PRODUCT | Products Law Year in Review: Key Developments from 2024 and Future Impacts for 2025

One of the most significant EU Products Law developments, particularly in the automotive sector, has been the adoption of the new General Product Safety Regulation (EU) 2023/988 (GPSR), which replaced the General Product Safety Directive 2001/95/EC (GPSD) on 13 December 2024.

Aiming at enhanced consumer safety, the GPSR addresses (new) safety challenges, particularly those associated with technologies that have evolved since the adoption of the GPSD in 2001. In doing so, the GPSR expanded the catalog of factors which determine whether a product is deemed safe. For example, safety factors now include product interconnectivity, (predictive) learning functionalities as well as safety-relevant cybersecurity features (including protection against loss of interconnection). Against this background, the GPSR will be particularly relevant for automated/autonomous driving (at all levels) as well as certain SDV (software defined vehicle) and connectivity features, e.g., driver monitoring systems, eCall, vehicle-to-vehicle communication, road condition analysis, OTA software updates, cyber security, etc. Furthermore, the GPSR generally introduces stricter product safety obligations, a new authority notification obligation via the Safety Business Gateway and explicit mandatory remedies in the event of a product safety recall. The GPSR also emphasizes the need for a product to be safe throughout its lifespan and thereby recognizes that new technologies might substantially modify a product, for instance through software updates.

The year 2025 will likely be characterized by economic operators / authorities trying to adapt to the GPSR. To avoid legal disputes, the requirements of the GPSR must be properly understood. To this end, the European Commission has published guidance, incl. answers to frequently asked questions on the application of the GPSR (GPSR FAQs)). In this document, the Commission stated that it will "provide a set of guidelines for businesses, specifically to help small and mid-sized companies and microenterprises to comply with their new obligations, as foreseen in Article 17 of the GPSR". Although these guidelines are not yet available, authorities are expected to increase inspections in 2025 to ensure compliance with the GPSR. Recent years have shown that authorities like the German Federal Motor Transport Authority ("Kraftfahrt-Bundesamt" or (KBA)) adapt quickly to new legislation, e.g., the KBA constantly monitors the market and infringements may lead to administrative fines to prevent risks to safety, health and the environment (Fine Proceeding). In 2022, the KBA initiated 499 Fine Proceedings, which rose to 525 in 2023 (i.e., an increase of more than 5%), when the German EU type-approval fining regulation took effect. A similar rise can be expected for the GPSR.

Authored by Sebastian Polly, Julia Wilkes and Lena Obenhuber.

The landscape of chemical products continues to remain in flux – with significant developments in litigation in 2024 and the anticipation of shifting regulatory frameworks under the new incoming administration.

Litigation regarding commonplace chemicals, including benzene, ethylene oxide (EtO), and perfluoroalkyl and polyfluoroalkyl (PFAS) continued and expanded. Litigation regarding the presence of benzene in gasoline continued, while there was an expansion of potential liability regarding benzene in new claims brought against skincare companies. Manufacturers and distributors of such products should anticipate a continued increase in such litigation. Personal injury claims regarding alleged EtO exposures have continued to be filed against companies that use the chemical to sterilize medical equipment. Personal injury and wrongful death claims regarding alleged EtO exposures have continued to be filed against companies that use the chemical to sterilize medical equipment and food products. However, Hogan Lovells represented one such company in obtaining a complete defense verdict before a jury in Philadelphia. These cases have been filed in multiple states, including California, Illinois, Georgia, and Pennsylvania. Finally, personal injury, consumer protection, and state attorney general cases regarding PFAS have continued – with claims targeting not only manufacturers, but also distributors, suppliers, and users of PFAS. In 2025, manufacturers, distributors, and users of chemical products should anticipate an increase in litigation from consumer protection groups, public interest groups, and state attorneys general as those entities respond to what is likely to be a scaling back of environmental regulations and enforcement actions under the Trump administration. 

On the regulatory front, the Biden Administration’s Environmental Protection Agency (EPA) promulgated two environmental rules regulating PFAS in 2024: 1) a Safe Drinking Water Act National Primary Drinking Water Regulation (NPDWR), which prescribed the maximum allowable levels of five PFAS in drinking water; and 2) the designation of two PFAS – perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) – as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Relying on its authority under the Toxic Substances and Control Act (TSCA), the EPA also announced a final rule banning the import and use of chrysotile asbestos, the only known form of asbestos still in use throughout the United States. Other notable measures taken by the EPA in 2024 include the adoption of a final rule requiring significant reductions in the emissions of EtO and a ban on the use of trichloroethylene (TCE) and perchloroethylene (PERC). The fate of these regulations in the Trump administration is unclear.

Authored by Megan Nishikawa, Amber Trincado and Leen Bukai.

In the United States, consumer product litigation, often based on contamination cases—particularly those involving PFAS, lead, pesticides, and the like— continues to rise.

These cases often seek economic damages on behalf of putative consumer classes, although plaintiffs often try to shoehorn their economic loss claims into a product liability theory of injury. Such cases are expected to persist as a key trend into 2025. The article will explore how these lawsuits are not only affecting specific product categories but also potentially impacting entire industries. 

As the litigation environment evolves, we anticipate the case law will further develop around critical defenses such as Article III standing and preemption. The article will take a deeper look at the legal landscape in these contamination cases and address the complex challenges facing businesses as they navigate this shifting terrain of litigation.

Authored by Lauren Colton, Trent Norris, Marc Marinaccio and Megan Dorsch.

PLD and AI Act impact in the life sciences sector

The new legal framework resulting from the adoption of the new Product Liability Directive (PLD) and the adoption of the European Artificial Intelligence (AI) Act will have a significant impact on national legislation, particularly in the life sciences sector. 

The 2024 Product Liability Directive (PLD), set to replace the 40-year-old PLD by the end of 2026, aims to modernize the EU's no-fault liability regime for defective products, including medicines, vaccines, and medical devices. It introduces harmonized procedural mechanisms to address the digital age, circular economy, and global supply chains, ensuring consumers are on equal footing with economic operators. The AI Act also brings significant changes for the life sciences sector, to which economic operators must adapt if their products use AI technologies.

Italy:

The evolving application of Article 2050 of the Civil Code introduces significant changes, particularly for life sciences companies. This strict liability regime, historically applied to dangerous activities, could now extend to AI systems in healthcare due to new EU legislation. As AI systems in medical devices are classified as "high risk" under the AI Act, liability assessments may shift, impacting both the manufacturing of intelligent medical devices and their use by healthcare professionals. Key developments under the new PLD include a 25-year expiry period under Article 17.2 for claims, which may have limited impact in Italy, as Italian courts often bypassed the previous 10-year limit through Civil Code provisions allowing longer limitation periods in cases of latent damage. Another concern is the requirement for evidence disclosure, challenging in a system where discovery is uncommon. While safeguards exist to prevent fishing expeditions, the enforcement practice of these rules by Italian courts will be crucial to balancing consumer protection with safeguarding businesses against excessive burdens.

Germany:

In 2024, the regulatory compliance defense has continued to be successful in Germany, with courts frequently dismissing liability claims against life sciences manufacturers based on the (rebuttable) presumption that EU marketing approval indicates the product is not defective, unless proven otherwise. A definitive ruling by the Federal Court of Justice on this issue is anticipated in 2025. Additionally, new provisions in the German Code of Civil Procedure, effective April 2025, enhance trade secret protection by allowing courts to classify dispute-related information as confidential upon request. Finally, collective redress mechanisms for product liability cases, including bodily injury, are theoretically possible but not yet practiced in Germany. This has led to numerous individual lawsuits, overwhelming the courts. A new "leading decision procedure" introduced in 2024 aims to streamline mass actions by allowing the Federal Court of Justice to provide early guidance on relevant legal questions concerning several pending cases. The impact of this new procedure on mass tort actions will be seen in 2025.

UK:

It is important to note that because the new PLD and the AI Act were implemented after Brexit, they will not be directly applicable in the UK. However, they will of course still be very relevant for UK based life sciences businesses who supply products into the EU.  The UK held a consultation from 2 August to 24 October 2023 and sought input on a long-term approach to ensure the regulatory framework and the UK’s product liability regime is “fit for the future” given technological developments. Ultimately, the government has not yet shown its cards on what changes there may be to the UK product liability framework and we will need to wait and see whether the introduction in the EU of the new PLD and the AI Act, as well as the Government’s recently announced AI strategy, have an influence on the UK’s regime particularly as applies to life sciences and health tech products. Key legislative developments for medical device regulation in the UK were announced in 2024, such as , the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR) which will introduce new surveillance requirements for medical and in vitro devices when it comes into force, and the MHRA’s revised Medical Device Regulations (MDR) Roadmap, published on 11 December 2024, which outlines timelines for consultations, legislation, and implementation of reforms to the UK Medical Device Regulations 2002. In 2025, attention will focus on the progression of the PSMR and the delivery of the new and amended legislation and reforms of the medical device regulatory framework set out in the MDR Roadmap.

France:

Recent French case law has highlighted key developments in product liability, particularly concerning healthcare products. In late 2023, the French Supreme Court reaffirmed that claimants may rely on fault-based tort liability rather than the defective product regime under the 1985 Product Liability Directive. The Court allowed claims based on producer fault, such as failing to remove known defective products from the market or exercising vigilance. This partial overlap between fault and defect prompted further questions, including a referral by a French Court of Appeal to the CJEU about whether fault-based liability relying on safety defects aligns with EU law. Additional questions concern the stricter time limits under the Directive compared to French tort law, especially in cases of progressive diseases. A CJEU ruling in 2025 is expected to clarify the interplay between fault-based and defective product liability regimes and address time-limit disparities. These rulings will have an impact on cases involving products placed on the market before the Directive’s repeal in December 2026 and may also influence the application of the 2024 Product Liability Directive, which extends expiry periods to 25 years for latent personal injuries.

Links to related contents:

• European Commission proposes new ground-breaking rules on product liability and AI civil liability
• The new impact assessment on the EU's AI Liability Directive proposal: an uncertain future ahead
• AI Act and GPSR – Bridging the gap between artificial intelligence and product safety in the EU
• New presumption of causal link relating to AI systems
• Implications of the EU AI Act on medtech companies
• Placing products on the market in Germany (EU): What you need to know about the new Product Liability Directive

Authored by Ina Brock, Christelle Coslin, Christian Di Mauro, Matthew Felwick, Matthias Schweiger, Charles-Henri Caron, Elise Martin, Benjamin Schulte, Elisa Rossi, and Viktoria Riederer