be published to assist companies to comply with the Act. As the EU has a more stringent regulatory framework, businesses are encouraged to adopt a proactive compliance strategy to mitigate risks including monitoring the publication of guidance and establishing understanding of cross-disciplinary frameworks relevant to the sector or industry.
On 17 July 2024, the King’s Speech highlighted the UK’s “pro-innovation” approach is to empower industry specific regulators (such as the Information Commissioner’s Office (ICO), the CMA, the FCA, and Ofcom) to implement bespoke measures to address the risks posed by AI within their sectors in accordance with guiding principles. On 13 January 2025, the Department for Science, Innovation and Technology published the AI Opportunities Action Plan which provided steps that the UK will take to boost economic efficiency and growth centred around AI, including building AI infrastructure, developing AI Growth Zones, establishing the UK as a hub for AI research, and creating a National Data Library.
On 22 November 2023, The Artificial Intelligence (Regulation) Bill, a Private Member’s Bill, was introduced to Parliament. Following the election of the Labour government in July 2024, this Bill was relaunched with its first reading on 4 March 2025. While the UK government has consistently resisted statutory AI regulation, favouring an adaptable and principles-based approach, this Bill reflects mounting pressure from legislators and industry stakeholders. It has been argued that existing voluntary guidelines lack enforceability, creating regulatory uncertainty.
As AI continues to advance, this legislative proposal marks an important moment in the UK’s AI governance strategy. The Bill proposes the establishment of an AI Authority, a dedicated regulatory body responsible for overseeing AI development and ensuring compliance with new legal requirements. By proposing a statutory AI authority and codified principles, the AI Bill aims to address regulatory gaps that may arise from the current sector-specific approach. The Bill also proposes the creation of a centralised supervisory body, similar to the EU AI Office under the AI Act, and therefore potentially aligns the UK more closely with the EU AI Act’s risk-based classification framework. These proposals contrast with the current UK regulatory model and the AI Opportunities Action Plan, as set out above, so, if passed, the AI Bill would mark a major policy shift, imposing legal obligations on AI developers for the first time.
Life Sciences
The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (the “Regulation”) will come into effect on 23 July 2025. The Regulation will amend the Human Medicines Regulations 2012 and Medicines for Human Use (Clinical Trials) Regulations 2004. This new framework enables the manufacture and delivery of point of care (POC) medicines and modular manufacturer (MM) medicines. POC manufacturing refers to personalised medicines made for the patient within a close proximity of the treatment facility, including operating theatres, pharmacies and ambulances, to allow medicines to be used quickly. POC medicines can include gene therapy and patient-specific prosthetics. MM medicines enable the manufacture of certain medicines in flexible, relocatable units, outside of traditionally large-scale pharmaceutical entities, while maintaining the regulatory oversight by manufacturers and regulators. The Regulation aims to support innovation by enabling manufacturing closer to patients to facilitate greater access to novel treatments. The UK will be the first country in the world to introduce such a regulatory framework. Although this new framework aims to increase the appeal of the UK as a destination to market new life-saving medicines, the Regulation introduces some unique potential product liability risks. POC medicines are highly personalised and involve input from healthcare professionals to make batch-specific medicine for the patient. This could increase the risk of human error and lead to disputes as to which entity in the manufacturing chain is liable for any adverse effects that may be caused. Manufacturers that aim to develop MM medicines may find that the decentralised and complex supply chains involving multiple factors could lead to unforeseen quality issues arising from remote manufacturing sites, potentially leading to more defective products.
‘Weight Loss’ Drugs
Ozempic and Wegovy (semaglutide) were authorised in the UK for the treatment of adults with insufficiently controlled type 2 diabetes mellitus, but are not authorised for encouraging weight loss. Notwithstanding this, they are used off-label for that purpose across the world. Following its approval for chronic weight management by the US FDA in August 2023, the first lawsuit was filed against Novo and Eli Lilly, alleging that taking Ozempic has caused gastroparesis, severe gastrointestinal issues, and other serious side-effects and lawsuits remain ongoing and are increasing across the US. However, in the UK, semaglutide is only available on NHS prescription for diabetes and obesity and is limited to a two-year treatment period. This means that the treatment is provided with monitoring by patients’ GPs so that serious side effects are more likely to be avoided or mitigated. Nevertheless, up to October 2023, the MHRA seized 369 potentially fake injector pens which could cause serious health issues. The MHRA reminded patients and the public only to obtain prescription-only medicines from qualified healthcare professionals.
Food
In the US, a lawsuit was filed against large food companies including Kraft Heinz, Mondelez, Post, Coca-Cola, PepsiCo, General Mills, Nestle USA, Kellanova, WK Kellogg, Mars and Conagra alleging that ultra-processed foods produced by these companies are engineered to be addictive and can cause type 2 diabetes and non-alcoholic fatty liver disease at an early age.
Parallels have been drawn to litigation against large tobacco companies that involved Philip Morris Inc., R. J. Reynolds, Brown & Williamson and Lorillard, which alleged that tobacco companies lied to the American public about the health effects of smoking cigarettes and second-hand inhalation. In 1998, the largest US tobacco companies signed the Tobacco Master Settlement Agreement to settle lawsuits seeking to recover tobacco-related health-care costs. In exchange, the companies agreed to pay, in perpetuity, various annual payments to compensate medical costs to care for persons with smoking-related illnesses. In March 2025, a Canadian Court approved a $23 billion settlement to end the “Big Tobacco” lawsuits.
Group actions in the UK in relation to tobacco products were unsuccessful and differences between UK and US law may mean that bringing a claim here in relation to ultra-processed food would be more difficult.
Conclusion
For the reasons set out above, the EU may soon be entering into an era where product liability related mass tort litigation is seen on a wider scale.
Whilst the EU legal and regulatory proposals discussed in this article will not apply in the UK post Brexit, the UK government remains vigilant in its goal of regulating new technologies, including AI. Whilst the UK government has so far adopted a “pro-innovation” approach to promote growth and investment, given the Artificial Intelligence (Regulation) Bill which aims to establish a framework for AI regulation in the UK, the UK might attempt to impose more safety restrictions, than previously expected.
The UK government continues with its proposed reform of the UK’s product safety regulation, and accordingly, the CPA may also be subject to reform proposals to account for the risks of new technologies, as indicated in recent government consultations. It is possible, however, that UK policymakers will wish to see how the new EU PLD fares, before any legislative proposals are put forward. Product liability litigation in the UK is therefore expected to remain relatively contained for the time being.
As far as possible, businesses should focus on keeping up to date with the latest regulatory changes that may be directly and indirectly applicable to their market. As more businesses are adopting new technologies and governments are committing to environmental and sustainable changes, businesses should be proactive in adopting these industry changes so they do not lag behind their competitors.